NEW PLANS – BETTER RATES – MORE BENEFITS in 2010
Open Enrollment
Begins October 1st for the Plan Year 2010 Prescription Drug Coverage Dental and Orthodontic Benefits $500 Wellness Benefit Guaranteed 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 tmiller@gpha.org Georgia Pharmacy Association Members Take Advantage of Premium 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 cars and 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 a devastating impact on individuals, families and businesses. During the course of your career, you are 3½ times more 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 receive premium discounts up to 30% on high-quality Individual Disability Income Insurance from Principal Life Insurance Company.
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. For costs and details of coverage, contact your Principal Life financial representative.
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December 2009
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Departments
DCH Reverses Policy on Retirees’ 90day Prescriptions FEATURE ARTICLES
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5 New Members 10 New Practitioner Leadership Conference Nomination Form 15 GPhA Member News 18 GPhF Annual Fund Giving Form 19 Pharm PAC Contribution Card 31 GPhA Board of Directors
Pharmacy in the News Advertisers
Member Contribution: Same, Same... Different... Georgia Drugs and Narcotics Agency Website APhA Immunization Program; October 24, 2009 NCPA Elects Hugh Chancy Fifth Vice President CPE Opportunity: A Model System to Promote Access to Good Quality Compounded Medicines
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The Insurance Trust Principal Financial Group Pharmacists Mutual Companies PharmStaff AIP Michael T. Tarrant Melvin M. Goldstein, P.C. Toliver & Gainer Alaska Continuing Education at Sea Georgia’s Own Credit Union Southeastern “Girls of Pharmacy” Leadership Weekend 32 The Insurance Trust
COLUMNS
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President’s Message Editorial
For an uptodate calendar of events, log onto
www.gpha.org.
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December 2009
PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President
Who’s Looking Out for Pharmacy? wo-thousand-nine may turn out to be a monumental year for health care in the United States. The U.S. House has narrowly passed a major health care reform bill that will see rough sailing as it passes to the Senate for consideration. Many of the complex negotiations will occur behind closed doors by a conference committee comprised of the leadership from the House, the Senate and the President’s representatives.
collective voice for all of its state association members on the national stage. Recently, NASPA joined with NCPA, APHA, NACDS, Food Marketing Institute, Healthcare Distribution Management Association, and the Pharmaceutical Care Management Association in writing letters to Congress urging that they reconsider AMP reimbursement in the health care reform bill. This was set under the deficit reduction act at a level that would reimburse pharmacies 30 percent below their acquisition cost. If implemented this would mean many pharmacies would close and impact the availability of pharmacy services to many patients. This is but one of the vital issues that pharmacy wants addressed in the healthcare reform bill.
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As I attended our region meetings this fall, many members were asking if pharmacy was being represented in the national health care debate. As your president, I have had the opportunity to participate in the National Community Pharmacy Association and the American Pharmacist Association’s legislative activity. Both of these organizations have an experienced and effective lobbying arm that has been able to articulate on behalf of the pharmacy profession. I have witnessed the National Community Pharmacy Association’s PAC grow from 450th in PAC strength to being in the top fifty! Both of these organizations have come to realize how pharmacy was left out of the debate when Medicare D was implemented. They both have stepped up their efforts to strengthen their lobbying to better represent the profession on a national level.
Another important issue to pharmacy is the need for PBM transparency. Thus far, the House and Senate versions of health care reform have PBM transparency for the Medicare Plans. With this implementation being included in the final version, pharmacy will score another win in its battle with the PBM industry. Our national organizations continue to promote the value of a pharmacist in providing improved health care outcomes. The American Pharmacists Association has pushed to include MTM Pharmacy Services in the new health care legislation to improve the quality and reduce the cost. The language was kept in the version that passed the House. Strangely enough, the lone Republican vote came from a Louisiana house member whose wife is a pharmacist!
Strength often comes from numbers. Georgia Pharmacy Association is a member of the National Alliance of State Pharmacy Associations (NASPA). This organization has also increased its efforts by committing to a full time executive director and staff. As such they are able to be a
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December 2009
Pharmacists are dedicated professionals that are highly respected in their communities. They often expect the political process to fairly represent their needs. My experience has been that many believe they have exercised their civic duty by voting in elections. Most do not interact with the state or national level elected representatives. Without the lobbying support of our national and state associations, our profession would be unrepresented in the political arena. Maine is one of four states that have lost its state association. Without someone to speak for pharmacists, it is little wonder that Maine was the last state to receive authority to immunize and this was accomplished because the Maine Department of Public Health saw the need and pushed for the legislation.
over 50,000 independent pharmacies in the United States and about the same percentage are members. I feel sure that the American Pharmacists Association has a similar membership makeup. Imagine what a powerful and effective lobbying effort could be generated if more of our profession would become a member of these organizations and actively contribute to their PACs. I realize that I am preaching to the choir, since readers of this article will be members of our state association. Unfortunately, only a couple of hundred of our members contribute to our PharmPAC. I would hope that all our members are also supportive of our national associations through membership and PAC contributions. As a member I would urge each of you to consider asking nonmember pharmacists that you encounter daily through your practice if they would consider joining the Georgia Pharmacy Association and making our state association one of the strongest in the nation!
The lifeblood of our associations is a strong membership. Georgia has over 12,000-licensed pharmacists with over 10,000 practicing within the state. Only a third of them are members of our state association. The National Community Pharmacy Association likewise has a pool of
When it comes to pharmacy, you can count on the fact that the Georgia Pharmacy Association is looking out for our profession!
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Sylivia D. Adams, R.Ph., Riverdale Carolyn M. Beale, Pharm.D., Fayetteville Purvi Bheda, Pharm.D., Atlanta Rebecca Davis, Pharm.D., Tifton Lance C. Faglie, Rincon Nicholas Hanson, Savannah Terry O. Jones, R.Ph., Athens William Tyler Landers, Griffin The Georgia Pharmacy Journal
Levis Aldine McConnell, III, B.S., Roswell Harry Eugene McGinnis, R.Ph., Summerville Michell B. Redding, Pharm.D., Atlanta Randy G. Richards, R.Ph., Cumming Jaclyn Danelle Scott, Pharm.D., Kathleen Batisha Tatum-Murray, Pharm.D., Atlanta Adam J. Toenes, Pharm.D., Dacula Harrell E Tweedy, Ph.D., Acworth 5
December 2009
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
A Holiday Gift Under Every Pharmacist’s Tree in Georgia ere is a gift for you to celebrate this Holiday Season. The gift of proven effective advocacy for your profession.
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See the announcement on the following page and letter to Governor Perdue. Your message was heard. Your elected government leaders responded. You have delivered proven effective advocacy for the profession of pharmacy.
It is the gift of bringing together a chorus of voices that are all united on the same music, singing the same verse so that our elected leadership in the State and the Federal Government will hear our concerns.
Here are two other outstanding accomplishments to put in your pharmacy stocking.
This fall the pharmacists of Georgia said to the state of Georgia it is wrong to penalize state retiree patients that seek to fill their 90-day prescriptions at their home town pharmacy. The Department of Community Health was convinced by the state contracted Pharmacy Benefit Manager to penalize patients if they did not use the contracted PBM mail order pharmacy for their 90-day prescriptions. “This is not right,” said the pharmacists of Georgia. Serving patients in our local community is the heart and soul of the home town community pharmacy. Sending prescriptions paid with Georgia Taxpayer funds to an out-of-state PBM owned pharmacy is just plain WRONG.
This past legislative session, Oren H. “Buddy” Harden, Jr., R.Ph., served his first term in the Georgia State House of Representatives. This added a new pharmacist voice at the state capitol. The members of the Georgia Pharmacy Association played a significant role in Buddy’s successful election. In November, former State Representative, Earl “Buddy” Carter, R.Ph., with supreme confidence in the support of the Georgia Pharmacy Association, resigned his State House position to run for the vacant seat in the State Senate from District 1 (Chatham, Bryant and Liberty Counties). His confidence was well placed and he won the race with over 82 percent of the vote. Pharmacy now has a pharmacist voice in the Georgia State Senate.
You, along with your patients, said to the state of Georgia this is wrong headed thinking and the state must reconsider their plan. Your state legislators heard you. Your local chambers of commerce heard you. Your Governor heard you. Your message was the members of the Georgia Pharmacy Associations want to be partners with the state in finding solutions to rising healthcare costs, not victims of self promoting PBMs who have a bulging bottom line profit to deliver for their stockholders. The Georgia Pharmacy Journal
Share this GPhA Journal with a pharmacy colleague who may not really know what is being done to ensure a better future for the profession of pharmacy through the work of the Georgia Pharmacy Association. Happy Holidays on behalf of the staff of GPhA. Jim 7
December 2009
PHARMACY NEWS
DCH Reverses Policy on Retirees’ 90-day Prescriptions he State of Georgia Retirees have an additional blessing to be grateful for this holiday season. They will not be financially penalized if they fill their 90-day prescriptions at their community pharmacy.
Cigna inquiries should be directed to their current contract representative. GPhA thanks each and every member who did not give up and stuck with GPhA’s efforts to get this DCH policy changed. GPhA thanks local legislators and the local Chambers of Commerce in the State of Georgia for their support. GPhA’s collective voices were heard and the citizens of Georgia have a special blessing today. GPhA also wants to express our gratitude to Governor Perdue’s office for the hundreds of calls they handled on this subject and for the great outcome.
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Due to the tenacious work of the Georgia Pharmacy Association, the Georgia Department of Community Health (DCH) has issued the following announcement to GPhA effective immediately. The Georgia State Health Benefit Plan (SHBP) vendors that offer the Medicare Advantage with a Medicare Part D prescription drug program will reimburse pharmacies for 90-day prescriptions at the same rate schedule as their mail order pharmacies provided they meet the credentialing requirements, vendor standards and accept the terms of the mail order pharmacy network contract. This applies to the SHBP Medicare Advantage plans only.
GPhA members have much to be thankful for this holiday season, including living in a country with an elected government where the citizens can petition for change. Please take time to thank your State Representative, your State Senator and the Governor for listening to the people of Georgia on this issue.
For questions regarding participation: United inquiries may call the Prescription Solutions pharmacy help desk at 800-613-3591 and The Georgia Pharmacy Journal
If GPhA members want to be heard the next time then it is imperative that they take time to say “thank you” this time! 8
December 2009
PHARMACY IN THE NEWS
CVS/Caremark Under U.S. FTC Investigation VS Caremark Corp, said the Federal Trade Commission is probing some of its business practices.
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Peter Kaplan, a spokesman for the Washington-based agency, said in a telephone interview. He wouldn’t discuss which practices are the targets of the probe.
CVS is confident it conducts business in compliance with antitrust laws, David Denton, Chief Financial Officer of CVS said today in an e-mailed statement. CVS was notified of the investigation in August and is cooperating, the Woonsocket, Rhode Island-based company said in a regulatory filing.
Company shares plunged $7.28, or 20 percent, to $28.87 in the New York Stock Exchange, the biggest one-day decline since 2001. GPhA representatives attended the FTC hearing in May 2009 when the FTC was considering the necessity of an investigation.
The FTC is investigating certain CVS business practices,
United Heathcare Faces $750K Fine in Georgia nited Healthcare has been slapped with a $750,000 fine for delaying claims payment to doctors and consumers. The combined fine is also shared by sister companies United Healthcare of Georgia, American Medical Security Life Insurance and Golden Rule Insurance.
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Georgia Insurance Commissioner John Oxendine has signed a consent order demanding that United Healthcare comply with state regulations, dating from August 1999, which demand that insurers make prompt claims payments. The state collects claims data every quarter to make sure that this happens. United Healthcare says it processes 97 percent of its claims for the state within 15 days, and 99 percent within 30 days. But the state apparently drew a different conclusion when it audited claims data covering the quarter ending March 31, 2009. The health plan faced similar charges in North Carolina last year--in addition to disputes over coordination of benefits, appeals, explanations of benefits and providers--and was forced to pay an $800,000 settlement. The Georgia Pharmacy Journal
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December 2009
MEMBER CONTRIBUTION
Same, Same... Different... Mary Meredith, R.Ph. Member Pharmacist Publix
he Georgia Pharmacy Association has a 134 year history of promoting and protecting the profession of Pharmacy in Georgia. Our elected Executive Committee members receive their direction through the combined efforts of the Association’s Standing Committees which include Government Affairs, Third Party, Public Relations and Student Affairs. Members of these committees are appointed by each of the Region Presidents as well as each Academy Chair in order to represent all of the varied interests of the Association members.
medication we dispensed was being used for. Today, product profit margins are out of our control, 90 plus percent of patients are covered by some third party, and we are required by law to counsel patients on all aspects of their prescription and OTC medicines, most times for free! From any business model, how do today’s pressures allow you to keep the doors open, the lights on, the computers running, the employees paid or your family fed and clothed?
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It’s human nature to let natural leaders and those with the most at stake carry the load. For years many of us have let the Independent Pharmacists carry that torch. But today’s legislative and market conditions including mergers, store closings and hiring freezes -- leaving none of us insulated from the risks of losing our jobs and our profession!
In September, it was my pleasure to represent the Academy of Employee Pharmacists in the Governmental Affairs Committee meeting. The committee was composed of Pharmacists from every practice setting and moderated by our president, Eddie Madden, and Stuart Griffin, GPhA Staff Government Affairs. Our charge was to establish three top priorities related to Government Affairs for the association to pursue this year.
Whether we are Independents or Chain Employees, Long Term Care or Educators, and even PBM employees, we all have bills to pay and families to support. It is time for all of us to put our differences aside and sit down at the table together. Not only does each of us need to contact our legislators about the very precarious ledge our profession sits on and the services we provide for their constituents, we need to reach out to those patients we serve every day and let them know that they, also, need to reach out to those same legislators if we are to survive as the most accessible health care practitioner.
It is no big secret that, over the years, it has sometimes been more than a little difficult to reach consensus on a common goal from such a diverse group of practitioners. However, on this day, as Stuart began to recap the Association’s legislative progress over the past two years with PBM, Mail Order and Influenza Protocol legislation, one voice after another joined the chorus. “Protecting our profession, our jobs, our livelihood and the people of Georgia is primary to our mission and code of ethics.”
Each of us joined and pay our dues to the Georgia Pharmacy Association for different reasons. Regardless of what your reasons are, NOW is the time to LET YOUR VOICE BE HEARD.
Today’s issues have reached back to the very root of why we all practice pharmacy, to serve the public. Unfortunately, there are very few of us who can afford to do that for free. When I was first licensed, 30 years ago, retail pharmacists were dispensers and merchants. We sold a product (pharmaceuticals) at a mark up (about 30%) and were required by law to refer a patient to their prescribing physician if we were asked what the The Georgia Pharmacy Journal
In preparing for this letter, I reviewed the History of the Georgia Pharmacy Association that is posted on our new web site and couldn’t help but feel how true it is that “the more things change, the more they stay the same.” See what you think. 12
December 2009
GEORGIA DRUGS AND NARCOTICS NEWS
Georgia Drugs and Narcotics Agency Website
Michael Karnbach, Pharm.D. Special Agent Georgia Drugs and Narcotics
he Georgia Drugs and Narcotics Agency (GDNA) serves as the law enforcement and administrative extension for the Georgia State Board of Pharmacy. Health care professionals utilize GDNA to stay current with the laws and regulations governing prescription medications in Georgia. GDNA Special Agents conduct routine inspections daily and provide personal education to licensed entities. These administrative inspections are an ideal time for pharmacists to ask questions or address concerns regarding the practice of pharmacy.
patients in the doctor’s office. This section addresses concerns raised by pharmacists and physicians when dispensing from the office. It also gives prescribers the information needed to dispense medication in a safe and lawful manner.
In an effort to reach more health care professionals in a more efficient manner, GDNA has overhauled and relaunched its website. The site, WWW.GDNA.GEORGIA.GOV , provides information for pharmacists and other health care professionals in a clear and concise manner. The site is not intended to serve as legal advice but instead, to give health care practitioners information at their fingertips. The site features several areas of specific interest.
Finally, pharmacists are encouraged to utilize the “Contact Us” section to schedule an inspection or answer additional questions. This section will allow viewers to find the appropriate GDNA Special Agent throughout the State. Email addresses and telephone numbers are also listed for each GDNA employee.
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The website also provides viewers with “Diversion Alerts” and “Press Releases” for the newest information and updates concerning prescription medication. Pharmacists are encouraged to utilize this area to identify the trends of abuse for the diversion of prescription medication.
To add information to the website you feel would be helpful for pharmacists or other health care professionals, please contact Special Agent Michael Karnbach at (404)549-1826 or michaelk@gdna.ga.gov.
The most utilized section of GDNA’s website is the frequently asked question (FAQ) section. This part of the site allows users to answer the most frequent issues such as: Electronic prescribing, physician assistant and nurse practitioner prescribing authority, counseling requirements, pharmacy technician ratios, stamped signatures on prescriptions, and physicians prescribing controlled substances for themselves or family members. Another section of interest is titled “Prescribers.” This section provides information for those prescribers who dispense or intend to dispense prescription medication to The Georgia Pharmacy Journal
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December 2009
GPHA MEMBER NEWS
APhA Immunization Program A Pharmacy Based Immunization Program was held on October 24, 2009, at Pharmacy Partners of GA, LLC, in Kennesaw, GA. This is an innovative and interactive training program that teaches pharmacists the skills necessary to become a primary source for vaccine information and administration. The program teaches the basics of immunology and focuses on practice implementation and legal/regulatory issues. As part of the training the participants gave (and received) subcutaneous and intramuscular injections. Thirty-seven participants attended this program. Each participant was awarded a certificate of achievement, and a total of 20 hours of continuing education credit for successful completion of all components of the program. 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: Joesph Aaron Hagar Badawy John M. Chafin, R.Ph. Hewlette D. Cook, R.Ph. Ray W. Crisp Blake Daniel Terry Dunn, R.Ph. Jaclyn A. Giddens Mary A. Harper, R.Ph. Shawn E. Hodges, Pharm.D. Jeffrey S. Jarvis, Pharm.D. Jonathan J. Knight, Pharm.D. Steven Lee Wendell Lifsey, R.Ph. Jessica Lipcsei Jim W. Loyd, Jr., B.S. Ricky McIntyre, R.Ph. John L. Moorhead, R.Ph. Samantha Morris Vishali Patel Stephen Todd Pledger, Pharm.D. Grace G. Poole, Pharm.D. Shannon Powell, RN Benny Raby, R.Ph.
The Georgia Pharmacy Journal
Many thanks to Daniel K. Forrister, Pharm.D., and Sukhmani Kaur Sarao, Pharm.D., for teaching the APhA PharmacyBased Immunization Class on October 24, 2009.
Melissa M. Rollins Amy Rutland Olivia R. Santoso, B.S. Terry D. Shaw, Pharm.D. Chad Smith, R.Ph. James Smith Carl L. Stanley, Jr., R.Ph. Ben Stanley, Pharm.D. Benjamin A. Starr, Pharm.D. John W. Thomas, Jr. R.Ph. Heather A. Tidwell Roy A. Tipton, R.Ph. Erica N. Williams
GPhA thanks Ted Hunt, R.Ph., from Pharmacy Partners of Georgia for the use of his facility for this program and for contributing the money from the table rentals on behalf of Pharm PAC.
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December 2009
GPHA MEMBER NEWS
Buddy Carter Wins Election to State Senate ormer House of Representatives member Buddy Carter, R.Ph., was elected to the Georgia State Senate in Senate District 1. Carter will be the only practicing pharmacist serving in the Georgia 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.
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Congratulations to Senator-elect Earl "Buddy" Carter from GPhA!
Whitfield County Annual Health Fair hitfield County, one of GPhA’s employers that are participating in the Diabetes Patient Self Management program, held a health fair on October 22, 2009. The health fair was held at the Whitfield County Recreation Department located on Gillespie Drive. This event provides employees an opportunity to increase health awareness by participating in health screenings. Samee Ellerbee, R.Ph., CDE, MPH(c), serves as a pharmacist coach through GPhA for the Dalton Ten City Challenge participants. Approximately 200 Whitfield County employees attended the health fair.
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December 2009
GPHA MEMBER NEWS
NCPA Elects Hugh Chancy, R.Ph. Fifth Vice President he National Community Pharmacists Association (NCPA) installed new Officers and Executive Committee Members for 2009-2010 at its 111th Annual Convention and Trade Exposition, held Oct. 17-21, in New Orleans, Louisiana. They are the association's governing body, who represent the voice of the members and direct the association's objectives.
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Two new officers were inducted at the 111th NCPA House of Delegates. They are Michele Belcher of Grants Pass, Oregon, and Hugh Chancy of Hahira, Georgia. These two individuals were named to the NCPA fourth and fifth vice president positions, respectively, which are both one-year terms. Belcher is a 1986 graduate of the Oregon State University College of Pharmacy. She is the owner of Grants Pass Pharmacy, Inc., which offers specialty services such as compounding prescription drugs and hospice care with a variety of facilities. Chancy is a 1988 graduate of the University of Georgia College of Pharmacy. He is the owner of Chancy Drugs in Hahira, Georgia, and President of the Council of Presidents of the Georgia Pharmacy Association. "We have a great team of dedicated pharmacy professionals committed to ensuring independent community pharmacies are able to adapt with the challenges of the 21st century," said Harrison. "I want to welcome Michele Belcher and Hugh Chancy in their roles as fourth and fifth vice president. NCPA is excited to have Michele and Hugh in these influential positions and we look forward to working with them next year and for years to come." NCPA's House of Delegates also passed eight resolutions focused on leveling the playing field for community pharmacies in the marketplace, preserving patient access to their services, and also contributing to causes that will benefit everyone 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 School of Pharmacy. He is co-owner of Kenmar Pharmacy in Marietta, Georgia, and is a partner in nine other Georgia pharmacies. He also owns and operates First Aid of America, an industrial first aid and safety supply company.
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Pharm PAC would like to encourage you to make a contribution today and help pharmacy look forward to a bright future in the state of Georgia.
Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D. • Professional Licensure Disciplinary Proceedings • Medicaid Recoupment Defense • Challenges in Medicaid Audits • OIG List Problems • SCX or Other Audits
Name: ________________________________ Address: _______________________________ _____________________________________ Phone Number: __________________________
Leroy Toliver has been a Georgia Registered Pharmacist for 34 years. He has been a practicing attorney for 25 years and has represented numerous pharmacists and pharmacies in all types of cases. Collectively, he has saved his clients millions of dollars.
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
Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100
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Sustainers Circle: When you check this box and provide valid credit card information you are making a 5 year commitment to make the same contribution for the next 5 years. Your credit card will automatically be charged annually on the date of your initial contribution. Contributions or gifts to Pharm PAC are not deductible as charitable contributions for Federal income tax purposes. 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 30324 You may also donate online. The Georgia Pharmacy Journal
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December 2009
Continuing Education for Pharmacists A 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 papers prepared by the Council of the Convention (CoC) titled "Focus On: Future Directions for USP." The learning objectives and assessment questions were developed by National Alliance of State Pharmacy Association's (NASPA) Continuing Education Advisory Panel. 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 Medicines Loyd 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 to describe non-governmental and governmental approaches to provide compounding standards and conformity assessments to these standards, and provide an overview of a proposed model system of standards and conformity assessments to standards that assure access to good quality compounded preparations Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Identify the non-governmental and governmental approaches to provide compounding standards and conformity assessments to these standards 2. Identify some of the non U.S. approaches to pharmacy compounding regulations 3. Identify the proposed model system of standards and conformity assessments to standards that could assure access to good quality compounded preparations.
Introduction: Extemporaneous compounding of preparations is a worldwide practice dating back centuries. Today, compounding is commonly defined as the preparation of a medicine in accordance with a licensed practitioner’s prescription or medication order. This definition evolves from a triad—the prescribing practitioner, the compounding professional, and the patient/ consumer. Historically, what was once viewed as an art is now deeply rooted in the scientific study of how to prepare and assess compounded preparations, together with provision of stability data to allow assignment of a beyond-use date (BUD). In the following white paper, USP’s Council of the Convention Section on the Quality of Compounded Medicines provides a general description of nongovernmental and governmental approaches to provide compounding standards and conformity assessment to these standards. Conformity
assessments may be conducted by various parties—first (compounding group/individual), second (purchasing group/individual), or third (group/individual independent of first or second party). While data are limited, all types of conformity assessments are likely to be conducted in the United States. The white paper then articulates a proposal for a model system of standards and conformity assessments to standards that assure access to good quality compounded preparations.1 United States Non-governmental Approaches 1. USP: Preparation and Process Standards: The compounding of the most “fully established and best understood” preparations for patient use was a founding principle for USP’s volunteer practitioners in 1820. USP still takes an active role in supporting the public’s access to the type 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 differences between the two, including differences in the relevant laws. The federal laws regulating veterinary compounding are found in the Animal Drug Amendment of 1968 and the Animal Medicinal Drug Use Clarification Act of 1996 (and related regulations and guidances) which are intended to protect consumers of foods of or from animals, as well as the animals themselves that might be treated with drugs, including compounded preparations. As with compounding for human use, there is controversy surrounding the distinction between legitimate compounding and manufacturing; the scope of the FDA’s role in regulating veterinary compounding; and the efficacy, safety, and appropriate labeling of these products, as well as other issues. A detailed discussion of the particular considerations that apply in the veterinary context is beyond the scope of this paper, but USP is committed to providing standards for compounding of preparations for both human and animal use, and the information and model system proposed herein is generally applicable to both human and veterinary compounding.
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compounding and works to ensure the quality of such therapy by creating national standards and guidelines for compounding both sterile and nonsterile medications. These standards are process standards in that they provide appropriate techniques and procedures to guide practitioners in compounding. They also are product standards (commonly referred to as preparation standards to distinguish compounded formulations from manufactured products) to allow testing, both of the materials used in a compounded preparation and also the compounded preparations themselves, to assess quality and establish a BUD. Taken together, these preparation and process standards appear in official compendia of the United States—the United States Pharmacopeia (USP) and National Formulary (NF). Just like manufactured medicines, compounded preparations must comply with the product standards in the USP and NF, which are recognized as official compendia in federal food and drug law. In addition, a number of States recognize USP’s process standards for compounding and require compliance with these standards. These legal requirements are discussed further below. In the 2005-2010 cycle, USP supported two Expert Committees that provided these compounding standards. The Compounding Pharmacy Expert Committee of USP’s Council of Experts is composed of 10 experts, with proven extemporaneous compounding expertise representing varied pharmacy environments such as hospital, ambulatory, academia, veterinary practice, and private
practice. The Sterile Compounding Expert Committee of USP’s Council of Experts is composed of 12 experts, also representing a wide range of pharmacy disciplines and infection control. These two Expert Committees: 1) develop compounded preparation monographs that can be used every day by pharmacists to prepare medications for patients requiring customized drug therapy, and 2) develop and revise General Chapters that describe good compounding practices. As an emanation of the standards from USP’s two Expert Committees in the Council of Experts, USP supports several compounding constituencies through publication of the Pharmacists’ Pharmacopeia (P2), now in its second edition. P2 contains more than 115 compounding monographs, for use in both humans and animal patients, and 75 supporting General Chapters, all of which were excerpted from the USP and NF. In USP’s ongoing effort to develop more preparation monographs, academic and other laboratories are performing method development and stability studies for both sterile and nonsterile preparations. When these studies are completed, they provide information to support decisions of the compounding Expert Committees relative to a BUD designation. Currently, 17 compounded preparations are under study. USP also is reaching out to professional organizations and others to obtain candidate formulations, materials, tests, procedures, and acceptance criteria for the two compounding Expert Committees. The total universe of formulations needed for compounded preparations is
unknown, but is well over 1,000. USP is attempting to focus on those that are most commonly compounded or that present the most significant risk. 2. Process Standards/Conformity Assessments for Site Accreditation: The Pharmacy Compounding Accreditation Board (PCAB) was launched in 2004 by eight pharmacyrelated organizations (including USP) as a voluntary accrediting body to assess compounding pharmacies against high quality standards for compounding. The founders of PCAB, and the pharmacists they represent, believed that standards against which compounding pharmacies can be tested are not only good for patients, but also good for the practice of pharmacy.2 To date, PCAB has accredited 65 compounding pharmacies. Each PCAB-accredited pharmacy undergoes a rigorous review of its policies and procedures and an onsite inspection against PCAB standards, which incorporate USP standards. The pharmacies that have achieved the milestone of PCAB accreditation have demonstrated their commitment to quality standards and procedures. However, participation levels in PCAB are less than hoped for among U.S. pharmacies, which include approximately 3000 to 4000 pharmacies that emphasize compounding capability. This may be attributed to the rigor of the accreditation process and the absence of “drivers” that would compel pharmacies to seek accreditation, e.g., reimbursement and insurance. Nevertheless, PCAB in recent months has seen an upswing in applications with over 140 pharmacies awaiting survey. Emerging “drivers” include professional organizational
2. Pharmacy Compounding Accreditation Board, www.pcab.info 2009.
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endorsements of PCAB (beyond PCAB’s governing board institutions), including the American Medical Association, American Veterinary Medical Association, American Animal Hospital Association, American Association of Equine Practitioners, and others, as well as incentives offered by liability insurers. In 2008, PCAB established a separate Accreditation Committee that now oversees the accreditation process, and more recently began the first formal review of PCAB standards since their adoption in 2004. The revised standards are expected to be available before the end of 2009. 3. Conformity Assessments for Practitioners: There are several organizations and accreditation activities that speak to conformity assessments for practitioners. The Accreditation Council for Pharmacy Education (ACPE) is the national agency responsible for the accreditation of professional degree programs in pharmacy. ACPE sets accreditation standards and guidelines for pharmacy education and conducts conformity assessment of institutions. Standardized assessment of practitioner competence also occurs through the North American Pharmacists Licensure Examination (NAPLEX) developed by the National Association of Boards of Pharmacy (NABP). NAPLEX is used by boards of pharmacy as part of their assessment of pharmacy practitioners’ competence prior to licensure. Certification through the Board of Pharmaceutical Specialties (BPS) is one additional conformity assessment for practitioners. BPS certification is a voluntary process by which a pharmacist’s education, experience, The Georgia Pharmacy Journal
knowledge, and skills in a particular practice area are confirmed as well beyond what is required for licensure; however, there is currently no BPS specialty in compounding. United States Government Approaches 1. Federal: The role of federal law and regulatory oversight of compounding has proven to be one of the most problematic for FDA, particularly in recent years. As a general rule, FDA has tended to avoid involvement with activities that relate to the practice of medicine and pharmacy, both of which traditionally are regulated at the level of the states in the U.S. However, FDA pays close attention to the quality of products regardless of whether they are manufactured products or compounded preparations. Sorting out the scope of state versus federal authority, and the demarcation between compounding and drug manufacturing, has proven elusive. Congressional efforts to resolve the issue have so far failed. For now, there is a legal and regulatory stalemate, leaving compounding practitioners and regulatory authorities in a state of uncertainty. The federal legal history leading up to this point helps illuminate the current situation. In FDA’s view, compounded drugs in interstate commerce are “drugs” under the Federal Food, Drug, and Cosmetic Act (FDCA), and are potentially subject to the full panoply of requirements (including pre-approval prior to marketing, such as a New Drug Application (NDA), good manufacturing practices (GMPs) required for manufacturing, and compliant labeling). In recognition of the role of compounding, FDA has generally, in the exercise of its 25
enforcement discretion, excused such compounded drugs from most requirements otherwise applicable to “drugs.” In particular, under FDA Compliance Policy Guidance (CPG) 460.200, eligible compounding has been exempted from: the adulteration provisions of the FDCA with respect to GMPs; the misbranding provisions regarding labeling with adequate directions for use; and the new drug requirements, that is, approval of an NDA or Abbreviated New Drug Application (ANDA). In 1997, Congress sought to codify many aspects of FDA’s compounding policy and generally provide a limited regulatory exemption from certain requirements of the FDCA for compounding. Section 127 of the FDA Modernization Act (FDAMA), which added §503A to the FDCA, in large part reflected CPG 460.200, and, among other things, provided that bulk drug substances used for compounding must comply with USP or NF requirements. To identify the compounding eligible for the less stringent regulatory requirements of 503A, Congress stipulated that such eligible compounders could not “advertise or promote the compounding of any particular drug, class of drug, or type of drug,” although the “compounding service” itself could be advertised and promoted. These limits on advertising were found by the 9th Circuit U.S. Court of Appeals in the Western States decision to be unconstitutional; moreover, the 9th Circuit held that the advertising restriction was not severable from the rest of FDCA 503A, thereby leaving at least the 9th Circuit in a pre-FDAMA condition (in terms of the application of the overall FDCA). The Supreme Court December 2009
later affirmed Western States, but declined to consider the severability issue. More recently, the 5th Circuit declined the request of pharmacists to find that compounded drugs are exempt from the “new drug” provisions of the FDCA, but also found that the unconstitutional advertising restrictions of FDCA 503A are severable (leaving what some 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’s current compounding policy continues to be reflected in the CPG it issued in the wake of the Western States decision.3 While these federal uncertainties are sorted out, USP continues to play an important role: 1) state law may incorporate USP process standards (e.g. General Chapters <797> Pharmaceutical Compounding – Sterile Preparations and <795> Pharmaceutical Compounding – Nonsterile Preparations) in regulating the practice of compounding, and 2) compounded preparations remain “drugs” under the FDCA and must comply with any applicable USP monographs if they use the name recognized in USP-NF. 2. State: In the U.S., pharmacy practice, including compounding, is regulated at the state level by state boards of pharmacy. Each state establishes and enforces its own laws and regulations governing the practice of pharmacy and performs routine inspections of pharmacies to ensure compliance. State boards also issue licenses to pharmacists— evaluating their competence to practice—and to pharmacies. When
needed, state boards also investigate complaints. There are times when states recognize standards from nongovernmental third parties; for example, several states recognize USP for sterile and nonsterile compounding and, to a more or lesser degree, other USP standards related to compounding, drug product labeling and packaging. In an effort to maintain a certain level of consistency among the states, NABP offers to boards of pharmacy model language that may be used when developing state laws or board rules. The current set of model regulations also contains the NABP Model Rules for Pharmacy Interns, Institutional Pharmacy, Pharmacist Care, Nuclear/Radiologic Pharmacy, and Sterile Pharmaceuticals. Non-U.S. Approaches 1. Argentina: In Argentina, the Health Department regulates the practice of pharmacy compounding. Legal difficulties abound for compounding practitioners because there are few established regulations to guide compounding practices and the guidelines that do exist are based on outdated legislation. Technical and scientific advances in drug therapy are not considered in the guidelines. Even though the regulatory framework may be lacking in certain respects, some restrictions do exist that ultimately limit patient access to medicines. For example, several dosage forms and therapeutic categories—such as troches, nasal preparations, and ophthalmics—are excluded and hormone replacement therapies, as well as medicines the U.S. would term over-the-counter, are not permitted to be compounded. In addition, Olanzapine (Zyprexa for schizophrenia/acute manic episodes)
is the only drug that cannot be used in compounding. 2. Brazil: The Brazilian National Health Surveillance Agency (ANVISA) regulates compounded pharmaceuticals. In 2005, ANVISA proposed new rules for compounding pharmacies, including: ∙ Disallowing compounded drugs of the same formulation as manufactured products; ∙ Setting limits on the marketing of products to the general public; and ∙ Requiring the pharmacist to provide the patient with more product information, including the drug formulation, adverse effects, and duration of treatment. Veterinary pharmaceuticals are regulated by a number of different agencies, including the Ministry of Agriculture and the Ministry of Agriculture, Cattle and Supplying. Brazil appears to be one of the most advanced countries in regards to compounding. Brazil has 306 Schools of Pharmacy and graduates 14,000 pharmacists per year. In contrast the U.S. has slightly over 100 Schools of Pharmacy. There are 7,211 pharmacies in Brazil that are solely engaged in compounding and 16,000 compounding pharmacists. Brazil offers Continuing Education (CE) on compounding over standard TV channels throughout the country. ANFARMAG is Brazil’s National Association of Compounding Pharmacies and has a membership of over 4,000 pharmacists.
3. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074398.htm.
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3. Germany: Federal Law, primarily the Arzneimittelgesetz, and subordinate federal directives, primarily the Apothekenbetriebsordnung, regulates the practice of pharmacy compounding in Germany. Extemporaneous preparation is mandatory when a prescription requiring compounding is presented to a community pharmacy. All dosage forms can be compounded; however, preparations that are difficult to compound (e.g. cytotoxic preps, injectables) can be compounded only after a pharmacist has completed special training. Over-the-counter (OTC) compounding is allowed and occurs frequently. There is a list of preparations that both community pharmacies and hospitals are not allowed to prepare, such as allergens used to trigger an allergic response in a patient. Beyond-use dating for 243 standardized formulas is provided in the Neues Rezeptur-Formularium (NRF). There are 21,570 pharmacies in Germany. 4. Spain: In Spain, regional governments regulate the practice of pharmacy compounding. Four levels of compounding exist: 1) Dispensing; 2) Topical; 3) Oral, rectal and vaginal; 4) Sterile. Beyond-use dates for compounded preparations are based on literature and references, such as USP-NF. Health authorities in Spain have a very restrictive attitude toward pharmaceutical compounding. Compounded medicines are generally regarded as the last resource and authorized almost exclusively when all other therapeutic alternatives have failed. Pharmacies that only engage in compounding are not allowed. If a pharmacy only performs Level 1 compounding; i.e., dispensing, it must subcontract with a pharmacy that The Georgia Pharmacy Journal
does other levels of compounding because it is against the law to refuse to serve any patient that enters a pharmacy. “Elaboracion a terceros” (third-party compounding) is the term used when a pharmacy contracts with another pharmacy specializing in higher-level compounding. Spanish patients receive most of their prescription medicines free or at little cost. However, compounded preparations are reimbursed according to a drug list that, according to Spanish practitioners, is currently out of date. Pharmacists are allowed to compound OTCs for sale in their own pharmacies, with the only limitation being that the medicine must be described in the Formulario Nacional (National Formulary). Additional specialized training is not required to be a compounding pharmacist. AEFF is the Spanish Association of Compounding Pharmacists. A Model System: The goal of any model system is to assure access to good quality compounded medicines, assist compounding practitioners— pharmacists and physicians—in delivering such preparations to patients, and ensure patient safety, above all. While a number of standards, including USP’s, exist to help ensure that compounded medicines are of good quality, the lack of strong conformity assessments to such standards leaves both practitioners attempting to provide access to good quality compounded medicines as well as patients/consumers who receive them at risk. In this setting, the Council of the Convention Section on Quality of Compounded Medicines offers the following model system of standards and conformity assessments, in which USP would 27
play a primary role in developing monographs and process standards and could play a role in other areas as well. 1. People, Process and Preparation Standards ∙ Ingredient and Preparation Standards (Product) Optimally, a preparation monograph in USP exists for all compounded preparations in the U.S. Compounding monographs are prioritized so that standards for the most frequently compounded articles are developed first. The Compounding Expert Committee, working with compounding practitioners, associations and others, develops a preparation monograph. The Committee takes into account safety and other considerations, such as intended use in target species. This input is obtained through a variety of sources, including FDA (whose views are represented by FDA liaisons to the Committee), NABP, and other practitioner and board associations. As noted above, conformance to such monographs is required under the FDCA. ∙ Compounding Sites Standards (Practice and Process) Optimally, practitioner associations and others, including associations representing state practitioner boards such as NABP, develop standards for all compounding sites (both in community and hospital locales where compounding is practiced, as well as practitioner office December 2009
practices). Practice standards (<795>, <797>, and others) developed by USP for compounding are recognized in state regulations and accreditation standards (similar to the treatment of compounding provided by NABP in its Model Pharmacy Act and Pharmacy Rules).
sites. When appropriate, a state board may deem nongovernmental bodies, such as PCAB or equivalent associations, suitable to accredit traditional compounding sites. Optimally, all sites engaging in significant compounding activity require accreditation. ∙ Adverse Event Reporting
∙ Practitioner Training and Accreditation (People) Adequate professional education and training curricula are adapted in schools of pharmacy to ensure that competencies in compounding are acquired and are supported by assessment through NAPLEX and licensure requirements through the state boards. An independent certifying body, such as BPS, builds an accreditation to define specialty certification of compounding practitioners. Optimally, all practitioners who compound complex or sterile preparations beyond a certain frequency are certified. 2. Conformity Assessments ∙ Site Accreditation Through Congressional and/or judicial and regulatory determinations, the line between compounding and manufacturing is clarified, with the states retaining responsibility for regulation of compounding and FDA retaining responsibility for regulation of manufacturing. State boards of pharmacy (and other disciplines’ boards), working with PCAB or equivalent national practitioner associations, are responsible for conformity assessments of all compounding The Georgia Pharmacy Journal
An adverse event reporting system that offers strong Federal confidentiality and privilege protections, as provided by the Patient Safety Act of 2005, is provided and maintained to ensure the capture of adverse events associated with compounded preparations, for deliberation and analysis regarding quality and safety. Summary: As a general matter, compounding remains both a responsibility for practitioners (those who prescribe compounded medicines as well as those who compound them) and an opportunity for their patients. At the same time, assurance that manufacturing does not occur under the guise of compounding is critically important. This white paper argues for a model system, building on good systems in the U.S. and other countries, that recognizes the interests of all parties in assuring access to good quality compounded preparations.
ABOUT USP and NASPA The United States Pharmacopeia (USP) is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States. USP also sets widely recognized standards for food ingredients and dietary supplements. USP sets standards for the quality, purity, strength, and consistency of these products–critical to the public health. USP’s standards are recognized and used in more than 130 countries around the globe. These standards have helped to ensure public health throughout the world for close to 200 years. More information can be found at www.USP.org The National Alliance of State Pharmacy Associations (NASPA) promotes leadership, sharing, learning, and policy exchange among state pharmacy associations and pharmacy leaders nationwide, and provides education and advocacy to support pharmacists, patients, and communities working together to improve public health. NASPA was founded in 1927 as the National Council of State Pharmacy Association Executives (NCSPAE). More information can be found at www.naspa.us
Reprinted with permission. Copyright 2009, The United States Pharmacopeial Convention. All rights reserved.
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Continuing Education for Pharmacists Quiz and Evaluation A Model System to Promote Access to Good Quality Compounded Medicines 1. Today’s definition of compounding evolves from a triad which includes all of the following EXCEPT: a. Patient c. Compounding professional b. Manufacturer d. Prescribing practitioner 2.
7. Which of the following regarding the Pharmacy Compounding 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.
Who may perform conformity assessments? a. Patient b. Pharmacy benefit manager c. Purchasing group d. None of the above
3. In compounding, product standards are also commonly referred to as a. Preparation standards b. Compounding standards c. Item standards d. Formulary standards
8. In the U.S. pharmacy practice, compounding is regulated at the state level by who? a. State pharmacy association b. State board of pharmacy c. Pharmacy Compounding Accreditation Board d. Food and Drug Administration 9. Which of the following countries does NOT allow “compounding only” pharmacies? a. Argentina c. Germany b. Brazil d. Spain
4. The Compounding Pharmacy Expert Committee of USP’S Council of Experts is composed of how many experts? a. 2 c. 10 b. 5 d. 12
10. Which of the following countries does not allow Olanzapine to be used in compounding? a. Argentina c. Germany b. Brazil d. Spain
5. The Sterile Compounding Expert Committee of USP’s Council of Experts is composed of how many experts? a. 2 c. 10 b. 5 d. 12 6. The Pharmacists’ Pharmacopeia contains which of the following a. 115+ compounding monographs for use in humans only b. 75 supporting general chapters excerpted from the USP and NF c. Both A+B d. B only
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Journal CPE Answer Sheet The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
A Model System to Promote Access to Good Quality Compounded Medicines This lesson is a knowledge-based CPE activity and targets to pharmacists. GPhA code: J09-12 ACPE#: 142-000-09-012-H04-P Contact Hours: 1.5 (0.15 CEU) Release Date: 12/15/2009 Expiration Date: 12/15/2012 1. Select one correct answer per question and circle the appropriate letter below using blue or black ink (no red ink or pencil.) 2. Members submit $4.00, Non-members must include $10.00 to cover the cost of grading and issuing statements of credit/ 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. 2. 3. 4. 5.
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2009 - 2010 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal Editor:
Jim Bracewell jbracewell@gpha.org
Managing Editor & Designer:
Kelly McLendon kmclendon@gpha.org
The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2009, Georgia Pharmacy Association, Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical including by photocopy, recording or information storage retrieval systems, without prior written permission from the publisher and managing editor. All views expressed in bylined articles are the opinions of the author and do not necessarily express the views or policies of the editors, officers or members of the Georgia Pharmacy Association.
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