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July Issue
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News & Information for Members
of the Kentucky Pharmacists Association
Vol. 7, No. 4
July 2012
TTHEHE KKENTUCKYENTUCKY
PPHARMACISTHARMACIST
RELEVANCE AND
RELATIONSHIPS
2012-13 KPhA President
Kimberly Sasser Croley
2012-13 KPhA President Kimberly S. Croley with her family, Bob, Robbie and Rachel.
July 2012
THE KENTUCKY PHARMACIST 2
Table of Contents
Table of Contents
Table of Contents— Oath— Mission Statement 2 President’s Perspective 3, 6-7 KPhA Professional Awards 4-5 KPERF Golf Scramble 8 2012 KPhA House of Delegates Report 9-10 134th KPhA Annual Meeting 11-15 July CE—GLP-1 Agonists Therapy 16-25 July Pharmacist/Pharmacy Tech Quiz 26 Pharmacy Time Capsules 27 From Your Executive Director 28 Bowl of Hygeia 29
Pharmacy Technician Certification Board 30 August CE— Asprin: Evolving Evidence 31-37 August Pharmacist/Pharmacy Tech Quiz 38 Pharmacists Mutual Companies 39 Pharmacy Law Brief 40-41 New Members of KPhA Board of Directors 42-43 Academy of Consultant Pharmacists Update 44 Sullivan University College of Pharmacy Graduates 45 Pharmacy Policy Issues 46-47 Fink named KPhA Professor in Leadership at UK 48 UK College of Pharmacy Graduates 49 KPhA Board of Directors 50 Frequently Called and Contacted 51
Oath of a Pharmacist
At this time, I vow to devote my professional life to the service of all humankind through the profession of
pharmacy.
I will consider the welfare of humanity and relief of human suffering my primary concerns.
I will apply my knowledge, experience, and skills to the best of my ability to assure optimal drug therapy
outcomes for the patients I serve.
I will keep abreast of developments and maintain professional competency in my profession of pharmacy.
I will embrace and advocate change in the profession of pharmacy that improves patient care.
I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.
Kentucky Pharmacists Association
The mission of the Kentucky Pharmacists Associa-
tion is to promote the profession of pharmacy, en-
hance the practice standards of the profession, and
demonstrate the value of pharmacist services within the
health care system.
Editorial Office:
© Copyright 2012 to the Kentucky Pharmacists Asso-ciation. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of member-ship dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.
Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email [email protected]. Website http://www.kphanet.org.
The Kentucky Pharmacy Education and Research Foun-
dation (KPERF), established in 1980 as a non-profit sub-
sidiary corporation of the Kentucky Pharmacists Associa-
tion (KPhA), fosters educational activities and research
projects in the field of pharmacy including career coun-
seling, student assistance, post-graduate education, con-
tinuing and professional development and public health
education and assistance.
It is the goal of KPERF to ensure that pharmacy in Ken-
tucky and throughout the nation may sustain the continu-
ing need for sufficient and adequately trained pharma-
cists. KPERF will provide a minimum of 15 continuing
pharmacy education hours. In addition, KPERF will pro-
vide at least three educational interventions through oth-
er mediums — such as webinars — to continuously im-
prove healthcare for all. Programming will be determined
by assessing the gaps between actual practice and ideal
practice, with activities designed to narrow those gaps
using interaction, learning assessment, and evaluation.
Additionally, feedback from learners will be used to im-
prove the overall programming designed by KPERF.
July 2012
THE KENTUCKY PHARMACIST 3
President’s Perspective
Adapted from KPhA President’s Address at Ray Wirth
Banquet, June 16, 2012
The Mission Statement of the Kentucky Pharmacists
Association is to promote the profession of pharmacy,
enhance the practice standards of the profession, and
demonstrate the value of pharmacist services within
the healthcare system. That certainly should be easy,
right?!
RELEVANCE and RELATIONSHIPS
Get used to hearing these two words. Everything I do
or say in this coming year will be related directly back
to RELEVANCE and RELATIONSHIPS. Why am I
using these two words to define my second term as
your President of KPhA? Because I believe they are
the quintessential ingredients to successfully keeping
KPhA strong, vibrant and meaningful to our member-
ship. They also provide the key to our movement to-
ward advancing the practice in new and innovative
ways.
Our Executive Director, Bob McFalls, and I recently
attended a leadership weekend co-sponsored by
Pharmacists’ Mutual Insurance and NASPA. It was
mediated by a lovely woman who really made us
delve deeply into what our perceptions of how we
could meet our membership’s needs versus what cur-
rent literature tells us that our membership states they
need. On some accounts, we were close to correct.
On others we were not in the ballpark. Toward the
end of the meeting, she reminded us that the word
“Association” is built around the word “Social” and
that it is truly human nature that is driving the Social
Media market not the other way around. She remind-
ed us that with FOUR GENERATIONS currently in
the workplace attempting to work together that
BUILDING RELATIONSHIPS and MAINTAINING
RELEVANCE is the only way to bridge the gap be-
tween these generations. Each generation looks at
another and asks, “Why do they do it like that?” It is a
right of passage that when you become old enough to
enter the workforce that you are allowed to ask that
question! At no other time has this question had more
relevance than now. We literally have pharmacists
(like myself) who started their career typing labels on
a manual typewriter (in my case a 1949 black Royal
with no number 1 so I used the lower case “L”) work-
ing alongside pharmacists who were not alive when
the Internet did not exist. We read articles all the time
discussing “digital natives” and I often wonder if I
qualify as even a “digital immigrant.” More often than
not I find myself an adapter rather than an adopter
because I have to wait until someone else shows me
how to use the technology on a daily basis. When I
think back to the proud feeling I had in college when I
wrote my first loop program in COBOL and now it is a
defunct computer language that most of you have
never heard of, I feel the weight of always playing
catch up to the younger people surrounding me.
Now, you are wondering how this relates back to my
two words, RELEVANCE and RELATIONSHIPS. I
believe for pharmacy to not only survive but flourish
as a healthcare profession that we must embrace the
different skill sets found between the generations and
use them to our advantage. Pharmacy is a “people
profession!” So often I hear pharmacists advise stu-
dents going to pharmacy school interviews, don’t say
“I want to be a pharmacist because I want to help
people.” I cannot fathom why they say that because
in my mind (and my heart) that is exactly what we do.
By embracing our differences, we older practitioners
can stay RELEVANT by learning new skills from the
new practitioners (especially technological skills) and
in turn we can help them learn how to build RELA-
TIONSHIPS.
Continued on Page 6
Kimberly Sasser
Croley
KPhA President
2012-2013
President’s Perspective
July 2012
THE KENTUCKY PHARMACIST 4
134th KPhA Annual Meeting
KPhA Professional Awards 2012
George F. Hammons, Barbourville, Ky., Bowl of Hygeia Award sponsored by the American Phar-
macists Association Foundation and the National Alliance of State Pharmacy Associations with sup-
port from Boehringer Ingelheim. Pictured with Amy Nicholas, Associate Director Healthcare Quality
and Outcomes at Boehringer Ingelheim and 2011-12 KPhA Chairman Clay Rhodes
Alyson Schwartz, Bardstown, Ky.
Pharmacist of the Year
Pictured with 2011-12 President Lewis
Wilkerson and Rhodes
Glenn Stark, Frankfort, Ky.
Distinguished Service Award
July 2012
THE KENTUCKY PHARMACIST 5
134th KPhA Annual Meeting
Patricia Robinson, Whitesburg, Ky., Technician of
the Year
Stacy Rowe, Louisville, Ky., Distinguished Young
Pharmacist of the Year, sponsored by Pharmacists
Mutual Insurance
Brian E. Fingerson, Louisville, Ky., Cardinal Health
Generation Rx Champions Award sponsored by
Cardinal Health Foundation. Pictured with Todd
Wright, Cardinal Health
Sullivan University College of Pharmacy student
chapter of APhA-ASP, Professional Promotion
Award
Lynn Harrelson, Louisville, Ky., Excellence in
Innovation Award sponsored by Upsher-Smith
Laboratories, Inc.
Senator Robert Stivers, (R-Manchester)
Meritorious Service Award
July 2012
THE KENTUCKY PHARMACIST 6
President’s Perspective
Continued from page 3
The digital age and smart phones have turned many
of us into isolationists without us realizing that is what
is happening. I see young people sitting around a ta-
ble together but not talking to one another because
they are busy texting someone else or surfing on the
Internet. By not having practiced talking to other peo-
ple they are at a disadvantage to those of us who talk
all the time (like me). We can teach active listening
skills and imprinting skills to younger pharmacists
making them more effective healthcare providers.
Working together, generations hand in hand, we all
become better pharmacists and find new relationships
that help us all move forward.
RELEVANCE also relates back to our colleges of
pharmacy. The student pharmacists who come to my
practice site are extremely well educated. Most an-
nounce to me on their first day that they plan to be a
clinical pharmacist not a
retail pharmacist. I am
afraid that I often shatter
their hopes on that first day
because I tell them that
every pharmacist is a clini-
cal pharmacist if they want
to be and that there are
many wonderful community
pharmacies but I do not
use the word retail unless I
am describing a clothing
store. In the recent report
to the Surgeon General on
the value of the pharmacist,
it was noted that 270+ mil-
lion people visit a community pharmacy each week.
There is absolutely no other profession that has that
kind of “Face Time” and they don’t have to own an
iPhone. We must parlay our accessibility as a strong-
hold for health and wellness. We must work with phy-
sicians to show them how we complement what they
do, not compete. KPhA’s honorees for Pharmacist of
the Year and Bowl of Hygeia have done just that. The
FDA is again discussing a “Pharmacist only” Class of
Drugs. But to prove our ability to manage disease,
monitor medication therapy, manage medication ther-
apy and take responsibility for dispensing our own
class of drugs, we are going to have to unchain the
computer stations and TALK TO PEOPLE. I realize
that the spot in front of the terminal is warm and
friendly but we are not computer programmers, we
are pharmacists and we don’t write in COBOL any-
more. We talk to patients and provide healthcare. Our
relationships with our patients make a difference to
their healthcare; take time to introduce yourself to new
patients. “Hello, my name is Kim Croley, and I am
your pharmacist.” Actively engage every patient on
refills; there is no better measure of adherence or abil-
ity to qualify appropriateness of therapy than by ask-
ing questions at the time of refills. In the hospital, take
the initiative to speak to patients on the nursing units.
Volunteer to work with the medication reconciliation
process at your hospital, I guarantee you will be able
to spot problems at the initial review.
At KPhA, we will be working alongside CAPP, our two
colleges of pharmacy at
UK and Sullivan, KSHP,
KY-ASCP Chapter and our
local affiliates to promote
our profession and its rele-
vance to the other profes-
sions within the healthcare
team, payers, legislators
and patients. Conversa-
tions will be held on your
behalf thru Rx Therapy
Management with other
entities to add new con-
tracts and clients for Medi-
cation Therapy Manage-
ment services. We will continue to add relevance to
our current contract with the Kentucky Retirement
System by helping their beneficiaries improve their
health and wellness. We will continue our conversa-
tions with the Medicaid managed care entities to show
the value added by the pharmacists and pharmacies
within their network and that by helping them “manage
care” thru appropriate medication use we have in es-
sence helped them “manage cost” which seems to be
a primary objective. Our Kentucky Pharmacy Educa-
tion and Research Foundation will be put to good use
KPhA President Kim Croley shares her vision with at-
tendees at the 2012 Ray Wirth Banquet.
July 2012
THE KENTUCKY PHARMACIST 7
President’s Perspective
helping us provide and coordinate continuous profes-
sional development. We will actively solicit continuing
education articles that broaden the knowledge base
and add to the skill sets of our members. We will work
with CAPP and our colleges of pharmacy and other
entities such as the state’s Quality Improvement Or-
ganization (QIO) also known as Health Care Excel to
engage in research opportunities that promote phar-
macists’ clinical activities and value to the healthcare
team. The Foundation will also look into setting up a
special fund for scholarships or grants and aids that
may accept memorial or honorary contributions from
members as part of its funding. Our Legislative net-
work promoting grass-
roots involvement and
the Government Af-
fairs contributions will
enhance our lobby-
ists’ efforts in show-
ing the relevance that pharmacists bring to the table.
I am going to ask our KPhA Board this year to stand
with me on your behalf and tell the world who we are
and what we do. We are healthcare providers and
medication use experts. We provide clinical services
and healthcare information that positively impacts dai-
ly life. We deserve compensation for the added value
we bring to the healthcare team whether it is fee for
service or a portion of a bundled payment. We should
have the authority to manage drug therapy as it re-
lates to disease states and we should have ready ac-
cess to all clinical information we need to make deci-
sions on our patients’ behalf. We are relevant to Man-
aged Care because we reduce unnecessary medica-
tions thus reducing cost. We are relevant to Health
Systems because we understand evidence-based
protocols and can operate independently within those
parameters. We are relevant to long-term care be-
cause we understand the complex drug regimens
coupled with the physiology of the senior adult. We
are relevant to Pediatrics because Dr. Kuhn has
taught us without a shadow of a doubt that pediatric
patients are not little adults! We are relevant to com-
munity pharmacies of all kinds because we build RE-
LATIONSHIPS with patients who
return to us time and again seeking
our knowledge, ex-
pertise, and care.
Every pharmacist in
every practice set-
ting is relevant and brings value to the healthcare
team. We must recognize that the small differences
between our practice choices simply add “different
flavorings” and don’t change the underlying greater
common human heart of us all. We must believe that
the trust forged in our relationships with patients is a
factor not often discussed but extremely relevant to
their health!
We must support each other in our pursuit of excel-
lence and relevance. “APRPh” is possible! We make
a difference! We are Pharmacists!
RELEVANCE RELATIONSHIPS
2012-13 KPhA Officers
Lewis Wilkerson — Chairman
Kimberly Sasser Croley — President
Duane Parsons — President-Elect
Frankie Hammons Abner — Secretary
Glenn Stark — Treasurer
July 2012
THE KENTUCKY PHARMACIST 8
134th KPhA Annual Meeting-KPERF Golf Scramble
2012 KPERF
Golf Scramble
1st Place: Robby Ryan, Cade Slaughter,
Kevin Lamping, Andy Young.
2nd Place: Chad Downing, Brian Smith,
Rahman Maniyar, Jarrod Carter.
Last Place: Mike Burleson, Kyle Burleson,
Steve Hart, Luke Hart.
Closest to Pin: Joel Thornbury.
Longest Drive: Chris Boling.
July 2012
THE KENTUCKY PHARMACIST 9
134th KPhA Annual Meeting-House of Delegates
Tyler Whisman, PharmD – 2012 Speaker of the
House
Matt Martin, PharmD – 2012 Vice-Speaker and
Chair of the Reference Committee
Joey Mattingly, PharmD – 2012 Parliamentarian
As usual, the 2012 KPhA Annual Meeting was quite a
success. While the meeting provides excellent contin-
uing education, networking opportunities and an in-
formative exhibit hall, the importance of the House of
Delegates can’t be understated. According to the
KPhA Bylaws, the House of Delegates meets at the
Annual Meeting to address important issues facing
the profession and the Association. A geographically
and professionally diverse group of Delegates from
the Commonwealth gathered to debate and make rec-
ommendations that will help shape the profession of
pharmacy.
Opening Session
The Opening Session of the House was held on
Thursday afternoon. Delegates received Committee
reports from the Professional Affairs, Government Af-
fairs and Organizational Affairs standing committees,
New Practitioner and Policy Review Ad Hoc commit-
tees and from Executive Officers. As you will see be-
low, the Board of Directors and each of the Commit-
tees were active over the past year and presented
several items for the House to consider. In addition to
committee and officer reports, Cassandra Beyerle
was nominated for the position of 2012-2013 Vice-
Speaker of the House of Delegates.
Reference Committee
Per KPhA House Rules, the Reference Committee
met on Friday morning to discuss the resolutions and
provide recommendations to the House. This meeting
was open to all KPhA members and was chaired by
Matt Martin. Members of the committee included, Bar-
ry Eadens, Kim Croley, Matt Carrico, Jamie Moline,
Lance Murphy, Ron Poole and Joey Mattingly
(Parlimentarian).
Closing Session
The closing House session was held on Saturday
morning where, after discussion of the Reference
Committee recommendations, the following resolu-
tions were passed:
2012.01 – Dues Change
The Board of Directors recommended a dues in-
crease effective January 1, 2013 as follows:
Active Member $225 Joint Member $335 Retired Member $120 1st Year Tier $70 2nd Year Tier $140 Joint Retired $180 Associate Member $225 Technician Member $50
2012.02 – Bylaws Change: Article 5.21 – Election
and Installation of Officers and Directors
In addition to a President, President-elect, Secretary,
Treasurer and Chair of the Board of Directors, the
Board of Directors shall have nine Directors. No more
than two of these nine Directors may be from the
same geographic region. Geographic regions shall
be determined by the Board of Directors every five
years with the advice and consent of the Organiza-
tional Affairs Committee.
Upon recommendation from the Reference Commit-
tee, the House charged the KPhA Board of Directors
to develop a policy establishing equitable representa-
tion on the Board. This policy shall be brought for-
ward for a vote at the 2013 KPhA House of Dele-
gates.
2012.03 – Bylaws Change: Article 1.14 – Techni-
cian Members
Any individual who is a Certified Registered Pharma-
cy Technician in good standing with the Pharmacy
Technician Certification Board Board of Pharmacy is
eligible for technician membership. Technician mem-
bers shall not be eligible to vote or hold office in the
Report of the 134th KPhA House of Delegates
July 2012
THE KENTUCKY PHARMACIST 10
134th KPhA Annual Meeting-House of Delegates
Association except as may be
provided by Article 9.15.
2012.04 – Compensation Trans-
parency
KPhA supports the development
of a transparent national standard
database for the cost of multi-
source generic products that is
updated in real time to be used in
determination of compensation
from payers.
2012.05 – Pseudoephedrine
KPhA strongly supports efforts to
reduce or eliminate the misuse of
pseudoephedrine and its nega-
tive impact on the citizens of the
Commonwealth.
KPhA supports legislative and law-enforcement ef-
forts to curtail the misuse of pseudoephedrine and
encourages policies that will provide access to the
best tools for that purpose which may include, but is
not limited to making pseudoephedrine a legend or
Scheduled drug without compromising patient care.
Our unique perspective from the front-lines of Ken-
tucky’s healthcare system gives us valuable insight
as to how those tools might be best utilized once
they are identified.
In addition to official policy statements that were
adopted, the House addressed other items as well.
Cassandra Beyerle was officially elected and appro-
priately sworn in as Vice-Speaker of the House of
Delegates. The House also approved the five candi-
dates to be submitted to the Governor for considera-
tion of appointment to the Board of Pharmacy. The
individuals are: Clinton Joseph Carr – Daviess Coun-
ty; Larry Allen Hadley – Franklin County; Don Bryan
Kupper – Oldham County; Peter Joseph Orzali, Jr. –
Campbell County and Joel Craig Thornbury – Pike
County. Additionally, the House approved the Board
of Directors’ recommendation for new appointments
to the RxTM Board of Managers (Clay Rhodes, Ange-
la Onkst and Tera McIntosh).
Looking Toward the Future
As previously stated, the House of Delegates once
again proved to be a forum for passionate debate re-
garding the future of the profession. KPhA now has
an official policy statement that will support efforts to
combat the misuse of pseudoephedrine in our state.
Furthermore, KPhA adopted a statement that ad-
dresses the compensation of multiple source products
and expanded opportunities for membership into the
Association. As we look toward the future, continued
change in the profession has to be acknowledged and
expected. Thus, if you are interested in helping shape
the future of the profession, consider serving on a
committee or becoming a delegate to the 135th KPhA
House of Delegates in 2013!
2012 Speaker of the House Tyler Whisman presides over the 134th KPhA House
of Delegates Opening Session at the 134th KPhA Annual Meeting at the Griffin
Gate Marriott Resort in Lexington, Ky. Below: The Reference Committee meets.
July 2012
THE KENTUCKY PHARMACIST 11
134th KPhA Annual Meeting
Thousands of
“Words” from
the 134th KPhA
Annual Meeting
All Photos
by Kelly Flora
Photography
except where
noted
Marriott Griffin Gate
Resort and Spa Lexington, KY
June 13-16, 2012
July 2012
THE KENTUCKY PHARMACIST 12
134th KPhA Annual Meeting
KPhA Would Like to Thank Our 2012 Sponsors
Event Sponsors American Pharmacy Services
Corporation Humana
Jefferson County Academy of Pharmacists
KY Governor’s Office of Health Information Exchange
KPhA District 1 Kentucky Independent Pharmacist
Alliance Kroger Co.
Medica Pharmacy Northern Kentucky Pharmacists
Association Perform Rx
Poole’s Pharmacy Care Rx Therapy Management
Sullivan University College of Pharmacy
University of Kentucky College of Pharmacy
Sponsoring Pharmacy’s Future KPhA Board of Directors
Frankie Hammons Abner Amanda Stark Burton
Leon Claywell Chris Clifton
Kimberly Croley Trish Freeman Joey Mattingly
Matt Martin Jeff Mills
Duane Parsons
J. Clay Rhodes Richard Slone, in memory of
Donald Lippert Glenn Stark Leah Tolliver
Tyler Whisman Lewis Wilkerson
Sam Willett
Cardinal Health Robert McFalls and staff National Association of Chain Drug Stores
KPERF Golf Hole Sponsors
AmerisourceBergen American Pharmacy Services Corp.
Capital Pharmacy and Medical Equipment
Leon and Margaret Claywell in honor of Alyson Schwartz, Pharmacist of the
Year The Clifton Family
Grant County Drugs & Custom Compounding
George Hammons, Frankie Abner, Tom Houchens
Medica Pharmacy Pharmacists Mutual Companies
Republic Bank & Trust Richard Slone, in memory of
Donald Lippert Rite Aid
Wayne’s Pharmacy Wal-Mart Pharmacies
Annual Meeting Supporter Community Trust Bank Rx Systems, Inc.
July 2012
THE KENTUCKY PHARMACIST 13
134th KPhA Annual Meeting
Abbott Diabetes Care
Aethon
Aligon Pharmaceuticals, Inc.
American Pharmacy Cooperative, Inc.
AmerisourceBergen
American Pharmacy Services Corp.
Cardinal Health
Dr. Comfort
Eli Lilly & Co.
EPIC Pharmacies
HD Smith
Humana
Kentucky Cabinet for Health &
Family Services
Kentucky Renaissance Pharmacy
Museum
KY Office of Health Information
Exchange
Kentucky Spirit Health Plan
Merck
National Government Services
Perform Rx
Pfizer
Pharmacists Mutual Companies
Pharmacy Plus
QS/1
Rite Aid
Rx Therapy Management
Samuels Products, Inc.
Smith Drug Company
SUCOP Student Organizations
UK COP Experiential Ed/ CAPP
UK Student Organizations
Vertex
Walgreens
… and our 2012 Exhibitors
July 2012
THE KENTUCKY PHARMACIST 14
134th KPhA Annual Meeting
Special thanks to David Sanders, Director of Federal
Government Relations for the National Community
Pharmacists Association, for serving as the keynote
speaker for the Saturday luncheon, sponsored by the
Sullivan University College of Pharmacy. From left,
KPhA Executive Director Robert McFalls, 2012-13
President Kim Croley, Sanders, SUCOP Dean Hieu
Tran.
Photo by Kelli Sheets
July 2012
THE KENTUCKY PHARMACIST 15
134th KPhA Annual Meeting
NASPA-NMA Student
Pharmacist Self-Care
Championship
The Judges: Dr. Joseph Fink, Dr. Mykel
Tydwell, Dr. Joey Mattingly
The Host:
KPhA 2011-12 President
Lewis Wilkerson
Teams of student pharmacists from Sullivan University Col-
lege of Pharmacy and the University of Kentucky College of
Pharmacy competed in this Jeopardy-like game to answer
questions about over-the-counter medications. The teams
were allowed to pick a life-line from the audience to help an-
swer the questions.
This program will be an
annual event at the
KPhA Annual Meeting.
Special thanks to Dr.
Holly Divine, Dr. Mela-
nie Mabins and Dr.
Misty Stutz for tailoring
this program for KPhA
and our students.
The Winners: Elizabeth Riner - UK, Lance Murphy - Sullivan,
Brooke Herndon - UK, Danielle Waymeyer - UK,
July 2012
THE KENTUCKY PHARMACIST 16
July 2012 CE-GLP-1 Agonists Therapy
GLP-1 Agonists Therapy in Individuals with
Type 2 Diabetes Mellitus:
A Review of Safety and Tolerability By: Lalita Prasad, PharmD, MS, BCPS, Assistant Professor of Clinical and Admin-
istrative Sciences, Sullivan University College of Pharmacy
Kristal L. Williams, PharmD, CDE, Assistant Professor of Pharmacy Practice, Butler University Col-
lege of Pharmacy and Health Sciences
Acknowledgements: Tracy Costello, assistant professor of pharmacy practice, Butler University Col-
lege of Pharmacy and Health Sciences
Reprinted with permission of the authors and the Indiana Pharmacists Alliance where this article originally appeared.
This activity may appear in other state pharmacy association journals.
There are no financial considerations that could be perceived as real or apparent conflicts of interest.
Universal Activity # 0143-9999-12-007-H01-P&T
1.5 Contact Hours (0.15 CEUs)
Objectives: At the conclusion of this lesson, the reader should be able to:
1. Explain the role of the incretin system in the development of diabetes and dis-
cuss the place in therapy for GLP-1 agonists.
2. Compare and contrast the adverse effects and safety profiles of the two FDA-
approved GLP-1 agonists, exenatide and liraglutide.
3. Discuss the appropriate use and recommendations of GLP-1 agonists in terms
of their safety profile.
4. Discuss the patient education that should be provided upon prescribing and/or dispensing exenatidine
and liraglutide based on the REMS system.
5. Discuss the proposed mechanism and risk factors the GLP-1 agonist safety concerns.
KPERF offers all
CE articles to
members online at
www.kphanet.org
“GLP-1 Agonists Therapy in
Individuals with Type 2 Diabe-
tes Mellitus: A Review of Safe-
ty and Tolerability” is one in a
series of continuing education
articles authored and gener-
ously contributed to the Ken-
tucky Pharmacists Association
by the Indiana Pharmacists
Alliance.
Recent medication advances in the treatment of type
2 diabetes mellitus (T2DM) have evolved around the
incretin system, specifically with a focus on the gluca-
gon-like peptide-1 (GLP-1) hormone. Research has
shown that GLP-1 hormones and receptors play an
integral and multifactorial role in the homeostasis of
glucose via pancreatic and extrapancreatic mecha-
nisms.1,2,3 GLP-1 hormones exert their effects by
binding to structurally distinct receptors which are lo-
cated in the α- and β-pancreatic islet cells, in addition
to the kidneys, lungs, heart, brain and the nervous
system.1,2 Through a constellation of activities, such
as stimulating insulin synthesis and release, decreas-
ing hepatic gluconeogenesis, increasing insulin sensi-
tivity and glucose uptake, decreasing glucagon secre-
tion, increasing satiety and decreasing gastric empty-
ing, the native GLP-1 hormones aid in regulating both
post-prandial and fasting glucose concentrations.1,2,3
However, shortly after release from the distal L cells
of the gastrointestinal tract in a nutrient-dependent
manner, biologically active native GLP-1 hormones
are rapidly cleaved at the N-terminal into an inactive
form by the dipeptidyl peptidase 4 (DPP4) en-
zyme.1,2,3 This cleavage of the biologically active
July 2012
THE KENTUCKY PHARMACIST 17
July 2012 CE-GLP-1 Agonists Therapy
GLP-1, results in a half-life of approximately 1.5
minutes and limits the glucose-lowering action of
GLP-1.1,2 In addition to degradation by the DPP4 en-
zyme, the physiological activity of native GLP-1 is
further limited by its’ rapid clearance from circulation
via the kidney.2 Furthermore, studies have shown the
incretin effect, which is the phenomenon that the in-
crease in insulin secretion after oral ingestion of glu-
cose is greater than that seen with IV glucose admin-
istration, particularly in postprandial states, is blunted
in individuals with T2DM, impeding the achievement
of euglycemia, further supporting their use as a via-
ble treatment option.1,3,4
Clinical investigations found that intravenous admin-
istration of recombinant human GLP-1 resulted in in-
creased insulin secretion, decreased glucagon re-
lease, and subsequently lowered fasting and post-
prandial levels in individuals with T2DM. While these
GLP-1 Agonist Adult Dosing Dosing in Renal Impairment
Exenatide (Byetta®)5
Available in pre-measured pens of 5- and 10 mcg
5 mcg twice daily for 30 days then, if tolerated, titrate to 10 mcg twice daily thereafter.
Inject subcutaneously within 60 minutes before breakfast and dinner (separate doses by at least 6 hours).
Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease: Avoid therapy
Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy
Normal renal function: Monitor patients carefully for the de-velopment of kidney dysfunction, and evaluate the continued need suspect exenatide induced kidney dysfunction
Liraglutide (Victoza®)6
Available in pre-measured pen with a dose titration feature
0.6 mg daily for 7 seven days, then increase to 1.2 mg or 1.8 mg
Inject subcutaneously daily regardless of timing of meals.
Note: 0.6 mg daily is ineffective for glycemic control
No renal adjustment needed. Exercise caution when initiating or increasing therapy.
Exenatide extended re-
lease (Bydureon®)7
Available as a carton of 4-single dose trays which include:
One vial containing 2 mg exenatide (as a white to off-white powder)
One prefilled syringe delivering 0.65 mL diluent
One vial connector
Two custom needles (23G, 5/16”) spe-cific to this deliv-ery system
2 mg once every 7 days.
Inject subcutaneously weekly regard-less of timing of meals.
If a dose is missed and the next regu-larly scheduled dose is due one or two days later, the patient should not ad-minister the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Severe renal impairment (creatinine clearance <30 ml/min) or end-stage renal disease: Avoid therapy
Moderate renal impairment (creatinine clearance 30 to 50 ml/min): Apply caution when initiating or increasing therapy
Table 1: GLP-1 Prescribing Information
July 2012
THE KENTUCKY PHARMACIST 18
July 2012 CE-GLP-1 Agonists Therapy
findings did demonstrate the positive therapeutic out-
comes that are associated with restoring and enhanc-
ing the incretin action of GLP-1 hormones, clinical use
was limited by a short-half life and inconvenient route
of administration.1-4 In addition to the aforementioned
glucose lowering effects, findings suggest GLP-1 hor-
mones have a positive impact on B-cell proliferation
and reduces apoptosis.2,4 Additionally, although fur-
ther studies are needed, it appears that both ex-
enatide and liraglutide exhibit the ability to preserve
beta cell function and improve cardiac function, in-
cluding but not limited to improving blood pressure,
lipid concentrations, myocardial function and cardiac
output, specifically by reducing left ventricular end di-
astolic pressure, all of which are possible concomitant
medical conditions in patients with T2DM.2,4 Thus,
the development of chemically enhanced GLP-1 re-
ceptor (GLP-1R) agonists with superior pharmacoki-
netic profiles and resistance to DPP4 enzyme degra-
dation has become the pharmacological target for the
treatment of T2DM.2,4 To date, there are two chemi-
cally modified GLP-1R agonists available in the Unit-
ed States, exenatide and liraglutide.
Exenatide (Byetta®, Amylin Pharmaceuticals Inc, San
Diego, California, and Eli Lilly, Indianapolis, Indiana),
a synthetically modulated version of GLP-1 made
from the venom of the Gila-monster, was Federal
Drug Administration (FDA) approved in April 2005 for
monotherapy or combination therapy with metformin,
a thiazolidinedione (TZD) or a sulfonylurea to improve
glycemic control in patients with T2DM.5 In October
2011, exenatide received FDA approval for its’ use in
combination with glargine insulin.5 Exenatide shares
53 percent homology with native human GLP-1 hor-
mones.2,3,5 Liraglutide (Victoza®, Novo Nordisk Inc,
Princeton, New Jersey), on the other hand, is de-
signed by recombinant DNA technology, shares 97
percent homology to native human GLP-1 hormones,
and was FDA-approved in January 2010 as adjunct to
diet and exercise to improve glycemic control in pa-
tients with T2DM.2,3,6 It is important to mention that
unlike exenatide, the manufacturer does not recom-
mend liraglutide as first-line therapy for the treatment
of T2DM.5,6 Recently, in February 2012, another long-
acting formulation, exenatide-extended release
(Bydureon®) was FDA approved.7 Bydureon® is ad-
ministered as a 2mg injection once weekly7. In clinical
trials, when compared to exenatide twice daily, pa-
tients on exenatide once weekly had significantly
greater reductions in their blood glucose without in-
creasing the risk of adverse effects, such as hypogly-
cemia.8 Both exenatide products and liraglutide,
which are all available via subcutaneous administra-
tion, mimic all of the glucose lowering actions of na-
tive human GLP-1 hormones.1-4,7 Specific dosing in-
formation can be found in Table 1.
According the to American Association of Clinical En-
docrinologists/American College of Endocrinology
(AACE/ACE) Glycemic Control Algorithm for individu-
als with T2DM published in 2009, GLP-1R agonists
are indicated as an option for first line therapy, partic-
ularly in individuals with elevated post-prandial glu-
cose concentrations.9 Furthermore, it recommends
GLP-1R agonists as an option for the second compo-
nent of dual therapy, in combination with metformin,
the cornerstone of therapy, or a TZD.9 Despite their
attractive efficacy, as demonstrated by A1c reductions
of approximately 0.8 and 1.5 percent for exenatide
twice daily and liraglutide once daily respectively, their
associated weight loss and unique multifactorial
mechanism of action, the safety profile of GLP-1R ag-
onists emerges as a concern.3,10 Efficacy, tolerability
and their adverse effect profiles, are some of the key
parameters considered when initiating and titrating
medication therapy. Clinical trials and post-marketing
surveillance for both exenatide and liraglutide have
demonstrated concerns with patient tolerability and
safety, specifically in regards to gastrointestinal intol-
erances, pancreatitis and the possibility of thyroid ma-
lignancies.3,10 The purpose of this article is to review
the safely profile of GLP-1R agonists and to educate
the pharmacist regarding recommendations for their
safe use in the treatment of diabetes.
GASTROINTESTINAL INTOLERANCES
Gastrointestinal (GI) disturbances, specifically nausea
and vomiting, are the most common treatment emer-
gent side effects associated with the use of GLP-1R
agonists.3,11,12,13 These GI side effects are most com-
monly experienced upon medication initiation and
dose escalations.10 In most cases, GLP-1R agonist
induced nausea and vomiting was transient and clas-
July 2012
THE KENTUCKY PHARMACIST 19
July 2012 CE-GLP-1 Agonists Therapy
sified as mild to moderate.3,12 The nausea associated
with GLP-1R agonists is thought to be related to a
multitude of effects, including peak drug concentra-
tions at the time of medication exposure, slowed gas-
tric emptying and stimulation of neutral GLP-1R re-
ceptors.8,12 In several studies, GLP-1R agonist asso-
ciated nausea and vomiting were reported at a higher
incidence than non-GLP-1R agonist comparators,
such as sulfonylureas, metformin and TZDs.10 The
LEAD-6 study, which compared exenatide 5 mcg
twice daily titrated up to 10 mcg twice daily after 4
weeks, to liraglutide 0.6 mg titrated up to 1.8 mg after
2 weeks, demonstrated the duration of GLP-1R ago-
nist induced nausea and vomiting was prolonged with
shorter acting agents. In this study, the majority of the
liraglutide-treated patients were nausea-free by week
6, compared to week 22 for the twice daily exenatide
group.14 Similarly, in the DURATION-1 trial, which
evaluated 2 mg exenatide once weekly to 10 mcg ex-
enatide twice daily, a significantly less proportion of
patients experienced treatment related-nausea with
the long-acting formulation when compared to twice-
daily administration.8 Clinical trials report the inci-
dence of nausea between 33 – 57.1 percent and of
vomiting between 12 – 17.4 percent for exenatide 10
mcg twice daily.11
Nausea rates observed in phase 3
trials of lirglutide 1.8 mg daily, were less than those
reported with twice daily exenatide and ranged from 7
– 40 percent.10 For some individuals, the GI disturb-
ances limited the use of GLP-1R agonist therapy, as
witnessed by the GI-induced discontinuation rates of
3 – 9 percent for exenatide 10 mcg twice daily.11
Strategies to prevent or alleviate GI intolerances as-
sociated with GLP-1R agonists include titrating doses
conservatively after initiating therapy.12 For ex-
enatide, if nausea occurs upon dosage escalation,
maintenance at the lower initial dose of 5 mcg twice
daily is appropriate; however, for liraglutide the target
dose should be at least 1.6 mg daily, as lower doses
are ineffective for glycemic control.5,6 Patients should
also be counseled that nausea is most often transi-
ent, to eat smaller meals to prevent gastrointestinal
intolerances and, if on exenatide twice daily, to ad-
minister the injection immediately prior to meal-time.3
One of the mechanisms by which GLP-1R agonists
lower post-prandial glucose concentrations is by de-
laying gastric emptying. As a result, GLP-1R agonists
may not be appropriate for individuals with gastro-
paresis, an autonomic disorder often complicated by
hyperglycemia. Exenatide use is not recommended in
patients with gastroparesis.5 While the product infor-
mation for liraglutide does not currently provide any
recommendations for its use in patients with gastro-
paresis secondary to insufficient data, the medication
guide for Liraglutide instructs patients to inform their
healthcare provider if they have or experience symp-
toms of gastroparesis.6
HYPOGLYCEMIA
The possibility of hypoglycemia is an ongoing con-
cern for medications with insulin secreting properties,
such as GLP-1 agonists, sulfonylureas and megliti-
nides, as well as insulin. In clinical trials the incidence
of hypoglycemia amongst treatment groups for both
exenatide and liraglutide were generally comparable
to placebo; and when mild to moderate hypoglycemia
was noted, it was associated with sulfonylurea
use.1,8,14 Furthermore, despite the improved glycemic
outcomes of the long-acting agents, the risk of hypo-
glycemia with liraglutide daily and exenatide once
weekly was less than that observed with sulfonylure-
as and twice daily exenatide.15 It is hypothesized that
the lower risk of hypoglycemia with GLP-1R agonists
is related two distinct characteristics. One character-
istic is its glucose-dependent mechanism of action.
The other is the fact that when an individual’s blood
glucose concentration is <65mg/dl (hypoglycemia),
GLP-1R agonists do not inhibit the secretion and ac-
tion of glucagon, thus allowing for a rise in glucose.16
Although, the 2009 American Diabetes Association
and the European Association for the Study of Diabe-
tes (ADA/EASD) diabetes management algorithm
classifies GLP-1R agonists as less validated tier 2
therapies, it recommends these medications, particu-
larly exenatide (the only FDA-approved GLP-1R ago-
nist at the time of algorithm publication) as a pre-
ferred adjunctive therapy for those individuals with
hazardous employment, such as vehicle or machin-
ery operators (i.e. truck, bus or forklift drivers and air-
line pilots, etc.) or construction workers in whom hy-
poglycemia is less desired.17 In clinical trials, patients
July 2012
THE KENTUCKY PHARMACIST 20
July 2012 CE-GLP-1 Agonists Therapy
treated with exenatide monotherapy experienced mild
to moderate hypoglycemia at a rate of 4-9 percent,
while 0-12 percent of patients on liraglutide experi-
enced mild to moderate hypoglycemia, which was
lower than the incidence observed with glimepiride
monotherapy, where hypoglycemia occurred in 24
percent of patients.16 However, due to the hypoglyce-
mic risk with concomitant therapy, the prescribing in-
formation for GLP-1R agonists includes a recommen-
dation to reduce the dose of secretagogues when
used in combination.5,6 Presently, only exenatide is
FDA-approved for combination therapy with insulin
glargine. Its prescribing information, likewise recom-
mends considering a dosage reduction for the insulin
dose, which should be considered upon GLP-1R ago-
nist initiation and dose escalation to lower the risk of
hypoglycemia.5
PANCREATITIS AND PANCREATIC CANCER
Post-marketing surveillance reports of acute pancrea-
titis in patients treated with exenatide prompted the
FDA to investigate the causality, and subsequently
include pancreatitis as a precaution to the product in-
formation for GLP-1R agonists (both exenatide and
liraglutide). Thirty cases of exenatide-induced acute
pancreatitis and six cases of hemorrhagic or necrotiz-
ing pancreatitis were cited in the FDA Adverse Re-
porting System (AERS) in 2008.5 A retrospective
chart review utilizing the AERS database was con-
ducted between 2004 and the third quarter of 2009 to
determine if there is sufficient data correlating pancre-
atitis to exentatide use.18,19 Although there were sev-
eral limitations to the methodology used, the study
found a >6-fold increase in the risk of pancreatitis with
the exentadine group when compared to the control
group (which consisted of patients treated with thiaz-
alidinediones or meglitinides).18,19 These findings
however, were inconsistent with other data analyses
and retrospective reviews, which reported similar inci-
dences of exenatide-induced pancreatitis to compara-
tor therapy.18,19 One of these studies, a retrospective
review of pharmacy claims data, evaluated the inci-
dence of pancreatitis over a one-year period of 28,000
prescriptions. In this study, 0.13 percent of the pa-
tients treated with exenatide experienced acute pan-
creatitis, which was comparable to rates observed
with other diabetes treatments, such as metformin or
sulfonylureas.20 An additional concern is the risk asso-
ciation between pancreatitis and pancreatic cancer.
Regarding pancreatic cancer event rates, the FDA
AERS study found a 2.9-fold increase when com-
pared to control agents.19
Regarding possible liraglutide-induced pancreatitis, in
clinical trials a total of seven cases were reported, in-
cluding acute pancreatitis, chronic pancreatitis and
necrotizing pancreatitis with deaths occurring in five,
two and one case(s), respectively.6 The overall occur-
rence of pancreatitis was higher in the liraglutide-
treated group than that observed with the comparator
agents (2.2 vs. 0.6 cases per 1000-patient-years).6
Despite these reports, an absolute causation of GLP-
1R agonists and pancreatitis has been difficult to es-
tablish, as both diabetes and obesity are associated
with their own risk of pancreatitis. The risk of develop-
ing pancreatitis in an individual with T2DM confers a
2.8-fold increase when compared to individuals with-
out T2DM.16 Obese individuals with T2DM are likely to
be prescribed a GLP-1R agonist due to a positive im-
pact on weight reduction and glycemic control; howev-
er, these patients are also at a higher risk of develop-
ing pancreatitis secondary to their concomitant medi-
cal conditions. Other risk factors for pancreatitis in-
clude hypertriglyceridemia, excessive alcohol intake,
gallstones and previous history of pancreatitis.21 Spe-
cific to exenatide therapy, the incidence of pancreatitis
was observed upon dose escalation to 10 mcg twice a
day.21 Recommendations are to observe patients for
pancreatitis after a dose escalation for either ex-
enatide or liraglutide. 21,22
Both exenatide and liraglutide have boxed warnings in
their label information regarding pancreatitis.5,6 As a
mandate from the FDA, Amylin Pharmaceuticals Inc.
must conduct six post-marketing studies on exenatide
to further explore the mechanism, incidence and risk
factors for the development of acute pancreatitis with
and without hemorrhagic and necrotizing complica-
tions.23
Practitioners should exercise caution when prescrib-
ing GLP-1R agonists for patients at risk of developing
pancreatitis, should educate patients of warning signs
July 2012
THE KENTUCKY PHARMACIST 21
July 2012 CE-GLP-1 Agonists Therapy
of pancreatitis and inform them to immediately discon-
tinue therapy and seek medical attention if pancreati-
tis is suspected.23
If pancreatitis is confirmed, GLP-1
therapy should not be re-initiated.3,5 This is a key ed-
ucational parameter that should be reinforced by the
pharmacist upon medication dispensing.
THYROID
The development of malignant thyroid tumors was
found in pre-clinical animal studies amongst rodents
who received liraglutide doses that were eight times
higher than the recommended human doses.6,24 In
clinical trials, five cases of papillary thyroid carcinoma
occurred in liraglutide-treated patients, compared to
two cases reported in the non-liraglutide group. How-
ever, one comparator patient had evidence of pre-
exisiting disease.6 Nonetheless, these findings raised
concerns about the development of C-cell hyperplasia
and medullary thyroid cancer in humans, prompting
the prescribing information for liraglutide to carry a
boxed warning for thyroid C-cell hyperplasia.24 Alt-
hough this specific type of cancer is rare in humans,
and the FDA warning states that the human relevance
of these findings is unclear, liraglutide therapy is con-
traindicated in patients with a family history of medul-
lary thyroid cancer or in patients with a history of mul-
tiple endocrine neoplasia syndrome type 2.6 The pro-
posed mechanism by which liraglutide causes C-cell
hyperplasia, and possibly cancer, is through in-
creased stimulation of calcitonin release, which is a
biomarker for medullary cancer. A two-year study
evaluating calcitonin concentrations in liraglutide-
treated patients did not show a difference when com-
pared to other anti-diabetes medications; however,
when compared to placebo, concentrations were ele-
vated.22,24 In an effort to attain definitive information
regarding the association of liraglutide and thyroid
cancer in humans, the FDA has mandated that the
manufacturer, Novo Nordisk, institute two surveillance
systems. One is to establish a cancer registry to mon-
itor the incidence of medullary thyroid cancer over the
next 15 years and the other is to conduct a five-year
epidemiological study, using a large healthcare claims
database, to compare the development of thyroid can-
cer among liraglutide-treated patients to those who
are liraglutide naïve.22,24
The FDA AERS database study also evaluated the
present data correlating thyroid cancer to exenatide
use.19
It found a statistically significant increase of
thyroid cancer in the exenatide-treated group.19
Therefore, the manufacturer of exenatide, Amylin
Pharmaceuticals Inc., acknowledges the presence of
benign C-cell tumors in rats treated with the exenatide
and has included this information in the package in-
sert.5
ALTERED KIDNEY FUNCTION
Post-marketing reports of both altered and worsening
kidney function exist for both exenatide and lirag-
lutide. In November 2009, the FDA released infor-
mation for healthcare professionals regarding 78 cas-
es of altered kidney function associated with ex-
enatide therapy.25 Between April 2005 and October
2008, 62 cases of acute renal failure and 16 cases of
renal insufficiency were noted. Although some cases
were reported in individuals with pre-existing renal
disease or with at least one risk factor for kidney dis-
ease, revisions were made to the product labeling re-
garding the evaluation for and dosing of exenatide in
kidney dysfunction.25 The product information for li-
raglutide also acknowledges post-marketing reports of
increased serum creatinine, acute renal failure, and
the development or worsening of chronic renal failure,
which in some cases, required hemodialysis.6 Unlike
exenatide, however, liraglutide is not renally excreted
and does not require renal dosage adjustments.5,6
Common GLP-1R associated side effects, including
nausea, vomiting, diarrhea and subsequent dehydra-
tion, may increase the risk of kidney abnormalities.5,6
As a result, exenatide and liraglutide manufacturers
recommend caution when initiating or increasing the
dose in patients with renal impairment.5,6
REMS
The Risk Evaluation and Mitigation Strategy (REMS),
was developed by the FDA in an effort to be proactive
on patient safety measures once a medication con-
cern is identified. The REMS program is designed to
provide both practitioners and patients with infor-
mation regarding medication safety concerns. In
most cases, the REMS will include a communication
plan for practitioners and a medication guide for pa-
July 2012
THE KENTUCKY PHARMACIST 22
July 2012 CE-GLP-1 Agonists Therapy
tients. Practitioner information highlights safety con-
siderations, current findings and makes recommen-
dations regarding appropriate pharmacotherapy for
specific patient populations. The patient medication
guide informs the individual about possible risk(s),
warning signs and appropriate action to take in the
event of a concern. Both exenatide and liraglutide
have a REMS. Table 2 outlines the REMS with these
agents.
Recent advances in the understanding of the patho-
genesis of diabetes have focused on the multiple hor-
monal deficiencies that result in clinical hyperglyce-
mia. The GLP-1R agonists represent a novel class of
treatment agents that add promise to the diabetes
treatment armamentarium, as they target these un-
derlying hormonal defects and may even have the
potential to delay disease progression by preserving
beta-cell functioning.2,4 Despite their overall benefit
on glycemic control, widespread use may be limited
by their toxicity profiles. Health care practitioners, in-
cluding pharmacists, should be aware of treatment-
related toxicities and assess the risk vs. benefit when
initiating or escalating therapy with these agents. A
clear understanding of patient risk factors for the de-
velopment of adverse effects, as well as familiarity
with the signs and symptoms of potential treatment-
related toxicities can aid in disease management. In
summary, the GLP-1R agonists can provide an effec-
tive means for glycemic control, when used in the
proper clinical situation.
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2. Drucker DJ. The biology of incretin hormones Cell
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Pancreatitis [Posted 06/13/2011] http://
www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/
ucm258826.htm Accessed 10.26.11
23. Byetta Safety Update for Healthcare Profession-
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tientsandProviders/
DrugSafetyInformationforHeathcareProfessionals/
ucm190406.htm. Accessed 10.26.11
24. Questions and Answers - Safety Requirements for
Victoza (liraglutide). http://www.fda.gov/Drugs/
DrugSafety/
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tientsandProviders/ucm198543.htm Accessed
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25. Information for Healthcare Professionals: Reports
of Altered Kidney Function in patients using Ex-
enatide (Marketed as Byetta)http://www.fda.gov/
Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPa-
tientsandProviders/
DrugSafetyInformationforHeathcareProfessionals/
ucm188656.htm. Accessed 10.26.11
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THE KENTUCKY PHARMACIST 24
July 2012 CE-GLP-1 Agonists Therapy
ATTENTION ALL PHARMACISTS AND PHARMACY TECHNICIANS WHO RECEIVE CE CREDIT
THROUGH KPERF
KPERF WILL FULLY IMPLEMENT CPE Monitor
SEPTEMBER 1, 2012 CPE Monitor, the continuing pharmacy education (CPE) tracking service developed by ACPE and the National Association of Boards of Pharmacy is now ready for use. KPERF, KPhA’s ACPE ac-credited provider of continuing education, initiated a trial run of the system during the 134th KPhA Annual Meeting. Following the success of the trial run, KPERF will upload all continuing educa-tion credits to the CPE Monitor beginning
Sept. 1, 2012.
The major change is CE statements of credit will no longer be mailed. Quizzes from The Kentucky Pharmacist will be graded as usual, submitted to ACPE, which will validate the information before sending it to NABP for the CPE Monitor. After CPE credits are processed by ACPE and NABP, you will be able to log into your NABP e-Profile and view all of your ACPE completed continuing education. No more keeping up with the certificates, misplacing them when you move on or producing them when asked by investigators.
In order to process your credit, KPERF MUST have your correct NABP e-Profile ID number and your birth month and day. This is YOUR PERSONAL NABP e-Profile ID, and it is not your li-cense number. If you need to verify your number or have not yet registered, please visit www.MyCPEMonitor.net as soon as possible. If you are unable to use a computer, you can call the NABP Customer Service line at 847-391-4406 to set up your profile and obtain your NABP e-Profile ID.
After September 1, if KPERF receives quizzes or evaluation sheets from live programs without the NABP e-Profile number and birthdate information, the credit WILL NOT be processed until that information is provided.
If you have any questions, contact Scott Sisco at [email protected] or call the NABP Customer Service Line at 847-391-4406 Monday through Friday 9 a.m. to 5 p.m. central time.
NABP Customer Service
[email protected] Tel: 847-391-4406 Fax: 847-391-4502 Hours: M-F, 9 AM to 5 PM central
About the Authors
Dr. Prasad is assistant professor of clinical & administrative sciences, Sullivan University College of Pharmacy, and clini-
cal pharmacist, University of Louisville Adult Internal Medicine Clinic, University of Louisville Hospital, Louisville.
Dr. Williams is assistant professor of pharmacy practice, Butler University College of Pharmacy and Health Sciences,
clinical instructor, Indiana University School of Medicine, and family medicine residency program clinical pharmacist, In-
diana University Health Methodist Family Medicine Center, Indianapolis.
July 2012
THE KENTUCKY PHARMACIST 25
July 2012 CE-GLP-1 Agonists Therapy
July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability
1. Glucagon like peptide-1 (GLP-1) are peptide hor-mones secreted from the: (Objective 1) A. Gastrointestinal tract B. Kidney C. Liver D. Muscle E. Pancreas 2. Which of the following mechanisms play a role in the development of type 2 diabetes? (Objective 1) A. Abnormal glucagon production B. Altered hepatic gluconeogenesis C. Decreased insulin secretion D. Increased insulin resistance E. All of the above 3. Which of the following statements are TRUE regard-ing GLP-1 agonists and the side effect of nausea? (Objective 3) A. Commonly experienced upon medication initiation B. Commonly experienced upon dose escalation C. Often transient and classified as mild to moderate D. Occurs at a higher rate with GLP-1 agonist com-
pared to other cornerstone therapies E. All of the above 4. According to the manufacturer recommendations, which of the following medications should be adjusted by a dosage reduction upon initiation of GLP-1 agonist in an effort to decrease the incidence of hypoglycemia? (Objective 3,5) A. Glipizide B. Insulin C. Nateglinide D. a and b E. all of the above 5. HB, a 55-year old female with type 2 diabetes and mild renal impairment, recently completed 2 weeks of liraglutide therapy. Her practitioner is interested in in-creasing her dose from 1.2 mg daily to 1.8 mg daily. Which of the following GLP-1 agonist associated side effects should be evaluated upon the dosage increase? (Objective 3) A. Thyroid Cancer B. Pancreatitis C. Kidney Dysfunction D. b and c E. All of the above
6. The proposed mechanism for C-cell hyperplasia and papillary thyroid carcinoma is: (Objective 5) A. Currently unknown B. Induction dehydration secondary to nausea, vomit-
ing and diarrhea C. Inhibition of glucagon release D. Stimulation of calcitonin release E. Stimulation of β-cells on the thyroid gland 7. Both exenatide and liraglutide require a REMS for which of the following safety concerns? (Objective 4) A. Hypoglycemia B. Nausea and vomiting C. Pancreatitis D. Thyroid Cancer E. Kidney Impairment 8. Patients with which of the following medical condi-tions and/or factors should not be a candidate for GLP-1 agonist therapy? (Objective 3,5) A. Gastroparesis B. Moderate creatinine clearance (30 – 50 ml/min) C. Machinery operator (i.e. airline pilot) D. Family history of hypertriglyceridemia E. Metformin use 9. In the glycemic control algorithm developed by the American Association of Clinical Endocrinologist and the American College of Endocrinology (AACE/ACE), GLP-1 agonists are recommended as first line therapy particularly for individuals with which of the following conditions/factors? (Objective 1) A. Elevated fasting blood glucose concentrations B. Elevated post-prandial blood glucose concentrations C. BMI > 40 kg/m2 D. b and c E. all of the above 10. Liraglutide requires a dosage adjustment in patients with renal impairment. A. True B. False
KPhA Social Media Links www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc
July 2012
THE KENTUCKY PHARMACIST 26
July 2012 CE-GLP-1 Agonists Therapy
July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability Universal Activity # 0143-9999-12-007-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10.A B Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD)
This activity is a FREE service to members of the Kentucky Pharmacists Association. The
fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self
addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601.
The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
Expiration Date: July 15, 2015 Successful Completion: Score of 80% will result in 1.5 contact hours or 0.15 CEUs.
Participants who score less than 80% will be notified and permitted one re-examination.
July 2012 — GLP-1 Agonists Therapy in Individuals with Type 2 Diabetes Mellitus: A Review of Safety and Tolerability TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-007-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10.A B Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD)
July 2012
THE KENTUCKY PHARMACIST 27
1987—Twenty-five years ago:
Major pharmacy issue of the year was the increase in physician office based dispensing.
Acuvue launched by J&J was the first disposable soft contact lens.
1962—Fifty Years Ago:
Trivalent oral polio vaccine (Sabin) was licensed in the U.S..
Rite-Aid (Pennsylvania), Meijer’s Michigan), and Wal-Mart (Arkansas) were formed.
1937—Seventy-five Years Ago:
Cook County Hospital in Chicago, Illinois was the site of the first blood bank, set up by Bernard Fantus.
1912—One hundred Years Ago:
Phenobarbital (Luminal) first marketed by Bayer in 1912.
1887---One hundred twenty-five years ago:
The National Institutes of Health established. The National Institutes of Health traces its roots to 1887, when a one-room laboratory was created within the Marine Hospital Service (predecessor agency to the U.S. Public Health Service (PHS).
By: Dennis B. Worthen Lloyd Scholar, Lloyd Library and Museum, Cincinnati, OH
One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satis-faction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org
Pharmacy Time Capsules
The following broad guidelines should guide an au-
thor to completing a continuing education article for
publication in The Kentucky Pharmacist.
Average length is 4-10 typed pages in a word pro-
cessing document (Microsoft Word is preferred).
Articles are generally written so that they are per-
tinent to both pharmacists and pharmacy techni-
cians. If the subject matter absolutely is not perti-
nent to technicians, that needs to be stated clearly
at the beginning of the article.
Article should begin with the goal or goals of the
overall program – usually a few sentences.
Include 3 to 5 objectives using SMART and meas-
urable verbs.
Feel free to include graphs or charts, but please
submit them separately, not embedded in the text
of the article.
Include a quiz over the material. Usually between
10 to 12 multiple choice questions.
Articles are reviewed for commercial bias, etc. by
at least one (normally two) pharmacist reviewers.
When submitting the article, you also will be
asked to fill out a financial disclosure statement to
identify any financial considerations connected to
your article.
Articles should address topics designed to narrow
gaps between actual practice and ideal practice in
pharmacy. Please see the KPhA website
(www.kphanet.org) under the KPERF link to see pre-
viously published articles.
Articles must be submitted electronically to the KPhA
director of communications and continuing education
([email protected]) by the 15th of the month pre-
ceding publication.
Have an idea for a continuing education article? WRITE IT!
Continuing Education Article Guidelines
Pharmacy Time Capsules
July 2012
THE KENTUCKY PHARMACIST 28
From Your Executive Director
MESSAGE FROM YOUR
EXECUTIVE DIRECTOR
Robert “Bob” McFalls
T his edition of The Kentucky Pharmacist fea-tures the 2012 graduating classes of the Sul-livan University College of Pharmacy and the University of Kentucky College of Pharmacy.
Graduates: KPhA sincerely congratulates you and welcomes you as the newest members of the profes-sion. Know that we look forward to your involvement and engagement as active members of the Kentucky Pharmacists Association.
This edition also features highlights from our 134th Annual Meeting & Convention. There is much to cele-brate as the photos tell the story of pharmacists and pharmacy technicians coming together to learn, net-work, debate policy and socialize together. This was my second Annual Meeting with you, and I thoroughly enjoyed every minute of it. I only wish that there had been more time to visit individually, and I look forward to having those opportunities in the coming days and at the 135th Annual Meeting next year. Stay tuned as we work to finalize details for 2013! We think you al-so will enjoy getting to know your new Directors and Officers along with finding relevance as you relate to the message from KPhA’s new President, Kimberly S. Croley.
I also am pleased to inform you that your Association has been awarded a new grant by the Kentucky De-partment of Public Health to advance our profession’s emergency readiness plans in terms of being able to assist with medication needs from affected patients and to be able to respond accordingly to future disas-ter events that occur within the Commonwealth. Since 2000, the nation has recorded more than 760 federal-ly recognized natural disasters that have disrupted normal living patterns. And Kentucky’s history has been one whereby we are likely to be more adversely affected—our state is 1.6 times more likely to be im-pacted on average. The new grant will help KPhA to advance our planning efforts and put operational plans into place. The Board has established a new Emergency Preparedness Committee that will provide needed guidance with our new work plan.
As I begin my second year of service as your Execu-tive, I cannot but note that we find ourselves at a crossroad in the practice of pharmacy when one con-siders the transition of the state Medicaid program to managed care, the aging of our state's population with its increasing chronic health care needs and medication reconciliation issues as well as critical dis-cussions with respect to the potential for building upon the trusted role of the pharmacist. In the last few months, we witnessed the release of a national report, Improving Patient and Health System Outcomes through Advanced Pharmacy Practice: A Report to the U.S. Surgeon General 2011. If you have not yet had the chance to review the report, I would encour-age you to do so. (see http://www.kphanet.org/Communications.aspx). The report utilizes objective data to advance the discussion of how models of in-novative care—that both include and involve pharma-cists—can begin the process of alleviating demands on our health care system while improving outcomes from several perspectives that include, among others, access, safety, quality, cost and provider shortages. The Report also describes existing, accepted, and successful models of health care delivery and patient care using pharmacists as health care providers and essential members of the health care team.
Along these lines, I enjoy hearing from you, our mem-bers, about these types of opportunities to discuss and strengthen the profession of pharmacy as a whole in accordance with our Association's mission. To bring clarity to these emerging issues, the Board of Directors will initiate a strategic discussion in August about our collective future. As we work together to develop a strategic plan, along with President Croley and the entire Board of Directors, I want to encourage you to contact any one of us with respect to your ide-as. We welcome your suggestions for responding to the challenges and opportunities that lie before all of us. And we promise to keep everyone posted on these emerging discussions as we work to address these challenges and opportunities together.
This is your KPhA--let us hear from you!
July 2012
THE KENTUCKY PHARMACIST 29
Help support the Bowl of Hygeia Award!
Bowl of Hygeia Fundraising Efforts
This year another 50+ Bowl of Hygeia recipi-ents will be added to our ranks. All are dedi-cated pharmacists who take community service seriously and endeavor to make a difference in a way that is meaning-ful. Their stories are in-spiring, and their atti-tudes are humble. All will make you proud. The Bowl of Hygeia has a rich history within
pharmacy and it represents well members of our pro-fession. That’s why I’m excited to be helping to carry forth the Bowl of Hygeia tradition through collabora-tion with the Kentucky Pharmacists Association as our Association works with the “stewards” of the Bowl of Hygeia, the National Alliance of State Pharmacy Associations, the APhA Foundation and the American Pharmacists Association. Before these national Phar-macy groups assumed responsibility for the Bowl, this prestigious award was in jeopardy of being extin-guished. If it were not for their agreement to carry for-ward the honor through a professional collaboration, 2010 would have been the last year the Bowl of Hy-geia was awarded. Given that this is an award presented at the state lev-el, the State Pharmacy Associations — including your Kentucky Pharmacists Assocaiation — along with NASPA, are working together to help make sure this award we hold so dearly is never at risk again. In or-der to sustain the award, each state association is working together to build an endowment sufficient to generate dividends that will fund the program in per-petuity. The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment ac-count, and to date we are almost half way to our goal of $600,000. As a recipient of the award, I am excited to be a lead-er in helping the Kentucky Pharmacists Association kick off its campaign. I want to be sure the Bowl of Hygeia continues to represent the hallmark of com-munity service in our profession. That’s why I am per-
sonally giving to this fund, and it’s why I think you’ll be interested to join me in making an investment in the future of the award. After all, it is the future recipients of the award that guarantee the legacy of our own awards. Our goal is to raise $5,000 as a collective gift from members of the Kentucky Pharmacists Association. And we’re eager to show our state pride by either meeting or exceeding this goal. Won’t you please help by making a contribution? There are two ways to give:
Online at: http://bit.ly/APhAFoundationDonation
and choose the Bowl of Hygeia endowment button. Kentucky will get credit by your ad-dress.
Or, you can send your check to:
AphA Foundation – Bowl of Hygeia 2215 Constitution Ave., NW
Washington, DC 20037-2985 Thank you in advance for joining me in this effort. Sincerely in Service I am, George Hammons, RPh Owner/President Knox Professional Pharmacy Bowl of Hygeia Award Recipient, 2012
July 2012
THE KENTUCKY PHARMACIST 30
Pharmacy Technician Certification Board
July 2012
THE KENTUCKY PHARMACIST 31
Aug. 2012 CE-Aspirin: Evolving Evidence
Aspirin: Evolving Evidence and Recommendations for
Use in Cardiovascular Disease
By: Lindsay Rogers, PharmD; Erika Webster, PharmD, BCPS, CDE; and Debbie Minor, PharmD G.V. (Sonny) Montgomery VA Medical Center Department of Pharmacy and The University of Mississippi Medical
Center Department of Medicine Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared.
There are no financial relationships that could be perceived as real or apparent conflicts of interest.
Universal Activity # 0143-9999-12-008-H01-P&T 1 Contact Hour (0.1 CEUs)
The goal of this review is to describe current recommendations for the use of aspirin (ASA) in cardiovascular disease (CVD) prevention based on recent and evolving evidence. Objectives: 1. Discuss recent findings and updates regarding the use of ASA for primary CVD prevention in diabetes. 2. Review the role of ASA as comparative or combination therapy in the management of atrial fibrillation
and acute coronary syndrome (ACS). 3. Highlight issues related to the use of ASA in the elderly. 4. Describe concerns with ASA discontinuation and potential consequences.
KPERF offers all
CE articles to
members online at
www.kphanet.org
Introduction
ASA is a potent inhibitor of both platelet aggregation
and prostaglandin synthesis. For more than 10 years,
ASA has been used and promoted as a cost-effective
agent for reducing the occurrence of further vascular
events in those with occlusive vascular disease.1-3
When used for secondary prevention in those with a
cardiovascular event history, the evidence is clear;
ASA reduces the risk of myocardial infarction (MI) by
one-third, stroke by one-quarter and vascular death
by one-sixth, with benefits far exceeding risks.4,5 For
those without history of an event (primary prevention),
evidence for the use of ASA is less clear and contro-
versial. Recent and emerging evidence provides
some clarification regarding the use of ASA for prima-
ry prevention in a variety of situations including diabe-
tes, atrial fibrillation, as combination therapy and in
the elderly. The purpose of this article is to review the
evolving evidence concerning ASA and CVD preven-
tion and highlight the current recommendations for
use based upon this data.
ASA in Diabetes
Diabetes is a chronic and progressive disease that
affects more than 340 million people worldwide.6 In
the United States, more than 26 million people have
diabetes, with this number expected to reach 30.3
million in the year 2030.7,8 As those with diabetes ap-
pear to have a two- to four-fold higher risk of CVD,
this increasing prevalence has led to greater con-
cerns for CVD development, the major cause of death
with the disease.6,9-11 In 2009, 7 million people in the
United States with diabetes also reported a CVD con-
dition.12 Over the past 10 years, the prevalence of di-
abetes in Kentucky has increased from 6.4 percent to
10.1 percent, in contrast to the national increase of
6.0 percent to 8.7 percent.13
In 1999, an American Heart Association (AHA) state-
ment concerning CVD and diabetes recommended
ASA for primary prevention unless contraindicated.14
The American Diabetes Association (ADA) and AHA
updated these recommendations for ASA as primary
prevention in 2007. In this statement, ASA was rec-
ommended for those with increased cardiovascular
risk defined as: >40 years old or with additional risk
factors for CVD (family history, hypertension, tobacco
use, dyslipidemia or albuminuria).2 Evidence support-
ing this recommendation was inconclusive and stud-
July 2012
THE KENTUCKY PHARMACIST 32
Aug. 2012 CE-Aspirin: Evolving Evidence
ies using ASA have been designed to more clearly
identify treatment strategies that reduce the CVD as-
sociated with diabetes.
Evidence for Primary Prevention
The 2009 Antithrombotic Trialists’ (ATT) Collaboration
meta-analysis examined the use of ASA in six primary
prevention trials (n=95,000, n=4,000 with diabetes)
with outcomes of serious vascular events (MI, stroke
or vascular death). Overall, 1,671 serious vascular
events occurred in the ASA group versus 1,883 in the
control, representing a 12 percent reduction. The re-
duction in nonfatal MI was significant whereas the re-
duction in stroke and vascular death was not. Howev-
er, extracranial and gastrointestinal bleeding was in-
creased by 55 percent in patients with diabetes, fur-
ther questioning the overall risk versus benefit in pri-
mary prevention.5
The Japanese Primary Prevention of Atherosclerosis
with Aspirin for Diabetes (JPAD) and the Prevention
of Progression of Arterial Disease and Diabetes
(POPADAD) trials were designed to provide more
conclusive evidence for the use of ASA. Both of these
multicenter trials included patients with no prior histo-
ry of CVD.11,15
The JPAD trial included 2,539 participants ages 30 to
85 years with controlled type 2 diabetes, randomized
to low-dose ASA or placebo. The primary endpoint
was occurrence of any cardiovascular event including
coronary, cerebrovascular or peripheral. The differ-
ence in events between the groups over the median
follow-up of 4.37 years was insignificant, with 68 in
the ASA group versus 86 with placebo. However, in
those 65 and older, there was a significant 32 percent
reduction in events with ASA, suggesting a benefit for
older patients. Overall, JPAD results suggest only a
small benefit for the use of ASA as primary prevention
in diabetes. Interpretation of the data is difficult be-
cause the study was underpowered due to the low
number of overall events.11
The POPADAD trial included 1,276 participants 40
years or older with type 1 or 2 diabetes and an ankle
brachial pressure index of 0.99. The trial evaluated if
the use of ASA and antioxidants, alone or combined,
would reduce cardiovascular events. Participants
were randomized to ASA plus placebo, antioxidant
plus placebo, ASA and antioxidant, or double place-
bo. The two primary endpoints were either a compo-
site of death from stroke or coronary heart disease
(CHD), nonfatal MI or stroke, and amputation above
the ankle due to ischemia or death from CHD or
stroke. After a median follow-up of 6.7 years, the
composite endpoint occurred in 117 participants not
on ASA versus 116 on ASA, with death from CHD or
stroke alone occurring in 35 not on ASA versus 43 on
ASA. The differences between the ASA and non-ASA
groups were not statistically significant for either end-
point, again questioning any benefit of ASA for prima-
ry prevention of CVD in diabetes.15
Collaboration of Evidence and Recommendations for
Use
In an effort to reconcile results, the ADA, AHA, and
American College of Cardiology Foundation (ACCF)
conducted a meta-analysis including the primary pre-
vention trials in the ATT meta-analysis, JPAD and
POPADAD. The authors concluded that ASA use pro-
duced an insignificant risk reduction of 9 percent and
15 percent, respectively, in fatal and nonfatal MI and
stroke.16
Based on these results, the combined groups con-
clude that ASA only modestly reduces CVD risk in
diabetes by about 10 percent, with the most benefit
seen in those with the greatest risk. They now recom-
mend that the use of ASA be based on the overall
cardiovascular risk profile. Use of the Framingham
risk assessment for this and suggestions for ASA use
are identified in the Table on page 30. Concurrent
therapies for reducing CVD risk are encouraged in-
cluding smoking cessation, control of hypertension,
uses of statins and lifestyle changes. These therapies
should be adopted first and may lower CVD risk to a
level that does not warrant ASA use. Other assess-
ment tools can also be used including the UKPDS
Risk Engine, the ARIC CHD Calculator and the ADA
Risk Assessment Tool. Since gastrointestinal bleed-
ing presents the greatest complication with ASA use,
a thorough evaluation for this risk also should occur
prior to initiation.16
July 2012
THE KENTUCKY PHARMACIST 33
Aug. 2012 CE-Aspirin: Evolving Evidence
ASA as Comparative or Combination Therapy -
Atrial Fibrillation and Acute Coronary Syndrome
Warfarin and ASA
Though warfarin is the drug of choice for primary pre-
vention of stroke in atrial fibrillation, it may not be suit-
able for all patients. A recent Danish study examined
the efficacy and safety of warfarin, ASA, the combina-
tion of warfarin plus ASA, or no treatment by linking
nationwide registries and identifying patients dis-
charged with non-valvular atrial fibrillation
(n=132,372). Study results supported that ASA alone
is neither safe nor effective in preventing stroke in
atrial fibrillation, with no net clinical benefit (stroke ver-
sus bleeding) at any level of stroke risk. Stroke risk
was calculated using CHADS2 and CHA2DS2-VASc
scores, while bleeding risk was evaluated using HAS-
BLED. Patients were further stratified based upon
risks of stroke and bleeding. Hazard ratios showed
that warfarin alone consistently lowered the risk of
thromboembolism/stroke greater than ASA alone or
no treatment, while the combination of warfarin plus
ASA provided no additional benefit.17
For patients at each thromboembolic risk level, the
risk of bleeding was increased in all treatment groups
compared to no treatment. Warfarin therapy alone
had a net clinical benefit in all but the lowest risk
group (CHA2DS2-VASc score of 0 and 1) where bene-
fits were neutral. Furthermore, the net clinical benefit
with warfarin was greatest in patients with the highest
bleeding risk. Researchers suggested that this could
be because this group had the highest stroke risk.
This study provides additional support for the lack of
ASA efficacy in atrial fibrillation, alone or in combina-
tion with warfarin, and should guide providers away
from this use.17
Clopidogrel and ASA
Clopidogrel plus ASA was compared to warfarin in the
Atrial Fibrillation Clopidogrel Trial with Irbesartan for
Prevention of Vascular Events (ACTIVE-W) trial. In
this trial, patients had an average of two risk factors
for stroke. Primary outcomes included first occurrence
of stroke, noncentral nervous systemic embolism, MI
or vascular death. Warfarin was superior to
clopidogrel plus ASA for prevention of vascular
events, with 165 events compared to 234 with the
combination. Rates of major hemorrhage were simi-
lar between groups; however, the clopidogrel plus
ASA group had more minor and total bleeds.18
Based
on these results, the combination of ASA and
clopidogrel is not recommended over warfarin when
patients are candidates for warfarin therapy.18,19
The Effect of Clopidogrel Added to Aspirin in Patients
with Atrial Fibrillation (ACTIVE-A) trial was conducted
to evaluate ASA plus clopidogrel versus ASA alone in
patients where warfarin was not an option due to risk
of bleeding, physician judgment, or patient prefer-
ence. The primary outcome was the composite of
stroke, MI, noncentral nervous systemic embolism, or
death from vascular causes. The annual rate of the
composite endpoint after a median of 3.6 years
follow-up was 6.8 percent in the clopidogrel-ASA
group versus 7.6 percent with ASA alone. The differ-
ence was attributed primarily to a reduction in the rate
of stroke (2.4 percent clopidogrel-ASA versus 3.3 per-
cent ASA). When evaluating adverse events, howev-
er, major bleeding was significantly increased in the
clopidogrel-ASA group (2.0 percent versus 1.3 per-
cent per year), including an excess of 13 fatal epi-
sodes.20
Based upon information from these studies, the AC-
CF/AHA/Heart Rhythm Society (HRS) included a rec-
ommendation concerning combination therapy in the
2011 Focused Update on the Management of Pa-
tients with Atrial Fibrillation. The class IIb recommen-
dation states that the combination of clopidogrel and
ASA might be considered as an option for primary
prevention of major vascular events in atrial fibrillation
when warfarin therapy is unsuitable.18-20
CHEST Guideline Updates
The recent CHEST guidelines published in February
2012 give updated recommendations regarding the
use of ASA in atrial fibrillation. For patients with a low
risk of stroke (CHADS2 score of 0), it is suggested
that no therapy be used. However, if medication ther-
apy is elected, ASA is recommended over oral antico-
agulation or combination therapy with ASA and
clopidogrel. For patients with an intermediate risk of
stroke (CHADS2 score of 1) and consistent with the
ACTIVE-W trial, oral anticoagulation is suggested
over no therapy, ASA or combination therapy with
July 2012
THE KENTUCKY PHARMACIST 34
Aug. 2012 CE-Aspirin: Evolving Evidence
ASA and clopidogrel. If warfarin is unsuitable or the
patient chooses not to take warfarin, combination
therapy with ASA and clopidogrel is suggested over
ASA alone. Consistent with the findings of the Danish
study evaluating warfarin and ASA, the guidelines al-
so recommend the use of warfarin alone over the
combination of warfarin and ASA in patients with atrial
fibrillation and stable coronary artery disease (CAD).21
Ticagrelor and ASA
Ticagrelor (Brilinta®), a new antiplatelet agent that
acts by binding and reversibly antagonizing adenosine
diphosphate, is indicated to reduce the rate of throm-
botic cardiovascular events in patients with ACS.22 In
the Platelet Inhibition and Patient Outcomes (PLATO)
trial, ticagrelor was found to be superior to clopidogrel
in secondary prevention of vascular events and death
with ACS. When comparing the two medications, ti-
cagrelor resulted in a decreased incidence of compo-
site death from vascular causes, MI or stroke (9.8 per-
cent versus 11.7 percent). All patients in this trial re-
ceived concomitant ASA 75-100 mg or a dose of 325
mg, if they had not been taking ASA prior to the trial.23
An interesting finding and limitation of the PLATO trial
was that ticagrelor had a relative lack of benefit in
North America compared to other sites throughout the
world. Recently, a subgroup analysis investigated this
finding; Cox regression analyses were performed to
assess the relationship between certain factors and
the regional differences in outcomes. It was identified
that North Americans received ASA doses of ≥300
mg/day more frequently than at other sites (53.6 per-
cent versus 1.7 percent, respectively). Out of the
many factors investigated, ASA dose was found to be
the main contributing factor accounting for regional
differences. Conclusions suggested that low-dose
concomitant ASA (75-100 mg), compared to higher
doses (≥300 mg), was associated with the lowest risk
of primary outcomes with ticagrelor versus
clopidogrel.25 Based upon this information and per the
approved prescribing information, it is recommended
that a maintenance dose of ASA, 75-100 mg daily, be
taken with ticagrelor.23-25
ASA in the Elderly
Antithrombotic therapy represents an important as-
pect of CAD treatment, the leading cause of death in
the elderly. In a 2002 ATT Collaboration meta-
analysis, ASA used for secondary prevention had a
similar MI, stroke and death relative risk reduction in
the elderly (>65 years, 19.4 percent) compared to
younger patients (23.1 percent), with greater absolute
benefit (4.5 percent versus 3.3 percent, respectively)
in the elderly, who have a higher risk of vascular
events.4,26 This supports the ACC/AHA recommenda-
tions for the use of low-dose ASA for secondary pre-
vention in elderly patients with ACS, chronic stable
angina, and undergoing PCI.27-29 As in PLATO, low-
dose versus high-dose ASA appears to be equally
effective in the elderly.3,24
Despite the evidence for ASA as secondary preven-
tion in this population, the support for primary preven-
tion remains inconclusive. The magnitude of risk ver-
sus benefit remains unknown and researchers em-
phasize the need for specific trials in the elderly. The
various age-related changes in pharmacokinetic and
dynamic parameters as well as physiology increase
their risk for bleeding and other complications. Current
recommendations suggest a risk stratification ap-
proach for the use of ASA for primary prevention in
the elderly population.26 The recent CHEST guidelines
suggest daily low-dose ASA (75 to 100 mg) over no
*Based on Framingham 10-year risk assessment. In general, most: a Men ≥50 and women ≥60 years with one additional risk factor: smoking, hypertension, family history of premature CVD,
Table: Use of Low-dose (75-162 mg/day) ASA for Primary CVD Prevention in Diabetes*
Recommended: High CVD risk (10-year risk >10 percent)a
AND no increased risk of bleeding
Not recommended: Low CVD risk (10-year risk <5 percent)b
Possibly consider: Intermediate CVD risk (10-year risk 5-10 percent)c
July 2012
THE KENTUCKY PHARMACIST 35
Aug. 2012 CE-Aspirin: Evolving Evidence
ASA therapy for those 50 years of age or older as
primary prevention. Per this recommendation, ASA
slightly reduces total mortality if taken over 10 years,
regardless of the cardiovascular risk profile. The re-
duction in MI for those at moderate to high risk of
CVD events is closely balanced with the increase in
major bleeds.21
ASA Discontinuation
It is estimated that approximately 50 percent of pa-
tients taking ASA for secondary prevention discontin-
ue therapy, with multiple reviews linking this to ad-
verse cardiovascular outcomes.30,31 A case-control
study using a primary care database specifically eval-
uated the risk of MI and death after ASA discontinua-
tion. Included were patients 50-84 years of age who
had ever received ASA for secondary prevention; cas-
es of MI or death were prospectively reviewed in
those continuing ASA versus those who did not.31
After a mean follow-up of 3.2 years, 876 patients had
a non-fatal MI and 346 died from CAD. The significant
outcomes included increased incidence of the com-
bined endpoint (non-fatal MI, death) and non-fatal MI
alone. When analyzed for recent versus distant ASA
discontinuation, those with a recent discontinuation
were at greater risk for outcomes. The authors con-
cluded that patients taking ASA for secondary preven-
tion who abruptly discontinue the medication place
themselves at a higher risk of MI compared to those
continuing treatment.31
Conclusion
Pharmacists frequently encounter patients who are on
ASA therapy and are in a unique role to influence pa-
tient care and decisions particularly in the area of
over-the-counter medications. Recent trials and re-
views have further enhanced our knowledge and
guided the continued effort to identify strategies for
the appropriate use of ASA in various situations in-
cluding the primary prevention of CVD. This infor-
mation concludes that ASA may be appropriate for
some patients, but in many situations its use is not
recommended. More emphasis has been placed on
assessing a patient’s overall cardiovascular risk be-
fore ASA is recommended, as those with a higher
baseline risk appear to have a greater absolute bene-
fit from therapy in some indications. By understanding
issues related to therapy, we can effectively impact
disease management and patient outcomes.
References
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ohrms/dockets/ac/03/briefing/4012B1_03_Appd%201-
Professional%20Labeling.pdf
2Buse JB, Ginsberg HN, Bakris GL, et al. Primary
prevention of cardiovascular diseases in people with
diabetes mellitus: a scientific statement from the
American Heart Association and the American
Diabetes Association. Circulation. 2007;115(1)114-26.
3Campbell CL, Smyth S, Montalescot G, Steinhubl
SR. Aspirin dose for the prevention of cardiovascular
disease: a systematic review. JAMA. 2007;297
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4Antithrombotic Trialists’ Collaboration. Collaborative
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stroke in high risk patients. BMJ. 2002;324(7329):71-
86.
5Antithrombotic Trialists’ (ATT) Collaboration, Baigent
C, Blackwell L, Collins R, et al. Aspirin in the primary
and secondary prevention of vascular disease: collab-
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6Diabetes [internet]. Washington, DC: World Health
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7Wild S, Roglic G, Green A, Sicree R, King H. Global
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8National Diabetes Fact Sheet. Centers for Disease
Control and Prevention Web site. http://www.cdc.gov/
diabetes/pubs/pdf/ndfs_2007.pdf.
9Diabetes Statistics [internet]. Alexandria, VA: Ameri-
can Diabetes Association; c1995-2011 Available from:
http://www.diabetes.org/diabetes-basics/diabetes-
statistics/
July 2012
THE KENTUCKY PHARMACIST 36
Aug. 2012 CE-Aspirin: Evolving Evidence
10Haffner SM. Coronary heart disease in patients with
diabetes. N Engl J Med. 2000 Apr 6;342(14):1040-
11Japanese Primary Prevention of Atherosclerosis
With Aspirin for Diabetes (JPAD) Trial Investigators,
Ogawa H, Nakayama M, Morimoto T, et al. Low-dose
aspirin for primary prevention of atherosclerotic
events in patients with type 2 diabetes: a randomized
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12Number (in millions) of persons with diabetes aged
35 years and older with self-reported cardiovascular
disease conditions, United States, 1997–
2007.Centers for Disease Control and Prevention
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fig1.htm. May 12, 2009.
13Diabetes Data and Trends. Centers for Disease
Control and Prevention Web site. http://www.cdc.gov/
diabetes/index.htm.
14Grundy SM, Benjamin IJ, Burke GL, et al. Diabetes
and cardiovascular disease: a statement for
healthcare professionals from the American Heart
Association. Circulation. 1999;100:1134-46.
15Prevention of Progression of Arterial Disease and
Diabetes Study Group, Belch J, MacCuish A, Camp-
bell I, et al. The prevention of progression of arterial
disease and diabetes (POPADAD) trial: factorial ran-
domised placebo controlled trial of aspirin and antioxi-
dants in patients with diabetes and asymptomatic pe-
ripheral arterial disease. BMJ. 2008;337:a1840.
16Pignone M, Alberts MJ, Colwell JA, et al. Aspirin for
primary prevention of cardiovascular events in people
with diabetes: a position statement of the American
Diabetes Association, a scientific statement of the
American Heart Association, and an expert consen-
sus document of the American College of Cardiology
Foundation. Circulation. 2010;121(24):2694-701.
17Olesen JB, Lip GY, Linhardsen J, et al. Risks of
thromboembolism with thromboprophylaxis in patients
with atrial fibrillation: A net clinical benefit analysis
using a ‘real world’ nationwide cohort study. Thromb
Haemost. 2011;106(4):739-49.
18The ACTIVE Investigators. Clopidogrel plus aspirin
versus oral anticoagulation for atrial fibrillation in the
Atrial fibrillation Clopidogrel Trial with Irbesartan for
prevention of Vascular Events (ACTIVE W):a random-
ised controlled trial. Lancet. 2006;367:1903-12.
19Wann SL, Curtis AB, January CT, et al. 2011 ACCF/
AHA/HRS Focused update on the management of
patients with atrial fibrillation (updating the 2006
guideline): A report of American College of Cardiology
Foundation/American Heart Association Task Force
on Practice Guidelines. Circulation. 2011;123:104-23.
20The ACTIVE Investigators. Effect of clopidogrel add-
ed to aspirin in patients with atrial fibrillation. N Engl J
Med. 2009;360:2066-78.
21Guyatt GH, Crowther M, Gutterman DD, Shuune-
mann HJ. Executive summary: antithrombotic therapy
and prevention of thrombosis, 9th ed: American Col-
lege of Chest Physicians evidence-based clinical
practice guidelines. Chest. 2012;141;7S-47S.
22Nawarskas JJ, Clark SM. Ticagrelor: a novel re-
versible oral antiplatelet agent. Cardiology in Review.
2011;19(2):95-100.
23Wallentin L, Becker RC, Budaj A, el al for the PLA-
TO Investigators. Ticagrelor versus clopidogrel in pa-
tients with acute coronary syndromes. N Engl J Med.
2009;361(11):1045-57.
24Mahaffey KM, Wojdyla DM, Carroll K, et al on behalf
of the PLATO Investigators. Ticagrelor compared with
clopidogrel by geographic region in the Platelet Inhibi-
tion and Patient Outcomes (PLATO) Trial. Circulation.
2011;124:544-54.
25AstraZeneca. Brilinta (ticagrelor) tablets [prescribing
information]. Wilmington (DE): 2011 Jul.
26Capodanno D, Angiolillo DJ. Antithrombotic therapy
in the elderly. J Am Coll Cardiol. 2010;56(21):1683-
92.
27Anderson JL, Adams CD, Antman EM, Bridges, et
al. ACC/AHA 2007 guidelines for the management of
patients with unstable angina/non–ST-elevation myo-
cardial infarction: a report of the American College of
Cardiology/American Heart Association Task Force
on practice guidelines (writing committee to revise the
2002 guidelines for the management of patients with
unstable angina/Non–ST-elevation myocardial infarc-
tion). J Am Coll Cardiol. 2007;20(7):e1-57.
28Fraker TD Jr., Fihn SD, Gibbons RJ, et al. 2007
July 2012
THE KENTUCKY PHARMACIST 37
Aug. 2012 CE-Aspirin: Evolving Evidence
Chronic angina focused update of the ACC/AHA
2002 guidelines for the management of patients with
chronic stable angina: a report of the American Col-
lege of Cardiology/American Heart Association Task
Force on Practice Guidelines Writing Group to devel-
op the focused update of the 2002 guidelines for the
management of patients with chronic stable angina. J
Am Coll Cardiol. 2007;50:2264 –74.
29 Kushner FG, Hand M, Smith SC, et al. 2009
Focused updates: ACC/AHA guidelines for the
management of patients with ST elevation
myocardial infarction (updating the 2004 guideline
and 2007 focused update) and ACC/AHA/SCAI
guidelines on percutaneous coronary intervention
(updating the 2005 guideline and 2007 focused up-
date): a report of the American College of Cardiology
Foundation/American Heart Association Task Force
on Practice Guidelines. J Am Coll Cardiol. 2009;54
(23):2205– 41.
30Sud A, Kline-Rogers EM, Eagle KA, et al. Adher-
ence to medications by patients after acute coronary
syndromes. Ann Pharmacother. 2005;39:1792-7.
31Rodriguez LA, Cea-Soriano L, Martin-Merino E, Jo-
hansson S. Discontinuation of low-dose aspirin and
risk of myocardial infarction: case-control study in UK
primary care. BMJ. 2011;343:d4094.
August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease
1. As primary prevention, ASA appears to decrease CVD risk in diabetes by approximately: A. 50 percent. B. 10 percent. C. 25 percent. D. 75 percent. 2. Based upon recent recommendations, all patients with Type 2 diabetes should receive ASA as primary CVD prevention. A. TRUE B. FALSE 3. In general, for preventing stroke in atrial fibrillation, ASA is: A. an alternative to warfarin. B. useful in combination with warfarin. C. is neither safe nor effective. 4. For decreasing vascular events in atrial fibrillation, the ACTIVE-W trial showed that: A. warfarin is equal to ASA plus clopidogrel. B. ASA plus clopidogrel is superior to warfarin. C. warfarin is superior to ASA plus clopidogrel. 5. The ACCF/AHA/HRS recommendations concern-ing therapy for primary prevention of major vascular events in patients with atrial fibrillation suggest that clopidogrel plus ASA might be an option when warfa-rin is unsuitable. A. True B. False
6. According to the recent CHEST guideline recom-mendations, patients with atrial fibrillation and at low risk of stroke should receive: A. ASA. B. clopidogrel. C. no therapy. D. warfarin. 7. To reduce the rate of thrombotic cardiovascular events in patients with ACS, ticagrelor should be tak-en with: A. clopidogrel. B. warfarin. C. aspirin. D. prasugrel. 8. Based upon PLATO results and prescribing infor-mation, the recommended daily maintenance dose of ASA to be taken with ticagrelor is: A. 75-100 mg. B. 325 mg. C. 650 mg. 9. Higher doses of ASA are needed in the elderly for both primary and secondary CVD prevention. A. True B. False 10. Discontinuing treatment with ASA for secondary CVD prevention is associated with: A. a higher risk of MI or death. B. no change in the risk for MI or death. C. a lower risk of MI or death.
July 2012
THE KENTUCKY PHARMACIST 38
Aug. 2012 CE-Aspirin: Evolving Evidence
August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease Universal Activity # 0143-9999-12-008-H01-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C 5. A B 7. A B C D 9. A B 2. A B 4. A B C 6. A B C D 8. A B C 10.A B C Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD)
This activity is a FREE service to members of the Kentucky Pharmacists Association. The
fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self
addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601.
The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.
Expiration Date: July 20, 2015 Successful Completion: Score of 80% will result in 1.0 contact hours or 0.10 CEUs.
Participants who score less than 80% will be notified and permitted one re-examination.
August 2012 — Aspirin: Evolving Evidence and Recommendations for Use in Cardiovascular Disease TECHNICIANS ANSWER SHEET. Universal Activity # 0143-9999-12-008-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C 5. A B 7. A B C D 9. A B 2. A B 4. A B C 6. A B C D 8. A B C 10.A B C Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________
NABP #_________________________________ Birthdate _______________________(MM/DD)
July 2012
THE KENTUCKY PHARMACIST 39
Pharmacists Mutual
July 2012
THE KENTUCKY PHARMACIST 40
Pharmacy Law Brief
Pharmacy Law Brief: Current Status of Conscience Clause Legislation
Author: Peter P. Cohron, B.S.Pharm., J.D., Practicing pharmacist and attorney, Henderson, KY.
Question: Several years ago we heard a great deal about pharmacists around the country refusing to dis-
pense medications in certain categories. That seems to have quieted down some. What is the current state of
the law on this, both around the country and in Kentucky? Can you comment on this from both the perspec-
tives of the employer and the employee pharmacist?
Response: First of all, a conscience clause, or
“refusal clause,” is a statute or regulation that allows
pharmacists to refuse to perform certain services,
usually dealing with abortion or clinically assisted sui-
cide, about which the pharmacist has a strong reli-
gious or moral issue. These laws permit the pharma-
cist to refuse patients certain medications or treat-
ments while protecting the pharmacist from any liabil-
ity arising from such refusals.
Conscience clauses arose initially out of the US Su-
preme Court’s ruling in Roe v. Wade in 1973 where
females were given the right to choose to do as they
desired with their bodies. Government could not inter-
fere with a patient’s personal, private choice. Four
states – not Kentucky – have enacted conscience
clause legislation specific to pharmacists, while four
more have “broad spectrum” clauses for health care
providers in general. Almost as many states, led by
former Illinois Governor Blagojevich’s emergency or-
der, have gone the opposite direction and mandated
that pharmacists must honor all legitimate prescrip-
tions presented to them.
Where has this issue gone? While conscience clause
advocates still work for their goal of relieving pharma-
cists from having to accept objectionable prescrip-
tions, the issue has certainly seemed to go dormant.
The overwhelming reason for this is that every case
to date regarding this issue has been decided in court
in favor of the patient, with the courts’ continuing reli-
ance on Roe and the ruling that the choice of therapy
belongs to the patient, not the pharmacist. Choice of
therapy refers back to – and is a part of – the court’s
ruling, the right of privacy and freedom of expression.
Without a substantial argument to negate this Consti-
tutional line of thought, and such an argument does
not seem to exist, state boards of pharmacy are cur-
rently shying away from addressing the issue. Why
spend time and effort on an issue that seems certain
to lose in the first round of any court action brought by
a patient?
Kentucky at this time does not have a conscience
clause in place for pharmacists. Relying on case his-
tory to attempt to see how a pharmacy case here
might be decided, one must look at analogous profes-
sions. Attorneys may refuse certain clients where
their strong moral opposition to the client’s case might
be detrimental to the client’s best interests. Physi-
cians may refuse to perform certain procedures re-
quiring a level of skill that might be unattainable when
the doctor has a strong objection to the procedure.
Unfortunately, this has not been extended to pharma-
cists in any jurisdiction, to my knowledge. The act of
properly preparing a prescription is not so demanding
of professional skills, courts have decided, to extend
these examples to our profession.
Other guidance is notably lacking. The APhA and the
AMA have both issued guidelines or passed resolu-
tions on the matter. In both cases, the results are
vague and not very helpful; while sympathy is extend-
ed to an objecting pharmacist, the patient and her
needs, both sets of guidelines emphasize, must be
met. At least one commentator says that pharmacy
schools should weed out those with objections prior to
admission to a pharmacy program!
Submit Questions: [email protected]
July 2012
THE KENTUCKY PHARMACIST 41
Do you have a story to tell?
Coming in future editions of The Kentucky Pharmacist : My Story: A Profile of a KPhA Member
The Kentucky Pharmacists Association is looking for members with a story to tell. Have a patient success story to
share? Find a new way to provide a service to the community? What makes you stand out in a crowd? Why did
you become a pharmacist?
Email Scott Sisco at [email protected] with a brief description of your story.
The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the
Museum, our state's leading preservation organization for pharmacy.
While contributions of any size are greatly appreciated, the following levels of annual giving have
been established for your consideration.
Friend of the Museum $100 Proctor Society $250 Damien Society $500 Galen Society $1,000
Name_________________________________ Specify gift amount________________________
Address ______________________________ City____________________Zip______________
Phone H_______________W____________ Email___________________________________
Employer name_____________________________________________for possible matching gift
Tributes in honor or memory of_____________________________________________________
Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502
The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax
deductible. A notice of your tax deductible contributions will be mailed to you annually.
Questions: Contact Lynn Harrelson @ 502-425-8642 or [email protected]
Pharmacy Law Brief
Employers have been generous in the past by asking
their pharmacists to make their objections known and
taking steps to put in place a policy to help a patient
when an objecting pharmacist is on duty. The phar-
macist could ask the patient to return when another,
non-objecting pharmacist was on duty or even refer
the patient to another pharmacy where that objection-
able prescription would be honored. The employers’
attitudes toward objecting pharmacists seemed to be
one of empathy but also patient-oriented. There is
some concern that in light of the end of the pharma-
cist shortage that employers may take a more strict
approach. This could include preferably hiring phar-
macists who convey no moral or religious issues to
their potential employers and even terminating phar-
macists who exhibit these issues in practice. Addition-
ally, some worry that honoring all legitimate prescrip-
tions may become a prerequisite for hiring.
Employee pharmacists certainly face some hard
choices. Our profession needs to be prepared for both
a demanding public and an unsympathetic employer.
Along with this, pharmacists should be reminded that
taking a stand might be very expensive, as malprac-
tice insurance generally does not cover conscience
issues. Taking a moral stand may be harder than ever
in the evolving world of pharmacy.
Disclaimer: The information in this column is intend-
ed for educational use and to stimulate professional
discussion among colleagues. It should not be con-
strued as legal advice. There is no way such a brief
discussion of an issue or topic for educational or dis-
cussion purposes can adequately and fully address
the multifaceted and often complex issues that arise
in the course of professional practice. It is always the
best advice for a pharmacist to seek counsel from an
attorney who can become thoroughly familiar with the
intricacies of a specific situation, and render advice in
accordance with the full information.
July 2012
THE KENTUCKY PHARMACIST 42
KPhA Board Welcomes New Members
KPhA sends email announcements weekly.
If you aren’t receiving:
eNews, Legislative Updates, Grassroots Alerts and other
important announcements, send your email address to
[email protected] to get on the distribution list.
Vice Speaker of House of Delgates — Cassandra
Beyerle is a 2010 graduate from the University of Ken-
tucky College of Pharmacy. In
2011, she completed a PY1
community pharmacy residency
with Sullivan University and
Medica Pharmacy and Wellness
Center. She is currently em-
ployed by Sullivan University
College of Pharmacy as an As-
sistant Professor in the Clinical
and Administrative Science De-
partment, with a clinical site at
Family Health Center Port-
land. Her ambulatory care clinic
services the patients of Family Health Center through dia-
betes and anticoagulation management. Cassy is an active
member of JCAP and the KPhA New Practitioner Commit-
tee.
Director — Matt Carrico currently is a pharmacist/owner
of Booneville Discount Drug in
Booneville, Ky. Matt graduated
in 2010 from the University of
Charleston in West Virginia and
previously worked for
Walgreens as a pharmacist in
Louisville and as a corporate
intern in Chicago. In his time
with Booneville Discount Drug,
Matt helped setup a MTM pro-
gram, an immunization clinic, a
340B program and a scholar-
ship for graduating seniors of
Owsley County High School. He is excited to be a part of
KPhA and looks forward to playing a role in the advance-
ment of our profession.
Sullivan University College of
Pharmacy Student Representa-
tive — Lance Murphy is the Stu-
dent Representative to the KPhA
Board of Directors from Sullivan
University College of Pharmacy.
He is a P-2 student representing
SUCOP as its APhA-ASP Presi-
dent. He was a three-time letter
winner, playing football, and re-
ceived his Bachelors of Science
in Biology from Morehead State
University in 2011.
Director — Robert Oakley is a 1977 graduate of the Uni-
versity of Kentucky College of Pharmacy. He also earned
an M.S. degree from the University
of Florida in 1982 and completed a
two-year ASHP Residency
at Shands Teaching Hospital. He is
a Fellow of KSHP and ASHP and a
past president of KSHP, JCAP and
served as a board member for both
organizations. Oakley won the
JCAP Pharmacist of the Year
Award (2006) and was co-winner of
the KPhA Professional Promotion
Award (2001). He has been director
of pharmacy at Baptist Hospital
East in Louisville since 1988.
Welcome to the new members
July 2012
THE KENTUCKY PHARMACIST 43
KPhA Board Welcomes New Members
Past President — Donnie Riley graduated from the Uni-
versity of Kentucky College of
Pharmacy in 1979. He is Presi-
dent of Riley White, Inc. and
Riley White Drugs- Russellville
& Clinic Pharmacy- Bowling
Green. He has served on the
KPhA Professional Affairs
Committee for numerous
years, and served on the KPhA
Board of Directors 1997 to
2000. He also served as Presi-
dent-Elect/President/ Chairman
of the Board 2000 to 2003. He
currently serves on the APSC Board of Directors and is the
APSC Secretary/Treasurer. Riley was the recipient of the
KPhA Distinguished Service Award in 2005 and the Uni-
versity of Kentucky College of Pharmacy Preceptor of the
Year in 2008. He has been married to Lillian B. Riley for 33
years and they have two children, Lindsey Riley and Lau-
ren Riley Stafford, PharmD.
University of Kentucky College of Pharmacy Student
Representative — Molly
Trent was born and raised in
the Lexington area and cur-
rently lives in Georgetown.
She completed her under-
graduate studies at the Uni-
versity of Kentucky and is now
a third-year student pharma-
cist at the UK College of Phar-
macy. She serves as the
APhA-ASP Chapter President
and is an active member of
Rho Chi and Phi Lambda Sig-
ma. When she’s not studying or participating in extracurric-
ular activities through school, she enjoys cheering on the
CATS and horseback riding.
of the KPhA Board of Directors
Thank you to our outgoing KPhA Board Members
From left: 2011-12
Chairman Clay
Rhodes, UK Rep.
Kelley Ratermann,
Sam Willett,
SUCOP Rep.
Amanda Jett,
Amanda Burton,
Glenn Stark, Presi-
dent Lewis Wilker-
son. Willett was
reelected for an-
other term and
Stark was appoint-
ed Treasurer by
the board.
July 2012
THE KENTUCKY PHARMACIST 44
KPhA Government Affairs Contribution
Name: ______________________________________________________________
Pharmacy: ___________________________________________________________
Email: ______________________________________________________________
Address: _____________________________________________________________
City: _______________________________________________ State: _________ Zip: ____________
Phone: ________________ Fax: _________________ E-Mail: ______________________________
Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs)
Credit Card (AMEX; Discover; MasterCard; VISA)
Account #: ____________________________________________________ Expiration date: _______
Address to which credit card statement is mailed (if different from above)
___________________________________________________________________________________
Mail to: Kentucky Pharmacists Association, 1228 US Highway 127 South, Frankfort, KY 40601
Academy of Consultant Pharmacists
Senior Care Corner from the KPhA Academy of Consultant Pharmacists
Submitted by Leah Tolliver PharmD, KPhA Board of Directors and Academy member
At the 134th KPhA Annual Meeting, June 13-16,
2012, the consultant pharmacist members met to dis-
cuss new officers for the Academy of Consultant
Pharmacists. Elisha Bischoff is the Chair, the vice-
chair position remains open and the three new direc-
tors are Peggy Canler, Terry Seiter and Gary Rice.
Let’s welcome them as new officers for the long-term
care Academy!
As a member of the KPhA Academy, an annual con-
tinuing education program is provided for all members
of KPhA. CE is free for Academy members. A contin-
uing education program was held April 29, 2012 at
the Kentucky Pharmacy Renaissance Museum. There
were 25 attendees, some of which joined as a new
Academy member! The CE programs included an up-
date in federal regulations that impact long-term care
pharmacy and Beers Criteria for Potentially Inappro-
priate Medication Use in Older Adults-2012 Update.
During the KPhA conference, a business meeting was
held for consultant pharmacists.
We look forward to adding new members and provid-
ing relevant information that impacts long-term care
pharmacy throughout the year.
Please contact President Elisha Bischoff,
[email protected], for information
about joining the Academy.
July 2012
THE KENTUCKY PHARMACIST 45
Congratulations SUCOP Class of 2012 The Sullivan University College of Pharmacy celebrated the graduation of its second class on June 7, 2012 at the Block Auditorium at Southeast Christian Church in Louisville, Ky.
The 88 graduates of the Class of 2012 were offered congratulations by Chancellor A. R. Sullivan and Presi-dent Glenn Sullivan, and heard a commencement address delivered by Mr. Michael Burleson, Executive Director of the Kentucky Board of Pharmacy and President of the Na-tional Association of Boards of Phar-macy.
The ceremony culminated with the recitation of the Oath of a Pharmacist delivered by Dr. Hieu T. Tran, Vice-President of the College of Health Sciences and Founding Dean and Professor of the College of Pharma-cy.
Sullivan University College of Pharmacy Class of 2012
July 2012
THE KENTUCKY PHARMACIST 46
Pharmacy Policy Issues
PHARMACY POLICY ISSUES:
The Overwhelming Cost
of Medication Misadventures Author: Tyler Stewart is a fourth-year pharmacy student at the University of Kentucky College of Pharmacy.
A native of Goshen, Ky., Tyler earned a B.S. in chemistry from Georgetown College prior to enrolling in phar-
macy school.
Issue: Further action on the part of the medical community needs to be taken in regards to minimizing medi-
cation misadventures and, in turn, reducing the costs they have on society.
Discussion: Medication misadventures, including duplicate therapy, insufficient therapy, improper dis-pensing and avoidable adverse drug events, cost pa-tients, insurance companies and providers both finan-cially and in terms of health outcomes. The current state of health care in this country, and more relevant to this discussion, the current state of our medication use system, has created a landscape in which pre-ventable medication related adverse events and inap-propriate drug therapies abound. Efforts have been made in the past to combat and minimize preventable medication errors or misadventures, but it is evident that more attention needs to be brought and efforts need to be made in order to preserve positive health and financial outcomes for our patients.
In regard to pharmacy practice and our role in com-bating this issue, little regulatory action has been tak-en in recent years. The most recent and outstanding regulatory action that was implemented was the Om-nibus Budget Reconciliation Act of 1990 (OBRA ’90). In requiring drug utilization reviews and the offer to counsel patients on prescriptions dispensed, OBRA ’90 placed pharmacists at the forefront of medical pro-fessionals who can review and intervene upon medi-cation misadventures. But, even with these regula-tions and the expanded power and responsibility pharmacists gained from them, a significant amount of misadventures still occur everyday.
In 1995, nearly 17 million hospital visits in this country were due to a drug related illness which in turn equat-ed to $76.6 billion in health care costs. That same year, it was also estimated that for every dollar spent on pharmaceuticals, another dollar was spent on treating problems that stemmed from sub-optimal medication use. The money spent on remedying pre-ventable medication misadventures is outstanding and an absolute waste of health care resources that could be better spent in various other areas of patient care.
Over the past couple of decades and into today, more and more individuals are being put on medications for chronic disease states. With the number of prescrip-tions being dis-pensed having in-creased by 39 per-cent from 1999 to 2009, coupled with only a nine percent increase in popula-tion over that same period of time, there is an in-creased risk of medication misad-ventures now more than ever. We also are continually see-ing new drugs be-ing brought to the market. All of this, combined with the increasing age of our population, has created a state of health care where patients are at risk for medication misadven-tures.
There has been a recent push toward expanding an-cillary services in pharmacies including vaccination services and medication therapy management. These services are designed to reduce the risk of disease and/or thoroughly monitor drug therapies, thereby op-timizing medication use and reducing the risk of medi-cation misadventures. These added services will no doubt help improve health outcomes in patients as well as reduce the risk of medication misadventures. But, with the ever-increasing amount of prescriptions dispensed, the increasing discovery of new and inno-vative medications available to treat myriad disor-ders, and the relatively new implementation and evo-
Have an Idea?:
This column is designed to
address timely and practical
issues of interest to
pharmacists, pharmacy
interns and pharmacy
technicians with the goal
being to encourage thought,
reflection and exchange
among practitioners.
Suggestions regarding topics
for consideration are
welcome. Please send them
July 2012
THE KENTUCKY PHARMACIST 47
Pharmacy Policy Issues
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lution of healthcare laws and services aimed at mini-mizing medication misadventures, awareness of this issue must be brought to light and policies regarding this issue must continue to be developed and promul-gated.
References:
Johnson JA, Bootman JL. Drug-related morbidity and mortality: A cost-of illness model. Ann. Internal Med. 1995; 155:1949-56
Kaiser Family Foundation. “Prescription Drug
Trends”. 2010. www.kff.org
Nau DP, Kirking DM. Why is medication use less than appropriate? in Fulda TR, Wertheimer Al (eds.) Phar-maceutical Public Policy, New York: Haworth Press (2007), pp. 477-98
Schatz R, Belloto RJ, White DB, Bachmann K. 2003. “Provision of Drug Information to Patients by Pharma-cists: The Impact of the Omnibus Budget Reconcilia-tion Act of 1990 a Decade Later”. Am. J. of Thera-peutics 10 (2): 92-103.
July 2012
THE KENTUCKY PHARMACIST 48
Dr. Fink named KPhA Endowed Professor in Leadership
Fink named first KPhA Endowed Professor Joseph L. Fink III, Professor of Pharmacy Law and
Policy in the UK College of Pharmacy, has been
named the Kentucky Pharmacists Association (KPhA)
Endowed Professor in Leadership. He was formally
recognized at KPhA’s Annual Meeting on June 14,
2012.
“Dr. Fink embodies the mission of KPhA,” said KPhA
President Lewis Wilkerson. “Over his distinguished
career, he has continued to promote the profession of
pharmacy, enhance the practice standards, and
demonstrate the value of pharmacy to countless peo-
ple across Kentucky, the nation and the world.”
Fink, highly respected as a pharmacist, lawyer and
educator within Kentucky and across the nation, is the
first UK College of Pharmacy faculty member to be
named the KPhA Professor in Leadership.
“Having been a member of the Kentucky Pharmacists
Association for many years, it is, indeed, an honor
and privilege to be named to this professorship,” said
Fink, who received his professional education in phar-
macy at the Philadelphia College of Pharmacy and
Science, and holds the degree Doctor of Law from
Georgetown University Law Center.
Fink's participation and leadership within professional
associations is extensive. He holds membership in a
number of professional organizations in both pharma-
cy and law, including KPhA, the American Pharma-
cists Association (APhA) and the American Bar Asso-
ciation. He is a Fellow of APhA and a former Vice
Speaker of the House of Delegates of the Association.
He chaired the committee for the latest revision of the
APhA Code of Ethics for Pharmacists and currently
serves the Association as its Parliamentarian for the
House of Delegates, where he mentors others inter-
ested in the delegate process.
He was founder and first president of the American
Society for Pharmacy Law and, while a pharmacy stu-
dent, was National President of the Student American
Pharmaceutical Association. He has encouraged, ad-
vised and mentored countless student leaders over
the years while serving as faculty advisor for the
APhA Academy of
Student Pharmacists
(APhA-ASP) organi-
zation and the Ken-
tucky Alliance of
Pharmacy Students.
The Kentucky Phar-
macists Association recognized him as "Pharmacist of
the Year" in 1988 and in 2002 conferred on him the
Distinguished Service Award for significant contribu-
tions to the profession over an extended period of
time.
In March 2012, he was recognized with the Linwood
F. Tice Award by the APhA-ASP for his personal com-
mitment to, and passionate support of, student phar-
macists throughout his career.
“When you think of pharmacy leadership, you think of
Joe Fink,” said Tim Tracy, Dean of the UK College of
Pharmacy. “Joe has quite literally trained and men-
tored a generation of pharmacy leaders and continues
to impact the next generation of leaders every day
here at the UK College of Pharmacy. He is most de-
serving of this professorship.”
“I also applaud the Kentucky Pharmacists Association
for their support for the UK College of Pharmacy. The
KPhA Professor of Leadership is another example of
how they continue to be a great partner for our Col-
lege.”
Dr. Joseph L. Fink, III with UKCOP Dean Timothy Tracy
and KPhA President Lewis Wilkerson.
July 2012
THE KENTUCKY PHARMACIST 49
University of Kentucky College of Pharmacy Class of 2012
Congratulations UKCOP Class of 2012
The University of Kentucky College of Pharmacy hon-
ored 148 students at the 2012 Graduation Recogni-
tion Ceremony May 4 at the UK Singletary Center for
the Arts.
Of those completing requirements for degrees, 14
students earned a PhD in pharmaceutical sciences,
seven students received a Master's degree in phar-
maceutical sciences and 127 students were awarded
the Doctor of Pharmacy (PharmD) degree.
Associate Dean Kelly M. Smith welcomed graduates
and their families and greetings from the College
were provided by Dean Timothy S. Tracy.
Following the presentation of diplomas, PharmD
graduates recited the Pharmacist's Oath led by Lewis
Wilkerson, president of the Kentucky Pharmacists
Association.
July 2012
THE KENTUCKY PHARMACIST 50
KPhA BOARD OF DIRECTORS
Lewis Wilkerson, Frankfort Chairman
[email protected] 502.695.6920
Kimberly Croley, Corbin President
[email protected] 606.304.1029
Duane Parsons, Richmond President-Elect
[email protected] 502.553.0312
Frankie Hammons Abner, Barbourville Secretary
[email protected] 606.627.7575
Glenn Stark, Frankfort Treasurer
Donnie Riley, Russelville Past President
Directors
Molly Trent, Georgetown Student Representative
Lance Murphy, Louisville Student Representative
Matt Carrico, Louisville
Chris Clifton, Erlanger
Trish Freeman, Lexington*
Joey Mattingly, Prospect
Matt Martin, Louisville
Jeff Mills, Louisville
Bob Oakley, Louisville
Richard Slone, Hindman
Leah Tolliver, Lexington
Sam Willett, Mayfield
* At-Large Member to Executive Committee
HOUSE OF DELEGATES
Matt Martin, Louisville Speaker of the House
Cassandra Beyerle, Louisville Vice Speaker of the House
KPERF ADVISORY COUNCIL
Kim Croley, Corbin
Ann Amerson, Lexington
KPhA/KPERF HEADQUARTERS
1228 US 127 South, Frankfort, KY 40601
502.227.2303 (Phone) 502.227.2258 (Fax)
www.kphanet.org
www.facebook.com/KyPharmAssoc
www.twitter.com/KyPharmAssoc
Robert McFalls, M.Div.
Executive Director
Matt Worthy, PharmD
Director of Professional & Clinical Services
Scott Sisco, MA
Director of Communications and Continuing Education
Kelli Sheets
Office Manager
Christine Richardson, PharmD
Clinical Pharmacist
Darcie Nixon
Administrative Coordinator & Billing Specialist
Nancy Baldwin
Receptionist/Office Assistant
KPhA Board of Directors
July 2012
THE KENTUCKY PHARMACIST 51
Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org Kentucky Society of Health Systems Pharmacists 1501 Twilight Trail Frankfort, KY 40601 (502) 223-5322 www.kshp.org
Kentucky Regional Poison Center (800) 222-1222
American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org
National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 [email protected]
Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu
Frequently Called and Contacted
Frequently Called and Contacted
KPhA Remembers KPhA desires to honor members
who are no longer with us.
Please keep KPhA informed by sending this information to [email protected].
Deceased members for each year will be honored permanently
at the KPhA office with a White Coat.
July 2012
THE KENTUCKY PHARMACIST 52
THE
Kentucky PHARMACIST
1228 US 127 South
Frankfort, KY 40601