36
November 2015 • Volume 13 Number 11 Online mental health Richard F. Sethre, PsyD, and Deb Rich, PhD Bronchitis Heather Hamernick, MD Anemia Julie Anderson, MD

MN Healthcare News Nov 2015

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Perspective: The Compassionate Care Act-Giving Minnesotans a choice By Senator Christine Ann “Chris” Eaton | 10 Questions: Shelley R. Stanton MD, The Federal Medical Center, Rochester | Environmental Health-The effects of air quality: Understanding the metrics By Monika Vadali PhD | Pulmonology-Bronchitis: From common coughs to chronic disease By Heather Hamernick MD | Oncology-Skin cancer: Prevention, detection & treatment By Kathryn Barlow MD & Julie Cronk MD | Home Care-Life Care Managers: Helping seniors live healthier, happier lives By Angela Nelson RN | Behavioral Health-Online mental health services: Click here for therapy By Richard F. Sethre PsyD, LP & Deb Rich PhD, LP, CPLC | Hematology-Anemia: Simple fatigue, or something more serious? By Julie Anderson MD, FAAFP, CIC | End-of-Life Issues-Advance care planning: Specify your wishes now By Thaddeus Mason Pope JD, PhD

Citation preview

November 2015 bull Volume 13 Number 11

Online mental health Richard F Sethre PsyD

and Deb Rich PhD

BronchitisHeather

Hamernick MD

AnemiaJulie Anderson MD

2 Minnesota HealtH care news November 2015

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race color religion gender disability familial status national origin or other protected statuses according to applicable federal state or local laws Some services may be provided by a third party All faiths or beliefs are welcome copy 2015 The Evangelical Lutheran Good Samaritan Society All rights reserved 15-G1553

T o rehabilitate a body we start with the mind and soul

If you or someone you know needs rehabilitation after an accident surgery illness or stroke we have a simple premise for you to consider To recover physically you need support mentally and emotionally How positive and how determined someone is can make all the difference We believe the most effective therapy treats your body mind and soul Thatrsquos our approach

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the MinneapolisSt Paul area

To make a referral or for more information call us at (888) GSS-CARE or visit wwwgood-samcomminnesota

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race color religion gender disability familial status national origin or other protected statuses according to applicable federal state or local laws Some services may be provided by a third party All faiths or beliefs are welcome copy 2015 The Evangelical Lutheran Good Samaritan Society All rights reserved 15-G1553

T o rehabilitate a body we start with the mind and soul

If you or someone you know needs rehabilitation after an accident surgery illness or stroke we have a simple premise for you to consider To recover physically you need support mentally and emotionally How positive and how determined someone is can make all the difference We believe the most effective therapy treats your body mind and soul Thatrsquos our approach

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the MinneapolisSt Paul area

To make a referral or for more information call us at (888) GSS-CARE or visit wwwgood-samcomminnesota

November 2015 Minnesota HealtH care news 3

4 News

7 PeOPLe

8 PeRsPeCTIVe

10 10 QUesTIONs

12 eNVIRONmeNTaL HeaLTH The effects of air quality

By Monika Vadali PhD

14 PULmONOLOgy Bronchitis

By Heather Hamernick MD

16 ONCOLOgy skin cancer By Kathryn Barlow MD

and Julie Cronk MD

18 CaLeNDaR

20 HOme CaRe Life care managers

By Angela Nelson RN

22 BeHaVIORaL HeaLTH Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

24 HemaTOLOgy anemia

By Julie Anderson MD FAAFP CIC

26 eND-Of-LIfe IssUes advance care planning

By Thaddeus Mason Pope JD PhD

November 2015 bull volume 13 Number 11

Senator Christine Ann ldquoChrisrdquo Eaton

Shelley R Stanton MD

The Federal Medical Center Rochester

Minnesota Heath Care News is published once a month by Minnesota Physician Publishing Inc Our address is 2812 East 26th Street Minneapolis MN 55406 phone 6127288600 fax 6127288601 email mppmppubcom We welcome the submission of manuscripts and letters for possible publication All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing Inc or this publication The contents herein are believed accurate but are not intended to replace medical legal tax business or other professional advice and counsel No part of this publication may be reprinted or reproduced without written per-mission of the publisher Annual subscriptions (12 copies) are $3600 Individual copies are $400

Publisher mike starnes | mstarnesmppubcom

editor Lisa mcgowan | lmcgowanmppubcom

AssociAte editor Richard ericson | rericsonmppubcom

Art director Joe Pfahl | joemppubcom

office AdministrAtor amanda marlow | amarlowmppubcom

Account executive stacey Bush | sbushmppubcom

Account executive Kylie engle | kenglemppubcom

Background and Focus Increasing evidence supports the link between access to mental health care and reducing health care costs Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider Many initiatives nationwide are addressing this issue It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015 Some states including Minnesota are also creating Behavioral Health Home programsObjectives We will review numerous initiatives that support the development of new pathways to behavioral health care We will introduce new ideas and discuss how to incorporate them into our health-care delivery system We will examine the value they can bring and the challenges they will face Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring

Panelists include bull Sarah Anderson MSW LICSW CEO Psych Recovery Inc bull Lee Beecher MD President Minnesota Physician-Patient Alliance bull Timothy P Gibbs MD FAPA DFAACAP Chief Medical Officer

Natalis Counseling and Psychology Solutionsbull Martha Lantz MSW LICSW MBA Executive Dir Touchstone Mental Healthbull Judge Kerry W Meyer Hennepin County Criminal Mental Health Court bull Jane C Pederson MD MS Chief Medical Quality Officer Stratis Health bull Jeff Schiff MD MBA Medical Director MN Dept of Human Services bull L Read Sulik MD Chief Integration Officer PrairieCare Sponsors include bull Janssen Pharmaceuticals Inc bull MN Community Healthcare Network bull MN Dept of Human Services bull Natalis Outcomes bull PrairieCare bull Psych Recovery Inc bull Stratis Health

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail call in or fax your registration by 1152015

Please send me tickets at $9500 per ticket Tickets may be ordered by phone at (612) 728-8600 by fax at (612) 728-8601 on our website (mppubcom) or by mail Make checks payable to Minnesota Physician Publishing Mail orders to MPP 2812 East 26th Street Mpls MN 55406 Please note tickets are non-refundable

Name

Company

Address

City State ZIP

TelephoneFAX

Card Exp Date Check enclosed Bill me Credit card (Visa Mastercard American Express or Discover)

Signature

Email

Thursday November 12 2015 bull 100-400 PMDowntown Minneapolis Hilton and Towers

FORTy-FOURTH SESSION

Behavioral Health IntegrationNew pathways to care

4 Minnesota HealtH care news November 2015

N e ws

Projects Funded to Help Aging Minnesotans Remain in Their Homesthe Minnesota Department of Human services has awarded more than $7 million in live well at Home grants to 62 organi-zations for projects focusing on allowing older Minnesotans to stay in their homes instead of moving to nursing homes or other care settings

ldquoMinnesota is a national leader in long-term services and supports for older adults in part because we provide this seed money to community organizations and providers to be creative in helping people remain in their homes as they agerdquo said lucinda Jesson human services commissioner ldquoin addition to helping meet daily needs such as nutrition and house-keeping these grants promote new technology and other innovations

that benefit both older Minneso-tans and their caregiversrdquo

according to DHs many of the recipients are nonprofit and community organizations all recipients will be required to generate income by charging for services through a sliding fee scale

the grants will help address the challenges of the statersquos aging 2030 initiative which addresses the challenges that come with the rate of aging Minnesotans and the preparations needed for the demo-graphic changes according to the website baby boomers are turning 65 at the rate of 10000 per day in the Us

Insurers Removing More Policies from MNsureHealth insurers in Minnesota are removing more options from Mnsure for 2016 enrollment after

losing all Preferredone health plans and more than 4750 plans from Blue cross and Blue shield of Minnesota and HealthPartners in 2015

Blue cross and Blue shield of Minnesota is removing policies that cover about 6500 people from the exchange and offering them directly to customers for 2016 that accounts for about 25 percent of current Blue cross policy holders that purchase insur-ance through Mnsure officials say if all of those enrollees renew their coverage outside of Mnsure it will cost the exchange between $800000 and $1 million in reve-nue next year because it will not be able to collect the 35 percent fee on those plans

Blue cross and Blue shield of Minnesota maintains that they are not removing policies to avoid the Mnsure fee the compa-ny says that it has consolidated several policies into one health plan they say is more effective but

because Minnesota laws will not allow them to eliminate old plans entirely the product change moves customers away from the exchange in some cases

ldquothe withhold from Mnsure has little if any material impact on our product decisionsrdquo said Blue cross and Blue shield of Min-nesota spokesman scott Keefer

Many of the policies it is re-moving from Mnsure are plati-num grade and it is currently the only insurer that offers this level of policies on the exchange some gold silver and bronze policies are being removed as well but new policies are being added it will send notices out to its custom-ers alerting them to rate increases and other changes and informing them that their plan will no longer be offered through Mnsure giving them the choice between taking no action and keeping their current policy directly through the insurer or choosing a new plan through Mnsure

there is concern that this trend will affect the future of Mnsure because it relies on the 35 percent fee per policy to help fund its operation

ldquoitrsquos something i have my eye onrdquo said alison orsquotoole Mnsure ceo ldquoand itrsquos potentially an issuerdquo

New Crisis Resource Website Launched the Minnesota Department of Human services has announced the launch of a new version of the MinnesotaHelpinfo web-site which features a new crisis link page to connect people with resources for a variety of immedi-ate crisis needs including mental health problems substance abuse problems emergency housing needs fear of being harmed or health care food job or trans-portation needs Minnesota resi-dents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence in addition the website has an online chat service available from 8 am to 430 pm on weekdays

ldquowe want to make sure that people know there is a single place the crisis link they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needsrdquo said lucinda Jesson DHs commissioner

the crisis link is part of the statersquos information and assistance program that also includes senior linkage line Disability linkage line and Veterans linkage line and is supported by several agen-cies in addition to DHs including the Minnesota Board on aging

Charity Care Decreased at Minnesota Hospitalsthere was a 63 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014 the first year Mnsure was implement-ed according to the Minnesota Department of Health (MDH)

specifically there was a 224 percent drop in charity care the component of uncompensated care in which hospitals provide care without expecting payment a de-cline of $346 million there was a greater drop in charity care for uninsured patients (246 percent) than there was for insured patients (178 percent) this was the second time since 2001 that charity care dropped in Minnesota

However there was a 93 percent increase in bad debt the component of uncompensated care in which hospitals expect payment but do not receive it that number increased $149 million from 2013 to 2014 when it reached $1742 million MDH said that the amount of bad debt has been ris-ing steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays

ldquowe are pleased that more Minnesotans now have the bene-fits of health coverage when they go to a hospitalrdquo said ed eh-linger MD Minnesota commis-sioner of health ldquoHowever the rising cost of health care continues to pose a threat to access to care without addressing health care costs through additional reforms or prevention efforts even those patients with insurance increasing-ly are struggling with medical bills and unpaid care or bad debtrdquo

Ucare Essentia Health Partner on Medicare PlanUcare and essentia Health have formed a Preferred Provider orga-nization (PPo) Medicare advan-tage Plan called essentiacare

to be eligible for essentiacare Minnesota patients must qual-ify for Medicare and live in the 10-county service area which includes aitkin clay Becker carl-ton cass crow wing Hubbard itasca lake and st louis coun-ties Patients will have two cover-age optionsmdashsecure which offers lower monthly premiums and high-er costs for copays and Grand

November 2015 Minnesota HealtH care news 5News to page 6

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

伀渀氀礀 㜀㔀  

吀䴀

䄀洀瀀氀椀昀椀攀搀 䌀愀瀀琀椀漀渀攀搀 吀攀氀攀瀀栀漀渀攀

一攀瘀攀爀 洀椀猀猀 愀渀漀琀栀攀爀 眀漀爀搀 漀昀 礀漀甀爀 瀀栀漀渀攀 挀漀渀瘀攀爀猀愀琀椀漀渀猀 吀栀攀 䌀氀愀爀椀琀礀글 䔀渀猀攀洀戀氀攀∡ 椀猀 愀 焀甀愀氀椀琀礀 挀愀瀀琀椀漀渀攀搀 瀀栀漀渀攀 眀椀琀栀 琀栀攀 戀攀猀琀 愀洀瀀氀椀昀椀挀愀琀椀漀渀 愀瘀愀椀氀愀戀氀攀 䄀渀 㠀 琀漀甀挀栀猀挀爀攀攀渀 挀愀渀 攀渀氀愀爀最攀 琀攀砀琀 愀猀 渀攀攀搀攀搀 䄀琀 琀栀攀 氀漀眀 瀀爀椀挀攀 漀昀 㜀㔀  Ⰰ 礀漀甀 挀愀渀琀 愀昀昀漀爀搀 琀漀 瀀愀猀猀 琀栀椀猀 漀昀昀攀爀 甀瀀䘀爀攀攀 䤀渀猀琀愀氀氀愀琀椀漀渀 刀攀焀甀椀爀攀猀 戀漀琀栀 氀愀渀搀氀椀渀攀 愀渀搀 椀渀琀攀爀渀攀琀 挀漀渀渀攀挀琀椀漀渀 䘀爀攀攀 挀愀瀀琀椀漀渀椀渀最 猀攀爀瘀椀挀攀 琀栀爀漀甀最栀 琀栀攀 䘀䌀䌀

圀漀爀搀猀䴀愀琀琀攀爀

㠀  ⤀ 㠀㔀ⴀ㘀㜀㔀㠀

䘀椀渀搀 琀栀攀 䔀渀猀攀洀戀氀攀 愀琀眀眀眀栀愀爀爀椀猀挀漀洀洀挀漀洀眀漀爀搀猀

吀爀礀 漀甀琀 漀甀爀 瀀爀漀搀甀挀琀猀 昀漀爀 礀漀甀爀猀攀氀昀 嘀椀猀椀琀 漀甀爀 猀栀漀眀爀漀漀洀 㔀㔀㔀 吀攀挀栀渀漀氀漀最礀 䐀爀Ⰰ 䔀搀攀渀 倀爀愀椀爀椀攀Ⰰ 䴀一 㔀㔀㐀㐀

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

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Age 76 Squamous Cell Carcinoma

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

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ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

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40

50

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70

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0

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0

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

2 Minnesota HealtH care news November 2015

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race color religion gender disability familial status national origin or other protected statuses according to applicable federal state or local laws Some services may be provided by a third party All faiths or beliefs are welcome copy 2015 The Evangelical Lutheran Good Samaritan Society All rights reserved 15-G1553

T o rehabilitate a body we start with the mind and soul

If you or someone you know needs rehabilitation after an accident surgery illness or stroke we have a simple premise for you to consider To recover physically you need support mentally and emotionally How positive and how determined someone is can make all the difference We believe the most effective therapy treats your body mind and soul Thatrsquos our approach

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the MinneapolisSt Paul area

To make a referral or for more information call us at (888) GSS-CARE or visit wwwgood-samcomminnesota

The Evangelical Lutheran Good Samaritan Society provides housing and services to qualified individuals without regard to race color religion gender disability familial status national origin or other protected statuses according to applicable federal state or local laws Some services may be provided by a third party All faiths or beliefs are welcome copy 2015 The Evangelical Lutheran Good Samaritan Society All rights reserved 15-G1553

T o rehabilitate a body we start with the mind and soul

If you or someone you know needs rehabilitation after an accident surgery illness or stroke we have a simple premise for you to consider To recover physically you need support mentally and emotionally How positive and how determined someone is can make all the difference We believe the most effective therapy treats your body mind and soul Thatrsquos our approach

Post-acute rehabilitation services from the Good Samaritan Society are offered at multiple inpatient and outpatient locations throughout Minnesota and the MinneapolisSt Paul area

To make a referral or for more information call us at (888) GSS-CARE or visit wwwgood-samcomminnesota

November 2015 Minnesota HealtH care news 3

4 News

7 PeOPLe

8 PeRsPeCTIVe

10 10 QUesTIONs

12 eNVIRONmeNTaL HeaLTH The effects of air quality

By Monika Vadali PhD

14 PULmONOLOgy Bronchitis

By Heather Hamernick MD

16 ONCOLOgy skin cancer By Kathryn Barlow MD

and Julie Cronk MD

18 CaLeNDaR

20 HOme CaRe Life care managers

By Angela Nelson RN

22 BeHaVIORaL HeaLTH Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

24 HemaTOLOgy anemia

By Julie Anderson MD FAAFP CIC

26 eND-Of-LIfe IssUes advance care planning

By Thaddeus Mason Pope JD PhD

November 2015 bull volume 13 Number 11

Senator Christine Ann ldquoChrisrdquo Eaton

Shelley R Stanton MD

The Federal Medical Center Rochester

Minnesota Heath Care News is published once a month by Minnesota Physician Publishing Inc Our address is 2812 East 26th Street Minneapolis MN 55406 phone 6127288600 fax 6127288601 email mppmppubcom We welcome the submission of manuscripts and letters for possible publication All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing Inc or this publication The contents herein are believed accurate but are not intended to replace medical legal tax business or other professional advice and counsel No part of this publication may be reprinted or reproduced without written per-mission of the publisher Annual subscriptions (12 copies) are $3600 Individual copies are $400

Publisher mike starnes | mstarnesmppubcom

editor Lisa mcgowan | lmcgowanmppubcom

AssociAte editor Richard ericson | rericsonmppubcom

Art director Joe Pfahl | joemppubcom

office AdministrAtor amanda marlow | amarlowmppubcom

Account executive stacey Bush | sbushmppubcom

Account executive Kylie engle | kenglemppubcom

Background and Focus Increasing evidence supports the link between access to mental health care and reducing health care costs Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider Many initiatives nationwide are addressing this issue It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015 Some states including Minnesota are also creating Behavioral Health Home programsObjectives We will review numerous initiatives that support the development of new pathways to behavioral health care We will introduce new ideas and discuss how to incorporate them into our health-care delivery system We will examine the value they can bring and the challenges they will face Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring

Panelists include bull Sarah Anderson MSW LICSW CEO Psych Recovery Inc bull Lee Beecher MD President Minnesota Physician-Patient Alliance bull Timothy P Gibbs MD FAPA DFAACAP Chief Medical Officer

Natalis Counseling and Psychology Solutionsbull Martha Lantz MSW LICSW MBA Executive Dir Touchstone Mental Healthbull Judge Kerry W Meyer Hennepin County Criminal Mental Health Court bull Jane C Pederson MD MS Chief Medical Quality Officer Stratis Health bull Jeff Schiff MD MBA Medical Director MN Dept of Human Services bull L Read Sulik MD Chief Integration Officer PrairieCare Sponsors include bull Janssen Pharmaceuticals Inc bull MN Community Healthcare Network bull MN Dept of Human Services bull Natalis Outcomes bull PrairieCare bull Psych Recovery Inc bull Stratis Health

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail call in or fax your registration by 1152015

Please send me tickets at $9500 per ticket Tickets may be ordered by phone at (612) 728-8600 by fax at (612) 728-8601 on our website (mppubcom) or by mail Make checks payable to Minnesota Physician Publishing Mail orders to MPP 2812 East 26th Street Mpls MN 55406 Please note tickets are non-refundable

Name

Company

Address

City State ZIP

TelephoneFAX

Card Exp Date Check enclosed Bill me Credit card (Visa Mastercard American Express or Discover)

Signature

Email

Thursday November 12 2015 bull 100-400 PMDowntown Minneapolis Hilton and Towers

FORTy-FOURTH SESSION

Behavioral Health IntegrationNew pathways to care

4 Minnesota HealtH care news November 2015

N e ws

Projects Funded to Help Aging Minnesotans Remain in Their Homesthe Minnesota Department of Human services has awarded more than $7 million in live well at Home grants to 62 organi-zations for projects focusing on allowing older Minnesotans to stay in their homes instead of moving to nursing homes or other care settings

ldquoMinnesota is a national leader in long-term services and supports for older adults in part because we provide this seed money to community organizations and providers to be creative in helping people remain in their homes as they agerdquo said lucinda Jesson human services commissioner ldquoin addition to helping meet daily needs such as nutrition and house-keeping these grants promote new technology and other innovations

that benefit both older Minneso-tans and their caregiversrdquo

according to DHs many of the recipients are nonprofit and community organizations all recipients will be required to generate income by charging for services through a sliding fee scale

the grants will help address the challenges of the statersquos aging 2030 initiative which addresses the challenges that come with the rate of aging Minnesotans and the preparations needed for the demo-graphic changes according to the website baby boomers are turning 65 at the rate of 10000 per day in the Us

Insurers Removing More Policies from MNsureHealth insurers in Minnesota are removing more options from Mnsure for 2016 enrollment after

losing all Preferredone health plans and more than 4750 plans from Blue cross and Blue shield of Minnesota and HealthPartners in 2015

Blue cross and Blue shield of Minnesota is removing policies that cover about 6500 people from the exchange and offering them directly to customers for 2016 that accounts for about 25 percent of current Blue cross policy holders that purchase insur-ance through Mnsure officials say if all of those enrollees renew their coverage outside of Mnsure it will cost the exchange between $800000 and $1 million in reve-nue next year because it will not be able to collect the 35 percent fee on those plans

Blue cross and Blue shield of Minnesota maintains that they are not removing policies to avoid the Mnsure fee the compa-ny says that it has consolidated several policies into one health plan they say is more effective but

because Minnesota laws will not allow them to eliminate old plans entirely the product change moves customers away from the exchange in some cases

ldquothe withhold from Mnsure has little if any material impact on our product decisionsrdquo said Blue cross and Blue shield of Min-nesota spokesman scott Keefer

Many of the policies it is re-moving from Mnsure are plati-num grade and it is currently the only insurer that offers this level of policies on the exchange some gold silver and bronze policies are being removed as well but new policies are being added it will send notices out to its custom-ers alerting them to rate increases and other changes and informing them that their plan will no longer be offered through Mnsure giving them the choice between taking no action and keeping their current policy directly through the insurer or choosing a new plan through Mnsure

there is concern that this trend will affect the future of Mnsure because it relies on the 35 percent fee per policy to help fund its operation

ldquoitrsquos something i have my eye onrdquo said alison orsquotoole Mnsure ceo ldquoand itrsquos potentially an issuerdquo

New Crisis Resource Website Launched the Minnesota Department of Human services has announced the launch of a new version of the MinnesotaHelpinfo web-site which features a new crisis link page to connect people with resources for a variety of immedi-ate crisis needs including mental health problems substance abuse problems emergency housing needs fear of being harmed or health care food job or trans-portation needs Minnesota resi-dents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence in addition the website has an online chat service available from 8 am to 430 pm on weekdays

ldquowe want to make sure that people know there is a single place the crisis link they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needsrdquo said lucinda Jesson DHs commissioner

the crisis link is part of the statersquos information and assistance program that also includes senior linkage line Disability linkage line and Veterans linkage line and is supported by several agen-cies in addition to DHs including the Minnesota Board on aging

Charity Care Decreased at Minnesota Hospitalsthere was a 63 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014 the first year Mnsure was implement-ed according to the Minnesota Department of Health (MDH)

specifically there was a 224 percent drop in charity care the component of uncompensated care in which hospitals provide care without expecting payment a de-cline of $346 million there was a greater drop in charity care for uninsured patients (246 percent) than there was for insured patients (178 percent) this was the second time since 2001 that charity care dropped in Minnesota

However there was a 93 percent increase in bad debt the component of uncompensated care in which hospitals expect payment but do not receive it that number increased $149 million from 2013 to 2014 when it reached $1742 million MDH said that the amount of bad debt has been ris-ing steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays

ldquowe are pleased that more Minnesotans now have the bene-fits of health coverage when they go to a hospitalrdquo said ed eh-linger MD Minnesota commis-sioner of health ldquoHowever the rising cost of health care continues to pose a threat to access to care without addressing health care costs through additional reforms or prevention efforts even those patients with insurance increasing-ly are struggling with medical bills and unpaid care or bad debtrdquo

Ucare Essentia Health Partner on Medicare PlanUcare and essentia Health have formed a Preferred Provider orga-nization (PPo) Medicare advan-tage Plan called essentiacare

to be eligible for essentiacare Minnesota patients must qual-ify for Medicare and live in the 10-county service area which includes aitkin clay Becker carl-ton cass crow wing Hubbard itasca lake and st louis coun-ties Patients will have two cover-age optionsmdashsecure which offers lower monthly premiums and high-er costs for copays and Grand

November 2015 Minnesota HealtH care news 5News to page 6

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

伀渀氀礀 㜀㔀  

吀䴀

䄀洀瀀氀椀昀椀攀搀 䌀愀瀀琀椀漀渀攀搀 吀攀氀攀瀀栀漀渀攀

一攀瘀攀爀 洀椀猀猀 愀渀漀琀栀攀爀 眀漀爀搀 漀昀 礀漀甀爀 瀀栀漀渀攀 挀漀渀瘀攀爀猀愀琀椀漀渀猀 吀栀攀 䌀氀愀爀椀琀礀글 䔀渀猀攀洀戀氀攀∡ 椀猀 愀 焀甀愀氀椀琀礀 挀愀瀀琀椀漀渀攀搀 瀀栀漀渀攀 眀椀琀栀 琀栀攀 戀攀猀琀 愀洀瀀氀椀昀椀挀愀琀椀漀渀 愀瘀愀椀氀愀戀氀攀 䄀渀 㠀 琀漀甀挀栀猀挀爀攀攀渀 挀愀渀 攀渀氀愀爀最攀 琀攀砀琀 愀猀 渀攀攀搀攀搀 䄀琀 琀栀攀 氀漀眀 瀀爀椀挀攀 漀昀 㜀㔀  Ⰰ 礀漀甀 挀愀渀琀 愀昀昀漀爀搀 琀漀 瀀愀猀猀 琀栀椀猀 漀昀昀攀爀 甀瀀䘀爀攀攀 䤀渀猀琀愀氀氀愀琀椀漀渀 刀攀焀甀椀爀攀猀 戀漀琀栀 氀愀渀搀氀椀渀攀 愀渀搀 椀渀琀攀爀渀攀琀 挀漀渀渀攀挀琀椀漀渀 䘀爀攀攀 挀愀瀀琀椀漀渀椀渀最 猀攀爀瘀椀挀攀 琀栀爀漀甀最栀 琀栀攀 䘀䌀䌀

圀漀爀搀猀䴀愀琀琀攀爀

㠀  ⤀ 㠀㔀ⴀ㘀㜀㔀㠀

䘀椀渀搀 琀栀攀 䔀渀猀攀洀戀氀攀 愀琀眀眀眀栀愀爀爀椀猀挀漀洀洀挀漀洀眀漀爀搀猀

吀爀礀 漀甀琀 漀甀爀 瀀爀漀搀甀挀琀猀 昀漀爀 礀漀甀爀猀攀氀昀 嘀椀猀椀琀 漀甀爀 猀栀漀眀爀漀漀洀 㔀㔀㔀 吀攀挀栀渀漀氀漀最礀 䐀爀Ⰰ 䔀搀攀渀 倀爀愀椀爀椀攀Ⰰ 䴀一 㔀㔀㐀㐀

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

November 2015 Minnesota HealtH care news 3

4 News

7 PeOPLe

8 PeRsPeCTIVe

10 10 QUesTIONs

12 eNVIRONmeNTaL HeaLTH The effects of air quality

By Monika Vadali PhD

14 PULmONOLOgy Bronchitis

By Heather Hamernick MD

16 ONCOLOgy skin cancer By Kathryn Barlow MD

and Julie Cronk MD

18 CaLeNDaR

20 HOme CaRe Life care managers

By Angela Nelson RN

22 BeHaVIORaL HeaLTH Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

24 HemaTOLOgy anemia

By Julie Anderson MD FAAFP CIC

26 eND-Of-LIfe IssUes advance care planning

By Thaddeus Mason Pope JD PhD

November 2015 bull volume 13 Number 11

Senator Christine Ann ldquoChrisrdquo Eaton

Shelley R Stanton MD

The Federal Medical Center Rochester

Minnesota Heath Care News is published once a month by Minnesota Physician Publishing Inc Our address is 2812 East 26th Street Minneapolis MN 55406 phone 6127288600 fax 6127288601 email mppmppubcom We welcome the submission of manuscripts and letters for possible publication All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing Inc or this publication The contents herein are believed accurate but are not intended to replace medical legal tax business or other professional advice and counsel No part of this publication may be reprinted or reproduced without written per-mission of the publisher Annual subscriptions (12 copies) are $3600 Individual copies are $400

Publisher mike starnes | mstarnesmppubcom

editor Lisa mcgowan | lmcgowanmppubcom

AssociAte editor Richard ericson | rericsonmppubcom

Art director Joe Pfahl | joemppubcom

office AdministrAtor amanda marlow | amarlowmppubcom

Account executive stacey Bush | sbushmppubcom

Account executive Kylie engle | kenglemppubcom

Background and Focus Increasing evidence supports the link between access to mental health care and reducing health care costs Primary care physicians often lack the expertise to diagnose behavioral health correctly and are not always able to easily refer a patient to a mental health care provider Many initiatives nationwide are addressing this issue It is so important that the ACA stipulated the development of the Behavioral Health Home in 2015 Some states including Minnesota are also creating Behavioral Health Home programsObjectives We will review numerous initiatives that support the development of new pathways to behavioral health care We will introduce new ideas and discuss how to incorporate them into our health-care delivery system We will examine the value they can bring and the challenges they will face Our panel of industry experts will outline the steps that must be taken to increase the overall access to mental health care and the broad improvement in population health that this increased access will bring

Panelists include bull Sarah Anderson MSW LICSW CEO Psych Recovery Inc bull Lee Beecher MD President Minnesota Physician-Patient Alliance bull Timothy P Gibbs MD FAPA DFAACAP Chief Medical Officer

Natalis Counseling and Psychology Solutionsbull Martha Lantz MSW LICSW MBA Executive Dir Touchstone Mental Healthbull Judge Kerry W Meyer Hennepin County Criminal Mental Health Court bull Jane C Pederson MD MS Chief Medical Quality Officer Stratis Health bull Jeff Schiff MD MBA Medical Director MN Dept of Human Services bull L Read Sulik MD Chief Integration Officer PrairieCare Sponsors include bull Janssen Pharmaceuticals Inc bull MN Community Healthcare Network bull MN Dept of Human Services bull Natalis Outcomes bull PrairieCare bull Psych Recovery Inc bull Stratis Health

MINNESOTA HEALTH CARE ROUNDTABLE

Please mail call in or fax your registration by 1152015

Please send me tickets at $9500 per ticket Tickets may be ordered by phone at (612) 728-8600 by fax at (612) 728-8601 on our website (mppubcom) or by mail Make checks payable to Minnesota Physician Publishing Mail orders to MPP 2812 East 26th Street Mpls MN 55406 Please note tickets are non-refundable

Name

Company

Address

City State ZIP

TelephoneFAX

Card Exp Date Check enclosed Bill me Credit card (Visa Mastercard American Express or Discover)

Signature

Email

Thursday November 12 2015 bull 100-400 PMDowntown Minneapolis Hilton and Towers

FORTy-FOURTH SESSION

Behavioral Health IntegrationNew pathways to care

4 Minnesota HealtH care news November 2015

N e ws

Projects Funded to Help Aging Minnesotans Remain in Their Homesthe Minnesota Department of Human services has awarded more than $7 million in live well at Home grants to 62 organi-zations for projects focusing on allowing older Minnesotans to stay in their homes instead of moving to nursing homes or other care settings

ldquoMinnesota is a national leader in long-term services and supports for older adults in part because we provide this seed money to community organizations and providers to be creative in helping people remain in their homes as they agerdquo said lucinda Jesson human services commissioner ldquoin addition to helping meet daily needs such as nutrition and house-keeping these grants promote new technology and other innovations

that benefit both older Minneso-tans and their caregiversrdquo

according to DHs many of the recipients are nonprofit and community organizations all recipients will be required to generate income by charging for services through a sliding fee scale

the grants will help address the challenges of the statersquos aging 2030 initiative which addresses the challenges that come with the rate of aging Minnesotans and the preparations needed for the demo-graphic changes according to the website baby boomers are turning 65 at the rate of 10000 per day in the Us

Insurers Removing More Policies from MNsureHealth insurers in Minnesota are removing more options from Mnsure for 2016 enrollment after

losing all Preferredone health plans and more than 4750 plans from Blue cross and Blue shield of Minnesota and HealthPartners in 2015

Blue cross and Blue shield of Minnesota is removing policies that cover about 6500 people from the exchange and offering them directly to customers for 2016 that accounts for about 25 percent of current Blue cross policy holders that purchase insur-ance through Mnsure officials say if all of those enrollees renew their coverage outside of Mnsure it will cost the exchange between $800000 and $1 million in reve-nue next year because it will not be able to collect the 35 percent fee on those plans

Blue cross and Blue shield of Minnesota maintains that they are not removing policies to avoid the Mnsure fee the compa-ny says that it has consolidated several policies into one health plan they say is more effective but

because Minnesota laws will not allow them to eliminate old plans entirely the product change moves customers away from the exchange in some cases

ldquothe withhold from Mnsure has little if any material impact on our product decisionsrdquo said Blue cross and Blue shield of Min-nesota spokesman scott Keefer

Many of the policies it is re-moving from Mnsure are plati-num grade and it is currently the only insurer that offers this level of policies on the exchange some gold silver and bronze policies are being removed as well but new policies are being added it will send notices out to its custom-ers alerting them to rate increases and other changes and informing them that their plan will no longer be offered through Mnsure giving them the choice between taking no action and keeping their current policy directly through the insurer or choosing a new plan through Mnsure

there is concern that this trend will affect the future of Mnsure because it relies on the 35 percent fee per policy to help fund its operation

ldquoitrsquos something i have my eye onrdquo said alison orsquotoole Mnsure ceo ldquoand itrsquos potentially an issuerdquo

New Crisis Resource Website Launched the Minnesota Department of Human services has announced the launch of a new version of the MinnesotaHelpinfo web-site which features a new crisis link page to connect people with resources for a variety of immedi-ate crisis needs including mental health problems substance abuse problems emergency housing needs fear of being harmed or health care food job or trans-portation needs Minnesota resi-dents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence in addition the website has an online chat service available from 8 am to 430 pm on weekdays

ldquowe want to make sure that people know there is a single place the crisis link they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needsrdquo said lucinda Jesson DHs commissioner

the crisis link is part of the statersquos information and assistance program that also includes senior linkage line Disability linkage line and Veterans linkage line and is supported by several agen-cies in addition to DHs including the Minnesota Board on aging

Charity Care Decreased at Minnesota Hospitalsthere was a 63 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014 the first year Mnsure was implement-ed according to the Minnesota Department of Health (MDH)

specifically there was a 224 percent drop in charity care the component of uncompensated care in which hospitals provide care without expecting payment a de-cline of $346 million there was a greater drop in charity care for uninsured patients (246 percent) than there was for insured patients (178 percent) this was the second time since 2001 that charity care dropped in Minnesota

However there was a 93 percent increase in bad debt the component of uncompensated care in which hospitals expect payment but do not receive it that number increased $149 million from 2013 to 2014 when it reached $1742 million MDH said that the amount of bad debt has been ris-ing steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays

ldquowe are pleased that more Minnesotans now have the bene-fits of health coverage when they go to a hospitalrdquo said ed eh-linger MD Minnesota commis-sioner of health ldquoHowever the rising cost of health care continues to pose a threat to access to care without addressing health care costs through additional reforms or prevention efforts even those patients with insurance increasing-ly are struggling with medical bills and unpaid care or bad debtrdquo

Ucare Essentia Health Partner on Medicare PlanUcare and essentia Health have formed a Preferred Provider orga-nization (PPo) Medicare advan-tage Plan called essentiacare

to be eligible for essentiacare Minnesota patients must qual-ify for Medicare and live in the 10-county service area which includes aitkin clay Becker carl-ton cass crow wing Hubbard itasca lake and st louis coun-ties Patients will have two cover-age optionsmdashsecure which offers lower monthly premiums and high-er costs for copays and Grand

November 2015 Minnesota HealtH care news 5News to page 6

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

伀渀氀礀 㜀㔀  

吀䴀

䄀洀瀀氀椀昀椀攀搀 䌀愀瀀琀椀漀渀攀搀 吀攀氀攀瀀栀漀渀攀

一攀瘀攀爀 洀椀猀猀 愀渀漀琀栀攀爀 眀漀爀搀 漀昀 礀漀甀爀 瀀栀漀渀攀 挀漀渀瘀攀爀猀愀琀椀漀渀猀 吀栀攀 䌀氀愀爀椀琀礀글 䔀渀猀攀洀戀氀攀∡ 椀猀 愀 焀甀愀氀椀琀礀 挀愀瀀琀椀漀渀攀搀 瀀栀漀渀攀 眀椀琀栀 琀栀攀 戀攀猀琀 愀洀瀀氀椀昀椀挀愀琀椀漀渀 愀瘀愀椀氀愀戀氀攀 䄀渀 㠀 琀漀甀挀栀猀挀爀攀攀渀 挀愀渀 攀渀氀愀爀最攀 琀攀砀琀 愀猀 渀攀攀搀攀搀 䄀琀 琀栀攀 氀漀眀 瀀爀椀挀攀 漀昀 㜀㔀  Ⰰ 礀漀甀 挀愀渀琀 愀昀昀漀爀搀 琀漀 瀀愀猀猀 琀栀椀猀 漀昀昀攀爀 甀瀀䘀爀攀攀 䤀渀猀琀愀氀氀愀琀椀漀渀 刀攀焀甀椀爀攀猀 戀漀琀栀 氀愀渀搀氀椀渀攀 愀渀搀 椀渀琀攀爀渀攀琀 挀漀渀渀攀挀琀椀漀渀 䘀爀攀攀 挀愀瀀琀椀漀渀椀渀最 猀攀爀瘀椀挀攀 琀栀爀漀甀最栀 琀栀攀 䘀䌀䌀

圀漀爀搀猀䴀愀琀琀攀爀

㠀  ⤀ 㠀㔀ⴀ㘀㜀㔀㠀

䘀椀渀搀 琀栀攀 䔀渀猀攀洀戀氀攀 愀琀眀眀眀栀愀爀爀椀猀挀漀洀洀挀漀洀眀漀爀搀猀

吀爀礀 漀甀琀 漀甀爀 瀀爀漀搀甀挀琀猀 昀漀爀 礀漀甀爀猀攀氀昀 嘀椀猀椀琀 漀甀爀 猀栀漀眀爀漀漀洀 㔀㔀㔀 吀攀挀栀渀漀氀漀最礀 䐀爀Ⰰ 䔀搀攀渀 倀爀愀椀爀椀攀Ⰰ 䴀一 㔀㔀㐀㐀

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

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V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

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V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

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V Infertility evaluation and treatment

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Clinics in Maple Grove Plymouth and Crystal

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several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

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60

70

0

10

20

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60

70

0

10

20

30

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60

70

0

10

20

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40

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0

10

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0

5

10

15

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25

30

35

0

5

10

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25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

4 Minnesota HealtH care news November 2015

N e ws

Projects Funded to Help Aging Minnesotans Remain in Their Homesthe Minnesota Department of Human services has awarded more than $7 million in live well at Home grants to 62 organi-zations for projects focusing on allowing older Minnesotans to stay in their homes instead of moving to nursing homes or other care settings

ldquoMinnesota is a national leader in long-term services and supports for older adults in part because we provide this seed money to community organizations and providers to be creative in helping people remain in their homes as they agerdquo said lucinda Jesson human services commissioner ldquoin addition to helping meet daily needs such as nutrition and house-keeping these grants promote new technology and other innovations

that benefit both older Minneso-tans and their caregiversrdquo

according to DHs many of the recipients are nonprofit and community organizations all recipients will be required to generate income by charging for services through a sliding fee scale

the grants will help address the challenges of the statersquos aging 2030 initiative which addresses the challenges that come with the rate of aging Minnesotans and the preparations needed for the demo-graphic changes according to the website baby boomers are turning 65 at the rate of 10000 per day in the Us

Insurers Removing More Policies from MNsureHealth insurers in Minnesota are removing more options from Mnsure for 2016 enrollment after

losing all Preferredone health plans and more than 4750 plans from Blue cross and Blue shield of Minnesota and HealthPartners in 2015

Blue cross and Blue shield of Minnesota is removing policies that cover about 6500 people from the exchange and offering them directly to customers for 2016 that accounts for about 25 percent of current Blue cross policy holders that purchase insur-ance through Mnsure officials say if all of those enrollees renew their coverage outside of Mnsure it will cost the exchange between $800000 and $1 million in reve-nue next year because it will not be able to collect the 35 percent fee on those plans

Blue cross and Blue shield of Minnesota maintains that they are not removing policies to avoid the Mnsure fee the compa-ny says that it has consolidated several policies into one health plan they say is more effective but

because Minnesota laws will not allow them to eliminate old plans entirely the product change moves customers away from the exchange in some cases

ldquothe withhold from Mnsure has little if any material impact on our product decisionsrdquo said Blue cross and Blue shield of Min-nesota spokesman scott Keefer

Many of the policies it is re-moving from Mnsure are plati-num grade and it is currently the only insurer that offers this level of policies on the exchange some gold silver and bronze policies are being removed as well but new policies are being added it will send notices out to its custom-ers alerting them to rate increases and other changes and informing them that their plan will no longer be offered through Mnsure giving them the choice between taking no action and keeping their current policy directly through the insurer or choosing a new plan through Mnsure

there is concern that this trend will affect the future of Mnsure because it relies on the 35 percent fee per policy to help fund its operation

ldquoitrsquos something i have my eye onrdquo said alison orsquotoole Mnsure ceo ldquoand itrsquos potentially an issuerdquo

New Crisis Resource Website Launched the Minnesota Department of Human services has announced the launch of a new version of the MinnesotaHelpinfo web-site which features a new crisis link page to connect people with resources for a variety of immedi-ate crisis needs including mental health problems substance abuse problems emergency housing needs fear of being harmed or health care food job or trans-portation needs Minnesota resi-dents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence in addition the website has an online chat service available from 8 am to 430 pm on weekdays

ldquowe want to make sure that people know there is a single place the crisis link they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needsrdquo said lucinda Jesson DHs commissioner

the crisis link is part of the statersquos information and assistance program that also includes senior linkage line Disability linkage line and Veterans linkage line and is supported by several agen-cies in addition to DHs including the Minnesota Board on aging

Charity Care Decreased at Minnesota Hospitalsthere was a 63 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014 the first year Mnsure was implement-ed according to the Minnesota Department of Health (MDH)

specifically there was a 224 percent drop in charity care the component of uncompensated care in which hospitals provide care without expecting payment a de-cline of $346 million there was a greater drop in charity care for uninsured patients (246 percent) than there was for insured patients (178 percent) this was the second time since 2001 that charity care dropped in Minnesota

However there was a 93 percent increase in bad debt the component of uncompensated care in which hospitals expect payment but do not receive it that number increased $149 million from 2013 to 2014 when it reached $1742 million MDH said that the amount of bad debt has been ris-ing steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays

ldquowe are pleased that more Minnesotans now have the bene-fits of health coverage when they go to a hospitalrdquo said ed eh-linger MD Minnesota commis-sioner of health ldquoHowever the rising cost of health care continues to pose a threat to access to care without addressing health care costs through additional reforms or prevention efforts even those patients with insurance increasing-ly are struggling with medical bills and unpaid care or bad debtrdquo

Ucare Essentia Health Partner on Medicare PlanUcare and essentia Health have formed a Preferred Provider orga-nization (PPo) Medicare advan-tage Plan called essentiacare

to be eligible for essentiacare Minnesota patients must qual-ify for Medicare and live in the 10-county service area which includes aitkin clay Becker carl-ton cass crow wing Hubbard itasca lake and st louis coun-ties Patients will have two cover-age optionsmdashsecure which offers lower monthly premiums and high-er costs for copays and Grand

November 2015 Minnesota HealtH care news 5News to page 6

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

伀渀氀礀 㜀㔀  

吀䴀

䄀洀瀀氀椀昀椀攀搀 䌀愀瀀琀椀漀渀攀搀 吀攀氀攀瀀栀漀渀攀

一攀瘀攀爀 洀椀猀猀 愀渀漀琀栀攀爀 眀漀爀搀 漀昀 礀漀甀爀 瀀栀漀渀攀 挀漀渀瘀攀爀猀愀琀椀漀渀猀 吀栀攀 䌀氀愀爀椀琀礀글 䔀渀猀攀洀戀氀攀∡ 椀猀 愀 焀甀愀氀椀琀礀 挀愀瀀琀椀漀渀攀搀 瀀栀漀渀攀 眀椀琀栀 琀栀攀 戀攀猀琀 愀洀瀀氀椀昀椀挀愀琀椀漀渀 愀瘀愀椀氀愀戀氀攀 䄀渀 㠀 琀漀甀挀栀猀挀爀攀攀渀 挀愀渀 攀渀氀愀爀最攀 琀攀砀琀 愀猀 渀攀攀搀攀搀 䄀琀 琀栀攀 氀漀眀 瀀爀椀挀攀 漀昀 㜀㔀  Ⰰ 礀漀甀 挀愀渀琀 愀昀昀漀爀搀 琀漀 瀀愀猀猀 琀栀椀猀 漀昀昀攀爀 甀瀀䘀爀攀攀 䤀渀猀琀愀氀氀愀琀椀漀渀 刀攀焀甀椀爀攀猀 戀漀琀栀 氀愀渀搀氀椀渀攀 愀渀搀 椀渀琀攀爀渀攀琀 挀漀渀渀攀挀琀椀漀渀 䘀爀攀攀 挀愀瀀琀椀漀渀椀渀最 猀攀爀瘀椀挀攀 琀栀爀漀甀最栀 琀栀攀 䘀䌀䌀

圀漀爀搀猀䴀愀琀琀攀爀

㠀  ⤀ 㠀㔀ⴀ㘀㜀㔀㠀

䘀椀渀搀 琀栀攀 䔀渀猀攀洀戀氀攀 愀琀眀眀眀栀愀爀爀椀猀挀漀洀洀挀漀洀眀漀爀搀猀

吀爀礀 漀甀琀 漀甀爀 瀀爀漀搀甀挀琀猀 昀漀爀 礀漀甀爀猀攀氀昀 嘀椀猀椀琀 漀甀爀 猀栀漀眀爀漀漀洀 㔀㔀㔀 吀攀挀栀渀漀氀漀最礀 䐀爀Ⰰ 䔀搀攀渀 倀爀愀椀爀椀攀Ⰰ 䴀一 㔀㔀㐀㐀

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

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Gallbladder

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Gastric Reflux

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oncologycancer

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advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

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Among the services we provide

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Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

there is concern that this trend will affect the future of Mnsure because it relies on the 35 percent fee per policy to help fund its operation

ldquoitrsquos something i have my eye onrdquo said alison orsquotoole Mnsure ceo ldquoand itrsquos potentially an issuerdquo

New Crisis Resource Website Launched the Minnesota Department of Human services has announced the launch of a new version of the MinnesotaHelpinfo web-site which features a new crisis link page to connect people with resources for a variety of immedi-ate crisis needs including mental health problems substance abuse problems emergency housing needs fear of being harmed or health care food job or trans-portation needs Minnesota resi-dents can find contact information for organizations that serve their specific needs and hotlines for suicide and domestic violence in addition the website has an online chat service available from 8 am to 430 pm on weekdays

ldquowe want to make sure that people know there is a single place the crisis link they can go to get information and phone numbers for helping professionals and agencies that meet a variety of immediate needsrdquo said lucinda Jesson DHs commissioner

the crisis link is part of the statersquos information and assistance program that also includes senior linkage line Disability linkage line and Veterans linkage line and is supported by several agen-cies in addition to DHs including the Minnesota Board on aging

Charity Care Decreased at Minnesota Hospitalsthere was a 63 percent drop in uncompensated care at Minnesota hospitals from 2013 to 2014 the first year Mnsure was implement-ed according to the Minnesota Department of Health (MDH)

specifically there was a 224 percent drop in charity care the component of uncompensated care in which hospitals provide care without expecting payment a de-cline of $346 million there was a greater drop in charity care for uninsured patients (246 percent) than there was for insured patients (178 percent) this was the second time since 2001 that charity care dropped in Minnesota

However there was a 93 percent increase in bad debt the component of uncompensated care in which hospitals expect payment but do not receive it that number increased $149 million from 2013 to 2014 when it reached $1742 million MDH said that the amount of bad debt has been ris-ing steadily in Minnesota and that the increase was due to patients taking on more of their rising health care costs through higher deductibles and copays

ldquowe are pleased that more Minnesotans now have the bene-fits of health coverage when they go to a hospitalrdquo said ed eh-linger MD Minnesota commis-sioner of health ldquoHowever the rising cost of health care continues to pose a threat to access to care without addressing health care costs through additional reforms or prevention efforts even those patients with insurance increasing-ly are struggling with medical bills and unpaid care or bad debtrdquo

Ucare Essentia Health Partner on Medicare PlanUcare and essentia Health have formed a Preferred Provider orga-nization (PPo) Medicare advan-tage Plan called essentiacare

to be eligible for essentiacare Minnesota patients must qual-ify for Medicare and live in the 10-county service area which includes aitkin clay Becker carl-ton cass crow wing Hubbard itasca lake and st louis coun-ties Patients will have two cover-age optionsmdashsecure which offers lower monthly premiums and high-er costs for copays and Grand

November 2015 Minnesota HealtH care news 5News to page 6

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

伀渀氀礀 㜀㔀  

吀䴀

䄀洀瀀氀椀昀椀攀搀 䌀愀瀀琀椀漀渀攀搀 吀攀氀攀瀀栀漀渀攀

一攀瘀攀爀 洀椀猀猀 愀渀漀琀栀攀爀 眀漀爀搀 漀昀 礀漀甀爀 瀀栀漀渀攀 挀漀渀瘀攀爀猀愀琀椀漀渀猀 吀栀攀 䌀氀愀爀椀琀礀글 䔀渀猀攀洀戀氀攀∡ 椀猀 愀 焀甀愀氀椀琀礀 挀愀瀀琀椀漀渀攀搀 瀀栀漀渀攀 眀椀琀栀 琀栀攀 戀攀猀琀 愀洀瀀氀椀昀椀挀愀琀椀漀渀 愀瘀愀椀氀愀戀氀攀 䄀渀 㠀 琀漀甀挀栀猀挀爀攀攀渀 挀愀渀 攀渀氀愀爀最攀 琀攀砀琀 愀猀 渀攀攀搀攀搀 䄀琀 琀栀攀 氀漀眀 瀀爀椀挀攀 漀昀 㜀㔀  Ⰰ 礀漀甀 挀愀渀琀 愀昀昀漀爀搀 琀漀 瀀愀猀猀 琀栀椀猀 漀昀昀攀爀 甀瀀䘀爀攀攀 䤀渀猀琀愀氀氀愀琀椀漀渀 刀攀焀甀椀爀攀猀 戀漀琀栀 氀愀渀搀氀椀渀攀 愀渀搀 椀渀琀攀爀渀攀琀 挀漀渀渀攀挀琀椀漀渀 䘀爀攀攀 挀愀瀀琀椀漀渀椀渀最 猀攀爀瘀椀挀攀 琀栀爀漀甀最栀 琀栀攀 䘀䌀䌀

圀漀爀搀猀䴀愀琀琀攀爀

㠀  ⤀ 㠀㔀ⴀ㘀㜀㔀㠀

䘀椀渀搀 琀栀攀 䔀渀猀攀洀戀氀攀 愀琀眀眀眀栀愀爀爀椀猀挀漀洀洀挀漀洀眀漀爀搀猀

吀爀礀 漀甀琀 漀甀爀 瀀爀漀搀甀挀琀猀 昀漀爀 礀漀甀爀猀攀氀昀 嘀椀猀椀琀 漀甀爀 猀栀漀眀爀漀漀洀 㔀㔀㔀 吀攀挀栀渀漀氀漀最礀 䐀爀Ⰰ 䔀搀攀渀 倀爀愀椀爀椀攀Ⰰ 䴀一 㔀㔀㐀㐀

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

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Itrsquos alwaysPERSONALto us

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EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

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Freedom Medicare Do more of what you love

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2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

dermatologyconsultantscom

Age 76 Squamous Cell Carcinoma

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

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Among the services we provide

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Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

which offers higher premiums and lower out-of-pocket costs

enrollees will have access to services at any of essentia Healthrsquos 68 clinics and 18 hospitals or at out-of-network providers if they are willing to pay higher out-of-pocket costs the plan also allows patients access to specialists at Mayo clinic at in-network benefit levels for more complex conditions if their physician refers them

Patients can enroll in essenti-acare during the fall open enroll-ment period for Medicare ad-vantage Plans which takes place oct 15 through Dec 7 coverage will be effective Jan 1 they are hosting informational meetings in october and november

the two organizations have a 5050 partnership in the plan meaning they will equally share in the planrsquos operation revenue and expenses

Tobacco Use Increases Risks for Peripheral Artery Diseasea new study from the University of Minnesota Medical schoolrsquos cardiovascular Division has shown that continued tobacco use has a devastating impact on the number of heart attacks serious leg artery blockages strokes and aneurysms in people with peripheral artery disease (PaD) researchers analyzed 2011 claims data from Blue cross and Blue shield of Minnesota for more than 22000 PaD patients

ldquoeveryone knows tobacco hurts health but until now no one has known how amazingly power-ful this impact is For people with PaD smoking is especially bad the health impact is lsquoright nowrsquo and the cost to the patient society and health payers is giganticrdquo said sue Duval PhD lead author of the study and associate professor

of medicine and biostatistics in the cardiovascular Division at the University of Minnesota Medical school ldquothis study represents one of the largest measurements of the impact of PaD on health in our state and the nation Because Minnesota is a state that is known to be lsquoheart healthyrsquo the impli-cations of this research and the costs of smoking are sure to be even higher around the country and worldrdquo

researchers also found that over the one-year period people with PaD who smoked had tre-mendous short-term health risks and that 49 percent of tobacco users with PaD were hospitalized that is 35 percent higher than the number of PaD patients who do not smoke tobacco those who smoked were also much more fre-quently admitted to hospitals for leg artery blockages heart disease stroke pneumonia and bronchitis the data showed that in addi-tion to increased health risks the average cost for each patient who

smoked tobacco was $17673 more in the first year than those who did not smoke

ldquoi have studied PaD for over two decades and these results startled me it also stuns me that patients families health systems and government do not seem shocked Preventable suffering continues every yearrdquo said alan Hirsch MD senior author of the study and professor of medicine epidemiology and community health in the cardiovascular Divi-sion at the University of Minneso-ta Medical school ldquotobacco use is to heart and vascular disease like gasoline thrown on a fire we know that each full effort to help a person quit smoking costs less than $500 compared to the nearly $18000 per year in added health care costs giving patients every tool to quit is the greatest health bargain around we must treat the causes of disease and not just consequences our lives and pocket books depend on this radical changerdquo

6 Minnesota HealtH care news November 2015

News from page 5

WHEN IT COMES TO GIFTS FOR YOUR KIDSLOTTERY TICKETS ARE A BAD BET

MUST BE 18 OR OLDER TO PLAY

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

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V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

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V Infertility evaluation and treatment

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Clinics in Maple Grove Plymouth and Crystal

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several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Burnsville 9524358516

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Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

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What does MS equal to youJoin the Movementreg at MSsocietyorg

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

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60

70

0

10

20

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70

0

10

20

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60

70

0

10

20

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40

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0

10

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0

5

10

15

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25

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35

0

5

10

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25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Jennifer Ballantine has been named executive director of Able Palms Home Health of Minne-apolis a Medicare certified home health agency managed by The Goodman Group Ballantine will be based in Chaska at the companyrsquos headquarters Most recently she served as the director of business development for Recover Health a home health agency where she previously held positions in mar-keting Medicare compliance training and business development Ballantine has a bachelorrsquos of science in business administration from Metropolitan State University

Richard Launer MD has joined Minnesota Eye Consultants as an ophthalmologist at its Maplewood location Launer earned his medical degree and completed his ophthalmology residency at the University of Minnesota where he has also served as an assistant adjunct professor of ophthal-mology Before joining Minnesota Eye Consultants Launer practiced with Progressive Eye Care and ProEyeCare Associates He emphasized using new

technologies and techniques to improve cataract and refractive surgery He was one of the first to perform topical small incision self-sealing cataract surgery and was the first to perform all laser lasik surgery in Minnesota

Ngozi Mbibi RN of The Mother Baby Center at Abbott Northwestern and ChildrenrsquosndashMinneapolis has been inducted as a fellow into the American Academy of Nursing She was one of 163 nurses in the US to be selected in 2015 Mbibi earned her midwifery license in Nigeria in 1978 where she worked for 24 years before coming to the US Here she earned her masterrsquos degree in nursing health care leadership and nursing education from Bethel University and a doc-tor of nursing practice from the University of Minnesota She serves as vice president of the National Association of Nigerian Nurses in North America which partners with Nigerian policymakers to address health issues that are prevalent in some Nigerian cultures

Caryn McGeary RN MHA has been named director of patient care services at Affiliated Com-munity Medical Centers (ACMC) McGeary earned her masters of healthcare administration degree from Bellevue University in Nebraska She has been with ACMC for 10 years in previous roles as the ACMC-Benson RN site manager and as the qual-ity and patient safety coordinator Prior to joining ACMC McGeary held positions at Douglas County

Hospital and Hennepin County Medical Center In her new role McGeary is responsible for planning organizing and directing the activities of the professional and support staff engaged in direct patient care for the 11-clinic system

Peo Ple

November 2015 MINNESoTA HEALTH CARE NEwS 7

Richard Launer MD

Ngozi Mbibi RN

Caryn McGeary RN MHA

Jennifer Ballantine

CO

MM

UN

ITY

SY

MP

OS

IUM

FRIDAY DECEMBER 4 2015Morning Option 900 ndash 1130 am (830 am check-in)Afternoon Option 100 ndash 330 pm (1230 pm check-in)

Plymouth Creek Center 14800 34th Ave N Plymouth MN 55447 (Free parking)

During this seminar you will

bull Deepen your understanding of executive functioning bull Discover the optimal conditions for developing executive functioning bull Learn more about evidence-based interventions that promote self-regulatory skills in children

THE IMPORTANCE OF

EXECUTIVE FUNCTIONING

The Neuroscience Its Variability in Development and Evidence-Based Interventions to Improve It

$40 Registration Fee Certificates of Attendance available

Featuring Philip Zelazo PhD

Dr Philip David Zelazo is currently the Nancy M and John E Lindahl Professor at the Institute of Child Development University of Minnesota Dr Zelazo earned his doctorate from Yale University advanced to a full professor of psychology and served as Canada Research Chair in developmental neuroscience

Learn more amp register at stdavidscenterorgSYMPOSIUMu

The Ultimate in Home Care and GuidanceLife Care Managers (RNs) are at the heart of our

whole person senior care approach that spark lives Find out more about Lifesprk at

lifesprkcom or call 952-345-8770

rdquoYou have to find what sparks a light in you so that you in your own way can illuminate the worldrdquo ndash Oprah Winfrey

Noble Caregiver of the Year Recipient Excellence in the Workplace Award2011 Entrepreneur of the Year Finalist

10SPARKING

LIVES

YEARS

CELEBRATING

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

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MS =

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

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St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

ldquoWill you take me to Oregonrdquo This was Daversquos plea as he slowly died from end-stage cancer At age 95 Dave had lost

his mobility independence and organ function but his mind remained sharp He didnrsquot want to die this way and his son could do little to help Daversquos son is now supporting my bill the Minnesota Compassionate Care Act so that other Minnesotans in his fatherrsquos situation will have an option to end their suffering

About the billThe Compassionate Care Act mod-eled after Oregonrsquos 1997 Death with Dignity Act (DWDA) allows terminally ill patients access to medication so they can end their suffering by painless means if and when they choose To protect the vulnerable only terminally ill adults who are of sound mind and able to request and self-administer the medication would qualify for aid in dying There are no lethal injections and this is not ldquoassisted suiciderdquo

As someone who has spent over 40 years work-ing with people with mental illnessmdashthe last 19 as a registered nursemdashI firmly oppose ldquoassistingrdquo patients in need of mental health services to end their lives Aid in dying gives those who are close to death with no chance of recovery an alternative when their agony becomes unbearable

I encourage you to read more about these differ-ences at wwwitsnotassistedsuicideorg or to visit wwwthebrittanyfundorg The latter site was launched to honor 29-year-old Brittany Maynard who moved her family to Oregon as she faced stage-four brain cancer Under that statersquos law she ended her life on her terms after telling loved ones ldquoThere is a difference between a person who is suicidal and a person who is dying I do not want to die I am dyingrdquo

Personal choicesPatients in consultation with their families and doctors should have the freedom to decide whatrsquos best In a Gallup poll 75 percent agreed that ldquodoctors should be allowed by law to end the patientrsquos life by some painless means when the patient and his or her family request itrdquo Oregon Washington Vermont and Mon-tana now allow aid in dying with legislation pending in 20 more states

Under my bill a patient must be an adult Min-nesota resident terminally ill and of sound mind A request for aid in dying must be made in writing twice at least 15 days apart and signed in the presence of two witnesses Two physicians must determine that the patient is terminally ill competent and free from coer-cion Any doubt or disagreement between physicians requires a third evaluation Patients are repeatedly

provided information about hospice palliative medi-cine and other treatment options They are also given the opportunity to rescind their request at any time

Some will oppose the bill for religious reasons To them end-of-life suffering is Godrsquos will and medical in-tervention is wrong I understand and respect this view Freedom of religion is a foundation of our democracy

No one will be required to participate in this law whether patient caretaker or physician

Others who oppose the bill do so based on misinformation They fear the law will be used against the disabled minority groups or the poor or that insurance companies or the

government will deny medical care to the terminally ill Some argue that better hospice care will make this op-tion unnecessary A look at the Oregon Public Health Divisionrsquos 1998-2014 data dispels these myths Of the patients who utilized DWDA

bullMostwerewhiteoverage65andwithadvancededucation

bullThetwomostcommondiagnosesweremalignantcancer (78 percent) and amyotrophic lateral sclero-sis or ALS (8 percent)

bullThemostcommonreasonsgivenwerelossofautonomy reduced ability to engage in enjoyable activities loss of dignity and loss of control of bodily functions

bullNinetypercentwereenrolledinhospice

Finally some fear the bill will begin a slippery slope leading to involuntary euthanasia That fearful speculation has no basis in reality In 17 years under Oregonrsquos DWDA there have been no instances of failure to comply with the guidelines of the law and no attempts to weaken the safeguards

A personal noteAs a nurse Irsquove seen a great deal of human suffering I have cared for people dying of many forms of can-cer ALS and Huntingtonrsquos chorea Many were content with the care they received from hospice and family Those who lived beyond their tolerance of pain and loss of dignity begged caregivers to help them die Aid in dying should not be a crime Individuals should have the option to determine how they live and die I hope that the Minnesota Compassionate Care Act will help begin this important conversation and that it results in less pain and suffering at the end of life

Track the status of the Compassionate Care Act (Senate bill SF 1880 or its companion House bill HF 2095) at wwwlegstatemnuslegtrackbillaspx

Contact your legislator at wwwlegstatemnusleglegdiraspx Unsure of your legislative district Visit wwwlegstatemnuslegdistrictfinderaspx

The Compassionate Care ActGiving Minnesotans a choice

Pe rsPeC T ive

8 Minnesota HealtH care news November 2015

senator Christine Ann ldquoChrisrdquo eaton

Sen Eaton (DFL) represents Minnesota Senate District 40 which includes Brooklyn Center and Brooklyn Park She serves as the DFL majority whip and as vice chair for the State and Local Government Committee Her special legislative concerns include health care labor issues social justice and the environment Sen Eaton has been a registered nurse and a member of the Minnesota Nurses Association for the past 19 years

Individuals should have the option

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

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Age 76 Squamous Cell Carcinoma

Age 25Melanoma

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

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ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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10

20

30

40

50

60

70

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70

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0

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0

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15

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35

0

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

ldquoIrsquove trusted the health care providers at Essentia Health for yearsrdquoldquoThatrsquos why Irsquom excited about EssentiaCarerdquoIntroducing EssentiaCare a new Medicare plan from UCare and Essentia Health EssentiaCare combines the health care you know and trust from Essentia Health with smart health coverage from UCare Benefits include no or low copays for doctor visits prescription drug coverage dental coverage travel coverage fitness programs and more If yoursquore eligible for Medicaremdashwhether or not yoursquore a current Essentia Health patientmdashfind out about an affordable new choice

Get plan details now for coverage beginning in January 2016 at EssentiaCareorg or call 218-722-4783 1-855-432-7027 toll free or TTY 1-800-688-2534 toll free 8 am to 8 pm daily

Paid Actor Portrayal

Limitations copayments and restrictions may apply This information is not a complete description of benefits Contact the plan for more information Benefits ldquo andor copayments may change on January 1 of each year EssentiaCare is a PPO plan with a Medicare contract Enrollment in EssentiaCare depends on contract renewal copy 2015 UCare H0735_091515_2 CMS Accepted (09202015)

95 x 12625UC699 2015 EssentiaCare_HCNAd_95x12625indd 1 10715 1149 AM

November 2015 Minnesota HealtH care news 9

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

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Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

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MS =

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

10 Questions

Please tell us about the Federal Medical Center Rochester The Federal Medical Center Rochester (FMC Rochester) is one of six medical centers in the Federal Bureau of Prisons (BOP) and has a medical and a mental health mission We are accredited by the Joint Commission and held to the same standards as any community health care institution FMC Rochester currently houses about 784 male inmates About half of those inmates are here for medical or psychiatric care while the other half are healthy individuals most of whom are from the Midwest We have multiple medical missions including infectious disease wound care rehabilitationphysical therapy and long-term care Our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We currently have 135 patients in our mental health units

How is it determined who is sent there Each BOP institution is

assigned a care level of 1 to 4 depending on its med-

ical or mental health resources When an

individual at a Care Level 1 2 or 3 in-stitution requires a higher level of care than is available at that institution his or her case is reviewed by BOP staff to determine where that

inmate should be housed Each medical center has a unique mis-sion and placement is based on matching the medical and psychi-atric needs of the inmate with the mission At FMC Rochester our primary mental health mission is the care and treatment of inmates with severe and persistent mental illnesses We have the same kinds of patients the state hospital did when it was open We currently have 135 patients in our mental health units

How do mental health services at an FMC differ from those offered at other correctional facilities As a Care Level 4 institution which offers the highest level of care we are able to provide acute and long-term care to the most severely mentally ill inmates in the BOP We have nurses on the units 24 hours a day seven days a week Each patient is assigned to a multidisciplinary team of professionals including a social worker psychiatrist psychologist and recreation therapist The patients meet individually with their team members regularly and with the entire team at least every 90 days Due to the nature of their illnesses nearly all the patients are on psychiatric medications

Patients are offered a variety of therapeutic programming in-cluding art and music therapy pet therapy group therapy employ-ment in our sheltered workshop or some other work or vocational training educational classes drug and alcohol treatment parenting classes etc Our patients reside in a therapeutic community of which we as treatment providers are an integral part as are the correctional staff

About half of the patients have been committed indefinitely by the federal courts after being found dangerous due to a mental dis-ease or defect These patients often had little care in the community prior to coming to prison and may have never fully participated in any treatment Our goal for these patients is to improve their func-tioning to the point where they may eventually be placed back in their communities with the support services they need to stay sta-ble and to keep the community safe Typically these patients spend years with us Some patients will never be well enough to leave and will spend their lives with us

Please talk about the day-to-day care you provide As chief psychiatrist I have administrative duties and I oversee the care of all the psychiatric patients I am fortunate to work with an outstanding group of psychiatrists who are highly skilled in caring for patients with severe mental illnesses We have very dedicated nursing social work vocational recreation correctional and psy-chology staff My clinical work includes providing direct outpatient psychiatric care to inmates who reside outside of the mental health unit I also provide psychiatric care to patients residing on our medical floors in the Nursing Care Centers Many of these patients suffer from neurocognitive difficulties

In addition I along with a mid-level provider act as the pri-mary medical providers for patients on our mental health units We have tried other models of medical care but found this to be the most effective way of providing the kind of integrated care these patients need The patients are more comfortable with a provider

A healing presence Shelley R Stanton MD The Federal Medical Center RochesterDr Stanton has devoted most of her career to the care and treatment of incarcerated individuals with severe and persistent mental illnesses Dr Stanton has also worked in community mental health as well as private practice in a large group medical practice at Marshfield Clinic in Wisconsin She has spent the last nine years working at FMC Rochester first as the clinical director overseeing the medical care at the institution and for the last six and a half years as the chief psychiatrist

10 Minnesota HealtH care news November 2015

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

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To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

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Gallbladder

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Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

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including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

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Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

who knows their psychiatric condition and more important knows them We are sensitive to potential medication interactions med-ication side effects as well as potential medical complications associated with some psychiatric symptoms such as psychogenic polydipsia Of course I consult with my medical colleagues at FMC Rochester and with my colleagues at Mayo Clinic

Is there enough care for the patients Yes Our challenge comes when patients are releasing to the community Many of the patients come from socioeconomically deprived backgrounds and they may be returning to an area where there are only minimal mental health services available Many are homeless and have no family support no financial resources and nearly all are too functionally impaired to work full time Our social workers devote their days to finding community resources for our patients but it can be a very frustrating and heartrending job

How does your staff of mental health care professionals work together to serve the inmates at FMC Rochester we all have offices in the same building and the nature of our work naturally brings us together frequently to discuss cases and consult with one another we rely heavily on each other for assistance with especially challenging patients we have no competing interests beyond keeping the public safe and providing appropriate medical and psychiatric care to our patients we have no productivity requirements no worries about reimbursement no one looking over our shoulders telling us how long a patient may stay with us the patientsrsquo needs drive our day so that is our focus it is really very straightforward

How does the care you provide at an FMC differ from the care psychiatrists provide in private practice First and foremost we are able to get to know our patients over months to years This makes an enormous difference in our ability to accurately diagnose and treat these severe disabling conditions Second all medications are administered through directly observed therapy and we know each day which patients did or did not take their medications This allows us to intervene immediately and address the adherence issues as they arise

What kind of personal safety issues must be considered when working in a prison Surprisingly working in a prison is much safer for a psychiatrist than working in a community hos-pital or emergency department Although some of our patients have committed acts of violence these nearly always were when the patients were symptomatic Because we know our patients so well we know when they are decompensating We emphasize safety and security above all else and all of us work together to ensure that our environment remains safe from the standpoint of no access to intoxicants and weapons This greatly reduces the risk of serious violence in our setting compared to the community In my 21 years of working in prisons I have only been assaulted one time and that was by a female patient at our medical center in Texas In my four years of training at the Mayo Clinic I was assaulted more times than that

Finally if a patient is losing control we have various ways to call for help and in no case does it take more than a few seconds for many additional staff to arrive at the scene and render assistance

Correctional facilities have been referred to as ldquothe nationrsquos safety net for mental health carerdquo What can you tell us about this We are still criminalizing mental illness and incarcerating people who should be in hospitals or other treatment settings The promise for community resources that was made when state hospitals closed was never kept and as far as I

can tell likely never will be kept without a major shift in public and political will Over 300000 individuals with serious mental illnesses are incarcerated in this country and most of them are not getting the treatment they need in or out of prison That is unconscionable to me On any given day over 5000 individuals with mental illness are housed in the Los Angeles County Jail New

York City releases over 25000 individuals with mental illnesses from its jails each year and most of these folks are released with absolutely no resources Jails and prisons are designed and staffed to house individuals charged or convicted of crimes not to diagnose and treat severe mental illnesses Mental illness is not a choice It is a chronic disease that needs treatment to reduce the suffering of its victims and to improve the safety of our communities

Respecting privacy concerns can you share some success stories Unfortunately I cannot provide any specific case histo-ries but I can tell you family members often say they have never seen their family member doing so well They often express a great sense of relief that the person is finally getting the care they need Our patients also frequently tell us we have provided the best care they have ever received medically and psychiatrically For me the most rewarding moment is when a patient is releasing to the community and comes by to say ldquogoodbyerdquo Invariably he tells me he is very grateful to have been in a place where people show such compassion and provide such excellent care to the patients I know then my goal to be a healing presence for the patients has been met

November 2015 Minnesota HealtH care news 11

Over 300000 individuals with serious mental

illnesses are incarcerated in this country

Personalized Assisted Living goes a long way toward optimizing

the daily quality of life for our residents If you have a loved one

that needs a friendly environment with a personalized care plan

designed just for them call or visit a Brookdale Community

near you Because caring for our residents is what we do and

itrsquos always personal to us

To learn more visit us online at brookdalecom

Itrsquos alwaysPERSONALto us

Alzheimerrsquos Association is a registered service mark of Alzheimerrsquos Disease and Related Disorders Association IncALL THE PLACES LIFE CAN GO is a trademark of Brookdale Senior Living Inc Nashville TN USA regReg US Patent and TM OfficeMNM3-RES20-0813 LMM

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

dermatologyconsultantscom

Age 76 Squamous Cell Carcinoma

Age 25Melanoma

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

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60

70

0

10

20

30

40

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60

70

0

10

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0

10

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0

10

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60

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0

10

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0

10

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0

5

10

15

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35

0

5

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25

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

EnvironmEntal HEaltH

12 Minnesota HealtH care news November 2015

Understanding the metricsBy Monika Vadali PhD

The effects of air quality

the term ldquoair qualityrdquo is broadly used to describe the condi-tion of air with relation to potential human health effects visibility odor or potential for deterioration of man-made

or natural structures while Minnesota fares well in comparisons with other regions itrsquos important to understand the factors contrib-uting to air quality the associated health risks and the tools avail-able to monitor daily conditions

Terms and definitionstwo terms are commonly used to discuss air quality

Pollutants are unwanted chemicals or other suspended partic-ulates that are found in air in quantities high enough to potentially endanger the environment or human health

Emissions refer to the discharge of these pollutants from a particular source (such as an industry) or a group of sources (such as vehicles on the road) into the air air quality gets degraded as the amount of pollutants in air increases this is called air pollution and the substances causing the damage are called air pollutants

air quality is influenced not only by the magnitude and quantity of air pollution sources but also by environmental factors such as the movement of air masses due to weather conditions temperature and the amount of sunlight and by the presence of buildings water bodies or mountains Poor air quality results when air pollutants reach concentrations that are high enough to potentially harm hu-mans or the environment

when winds are sufficiently strong pollutants are effectively dispersed and high concentrations are less likely However when pollutants are trapped due to weather conditions (inversions) ter-rain (mountains or buildings) or other features that limit the free movement of air pollutant concentrations may increase to unhealthy levels creating a poor air quality day

the environmental Protection agency (ePa) has established a uniform air Quality index (aQi) for people to assess air quality on specific days and in specific locations the Minnesota Pollution control agency (MPca) posts a statewide aQi based on these ePa standards on its home page at wwwpcastatemnus calculated from the worst-case measurement of five common air pollutants the MPca site includes a map color coded to show conditions through-out the state along with links to display more detailed information one screen allows users to view city-by-city levels of the five pollut-ants comprising the eParsquos air Quality index

bull Particulate matter ranging in size from 25 micrometers (PM25) to 10 micrometers (PM10)

Psychiatric Care evolved888-9-prairie prairie-carecom

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

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Age 76 Squamous Cell Carcinoma

Age 25Melanoma

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CURED CURED CURED

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

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mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

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MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

bullGround-level ozone (o3)

bullnitrogen dioxide (no2)

bullcarbon monoxide (co)

bullsulfur dioxide (so2)

The local pictureMinnesotarsquos air quality is generally good and has been improving for most pollut-ants the poorest air quality in the state is found in the Minneapolisndashst Paul metro-politan area the cleanest air is found in remote areas of northern Minnesota where health risks from air pollution are as much as 100 times lower than in the twin cities urban core locations near traffic or industrial sources of air pollution have poorer air quality than locations further away from these types of sources Minnesota currently meets all national ambient air Quality stan-dards and trends show that concentra-tions of most pollutants have decreased over the last few decades toxic air pollutants of concern (those without air quality standards) have gradually decreased to where they are below levels of health concern individually although the cumulative effect of multiple pol-lutants is still a concern in some areas while Minnesota meets the standards research has shown that even low levels of air pollution below the standards may cause detrimental health effects

the Minneapolisndashst Paul metropolitan area has better air qual-ity than most Us cities of similar size the american lung asso-ciationrsquos state of the air 2013 study (wwwstateoftheairorg2013assetsala-sota-2013pdf) which ranked cities and counties across the country gave Minnesota good grades for ozone pollution and average grades for particle pollution Minnesotarsquos relatively clean air is due to the fact that the prevailing winds effectively carry away the pollutants produced here and much of the time our air comes in from unpolluted areas to the north and west

since the enactment of the clean air act in 1970 and clean air act amendments in 1977 and 1990 concentrations of traditional air pollutants have generally decreased However as scientists learn more about the health effects of these pollutants standards have also become stricter resulting in more air alert days

as the understanding of air pollution continues to evolve new methods of environmental protection must be explored it is becom-ing increasingly obvious that it is not enough to control single pol-lutants from individual sources there is growing recognition of the need to reduce air pollution emissions from scattered less regulated sources such as transportation and residential combustion

Health concernsthere is evidence that air pollution is associated with many respi-ratory and cardiovascular diseases including asthma pneumonia bronchitis stroke and heart attack the severity of the effects depends on factors such as the type of pollutant levels and duration

of exposures and the individualrsquos level of susceptibility Generally young children pregnant women and the elderly are the most at-risk populations two pollutants in particular are increasingly being

studied for poor air quality-related health effects these are particulates (PM25 and ultrafine) and ozone

the MPca and the Minnesota Depart-ment of Health (MDH) recently analyzed air quality and health data to estimate effects of air pollution on health outcomes for people living in the seven-county twin cities metro area the report ldquolife and

Breath How air pollution affects public health in the twin citiesrdquo used baseline data from 2008 the year with the most recent data available that allowed for linking of air pollution levels and health outcomes although the air quality in Minnesota is currently good and meets federal standards even low and moder-ate levels of air pollution can contribute to serious illnesses and early death the

analysis found that air pollution contributed to about 2000 deaths 400 hospitalizations and 600 emergency room visits in the twin cities in 2008

The effects of air quality to page 34

November 2015 Minnesota HealtH care news 13

The MinneapolisndashSt Paul metropolitan area has better air quality than most US

cities of similar size

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

dermatologyconsultantscom

Age 76 Squamous Cell Carcinoma

Age 25Melanoma

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CURED CURED CURED

SunButterreg is for peanut and nut allergic children and great for everyone

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

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50

60

70

0

10

20

30

40

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60

70

0

10

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70

0

10

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0

10

20

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60

70

0

10

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0

10

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0

5

10

15

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35

0

5

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15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Pulmonology

Bronchitis is a very common illness that nearly everyone experi-ences at some point It is caused by swelling and inflammation of the bronchi which are the upper airways of the lungs The

main symptom of bronchitis is a cough which may be dry or may bring up mucus (phlegm) Other symptoms can include wheezing chest tightness and fever that is usually less than 1005degF Some people also get a sore throat headache and body aches The disease takes two forms acute and chronic

Acute bronchitisMost often caused by a virus acute bronchitis produces coughs that typically last about one to three weeks Another term for acute

bronchitis is a ldquochest coldrdquo The main difference between a com-mon cold and bronchitis is that a cold virus settles in the head and produces symptoms such as sore throat sinus congestion and runny nose whereas a bronchitis virus settles in the bronchi and produces a bothersome cough Often a virus can first produce a cold and then move into the chest to cause bronchitis symptoms

Bronchitis may also be caused by inhaling irritants such as pollution smoke or airborne chemicals Avoiding these irritants usually helps the cough resolve

Some people are particularly susceptible to acute bronchitis These include smokers those with asthma or other underlying lung disease such as emphysema and those with diminished immunity including babies pregnant women the elderly and those undergoing treatment for cancer or immune disorders

Viruses that cause acute bronchitis include rhinovirus coronavi-rus respiratory syncytial virus and parainfluenza virus all of which are easily spread from person to person If you are ill with a cough you should avoid situations that could spread your infection to others such as schools the workplace (especially if it involves being near other people) airplanes and shopping Do not visit anyone in the hospital and take care to avoid close contact with people with lowered immunity

One special type of acute bronchitis is caused by the influenza virus also known as ldquothe flurdquo When influenza virus infects the bronchi the symptoms are usually more severe than typical bronchi-tis and can include high fevers severe fatigue terrible body aches and feeling very ill There is an anti-viral treatment medicine for influenza that may be an appropriate treatment for some people The yearly influenza vaccine helps protect against this illness and also protects against complications of influenza including pneumonia and even heart attacks

Less than 1 percent of the time bronchitis is caused by the bacterium Bordetella pertussis resulting in the highly contagious disease known as pertussis or whooping cough This should be suspected if the cough persists for at least two weeks and comes in severe attacks or is accompanied by a high-pitch whooping sound when breathing in while coughing Whooping cough can be diag-nosed with a nasal swab test in the doctorrsquos office Since whooping cough is caused by bacteria it may be treated with an antibiotic

Antibiotics are not effective against viruses though which are the leading cause of acute bronchitis Unnecessary use of antibiotics 14 MInneSOTA HeALTH cAre neWS November 2015

BronchitisFrom common coughs to chronic disease

By Heather Hamernick MD

Donrsquot be afraid

living allows time to take up old hobbies - painting reading bridge - or to pursue new ones Membership to the Wellness Center complete with indoor pool and exercise classes keeps the body active and strong

including Bible study discussion groups and peaceful gardens nurture the spirit

- wine amp cheese happy hours restaurant amp theatre outings holiday parties and more - create meaningful opportunities to re-connect with family and old friends - and make new ones as well

Call today at for a tour of our beautiful home beside Cedar Lake or visit us at

3700 Cedar Lake Avenue Minneapolis Minnesota 55416

Jones-Harrison Assisted Living is committed to the whole being of our residents providing them with the best possible opportunity to continue to lead full and independent lives

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

dermatologyconsultantscom

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

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November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

may also produce severe diarrhea and allergic reactions and may build up resistance to future antibiotics

Instead patients with viral forms of acute bronchitis should try to alleviate symptoms That includes plenty of rest and fluids to keep well hydrated Also commonly recommended hu-midifiers cough drops to help keep the throat moist anti-pain and anti-fever medicines such as ibupro-fen or acetaminophen cough suppressants such as dextromethorphan and mucus-thinning medication such as guaifenesin These treatments are all avail-able over the counter

Many people think that a cough with mucus production means there is a bacterial infection but this is a myth It is normal for a virus to cause mucus production which can be clear white yellow green or brown An antibiotic will not cure this Sometimes people expect to get an antibiotic for bron-chitis because they got one the last time they had bronchitis and it seemed to make it go away This is almost always a coincidence of timing since bronchitis usually goes away within one to three weeks on its own

Acute bronchitis can be miserable and patients often seek med-ical care because the cough is causing lack of sleep missed work or school and trouble talking or exercising Most healthy people with acute bronchitis will get over it within a few weeks though and

there is no cure that can make it go away faster You may be able to save yourself a trip to the doctor if you focus on giving your body a chance to heal while alleviating your symptoms with the abovemen-tioned treatments However some people should go to the doctor

when they get bronchitis They include children six months and under pregnant women adults age 65 and older people with asthma or emphysema or any other chronic lung condition heavy smokers heavy drinkers of alcohol and anyone else with a compromised immune system These people are more likely to get a complication of bronchitis such as pneumonia

There are also certain symptoms that should prompt a visit to the doctor when there is a cough that seems like bronchitis These include a fever above 1004degF that lasts longer than 24 hours increasing or se-vere shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis

The best ways to prevent acute bronchitis are to not smoke to wash hands frequently especially during cold and flu season and to avoid contact with other people who are coughing

A fairly common complication of acute bronchitis is called the ldquopost infectious coughrdquo This is characterized by a lingering dry

Bronchitis to page 32

November 2015 MInneSOTA HeALTH cAre neWS 15

Antibiotics are not effective against the

viruses that cause most cases of acute bronchitis

Did you knowbull Diabetic retinopathy can be controlled and

diabetic patients need regular eye exams tomaintain vision and good eye health

bull Diabetes Type ll can also cause vision changesbull Glaucoma must be diagnosed in early stages in

order to prevent vision lossbull All children entering school need a comprehen-

sive eye exam because vision screenings do notdetect a number of eye disorders

bull To maintain eye health everybody from babiesto boomers to older adults needs a regular eyeexam by a family eye doctor

To locate an optometrist near you and find comprehensive information about eye health visit

httpMinnesotaaoaorg

Minnesota Optometric Association

Doctors on the frontline of eye and vision care

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

[ ] AD Anne Taylor

[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

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V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

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V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

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V Infertility evaluation and treatment

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Clinics in Maple Grove Plymouth and Crystal

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several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Burnsville 9524358516

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Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

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60

70

0

10

20

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60

70

0

10

20

30

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60

70

0

10

20

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40

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0

10

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0

5

10

15

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25

30

35

0

5

10

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25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

OncOlOgy

Skin cancer is the most common form of cancer in the US In 2015 22 million Americans will be diagnosed with either basal cell by far the most common or squamous cell carcino-

ma according to the American Cancer Society Another 73870 will be diagnosed with malignant melanoma It is more important than ever to know the warning signs of these cancers their treatments and preventive steps you can take

PreventionDespite the staggering numbers skin cancer is one of the most preventable forms of cancer Regular use of sunscreen protective hats and clothing is key to skin cancer prevention The best thing

you can do is to apply a broad-spectrum sunscreen Check labels for products that filter both UVA and UVB light with SPF ratings of 30 or higher Apply 30 minutes before going out in the sun and again after 30 minutes of continual exposure Remember that sunscreen needs to be reapplied every two hours or immediately after swim-ming or heavy sweating

Skin cancers and treatmentActinic keratosis (AK) a type of precancer occurs when UV

light damages skin cells AKs are rough dry or scaly areas that develop over sun-exposed skin and are considered precancerous lesions Some studies have shown that topical retinoids derivatives of vitamin A in prescription creams often used for acne can treat precancers as well as improve signs of sun damage Topical vitamin C serums are believed to have an antioxidant effect on the skin and help prevent signs of sun damage

Although wersquore learning more about the benefits of vitamin A and vitamin C we typically recommend proven in-office treatments Your dermatologist may use liquid nitrogen to ldquofreezerdquo and kill the bad cells If you have multiple AKs your dermatologist may recom-mend photodynamic therapy or ldquoblue-lightrdquo After a topical medi-cation is applied to the AKs to render them more sensitive to light the area is exposed to a specific wavelength of visible non-UV light destroying the precancer cells This type of therapy is also used in some cases of more advanced skin cancers

To treat some AKs we may prescribe a topical prescription cream containing 5-fluorouracil (5-FU) applied over a two- to four-week period Imiquimod a topical immune-stimulator causes a localized immune response in the skin to combat AKs Ingenol mebutate a derivative of a plant sap and diclofenac a topical medication with an

Prevention detection and treatmentBy Kathryn Barlow MD and Julie Cronk MD

16 MInneSoTA HeAlTH CARe newS November 2015

Skin cancer

H2462_92682 Accepted 10142015 HealthPartners is a Cost plan with a Medicare contract Enrollment in HealthPartners

depends on contract renewal copy2015 HealthPartners

Our Medicare plans help you live an active life Yoursquore free to roam with our

travel coverage And yoursquoll likely be free to keep your doctor Learn more at

healthpartnerscommedicare

Freedom Medicare Do more of what you love

Medicare

2INFORMATIONJob Number 245-14013 Trim 40 x 525 in Modifi cation Date October 23 2015 1258 PM

Client HealthPartners Bleed 40 x 525 in Output Date 102315

Description Medicare 2015 Print [Dog] [MN Health Care News 4x525]

Live 325 x 45 in Page 1

File Path ProductionClientsHealthPartners245-14013 Medicare 2015 Print Production

SIGN-OFF Notes

[ ] CD Peter Tressel

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[ ] CW Terry Thomas

[ ] AS Mark Jenson

[ ] AM Linda Gogolin

[ ] PM Krista Kraabel

[ ] PA Mike Fritz

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

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MS =

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November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

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St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

ingredient similar to ibuprofen or other nonsteroidal anti-inflammato-ry drugs are also used topically to treat and remove AKs

If more conservative treatments fail carbon dioxide lasers can be employed to remove layers of skin ldquoresurfacingrdquo it to remove AKs

Basal cell carcinoma (BCC) the most common type of skin cancer usually starts as a sore or ldquopim-plerdquo that does not heal BCC is common in areas of chronic sun exposure BCCs are usually pink trans-lucent or skin colored although some can be more scar-like in appearance or may be flat scaly and red BCCs bleed easily when rubbed or even when washed Although they are usually slow-growing tumors they must be removed or they will continue to grow deeper and wider Basal cell carcino-ma rarely spreads to other parts of the body but if yoursquove had one BCC you have about a 40 percent chance of having another one

Squamous cell carcinoma (SCC) cancers can arise from precancers (AKs) and are also related to chronic sun expo-sure They usually appear as a wart or scaly pink bump that may be tender and may bleed These tumors have a higher chance of metas-tasizing than BCC but the overall risk is still low

Melanoma is the most serious type of skin cancer because it has a much higher potential to metastasize The American Cancer Soci-ety estimates there will be 73870 cases in 2015 and 9940 deaths Melanoma lesions are usually dark irregular spots that can start as a new mole or are an existing mole that has begun to change Be-cause melanoma can be life threatening you need to watch for these ldquoABCDerdquo signs in new or changing moles

bull Asymmetry in which the two halves of the lesion do not match

bull Borders that are irregular or jagged rather than smooth and even

bull Colors that are varied and multiple including various shades of brown blue black or even sometimes red

bull Diameters that are greater than that of a pencil eraser (6mm) Keep in mind that melanomas can also be smaller than this however

bull Evolution or change to any mole

Surgical and nonsurgical approachesThe good news is that BCCs and SCCs are easily treated especially when diagnosed early when the lesion is small There are several methods of treating these cancers and your dermatologist can help you decide which method is best given the location tumor type and other characteristics

Mohs surgery is a method of treating non-melanoma skin cancer with a 98 to 99 percent cure rate This procedure involves numbing the area with a local anesthetic then removing the tumor along with a small rim of normal tissue The tissue is then cut into thin sections and put on microscope slides and stained so the doctor can examine 100 percent of the margins The dermatologist who should have specific training for Mohs surgery can then go back to

any area with remaining tumor and remove more skin from just that area once the entire tumor is removed the doctor can then repair the area or it may heal by itself This method is reserved for specific locations such as the head and neck hands and feet or other areas that require sparing as much normal skin as possible It is also used

for more aggressive or larger tumors and tumors in persons with suppressed immune systems

Simple excision is another common way of treating non-complicated basal and squamous cell carcinomas Most melanomas are also treated with this method The surgeon takes an appropriate mar-gin of normal skin and usually closes the area with stitches Certain patients with melanoma may also

require surgical removal of a lymph node which is examined for spread of the cancer Fortunately recent research has given doc-tors new drugs to use for cases of metastatic melanoma Before these discoveries there were limited treatments for more serious cases of melanoma

Many basal cell carcinomas and su-perficial less serious squamous cell carcinomas can be treated by a method called electrodessication and curettage or ldquoscrape and burnrdquo This involves scraping out the tumor cells with an instrument called a curette and then destroying the cells with electrocautery or

Skin cancer to page 19

November 2015 MInneSoTA HeAlTH CARe newS 17

Skin cancer is one of the most preventable

forms of cancer

I am passionate about being an advocate for the elderly and disabled including in maltreatment injury and wrongful death claims

Other services includebull nursing home litigation

bull health care agent appointments

bull elder abuse and neglect

bull elder mediation

bull nursing home resident rights

bull estate planning

bull speaker

Please contact

Suzanne M Scheller Esq Scheller Legal Solutions LLC6312 113th Place NorthChamplin MN 55316

7636470042suzyschellerlegalsolutionscom

Elder and Advocacy Services

wwwschellerlegalsolutionscom

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

Eagan bull St Paul bull Vadnais Heights bull Woodbury bull 651-209-1600

dermatologyconsultantscom

Age 76 Squamous Cell Carcinoma

Age 25Melanoma

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CURED CURED CURED

SunButterreg is for peanut and nut allergic children and great for everyone

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

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ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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10

20

30

40

50

60

70

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70

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0

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0

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15

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35

0

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

International Survivors of Suicide Loss DayInternational Survivors of Suicide Loss

Day (Nov 21) is a day when family and friends affected by suicide loss gather to remember their loved ones and find com-fort healing and support

More than 41000 suicides occurred in the US in 2013 according to the Centers for Disease Control and Prevention making it the 10th leading cause of death in the country Suicide almost always results from the pain and desperation of a mental illness according to the American Founda-tion for Suicide Prevention (AFSP) which says that at least 90 percent of all people who died by suicide were suffering from a mental illness at the time

When a friend or loved one takes their own life it can leave a lot of unanswered questions and a range of intense emotions including loneliness pain grief anger sadness and guilt Reaching out to a qualified mental health professional for counseling or joining support groups of other people who have experienced a loss from suicide can help with the healing process Find more information and resources at wwwafsporg

18 Minnesota HealtH care news November 2015

Calendar Nov-Dec 2015Nov18 Scleroderma Support Group

The Scleroderma Foundation Minnesota Chapter presents this free support group for those affected by scleroderma to share concerns information peer support and encouragement For more information call Karen at (952) 926-8848

Wednesday Nov 18 6ndash730 pm Southdale Medical Building Rm C-62A 6545 France Ave S Edina

19 Binge Eating Disorder Class Park Nicolletrsquos Melrose Center offers this

free information session for anyone who would like to learn what binge eating disorder is and what treatments are available No registration required Call 952-993-1000 for more information

Thursday Nov 19 6ndash 7 pm Melrose Center 3525 Monterey Dr St Louis Park

Dec2 Weight Loss Surgery Support Group

The University of Minnesota Medical Center hosts this free support group for patients who have undergone weight loss surgery or those who are considering it No registration neces-sary Friends and family members welcome Call (612) 626-6666 for more information

Wednesday Dec 2 630ndash8 pm University of Minnesota Medical Center East BuildingmdashBrennan Center 2450 Riverside Ave Minneapolis

4 Parkinsonrsquos Disease Support GroupAllina Health offers this free support group

for people affected by Parkinsonrsquos disease to learn more about available resources and share questions concerns and feelings about the disease Call Sue at (612) 273-3868 to sign up or for more information

Friday Dec 4 1ndash3 pm Fairview Rehab Services 2200 University Ave W Ste 140 St Paul

8 Coping with Cancer RecurrencePark Nicollet presents this free class

for people experiencing a cancer recurrence to share their experiences and connect with others sharing similar experiences Call (952) 993-5700 to sign up

Tuesday Dec 8 1030ndash1130 am Park Nicollet Frauenshuh Cancer Center Curtis amp Arlene Carlson Family Community Rm 3931 Louisiana Ave S St Louis Park

10 Car Seat ClinicHealthPartners offers this free class to

teach parents and caregivers how to install and use child car restraints Seven out of 10 car and booster seats are installed incorrectly according to the Minnesota Department of Public Safety Come learn the correct way from trained technicians Call (651) 357-2798 to set an appointment time

Thursday Dec 10 Regions Hospital 640 Jackson St St Paul

21 Brain Tumor Support GroupHealthEast hosts this free support group

for brain tumor survivors and their loved ones Join the informal group discussion for support education and a source of hope and encouragement No registration required other dates are available Call Kathy at (651) 232-3987 to sign up or for more information

Monday Dec 21 7ndash830 pm St Josephrsquos Hospital 3M Conference Center Rms AB 45 W 10th St St Paul

28 Parents of Children with Special Needs Group

Arc Greater Twin Cities hosts this free net- working group for parents of children with all types of intellectual and developmental disabilities Come meet others in similar situations and gain insights from their experiences For more information or to sign up call at (952) 920-0855

Monday Dec 28 6ndash8 pm Therapy OPS 2925 Buckley Way Inver Grove Heights

Dec3 Survivors of Suicide Support Group

Have you experienced the death of a loved one through suicide This support group hosted by Bradshaw Grief Resource Center will connect you with other individuals and families who understand For more information call (651) 489-1349 Thursday Dec 3 7ndash8 pm Bradshaw Group 4600 Greenhaven Dr White Bear Lake

Send us your newsWe welcome your input If you have an event you would like to submit for our calendar please send your submission to MPPCalendar 2812 E 26th St Minneapolis MN 55406 Email submissions to amarlowmppubcom or fax them to (612) 728-8601 Please note We cannot guarantee that all submissions will be used CME CE and symposium listings will not be published

Americarsquos leading source of health

information online

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

weight loss surgery (bariatrics)

Gallbladder

hernia

endocrine (parathyroid thyroid and adrenal)

Gastric Reflux

bowel (colon resections)

oncologycancer

technoloGYRobot

advanced laparoscopy

endoscopy

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

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Burnsville 9524358516

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Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

November 2015 MInneSoTA HeAlTH CARe newS 19

burning This method is quick and simple and the area heals in a couple of weeks

Some BCCs and SCCs can be treated by non-surgical methods Photodynamic therapy may be used to treat some superficial types of BCCSCC usually in several sessions

when lesions are superficial an anticancer cream can sometimes be used The advantage to this method is that the risk of scarring is great-ly reduced The main disadvantage is that the chances of curing the tumor are usually lower than with surgical methods especially if the tumor is deeper or more aggressive

one of the anticancer creams involves immunotherapy a form of cancer treatment that uses your bodyrsquos immune system to attack cancer cells Imiquimod draws your immune systemrsquos attention to the area to kill the cancer cells with interferon It can make the treated area become red and irritated but that ceases when you stop using the medication A course of treatment usually lasts several weeks

Chemotherapy cream is another way to treat certain superficial skin cancers 5-fluorouracil is a topical chemotherapy cream that is

also used for several weeks and has some of the same side effects we see with Imiquimod

Finally there are a couple of oral medications that have been approved for the treatment of ad-vanced or metastatic BCC These drugs are mostly used in rare cases where a patient cannot tolerate surgery or where the tumor has spread beyond the skin to other parts of the body Cure rates with these drugs are lower than with surgery and side effects can limit their use

ConclusionKnowing how skin cancer is treated is import-ant However the best way to treat skin cancer is to avoid getting it in the first place Skin can-cer is preventable with proper use of sunscreen avoiding tanning beds and seeing your doctor every year for a full-body skin screening And if you see any mole that is changing bleeding or itching make an appointment with your dermatologist

Kathryn Barlow MD and Julie cronk MD are fellows of the American Academy of Dermatology and board-certified dermatologists with Dermatol-ogy Consultants Dr Cronk is also a fellow of the American College of Mohs Surgery

Skin cancer from page 17

Recent research has given doctors new drugs to use

If yoursquore a Baby Boomer age 65 or older itrsquos time to fi nd your groove with Medicare UCare is ready with health plans that are as fl exible and forward-thinking as you are

UCare for SeniorsSM lets you choose from plans that cover prescription drugs travel eyewear dental fi tness programs like Healthways SilverSneakersreg Fitness and more There are low or no co-pays for primary care visits with most plans And yoursquoll get to talk to a real person 247 when you call customer service Itrsquos just what yoursquod expect from health care that starts with you

Learn more about the benefi ts of UCare for Seniors in our new eGuide to Medicare at ucareplansorg Or call (toll free) 1-877-523-1518 (TTY) 1-800-688-2534 8 am to 8 pm daily

UCare for Seniors is an HMO-POS plan with a Medicare contract Enrollment in UCare for Seniors depends on contract renewal copy2015 UCare H2459_101512 CMS Accepted (10202012)

YOU STILL HAVE ALL THE RIGHT MOVES WErsquoVE BEEN EXPECTING YOU

UC693 2015 Boomer MPP MN Health Care News_Hippieindd 1 91415 903 AM

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

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Gallbladder

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Gastric Reflux

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oncologycancer

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advanced laparoscopy

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Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

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Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Home Care

Betty nervously waits in the doctorrsquos office for them to call her name Shersquos had an eventful couple of weeks Her husband died only a month ago and last week she ended up in the

emergency room (ER) after she fell in her kitchen With everything that was going on she forgot to fill her prescription As she sits there she holds on tight to her purse which contains a complete list of her current medications (did she remember all of them) as her thoughts wander to her recent trip to the ERmdashshersquos fearful the doctors will suggest she stop driving Without a car how will she

get to the store church or knitting groupmdashshe looks forward to that group each week Instantly she feels sad for the second time this month and worries about her independence eroding Finally her name is called and shersquos in the clinic exam room An hour later shersquos in her car thinking ldquoWhy didnrsquot I ask the questions I had Whatrsquos this new medication supposed to do again Am I calling the occupational therapist or are theyrdquo Her mind wanders againmdashldquoHas it really been just a few weeks since Joe died I need to stop at his grave on my way home Funny the doctor never asked about thatrdquo

A few weeks later Betty ends up in the hospital And the cycle continues

A growing problemBettyrsquos situation is an example of an all-too-familiar experience shared by seniors and those who care for them most often their adult children This roller coaster of health care crisis is costing seniors more than they realize hitting not just their finances but also their quality of life In 2014 nearly 18 percent of Medicare patients who were hospitalized were readmitted within one month costing an estimated $26 billion Of that amount $17 billion represented readmissions that were potentially avoidable This readmission impact has hit 27 percent of Minnesota hospitals with 36 facilities being penalized for high readmission rates

As Bettyrsquos example illustrates it isnrsquot just a ldquohealth carerdquo issuemdashit is a life issue A study by researchers at Bostonrsquos Beth Israel Deaconess Medical Center (Annals of Internal Medicine June 2015) found that many of the risk factors for readmissions especially those occurring eight days or longer after discharge are beyond the typical scope of hospital efforts with many involving socioeconomic status or access to personal support systems There is widespread recognition of the need for change Ten years ago Lifesprk began building a new model to do exactly that start with peoplersquos individ-ual wishes and goals then use a whole person approach combined with ongoing advocacy and guidance

A new approach Life care managersImagine the difference if Betty had had someone with her at her doctorrsquos appointment Better yet if she had a nurse by her side who

20 MInnESOTA HEALTH CARE nEWS November 2015

Helping seniors live healthier happier lives

By Angela Nelson RN

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

suRGical eXPeRtisebreast cancer

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Gallbladder

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advanced laparoscopy

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Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

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November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

would ask the right questions record the information and relay that information to Bettyrsquos family The nurse would help Betty and her family keep the focus on her goals and wishes taking a whole person approach to get to know Betty and what matters most to her The nurse would be an advocate in the midst of all of Bettyrsquos life changes regardless of whether she was at home in the doctorrsquos office in the hospital or even in a nursing home

nurses like this are called life care managers (LCMs) We have seen improved outcomes for seniors who use LCMs as part of their whole person senior care approach LCMs carefully monitor seniorsrsquo health to make sure small issues donrsquot be-come larger ones This proactive approach eliminates unplanned hospitalization and dramatically reduces long-term care costs Itrsquos also helping seniors to live healthier more independent lives something Life sprk calls living a ldquosparked liferdquo

In 2014 Lifesprk conducted a baseline study to document the impact of its whole person senior care approach We tracked hospitalizations and ER visits as well as quality of life indicators such as connectedness happiness control and engagement Com-paring data on client experiences in the year prior to our services

with data from one year after these services the study found a 73 percent reduction in hospitalizations and a 52 percent reduction in ER visits for community clients While many factors contribute to this reduction one of the key factors for this success is the use of an

LCM who is trained to address not only any concerns seniors face but also their individual goals purpose and passion

The LCM roleLCMs become the trusted advocate for a personrsquos whole lifemdashencompassing everything from health and wellness to purpose and passion It all starts with an innovative discovery process In Bettyrsquos case long before she ended up in the physicianrsquos waiting room the LCM would have worked with her to identify her specific goals and passions and to help her and her family build a pathway to those goals Those goals can be as simple as continuing to attend church and her

knitting group each week or as complex as travel and regaining the strength to walk Her dedicated LCM would then work side-by-side with Betty and her family to implement their plan and to catch any issues that would interfere with reaching those goals

November 2015 MInnESOTA HEALTH CARE nEWS 21

LCMs cross all settings and work with every

type of provider

Life care managers to page 30

To schedule an appointment at any of our 13 locations please call 763-780-6699 or visit wwwsgsmncom

RemaRkable caRewhen it counts

we realize that any surgery is a major event in your life thatrsquos why we make every effort to make you feel at ease when you visit specialists in General surgery yoursquoll receive care that is tailored to you as an individual From discussing the details of your surgery in familiar terms to helping answer any questions our coordinated team of surgeons and staff will be with you every step of the way

at specialists in General surgery you can count on us to provide you the surgical expertise you need and the remarkable care you deserve

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Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Behavioral health

Health care providers regularly communicate with their patients through online portals email and text messages video discussions and more Much of this communication

involves routine matters but in the case of mental health assessment and treatment the telehealth umbrella has expanded to include

actual ongoing therapy sessionsmdashan arrangement that seems to work for patients and providers on both ends of the line

A growing trendAll telehealth services require an adjustment to new technology For mental health services the adjustment goes beyond connection speeds and web savvy Mental health therapy sessions often require discussion of concerns and problems that are hard enough for some patients to share in person and sharing these private matters in a video discussion may seem threatening at first For this reason when telehealth services were first developed most medical professionals thought that they could be most helpful for superficial commu-nications such as routine check-in appointments with a primary medical professional The very notion of delivering mental health assessmentsmdashor providing ongoing mental health treatmentmdashvia telehealth services was considered to be too radical for both patients and their mental health professionals

To the surprise of many this turned out not to be the case Adventuresome mental health professionals and their patients grad-ually eased into video sessions finding to their surprise that video sessions actually can work very well Research supports this obser-vation One recent report examined 92 studies comparing Inter-net-based therapy with in-person therapy concluding that the differ-ences between the two were ldquonot statistically significantrdquomdashoverall they were about equal with regard to both effectiveness and patient satisfaction A separate review of 148 studies focusing on video men-tal health therapy revealed high levels of patient satisfaction

Patient experiencesThere are several possible reasons that video mental health sessions could be preferable to in-person sessions For example many Minne-sotans live in parts of the state that are underserved by mental health providers Video sessions allow them to receive much-needed mental health services in their community avoiding long-distance travel to the closest mental health clinic which could be in another county or

22 MInnesOTA HeAlTH cARe news November 2015

Online mental health services

By Richard F Sethre PsyD LP and Deb Rich PhD LP CPLC

Click here for therapy

V Low- and high-risk obstetrics

including older moms-to-be

V Certified nurse midwifery

V Gynecologic care including well-woman screenings and in-office procedures

V Gynecologic surgeries including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

V Menopause Clinic including management of peri-menopause

V Center for Urinary and Pelvic Health including urodynamics (urinary leaking evaluation)

V Nutrition and wellness consultations

V Infertility evaluation and treatment

Patient-friendly early morning evening and Saturday hours

Appointments

763-587-7000

Clinics in Maple Grove Plymouth and Crystal

wwwOakdaleOBGYNcom

The Best Choice for Womenrsquos Health Care

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

Skin cancer can occur at any age but when caught early it is the most curable cancer

Screening bull Diagnosis bull Treatment

We are the skin cancer experts offering Mohs surgery the most advanced skin cancer treatment available Request an appointment online or call 651-209-1600

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Age 76 Squamous Cell Carcinoma

Age 25Melanoma

Age 55 Basal Cell Carcinoma

CURED CURED CURED

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

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This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

several hours away from home Other patients may lack transpor-tation or have mobility problems that limit their ability to drive or suffer from chronic pain or chronic weakness All of these patients may find it difficult or even impossible to use the limited transpor-tation options available to them and many welcome the opportunity to see their mental health professional in the comfort of their own home

People with fear of leaving their home (agoraphobia) or fear of interacting with other people (social anxiety) may also pre-fer video sessions At some point in their treatment it will be necessary for them to venture out to face their anxieties but early on in their treatment it actually may be preferable for them to remain in the safety of their home

while not always possible most patients are most comfortable if they have at least one in-person meeting with their psychiatrist or therapist before shifting to video sessions This may vary with age though Younger patients tend to gain comfort with video sessions more quickly than older people who did not grow up using computers and socializing with Facebook FaceTime and other social networking tools Other people who have come to expect the convenience of social networking online shopping and other digital conveniences may expectmdashand even demandmdashthe same level of convenience for their mental health needs

some individual patients are in particular need of video mental health services One of the authors of this piece specializes in mental health services for women who have experienced challenges during or after pregnancy or who have required extensive treatment in the hope of getting pregnant she has been contacted by women who live in remote rural areas in the Us or live abroad They may have arranged for periodic travel to a central area for standard prenatal care However once having experienced significant medical and emotional challenges they may become desperate for the help of a specialist without access to her video services these patients would have remained isolated and without adequate care she has found video sessions to be remarkably effective and appreciated Her patients usually reach out by email and are able to schedule a session within days Intake forms and financial contracts are all handled by email The therapy is supplemented with vetted websites for resource information and support Most of these patients have shown dra-matic improvement with just a few sessions without timely access to her specialty telehealth services these women may have unneces-sarily struggled with tragic circumstances and treatable conditions

Video mental health sessions may also be very beneficial for peo-ple in urban areas who may have adequate access to mental health services but are busy with work or family needs Research has found that many people who use mental health video sessions appreciate the convenience of eliminating travel time to their sessions For others who cannot afford the travel necessary to get to in-person appointments video sessions can encourage them to seek the help they need

Before you log onIf you are interested in trying video mental health services here is what you should know

bullYou will need to confirm that your insurance company covers telehealth services and that it will pay for video mental health

services Due to increasing awareness of the benefits to patients and the cost savings to insurers an increasing number of insurance companies are doing somdashbut confirm this before you start

bullYouwillneedtofindapsychiatristortherapist who has the interest skills and resources to provide video services contacting your insurance company or doing an online search will help you locate these professionals

bullIfpossibleitishelpfultomeetatleastonce in person This helps to build comfort for both the patient and the mental health professional but may

not always be possible when the patient is in a remote area has seri-ous mobility problems or is highly anxious about leaving the home

bull Therapists need to ensure that the telehealth services that they are providing are in compliance with the rules of their licensing

Online mental health services to page 31

November 2015 MInnesOTA HeAlTH cARe news 23

Confirm that your insurance company

covers telehealth services

Read us onlineWherever you are

wwwmppubcom

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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SUNFLOWER SPREAD

End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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10

20

30

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70

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70

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Hematology

ldquoJane Smithrdquo is a 45-year-old woman who is meeting with her family physician at a nearby clinic for her annual wellness exam She is concerned because she has felt tired and weak

for the last few months At times she is short of breath and her friends have even commented that she appears pale As patients often do she has done some of her own research online Could it be anemia she asks

This is a common question for physicians to address Although there are a multitude of causes for fatigue anemia is certainly one possibility Janersquos doctor gets her complete history and performs a thorough examination When her blood count test comes back with a low hemoglobin count of 95 Janersquos suspicion of anemia is confirmed So now what What is the next step Before her family doctor can pursue treatment options with Jane it is important to review the definition of anemia address symptoms and risk factors and attempt to determine the cause

Definition and symptomsAnemia is a condition in which there are not enough healthy red blood cells to carry the right amount of oxygen to the tissues in the body Anemia can be caused by inadequate production of red blood cells blood loss or the inappropriate destruction of red blood cells in the body Based on the cause anemia may be a temporary problem or it can continue over several years

The red blood cells made in the bones carry a protein known as hemoglobin that delivers oxygen and carbon dioxide to the tissues A normal hemoglobin level is 12 to 16 gmdL for women and 14 to 18 gmdL for men Anemia can vary in severity If the hemoglobin loss is gradual over time it may not be recognized until it is profoundly low

Symptoms of anemia are varied but most people will experience fatigue and weakness Other common symptoms include pale skin rapid heartbeat shortness of breath chest discomfort or headache It is important to note that some people have no symptoms at all For example a patient like Jane may donate blood and then be told that her counts are ldquooffrdquo In this case the physician may ask Jane if she has a family history of anemia such as thalassemia or sickle cell anemia or a bleeding disorder any of which could lead to inap-propriate loss of blood The physician should also question if she is taking a blood thinner like aspirin which can lead to bleeding in the intestine It would also be prudent to ask about Janersquos menstrual cycle and the possibility of pregnancy as both may provide a clue to the underlying cause of her low hemoglobin levels

24 MInneSOTA HeALTH CAre neWS November 2015

AnemiaSimple fatigue or something

more seriousBy Julie Anderson MD FAAFP CIC

For directions or additional information about the Minneapolis Clinic of Neurology

Visit us online at wwwminneapoliscliniccom

Exceptional Personalized Neurologic Care

Burnsville 9524358516

Coon Rapids 7634278320

Edina 9529207200

Golden Valley 7635880661

Maple Grove 7633024114

Outreach Clinics throughout MN amp western WI

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

fibromyalgia reliefbull Detoxification

bull Core body temperature supportbull Improved circulationbull Lymphatic drainagebull Relief from persistent infectionbull Speeds healing of soft tissue injuries

Have You heardabout the BioMat

Mini BioMat 33x20$65000

BioMat Professional 74x28$165000

For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Vitamin deficienciesWith hundreds of different known types of anemia to consider searching for the source can be daunting Many cases of anemia are due to vitamin deficiency which as the name implies results from inadequate levels of certain vitamins in the body

Iron deficiency the most common of vitamin deficiencies can be caused by blood loss from injury heavy periods colon polyps or ulcers as well as from inadequate iron absorption from prior digestive surgeries or inflammatory bowel diseases like Crohnrsquos disease or celiac disease It may also be due to a diet deficient in iron and typically is treated with iron replacement

Deficiencies of other vitamins including folic acid and B12 can also cause anemia If Jane is an alcoholic there is a good chance this could be an underlying cause of this type of anemia Some patients get plenty of B12 in their diet but their bodies do not absorb the vitamin adequately resulting in the more rare illness known as pernicious anemia

Family physicians will typically run a complete blood count and test vitamin levels to help determine whether vitamins are to blame If so treatment would consist of replacement of the appropriate vitamin Iron-rich foods including meat beans and dark leafy

vegetables should be taken with vitamin C which aids in the absorption of iron Folate may be found in fruits vegetables and

cereals B12 is often fortified in foods

Medical conditionsBecause virtually any chronic medical condition can affect the production of red blood cells many people with chronic illness also suffer from anemia In patients with kidney disease cancers and inflamma-tory disorders physicians can differentiate this type of anemia from iron deficiency by looking at the various sizes and shapes of the red cells in the blood and by ruling out other sources of low hemoglobin Therefore it is important for patients to tell their doctors about any past medical problems as these may provide a clue

to the cause of the anemia Before concluding that the chronic disease is the cause of anemia it is worth investigating other potential causes ldquoAnemia of chronic diseaserdquo is typically a diag-nosis made only after all others are excluded

Other types of anemia may be caused by improper manufacturing of the red blood

cells as is the case in various diseases such as multiple myeloma myelodysplasia or leukemia If these conditions are suspected the physician can typically determine the source by looking at the condition of the other cells in the blood or in the bone marrow

Anemia to page 29

November 2015 MInneSOTA HeAlTH CAre neWS 25

Anemia may be a temporary problem or it can continue over several years

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Screening bull Diagnosis bull Treatment

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End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

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November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

End-of-LifE issuEs

What will happen if you experience a serious illness that prevents you from making your own health care deci-sions How will you ensure that you receive the kind of

care you want Will your family know enough about your values to feel comfortable making medical decisions on your behalf To adequately address these questions every adult Minnesotan should do advance care planning (ACP)

Advance care planning is importantAt some point serious illness will probably prevent you from being able to make or communicate your own health care decisions You will lose decision making ldquocapacityrdquo the ability to understand the significant benefits risks and alternatives to proposed health care and to make and communicate a health care decision You will be unable to direct your medical care Unless you plan for this you will likely be treated in ways and in settings that you do not want

Fortunately you can take steps now to make your ldquovoicerdquo heard later Advance care planning (ACP) is the process of discussing and documenting your end-of-life wishes Because ACP allows you to specify in advance how you want to be treated it helps assure that you receive medical care aligned with your values and preferences The goal is to ensure both that you get the care you want and that you avoid the care you do not want

ACP is a multistep process First have multiple conversations with your family friends and clinicians to explore and consider your health care values and goals For example if you were dying how important would it be to avoid pain and suffering even if it means that you might not live as long How important is it to be alert even if it means that you might be in pain Would you rather be more conscious and have some pain Or would you rather have less pain and be groggier

Once you have identified your values and goals you need to communicate them There are three main objectives 1) choose your health care agent 2) document your preferences and values and 3) translate your preferences and values into medical orders

Choose your own health care agent When you are unable to make your own medical decisions you will want to select someone whom you trust to make those decisions on your behalf If you do not make a selection one will be made for you But that is a risky approach The person whom someone else (like a probate court judge) selects may be unaware or unwilling to follow your wishes Choose your own health care agent

In Minnesota the main written legal instrument for identifying a substitute decision maker is the ldquohealth care directiverdquo This is a

Specify your wishes nowBy Thaddeus Mason Pope JD PhD

26 MInnesOTA HeAlTH CAre neWs November 2015

Advance care

planning

MSA - MN Healthcare July 2013pdf 1 61213 1523

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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For more details please visit wwwcrystalbiomatcom

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

simple form that includes a health care power of attorney by which you can formally appoint your ldquohealth care agentrdquo You should probably also designate one or more alternate back-up agents in case your first named agent is not reasonably available to serve

By appointing an agent you are not surrendering any con-trol Your agents will not have authority to make health care decisions for you unless you lack decision-making capacity If you can decide and speak for yourself clinicians will look to you not to your agents Further-more even when they have au-thority your agents must make health care decisions for you based both on any instructions that you provide in your health care directive and on any wishes you made known to the agent Finally note that health care directives cover only health care decisions They have no effect over financial affairs that are unrelated to your health care

Document your preferences and values In the same health care directive through which you appoint your health care agent you can also include health care ldquoinstructionsrdquo This part of the directive used to be known as a ldquoliving willrdquo These instructions are written statements of your values preferences or guidelines regarding health care Typically these specify what medical treatment you do or do not want under certain stated medical circumstances

For example would you want to be maintained on a mechanical ventilator (breathing machine) if you were permanently uncon-scious Would you want medicine to treat pneumonia if you had the incurable brain illness known as Alzheimerrsquos and were unable to recognize your family or carry on a conversation The better forms and worksheets go beyond a narrow focus on specific interventions and also help you more broadly define the things that make your life worth living

While most health care directive instructions are about medi-cal treatment you can also include two other types of instructions First you can clarify your intentions regarding anatomical gifts Do you want to donate any parts of your body including organs tis-sues and eyes when you die second you can clarify your intentions regarding funeral practices What do you want to happen with your body (burial cremation)

Translate your preferences and values into medical orders ev-ery adult Minnesotan should have an advance health care directive But some Minnesotans should not stop there In addition those who are already seriously ill or frail with a life-limiting or terminal illness should also have Provider Orders for life-sustaining Treatment (POlsT) POlsT is designed to document wishes only in the final stages of life so it is appropriate only when death within the next year would not be unexpected

POlsT has several advantages First while there are dozens of advance directive forms there is a single standardized Minnesota POlsT It is only one double-sided page usually on bright pink pa-per This uniformity and simplicity makes the form easy to find and

easy to follow second POlsT follows the person in any care setting (hospital nursing home residence) Third unlike an advance health care directive POlsT is intended to apply immediately not only upon the satisfaction of certain specified conditions

readers may recall the August 2015 case in which Ma-plewood paramedics stopped re-suscitation efforts on a 71-year-old nursing home resident at her husbandrsquos request Those paramedics were later placed on administrative leave emer-gency workers like eMTs and paramedics are legally required to prolong the lives of dying patients unless they have a spe-

cific order from a physician A POlsT is such an order An advance health care directive is not

Periodically update your planning documentsACP is not a one-time event but an ongoing process As your life circumstances change so may your health care preferences experts recommend that you revisit your ACP documents at any of the five Drsquos every decade at the death of a loved one divorce new diagno-sis or significant decline in condition You can always change your

November 2015 MInnesOTA HeAlTH CAre neWs 27

Every adult Minnesotan should have an advance health care directive

Advance care planning to page 28

In the next issue

bull Preventing Winter Falls

bull Prostate Cancer

bull Rotator cuff injuries

Your Guide to Consumer Information

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

fibromyalgia reliefbull Detoxification

bull Core body temperature supportbull Improved circulationbull Lymphatic drainagebull Relief from persistent infectionbull Speeds healing of soft tissue injuries

Have You heardabout the BioMat

Mini BioMat 33x20$65000

BioMat Professional 74x28$165000

For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

mind about the care you want by revoking or updating your health care directive or POlsT

Local ACP resourcesWhile completing a health care directive is a standard part of any estate planning discussion you do not need a lawyer numer-ous ready-to-use resources are available to guide and record your advance care planning First several Minnesota state government

agencies (like the Department of Health and the Attorney Gener-alrsquos Office) provide ACP materi-als second most area hospitals and health insurance companies share ACP tools and forms both with their patients and on their websites Third many religious organizations distribute their own ACP materials Fourth doz-ens of expert nonprofit organi-

zations offer their ACP resources for free some of the most effective and respected are listed in the sidebar

Medicare coverage is comingFor decades physicians and other clinicians have been reluctant to take the necessary time to carefully address patientsrsquo wishes goals

and fears regarding their end-of-life care After all they are paid more for doing than for just talking While some private insurers already pay for ACP consultations this year Medicare announced plans to pay physicians to counsel patients about end-of-life options beginning on Jan 1 2016 since most private insurers follow Medi-carersquos lead ACP should soon be far more available

SummaryPlan your future medical care Discuss your end-of-life wishes and put them in writing These are not easy issues to talk about But they are some of the most important discussions that you will ever have Your wishes cannot be followed if no one knows what they are

Thaddeus Mason Pope Jd Phd is director of the Health Law Institute at Hamline University

Advance care planning from page 27

28 MInnesOTA HeAlTH CAre neWs November 2015

Advance care plannning is not a one-time event but an ongoing

process Advance Care Planning Resources

ABA Consumerrsquos Toolkit wwwamericanbarorggroupslaw_agingresourceshtml

Conversation Project theconversationprojectorg

five Wishes wwwagingwithdignityorgfive-wishesphp

Honoring Choices Minnesota wwwhonoringchoicesorg

national Health Care decisions day wwwnhddorg

PoLsT Minnesota wwwpolstmnorg

ldquoMultiple sclerosis upended the plans I had forcing me to face uncertainty Irsquove learned to adapt and focus on whatrsquos truly important to merdquo

mdash Susan diagnosed in 1995

What does MS equal to youJoin the Movementreg at MSsocietyorg

dreams lost dreams rebuilt

MS =

pubed11_MNHealthAdindd 1 52511 1058 AM

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

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ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

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bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

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40

50

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70

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0

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0

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

November 2015 MInneSOTA HeALTH CAre neWS 29

Hemolytic anemia is a condition in which the red blood cells are inappropriately destroyed in the body before their normal lifespan is over This can be the result of infection cancer medications or inherited conditions affecting the bodyrsquos hemoglobin such as thalassemia or sickle cell disease In patients with these latter two conditions the blood count may suggest iron deficiency leading health care providers to treat them inappropriately with iron There-fore it is critical to consider thalassemia or sickle cell disease in patients that are at risk for them

Thalassemia a blood disorder affecting the production of hemoglobin is inherited in a recessive manner This means that if both of your parents carry a gene you have a one in four chance to inherit the condition Millions of people partic-ularly those of Mediterranean descent carry a beta-thalassemia genetic trait

Sickle cell disease another recessive genetic disorder causes the red blood cells to take on an unusual shape It also makes it difficult for the red cells to carry hemoglobin and therefore oxygen around the body This condition can lead to many health problems including severe pain caused by blood vessel constriction stroke or even death Most people with the sickle cell trait are of African descent The national Institute of Health states that about one in 5000 people in the US have sickle cell disease

Treatment of sickle cell anemia consists of supplementing oxygen and administering pain-relieving medications while treat-ment of thalassemia may require blood transfusions or removal of the spleen

In general if an underlying source cannot be found after a phys-ical examination a review of the patientrsquos history and a laboratory evaluation it is important for the physician to investigate sources of

internal bleeding This may include an upper endoscopy of the stomach and small intestine as well as a colonoscopy

Getting back to our patientIn the case of ldquoJane Smithrdquo her family phy-sician determined that it was her heavy men-

strual periods that were causing her anemia She was treated with hormone therapy and iron replacement Janersquos doctor reviewed the importance of a follow-up appointment with her When she returned for another visit a few months later her anemia had been resolved Both the physician and patient were thankful that her symptoms had disappeared and because of proper treatment and communication between Jane and her doctor she is feeling better and is left with a greater understanding about her health

Julie anderson mD FaaFP CIC is a board-certified family physician at St Cloud Medical Group She is a past president of the Minnesota Academy of Family Physicians and a trustee on the American Academy of Family Physicians Foundation

Anemia from page 25

Some people have no symptoms at all

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

Duluth bull Mankato bull MetroMoorhead bull St CloudTe

lepho

neEq

uipm

ent

Dis

trib

utio

n(T

ED)

Prog

ram

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

fibromyalgia reliefbull Detoxification

bull Core body temperature supportbull Improved circulationbull Lymphatic drainagebull Relief from persistent infectionbull Speeds healing of soft tissue injuries

Have You heardabout the BioMat

Mini BioMat 33x20$65000

BioMat Professional 74x28$165000

For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

60

70

0

10

20

30

40

50

0

10

20

30

40

50

0

5

10

15

20

25

30

35

0

5

10

15

20

25

30

35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

In the clinic her LCM would have held her hand written down her concerns and listened as Betty shared stories of her husband The LCM would have guided the questions during her appointment then recorded and explained what it all meant so that Betty could incorporate the physicianrsquos orders into her daily life Another important role of the LCM is to keep families informed of health changes and updates helping to ease the burden of coordina-tion and caregiving demands on the family

The LCM also serves as a hub for the team of providers involved in the clientrsquos caremdasha service that is often missing or provided only on a short-term basis under other senior care models LCMs cross all settings and work with every type of provider They become the eyes and ears in the clientrsquos home providing hands-on support to implement the physicianrsquos care plan at home and address critical needs such as support for physician appointments and medication management They also address psychosocial and non-medical needs such as purpose and passion which are powerful ways to keep people active in control and healthy Remember Bettyrsquos passion for knitting

LCMs not only help with social supports but they encourage them Knowing that life can still continue according to their wishes

and goals even as their functionality may change gives seniors a heightened sense of wellbeing because they are engaged and happy This sense of purpose focuses their mind not on whatrsquos ailing them but on the meaning and richness of their life

Hope for the future The national Institutes of Health stresses the need ldquofor proven treatments and approaches that not only provide measurable outcomes but also take into account patientsrsquo wishes and

preferencesrdquo While Bettyrsquos story paints a common picture of todayrsquos senior there is hope that with new innovations and approaches to care providers will begin to see the value in focusing on the whole person and not just fragmented care with a narrow medical emphasis Research shows

that whole person senior care does in fact work to keep people out of the hospital and living healthier more independent lives

angela Nelson rN is director of community life care management for Lifesprk

Life care managers from page 21

30 MInnESOTA HEALTH CARE nEWS November 2015

Whole person senior care does in fact work

PUT THE SQUEEZE ON

HIGH BLOOD PRESSURE

The Minnesota Diabetes and Heart Health Collaborative Working together to keep you informed

bull Trackyourbloodpressureandsharewithyourdoctor

bull Medicinescanmakeadifferenceifyoutakethem

bull Eathealthyandbeactive

bull Avoidsalt

bull Donotsmoke

If you have diabetes controlling your blood pressure can help protect you from heart attack stroke blindness and kidney disease

Minnesota Diabetes ampHeart Health Collaborative

wwwmn-dcorgAdapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard

Do you have patients with trouble usingtheir telephone due to hearing loss speechor physical disability

If sohellipthe TED Programprovides assistive telephoneequipment at NO COSTto those who qualify

Please contact usor have your patientscall directly for moreinformation

1-800-657-3663wwwtedprogramorg

The Telephone Equipment Distribution Program is funded through theDepartment of Commerce Telecommunications Access Minnesota (TAM)and administered by the Minnesota Department of Human Services

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November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

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cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

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Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

November 2015 MInnesOTA HeAlTH cARe news 31

board You should expect the therapist to review this with you If in doubt be sure to ask about this

bullensuring privacy and confidentiality is always crucial for all mental health services and video sessions require a higher level of attention to these issues You will need to determine whether you can use skype or other online conferencing tools for example You should ask the mental health professional whether video sessions are encrypted and whether the sessions are saved as part of the treatment record

bullYou and your professional will need to have plans to handle technological problems as well as issues that arise during the session For example you will need a computer and Internet connection that are adequate for video conferencing since even the best technology will fail at times you will need to have a backup plan in case the video connection is dropped (usually a quick phone call can keep the discussion moving until the con-nection is reestablished) In particular the professional will need

to know what you will do if the video discussion is upsetting or if you get distressed and need support that cannot be provided online This usually involves having a plan for reaching out to friends or loved ones or allowing the professional to reach out to them and to have them check in with you

ConclusionResearch consistently finds that when mental health patients receive appro-priate mental health services at the time they need them they feel and do better In addition timely mental health services often reduce medical and other social expenses in the long run Video sessions can provide con-venient productive access to mental health services that might otherwise

not be available and can effectively serve patients while reducing medical expenses

richard F Sethre PsyD lP is a licensed psychologist and practice manage-ment consultant in Golden Valley with a special focus on health care psychol-ogy His Mental Health Concierge blog provides resources for consumers and professionals Deb rich PhD lP CPlC is a licensed psychologist in St Paul specializing in reproductive health psychology She is the founder and director of Shoshana Center for Reproductive Health Psychology and MommaCare Training and Outreach

Online mental health services from page 23

Video sessions can provide convenient productive access to

mental health services

the bene ts of yogaDiscoverRight now new students get a FREE WEEK of unlimited yoga

See you soon at any one of our 8 Minnesota locations

Eden Prairie bull Edina bull Minneapolis bull Minnetonka

St Louis Park bull St Paul bull Stadium Village bull Uptown We are so sure the BioMat will improve your health that we accept returns for full refund if you are not satisfied for any reason If you order through us you will also receive a 30 year repair guarantee and lifetime trade-in policy

This amazing medical-grade infrared heating mat can change your life for the better It is used in homes and professional healing practices all over the world The BioMat provides immediate and dramatic relief for people suffering from a wide variety of chronic

conditions that have not responded well to medication therapy A brief overview of benefits from using the BioMat

bull Stress and anxiety reliefbull Improved mobility and flexibilitybull Chronic and acute pain reliefbull Arthritis neuropathy and

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Have You heardabout the BioMat

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For more details please visit wwwcrystalbiomatcom

8666897336

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

0

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70

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70

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35

October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

S1

22

5rdquo

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5indd 1 111913 809 PM

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

cough despite healing from the virus of bronchitis It happens when the inflammation of bronchitis is so bad that the body has trouble healing the bronchi tissue It can sometimes last eight weeks or even longer but should not be accompanied by any fevers chills sweats weight loss or significant shortness of breath It is essential to see a doctor for any cough that lasts eight weeks or more even if no other concerning symptoms are present

Chronic bronchitisDefined by coughs lasting for at least three months at least two years in a row chronic bronchitis is a form of Chronic Obstructive Pulmonary Disease (COPD) The term ldquoobstructiverdquo means that air gets trapped in the lungs which can cause shortness of breath With chronic bronchitis people tend to get coughs very easily when exposed to viruses

The most common underlying cause of chronic bronchitis is a current or past history of smoking tobacco People with chronic bronchitis may need special medications when they get a bad cough including inhalers steroids such as prednisone and sometimes an antibiotic to prevent pneumonia Anyone who gets recurrent coughs should see a doctor to see if there could be underlying chronic bronchitis

ConclusionAcute bronchitis is very common especially during the winter months It is almost always caused by a virus that is easily spread from person to person and typically lasts two to three weeks or more Antibiotics are not effective against the viruses that cause most cases of acute bronchitis The usual treatments are air humid-ification cough drops and cough syrups See a physician if there is a fever above 1004degF that lasts longer than 24 hours increasing

or severe shortness of breath coughing up blood a cough that lasts longer than three to four weeks and recurrent episodes of bronchitis People with lowered immune systems such as babies pregnant women the elderly and those undergoing cancer or im-

mune disease treatments should see a doctor when they get bronchi-tis To prevent acute bronchitis this winter wash hands frequently avoid smoking and avoid contact with others who are coughing

Chronic bronchitis is usually caused by an underlying history of smoking and occurs when coughs happen frequently and recur-ringly This usually requires a different treatment strategy than acute bronchitis which may include inhalers steroids or antibiotics

Heather Hamernick MD is a board-certified family physician with Parkview Medical Clinic in New Prague Minn Her medical interests include urgent care travel medicine obstetrics pediatrics and evidence-based medicine

Bronchitis from page 15

32 MInneSOTA HeAlTH CAre neWS November 2015

Acute bronchitis produces coughs that typically last about one to three weeks

Each month members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system There is no charge to join the association and everyone is invited

1 I would support Minnesota legislation granting terminally ill patients the right to end their lives painlessly in a medically managed setting

3 I believe end-of-life legislation must guarantee that patient decisions are not infl uenced by any outside entity or by fi nancial considerations

5 I believe the difference between suicide and terminal illness must be made clear in legislation around end-of-life issues

2 I believe that the needs of the individual patient should outweigh political social or religious agendas in shaping policy regarding end-of-life decisions

4 I believe that end-of-life legislation must specify clearly the medical conditions that allow patients the choice to end their lives

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

Strongly agree

Agree No opinion Disagree Strongly disagree

For more information please visit wwwmnhccaorg

We are pleased to present results of the most recent survey

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October 2015 SurveyMINNESOTA HEALTH CARE CONSUMER ASSOCIATION

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

Preventive Cardiology Consultants6545 France Avenue Suite 125 Edina MN 55435

phone 9529295600 fax 9529295610 wwwpccmncom

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

S975rdquo

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Be heard in debates and discussions that shape the future of health care policy There is no cost to join this informed and informative online community

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys

wwwmnhccaorg

JOIN US

November 2015 Minnesota HealtH care news 33

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

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are interested in learning how to preventone we can design a set of just-for-yousolutions

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bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

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bull Dietary counselingExercise prescriptions

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Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

the report estimates that in 2008 about 6 to 13 percent of all residents in the twin cities metro area who died and about 2 to 5 percent who visited the hospital or emergen-cy room for heart and lung problems did so because fine particles or ground-level ozone (the two air pollutants with the most potential for direct harm to peoplersquos health) made their conditions worse

the findings of the report also reiterate the fact that air pollution doesnrsquot affect everyone in the same way the groups most affected by air pollution are people of color elderly residents children with uncontrolled asthma and people living in poverty Vulnerable pop-ulations may experience more health effects because these populations already have higher rates of heart and lung conditions and they often lack the resources to deal with the added stress of air pollution as a result they experience more hospital-izations emergency room visits for asthma and death related to air pollution in addition minorities and those of lower socio-economic status tend to live in areas where they are exposed to higher levels of air pollution

Learn moreMPca and MDH with support from their partners have developed a website called Be air aware (httpsbeairawaremnorg) which

features data on air quality and health outcomes and showcases projects developed funded and implemented through clean air Minnesota Minnesotarsquos voluntary public-private partnership on air quality clean air Minnesota is a forum for leaders from business nonprofit organizations and government to work together to lessen the impacts of air pollution

Be air aware is a new resource for citizens communities and businesses con-cerned about health and air quality the site distills and simplifies information about all major air pollutants in Minnesotamdashboth outdoor air and indoor air it provides valu-able tips to protect individuals and families information on current air condition and

forecasts and relevant research about air pollution it also has some best practices and tips for business owners to consider

monika vadali PhD is a research scientistrisk assessor at the Minnesota Pollution Control Agency focusing primarily on facility air emissions She earned her doctorate in environmental health at the University of Minnesota

The effects of air quality from page 13

34 Minnesota HealtH care news November 2015

Air pollution doesnrsquot affect everyone in

the same way

Elizabeth Klodas MDFASCC is a preventive

cardiologist She isthe founding Editor inChief of CardioSmart

for the AmericanCollege of Cardiologywwwcardiosmartorg

a published authorand medical editor for

webMD She is a memberof several national

committees on improvingcardiac health and afrequent lecturer on

the topic

Preventive Cardiology Consultants isfounded on the fundamental belief thatmuch of heart disease can be avoidedin the vast majority of patients andsignificantly delayed in the rest by prudentmodification of risk factors and attainablelifestyle measures

We are dedicated to creating a true part-nership between doctor and patient workingtogether to maximize heart health Wespend time getting to know each patientindividually learning about their lives andlifestyles before customizing treatmentprograms to maximize their health

Whether you have experienced any typeof cardiac event are at risk for one or

are interested in learning how to preventone we can design a set of just-for-yousolutions

Among the services we provide

bull One-on-one consultations withcardiologists

bull In-depth evaluation of nutrition andlifestyle factors

bull Advanced and routine blood analysis

bull Cardiac imaging including (as required)stress testing stress echocardiographystress nuclear imaging coronary calciumscreening CT coronary angiography

bull Vascular screening

bull Dietary counselingExercise prescriptions

Now accepting new patients

A unique perspective on cardiac care

To schedule an appointment or to learn more about becominga patient please contact

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Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

Victozareg (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY Please consult package insert for full prescribing information

WARNING RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carci-noma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitor-ing with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions]

INDICATIONS AND USAGE Victozareg is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus Important Limitations of Use Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise Based on spon-taneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitis Victozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settings The concurrent use of Victozareg and prandial insulin has not been studiedCONTRAINDICATIONS Do not use in patients with a personal or family history of medullary thyroid car-cinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsWARNINGS AND PRECAUTIONS Risk of Thyroid C-cell Tumors Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas andor carcinomas) at clinically rele-vant exposures in both genders of rats and mice Malignant thyroid C-cell carcinomas were detected in rats and mice A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls It is unknown whether Victozareg will cause thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies In the clinical trials there have been 6 reported cases of thyroid C-cell hyperplasia among Victozareg-treated patients and 2 cases in comparator-treated patients (13 vs 10 cases per 1000 patient-years) One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations gt1000 ngL suggesting pre-existing disease All of these cases were diagnosed after thyroidectomy which was prompted by abnormal results on routine protocol-specified measurements of serum calcitonin Five of the six Victozareg-treated patients had elevated calcitonin concentrations at baseline and throughout the trial One Victozareg and one non-Victozareg-treated patient developed elevated calcitonin concentrations while on treatment Calcitonin a biological marker of MTC was measured throughout the clinical development program The serum calcitonin assay used in the Victozareg clinical trials had a lower limit of quantification (LLOQ) of 07 ngL and the upper limit of the refer-ence range was 50 ngL for women and 84 ngL for men At Weeks 26 and 52 in the clinical trials adjusted mean serum calcitonin concentrations were higher in Victozareg-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator At these timepoints the adjusted mean serum calcitonin values (~10 ngL) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 01 ngL or less Among patients with pre-treatment serum calcitonin below the upper limit of the reference range shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victozareg 18 mgday In trials with on-treatment serum calcitonin measurements out to 5-6 months 19 of patients treated with Victozareg 18 mgday developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 08-11 of patients treated with control medication or the 06 and 12 mg doses of Victozareg In trials with on-treatment serum calcitonin measurements out to 12 months 13 of patients treated with Victozareg 18 mgday had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range compared to 06 0 and 10 of patients treated with Victozareg 12 mg placebo and active control respectively Otherwise Victozareg did not produce consistent dose-dependent or time-dependent increases in serum calcitonin Patients with MTC usually have calcitonin values gt50 ngL In Victozareg clinical trials among patients with pre-treatment serum calcitonin lt50 ngL one Victozareg-treated patient and no comparator-treated patients developed serum calcitonin gt50 ngL The Victozareg-treated patient who developed serum calcitonin gt50 ngL had an elevated pre-treatment serum calcitonin of 107 ngL that increased to 307 ngL at Week 12 and 535 ngL at the end of the 6-month trial Follow-up serum calcitonin was 223 ngL more than 25 years after the last dose of Victozareg The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 193 ngL at baseline to 448 ngL at Week 65 and 381 ngL at Week 104 Among patients who began with serum calcitonin lt20 ngL calcitonin elevations to gt20 ngL occurred in 07 of Victozareg-treated patients 03 of placebo-treated patients and 05 of active-comparator-treated patients with an incidence of 11 among patients treated with 18 mgday of Victozareg The clinical significance of these findings is unknown Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (eg a mass in the neck dysphagia dyspnea or persistent hoarseness) It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC and such monitoring may increase the risk of unnecessary procedures due to low test specificity for serum calcitonin and a high background incidence of thyroid disease Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victozareg if serum calcitonin is measured and found to be elevated the patient should be referred to an endocrinologist for further evaluation Pancreatitis Based on spontaneous post-marketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg After initia-tion of Victozareg observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain sometimes radiating to the back and which may or may not be accompanied by vomiting) If pancreatitis is suspected Victozareg should promptly be discontinued and appropriate management should be initiated If pancreatitis is confirmed Victozareg should not be restarted Consider antidiabetic therapies other than Victozareg in patients with a history of pancreatitis In clinical trials of Victozareg there have been 13 cases of pancreatitis among Victozareg-treated patients and 1 case in a comparator (glimepiride) treated patient (27 vs 05 cases per 1000 patient-years) Nine of the 13 cases with Victozareg were reported as acute pancreatitis and four were reported as chronic pancreatitis In one case in a Victozareg-treated patient pancre-atitis with necrosis was observed and led to death however clinical causality could not be established Some patients had other risk factors for pancreatitis such as a history of cholelithiasis or alcohol abuse Use with Medications Known to Cause Hypoglycemia Patients receiving Victozareg in combination with an insulin secretagogue (eg sulfonylurea) or insulin may have an increased risk of hypoglycemia The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly admin-istered insulin secretagogues) or insulin Renal Impairment Victozareg has not been found to be directly nephrotoxic in animal studies or clinical trials There have been postmarketing reports of acute renal failure and worsening of chronic renal failure which may sometimes require hemodialysis in Victozareg-treated patients Some of these events were reported in patients without known underlying renal disease A majority of the reported events occurred in patients who had experienced nausea vomiting diarrhea or dehydration Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents including Victozareg Use caution when initiating or escalating doses of Victozareg in patients with renal impairment Hypersensitivity Reac-tions There have been postmarketing reports of serious hypersensitivity reactions (eg anaphylactic reactions and angioedema) in patients treated with Victozareg If a hypersensitivity reaction occurs the patient should discontinue Victozareg and other suspect medications and promptly seek medical advice Angio-edema has also been reported with other GLP-1 receptor agonists Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be pre-disposed to angioedema with Victozareg Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly com-pared to rates in the clinical trials of another drug and may not reflect the rates observed in practice The safety of Victozareg has been evaluated in 8 clinical trials A double-blind 52-week monotherapy trial com-pared Victozareg 12 mg daily Victozareg 18 mg daily and glimepiride 8 mg daily A double-blind 26 week add-on to metformin trial compared Victozareg 06 mg once-daily Victozareg 12 mg once-daily Victozareg 18

mg once-daily placebo and glimepiride 4 mg once-daily A double-blind 26 week add-on to glimepiride trial compared Victozareg 06 mg daily Victozareg 12 mg once-daily Victozareg 18 mg once-daily placebo and rosiglitazone 4 mg once-daily A 26 week add-on to metformin + glimepiride trial compared double-blind Victozareg 18 mg once-daily double-blind placebo and open-label insulin glargine once-daily A double-blind 26-week add-on to metformin + rosiglitazone trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and placebo An open-label 26-week add-on to metformin andor sulfonylurea trial com-pared Victozareg 18 mg once-daily and exenatide 10 mcg twice-daily An open-label 26-week add-on to metformin trial compared Victozareg 12 mg once-daily Victozareg 18 mg once-daily and sitagliptin 100 mg once-daily An open-label 26-week trial compared insulin detemir as add-on to Victozareg 18 mg + metformin to continued treatment with Victozareg + metformin alone Withdrawals The incidence of withdrawal due to adverse events was 78 for Victozareg-treated patients and 34 for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer This difference was driven by withdrawals due to gastrointestinal adverse reactions which occurred in 50 of Victozareg-treated patients and 05 of comparator-treated patients In these five trials the most common adverse reactions leading to with-drawal for Victozareg-treated patients were nausea (28 versus 0 for comparator) and vomiting (15 versus 01 for comparator) Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials Common adverse reactions Tables 1 2 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer Most of these adverse reactions were gastrointestinal in nature In the five double-blind clinical trials of 26 weeks duration or longer gastrointestinal adverse reactions were reported in 41 of Victozareg-treated patients and were dose-related Gastrointestinal adverse reactions occurred in 17 of comparator-treated patients Common adverse reactions that occurred at a higher incidence among Victozareg-treated patients included nausea vomiting diarrhea dyspepsia and constipation In the five dou-ble-blind and three open-label clinical trials of 26 weeks duration or longer the percentage of patients who reported nausea declined over time In the five double-blind trials approximately 13 of Victozareg-treated patients and 2 of comparator-treated patients reported nausea during the first 2 weeks of treatment In the 26-week open-label trial comparing Victozareg to exenatide both in combination with metformin andor sulfo-nylurea gastrointestinal adverse reactions were reported at a similar incidence in the Victozareg and exenatide treatment groups (Table 3) In the 26-week open-label trial comparing Victozareg 12 mg Victozareg 18 mg and sitagliptin 100 mg all in combination with metformin gastrointestinal adverse reactions were reported at a higher incidence with Victozareg than sitagliptin (Table 4) In the remaining 26-week trial all patients received Victozareg 18 mg + metformin during a 12-week run-in period During the run-in period 167 patients (17 of enrolled total) withdrew from the trial 76 (46 of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9 of withdrawals) doing so due to other adverse events Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued unchanged treatment with Victozareg 18 mg + metformin During this randomized 26-week period diarrhea was the only adverse reaction reported in ge5 of patients treated with Victozareg 18 mg + metformin + insulin detemir (117) and greater than in patients treated with Victozareg 18 mg and metformin alone (69)Table 1 Adverse reactions reported in ge5 of Victozareg-treated patients in a 52-week monotherapy trial

All Victozareg N = 497 Glimepiride N = 248Adverse Reaction () ()Nausea 284 85Diarrhea 171 89Vomiting 109 36Constipation 99 48Headache 91 93

Table 2 Adverse reactions reported in ge5 of Victozareg-treated patients and occurring more frequently with Victozareg compared to placebo 26-week combination therapy trials

Add-on to Metformin TrialAll Victozareg + Metformin

N = 724Placebo + Metformin

N = 121Glimepiride + Metformin

N = 242Adverse Reaction () () ()Nausea 152 41 33Diarrhea 109 41 37Headache 90 66 95Vomiting 65 08 04

Add-on to Glimepiride TrialAll Victozareg +

Glimepiride N = 695Placebo + Glimepiride

N = 114Rosiglitazone +

Glimepiride N = 231Adverse Reaction () () ()Nausea 75 18 26Diarrhea 72 18 22Constipation 53 09 17Dyspepsia 52 09 26

Add-on to Metformin + GlimepirideVictozareg 18 + Metformin + Glimepiride N = 230

Placebo + Metformin + Glimepiride N = 114

Glargine + Metformin + Glimepiride N = 232

Adverse Reaction () () ()Nausea 139 35 13Diarrhea 100 53 13Headache 96 79 56Dyspepsia 65 09 17Vomiting 65 35 04

Add-on to Metformin + RosiglitazoneAll Victozareg + Metformin +

Rosiglitazone N = 355Placebo + Metformin + Rosiglitazone

N = 175Adverse Reaction () ()Nausea 346 86Diarrhea 141 63Vomiting 124 29Headache 82 46Constipation 51 11

Table 3 Adverse Reactions reported in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Exenatide

Victozareg 18 mg once daily + metformin andor sulfonylurea

N = 235

Exenatide 10 mcg twice daily + metformin andor sulfonylurea

N = 232Adverse Reaction () ()Nausea 255 280Diarrhea 123 121Headache 89 103Dyspepsia 89 47Vomiting 60 99Constipation 51 26

Table 4 Adverse Reactions in ge5 of Victozareg-treated patients in a 26-Week Open-Label Trial versus Sitagliptin

All Victozareg + metformin N = 439

Sitagliptin 100 mgday + metformin N = 219

Adverse Reaction () ()Nausea 239 46Headache 103 100Diarrhea 93 46Vomiting 87 41

Immunogenicity Consistent with the potentially immunogenic properties of protein and peptide pharma-ceuticals patients treated with Victozareg may develop anti-liraglutide antibodies Approximately 50-70 of Victozareg-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 86 of these Victozareg-treated patients Sampling was not performed uniformly across all patients in the clinical trials and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies Cross-reacting anti-liraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 69 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 48 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials These cross-reacting antibodies were not tested

for neutralizing effect against native GLP-1 and thus the potential for clinically significant neutralization of native GLP-1 was not assessed Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 23 of the Victozareg-treated patients in the double-blind 52-week monotherapy trial and in 10 of the Victozareg-treated patients in the double-blind 26-week add-on combination therapy trials Among Victozareg-treated patients who developed anti-liraglutide antibodies the most common category of adverse events was that of infections which occurred among 40 of these patients compared to 36 34 and 35 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively The specific infections which occurred with greater frequency among Victozareg-treated anti-body-positive patients were primarily nonserious upper respiratory tract infections which occurred among 11 of Victozareg-treated antibody-positive patients and among 7 7 and 5 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Among Victozareg-treated antibody-negative patients the most common category of adverse events was that of gastrointestinal events which occurred in 43 18 and 19 of antibody-negative Victozareg-treated placebo-treated and active-control-treated patients respectively Antibody formation was not associated with reduced efficacy of Victozareg when comparing mean HbA1c of all antibody-positive and all antibody-negative patients However the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victozareg treatment In the five double-blind clinical trials of Victozareg events from a composite of adverse events potentially related to immunogenicity (eg urticaria angioedema) occurred among 08 of Victozareg-treated patients and among 04 of comparator-treated patients Urticaria accounted for approximately one-half of the events in this composite for Victozareg-treated patients Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies Injection site reactions Injection site reactions (eg injection site rash erythema) were reported in approximately 2 of Victozareg-treated patients in the five double-blind clinical trials of at least 26 weeks duration Less than 02 of Victozareg-treated patients discontinued due to injection site reactions Papillary thyroid carcinoma In clinical trials of Victozareg there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victozareg and 1 case in a comparator-treated patient (15 vs 05 cases per 1000 patient-years) Most of these papillary thyroid carcinomas were lt1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound Hypoglycemia In the eight clinical trials of at least 26 weeks duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients (23 cases per 1000 patient-years) and in two exenatide-treated patients Of these 11 Victozareg-treated patients six patients were concomitantly using metformin and a sulfonylurea one was concomitantly using a sulfonylurea two were concomitantly using metformin (blood glucose values were 65 and 94 mgdL) and two were using Victozareg as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treat-ment during a hospital stay) For these two patients on Victozareg monotherapy the insulin treatment was the likely explanation for the hypoglycemia In the 26-week open-label trial comparing Victozareg to sitagliptin the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose lt56 mgdL was comparable among the treatment groups (approximately 5)Table 5 Incidence () and Rate (episodespatient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials

Victozareg Treatment Active Comparator Placebo ComparatorMonotherapy Victozareg (N = 497) Glimepiride (N = 248) NonePatient not able to self-treat 0 0 mdashPatient able to self-treat 97 (024) 250 (166) mdashNot classified 12 (003) 24 (004) mdashAdd-on to Metformin Victozareg + Metformin

(N = 724)Glimepiride +

Metformin (N = 242)Placebo + Metformin

(N = 121)Patient not able to self-treat 01 (0001) 0 0Patient able to self-treat 36 (005) 223 (087) 25 (006)Add-on to Victozareg + Metformin

Insulin detemir + Victozareg + Metformin

(N = 163)

Continued Victozareg + Metformin alone

(N = 158)

None

Patient not able to self-treat 0 0 mdashPatient able to self-treat 92 (029) 13 (003) mdashAdd-on to Glimepiride Victozareg +

Glimepiride (N = 695)Rosiglitazone +

Glimepiride (N = 231)Placebo +

Glimepiride (N = 114)Patient not able to self-treat 01 (0003) 0 0Patient able to self-treat 75 (038) 43 (012) 26 (017)Not classified 09 (005) 09 (002) 0Add-on to Metformin + Rosiglitazone

Victozareg + Metformin + Rosiglitazone

(N = 355)

None

Placebo + Metformin + Rosiglitazone

(N = 175)Patient not able to self-treat 0 mdash 0Patient able to self-treat 79 (049) mdash 46 (015)Not classified 06 (001) mdash 11 (003)Add-on to Metformin + Glimepiride

Victozareg + Metformin + Glimepiride

(N = 230)

Insulin glargine + Metformin +

Glimepiride (N = 232)

Placebo + Metformin + Glimepiride

(N = 114)Patient not able to self-treat 22 (006) 0 0Patient able to self-treat 274 (116) 289 (129) 167 (095)Not classified 0 17 (004) 0

One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat This patient had a history of frequent hypoglycemia prior to the studyIn a pooled analysis of clinical trials the incidence rate (per 1000 patient-years) for malignant neoplasms (based on investigator-reported events medical history pathology reports and surgical reports from both blinded and open-label study periods) was 109 for Victozareg 63 for placebo and 72 for active comparator After excluding papillary thyroid carcinoma events [see Adverse Reactions] no particular cancer cell type predominated Seven malignant neoplasm events were reported beyond 1 year of exposure to study medica-tion six events among Victozareg-treated patients (4 colon 1 prostate and 1 nasopharyngeal) no events with placebo and one event with active comparator (colon) Causality has not been established Laboratory Tests In the five clinical trials of at least 26 weeks duration mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 40 of Victozareg-treated patients 21 of placebo-treated patients and 35 of active-comparator-treated patients This finding was not accompanied by abnormalities in other liver tests The significance of this isolated finding is unknown Vital signs Victozareg did not have adverse effects on blood pressure Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victozareg compared to placebo The long-term clinical effects of the increase in pulse rate have not been established Post-Marketing Experience The following additional adverse reactions have been reported during post-approval use of Victozareg Because these events are reported voluntarily from a population of uncertain size it is generally not possible to reli-ably estimate their frequency or establish a causal relationship to drug exposure Dehydration resulting from nausea vomiting and diarrhea Increased serum creatinine acute renal failure or worsening of chronic renal failure sometimes requiring hemodialysis Angioedema and anaphylactic reactions Allergic reactions rash and pruritus Acute pancreatitis hemorrhagic and necrotizing pancreatitis sometimes resulting in deathOVERDOSAGE Overdoses have been reported in clinical trials and post-marketing use of Victozareg Effects have included severe nausea and severe vomiting In the event of overdosage appropriate supportive treat-ment should be initiated according to the patientrsquos clinical signs and symptomsMore detailed information is available upon request For information about Victozareg contact Novo Nordisk Inc 800 Scudders Mill Road Plainsboro NJ 08536 1minus877-484-2869Date of Issue April 16 2013 Version 6Manufactured by Novo Nordisk AS DK-2880 Bagsvaerd DenmarkVictozareg is covered by US Patent Nos 6268343 6458924 7235627 8114833 and other patents pending Victozareg Pen is covered by US Patent Nos 6004297 RE 43834 RE 41956 and other patents pendingcopy 2010-2013 Novo Nordisk 0513-00015682-1 52013

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The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks

The change begins at VictozaProcom

Victozareg is a registered trademark of Novo Nordisk AScopy 2013 Novo Nordisk All rights reserved 1013-00018617-1 December 2013

Indications and UsageVictozareg (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitusBecause of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans prescribe Victozareg only to patients for whom the potential benefits are considered to outweigh the potential risk Victozareg is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exerciseBased on spontaneous postmarketing reports acute pancreatitis including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victozareg Victozareg has not been studied in patients with a history of pancreatitis It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victozareg Other antidiabetic therapies should be considered in patients with a history of pancreatitisVictozareg is not a substitute for insulin Victozareg should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis as it would not be effective in these settingsVictozareg has not been studied in combination with prandial insulin

Important Safety InformationLiraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice It is unknown whether Victozareg causes thyroid C-cell tumors including medullary thyroid carcinoma (MTC) in humans as human relevance could not be ruled out by clinical or nonclinical studies Victozareg is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Based on the findings in rodents monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials but this may have increased the number of unnecessary thyroid surgeries It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors Patients should be counseled regarding the risk and symptoms of thyroid tumorsDo not use in patients with a prior serious hypersensitivity reaction to Victozareg or to any of the product componentsPostmarketing reports including fatal and non-fatal hemorrhagic or necrotizing pancreatitis Discontinue promptly if pancreatitis is suspected Do not restart if

pancreatitis is confirmed Consider other antidiabetic therapies in patients with a history of pancreatitisWhen Victozareg is used with an insulin secretagogue (eg a sulfonylurea) or insulin serious hypoglycemia can occur Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemiaRenal impairment has been reported postmarketing usually in association with nausea vomiting diarrhea or dehydration which may sometimes require hemodialysis Use caution when initiating or escalating doses of Victozareg in patients with renal impairmentSerious hypersensitivity reactions (eg anaphylaxis and angioedema) have been reported during postmarketing use of Victozareg If symptoms of hypersensitivity reactions occur patients must stop taking Victozareg and seek medical advice promptlyThere have been no studies establishing conclusive evidence of macrovascular risk reduction with Victozareg or any other antidiabetic drugThe most common adverse reactions reported in ge5 of patients treated with Victozareg and more commonly than in patients treated with placebo are headache nausea diarrhea dyspepsia constipation and anti-liraglutide antibody formation Immunogenicity-related events including urticaria were more common among Victozareg-treated patients (08) than among comparator-treated patients (04) in clinical trialsVictozareg has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patientsThere is limited data in patients with renal or hepatic impairment In a 52-week monotherapy study (n=745) with a 52-week extension the adverse reactions reported in ge 5 of patients treated with Victozareg 18 mg Victozareg 12 mg or glimepiride were constipation (118 84 and 48) diarrhea (195 175 and 93) flatulence (53 16 and 20) nausea (305 287 and 85) vomiting (102 131 and 40) fatigue (53 32 and 36) bronchitis (37 60 and 44) influenza (110 92 and 85) nasopharyngitis (65 92 and 73) sinusitis (73 84 and 73) upper respiratory tract infection (134 143 and 89) urinary tract infection (61 104 and 52) arthralgia (24 44 and 60) back pain (73 72 and 69) pain in extremity (61 36 and 32) dizziness (77 52 and 52) headache (73 112 and 93) depression (57 32 and 20) cough (57 20 and 44) and hypertension (45 56 and 69)

Please see brief summary of Prescribing Information on adjacent page

Victozaregmdasha force for change in type 2 diabetes

Weight loss up to 55 lbab

Low rate of hypoglycemiac

Reductions up to -11a

A change with powerful long-lasting benefits

a18 mg dose when used alone for 52 weeks bVictozareg is not indicated for the management of obesity Weight change was a secondary end point in clinical trials cIn the 8 clinical trials of at least 26 weeksrsquo duration hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victozareg-treated patients

A 52-week double-blind double-dummy active-controlled parallel-group multicenter study Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victozareg 12 mg (n=251) Victozareg 18 mg (n=246) or glimepiride 8 mg (n=248) The primary outcome was change in A1C after 52 weeks