The Georgia Pharmacy Journal: December 2009

The Georgia Pharmacy Journal December 20092

Open EnrollmentBegins October 1st for the Plan Year 2010

Prescription Drug CoverageDental and Orthodontic Benefits

$500 Wellness BenefitGuaranteed Issue Term Life Insurance... up to $50,000

(with no underwriting requirements)

Call or e-mail TODAY to schedule a time to discuss your health insurance needs.Trevor Miller – Director of Insurance Services

404.419.8107 or email at [email protected]

NEW PLANS – BETTER RATES – MORE BENEFITS in 2010

Georgia Pharmacy Association Members Take Advantage ofPremium Discounts Up to 30% on Individual Disability

Insurance

Have you protected your most valuable asset? Many people realize the need to insure personal belongings like carsand homes, but often they neglect to insure what provides their lifestyle and financial well-being - their income!

The risk of disability exists and the financial impact of a long-term disability (90 days or more) can have adevastating impact on individuals, families and businesses. During the course of your career, you are 3½ timesmore likely to be injured and need disability coverage than you are to die. (Health Insurance Association of America,2000)

As a member of the Georgia Pharmacy Association, you can help protect your most valuable asset and receivepremium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life InsuranceCompany.

For more information visit www.gphainsurance.com.

* Association Program subject to state approval. Policy forms HH 750, HH 702, HH 703. This is a general summary only. Additional guidelines apply. Disability insurance has limitations and exclusions. Forcosts and details of coverage, contact your Principal Life financial representative.


F E A T U R E A R T I C L E S

11 Pharmacy in the News

12 Member Contribution: Same, Same... Different...

13 Georgia Drugs and Narcotics Agency Website

14 APhA Immunization Program; October 24, 2009

16 NCPA Elects Hugh Chancy Fifth Vice President

23 CPE Opportunity: A Model System to PromoteAccess to Good Quality Compounded Medicines

C O L U M N S

4 President’s Message

7 Editorial

For an uptodate calendarof events, log onto www.gpha.org.

8DCH Reverses Policy on

Retirees’ 90day Prescriptions

Departments5 New Members10 New Practitioner Leadership

Conference Nomination Form15 GPhA Member News18 GPhF Annual Fund Giving Form19 Pharm PAC Contribution Card31 GPhA Board of Directors

Advertisers2 The Insurance Trust2 Principal Financial Group6 Pharmacists Mutual Companies16 PharmStaff17 AIP 16 Michael T. Tarrant19 Melvin M. Goldstein, P.C.19 Toliver & Gainer20 Alaska Continuing Education at Sea21 Georgia’s Own Credit Union22 Southeastern “Girls of Pharmacy”

Leadership Weekend32 The Insurance Trust

P R E S I D E N T ’ S M E S S A G E


Two-thousand-nine may turn out to be amonumental year for health care in the UnitedStates. The U.S. House has narrowly passed a

major health care reform bill that will see rough sailing asit passes to the Senate for consideration. Many of thecomplex negotiations will occur behind closed doors by aconference committee comprised of the leadership fromthe House, the Senate and the President’s representatives.

As I attended our region meetings this fall, many memberswere asking if pharmacy was being represented in thenational health care debate. As your president, I have hadthe opportunity to participate in the National CommunityPharmacy Association and the American PharmacistAssociation’s legislative activity. Both of theseorganizations have an experienced and effective lobbyingarm that has been able to articulate on behalf of thepharmacy profession. I have witnessed the NationalCommunity Pharmacy Association’s PAC grow from 450th

in PAC strength to being in the top fifty! Both of theseorganizations have come to realize how pharmacy was leftout of the debate when Medicare D was implemented.They both have stepped up their efforts to strengthentheir lobbying to better represent the profession on anational level.

Strength often comes from numbers. Georgia PharmacyAssociation is a member of the National Alliance of StatePharmacy Associations (NASPA). This organization hasalso increased its efforts by committing to a full timeexecutive director and staff. As such they are able to be a

collective voice for all of its state association members onthe national stage. Recently, NASPA joined with NCPA,APHA, NACDS, Food Marketing Institute, HealthcareDistribution Management Association, and thePharmaceutical Care Management Association in writingletters to Congress urging that they reconsider AMPreimbursement in the health care reform bill. This was setunder the deficit reduction act at a level that wouldreimburse pharmacies 30 percent below their acquisitioncost. If implemented this would mean many pharmacieswould close and impact the availability of pharmacyservices to many patients. This is but one of the vital issuesthat pharmacy wants addressed in the healthcare reformbill.

Another important issue to pharmacy is the need for PBMtransparency. Thus far, the House and Senate versions ofhealth care reform have PBM transparency for theMedicare Plans. With this implementation being includedin the final version, pharmacy will score another win in itsbattle with the PBM industry.

Our national organizations continue to promote the valueof a pharmacist in providing improved health careoutcomes. The American Pharmacists Association haspushed to include MTM Pharmacy Services in the newhealth care legislation to improve the quality and reducethe cost. The language was kept in the version that passedthe House. Strangely enough, the lone Republican votecame from a Louisiana house member whose wife is apharmacist!

Eddie M. Madden, R.Ph.GPhA President

Who’s Looking Out for Pharmacy?

5The Georgia Pharmacy Journal December 2009

Pharmacists are dedicated professionals that are highlyrespected in their communities. They often expect thepolitical process to fairly represent their needs. Myexperience has been that many believe they have exercisedtheir civic duty by voting in elections. Most do notinteract with the state or national level electedrepresentatives. Without the lobbying support of ournational and state associations, our profession would beunrepresented in the political arena. Maine is one of fourstates that have lost its state association. Without someoneto speak for pharmacists, it is little wonder that Maine wasthe last state to receive authority to immunize and this wasaccomplished because the Maine Department of PublicHealth saw the need and pushed for the legislation.

The lifeblood of our associations is a strong membership.Georgia has over 12,000-licensed pharmacists with over10,000 practicing within the state. Only a third of themare members of our state association. The NationalCommunity Pharmacy Association likewise has a pool of

over 50,000 independent pharmacies in the United Statesand about the same percentage are members. I feel surethat the American Pharmacists Association has a similarmembership makeup. Imagine what a powerful andeffective lobbying effort could be generated if more of ourprofession would become a member of theseorganizations and actively contribute to their PACs.

I realize that I am preaching to the choir, since readers ofthis article will be members of our state association.Unfortunately, only a couple of hundred of our memberscontribute to our PharmPAC. I would hope that all ourmembers are also supportive of our national associationsthrough membership and PAC contributions. As amember I would urge each of you to consider asking non-member pharmacists that you encounter daily throughyour practice if they would consider joining the GeorgiaPharmacy Association and making our state associationone of the strongest in the nation!

Sylivia D. Adams, R.Ph., RiverdaleCarolyn M. Beale, Pharm.D., Fayetteville

Purvi Bheda, Pharm.D., AtlantaRebecca Davis, Pharm.D., Tifton

Lance C. Faglie, RinconNicholas Hanson, Savannah

Terry O. Jones, R.Ph., AthensWilliam Tyler Landers, Griffin

Levis Aldine McConnell, III, B.S., RoswellHarry Eugene McGinnis, R.Ph., Summerville

Michell B. Redding, Pharm.D., AtlantaRandy G. Richards, R.Ph., Cumming

Jaclyn Danelle Scott, Pharm.D., KathleenBatisha Tatum-Murray, Pharm.D., Atlanta

Adam J. Toenes, Pharm.D., DaculaHarrell E Tweedy, Ph.D., Acworth

Welcome to GPhA!The following is a list of new members who have joined Georgia’s premier

professional pharmacy association!

When it comes to pharmacy, you can count on the fact that the GeorgiaPharmacy Association is looking out for our profession!

E X E C U T I V E V I C E P R E S I D E N T ’ S E D I T O R I A L

Jim BracewellExecutive Vice President / CEO

A Holiday Gift Under EveryPharmacist’s Tree in Georgia


Here is a gift for you to celebrate this HolidaySeason. The gift of proven effective advocacyfor your profession.

It is the gift of bringing together a chorus of voices that areall united on the same music, singing the same verse sothat our elected leadership in the State and the FederalGovernment will hear our concerns.

This fall the pharmacists of Georgia said to the state ofGeorgia it is wrong to penalize state retiree patients thatseek to fill their 90-day prescriptions at their home townpharmacy. The Department of Community Health wasconvinced by the state contracted Pharmacy BenefitManager to penalize patients if they did not use thecontracted PBM mail order pharmacy for their 90-dayprescriptions. “This is not right,” said the pharmacists ofGeorgia. Serving patients in our local community is theheart and soul of the home town community pharmacy.Sending prescriptions paid with Georgia Taxpayer fundsto an out-of-state PBM owned pharmacy is just plainWRONG.

You, along with your patients, said to the state of Georgiathis is wrong headed thinking and the state mustreconsider their plan. Your state legislators heard you.Your local chambers of commerce heard you. YourGovernor heard you. Your message was the members ofthe Georgia Pharmacy Associations want to be partnerswith the state in finding solutions to rising healthcarecosts, not victims of self promoting PBMs who have abulging bottom line profit to deliver for theirstockholders.

See the announcement on the following page and letter toGovernor Perdue. Your message was heard. Your electedgovernment leaders responded. You have deliveredproven effective advocacy for the profession of pharmacy.

Here are two other outstanding accomplishments to putin your pharmacy stocking.

This past legislative session, Oren H. “Buddy” Harden,Jr., R.Ph., served his first term in the Georgia State Houseof Representatives. This added a new pharmacist voice atthe state capitol. The members of the Georgia PharmacyAssociation played a significant role in Buddy’s successfulelection.

In November, former State Representative, Earl “Buddy”Carter, R.Ph., with supreme confidence in the support ofthe Georgia Pharmacy Association, resigned his StateHouse position to run for the vacant seat in the StateSenate from District 1 (Chatham, Bryant and LibertyCounties). His confidence was well placed and he wonthe race with over 82 percent of the vote. Pharmacy nowhas a pharmacist voice in the Georgia State Senate.

Share this GPhA Journal with a pharmacy colleague whomay not really know what is being done to ensure a betterfuture for the profession of pharmacy through the work ofthe Georgia Pharmacy Association.

Happy Holidays on behalf of the staff of GPhA.

Jim


The State of Georgia Retirees have anadditional blessing to be grateful forthis holiday season. They will not be

financially penalized if they fill their 90-dayprescriptions at their community pharmacy.

Due to the tenacious work of the GeorgiaPharmacy Association, the GeorgiaDepartment of Community Health (DCH)has issued the following announcement toGPhA effective immediately.

The Georgia State Health Benefit Plan(SHBP) vendors that offer the MedicareAdvantage with a Medicare Part Dprescription drug program will reimbursepharmacies for 90-day prescriptions at thesame rate schedule as their mail orderpharmacies provided they meet thecredentialing requirements, vendor standardsand accept the terms of the mail orderpharmacy network contract. This applies tothe SHBP Medicare Advantage plans only.

For questions regarding participation: Unitedinquiries may call the Prescription Solutionspharmacy help desk at 800-613-3591 and

Cigna inquiries should be directed to theircurrent contract representative.GPhA thanks each and every member who didnot give up and stuck with GPhA’s efforts toget this DCH policy changed. GPhA thankslocal legislators and the local Chambers ofCommerce in the State of Georgia for theirsupport. GPhA’s collective voices were heardand the citizens of Georgia have a specialblessing today. GPhA also wants to expressour gratitude to Governor Perdue’s office forthe hundreds of calls they handled on thissubject and for the great outcome.

GPhA members have much to be thankful forthis holiday season, including living in acountry with an elected government where thecitizens can petition for change.

Please take time to thank your StateRepresentative, your State Senator and theGovernor for listening to the people ofGeorgia on this issue.

If GPhA members want to be heard the nexttime then it is imperative that they take time tosay “thank you” this time!

P H A R M A C Y N E W S

DCH Reverses Policy onRetirees’ 90-dayPrescriptions


P H A R M A C Y I N T H E N E W S

CVS/Caremark Under U.S. FTC Investigation

CVS Caremark Corp, said the Federal TradeCommission is probing some of its businesspractices.

CVS is confident it conducts business in compliance withantitrust laws, David Denton, Chief Financial Officer ofCVS said today in an e-mailed statement. CVS wasnotified of the investigation in August and is cooperating,the Woonsocket, Rhode Island-based company said in aregulatory filing.

The FTC is investigating certain CVS business practices,

Peter Kaplan, a spokesman for the Washington-basedagency, said in a telephone interview. He wouldn’t discusswhich practices are the targets of the probe.

Company shares plunged $7.28, or 20 percent, to $28.87in the New York Stock Exchange, the biggest one-daydecline since 2001.

GPhA representatives attended the FTC hearing in May2009 when the FTC was considering the necessity of aninvestigation.

United Heathcare Faces $750K Fine inGeorgia

United Healthcare has been slapped with a$750,000 fine for delaying claims payment todoctors and consumers. The combined fine is

also shared by sister companies United Healthcare ofGeorgia, American Medical Security Life Insuranceand Golden Rule Insurance.

Georgia Insurance Commissioner John Oxendine hassigned a consent order demanding that UnitedHealthcare comply with state regulations, dating fromAugust 1999, which demand that insurers makeprompt claims payments. The state collects claims dataevery quarter to make sure that this happens.

United Healthcare says it processes 97 percent of itsclaims for the state within 15 days, and 99 percentwithin 30 days. But the state apparently drew adifferent conclusion when it audited claims datacovering the quarter ending March 31, 2009. Thehealth plan faced similar charges in North Carolina lastyear--in addition to disputes over coordination ofbenefits, appeals, explanations of benefits andproviders--and was forced to pay an $800,000settlement.


M E M B E R C O N T R I B U T I O N

Same, Same... Different...

The Georgia Pharmacy Association has a 134 yearhistory of promoting and protecting theprofession of Pharmacy in Georgia. Our elected

Executive Committee members receive their directionthrough the combined efforts of the Association’sStanding Committees which include Government Affairs,Third Party, Public Relations and Student Affairs.Members of these committees are appointed by each ofthe Region Presidents as well as each Academy Chair inorder to represent all of the varied interests of theAssociation members.

In September, it was my pleasure to represent theAcademy of Employee Pharmacists in the GovernmentalAffairs Committee meeting. The committee wascomposed of Pharmacists from every practice setting andmoderated by our president, Eddie Madden, and StuartGriffin, GPhA Staff Government Affairs. Our charge wasto establish three top priorities related to GovernmentAffairs for the association to pursue this year.

It is no big secret that, over the years, it has sometimesbeen more than a little difficult to reach consensus on acommon goal from such a diverse group of practitioners.However, on this day, as Stuart began to recap theAssociation’s legislative progress over the past two yearswith PBM, Mail Order and Influenza Protocol legislation,one voice after another joined the chorus. “Protecting ourprofession, our jobs, our livelihood and the people ofGeorgia is primary to our mission and code of ethics.”

Today’s issues have reached back to the very root of whywe all practice pharmacy, to serve the public.Unfortunately, there are very few of us who can afford todo that for free. When I was first licensed, 30 years ago,retail pharmacists were dispensers and merchants. Wesold a product (pharmaceuticals) at a mark up (about30%) and were required by law to refer a patient to theirprescribing physician if we were asked what the

medication we dispensed was being used for. Today,product profit margins are out of our control, 90 pluspercent of patients are covered by some third party, andwe are required by law to counsel patients on all aspects oftheir prescription and OTC medicines, most times forfree! From any business model, how do today’s pressuresallow you to keep the doors open, the lights on, thecomputers running, the employees paid or your family fedand clothed?

It’s human nature to let natural leaders and those with themost at stake carry the load. For years many of us have letthe Independent Pharmacists carry that torch. But today’slegislative and market conditions including mergers, storeclosings and hiring freezes -- leaving none of us insulatedfrom the risks of losing our jobs and our profession!

Whether we are Independents or Chain Employees, LongTerm Care or Educators, and even PBM employees, weall have bills to pay and families to support. It is time forall of us to put our differences aside and sit down at thetable together. Not only does each of us need to contactour legislators about the very precarious ledge ourprofession sits on and the services we provide for theirconstituents, we need to reach out to those patients weserve every day and let them know that they, also, need toreach out to those same legislators if we are to survive asthe most accessible health care practitioner.

Each of us joined and pay our dues to the GeorgiaPharmacy Association for different reasons. Regardless ofwhat your reasons are, NOW is the time to LET YOURVOICE BE HEARD.

In preparing for this letter, I reviewed the History of theGeorgia Pharmacy Association that is posted on our newweb site and couldn’t help but feel how true it is that “themore things change, the more they stay the same.” Seewhat you think.

Mary Meredith, R.Ph.Member Pharmacist

Publix


G E O R G I A D R U G S A N D N A R C O T I C S N E W S

Georgia Drugs and Narcotics AgencyWebsite

The Georgia Drugs and Narcotics Agency (GDNA)serves as the law enforcement and administrativeextension for the Georgia State Board of

Pharmacy. Health care professionals utilize GDNA to staycurrent with the laws and regulations governingprescription medications in Georgia. GDNA SpecialAgents conduct routine inspections daily and providepersonal education to licensed entities. Theseadministrative inspections are an ideal time forpharmacists to ask questions or address concernsregarding the practice of pharmacy.

In an effort to reach more health care professionals in amore efficient manner, GDNA has overhauled andrelaunched its website. The site,WWW.GDNA.GEORGIA.GOV , provides informationfor pharmacists and other health care professionals in aclear and concise manner. The site is not intended toserve as legal advice but instead, to give health carepractitioners information at their fingertips. The sitefeatures several areas of specific interest.

The most utilized section of GDNA’s website is thefrequently asked question (FAQ) section. This part of thesite allows users to answer the most frequent issues suchas: Electronic prescribing, physician assistant and nursepractitioner prescribing authority, counselingrequirements, pharmacy technician ratios, stampedsignatures on prescriptions, and physicians prescribingcontrolled substances for themselves or family members.

Another section of interest is titled “Prescribers.” Thissection provides information for those prescribers whodispense or intend to dispense prescription medication to

patients in the doctor’s office. This section addressesconcerns raised by pharmacists and physicians whendispensing from the office. It also gives prescribers theinformation needed to dispense medication in a safe andlawful manner.

The website also provides viewers with “Diversion Alerts”and “Press Releases” for the newest information andupdates concerning prescription medication. Pharmacistsare encouraged to utilize this area to identify the trends ofabuse for the diversion of prescription medication.

Finally, pharmacists are encouraged to utilize the“Contact Us” section to schedule an inspection or answeradditional questions. This section will allow viewers tofind the appropriate GDNA Special Agent throughout theState. Email addresses and telephone numbers are alsolisted for each GDNA employee.

To add information to the website you feel would behelpful for pharmacists or other health care professionals,please contact Special Agent Michael Karnbach at(404)549-1826 or [email protected].

Michael Karnbach, Pharm.D.Special Agent

Georgia Drugs and Narcotics


G P H A M E M B E R N E W S

APhA Immunization Program

Joesph AaronHagar BadawyJohn M. Chafin, R.Ph.Hewlette D. Cook, R.Ph.Ray W. CrispBlake DanielTerry Dunn, R.Ph.Jaclyn A. GiddensMary A. Harper, R.Ph.Shawn E. Hodges, Pharm.D.Jeffrey S. Jarvis, Pharm.D.Jonathan J. Knight, Pharm.D.Steven LeeWendell Lifsey, R.Ph.Jessica LipcseiJim W. Loyd, Jr., B.S.Ricky McIntyre, R.Ph.John L. Moorhead, R.Ph.Samantha MorrisVishali PatelStephen Todd Pledger, Pharm.D.Grace G. Poole, Pharm.D.Shannon Powell, RNBenny Raby, R.Ph.

Melissa M. RollinsAmy RutlandOlivia R. Santoso, B.S.Terry D. Shaw, Pharm.D.Chad Smith, R.Ph.James SmithCarl L. Stanley, Jr., R.Ph.Ben Stanley, Pharm.D.Benjamin A. Starr, Pharm.D.John W. Thomas, Jr. R.Ph.Heather A. TidwellRoy A. Tipton, R.Ph.Erica N. Williams

A Pharmacy Based Immunization Program was held on October 24, 2009, atPharmacy Partners of GA, LLC, in Kennesaw, GA. This is an innovative andinteractive training program that teaches pharmacists the skills necessary to become aprimary source for vaccine information and administration. The program teaches thebasics of immunology and focuses on practice implementation and legal/regulatoryissues. As part of the training the participants gave (and received) subcutaneous andintramuscular injections. Thirty-seven participants attended this program. Eachparticipant was awarded a certificate of achievement, and a total of 20 hours ofcontinuing education credit for successful completion of all components of theprogram.

The goals of the program were to:• Provide comprehensive immunization education and training.• Provide pharmacists with the knowledge, skills, and resources necessary to

establish and promote a successful immunization service.• Teach pharmacists to identify at-risk patient populations needing

immunizations.• Teach pharmacists to administer immunizations in compliance with legal

and regulatory standards.

Participants that attended the program:

GPhA thanks Ted Hunt, R.Ph., fromPharmacy Partners of Georgia for the use of hisfacility for this program and for contributingthe money from the table rentals on behalf ofPharm PAC.

Many thanks to Daniel K. Forrister,Pharm.D., and Sukhmani Kaur Sarao,Pharm.D., for teaching the APhA Pharmacy-Based Immunization Class on October 24,2009.



Buddy Carter Wins Election to State Senate

Former House of Representatives member Buddy Carter, R.Ph., was elected to the GeorgiaState Senate in Senate District 1. Carter will be the only practicing pharmacist serving in theGeorgia State Senate. This seat was vacated by Eric Johnson, who expressed support for Carter

who ran opposed by Billy Hair, former Chatham County Commissioner Chairman.

Congratulations to Senator-elect Earl "Buddy" Carter from GPhA!

Whitfield County Annual Health Fair

Whitfield County, one of GPhA’s employers that are participating inthe Diabetes Patient Self Management program, held a health fairon October 22, 2009. The health fair was held at the Whitfield

County Recreation Department located on Gillespie Drive. This eventprovides employees an opportunity to increase health awareness byparticipating in health screenings. Samee Ellerbee, R.Ph., CDE, MPH(c),serves as a pharmacist coach through GPhA for the Dalton Ten CityChallenge participants. Approximately 200 Whitfield County employeesattended the health fair.



NCPA Elects Hugh Chancy, R.Ph. Fifth Vice President

The National Community Pharmacists Association (NCPA) installednew Officers and Executive Committee Members for 2009-2010 at its111th Annual Convention and Trade Exposition, held Oct. 17-21, in

New Orleans, Louisiana. They are the association's governing body, whorepresent the voice of the members and direct the association's objectives.

Two new officers were inducted at the 111th NCPA House of Delegates.They are Michele Belcher of Grants Pass, Oregon, and Hugh Chancy ofHahira, Georgia. These two individuals were named to the NCPA fourth andfifth vice president positions, respectively, which are both one-year terms.

Belcher is a 1986 graduate of the Oregon State University College ofPharmacy. She is the owner of Grants Pass Pharmacy, Inc., which offersspecialty services such as compounding prescription drugs and hospice carewith a variety of facilities. Chancy is a 1988 graduate of the University ofGeorgia College of Pharmacy. He is the owner of Chancy Drugs in Hahira,Georgia, and President of the Council of Presidents of the Georgia PharmacyAssociation.

"We have a great team of dedicated pharmacy professionals committed toensuring independent community pharmacies are able to adapt with thechallenges of the 21st century," said Harrison. "I want to welcome MicheleBelcher and Hugh Chancy in their roles as fourth and fifth vice president.NCPA is excited to have Michele and Hugh in these influential positions andwe look forward to working with them next year and for years to come."

NCPA's House of Delegates also passed eight resolutions focused on levelingthe playing field for community pharmacies in the marketplace, preservingpatient access to their services, and also contributing to causes that will benefiteveryone as a whole.

The NCPA Executive Committee also includes GPhA member John T.Sherrer, R.Ph., who is a 1977 graduate of Mercer University Southern Schoolof Pharmacy. He is co-owner of Kenmar Pharmacy in Marietta, Georgia, and isa partner in nine other Georgia pharmacies. He also owns and operates FirstAid of America, an industrial first aid and safety supply company.


Pharm PAC would like to encourage you tomake a contribution today and help pharmacylook forward to a bright future in the state of

Georgia.

Name: ________________________________

Address: _______________________________

_____________________________________

Phone Number: __________________________

Email Address: __________________________

Contribution: $__________________________

(Circle the Pledge Level to which you wish to belong.)$1 - $250 - Patriot$251 - $500 - Representative$501 - $1000 - Senator$1001+ - Governor’s Circle

� Sustainers Circle: When youcheck this box and provide valid credit card informationyou are making a 5 year commitment to make the samecontribution for the next 5 years. Your credit card willautomatically be charged annually on the date of your initial contribution.

Contributions or gifts to Pharm PAC are not deductibleas charitable contributions for Federal income taxpurposes.

Name on the Credit Card:

_____________________________________

Credit Card Number:

_____________________________________

CSV#: ________ Expiration Date: ____________

Signature: ______________________________Contributions made to Pharm PAC are not tax deductible.

Detach this form and complete it and return it to: Pharm PAC, 50 Lenox Pointe, NE

Atlanta, GA 30324You may also donate online.

Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D.

• Professional LicensureDisciplinary Proceedings

• Medicaid Recoupment Defense• Challenges in Medicaid Audits• OIG List Problems• SCX or Other Audits

Leroy Toliver has been a Georgia RegisteredPharmacist for 34 years. He has been a practicing

attorney for 25 years and has represented numerouspharmacists and pharmacies in all types of cases.Collectively, he has saved his clients millions of

dollars.

Toliver and Gainer,LLP

942 Green Street, SWConyers, GA 30012-5310

[email protected]


Continuing Education for PharmacistsA Model System to Promote Access to Good Quality Compounded Medicines

This continuing education monograph is adapted from the United States Pharmacopeial Convention (USP) series of white papersprepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives andassessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education AdvisoryPanel. No financial support was received for this activity. This activity may appear in other state pharmacy association journals.

Council of the Convention Section on the Quality of Compounded MedicinesLoyd V. Allen, Jr., Ph.D., Section Chair (University of Oklahoma College of Pharmacy)Dawn M. Boother, D.V.M., Ph.D. (Member-at-Large)Lucinda L. Maine, Ph.D. (American Association of Colleges of Pharmacy)Rebecca P. Snead, R.Ph. (National Alliance of State Pharmacy Associations)

Goals: The goals of this lesson are todescribe non-governmental andgovernmental approaches to providecompounding standards andconformity assessments to thesestandards, and provide an overview ofa proposed model system ofstandards and conformityassessments to standards that assureaccess to good quality compoundedpreparations

Objectives: At the conclusion of thislesson, successful participants shouldbe able to:1. Identify the non-governmental andgovernmental approaches to providecompounding standards andconformity assessments to thesestandards2. Identify some of the non U.S.approaches to pharmacycompounding regulations3. Identify the proposed modelsystem of standards and conformityassessments to standards that couldassure access to good qualitycompounded preparations.

Introduction: Extemporaneouscompounding of preparations is aworldwide practice dating backcenturies. Today, compounding iscommonly defined as the preparationof a medicine in accordance with alicensed practitioner’s prescription ormedication order. This definitionevolves from a triad—the prescribingpractitioner, the compoundingprofessional, and the patient/consumer. Historically, what wasonce viewed as an art is now deeplyrooted in the scientific study of howto prepare and assess compoundedpreparations, together with provisionof stability data to allow assignmentof a beyond-use date (BUD).

In the following white paper,USP’s Council of the ConventionSection on the Quality ofCompounded Medicines provides ageneral description of non-governmental and governmentalapproaches to provide compoundingstandards and conformity assessmentto these standards. Conformity

assessments may be conducted byvarious parties—first (compoundinggroup/individual), second(purchasing group/individual), orthird (group/individual independentof first or second party). While dataare limited, all types of conformityassessments are likely to beconducted in the United States. Thewhite paper then articulates aproposal for a model system ofstandards and conformityassessments to standards that assureaccess to good quality compoundedpreparations.1

United States Non-governmentalApproaches1. USP: Preparation and ProcessStandards: The compounding of themost “fully established and bestunderstood” preparations for patientuse was a founding principle forUSP’s volunteer practitioners in 1820.USP still takes an active role insupporting the public’s access to thetype of customized therapy offered by

1. This paper is intended to address both compounding for human use and compounding for veterinary use. However, there are some significant differencesbetween the two, including differences in the relevant laws. The federal laws regulating veterinary compounding are found in the Animal Drug Amendment of1968 and the Animal Medicinal Drug Use Clarification Act of 1996 (and related regulations and guidances) which are intended to protect consumers of foodsof or from animals, as well as the animals themselves that might be treated with drugs, including compounded preparations. As with compounding for humanuse, there is controversy surrounding the distinction between legitimate compounding and manufacturing; the scope of the FDA’s role in regulating veterinarycompounding; and the efficacy, safety, and appropriate labeling of these products, as well as other issues. A detailed discussion of the particular considerationsthat apply in the veterinary context is beyond the scope of this paper, but USP is committed to providing standards for compounding of preparations for bothhuman and animal use, and the information and model system proposed herein is generally applicable to both human and veterinary compounding.


compounding and works to ensurethe quality of such therapy by creatingnational standards and guidelines forcompounding both sterile andnonsterile medications. Thesestandards are process standards inthat they provide appropriatetechniques and procedures to guidepractitioners in compounding. Theyalso are product standards(commonly referred to as preparationstandards to distinguish compoundedformulations from manufacturedproducts) to allow testing, both of thematerials used in a compoundedpreparation and also thecompounded preparationsthemselves, to assess quality andestablish a BUD. Taken together,these preparation and processstandards appear in officialcompendia of the United States—theUnited States Pharmacopeia (USP)and National Formulary (NF). Justlike manufactured medicines,compounded preparations mustcomply with the product standards inthe USP and NF, which arerecognized as official compendia infederal food and drug law. Inaddition, a number of Statesrecognize USP’s process standards forcompounding and requirecompliance with these standards.These legal requirements arediscussed further below.

In the 2005-2010 cycle, USPsupported two Expert Committeesthat provided these compoundingstandards. The CompoundingPharmacy Expert Committee ofUSP’s Council of Experts iscomposed of 10 experts, with provenextemporaneous compoundingexpertise representing variedpharmacy environments such ashospital, ambulatory, academia,veterinary practice, and private

practice. The Sterile CompoundingExpert Committee of USP’s Councilof Experts is composed of 12 experts,also representing a wide range ofpharmacy disciplines and infectioncontrol. These two ExpertCommittees: 1) developcompounded preparationmonographs that can be used everyday by pharmacists to preparemedications for patients requiringcustomized drug therapy, and 2)develop and revise General Chaptersthat describe good compoundingpractices.

As an emanation of the standardsfrom USP’s two Expert Committeesin the Council of Experts, USPsupports several compoundingconstituencies through publication ofthe Pharmacists’ Pharmacopeia (P2),now in its second edition. P2 containsmore than 115 compoundingmonographs, for use in both humansand animal patients, and 75supporting General Chapters, all ofwhich were excerpted from the USPand NF. In USP’s ongoing effort todevelop more preparationmonographs, academic and otherlaboratories are performing methoddevelopment and stability studies forboth sterile and nonsterilepreparations. When these studies arecompleted, they provide informationto support decisions of thecompounding Expert Committeesrelative to a BUD designation.Currently, 17 compoundedpreparations are under study. USPalso is reaching out to professionalorganizations and others to obtaincandidate formulations, materials,tests, procedures, and acceptancecriteria for the two compoundingExpert Committees. The totaluniverse of formulations needed forcompounded preparations is

unknown, but is well over 1,000. USPis attempting to focus on those thatare most commonly compounded orthat present the most significant risk.

2. Process Standards/ConformityAssessments for Site Accreditation:The Pharmacy CompoundingAccreditation Board (PCAB) waslaunched in 2004 by eight pharmacy-related organizations (includingUSP) as a voluntary accrediting bodyto assess compounding pharmaciesagainst high quality standards forcompounding. The founders ofPCAB, and the pharmacists theyrepresent, believed that standardsagainst which compoundingpharmacies can be tested are not onlygood for patients, but also good forthe practice of pharmacy.2 To date,PCAB has accredited 65compounding pharmacies. EachPCAB-accredited pharmacyundergoes a rigorous review of itspolicies and procedures and an onsiteinspection against PCAB standards,which incorporate USP standards.

The pharmacies that haveachieved the milestone of PCABaccreditation have demonstrated theircommitment to quality standards andprocedures. However, participationlevels in PCAB are less than hoped foramong U.S. pharmacies, whichinclude approximately 3000 to 4000pharmacies that emphasizecompounding capability. This may beattributed to the rigor of theaccreditation process and the absenceof “drivers” that would compelpharmacies to seek accreditation, e.g.,reimbursement and insurance.Nevertheless, PCAB in recent monthshas seen an upswing in applicationswith over 140 pharmacies awaitingsurvey. Emerging “drivers” includeprofessional organizational

2. Pharmacy Compounding Accreditation Board, www.pcab.info 2009.


endorsements of PCAB (beyondPCAB’s governing boardinstitutions), including the AmericanMedical Association, AmericanVeterinary Medical Association,American Animal HospitalAssociation, American Association ofEquine Practitioners, and others, aswell as incentives offered by liabilityinsurers.

In 2008, PCAB established aseparate Accreditation Committeethat now oversees the accreditationprocess, and more recently began thefirst formal review of PCAB standardssince their adoption in 2004. Therevised standards are expected to beavailable before the end of 2009.

3. Conformity Assessments forPractitioners: There are severalorganizations and accreditationactivities that speak to conformityassessments for practitioners. TheAccreditation Council for PharmacyEducation (ACPE) is the nationalagency responsible for theaccreditation of professional degreeprograms in pharmacy. ACPE setsaccreditation standards andguidelines for pharmacy educationand conducts conformity assessmentof institutions. Standardizedassessment of practitionercompetence also occurs through theNorth American PharmacistsLicensure Examination (NAPLEX)developed by the NationalAssociation of Boards of Pharmacy(NABP). NAPLEX is used by boardsof pharmacy as part of theirassessment of pharmacy practitioners’competence prior to licensure.Certification through the Board ofPharmaceutical Specialties (BPS) isone additional conformity assessmentfor practitioners. BPS certification is avoluntary process by which apharmacist’s education, experience,

knowledge, and skills in a particularpractice area are confirmed as wellbeyond what is required for licensure;however, there is currently no BPSspecialty in compounding.

United States GovernmentApproaches1. Federal: The role of federallaw and regulatory oversight ofcompounding has proven to be one ofthe most problematic for FDA,particularly in recent years. As ageneral rule, FDA has tended to avoidinvolvement with activities that relateto the practice of medicine andpharmacy, both of which traditionallyare regulated at the level of the statesin the U.S. However, FDA pays closeattention to the quality of productsregardless of whether they aremanufactured products orcompounded preparations. Sortingout the scope of state versus federalauthority, and the demarcationbetween compounding and drugmanufacturing, has proven elusive.Congressional efforts to resolve theissue have so far failed. For now, thereis a legal and regulatory stalemate,leaving compounding practitionersand regulatory authorities in a state ofuncertainty.

The federal legal history leadingup to this point helps illuminate thecurrent situation. In FDA’s view,compounded drugs in interstatecommerce are “drugs” under theFederal Food, Drug, and CosmeticAct (FDCA), and are potentiallysubject to the full panoply ofrequirements (including pre-approvalprior to marketing, such as a NewDrug Application (NDA), goodmanufacturing practices (GMPs)required for manufacturing, andcompliant labeling). In recognition ofthe role of compounding, FDA hasgenerally, in the exercise of its

enforcement discretion, excused suchcompounded drugs from mostrequirements otherwise applicable to“drugs.” In particular, under FDACompliance Policy Guidance (CPG)460.200, eligible compounding hasbeen exempted from: the adulterationprovisions of the FDCA with respectto GMPs; the misbranding provisionsregarding labeling with adequatedirections for use; and the new drugrequirements, that is, approval of anNDA or Abbreviated New DrugApplication (ANDA).

In 1997, Congress sought tocodify many aspects of FDA’scompounding policy and generallyprovide a limited regulatoryexemption from certain requirementsof the FDCA for compounding.Section 127 of the FDAModernization Act (FDAMA), whichadded §503A to the FDCA, in largepart reflected CPG 460.200, and,among other things, provided thatbulk drug substances used forcompounding must comply with USPor NF requirements. To identify thecompounding eligible for the lessstringent regulatory requirements of503A, Congress stipulated that sucheligible compounders could not“advertise or promote thecompounding of any particular drug,class of drug, or type of drug,”although the “compounding service”itself could be advertised andpromoted. These limits on advertisingwere found by the 9th Circuit U.S.Court of Appeals in the Western Statesdecision to be unconstitutional;moreover, the 9th Circuit held thatthe advertising restriction was notseverable from the rest of FDCA503A, thereby leaving at least the 9thCircuit in a pre-FDAMA condition(in terms of the application of theoverall FDCA). The Supreme Court


later affirmed Western States, butdeclined to consider the severabilityissue. More recently, the 5th Circuitdeclined the request of pharmacists tofind that compounded drugs areexempt from the “new drug”provisions of the FDCA, but alsofound that the unconstitutionaladvertising restrictions of FDCA503A are severable (leaving whatsome now call a “503A safe harbor”).

Thus, in the 5th Circuit, 503A,absent the advertising provision,applies to eligible compounders.Elsewhere in the country, FDA’scurrent compounding policycontinues to be reflected in the CPGit issued in the wake of the WesternStates decision.3

While these federal uncertaintiesare sorted out, USP continues to playan important role: 1) state law mayincorporate USP process standards(e.g. General Chapters <797>Pharmaceutical Compounding – SterilePreparations and <795>Pharmaceutical Compounding –Nonsterile Preparations) in regulatingthe practice of compounding, and 2)compounded preparations remain“drugs” under the FDCA and mustcomply with any applicable USPmonographs if they use the namerecognized in USP-NF.

2. State: In the U.S., pharmacypractice, including compounding, isregulated at the state level by stateboards of pharmacy. Each stateestablishes and enforces its own lawsand regulations governing thepractice of pharmacy and performsroutine inspections of pharmacies toensure compliance. State boards alsoissue licenses to pharmacists—evaluating their competence topractice—and to pharmacies. When

needed, state boards also investigatecomplaints. There are times whenstates recognize standards from non-governmental third parties; forexample, several states recognize USPfor sterile and nonsterilecompounding and, to a more or lesserdegree, other USP standards relatedto compounding, drug productlabeling and packaging.

In an effort to maintain a certainlevel of consistency among the states,NABP offers to boards of pharmacymodel language that may be usedwhen developing state laws or boardrules. The current set of modelregulations also contains the NABPModel Rules for Pharmacy Interns,Institutional Pharmacy, PharmacistCare, Nuclear/Radiologic Pharmacy,and Sterile Pharmaceuticals.

Non-U.S. Approaches1. Argentina: In Argentina, theHealth Department regulates thepractice of pharmacy compounding.Legal difficulties abound forcompounding practitioners becausethere are few established regulationsto guide compounding practices andthe guidelines that do exist are basedon outdated legislation. Technicaland scientific advances in drugtherapy are not considered in theguidelines. Even though theregulatory framework may be lackingin certain respects, some restrictionsdo exist that ultimately limit patientaccess to medicines. For example,several dosage forms and therapeuticcategories—such as troches, nasalpreparations, and ophthalmics—areexcluded and hormone replacementtherapies, as well as medicines theU.S. would term over-the-counter, arenot permitted to be compounded. Inaddition, Olanzapine (Zyprexa forschizophrenia/acute manic episodes)

is the only drug that cannot be usedin compounding.

2. Brazil: The Brazilian NationalHealth Surveillance Agency(ANVISA) regulates compoundedpharmaceuticals. In 2005, ANVISAproposed new rules for compoundingpharmacies, including:∙ Disallowing compounded

drugs of the sameformulation asmanufactured products;

∙ Setting limits on themarketing of products tothe general public; and

∙ Requiring the pharmacist toprovide the patient withmore productinformation, includingthe drug formulation,adverse effects, andduration of treatment.

Veterinary pharmaceuticals areregulated by a number of differentagencies, including the Ministry ofAgriculture and the Ministry ofAgriculture, Cattle and Supplying.Brazil appears to be one of the mostadvanced countries in regards tocompounding. Brazil has 306 Schoolsof Pharmacy and graduates 14,000pharmacists per year. In contrast theU.S. has slightly over 100 Schools ofPharmacy. There are 7,211pharmacies in Brazil that are solelyengaged in compounding and 16,000compounding pharmacists. Braziloffers Continuing Education (CE) oncompounding over standard TVchannels throughout the country.ANFARMAG is Brazil’s NationalAssociation of CompoundingPharmacies and has a membership ofover 4,000 pharmacists.

3. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074398.htm.


3. Germany: Federal Law, primarilythe Arzneimittelgesetz, andsubordinate federal directives,primarily theApothekenbetriebsordnung, regulatesthe practice of pharmacycompounding in Germany.Extemporaneous preparation ismandatory when a prescriptionrequiring compounding is presentedto a community pharmacy. All dosageforms can be compounded; however,preparations that are difficult tocompound (e.g. cytotoxic preps,injectables) can be compounded onlyafter a pharmacist has completedspecial training. Over-the-counter(OTC) compounding is allowed andoccurs frequently. There is a list ofpreparations that both communitypharmacies and hospitals are notallowed to prepare, such as allergensused to trigger an allergic response ina patient. Beyond-use dating for 243standardized formulas is provided inthe Neues Rezeptur-Formularium(NRF). There are 21,570 pharmaciesin Germany.

4. Spain: In Spain, regionalgovernments regulate the practice ofpharmacy compounding. Four levelsof compounding exist: 1) Dispensing;2) Topical; 3) Oral, rectal andvaginal; 4) Sterile. Beyond-use datesfor compounded preparations arebased on literature and references,such as USP-NF. Health authorities inSpain have a very restrictive attitudetoward pharmaceutical compounding.Compounded medicines are generallyregarded as the last resource andauthorized almost exclusively whenall other therapeutic alternatives havefailed. Pharmacies that only engage incompounding are not allowed. If apharmacy only performs Level 1compounding; i.e., dispensing, it mustsubcontract with a pharmacy that

does other levels of compoundingbecause it is against the law to refuseto serve any patient that enters apharmacy. “Elaboracion a terceros”(third-party compounding) is theterm used when a pharmacy contractswith another pharmacy specializing inhigher-level compounding. Spanishpatients receive most of theirprescription medicines free or at littlecost. However, compoundedpreparations are reimbursedaccording to a drug list that,according to Spanish practitioners, iscurrently out of date. Pharmacists areallowed to compound OTCs for salein their own pharmacies, with theonly limitation being that themedicine must be described in theFormulario Nacional (NationalFormulary). Additional specializedtraining is not required to be acompounding pharmacist. AEFF isthe Spanish Association ofCompounding Pharmacists.

A Model System: The goal of anymodel system is to assure access togood quality compounded medicines,assist compounding practitioners—pharmacists and physicians—indelivering such preparations topatients, and ensure patient safety,above all. While a number ofstandards, including USP’s, exist tohelp ensure that compoundedmedicines are of good quality, thelack of strong conformity assessmentsto such standards leaves bothpractitioners attempting to provideaccess to good quality compoundedmedicines as well aspatients/consumers who receivethem at risk. In this setting, theCouncil of the Convention Sectionon Quality of CompoundedMedicines offers the following modelsystem of standards and conformityassessments, in which USP would

play a primary role in developingmonographs and process standardsand could play a role in other areas aswell.

1. People, Process andPreparation Standards

∙ Ingredient and PreparationStandards (Product)

Optimally, a preparationmonograph in USP exists for allcompounded preparations in theU.S. Compounding monographsare prioritized so that standardsfor the most frequentlycompounded articles aredeveloped first. TheCompounding ExpertCommittee, working withcompounding practitioners,associations and others, developsa preparation monograph. TheCommittee takes into accountsafety and other considerations,such as intended use in targetspecies. This input is obtainedthrough a variety of sources,including FDA (whose views arerepresented by FDA liaisons tothe Committee), NABP, andother practitioner and boardassociations. As noted above,conformance to suchmonographs is required under theFDCA.

∙ Compounding SitesStandards (Practice andProcess)

Optimally, practitionerassociations and others, includingassociations representing statepractitioner boards such asNABP, develop standards for allcompounding sites (both incommunity and hospital localeswhere compounding is practiced,as well as practitioner office


practices). Practice standards(<795>, <797>, and others)developed by USP forcompounding are recognized instate regulations andaccreditation standards (similarto the treatment of compoundingprovided by NABP in its ModelPharmacy Act and PharmacyRules).

∙ Practitioner Training andAccreditation (People)

Adequate professional educationand training curricula are adaptedin schools of pharmacy to ensurethat competencies incompounding are acquired andare supported by assessmentthrough NAPLEX and licensurerequirements through the stateboards. An independent certifyingbody, such as BPS, builds anaccreditation to define specialtycertification of compoundingpractitioners. Optimally, allpractitioners who compoundcomplex or sterile preparationsbeyond a certain frequency arecertified.

2. Conformity Assessments

∙ Site Accreditation

Through Congressional and/orjudicial and regulatorydeterminations, the line betweencompounding and manufacturingis clarified, with the statesretaining responsibility forregulation of compounding andFDA retaining responsibility forregulation of manufacturing. Stateboards of pharmacy (and otherdisciplines’ boards), working withPCAB or equivalent nationalpractitioner associations, areresponsible for conformityassessments of all compounding

sites. When appropriate, a stateboard may deem non-governmental bodies, such asPCAB or equivalent associations,suitable to accredit traditionalcompounding sites. Optimally, allsites engaging in significantcompounding activity requireaccreditation.

∙ Adverse Event Reporting

An adverse event reportingsystem that offers strong Federalconfidentiality and privilegeprotections, as provided by thePatient Safety Act of 2005, isprovided and maintained toensure the capture of adverseevents associated withcompounded preparations, fordeliberation and analysisregarding quality and safety.

Summary: As a general matter,compounding remains both aresponsibility for practitioners (thosewho prescribe compoundedmedicines as well as those whocompound them) and an opportunityfor their patients. At the same time,assurance that manufacturing doesnot occur under the guise ofcompounding is critically important.This white paper argues for a modelsystem, building on good systems inthe U.S. and other countries, thatrecognizes the interests of all partiesin assuring access to good qualitycompounded preparations.

ABOUT USP and NASPAThe United States Pharmacopeia(USP) is an official publicstandards–setting authority for allprescription and over–the–countermedicines and other health careproducts manufactured or sold in theUnited States. USP also sets widelyrecognized standards for foodingredients and dietary supplements.USP sets standards for the quality,purity, strength, and consistency of theseproducts–critical to the public health.USP’s standards are recognized andused in more than 130 countries aroundthe globe. These standards have helpedto ensure public health throughout theworld for close to 200 years. Moreinformation can be found atwww.USP.org

The National Alliance of StatePharmacy Associations (NASPA)promotes leadership, sharing, learning,and policy exchange among statepharmacy associations and pharmacyleaders nationwide, and provideseducation and advocacy to supportpharmacists, patients, and communitiesworking together to improve publichealth. NASPA was founded in 1927 asthe National Council of State PharmacyAssociation Executives (NCSPAE).More information can be found atwww.naspa.us

Reprinted with permission. Copyright2009, The United StatesPharmacopeial Convention. All rightsreserved.


Continuing Education for PharmacistsQuiz and Evaluation A Model System to Promote Access to Good Quality Compounded Medicines

1. Today’s definition of compounding evolves from atriad which includes all of the following EXCEPT:

a. Patient c. Compounding professionalb. Manufacturer d. Prescribing practitioner

2. Who may perform conformity assessments?a. Patientb. Pharmacy benefit managerc. Purchasing groupd. None of the above

3. In compounding, product standards are alsocommonly referred to as

a. Preparation standardsb. Compounding standardsc. Item standardsd. Formulary standards

4. The Compounding Pharmacy Expert Committeeof USP’S Council of Experts is composed of how manyexperts?

a. 2 c. 10b. 5 d. 12

5. The Sterile Compounding Expert Committee ofUSP’s Council of Experts is composed of how manyexperts?

a. 2 c. 10b. 5 d. 12

6. The Pharmacists’ Pharmacopeia contains which ofthe following

a. 115+ compounding monographs for use in humans only

b. 75 supporting general chapters excerpted from the USP and NF

c. Both A+Bd. B only

7. Which of the following regarding the PharmacyCompounding Accreditation Board (PCAB) is true?

a. PCAB was launched in 2004 by USP b. In 2008 PCAB established a separate

Accreditation Committee to oversee the accreditation process

c. PCAB accreditation does not necessarily include an onsite inspection

d. There are approximately 1000 pharmacies in the United States that have compounding capability.

8. In the U.S. pharmacy practice, compounding isregulated at the state level by who?

a. State pharmacy associationb. State board of pharmacyc. Pharmacy Compounding Accreditation Boardd. Food and Drug Administration

9. Which of the following countries does NOT allow“compounding only” pharmacies?

a. Argentina c. Germanyb. Brazil d. Spain

10. Which of the following countries does not allowOlanzapine to be used in compounding?

a. Argentina c. Germanyb. Brazil d. Spain


J o u r n a l C P E A n s w e r S h e e t

The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as aprovider of continuing pharmacy education.

A Model System to Promote Access to Good Quality Compounded MedicinesThis lesson is a knowledge-based CPE activity and targets to pharmacists.GPhA code: J09-12ACPE#: 142-000-09-012-H04-PContact Hours: 1.5 (0.15 CEU)Release Date: 12/15/2009Expiration Date: 12/15/20121. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink orpencil.)2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements ofcredit/ Please send check or money order only. Note: GPhA members will receive priority in processing CE.Statements of credit for GPhA members will be mailed within four weeks of receipt of the course quiz.

1. A B C D 6. A B C D2. A B C D 7. A B C D3. A B C D 8. A B C D4. A B C D 9. A B C D5. A B C D 10. A B C D

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1. The activity met my educational needs: 1 2 3 4 5 2. Relevance to pharmacy practice: 1 2 3 4 5 3. The learning objectives were achieved: 1 2 3 4 5 4. Activity was presented in a fair and unbiased manner: 1 2 3 4 5 5. How long did it take to complete this activity? ______

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Remove this page from the Journal and mail this completed quiz and evaluation to: GPhA, 50 Lenox Pointe NE,Atlanta, GA 30324.


The Georgia Pharmacy JournalEditor: Jim Bracewell

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The Georgia Pharmacy Journal® (GPJ) is the official publication of theGeorgia Pharmacy Association, Inc. (GPhA). Copyright © 2009, GeorgiaPharmacy Association, Inc. All rights reserved. No part of this publicationmay be reproduced or transmitted in any form or by any means, electronicor mechanical including by photocopy, recording or information storageretrieval systems, without prior written permission from the publisher andmanaging editor.

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2009 - 2010 GPhA

BOARD OF DIRECTORS

Name PositionRobert Bowles Chairman of the BoardEddie Madden PresidentDale Coker President-ElectJack Dunn First Vice PresidentRobert Hatton Second Vice PresidentJim Bracewell Executive Vice President/CEOHugh Chancy State-at-LargeAshley Dukes State-at-LargeKeith Herist State-at-LargeJonathan Marquess State-at-LargeSharon Sherrer State-at-LargeAndy Rogers State-at-LargeAlex Tucker State-at-LargeHeather DeBellis Region One PresidentTony Singletary Region Two PresidentJohn Drew Region Three PresidentBill McLeer Region Four PresidentShobhna Butler Region Five PresidentBobby Moody Region Six PresidentMike Crooks Region Seven PresidentLarry Batten Region Eight PresidentJason Rich Region Nine PresidentChris Thurmond Region Ten PresidentMarshall Frost Region Eleven PresidentKen Eiland Region Twelve PresidentRenee Adamson ACP ChairmanLiza Chapman AEP ChairmanBurnis Breland AHP ChairmanTim Short AIP ChairmanDeAnna Flores APT ChairmanRick Wilhoit ASA ChairmanJohn T. Sherrer Foundation ChairmanMichael Farmer Insurance Trust ChairmanFred Barber Ex Officio - President, GA Board of

PharmacyDon Davis Ex Officio - Chairman, GSHPGina Ryan Johnson Ex Officio MercerMeagan Spencer Barbee Ex Officio Mercer ASPRusty Fetterman Ex Officio South Garrick Schenck Ex Officio South ASPDaniel Forrister Ex Officio UGALance Faglie Ex Officio UGA ASP

Documents

The Georgia Pharmacy Journal: December 2009