The Official Publication of the Georgia Pharmacy Association
April 2009
GPhA’s 134th Annual Convention June 20-24, 2009 Sawgrass Marriott Golf and Spa Resort
Come join the pharmacy fun!
Volume 31, Number 5
www.gpha.org
NEW PLANS – BETTER RATES – MORE BENEFITS in 2009
Look what’s NEW in 2009... Reduced Rates Prescription Drug Coverage Dental and Orthodontic Benefits Guaranteed Issue Term Life Insurance... up to $150,000 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 e-mail 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
GPhA Convention Registration Information June 2024, 2009 Ponte Vedra Beach, Florida Sawgrass Golf Resort and Spa, A Marriott Resort FEATURE ARTICLES
8 16 17 21
GPhA’s Legislative Affairs WrapUp GPhA Convention Registration Form GPhF Carlton Henderson Memorial Golf Tournament Registration May is Disability Insurance Awareness Month
5 11 11 14 15 19 22 30
Pharmacy Reminder New Members Mercer University News Pharmacy-Based Immunization Delivery BLS Healthcare Provider Course Pharmacy School Alumni Dinner Information Journal CE GPhA Board of Directors
Advertisers 2 2 5 7 8 9 10 11 20 29 29 31 32
The Insurance Trust Principal Financial Group Michael T. Tarrant Pharmacists Mutual Companies GoodSense PQC Design Concepts, Inc. Melvin M. Goldstein, P.C. AIP PharmStaff Toliver & Gainer PACE The Insurance Trust
COLUMNS
4 6
President’s Message Editorial
For an uptodate calendar of events, log onto
www.gpha.org.
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PRESIDENT’S MESSAGE Robert Bowles, Jr. , R.Ph., CDM, CFts GPhA President
Immunization Law and What it means for you as a Pharmacist patients. Remember Eddie Madden? His theme for his year as President is “Preserving the Triad.” Compounding allows us to work with the physician and patient to meet the individual needs of the patient.
am often asked, how can I provide more patient care? There are a number of ways that this can be accomplished.
I
I would encourage each of us to be actively involved in medication therapy management. CCRx will soon release patients to us for us to begin this year’s MTMs. I would suggest you complete the ones that are sent to you quickly. I am confident that more will follow if you do this. If you feel that you do not have the time to complete the MTMs, I would suggest you contract with someone to do these for you. I feel that the changing paradigm of pharmacy is dependent on us responding to this opportunity. *Don’t let this moment pass us by.*
Are you providing immunizations? Last year an interpretation of the law challenged our ability to provide immunization under protocol. Fortunately, through Governor Perdue’s interest in the well-being of the citizens of Georgia, he provided the means for us to provide influenza vaccinations to our patients. As soon as we were made aware of the interpretation that challenged our ability to provide immunizations under protocol, GPhA responded. I appointed an immunization task force chaired by Dr. Sharon Sherrer. This group worked endless hours seeking the passage of HB 217. This legislation passed and now influenza vaccines can be given under a physician- pharmacy protocol to anyone thirteen years or older. Georgia law requires that we register all patients receiving vaccines. It is important for you to contact G.R.I.T.S. now and become eligible and trained to partner with G.R.I.T.S. so that your patients will be registered as receiving their immunization. You may contact the G.R.I.T.S. training coordinator at 1-888223-8644 or email us at immreg@dhr.state.ga.us.
Are you fitting diabetic shoes? There are a number of companies supplying diabetic shoes. this is a great area to begin additional patient care. We must engage ourselves with our patients and proactively seek new ways to anticipate and fully satisfy their health needs. Fitting diabetic shoes is just one of the ways that we can work toward fully meeting our patients’ needs. Are you compounding? Again, with better engagement this is another way of working toward total care for our The Georgia Pharmacy Journal
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The new immunization law requires the pharmacy provider to have completed a course of training accredited by the Accreditation Council for Pharmacy Education or similar health authority or professional body approved by the Georgia State Board of Pharmacy. Additionally, the pharmacist must hold current certification in Basic Cardiac Life Support.
It is essential for you to pre-register for this training. Registration for the convention is simple. You may go to GPhA website at www.gpha.org and register or you can register on this same site for the “APhA Pharmacy Based Immunization Delivery” program on Saturday. Registration for the “BLS Healthcare Provider Course” can be completed on the website as well. There is an additional fee for each of these training programs.
GPhA has responded to the passage of this legislation and the need for pharmacists to be properly certified. On Saturday, June 20, 2009, “Pharmacy-Based Immunization” will be provided at our annual convention which will be held at Sawgrass. This program will begin at 7:30 a.m., and conclude at 6 p.m.. Additionally, GPhA will be providing the “BLS Healthcare Provider Course” on Monday, June 22, 2009. This is your opportunity to seize the moment and be certified to provide influenza vaccines to your patients.
Do not delay! Make arrangements now to attend this year’s convention in Ponte Vedra. Be prepared to be part of the changes that are taking place in your practice.
Questioning the wisdom of your financial plan?
Pharmacy Reminder: Overview of Fraud, Waste and
If so, this ad entitles you to:
Abuse Chapter (Rev.1, 02-08-06) This affects anyone involved in billing the government for Med D services. All Part D plan Sponsors (hereinafter “Sponsors”) are required to have a comprehensive plan to detect, correct and prevent fraud, waste and abuse. 1. This requirement is listed as one of the compliance plan elements in the Medicare Prescription Drug Benefit final regulations published on January 28, 2005. 2. The final regulations list the core elements of a compliance plan, to include a comprehensive fraud, waste and abuse program. 3. The specific requirements of the compliance program for the Part D benefit include:
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.
Written Policies and Procedures, Compliance Officer and Compliance Committee, Training and Education, Effective Lines of Communication, Enforcement of Standards through well publicized disciplinary guidelines, Monitoring and Auditing Corrective Action Procedures, Comprehensive Fraud and Abuse Plans – Procedures to voluntarily self-report potential fraud or misconduct As part of the Medicare Part D – Prescription Drug Benefit, CMS released final guidance in April 2006 for compliance guidance to all Medicare Part D Sponsors titled “CMS Prescription Drug Benefit Manual, Chapter 9 – Part D Program to Control Fraud, Waste and Abuse”. Section 50.2.3 of the Manual dictates that all Sponsors and their “downstream entities”, which include pharmacists and pharmacy workforce members engaged in delivering any Medicare services, receive general and specialized training to prevent fraud, waste and abuse. There are two programs available: www.naspa.learnsomething.com (small charge) and www.bcbsal.org/rxfwatraining (free).
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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.
May 2009
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
LearnAboutEprescriptions.com: A website every pharmacy professional should visit earnAboutEprescriptions.com is a website every pharmacy should recommend to their patients and physicians.
adopt e-prescribing. Most physician practices are just becoming aware of the large amount of dollars they are missing out on their billing to Medicare and of course if they e-prescribe for the Medicare patients they certainly are going to use the technology for all of their patients.
L
Has e-prescribing arrived in Georgia yet? Like so many questions about the healthcare system and the technology that is evolving everyday the answer is both Yes and No.
Last month many pharmacies across the state began to post signs in the store windows, “E-Prescriptions Accepted Here” as a public awareness campaign to patients to tell their physicians that their pharmacy is ready to accept e-prescriptions. There appears to be a significant portion of the public that is beginning to ask their doctor about e-prescriptions due to the convenience and the added benefit of reduced errors -- but most importantly, the prescription is much more likely to meet the formulary requirements of their health insurance plan and save an extra phone call back to the doctor’s office.
Over 340,000 e-prescribing transactions took place in Georgia this past March. That is a 149 percent increase over the month of December 2008, so the obvious answer is “yes” e-prescribing has come to our state like a rising tide but not like a flash flood. Is pharmacy ready to deal with this coming event? I think the answer is a resounding yes. Today less then 27 percent of retail pharmacies are not able to accept e-prescriptions. Another way to look at it is three out of four retail pharmacies in Georgia are receiving e-prescriptions as of March 2009.
LearnAboutEprescriptions.com, is a website about the future that is arriving at your pharmacy today.
Physicians may or may not be prepared for the transition to e-prescribing. The 340,000 transactions in the month of March and the rapid rate of growth indicate new eprescriptions are coming forth each day. CMS’s new 2 percent additional payment incentive for e-prescribing for Medicare patients is a huge inducement for physicians to
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*Dividends cannot be guaranteed; however, they have been returned uninterrupted since 1909. † Notice: This is not a claims reporting site. You cannot electronically report a claim to us. To report a claim, call 800-247-5930. Not all products available in every state. Pharmacists Mutual Insurance Company is not licensed in HI or FL. The Pharmacists Life Insurance Company is not licensed in AK, FL, HI, MA, ME, NH, NJ, NY or VT. Pro Advantage Services, Inc., d/b/a Pharmacists Insurance Agency (in CA) is not licensed in HI. Check with a representative or the company for details on coverages and carriers.
GPhA’s Legislative Affairs Wrap-Up by Stuart Griffin, Director of Governmental Affairs - sgriffin@gpha.org The 2009 Legislative Session was among the most successful legislative sessions in GPhA’s history. With the Georgia budget facing a $2.8 billion shortfall, passing any type of legislation was exponentially difficult. With this large hurdle, GPhA was able to pass two controversial pieces of legislation.
HB 614 provided for the establishment of a program for the monitoring of prescribing and dispensing Schedule II, III, IV or V controlled substances by the Georgia Drugs and Narcotics Agency. HB 614 was a mere shadow of its original version, HB 273, which Rep. Ron Stephens introduced during the early part of the session. Rep. Sharon Cooper, chair of the House Health and Human Services Committee, took issue with the bill and decided to rewrite the bill and introduce it as HB 614. The Georgia Drugs and Narcotics Agency felt as if this was the only way to get the bill passed and secure the federal funding for the program considering Rep. Cooper chaired the committee the bill would ultimately pass through. HB 614 was not an ideal piece of legislation and the public took notice of that. A good number of nationally syndicated news media outlets told their listeners that HB 614 was a violation of the public’s privacy. During the time it took for HB 273 to morph into HB 614, a lot of attention was drawn to the weaknesses of the bill and it was ultimately killed in the Senate by a vote of 25 – 29.
Sometimes overlooked, the defensive portion of our legislative agenda was the most successful. GPhA stopped 100percent of our proposed defensive agenda including, but not limited to, Immunosuppressant Generic Substitution Legislation (HB 523, SB 209) and Epilepsy Generic Substitution Legislation (HB 618). These types of bills were heavily supported by the leadership of the General Assembly, making them even more difficult to stop. As previously mentioned, accomplishing the passage of any bills during a legislative session that is centered around a recessionfocused budget was difficult for any industry or professional organization in 2009, but GPhA found a way not only to be successful, but to thrive during this time. Following are the descriptions and results of our main objectives leading into the 2009 legislative session.
GPhA will be formulating a new strategy for the bill and we will be taking it back to the legislature for the 2010 legislative session.
HB 614 – Prescription Drug Monitoring Sponsor: Rep. Sharon Cooper Status: defeated in the Senate 25-29
HB 217 – Influenza Protocol Sponsor: Rep. Jimmy Pruett Status: Passed HB 217 authorizes the use of influenza vaccine orders for a group of patients and provides for influenza protocol agreements between physicians and pharmacists. A physician may enter into a protocol agreement with a maximum of 10 pharmacists living within a contiguous county of the physician’s county. Pharmacies that are chains, by definition, may enter into protocol with one doctor per public health region. The protocol under HB 217 authorizes the pharmacist to administer epinephrine in the case of an adverse reaction to the vaccine. HB 217 was a bill that went through a number of revisions before a compromise was reached between the Governor’s office, the Medical Association of Georgia, numerous nurses’ organizations, and the Georgia Pharmacy Association. The Governor’s office wanted to secure a bill that would first and foremost give the public access to the influenza vaccine. The Georgia General Assembly understands the need for other vaccines to be added under protocol. One of GPhA’s number 1 priorities for the 2010 legislative session will be to add vaccines
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which can be administered by pharmacists under a protocol agreement.
As many of you know, Senator Hawkins was GPhA’s legislator of the year during the 2009 legislative session. Senator Hawkins spent countless hours educating himself and his fellow Senators on the questionable business practices performed by PBMs.
SB 123 – Pharmacy Benefits Manager Licensure and Regulation Sponsor: Senator Lee Hawkins Status: Passed
Representative Austin Scott carried our PBM bill during the 2008 legislative session. Representative Scott took time out, once again, from his busy session as the Chairman of the Governmental Affairs Committee to help us with SB123 in the House. Chairman Scott also recently announced his bid for the Governor’s office in the 2010 election.
SB 123 provides for regulation and licensure of pharmacy benefits managers by the Commissioner of Insurance. SB 123 provides that a pharmacy benefits manager may not engage in the practice of medicine and provides that a condition of licensure be adhering to the provisions in the ‘Pharmacy Audit Bill of Rights’.
We appreciate their dedication to the healthcare providers of Georgia and we all owe them a debt of gratitude.
GPhA would like to extend recognition to two Georgia legislators who spent numerous hours helping the Georgia pharmacists to pass SB123 - Senator Lee Hawkins and Representative Austin Scott.
“We implemented PQC in our pharmacy four months ago – it was easy. I have noticed an enhanced effort from the staff to work together to avoid and eliminate quality-related events.” Pharmacy Quality Commitment® (PQC) is what you need! PQC is a continuous quality improvement (CQI) program that supports you in responding to issues with provider network contracts, Medicare Part D requirements under federal law, and mandates for CQI programs under state law. When PQC is implemented in your pharmacy, you will immediately improve your ability to assure quality and increase patient safety. Do you have a CQI program in place?
Call toll free (866) 365-7472 or go to www.pqc.net for more information. PQC is brought to you by your state pharmacy association.
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Design Concepts Inc. THE CURE FOR THE COMMON PHARMACY. Effective Pharmacy Design Featuring Innovative Store Fixtures and Custom Wood With more than 44 years experience, Design Concepts, Inc. is the answer to your ppharmacyy design g needs. Whether yyou are startingg a new ppractice or lookingg to improve p your existing one, Design Concepts, Inc. has the experience to take your pharmacy to the next level. Design Concepts, Inc. puts as much care into designing your pharmacy as you give to your patients.
In 44 years, Design Concepts, Inc. has served many of Georgia’s leading pharmacies:
Franks Rx, Dalton Fievet Rx, Washington Lamberts Rx, Palmetto Claxton-Cole Rx, Griffin Bay Rx, Locust Grove Tuxedo Pharmacy, Atlanta Metta International Rx, Chamblee Olde Time Rx, Canton
Lee-King Lee-Goodrum Rx, Newnan Jasper Drug, Jasper Kemps Rx, Claxton Carmichaels Rx, Madison Madison Rx, Madison Citizens Rx, Flowery Branch Franklin Pharmacy, Franklin Little Five Points Rx, Atlanta
Contact Lee Bixler and his experienced team at: 1-770-942-9834
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Terry Arke, North Palm Beach, FL Damali Aida Brown, Kennesaw Demetrice Lashelle Browning, Covington Kari M. Coody, Hawkinsville John Fleischmann, Suwanee Kimberly DeAnna Flores, Douglasville Melissa Grace Hutchens, Acworth Shana N. Jackson, Savannah Linda Gail Lowney, Dallas Pamela F. McCoury, Macon Joshua Bennett Morgan, Atlanta
Sonia Northway, Cumming Mark Okamoto, Suwanee Chioma C. Otuonye, Locust Grove Matthew Scott Owens, Jefferson Nina Grace Patterson, Dallas Andrea Peek Pierce, Brunswick Julie Shell, Acworth Grady Christopher Tate, Rome Tracy Somers Ward, Atlanta Samuel Robinson Wilson, Savannah
MERCER UNIVERSITY NEWS main goal of Mercer University’s Hypertension & Cholesterol Committee is to serve a varied demographic. To achieve this aim, a recent Blood Pressure and Brown Bag Event was held at Atlanta’s oldest synagogue, The Temple on Peachtree Street. Screenings were held during and after Sunday classes and service, mainly for the parents of students at the religious school, along with other members and staff. Different age groups were screened - from young adults to the middle aged and elderly. For each patient, the committee tried to teach the meaning of systolic/diastolic pressure and the impact and importance of blood pressure on overall health. For those with hypertension, the committee actively sought to educate patients on their hypertension goals and various strategies on lowering blood pressure. Body Mass Index calculations were also performed for those interested in knowing their ideal body weight and further counseling was offered on weight loss and cholesterol reduction. Patients were also encouraged to bring their medications for a brown bag session. At the end of the session, the students screened about 40 patients. The event definitely served to tie Mercer University students to the community and forged a connection with the Temple’s members.
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The Georgia Pharmacy Journal
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GPhA Convention June 20-24, 2009 Sawgrass Golf Resort and Spa, Ponte Vedra Beach, Florida Register Online Today for...
Preserving the Triad GPhA’s 2009 Convention will be held at the Sawgrass Golf Resort and Spa in June. This is a favorite venue of GPhA members. With quick access to the gorgeous beach, a spacious and luxurious hotel and spa, and delicious food, we are assured a relaxing and educational convention. GPhA offers an “early bird” convention rate through the end of April. Hotel rooms fill quickly so make your reservations now and plan to attend the 2009 Convention. Register online at www.gpha.org or call 404.231.5074 to receive a paper registration form. GPhA Registration Type GPhA Member GPhA Member with Spouse or Guest and Student Sponsorship GPhA Member with Spouse or Guest GPhA Member with Student Sponsorship Spouse or Guest Only Registration (Does Not Include CE) GPhA Non-Member GPhA Non-Member with Spouse or Guest and Student Sponsorship GPhA Non-Member with Spouse or Guest GPhA Non-Member with Student Sponsorship
Early Bird $295 $660 $535 $420 $240 $470 $835 $710 $595
Sawgrass Golf Resort and Spa, A Marriott Resort For Resort Reservations call: 1.800.457.4653 & indictate you are attending the GPhA convention. Room Block Expires 5/15/2009 so make your reservations today! Single or Double Room $179 Island Green Villa Suite (1 Bedroom and Full Kitchen) $199 Island Green Villa Suite (2 Bedroom and Full Kitchen) $378 Rates include Parking (a $10 per day value) and Internet Access (a $12.95 per day value).
5/1-6/1 $320 $710 $585 $445 $265 $495 $885 $760 $620
After 6/1 $345 $735 $610 $470 $265 $520 $910 $645 $645
Convention Registration Fee: includes admittance to CE Sessions, Sunday Opening Dinner, All Refreshments, Exhibits and Entertainment, President’s Reception, Awards Banquet, Coffee/Dessert Reception.
Tentative GPhA Annual Convention Programming HIV/AIDS: The Pharmacists Perspective Marketing for Compounding Program New Drug Update 2009 Medicare Diabetes Screening Project Medication Errors Managing and Monitoring Diabetes Execution - The Art of Turning Pharmacy Vision Into Reality Pharmacy Law Update *APhA Pharmacy-Based Immunization Delivery Program *BLS Healthcare Provider Course *additional fee applies Additional details on the tentative programs will be posted to www.gpha.org as they become available. The Georgia Pharmacy Association is accredited by the Accreditation Council of Pharmacy eduction as a provider of continuing pharmacy education. These activities are eligible for ACPE credit; see final CPE activity announcement for specific details.
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Annual Convention CPE Opportunities June 20-24, 2009, at Ponte Vedra Beach, Florida Marriott Sawgrass Resort With eighteen educational sessions planned, pharmacy professionals from all practice settings can take advantage of the diverse educational opportunities being offered at the GPhA Annual Meeting. Don't miss an opportunity to partake in programming that can impact your role in pharmacy practice by attending sessions that will address key issues facing the profession. We know you will come away with validation of the importance of your role as viable members of the public health team. Early Bird pricing expires April 30! Save money and register now. Below you will find a full listing of CPE opportunities being offered at the Convention. Register for the convention now by visiting www.gpha.org so you will not miss the Early Bird, or call 404-231-5074. We look forward to seeing you there! Saturday, June 20 7:30 a.m.–6:00 p.m.: APhA Pharmacy Based Immunization Delivery 9:00–10:00 a.m.: OSHA...Is Your Pharmacy Ready for Inspection? 9:00–11:00 a.m.: Managing and Monitoring Diabetes 10:30 a.m.–12:00 p.m.: COPD - New Therapeutic Guidelines 12:45–1:45 p.m.: How to Effectively Market Your Compounding Practice Generational Alphabet Soup: What is Your Letter? 2:00–3:00 p.m.: Community Associated MRSA Update 2:00–4:00 p.m.: HIV/AIDS: The Pharmacist's Perspective Sunday, June 21 8:00–10:00 a.m.: New Drug Update 2009 for Pharmacists Execution - The Art of Turning Pharmacy Vision Into Reality 10:15–11:45 a.m.: Reducing Medication Errors Through Implementing a Continuous Quality Improvement Program 1:15–4:00 p.m.: First General Session (Immunization 2009 Update) Monday, June 22 8:00–9:00 a.m.: Brown Bag Competition 9:15 a.m.–12:00 p.m.: Second General Session (OTC Bowl 2009) 1:00–3:00 p.m.: BLS Healthcare Provider Course Tuesday, June 23 9:30 a.m.–12:30 p.m.: Third General Session (Advancing the Future of Pharmacy Through Political Advocacy) 1:00–3:00 p.m.: Pharmacist Patient Assessment... Today and Tomorrow 3:15–5:15 p.m.: Pharmacy Law: "You are over 21, but are you Legal?"
The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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Pharmacy-Based Immunization Delivery Saturday, June 20, 2009 (7:30 a.m. - 6:00 p.m.) Hosted by: GPhA Each participant must be CPR or BLS certified in order for the certificate of achievement to be valid. Visit www.gpha.org for details regarding the BLS Healthcare provider course that will be offered at the convention in June. To register for this event, visit www.gpha.org. Registration for these events can be found on the convention registration page. For more information about this program, including continuing pharmacy education details, visit www.gpha.org. Registration for this event closes May 20, 2009, to allow adequate time to complete the home study. No exceptions will be made. Course hand books containing materials for both the self study component and the live seminar will be mailed upon receipt of payment. The GPhA reserves the right to cancel the Pharmacy-Based Immunization Program if fewer than 20 participants are registered by May 20, 2009. In the event the program is cancelled, pre-pais money will be refunded promptly. Pharmacy-Based Immunization Delivery 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. The purpose of this educational program: 1. Provide comprehensive immunization education and training 2. Provide pharmacists with the knowledge, skills, and resources necessary to establish and promote a successful immunization service 3. Teach pharmacists to identify at-risk patient populations needing immunizations 4. Teach pharmacists to administer immunizations in compliance with legal and regulatory standards The American Pharmacists Association and the Georgia Pharmacy Association are accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Pharmacy-Based Immunization Delivery: A Certificate Program for Pharmacists was developed by the American Pharmacists Association, and is supported inpart by an educational grant from VaxServe.
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BLS Healthcare Provider Course Monday, June 22, 2009 (1:00 p.m. - 3:00 p.m.) Hosted by: GPhA BLS for Healthcare Provider card is issued upon successful completion of the course. The card is valid for a period of 2 years. Course Description: The BLS Healthcare Provider Course is designed to provide a wide variety of healthcare professionals the ability to recognize several life-threatening emergencies, provide CPR, use an AED, and relieve choking in a safe, timely and effective manner. The course is intended for certified or noncertified, licensed or nonlicensed healthcare professionals. Course Length: Approximately 2 hours Intended Audience: Healthcare providers such as physicians, pharmacists, nurses, paramedics, emergency medical technicians, respiratory therapists, physical and occupational therapists, physician's assistants, residents or fellows, or medical or nursing students in training, aides, medical or nursing assistants, police officers, and other allied health personnel. Instructor: Linda Bell, MSN, ARNP, EMT-P Task Force Chairman for NE Florida #3 AHA ECC Family Nurse Practitioner Programs Coordinator for Consultant Services, AHA Training Center for BLS, ACLS, PALS, NRP programs Contact information: For information contact Mary Ellen Chapman at mechapman@gpha.org or 404.419.8126 Registration fee: $60.00 per person Please be advised that this program is subject to cancellation if the required minimum number of registrants is not met by May 20, 2009. Register for this program at www.gpha.org.
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GPhA Convention, June 20-24, 2009 REGISTRATION FORM PLEASE PRINT CLEARLY Name ________________________________________________________________________ first m.i. last nickname Name for Convention Badge _______________________________________________________ Georgia License Number (If applicable) _______________________________________________ Pharmacy or Company Name _______________________________________________________ E-mail _______________________________________________________________________ Address ______________________________________________________________________ City _______________________________________ State _____________ Zip ____________ Phone ________________________________________________________________________ Spouse or Guest (required if attending Convention events): Name ________________________________________________________________________ first m.i. last nickname Payment (Please indicate the type of registration by circling the amount): GPhA Registration Type GPhA Member GPhA Member with Spouse or Guest and Student Sponsorship GPhA Member with Spouse or Guest GPhA Member with Student Sponsorship Spouse or Guest Only Registration (Does Not Include CE) GPhA Non-Member GPhA Non-Member with Spouse or Guest and Student Sponsorship GPhA Non-Member with Spouse or Guest GPhA Non-Member with Student Sponsorship
5/1-6/1 $320 $710 $585 $445 $265 $495 $885 $760 $620
After 6/1 $345 $735 $610 $470 $265 $520 $910 $645 $645
PLEASE REGISTER SEPARATELY - - - if you and your spouse are both pharmacists. If you register as a member or non-member with a spouse, your spouse WILL NOT be able to attend events for CE credit. _____ Check enclosed OR _____ Visa _____ MasterCard _____ AmEx _____ Discover VIN #______________ Name as it appears on the Card __________________________________ Credit Card Number ______________________________________ Expiration Date ___________ Signature _____________________________________________________________________ Complete this form and return to GPhA with your check or charge authorization for the full amount of registration fees. This form cannot be processed unless all information is provided. All registration cancellations must be in writing. Cancellations received before May 1, 2009, will be refunded less a $25 cancellation fee. After May 1, 2009, a $55 cancellation fee will be applied.
For answers to your questions call 404.231.5074. Online registration available at www.gpha.org. For registration by Mail: Send your completed registration form to: GPhA Convention Registration 50 Lenox Pointe NE, Atlanta, Georgia 30324 By Fax: 404.237.8435 (24 hours)
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__ Yes, I would like to participate in the 10th Annual Foundation Golf Outing on June 22, 2009 __ Individual Player ($200) __ Foursome ($800) __ * Friend of the Foundation ($1250) __ Other (please identify) _________________________________________________
__ No, I cannot participate but would like to support the Foundation with a tax deductible gift as provided by law. _____________________________ ____
Enclosed is my check for $_______ or Bill my credit card for $_______
(AmEx Visa M/C Disc)
Credit Card #: __________________________________ Security #: ______ Exp.Date: _______
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May 2009
Spectacular Florida Family Getaways, For Kids Of All Ages At Sawgrass Golf Resort & Spa, A Marriott Resort, we never forget the Golden Rule for Kids – give them something to do. Sure, you’re here to spend time with the family, but for parents who’d love to steal a few precious moments alone, we offer our Sawgrass Grasshopper Gang … a Florida family getaway package that lets Mom and Dad get away for a spell. Rest easy knowing your children are enjoying a fun-filled day of exciting activities – all under the watchful eyes of our trained youtheducation specialists. A special program designed to bring all sorts of Florida family fun to our pintsized guests, the Grasshopper Gang features: * Arts and crafts * Sandcastle sculpting * "Pizza and pool" parties * "Dive-in" movies * Scavenger hunts * Pajama parties * Beach fun * Nature hikes Additonal fees apply. See Sawgrass Marriott for details.
Fifth Annual Academy of Employee Pharmacists Academy Cup Challenge Tennis Tournament Monday, June 22, 2009 AEP resurrected the tennis tournament as a challenge to all other academies to get more people involved. The round robin format allows each person to keep his or her own score. At the end of the tournament the scores are tallied by academy and an overall winner is announced and that academy gets the coveted AEP Tennis Tournament Academy Cup. Also, the top male and female winners are awarded prizes. Come join us! Name: ____________________________________________________________________________ Address: _____________________________________ City, ST: ________________ Zip: ___________ Phone: __________________________ Email: ____________________________________________ Academy You Represent: _______________________________________________________________ Thereis a registration fee of $40.00 that I will pay (circle the one that applies): by check. or by credit card. Charge the following credit card (circle the type of card you intend to use): Visa MasterCard Discover AmEx Name as it appears on the card: ___________________________________________________________ Card Number: ________________________________________________ Exp: ___________________ CVV #: __________________ Signature: _________________________________________________________________________ You may also sign up by registering at www.gpha.org. The Georgia Pharmacy Journal
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May 2009
Mercer University College of Pharmacy and Health Sciences Alumni Dinner Monday, June 22, 2009, at Tento Churrascaria, Brazilian Steak House 528 North First Street, Jacksonville Beach, FL 32250, 904.246.1580 7:30 p.m. I will attend the Alumni Dinner for alumni spouses and friends of Mercer University’s College of Pharmacy and Health Sciences. Please make ______ reservations at $35.00 per person, and there will be a cash bar available. _______ Yes, I would like to sponsor ______ student(s) for the alumni dinner at $35.00 each. Name: ______________________________________________ Name of spouse and/or guest(s): Address: City:
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University of Georgia College of Pharmacy Alumni Dinner Buffet Monday, June 22, 2009, at the Magnolia Terrace at Sawgrass Plantation 7:30 p.m. I will attend the Alumni Dinner for alumni spouses and friends of University of Georgia College of Pharmacy. Please make ______ reservations at $35.00 per person, and there will be a cash bar available. _______ Yes, I would like to sponsor ______ student(s) for the alumni dinner at $35.00 each. Name: ______________________________________________ Name of spouse and/or guest(s): Address: City:
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May 2009
!" #! $ % &' '
Pharmacy News
May is “DIAM” – Disability Insurance Awareness Month by Trevor Miller, Director of Insurance Services - tmiller@gpha.org any people have bought life insurance after giving serious thought to how their death might impact their family's living standards. Few, though, give the same level of consideration to disability insurance. Ironically, the typical employee faces a much higher risk of extended disability than of premature death. But for a variety of reasons, disability insurance remains one of the most overlooked and misunderstood forms of insurance.
illness or accident. If it’s insufficient, your employer may offer you the option to increase your disability benefit, often through a voluntary payroll deduction. Another option is to purchase coverage on your own.
M
Ask yourself these 4 simple questions: “Why do I come to work every day?” “What would happen if I were to become partially or totally disabled?” “How long would my employer keep me on payroll if I were to become disabled?” “Where would my income come from if I become disabled?”
Though disability is behind a significant number of home foreclosures and personal bankruptcies, insuring against it has not been a high priority for most employees because many assume they're already covered through Social Security, state-mandated Workers' Compensation or employer-provided group plans. However, there are numerous holes in this safety net of coverage. Only about 39 percent of the 2.1 million workers who applied for Social Security Disability Insurance benefits in 2005 were approved. And those who were approved got an average benefit of $1,004 monthly – hardly enough to replace the average worker's income. Workers compensation covers only work-related disabilities, but 95 percent of disabling accidents and illnesses are not workrelated. And what about your coverage through work? It’s a great employee benefit, but not all employers offer this benefit. Only 36 percent of all full-time employees have access to long-term disability insurance through their employers and those policies average only 60 percent of an employee’s annual income. So what’s a worker to do? Explore his or her or options. If your employer offers disability coverage, take the time to find out if the coverage would be sufficient to meet your income replacement needs in the event of a disabling
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You may not realize it, but your home, your car and your jewelry are NOT your most valuable assets. It's your ability to earn an income, every day of every month of every year of your life. Without it, you wouldn’t be able to pay your monthly mortgage, pay your utilities or make your car loan payment. May is Disability Insurance Awareness Month (DIAM), and this is the perfect time for a disability insurance “reality check.” Take this opportunity to make sure you would be secure financially in the event of a disability that keeps you out of work for an extended period of time. The Georgia Pharmaceutical Services Insurance Agency has teamed up with Principal Financial Group to offer all members of the Georgia Pharmacy Association and their employees Disability Insurance (DI) with discounts up to 30 percent off traditional DI quotes. Call our offices today to schedule a time to discuss your individual needs or the needs of your employees and your business.
May 2009
continuing education for pharmacists Personalized Medicine: Pharmacogenetics as a Method for Improving Patient Outcomes Jon E. Sprague, R.Ph., Ph.D.*, Donald L. Sullivan, R.Ph., Ph.D.‥, and Michael D. Kane, Ph.D.§
Goal. This program is intended to
Introduction
review the fundamentals of pharmacogenetics and genetic testing as a means to improve patient outcomes.
To many pharmacists, it seems like only yesterday that monoclonal antibodies, used to treat various cancers and arthritis, were the new wonder drugs. Advances in drug therapy are changing so rapidly that most health care professionals can hardly keep up. For years, health care professionals have known that different groups of patients can react differently to the same medication. The elderly, children, and even some ethnic groups need dosage adjustments to prevent toxic drug levels or adverse effects. Now, we are beginning to realize that each and every individXDO PD\ QHHG YHU\ VSHFLÀF GRVDJH adjustments based on his/her own genetic make up and DNA. This is the emerging science of pharmacogenetics (or pharmacogenomics) and pharmacists will play a major role. Leading the rationale for deploying pharmacogenetics in SKDUPDF\ LV WKH ÀQGLQJ WKDW WR SHUFHQW RI SDWLHQW YDULDQFH LQ warfarin dosing can be attributed to genetic variations in the genes that encode its pharmacological target (VKORC) and its principal route of metabolism (CYP2C9 or 3 & 1. In simple terms, pharmacogenetics involves the screening of patients to identify those who harbor slight changes in their gene sequences that predispose them to adverse drug reactions (ADRs). For example, if a patient harbors a simple change in a spe-
Objectives. At the conclusion of this lesson, successful participants should be able to: 1. compare and contrast pharmacogenetics and pharmacogenomics; 2. demonstrate an understanding of basic DNA terminology and genomic variations; 3. explain “personalized medicine� from the standpoint of drug metabolism, bioactivation, and pharmacologic target screening; 4. describe the limitations to implementing pharmacogenetic screening in health care; and 5. apply knowledge of pharmacogenetics to the initiation of warfarin therapy. *
The Department of Pharmaceutical and Biomedical Sciences, The Raabe College of Pharmacy, Ohio Northern University, Ada, Ohio 45810 ‥
The Department of Pharmacy Practice, The Raabe College of Pharmacy, Ohio Northern University, Ada, Ohio 45810 §
Department of Computer and Informational Technology, Purdue University, West Lafayette, IN 47907
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FLÀF JHQH VHTXHQFH WKDW UHVXOWV LQ a decreased ability to metabolize a drug, its clearance rate from the body will be decreased (compared to normal patients), and there will be an increased risk of inadvertent overdosing if the normal dose of that drug is administered. The most exciting part of pharmacogenetics is the role the community pharmacist can play in its adaptation and use. After all, it is well known that the community pharmacist has the greatest amount of individual patient contact in the health care system. Dr. Alan Guttmacher, MD, member of the government’s Advisory Committee on Genetics, Health, and Society, states that genetic testing for clinical interventions may be applicable to 2 percent of the populaWLRQ QRZ EXW WKDW PD\ JURZ WR percent in the future. The primary goal of this program is to introduce pharmacists to pharmacogenetics and the role it will play in patient care in community pharmacies. The Institute of Medicine HVWLPDWHV WKDW GHDWKV RFcur annually due to ADRs. Other studies have suggested that, in the hospital setting, 6.7 percent or over two million hospitalized patients H[SHULHQFH $'5V ZLWK RYHU of those patients succumbing to these ADRs. ADRs are, therefore, the 4th leading cause of death in the United States and are one of the leading, preventable public health issues today. ADRs associated with the
May 2009
Table 1 Pharmacogenetic vs. Pharmacogenomic Pharmacogenetic
Pharmacogenomic
Principle Characteristic Inherited variation in drug effect
Use of genomic technology to identify new drug targets
Target Population
Individual patient/small groups
Large populations
Target Genes
Single or small number of genes
Complex pathways or whole genome
Example
CYP2C9
New drug development for depression
*HQHUDOL]HG *RDO
'UXJ 6DIHW\
(QKDQFHG (IĂ€FDF\
therapeutic treatment of disease in many cases are coupled with elevations in plasma drug concentrations. Drug-drug interactions commonly screen for potential CYP drug interactions that can result in elevations in drug levels. However, pharmacogenetic alterations in drug metabolism enzymes can also GLUHFWO\ LQĂ XHQFH GUXJ FRQFHQWUDtions in the blood. For example, CYP2D6 and CYP2C9 mutations have been associated with elevations in concentrations in paroxetine3 and warfarin4 levels, respectively. Therefore, increasing the accessibility and utility of genetic screening for CYP polymorphisms (drug metabolism enzymes) will reduce ADRs. Response to drug therapy varies markedly across therapeutic areas. For example, the estimated response rate to the selective serotonin reuptake inhibitors (SSRIs) used in the treatment of depression LV SHUFHQW5. The resistance to the antiplatelet drug clopidogrel KDV EHHQ HVWLPDWHG WR EH XS WR percent6. Clopidogrel is a prodrug that requires CYP3A4 bioactivation6, and changes in the gene that regulate CYP3A4 enzyme synthesis will result in clopidogrel not being effective in some patients. Therefore, pharmacogenetic screening can both reduce the rate of ADRs and also enhance overall therapeutic response to drug therapy E\ LGHQWLI\LQJ SDWLHQWV GHĂ€FLHQW LQ prodrug bioactivation processes.
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Fundamentally, pharmacogenetics is aimed at increasing drug safety DQG GUXJ HIĂ€FDF\ DVVXUDQFH EDVHG on genetic screening of patients. The patient concerns with genotyping in the clinic, which are also applicable to electronic health records (EHR) in general, are SULYDF\ DQG VHFXULW\ 7KH EHQHĂ€WV of incorporating genotyping (genetic information) in therapeutics and medicine are questioned when the risk of ‘information abuse’ is considered. For example, a patient may be unwilling to utilize WKH EHQHĂ€WV RI JHQRW\SLQJ LI WKH\ fear that their employer and/or insurance provider can utilize the same information to (accurately or inaccurately) predict the patient’s future health status. This dilemma involves both societal and genetic components. At the genetic level, the validity of extrapolative health assessment based solely on genotypic data has not been broadly established and is limited to a few known genetic diseases. Yet, it should be noted that the risk of ADRs based on known genetic anomalies in drug metabolism enzymes has been established and UHSUHVHQWV D VKRUW WHUP EHQHĂ€W LQ clinical genotyping.
Pharmacogenetic vs. Pharmacogenomic Although most pharmacists use the terms pharmacogenetics and pharmacogenomics interchangeably, the two terms actually have
23
different meaning. Pharmacogenetics is an inherited variation in drug effects based on a single gene interaction with drugs. These single gene interactions can alter drug disposition, safety, tolerability DQG HIĂ&#x20AC;FDF\ Pharmacogenomics represents the effect of a drug on gene expression OR the use of genomic technologies to identify new drug targets. In the latter case, identifying a gene that is expressed very highly in a diseased tissue, yet very low expression is seen in the normal state, could be used to identify that gene as a drug target or a biomarker of the disease state. Therefore, Ă&#x20AC;QGLQJ D VLQJOH FKDQJH LQ D &<3 gene would represent a pharmacogenetic and not a pharmacogenomic trait (Table 1). Single gene changes will be referred to as pharmacogenetic from this point forward.
Human Genome Overview Every human cell, with the exception of reproductive cells, contains 23 chromosomes. A genome is a patientâ&#x20AC;&#x2122;s complete set of chromosomes. These chromosomes carry the genetic coding for all proteins in every cell. Chromosomes consist of DNA tightly wound around special protein structures called histones. DNA is comprised of a string of four nucleotide bases: adenine, guanine, thymine, cytosine (more commonly referred to as A, G, T and C, respectively). They are linked together in a double helix. A segment of DNA containing all the information needed to encode for one protein is called a gene. For H[DPSOH WKH 3 &<3 HQ]\PHV are proteins. Thus, a gene found on a chromosome codes for the synWKHVLV RI HDFK VSHFLĂ&#x20AC;F &<3 HQ]\PH
Single Nucleotide Polymorphisms (SNPs) Within the nucleus of the cell, DNA is transcribed into messenger RNA (mRNA). In the cytoplasm of the cell, every three nucleotide bases on the mRNA codes for a single amino acid in the resulting protein. Within the ribosome, transfer
May 2009
since drug dosing represents the introduction of an otherwise foreign compound or chemical to the body. SNP &ODVVLĂ&#x20AC;FDWLRQV 1. Non-synonymous (missense) results in translation of a different amino acid. For example, ACG codes for the amino acid threonine. If a SNP occurs convertFigure 1. Normally, ACG codes for the amino acid threo- ing the ACG to CCG, nine (Thr). With the SNP example above, the ACG code the amino acid coded is switched to CCG which codes the amino acid proline (Pro). This change in amino acid results in the synthesis for is proline. Now the of a non-functional protein. Ă&#x20AC;QDO SURGXFW SURWHLQ LV incorrect and unable to RNA (tRNA) brings the amino acid function in a normal fashion. coded for by three nucleotide bases 2. Synonymous (sense) results on the mRNA (see Figure 1). For in the translation of the same example, ACG codes for the amino amino acid. Many amino acids are acid threonine. As the amino acid coded for by several different three chain grows, the protein is formed. nucleotide base sequences. Using SNPs occur when there is a single the threonine example, if ACG is nucleotide base change in the geconverted to ACA then threonine is nome, and are of concern when the still added during protein syntheSNP occurs in the three nucleotide sis and the overall function of the base sequence coding for an amino protein is maintained. acid (i.e., codon). Thus, there is a 3. Nonsense results in the mistake in the â&#x20AC;&#x153;codingâ&#x20AC;? region of insertion of a stop codon which terWKH '1$ WKDW HQFRGHV D VSHFLĂ&#x20AC;F minates protein synthesis early. protein, enzyme or receptor. CodThese SNPs are used to charactering polymorphisms (mistakes in ize genetic differences between inWKH '1$ DUH WKXV FODVVLĂ&#x20AC;HG EDVHG dividuals. Thus, patients can then on the effects this single nucleotide be differentiated based on SNPs base change makes in the amino VSHFLĂ&#x20AC;F WR D SURWHLQ )RU H[DPSOH acid delivered to the ribosome (see a SNP(*) in CYP2C9 may occur on below). the 2nd gene (or allele). Thus, this It is important to note that VSHFLĂ&#x20AC;F 613 ZRXOG EH SUHVHQWHG DV SNPs are very common in the huCYP2C9*2. Because humans inman genome, and it is estimated herit one copy of a gene from each that a SNP can occur about every parent, SNPs may also be repre EDVH SDLUV ZKLFK WRWDOV ZHOO sented as CYP2C9*2/*2. The *2/*2 over a possible one million SNPs is simply rendering an identity to per individual. Technically speakeach of the two potentially variable LQJ D JHQHWLF YDULDWLRQ DW VSHFLĂ&#x20AC;F genes (e.g., gene from mom/gene base-pair must occur in at least from dad). 1 percent of the population to be Many other known SNPs are termed a SNP7. Most of these are under investigation within disbenign changes in the genome that ease research groups to identify have no impact on our health, yet those that are genetically linked to SNPs that occur in genes involved disease risk, ultimately to idenin drug metabolism and drug-tartify patients who are genetically get pharmacology are of interest in SUHGLVSRVHG WR D VSHFLĂ&#x20AC;F GLVHDVH RU pharmacogenetics. These otherwise disorder, thereby allowing more efharmless SNPs become a concern fective diagnostics and prophylactic
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treatments.
Types of ADRs based on SNPs There are three types of ADRs that can be associated with SNPs: 1. decreased drug clearance due to decreased metabolism, which results in higher blood levels of the drug; 2. increased drug clearance due to an increase in metabolism, which results in lower blood levels of the drug; and 3. decreased prodrug bioactivation, which results in lower blood levels of active drug in the body. These are described in Table 2. In this case, prodrug bioactivation LV GHĂ&#x20AC;QHG DV WKH DFWLYDWLRQ RI D SURGUXJ E\ D 3 HQ]\PH WR WKH pharmacologically-active drug in the patientâ&#x20AC;&#x2122;s body for the drug to be effective. For example, clopidogrel is a prodrug that is bioactivated by CYP3A4. Clopidogrel resistance may result from a patient having a SNP in CYP3A4 (resulting in decreased levels of CYP3A4). Other selected drugs requiring bioactivation before drug initiation, and thus potential targets for SNP screening, are listed in Table 3.
SNP and ADRs associated with Antidepressant Therapy One potential area of concern with SNP-mediated metabolism is the antidepressants, namely the tricyclic antidepressants (TCAs). TCAs have a narrow therapeutic window and are, therefore, more susceptible to ADRs. Because TCAs are metabolized by CYP2D6, a SNP in 2D6 can result in higher drug concentrations and subsequently toxicity. CYP2D6*4 is the most common variant gene in Caucasians with a population frequency RI a SHUFHQW8. Poor metabolizers (PM), those with CYP2D6 polymorphisms, have higher concentrations of antidepressants than their extensive metabolizer (EM) comparison group9. Indeed, patients with CYP2D6 polymorphisms have been demonstrated to have an increased risk of ADRs and to not respond
May 2009
Table 2 Genetic basis for adverse drug reactions (ADRs) in drug metabolism ADR Type
Effect of SNP on Metabolic Enzyme
Effect on Peak Drug Plasma Concentration
ADR
Remediation of ADR Risk
Decreased Clearance
(1) Decreased enzyme activity (2) Altered enzyme activity
Upon normal dosing, peak plasma concentrations will exceed normal levels due to decreased metabolic capability of the patient
Risk of druginduced toxicity due to inadvertent overdosing of patient
Decrease the drug dose or choose an alternate drug therapy
Increased Clearance
Increased enzyme activity and/or inducibility
Upon normal dosing, peak plasma concentrations will QRW UHDFK HIĂ&#x20AC;FDFLRXV levels due to increased metabolic capability of the patient
Risk of undermedicating due to increased drug PHWDEROLVP
Increase the drug dose or choose an alternate drug WKHUDS\
(1) Decreased enzyme activity DOWHUHG HQ]\PH activity
Drug will not be activated. Therefore, HIĂ&#x20AC;FDFLRXV OHYHOV ZLOO not be reached.
Risk of undermedicating due to WKH DEVHQFH RI bioactivation of the prodrug
Choose an alternate drug WKHUDS\
Decreased Bioactivation
Warfarin and CYP2C9 Polymorphisms
Table 3 Selected drugs that require cytochrome P450 activation Parent Drug
Active Metabolite CYP2D6 Activation amitriptyline nortriptyline codeine morphine morphine morphine-6-glucuronide tramadol o-desmethyltramadol CYP3A4 Activation FDUEDPD]HSLQH FDUEDPD]HSLQH HSR[LGH FORSLGRJUHO XQLGHQWLĂ&#x20AC;HG citalopram desmethylcitalopram diazepam desmethyldiazepam Ă XR[HWLQH QRUĂ XR[HWLQH isosorbide dinitrate isosorbide 5-mononitrate primidone phenobarbital venlafaxine o-desmethylvenlafaxine verapamil norverapamil zidovudine zidovudine triphosphate
to TCA therapy11. By comparison, SSRIs have a much broader therapeutic window than the TCAs. However, CYP2D6 polymorphisms have been associated with higher plasma drug concentrations3,12 and potential ADRs13 with SSRIs. Thus, the narrow therapeutic window associated with TCA therapy makes them a logical candidate for CYP2D6 SNP screening.
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In August RI WKH U.S. Food and Drug Administration (FDA) updated the warfarin prescribing guidelines to include genetic testing14. Warfarin is a racemic mixture of the R- and S-warfarin forms of the drug. Swarfarin is approximately three times more potent than R-warfarin15. S-warfarin is predominantly metabolized by CYP2C94. In order to induce its anticoagulant effects, warfarin pharmacologically inhibits vitamin K epoxide reductase complex 1 (VKORC)16. The FDA guidelines, therefore, recommend CYP2C9 and VKORC screening for patients upon initiation of
25
warfarin therapy. Maintenance therapy should still be guided by the patientâ&#x20AC;&#x2122;s International Normalized Ratio (INR) measurement of prothrombin time in coagulation. 7KHVH QHZ JXLGHOLQHV DUH WKH Ă&#x20AC;UVW steps made to â&#x20AC;&#x153;personalized medicineâ&#x20AC;? through the use of pharmacogenetic data. Table 4 presents an example dosing regimen for ZDUIDULQ EDVHG RQ VSHFLĂ&#x20AC;F 613V LQ CYP2C9.
SNP Testing Methods and Privacy Concerns There are numerous methods for genetically screening patients prior to, or coinciding with, the initiation of drug therapy. Under ideal conditions, the results from a genetic screen for a patient are available immediately upon receipt of a prescription, and the pharmacist on-site can utilize this information as part of a decision support process during drug dispensing. Historically speaking, most genetic information has been derived from straight-forward gene sequencing, which involves a basic research laboratory environment (i.e., not a clinical testing environment) and expensive instrumentation. Although the utilization of DNA se-
May 2009
quencing methods as a SNP screening technique is possible, other methods have been (and continue to be) developed that are designed to test for known SNPs that are much more feasible within the paradigm of clinical genotyping. In all cases, the adoption of clinical genotyping testing methods requires that the testing be carried out quickly, provide rigorous results, and be relatively inexpensive. This can be achieved by OLPLWLQJ WKH WHVW WR VSHFLĂ&#x20AC;F JHQHWLF variations (SNPs) in the patientâ&#x20AC;&#x2122;s sample that are relevant to drug VDIHW\ DQG HIĂ&#x20AC;FDF\ %\ OLPLWLQJ WKH SNPs that are screened for each patient, the test can be carried out much more quickly and costeffectively, and can alleviate many of the privacy concerns inherent to genetic testing in the clinic. The management of privacy concerns to the patient is paramount to the adoption and implementation of personalized medicine. There are minimal privacy concerns associated with SNPs in genes associated with drug targets and drug metabolism processes. In contrast, most patients will be much more concerned about genetic variations that indicate the patient is at an elevated risk of developing a serious disease, and any deleterious effects that this knowledge may have on their employment or insurance prospects if the testing results were made available to these entities. Therefore, a critical component of patient counseling in personalized medicine will be the fact that the testing methods are OLPLWHG WR GUXJ VDIHW\ DQG HIĂ&#x20AC;FDF\ assessments, which arguably can RQO\ EHQHĂ&#x20AC;W WKH SDWLHQW KHDOWK insurer and employer. DNA samples can be obtained from a wide variety of sources. Most common sources include samples obtained from buccal swabs or hair. It is important to note that red blood cells (RBCs) and platelets do NOT have chromosomal DNA, since these â&#x20AC;&#x153;cellsâ&#x20AC;? are derived from progenitor cells in the bone marrow. Even though RBCs and platelets lack chromo-
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Table 4 One example of warfarin dosing based on CYP2C9 genotyping Mutation
Increased Clearance
CYP2C9*1/*1
Decreased Clearance
27%
Dosage Adjustment dose x 1.27
&<3 &
GRVH [
&<3 &
GRVH [
&<3 &
GRVH [
&<3 &
GRVH [
&<3 &
GRVH [
Developed from Caraco et al 19 Because humans inherit one copy of a gene from each parent, SNPs may be represented as CYP2C9*2/*2. The *2/*2 is simply rendering an identity to each of the two potentially variable genes (e.g., gene from mom/gene from dad).
somal DNA, a â&#x20AC;&#x153;DNA sampleâ&#x20AC;? can still be derived from a blood sample due to the presence of other DNAcontaining white blood cells in the blood (i.e., neutrophils, eosinophils, lymphocytes, monocytes, etc.).
Case Application of Pharmacogenetic Data to Patient Care QQ is a 69-year-old female who has arrived at the emergency department after traveling for six hours non-stop from central Pennsylvania. She states that she fell getting out of the car and that her calf hurt really badly afterwards. Doppler studies reveal that she has deep vein thrombosis. She is now at the pharmacy to get a prescription Ă&#x20AC;OOHG IRU ZDUIDULQ DV SDUW RI KHU treatment plan. Her physician has written for warfarin 5 mg daily. Because the pharmacy is progressive and utilizes cutting edge technology, the pharmacist follows the current FDA guidelines and conducts a genetic screen for CYP2C9 and VKORC. This testing takes several hours to complete, but reveals a SNP in CYP2C9*1/*3. As a result of this SNP, CYP2C9 activity will be reduced. This reduction in CYP2C9 activity increases the patientâ&#x20AC;&#x2122;s warfarin levels and INR, and enhances the likelihood of bleeding. In order to prevent these toxicities, the pharmacist uses the dosing information in Table 4 to calculate a new initial dose of 3 mg
26
PJ LQLWLDOO\ SUHVFULEHG [ In order to implement this dosage change, the pharmacist needs to educate both the physician and patient about pharmacogenetics to varying degrees. This educational FRPSRQHQW ZLOO EH LQLWLDOO\ GLIĂ&#x20AC;FXOW but will become easier as the level of understanding about the health FDUH EHQHĂ&#x20AC;WV GHULYHG IURP SKDUPDcogenetic testing grows.
Conclusions The problem with ADRs in the community setting is that research available regarding incidence and prevalence of ADRs is lacking. The rate of ADRs in the community (outpatient) setting is unknown2. It is known that community pharmacists with a greater workload are more likely to dispense medications to patients with drug-drug interactions17. Furthermore, the relative risk for dispensing a medication with a drug-drug interaction increases by over 3 percent for each prescription processed SHU SKDUPDFLVW KRXU DQG E\ percent for each additional prescription per pharmacy staff hour. Finally, another study found that when physicians prescribe medications with drug interactions, they typically do not document this in the patient chart. In fact, 16 to 37 percent of patients had no documentation in the patient chart of drugs with potential drug-drug interactions18. The researchers
May 2009
suggested that the physicians may not have even known the patient was on medications with the potential for drug-drug interactions. Thus, preventing ADRs associated with drug-drug interactions represents an area requiring some focused attention by pharmacists. Expanding the pharmacistsâ&#x20AC;&#x2122; role in the area of drug-gene interaction screening is the next logical step in preventing ADRs. Many factors have contributed to obstacles that limit the utilization of genomic data to routine use in patient care. Concerns over privacy, security and ethical issues are just a few of the issues that have limited this translation from â&#x20AC;&#x153;bench to bedside.â&#x20AC;? We suggest that targeting known SNPs in 3 PHWDEROL]LQJ HQ]\PHV ZLOO avoid these issues and will place pharmacists at the forefront in the management of genomic data in health care. With the pharmacist as the key player, patients will only be screened for metabolizing enzyme and drug target SNPs, and only these data will be stored. No other genomic anomalies will be screened or collected by the pharmacist. In the future, patients should be able to enter any hospital or community pharmacy practice setting and obtain a buccal swab sample of DNA that will be immediately screened for clinically-relHYDQW 3 SRO\PRUSKLVPV 7KLV information will then be seamlessly LQWHJUDWHG LQWR SUHVFULSWLRQ Ă&#x20AC;OOLQJ systems. During the prescription Ă&#x20AC;OOLQJ SURFHVV WKH SKDUPDFLVW ZLOO be â&#x20AC;&#x153;alertedâ&#x20AC;? if there is a drug-genomic interaction. The pharmacist will then be provided therapeutic and genomic data that will assist the consultation with the physician to tailor the patientâ&#x20AC;&#x2122;s drug therapy. This future will only happen if pharmacists are willing to embrace pharmacogenetics as an opportunity to prevent ADRs and improve overall health care. References 1. Flockhart, D.A., Gage, B., GanGROĂ&#x20AC; 5 .LQJ 5 /\RQ ( 1XVVEDXP R., Oâ&#x20AC;&#x2122;Kane, D., Schulman, K., Veen-
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stra, D., Williams, M., and Watson, M.S. Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin. Genetics in Medicine )HEUXDU\ 2. Committee on Quality of Health Care in America: Institute of Medicine. To err is human: building a safer health system. Washington, D.C., 1DWLRQDO $FDGHP\ 3UHVV 3. Sawamura K, Suzuki Y, Someya T. Effects of dosage and CYP2D6mutated allele on plasma concentration of paroxetine. Eur. J. Clin. Pharmacol. 4. Aithal GP, Day CP, Kesteven PJ, Daly AK. Association of polymorSKLVPV LQ F\WRFKURPH 3 &<3 & with warfarin dose requirement and risk of bleeding complications. Lancet. 1998;353:717-719. 5. Doris A, Ebmeier K, Shajahan P. Depressive illness. Lancet. 1999;354:1369-1375. 6. Nguyen TA, Diodati JG, Pharand C. Resistance to clopidogrel: a review of the evidence. J Am Coll Cardiol 7. http://www.ornl.gov/sci/ techresources/Human_Genome/faq/ snps.shtml 8. Bradford LD. CYP2D6 allele frequency in European Caucasians, Asians, Africans and their descendants. Pharmacogenomics 9. Mulder H, Herder A, Wilmink FW, Tamminga WJ, Belister SV, Egberts AC. The impact of cytochrome 3 ' JHQRW\SH RQ WKH XVH DQG interpretation of therapeutic drug monitoring in long-stay patients treated with antidepressant and antipsychotic drugs in daily psychiatric practice. Pharmacoepidemiol. Drug Saf. 6WHLPHU : =RSI . YRQ Amelunxen S, Pfeiffer H, Bachofer J, Popp J, Messner B, Kissling W, Leucht S. Amitriptyline or not, that is the question: pharmacogenetic testing RI &<3 ' DQG &<3 & LGHQWLĂ&#x20AC;HV patients with low or high risk of side effects in amitriptyline therapy. Clin. Chem 11. Chen S, Chou WH, Blouin RA, 0DR = +XPSKULHV // 0HHN 4& 1HLOO JR, Martin WL, Hays LR, Wedlund PJ. 7KH F\WRFKURPH 3 ' &<3 ' enzyme polymorphism: screening costs DQG LQĂ XHQFH RQ FOLQLFDO RXWFRPHV in psychiatry. Clin Pharmacol Ther. 12. Charlier C, Broly F, Lhermitte M, Pinto E, Ansseau M, Plomteux G. Polymorphisms in the CYP2D6 gene: association with plasma concentrations
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RI Ă XR[HWLQH DQG SDUR[HWLQH Ther. Drug Monit. 13. Kaneda Y. Serotonin syndrome â&#x20AC;&#x201C; â&#x20AC;&#x2DC;potentialâ&#x20AC;&#x2122; role of the CYP2D6 genetic polymorphism in Asians. Int. J. Neuropsychopharmacol 14. FDA Website. http://www.fda. JRY EEV WRSLFV QHZV QHZ KWPO $FFHVVHG 15. Choonara IA, Cholerton S, Haynes BP, Breckenridge AM, Park BK. Stereoselective interaction between the R Enantiomer of warfarin and cimetidine. Br. J. Clin. Pharmacol. 1986: 21:271-277. 16. Lee CR. Warfarin initiation and the potential role of genomicguided dosing. Clin. Med. Res. 17. Malone DC, Abarca J, Skrepnek, GH. et al. Pharmacist workload and pharmacy characteristics associated with the dispensing of potentially clinically important drug-drug interactions. Medical Care. 45(5) 456-462. 18. Lafta, Simpkins MA and Kaatz S et al. What do medical records tell us about potentially harmful co-prescribing? The Joint Commission Journal on Quality and Patient Safety 19. Caraco Y, Blotnick S, Muszkat M. CYP2C9 Genotype-guided Warfarin 3UHVFULELQJ (QKDQFHV WKH (IĂ&#x20AC;FDF\ DQG Safety of Anticoagulation: A Prospective Randomized Controlled Study. Clin Pharmacol Ther
The content of this lesson was developed by the Ohio Pharmacists )RXQGDWLRQ 831 + 3 3DUWLFLSDQWV VKRXOG QRW seek credit for duplicate content.
May 2009
continuing education quiz Personalized Medicine: Pharmacogenetics as a Method for Improving Patient Outcomes
1. Where do ADRs rank as the leading cause of death in the United States? a. 1st c. 3rd b. 2nd d. 4th
For questions 7-10, use this mini case. -6 LV D <20 ZLWK D \HDU KLVWRU\ RI DWULDO Ă&#x20AC;EULOODWLRQ +LV SK\VLcian places him on warfarin 5 mg a day for stroke prevention. Genetic testing reveals a CYP2C9*1/*1 SNP which would result in an increased clearance of warfarin.
3KDUPDFRJHQHWLFV LV GHĂ&#x20AC;QHG DV a. the effects of a drug on gene expression. b. inherited variation in drug effects based on a single gene interaction with drugs. c. use of genomic technologies to identify new drug targets. d. drugs developed and derived from genes.
7. Because of this SNP, JS would be predicted to have warfarin plasma concentrations that: a. are higher than expected for the prescribed dose. b. are lower than expected for the prescribed dose. c. would be as expected for the prescribed dose.
3. SNPs result in a synonymous (sense) translation if the single nucleotide mistake in the coding sequence results in the: a. amino acid substitution being the same as the normal protein amino acid. b. amino acid substitution being different from the normal protein amino acid. c. termination of protein synthesis.
8. In discussing JSâ&#x20AC;&#x2122; pharmacogenetic results, the pharmacist should explain that the genetic information obtained: a. helps determine a safe and effective warfarin dosage. b. will determine a warfarin dosage to cure his atrial Ă&#x20AC;EULOODWLRQ c. tells all about his susceptibility to disease.
4. A SNP in CYP2C9 resulting in decreased enzyme activity may result in: a. decreased drug clearance. b. increased risk of drug-induced toxicity. c. potentially choosing an alternative drug. d. all of the above.
9. Which of the following statements about the risk of ADRs pertain to the initially prescribed dose? a. There is risk for drug-induced toxicity due to inadvertent overdosing. b. There is risk of under-medicating JS due to increased drug metabolism. c. There is risk of under-medicating JS due to the absence of bioactivation of the prodrug. d. There is risk for drug-induced toxicity due to enhanced bioactivation of the prodrug.
5. CYP2D6 has potential for SNP screening with tricyclic antidepressants (TCAs) dosing because: a. CYP2D6 is the pharmacological target for TCAs. b. TCAs are rarely associated with ADRs. c. CYP2D6 is rarely associated with genetic polymorphisms. d. TCAs have a narrow therapeutic window.
%DVHG RQ WKH JHQHWLF LQIRUPDWLRQ REWDLQHG ZKDW would be your suggested starting dose (rounded)? a. 2 mg c. 5 mg b. 4 mg d. 6 mg
,Q $XJXVW )'$ XSGDWHG WKH ZDUIDULQ SUHVFULEing guidelines to include genetic testing for: a. CYP2D6. c. VKORC. b. CYP3A4. d. all CYP isoforms.
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The Georgia Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Personalized Medicine: Pharmacogenetics as a Method for Improving Patient Outcomes Volume XXVI, No. 12 This lesson is a Knowledge Based CPE Activity and is targeted to pharmacists in all practice settings. GPhA Code J09-05 Program Number: 142-999-09-005-H01-P CE Hours: 1.0 (0.10 CEUs) Release Date: 5/5/2009 Expiration: 11/15/2011
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