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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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Departments
Dale Coker, R.Ph., FIACP GPhA President 2010-2011
GPhA New Members GPhA Convention Information Member News GPhA Board of Directors
Advertisers
FEATURE ARTICLES
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Introducing the New and Improved GPhA Pharm PAC
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Mr. Whitworth Goes to Washington
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The Insurance Trust Principal Financial Group Melvin M. Goldstein, P.C. Bowl of Hygeia Logix, Inc. Michael T. Tarrant Design Plus Store Fixtures, Inc. Pharmacists Mutual Companies AIP GPhA Workers Compensation Toliver & Gainer Pharmacy Trader GPhA Career Center The Insurance Trust
CPE Opportunity: Generic Anti-Epileptic Drug Substitution: What are the Issues?
COLUMNS
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President’s Message Editorial
For an up-to-date calendar of events, log onto
www.gpha.org.
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June 2010
PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President
A Great Year for GPhA ow, has my year as President of the Georgia Pharmacy Association gone by fast! It seems only a few months ago that I began as president for the 2009-2010 year. As this year’s president I have had the unique experience of having completed the last four years on the Executive Committee with Jim Bracewell as our Executive Vice President & CEO. At the beginning, I was impressed with Jim’s take on the state of the Association’s financial conditions and his goal of correcting the issues he saw over the next three years.
Hatton, Pharm.D., for their support and leadership in making this year a success. I would like to also thank Jackie Cochran, our in-house CPA, for the outstanding job she has done over the last couple of years in giving us financial reports that are timely and accurate. Without these reports, we would not be able to see where we are or where we have to go. Jackie is retiring this year, and I wish her the best in her retirement. We will miss her great work!
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As I reflect on other aspects of the year, I asked the Executive Committee to support the development of a Strategic Plan. They did so and we had great success in developing a plan and are now implementing this plan for the Association. Our plan was very simple, focusing on the development of membership and the expansion of our advocacy for pharmacy in the political and public arena. I have seen it already taking root and providing direction toward growing our membership and strengthening our governmental advocacy program. Our goal is to stay focused on the Strategic Plan, and we must ask ourselves each time we take an action if the time, effort and expense justify as working toward the plan’s goals. I would like to give a special thanks to the thirteen Association members and staff who gave up their Saturday and Sunday in October to make the Strategic Plan a reality.
For several years, our Association has been operating on proceeds from the income of our reserves. Jim was quick to point out that this was a dangerous process, since one day our reserves may not yield sufficient income growth to permit our use of the Board of Director’s allocated percentage of that growth. In retrospect, it was as though he was looking into a crystal ball! We all know what happened to the stock market and economy in 2008. My year represented the first year where our Association budget had to operate without two to three hundred thousand dollars from the growth income. As such, the Executive Committee, with Jim’s drafting of a proposed budget, met at our Board retreat in July and had to make many hard decisions to cut programs and expenses within the Association’s operations. As a member looking at the Association’s operations, I believe that this was done without inducing a lot of pain in relationship to the services that our Association provides. Our budget this year is tight, but it appears we will make it and finish with a leaner, more efficient operation of the Association. Our Association remains financially strong thanks to the past leadership that has had the wisdom to establish and maintain our reserves.
Our government affairs program has had a great year. Success starts with good planning. This was begun at our annual legislative retreat in August of last year. The retreat gives us the opportunity to meet with our pharmacist legislators and share our legislative desires and needs with them to get their input on what agenda items are feasible. We can then present the ideas to the Board of Directors at our fall meeting in Calloway Gardens the last weekend of August for their input and direction for a legislative agenda for the next session.
I would like to commend my fellow Executive Committee members, Robert Bowles, Jr., R.Ph., CDM, CFts; Dale Coker, R.Ph., FIACP; Jack Dunn, Jr., R.Ph., and Robert
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also had success supporting a bill proposed by the Georgia Society of Health System Pharmacists. This bill will give statutory authority for health system pharmacists to follow a system protocol that allows pharmacists to order lab tests, monitor and adjust medications for patients within the health system. I am proud of our accomplishments and believe that they have supported my theme of “Preserving the Triad.�
Our Association is very fortunate to have talented people working for us. Stuart Griffin has quickly become an effective leader as our full-time lobbyist. Stuart is a very intense and focused individual who has a passion for success and this passion has reflected in a great legislative success for GPhA in the legislative arena. Stuart along with AIP Director Jeff Lurey, was to make this an exceptional year for pharmacy in Georgia by skillfully using our grassroots network.
Membership has value. Our greatest opportunity for improving our financial strength in our operations lies in growing our membership. Kelly McLendon, our Director of Public Affairs, our “creative digital native� is charged with communications and membership. Have you noticed the timely, professionally executed Journal each month, both in print and electronic versions and the weekly electronic Pharm-O-Gram during the legislative session and the new membership benefit this spring is your CE certificate and records are stored online for easy access. Members can also use our functional website to look up fellow GPhA members at the click of the homepage.
Our PBM bill is on the Governor’s desk awaiting his signature. Likewise, we have passed a remedy for the faxed prescription issue when it did not come from the prescriber’s office. While passing this bill, we were also able to correct an e-prescribing problem that was brought to us at our fall dinner meeting with the Medical Association of Georgia’s Executive Committee, of not being able to electronically designate brand necessary on the electronic script. Running defense is another important measure during the legislature. We were able to complete the year without mandates against generic substitution, which would have been a nightmare for pharmacists to handle had these become law. Another injustice for pharmacists providing vaccinations was remedied during the session. Pharmacists can now administer FluMist as part of their protocol. We
Trevor Miller, our Director of Insurance Services oversees a unique health insurance program, one that is not available to any other pharmacy association in the country. So why is not every pharmacist in Georgia a member? It could be because no GPhA member has invited them to join. There are approximately 8,500 non-member practicing pharmacists in Georgia. As you encounter them, invite them to become involved and support our profession and our Association in making the practice of pharmacy stronger in Georgia. Our success this past legislative session is a great example of how working together we can achieve significant results. This is an important reason for belonging to our Association.
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An important leg of our legislative efforts is the strength of Pharm PAC. During the last quarter, I assumed the position as PAC Chairman. Looking at the contributions, only 178 of our membership had contributed to our PAC. This is a big election year with much at stake. The Governor’s Office, Lt. Governor’s Office, and Insurance Commissioner are all positions of influence in which that our Association has vital interest. Many of our State Senators are retiring or running for another office and a large number of House seats are open or contested. With these elections, many new positions of power in chairmanships of committees will be up for appointment.
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Our PAC has to compete against other health care professional associations for leverage in the political process.
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June 2010
Evidence of this power can be seen in the chairmanship of the House and Senate Health and Human Services committees where the chairman is either a physician or the spouse of a physician. The Medical Association of Georgia has distributed up to three times what our Association has invested in the political process. We have less than fifty thousand dollars in our PAC operating fund. My goal is to have a PAC that will be able to compete in the one hundred and fifty thousand dollar range, which will put us on par with the Medical Association. We are restructuring our giving programs where you can charge your credit card on a monthly basis. This is a painless way to contribute and is a very effective way in which to support and strengthen our PAC. I have asked our PAC Board to focus on their respective Regions and contact our membership to help us achieve our goal. Consider visiting our website and making your contribution today.
to bond together and explore issues facing our profession and the Association. This year, they were given the challenge of taking our Association’s strategic plan and elaborating on their thoughts of how to better implement the plan. We received many good ideas and have already begun using their recommendations. From these classes, we strive to include the graduates in committees and keep them involved to become future leaders of our Association. As we look back on past classes, some have gone on to serve on the Executive Committee and become President of our Association. Much of our Association’s financial success relies on having a great convention. I would like to recognize two of our employees who have been key in making each year’s convention effective for our membership. Ruth Ann McGehee is a behind-the-scenes Director who skillfully plans and executes the program for the convention. She along with Mary Ellen Chapman works tirelessly with our CE Planning Committee to ensure that we have relevant and effective CE Programs for our members. She orchestrates every convention event and makes our convention run like clockwork. Thanks, Ruth Ann for all the hard work you do. We also owe a special thanks to Sid Anderson, whom we lost this year. Sid worked diligently to make sure our Exhibit Hall had a large representation of Exhibits for our members to visit and enjoy. His efforts will be apparent at this year’s convention, and he will be greatly missed.
Annually our Association participates in two great events: VIP Day at the Georgia Capitol and New Practitioners Leadership Conference. VIP Day at the Georgia Capitol has witnessed greater and greater participation by the pharmacy students from Mercer, South, and UGA Pharmacy Schools. Next year we are expecting additional participation from the new Philadelphia College of Pharmacy in Gwinnett County. With the event hosting nearly 300 last year, we expect to outgrow the Sloppy Floyd Building site and are planning to hold the event at the Railroad Depot. I believe this experience for the young pharmacy students provides them with a greater understanding of what the State Legislature is about and makes them more prepared for the future when they become involved in grassroots lobbying for our profession. They not only see first hand that their representatives are approachable but that they understand where and how the legislative procedures are conducted at the Capitol. They also get to meet and have a photo op with the Governor. I would also like to encourage a larger participation from our practicing pharmacists. This is a great opportunity to become more involved with grassroots lobbying and makes for a most impressive day with everyone wearing his or her white lab coats as we flood the Capitol Hall with such a large volume of pharmacists.
Our Association is comprised of many entities and takes quite an effort to manage. This would not be possible without a skilled staff. They are all to be commended for their hard work and dedicated efforts during a tight budget year to make our Association the success that it is. In closing, I wish to thank the membership for trusting me to lead such a fine organization. I have been proud to travel throughout this country representing one of the top Associations in the nation! I am looking forward to turning the lead over to Dale Coker. Dale is dedicated, thoughtful, and deliberate in his plans for our future. I am certain that we will have a great year ahead.
Our Foundation, through John Sherrer’s leadership and with the hard work of Regena Banks, sponsors our other event that I believe brings a significant reward to our Association. Each year the Foundation seeks nominations for 20 new practitioners to participate in the New Practitioners Leadership Conference. These are energetic and bright young minds of Pharmacy’s future leaders. During the two-day conference, they are given opportunities
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June 2010
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
GPhA Pharm PAC A New Beginning ou may have heard that phrase “This is not your father’s Oldsmobile.” That slogan was used to draw attention to a major change happening in that automobile product line.
square political debates has long since been replaced with TV advertisements, websites, email, direct mail, and televised debates. The challenge today is for a candidate to get his or her message and name heard above the swell of political propaganda in the media.
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Your GPhA Pharm PAC has recently reinvented itself in a major effort to ensure that GPhA in the future will be at the political table when the issues of health care are discussed. Pharmacy in Georgia can no longer be on the menu. GPhA will be at the political table advocating for the profession’s future as the new health care policies are developed from the federal health reform effort.
Money is the Mother’s Milk of Politics. Without it few candidates survive. It is up to pharmacy to put our money where our mouth is and support our state office holders who support the pharmacy profession we care about. GPhA has birthed a new baby with the new GPhA Pharm PAC. Will the baby grow up to be healthy and strong or will it be starved for lack of support by the profession? We believe we have the potential for a superstar with our new PAC baby and with your personal help our baby will emerge to be a champion for pharmacy.
Our new Pharm PAC must produce a new level of power for pharmacy. The new Pharm PAC will be a high speed, low drag model ready to compete in today’s intense political environment. GPhA’s President, Eddie Madden, R.Ph., has accepted the challenge to lead this new Political Action Committee into this new era in Georgia politics. “We can no longer be a footnote in the politics of health care,” said Madden. “The success of pharmacy to expand our role in health care is directly proportional to our financial and personal commitment.” GPhA has had a history of supporting political candidates at about one third or less of the level of most other Georgia professional associations. Serving in political office today is an extremely expensive undertaking in large part due to the cost of media. Candidates must participate in expensive TV time to be considered a viable candidate. The time of the courthouse
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June 2010
PHARM PAC
New GPhA Pharm PAC Gift Club Levels Adopted by the PAC Board for use beginning in June 2010
Titanium Member $2400 per year or *$200 per month
Platinum Member $1200 per year or *$100 per month
Gold Member $600 per year or *$50 per month
Silver Member $300 per year or *$25 per month
Bronze Member $150 per year or *$12.50 per month GPhA PAC Member $25-up * You can join a Pharm PAC Gift Club with a monthly contribution on your credit card by calling Kelly McLendon at 404-419-8116 and she can set it up for you over the phone. It is the easiest and most consistant way to help Pharm PAC become the political power pharmacists need for their profession. You may also write a one time check and mail it to GPhA Pharm PAC, 50 Lenox Pointe, NE, Atlanta, GA 30324. Contributions to Pharm PAC are not tax deductible as charitable contributions.
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June 2010
PHARM PAC
Who are the GPhA Pharm PAC Board of Directors? Article IV, Section 4.31 There may be up to 15 Directors, 12 of whom shall be nominated by the GPhA’s region presidents, one from each region, and the others shall be the GPhA’s President-Elect, the GPhA’s Executive Vice President and the Chair of the Political Action Committee. Chairman: Eddie Madden, 2010-2011 Vice Chairman: Tommy Whitworth, 2010-2011 GPhA President-Elect: Jack Dunn, 2010-2011 Secretary: EVP Jim Bracewell, Exoffico (non-voting)
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Region One Dean Stone Metter, GA
Region Seven Jim McWilliams Temple, GA
Region Two Keith Dupree Leesburg, GA
Region Eight T. M. Bridges Hazlehurst, GA
Region Three Judson Mullican Midland, GA
Region Nine Mark Parris Blue Ridge, GA
Region Four Tommy Whitworth LaGrange, GA
Region Ten Stacy Dickens Watkinsville, GA
Region Five Mahlon Davidson Oxford, GA
Region Eleven Stewart Flanagin Augusta, GA
Region Six Robert Moody Macon, GA
Region Twelve Mark Cooper Dublin, GA
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PHARM PAC
GPhA Pharm PAC Frequently Asked Questions he following questions are often asked about Political Action Committees. If your question is not answered, do not hesitate to contact GPhA EVP, Jim Bracewell, at jbracewell@gpha.org or Director of Government Affairs, Stuart Griffin, at sgriffin@gpha.org.
T
How much is the PAC allowed to contribute to a candidate? $2400 per election cycle.
What is an election cycle? A primary election is a cycle and the General Election is a cycle, but also if there is a runoff election that too is an election cycle. What is the limit on the amount of money an individual can give to the PAC? An individual is limited to the same contribution level as the PAC.
Questioning the wisdom of your financial plan?
Can my pharmacy give to the PAC? Yes, company and corporate checks can be given to the Pharm PAC.
If so, this ad entitles you to:
Can I give money to the PAC and have the PAC give that money to the candidate I support? No, you cannot restrict your contribution to the PAC, but you can ask the PAC Board to consider your favorite candidate for support. Can the PAC support candidates seeking election to Congress? No, since GPhA is a state PAC we cannot contribute to a federal election. Does the PAC support candidates for election to city and county offices? No, the Pharm PAC is for the support of state legislative offices only. Does the PAC report my contribution to the State Ethic Commission? Yes, we are required to report all contributions. Does the PAC report its contributions to the State Ethics Commission? Yes, we are required to report all contributions made to candidates. Can I use my credit card to give money to the PAC? Yes, and GPhA can set you up for monthly contributions also. Is my contribution to the PAC tax deductible? No, your contribution to the PAC is not tax deductible.
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A cup of coffee, and a second opinion. You’re welcome to schedule a time to come in or talk via conference call about your financial goals and what your portfolio is intended to do for you and your family. I’ll review it with you and give you my opinion – without obligation. Either way, the coffee is on me.
Michael T. Tarrant Financial Network Associates 1117 Perimeter Center West, Suite N-307 Atlanta, GA 30338 • 770-350-2455 mike@fnaplanners.com www.fnaplanners.com i An Independent Financial Planner since 1992 Focusing on Pharmacy since 2002 i Securities, certain advisory services and insurance products are offered through INVEST Financial Corporation (INVEST), member FINRA/SIPC, a federally registered Investment Adviser, and affiliated insurance agencies. INVEST is not affiliated with Financial Network Associates, Inc. Other advisory services may be offered through Financial Network Associates, Inc., a registered investment adviser.
June 2010
PHARM PAC
Mr. Whitworth Goes to Washington
Thomas H. Whitworth CDM, R.Ph.
Note from Executive Vice President Jim Bracewell: Tommy Whitworth, R.Ph., made his seventh consecutive annual trip to our nation’s capital on behalf of pharmacy. I asked Tommy to share his reflections with us on what the effort means to him and hopefully to each of you.
John T. Sherrer, R.Ph., Congressman Lynn Westmoreland, Tommy Whitworth, CDM, R.Ph., and Jerome Yates, R.Ph.
he privilege of living and working in America can never be taken for granted. The privilege and responsibility to be a pharmacist in the greatest and freest country in the world should never be taken for granted either.
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On Monday, May 10, 2010, I and approximately 400 other pharmacists from every nook and cranny in this great land descended on Washington, D.C., for the NCPA’s 42nd Annual Conference on National Legislation and Government Affairs. This was my seventh consecutive trip to our nation’s capitol. No other country on the planet offers the freedom and access to its government as does the United States. I was accompanied by several fellow pharmacists from Georgia, all who have the same passion and dedication to voice their opinions and concerns to our lawmakers. This past decade has been tumultuous to say the least for our profession. While on one hand you sense the urgency that this may possibly be the bitter end to a once grand and glorious profession. On the other hand, you optimistically sense that we are at the dawn of possibly our greatest opportunity in decades. I started this annual trek seven years ago as a rank and file member of the GPhA. Each year Georgia has represented itself well in this worthwhile endeavor. The Executive Committee along with our NCPA leader within the state always inspires me with their dedication not only to the profession, but also to the members they represent. This year was especially remarkable when one of the first people I saw on arrival was, my hero, John T. Sherrer, R. Ph., there with his lovely wife Sharon Sherrer, Pharm.D. As The Georgia Pharmacy Journal
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many of your know John fought and survived the greatest challenge of his life last year when he suffered a tragic stroke just days following last year’s conference. I felt humbled by his presence this year. John epitomizes the very essence and character of the greatest profession on earth. His tireless devotion and never give up attitude inspire me to “keep on keeping on.” Each year the challenges always seem to be greater. This year was certainly no different. Bruce Roberts, NCPA’s Executive Vice President, addressed us for the last time. As many know Bruce is stepping down to pursue other interests and we wish him well. I consider Bruce not only as one of the greatest leaders we have had in the pharmacy profession but truly a great friend that will leave NCPA a better organization than it was when he started. Following Bruce were many other speakers from representatives from the FTC, Peter Levitas who updated us on the agency’s’ ongoing investigation of the CVS/Caremark merger, to Dr Jeffrey Kelman, Chief Medical Director for CMS, each one stating that progress is slowly but steadily being made to ensure that Independent Pharmacy has its rightful place at the table. As Dr. Kelman stated so emphatically -- you either have a place at the table or you are on the menu. Dr. Kelman reminded us that not only do we have a place at the table, but he saw much better days ahead for our profession. This cautious optimism did not happen by chance. It happened as a result of many years of hard and steady work, not only from our national and state pharmacy leaders, but the rank and file members, These members selflessly give up 3 to 4 days to pound the streets and sit down with our respective elected Senators and Representatives to share our stories, concerns and hopes for our profession every year. Believe it or not, this year I feel that many understand that our profession has been besieged by the unscrupulous activities of the unregulated PBMs. The new health care reform bill specifically addresses the need for transparency in the new Health Exchanges. We scored many other non-partisan victories this year. Both sides of the aisle commended us for our roles we play daily in taking care of our patients. Issues that we have been talking about for years are suddenly becoming a reality when our representatives and senators tell us they understand. The highlights from the speaker of the week were 1) Pharmacists have been exempted from Medicare DME accreditation requirement 2) PBMs will have more transparency in the Health Exchanges 3) Medication Therapy Management was mentioned by nearly every speaker which I believe cannot be over emphasized. The closure of the “Donut Hole” was a great victory for our senior patients. The ongoing FTC Investigation of the unholy alliance of CVS/Caremark gives us hope that justice will soon prevail. In summation, I write this article not to approve or disapprove of the recent health care reform bill that was recently passed but to challenge each and every pharmacist in this state and nation to seize the moment. Like our great friend and colleague John Sherrer, never give up. Next year we need to descend on Washington not by the hundreds, but by the thousands to show and demonstrate to our elected officials that our patients are worth the fight. My thoughts and prayers are for this great country to survive and thrive. The hard work of making sure we remain at the table and not on the menu will be our number 1 priority. God bless America, God bless Pharmacy and its patients and God bless each and every one of you my fellow pharmacists.
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June 2010
GPHA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! John D. McMillin, Savannah Erin Andrea O’Rourke, Augusta Gordon Brain Robinson, Pharm.D., Atlanta Breonna J. Shepherd, Pharm.D., Hephzibah Kenan Smith, Alpharetta Victoriya Solibean, Hinesville Jill Stanley, Pharm.D., Milledgeville Carmencita Thompson, Dallas Brittany Wangness, Savannah Coral Winter, Savannah
Rashi Chandra, Pharm.D., Augusta Aaron Dalton, Savannah Meghan Michelle Devine, Augusta Diana K. Houng, Augusta Stephanie Melcher Jackson, C.Ph.T., Grovetown Travis K. Ledford, Lillington, NC Clark Lee, Augusta John Lee Lawton, Jr. Pharm.D., Brunswick Ketrin Lezo, Jacksonville, FL Erin McGavin, Savannah
If you or someone you know wishes to join the Georgia Pharmacy Association you need only visit www.gpha.org and click “Join” at the top of the page. You can pay by credit card and your membership begins immediately. If you have any questions please call Kelly McLendon at 404-419-8116.
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GPhA Convention, June 26-30, 2010 Embassy Suites & Conference Center at Kingston Plantation, Myrtle Beach, South Carolina Register Now at www.gpha.org. GPhA’s 2010 Convention will be held at the Kingston Plantation in June. This is a favorite venue of GPhA members. With direct access to the to the beach and beautiful accommodations, we are assured a relaxing and educational convention. Make your reservations now and plan to attend the 2010 Convention. Register online now at www.gpha.org or call Kelly McLendon at 404-419-8116.
Over 25 hours offered: Three hours of Disaster Preparedness Training– Required for License Renewal, MTM for Patients with Diabetes, OTC Pain Management, OSHA Training, HIV/AIDS, Immunization Update 2010, Pharmacy Law, Store Report Card to Bring Back Profit to Pharmacy, Hormone Compounding Update, Pain Management with Opioids, ABCs of Metabolic Syndrome – Visit www.gpha.org for a complete schedule and CPE details. GPhA Registration Types: GPhA Member GPhA Non-Member
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Registration Options: Spouse and Guest Registration (Does not include CPE) $265 Student Co-Sponsorship $125 The Georgia Pharmacy Association is accredited by the Accreditation Council of Pharmacy Education as a provider of continuing pharmacy education. For details regarding the continuing education programs please go to www.gpha.org.
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June 2010
MEMBER NEWS
rank Edward Johnson, R.Ph., is celebrating his 85th birthday and his 60th anniversary of practicing pharmacy in June of 2010. He has spent most of his practicing years in Alma, GA, and continues to serve his community as a relief pharmacist. His daughter, Debbie Johnson, is a pharmacist in Savannah, GA. Frank has been a member of GPhA since 2000. We congratulate him on his years of service and wish him a happy birthday.
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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
Thinking of selling your Pharmacy? Buyer looking for quality, stable independent pharmacy for sale. Anywhere in Georgia considered. Not a broker. Call or email for a confidentiality agreement. 678-476-5440 or pharmacytrader@earthlink.net.
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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.
Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100
June 2010
FEATURE ARTICLE
GPhA Inducts Dale Coker President 2010-2011 n 1977 Dale Coker, R.Ph., FIACP received a bachelor of science degree in pharmacy from the University of Georgia College of Pharmacy. From 1977 until 1991, he worked one year in independent pharmacy and thirteen years in the chain drug store industry. He operated a Medicine Shoppe franchise pharmacy from 1991 until 1993, when he opened a traditional independent pharmacy in Ball Ground, GA.
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In 2000, Dale brought in a partner, Larry Wilson, a retired Army Nurse Practitioner to help develop a compounding niche. In two years, they added a 400 square foot addition to accommodate the growing compounding business. By 2004, compounding had grown to the point that they decided to open a compounding only pharmacy. Dale received his initial compounding training from PCCA, and began specializing in bio-identical hormone replacement. Although they now do a wide variety of compounding, including sterile, their main emphasis remains BHRT. Dale has attended numerous conferences and seminars to stay abreast of current compounding practices. Taking physicians, nurses, nurse practitioners and physicians assistants to these seminars has proven to be the most effective marketing to promote their business and build professional relationships. Cherokee Custom Script Pharmacy was the first pharmacy in Georgia to receive national accreditation through Pharmacy Compounding Accreditation Board (PCAB). Dale was awarded with the Innovative Pharmacist of the year award at the 2006 Georgia Pharmacy Association Convention. In the tradition of innovation, he was one of the developers of the patented Topi-Click ™ metered topical dosing device. This device has proven to be a huge improvement over other methods to conveniently dose topical preparations, and is being used by many compounding pharmacies across the country.
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Staff of Cherokee Custom Script Pharmacy (from left to right) Kelly Jackson, Larry Wilson, Hollie Thompson, Gigi Curry and Sarah Mash.
youth baseball and basketball coach, and he is a lay leader in Hillside United Methodist Church. Dale is also vice president of his homeowners association.
Dale has served the pharmacy profession as president of Cherokee-Pickens Pharmacy Association, as Georgia Pharmacy Association (GPhA) Ninth Region President, Second Vice President, First Vice President, PresidentElect, and will be inducted as president of the GPhA at the June Convention in Myrtle Beach, South Carolina. Dale also serves on the board of directors of the Academy of Independent Pharmacy (AIP) and chairman of the AIP Compounding Section.
Dale and his wife, Susan, will be celebrating their 34th wedding anniversary in August. Their daughter, Laura, just completed her third year of pharmacy school at Mercer University College of Pharmacy and Health Sciences. Their son, Scott, just finished his second year at the University of Georgia majoring in speech communications.
In his personal life Dale works with Cherokee County Habitat for Humanity, where he is a past president. He is a
Dale, Scott and Susan with Laura at Laura’s pinning Ceremony at Mercer University.
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Dale Coker’s CV Education BS Pharmacy, University of Georgia, 1977 Employment History June, 1991 – Present, Independent Pharmacy Owner Medicine Shoppe - June, 1991- March, 1993 Ball Ground Pharmacy - June, 1993 – January, 2007 Cherokee Custom Script Pharmacy - May, 2004 – Present June, 1977 – June, 1991, Employee Pharmacist Eckerd Drug - May, 1980 – May, 1991 SuperX Drug - July, 1979 – May, 1980 Hiram Drug – Feb, 1978 – July, 1979 Dunaway Drug – July, 1977 – Feb, 1978 Professional Affiliations National Community Pharmacists Association American Pharmacists Association Professional Compounding Centers of America International Academy of Compounding Pharmacists Georgia Pharmacy Association Academy of Independent Pharmacists Professional Accreditation Cherokee Custom Script Pharmacy Accredited by Professional Compounding Accreditation Board (first pharmacy in Georgia and among the first twenty-five nationally to achieve pharmacy compounding accreditation) Professional Speaking Experience Speaker for Mercer School of Pharmacy National Community Pharmacy Association (NCPA) chapter on topic of Jr. Partnership opportunities Speaker for Mercer NCPA chapter on topic of Compounding Pharmacy opportunities Speaker for University of Georgia School of Pharmacy NCPA chapter on topic of Jr. Partnership opportunities Speaker for Georgia Pharmacy Association for Pharmacist continuing education credits Speaker at Georgia Pharmacy Association annual convention Offices Held Cherokee-Pickens Pharmacy Association, President; Georgia Pharmacy Association Region 9, President; Georgia Pharmacy Association, Board of Directors; Academy of Independent Pharmacists, Board of Directors; Georgia Pharmacy Association, Compounding Section Chairman; Georgia Pharmacy Association, Executive Committee; Cherokee County Habitat for Humanity, President; Hillside United Methodist Church, Men’s Ministry President Awards Rho Chi (top 10% of graduating class)-University of Georgia Pharmacy School, 1977 Georgia Pharmacy Association Innovative Pharmacist of the year award, 2006 Community Involvement Cherokee County Habitat for Humanity; youth baseball and basketball coach; Hillside United Methodist Lay Leader; Youth Mentor
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SUPPORTING PHARMACISTS. ADVANCING CAREERS. Find the best jobs and highly qualified pharmacists Georgia has to offer.
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May 2010
Continuing Education for Pharmacists Generic Anti-Epileptic Drug Substitution: What are the Issues? Erin E. Mancl, Pharm.D. Candidate, University of Wisconsin School of Pharmacy and Barry E. Gidal, Pharm.D., Professor, University of Wisconsin School of Pharmacy and Department of Neurology
Goal: The goal of this session is to discuss issues associated with generic substitution of anti-epileptic drug therapy.
Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Recognize the FDA requirements for generic product approval 2. Identify the concerns in bioequivalence testing for AED therapies 3. Identify the clinical and economic implications of AED generic substitution
Background: Epilepsy affects approximately 2.5 million people in the United States.1 Each year, there are roughly 200,000 new cases diagnosed, with annual direct and indirect costs amounting to $15.5 billion. Epilepsy is characterized by recurrent seizures, defined as abnormal electrical activity in the brain. Seizures can occur in a number of settings, including metabolic, toxic, and infectious conditions2; however, seizures occurring in these conditions do not necessarily constitute a diagnosis of epilepsy. Epilepsy is defined as two or more seizures that are not provoked by other illnesses or circumstances.3 Since it is difficult to capture a seizure in the healthcare setting (i.e., for a provider to witness), a thorough history of the event from the patient and any witnesses is crucial for diagnosis. Patients The Georgia Pharmacy Journal
experiencing recurrent seizures are at an increased risk of complications such as cognitive impairment, problems with memory, and delayed neurodevelopment and the seizures are life-threatening; therefore, chronic treatment is often needed. The ultimate goal of therapy for epilepsy is for a patient to have no seizures (i.e., be seizure-free) as well as minimal side effects from anti-epileptic drug (AED) therapy. Therapeutic doses of AED therapies are highly individualized, usually requiring careful titration with close monitoring. Despite many therapeutic options and extensive research efforts, more than one-third of epilepsy patients continue to have seizures with treatment.1 This difficulty in achieving seizure control coupled with the potential complications of repeated ictal events, result in a justified reluctance to adjust therapy if a patient achieves the ideal balance of no seizures or side effects.
benefit is based on the assumption that a generic product has the same pharmacokinetic and pharmacodynamic profile as that of its brand-name counterpart. Although bioequivalence may be proven when applying for generic drug approval, many clinicians question whether this translates to therapeutic equivalence. In a recent survey, neurologists were asked to complete a case review regarding a patient who experienced loss of seizure control due to a generic AED switch.4 On average, serum levels were 33% lower at the time of the breakthrough seizure compared to the pre-switch level. Nearly all patients (92%) were switched back to brand AED and 96% of these patients regained seizure control after the switch back. To explore this issue further, the remainder of this lesson will review the process of generic drug approval and summarize current evidence of clinical nonequivalence as well as economic considerations with AED generic substitution.
While there are many reasons a patient may not have adequate control (e.g., inadequate doses, noncompliance, drug interactions), one of the more recent concerns is AED generic substitution. That is, switching a patient’s medication from the brand-to-generic or even genericto-generic if there are multiple generic product manufacturers. While generic products have the potential to offer tremendous cost-savings for patients and third-party payers, this
FDA Generic Drug Approval:
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Currently the Food and Drug Administration (FDA) approves a generic formulation if the manufacturer can prove bioequivalence to the approved brand-name product.5 The generic product must contain an identical amount of active ingredient in the same dosage form to be given by the same route. In addition, the product must be manufactured in compliance with Good Manufacturing Practices. June 2010
Finally, the rate and extent of absorption of active ingredient must not be significantly different from the brand-name medication. To measure these parameters, an in vivo bioequivalence test is required and is usually conducted in 24-36 healthy adults. This test is generally performed as a smaller, single-dose crossover study. The area under the curve (AUC) of the drug concentration-time curve and maximum plasma concentration (Cmax) must be similar, defined as the 90% confidence interval of the log-transformed ratios of AUC and Cmax between brand and generic products falling within 80-125% range. If these criteria are met, the product is considered bioequivalent to the brand formulation and therefore interchangeable. The actual difference in mean plasma concentrations is small. In fact, when assessing approved generics, the FDA has found a mean bioavailability difference of 3.5% between generic and brand equivalents.6 The FDA has rated all generic drugs “A” or “B”.7 “A” drugs are considered bioequivalent to the brand-name product, either because they have demonstrated equivalence in human bioavailability studies (“AB”) or are unlikely to have bioavailability problems (“AA”). “B” drugs have not demonstrated bioequivalence by an in vivo test; examples include extended release dosage forms, drugs with known differences in bioequivalence, as well as products with unavailable or insufficient bioequivalence information. Only A-rated products are interchangeable with their brandname equivalents.
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Given these requirements, how might brand-name and generic antiepileptic drugs differ? First, bioequivalence tests for AED medications are performed as single-dose tests and they are not conducted in patients with epilepsy, the group of patients who will be using these medications long-term. Differences in drug absorption, distribution, metabolism, and excretion may differ based on age, sex, ethnicity, smoking status, genetic variation and concomitant medication use. These variants may be highly significant in patients with epilepsy. For example, the studies are not conducted in children or older adults, which are two groups identified as having a higher risk of developing epilepsy. Age-related declines in absorption time and excretion due to physiologic changes in the intestine, liver, and kidney, may have a significant impact on the plasma levels of medications. In addition, stomach and intestinal pH vary depending on concurrent therapy (i.e., proton pump inhibitor) and age, as organs develop in the young child and tend to slow acid production with age. For medications that need to be absorbed in a particular form (ionized or nonionized), the pH can be an important factor in the ultimate level of drug that reaches systemic circulation. Phenytoin is one such example, as it must be in the ionized form for absorption; therefore, alterations in the stomach pH and/or product formulation (salt, acid) may significantly impact the extent of absorption. Such differences in age and concomitant medications, along with other factors, cannot be accounted for in the bioequivalence testing conducted in healthy adults.
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Furthermore, for a drug to circulate in the plasma after oral administration, drug disintegration, dissolution, and absorption across mucosal membranes in the intestine or lymph must occur in a timely fashion. One concern regarding bioequivalence is that the excipients (i.e., any inactive ingredient in the formulation) of the generic product do not need to be the same as the brand-name counterpart. Changes in excipient identity or amount may alter those pharmacokinetic parameters not measured for in bioequivalence testing. For many drugs, these variations make little or no difference in the therapeutic affect of the medication. However, for drugs with narrow therapeutic indices, including AED therapies, subtle differences in formulation may result in pharmacokinetic disparities that put patients at an increased risk of breakthrough seizures or side effects. Specifically, drug formulations with low solubility and absorption (i.e., phenytoin and carbamazepine) are perhaps the most threatened group regarding bioequivalence, as subtle changes in absorption can cause significant differences in plasma concentrations. Moreover, perhaps the most important issue is that the FDA does not require any testing to prove bioequivalence among the generic products. Based on this information, two generic drug products may each be bioequivalent to the brand-name medication, but may fall on opposite ends of the ranges and be different enough from each other to cause problems. A major concern surrounding this issue is that pharmacies often switch generic product manufacturers and are not required to inform the patient or June 2010
provider of this switch.8 As of 2009, in the United States there were 17 brand-name AEDs available (excluding benzodiazepines), with 11 available generically.9 The generic manufacturers for each medication ranged from 3 to 42. This kind of data has prompted several national organizations, including the American Academy of Neurology, American Epilepsy Society, and Epilepsy Foundation, to draft position statements recommending that patients and providers be notified and consent given before switching a patient’s AED therapy.10,11,12
Clinical Evidence: Evidence supporting the concern of AED generic substitution is found in several recently published casecontrol studies and surveys. First, in a retrospective analysis, switchback rates of several classes of medications, including AEDs, antidepressants, and cholesterol-lowering drugs, were assessed to compare switchback rates of AEDs versus non-AEDs.13 For all medications, patients were taking branded drugs for at least 3 months before switching to a generic equivalent. A switchback was then defined as converting back to the branded drug. Between January 2002 and March 2006, data collected revealed a high switchback rate for AEDs (12.9%-20.9%) as compared to the non-AED classes of drugs (1.52.9%). In addition, a specific analysis was conducted looking at dosages of brand and generic lamotrigine, which found that for patients who remained on generic lamotrigine, a dose change of +6.2% was required (p<0.0001). Limitations to this study include that it was retrospective, and reasons for switchbacks were not specifically assessed.
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A retrospective case control analysis was conducted utilizing health claims data of cases (n=416) receiving care in an ambulance, emergency room, or inpatient hospital with a primary epilepsy diagnosis between July 1, 2006 and December 31, 2006.14 The control group (n=1248) had a primary epilepsy diagnosis in a physicianâ&#x20AC;&#x2122;s office during the same date range. Cases were eligible if they included stable patients (i.e., had not been hospitalized in the last 6 months with a primary epilepsy diagnosis) between ages 12-64 years old, and had continuous insurance eligibility for 6 months prior to the date of hospitalization or clinic visit. Cases and controls were matched in a 1:3 ratio by age and epilepsy diagnosis. These dates were chosen because the range was shortly after a generic version of zonisamide became available. There were no significant differences between groups regarding demographics or diagnosis. Results demonstrated cases were significantly more likely to have an A-rated AED formulation switch than controls (odds ratio [OR] 1.81, 95% confidence interval [CI] 1.25-2.63). This analysis found an association between recent AED formulation switching and obtaining care in an inpatient or emergency care setting. Limitations include the fact that concomitant medications, which may have introduced drug interactions with the AED therapy, as well as patients experiencing breakthrough seizures who did not seek medical care were not accounted for. So, this study may in fact under-report the problem. In a separate case-control analysis, cases of patients having an epileptic event requiring acute care were compared to control patients to 26
determine the odds of having an AED substitution with an acute event.15 Cases (n=991) of patients receiving care in an ambulance, emergency department, or hospital with a primary epilepsy diagnosis between October 1, 2005 and December 31, 2006 were matched in 1:3 for gender, age, and epilepsy diagnosis to controls (patients with epilepsy who did not have an event, n=2973). AED substitution rates for the cases and controls were found to be 11% and 6%, respectively. Cases were significantly more likely to have an Arated AED formulation substitution than controls (OR 1.84, 95% CI 1.442.36). This analysis concluded that patients having an event were 80% more likely to have had a recent AED substitution compared to matched controls not having an event. Similar to the previous study, limitations include lack of information regarding concomitant medications and patients experiencing seizures or side effects who did not seek medical care. Finally, a more recent case-control study was conducted in the United States which looked at the potential association of A-rated switching of AED therapy and breakthrough seizures.16 Using claims data between January 2005 and December 2007, individuals with a documented exacerbation of epilepsy (n=2949) were compared to those with the same baseline epilepsy diagnosis who did not have an exacerbation (n=8847) to determine whether there was a difference in switch rates between A-rated AEDs within 90 days. In unadjusted data, cases were significantly more likely to be associated with an A-rated AED switch than controls (OR 1.51, 95% CI 1.29-1.76). However, when potential confounders including June 2010
patient age, 2005 Charlson comorbity index, total number of AEDs, number of new interacting drugs, new AEDs in the 90 days prior to the exacerbation, and change in epilepsy diagnosis in 6 months prior to the exacerbation were accounted for, the adjusted odds ratio became nonsignificant (OR 1.08, 95% CI 0.91-1.29). Results of this study revealed that the potential for breakthrough seizures occurring due to an A-rated AED switch depends on many factors including overall control of disease during the switch as well as other variables that can affect AED plasma levels. Taken together, these studies suggest that a correlation exists between acute events requiring medical care and recent AED substitution. However, when accounting for potential confounders such as age, number of AEDs, number of new interacting drugs, or a recent change in epilepsy diagnosis, there was no significant association in the number of breakthrough seizures or adverse events with a recent AED switch. Thus, it may be that only certain populations are at significant risk for having an acute event due to an AED switch.
Economic Implications: Generic drugs have tremendous costsavings potential. Generic medications generally cost 80-85% less than brand-name medications.17 The FDA has estimated that if the use of generic medications was increased to reduce total prescription costs by just 10%, this would amount to a estimated $14 billion in savings. However, such cost-savings is negligible if the switch leads to expensive consequences, such as hospitalizations, provider office visits, The Georgia Pharmacy Journal
or days of work lost. In fact, these cost implications have been assessed in recent reports. Using health claims data from Quebecâ&#x20AC;&#x2122;s provincial health plan, 671 patients using branded lamotrigine to treat their epilepsy were followed.18 Authors projected Canadian costs of treatment into the United States setting and found that overall healthcare costs would be 69% higher during generic AED use compared to brand AED use. Specifically, when comparing periods of branded and generic use, significant total projected health costs during the time patients received the generic product were found ($17502500 per person-year, p<0.01). These excessive costs were attributed to the probability of increased physician visits, hospitalizations, and utility of pharmacy services. A more recent review discussed economic implications of generic substitution of all AEDs.19 In addition to summarizing data from Lelorier et al., authors discussed the outcomes of a review of claims data in the United States for more than 33,600 patients from 2000-2007. In this assessment, periods of generic AED treatment were associated with higher annual medical costs (adjusted cost difference [CD] $3186, 95% CI 2359-4012) and total costs (adjusted CD $3254, 95% CI 2403-4105). Considering the data from these economic analyses, authors drafted an expert opinion recommending that (1) patients stable on a branded AED should not be switched to a generic without patient and provider consent, (2) patients should not be switched from one generic AED formulation to another, and (3) generic versions of branded AEDs can be used to initiate
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monotherapy if their supply can be guaranteed for the duration of the patientâ&#x20AC;&#x2122;s therapy. Summary and Conclusions: Patients with epilepsy often require chronic therapy to control their condition. The ultimate treatment goal, which is difficult to achieve, is for the patient to be seizure-free with no side effects from drug therapy. Recent evidence suggests that AED generic substitution may place patients at an increased risk for seeking medical attention due to breakthrough seizures and/or side effects. However, research efforts should focus on whether there are certain high-risk groups of patients, as one study found that an A-rated AED switch was not associated with breakthrough seizures when confounding factors were accounted for. Preliminary economic evaluations demonstrate that generic AED drug use results in cheaper drug cost but is associated with higher total medical costs when compared to brand-name AED drug use. Pharmacies should inform patients and providers of AED generic substitutions so a decision can be made about whether the substitution would pose a significant risk to the patient. In addition, all healthcare providers should make an effort to report cases in which generic AED substitution is related to breakthrough seizures or side effects to the FDA using the MedWatch system. Finally, close monitoring, which may include blood levels, should be considered during a necessary switch.
Reprinted with permission of the authors.
June 2010
References: 1. Center for Disease Control and Prevention. Epilepsy. 2010. Available at www.cdc.gov. Accessed Feb 1 2010. 2. Annegers JF, Hauser WA, Lee JR, Rocca WA. Incidence of acute symptomatic seizures in Rochester, Minnesota, 1935-1984. Epilepsia. 1995;36(4):327-333. 3. Leppick IE. Contemporary Diagnosis and Management of the Patient with Epilepsy, 2d ed. Newtown, PA, Handbooks in Health Care, 1996. 4. Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology. 2008;71:525-530. 5. Food and Drug Administration. Abbreviated new drug application (ANDA): generics. 2009. Available at www.fda.gov. Accessed Jan 11 2010. 6. Bialer M. Generic products of antiepileptic drugs (AEDs): is it an issue? Epilepsia. 2007;48:1825-1832. 7. Food and Drug Administration. Drug Approvals and Databases. 2010. Available at www.fda.gov. Accessed May 10 2010. 8. Greenberg P. Does generic substitution always make sense? J Med Econ. 2008;11:547-553. 9. Gauthier-Lewis M, Riley TT. Generic substitution of antiepileptic medications in patients with epilepsy: is this a potential problem? Am J Health Syst Pharm. 2009;66:1903-1904. 10. Liow K, Barkley GL, Pollard JR, et al. American Academy of Neurology. Position statement on the coverage of anticonvulsant drugs for the treatment of epilepsy. Neurology. 2007;68:1249-1250. 11. American Epilepsy Society. Position statement on the substitution of different formulations of antiepileptic drugs for the treatment of epilepsy. 2007. Available at www.aesnet.org. Accessed Jan 11 2010. 12. Epilepsy Foundation. Statement on substitution of generic antiepileptic drugs. 1996. Available at www.epilepsyfoundation.org. Accessed Jan 11 2010. 13. Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007;48(3):464-469. 14. Zachry WM 3rd, Doan QD, Clewell JD, Smith BJ. Case-control analysis of ambulance, emergency room, or inpatient hospital events for epilepsy and antiepileptic drug formulation changes. Epilepsia. 2009;50(3):493500. 15. Rascati KL, Richards KM, Johnsrud MT, Mann TA. Effects of antiepileptic drug substitutions on epileptic events requiring acute care. Pharmacotherapy. 2009;29(7):769-774. 16. Devine ST, Weisbart E, Barron J, Behm A. Acute epilepsy exacerbations in patients switched between A-rated antiepileptic drugs. Curr Med Res Opin. 2010;26(2):455-463. 17. Food and Drug Administration. Facts and myths about generic drugs. 2009. Available at www.fda.gov. Accessed Jan 11 2010. 18. LeLorier J, Duh MS, Paradis PE, Lefebvre P, Weiner J, Manjunath R, Sheehy O. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology. 2008;27:2179-2186. 19. Duh MS, Cahill KE, Paradis PE, Cremieux PY, Greenberg PE. The economic implications of generic substitution of antiepileptic drugs: a review of recent evidence. Expert Opin Pharmacother. 2009;10(14):2317-2328.
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Continuing Education for Pharmacists Quiz and Evaluation Anti-Epileptic Drug Subscription: What are the Issues? 1. Which of the following is required by the FDA for a generic drug to be approved? A. Manufactured in compliance with Good Manufacturing Practices B. Identical excipient content and concentration C. Bioequivalence D. All of the above E. A and C F. A and B
6. Which group of medications is most likely to have significant changes in plasma concentrations with altered absorption? A. Narrow therapeutic index drugs with low solubility B. Wide therapeutic index drugs with high solubility C. Narrow therapeutic index drugs with high solubility D. Wide therapeutic index drugs with low solubility 7. Results from a recent case-control study revealed that, after changing from a brand product to generic formulation, which of the following classes of medications was significantly associated with higher switchback rates? A. Antidepressants B. Antiepileptic drugs C. Cholesterol-lowering drugs D. A and B
2. According to the FDA, what defines bioequivalence? A. 90% confidence interval of AUC and Cmax between brand and generic falling between 80-125% B. AUC and Cmax between brand and generic falling between 80-125% C. 90% confidence interval of log-transformed ratios of AUC and Cmax between brand and generic falling between 80-125% D. 95% confidence interval of AUC and Cmax between brand and generic falling between 80-125%
8. Which of the following was identified as a potential confounder when assessing AED switchback rates? A. Gender B. Number of new interacting medications C. Dose of antiepileptic drug D. All of the above
3. Which of the following most accurately describes how a bioequivalence test is usually conducted? A. Large single-dose crossover study in healthy subjects B. Small single-dose crossover study in healthy subjects C. Small multiple-dose crossover study in healthy subjects D. Small single-dose crossover study in subjects with the condition the medication treats
9. Which of the following is a conclusion that Canadian authors made after retrospective assessment of claims data in Canada for patients using lamotrigine to treat their epilepsy? A. Overall healthcare costs in the US would be higher during generic AED use than brand AED use B. Overall healthcare costs in the US would be lower during generic AED use than brand AED use C. Generic AED use would be associated with an increased probability of hospitalizations and physician visits D. A and C
4. Which of the following is not considered in bioequivalence tests? A. Concomitant medications B. Smoking status C. Genetic variation D. Age E. All of the above
10. Which of the following is a disadvantage of the currently available literature regarding AED generic substitution? A. All studies analyze insurance claims data or doctorsâ&#x20AC;&#x2122; reporting, which limit results to those who seek medical attention B. There are no economical analyses available to date C. There is no reporting that switching back to the original brand resulted in regaining of seizure control D. No study has assessed for a required change in dosage when switching from a brand to generic AED product
5. How does the FDA test for bioequivalence between generic products (i.e., from various manufacturers) of the same active medication? A. Small single-dose crossover study in healthy subjects B. Small multiple-dose crossover study in healthy subjects C. Small single-dose crossover study in subjects with the condition the medication treats D. The FDA does not test for bioequivalence among generic products
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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. No financial was received for this activity. This continuing education activity may appear in other state pharmacy association Journals.
Genertic Anti-Epileptic Drug Substitution: What are the Issues? This lesson is a knowledge-based CPE activity and is targeted to pharmacists. GPhA code: J10-06 ACPE#: 0142-0000-10-006-H01-P Contact Hours: 1.5 (0.15 CEU) Release Date: 06/01/2010 Expiration Date: 06/01/2013 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 emailed or 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
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The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 2010, 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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