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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.
The Georgia Pharmacy Journal
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May 2010
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2010 GPhA Convention, June 26-30, 2010 Embassy Suites & Conference Center at Kingston Plantation Myrtle Beach, SC FEATURE ARTICLES
12 20 21
GPhA Government Affairs Legislative Update
Former GPhA President, Winston “Rusty” O. Bullard, Dies
CPE Opportunity: Oral anticoagulation without protimes: A review of two emerging agents that may come to market.
Departments 5 Pharm PAC Contribution Card 7 GPhA New Members 13 Pharmacy-Based Immunization Programs 14 Pharmaceutical Care for Patients With Diabetes 17 GPhA Members in the News 18 GPhF Golf Tournament Information 30 GPhA Membership Application 31 GPhA Board of Directors
Advertisers 2 2 5 6 7 8 10 11 15 16 17 20 32
The Insurance Trust Principal Financial Group Melvin M. Goldstein, P.C. Logix, Inc. Design Plus Store Fixtures, Inc. Pharmacists Mutual Companies AIP Mercer University Alumni Dinner & UGA Alumni Dinner GPhA Workers Compensation Toliver & Gainer Georgia Campus - Philadelphia College of Osteopathic Medicine Michael T. Tarrant The Insurance Trust
COLUMNS
4 6
President’s Message Editorial
For an up-to-date calendar of events, log onto
www.gpha.org.
The Georgia Pharmacy Journal
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May 2010
PRESIDENT’S MESSAGE Eddie M. Madden, R.Ph. GPhA President
On to Myrtle Beach
It was June 6, 1966 (6/6/66), the day of my high school graduation. I could hardly wait to pile into the car with several of my graduation classmates and blaze a trail through South Carolina to that mystic place known as Myrtle Beach! I can still hear the music playing from the Tilt-A-Whirl and the Scrambler located on the amusement park square of downtown Myrtle Beach. The lights were dazzling to a country boy from a rural Georgia town. Boy, was that place a zoo! There must have been 10,000 teenagers filling the sidewalks, and the car ride down Ocean Boulevard was horrific. Cars bumper-to-bumper and barely moving, convertibles with teenagers yelling at each other and good-looking girls everywhere! As with today’s teenagers, we had to be close to our high school buddies, male and female, and we all tried to stay at the same or nearby hotels so we could Pa-a-a-r-r-r-t-t-t y! And party we did. I remember seeing the sunrise over the water as I was driving back to my hotel room on many of the mornings. Boy, those were the good old days!
For you golfers, Myrtle Beach was featured in the May issue of Golf Digest as being a super place to go. There are 113 and a half 18 hole golf courses along the Grand Strand. Tee times and bar stools are inexhaustible. I have played several of the courses. I remember one of my many visits to Myrtle Beach. I was playing on one of the golf courses that ran along Ocean Boulevard, a busy four-lane highway with a median. I struck my tee shot and shanked (hit it sideways for those of you who aren’t that familiar with golf) it into the middle of that busy four-lane. Being the frugal person that I am, I had to retrieve my ball. I must have been a sight, waiting on traffic in my golf shorts and spikes to dash out in the median to get my $2.00 ball. That’s but one of my many golf stories I could share with you. Golfers, you get the message. There is a lot of opportunity to sneak off to great links at really very affordable prices!
Forty-four years later on June 26, 2010, our Association will be back in Myrtle Beach. The amusement park is long gone from the downtown square but it is still a fabulous place to go and for the student pharmacists and young folks still a great place to party. I won’t be able to hang with them and see the sunrises this time. Our Association is having its annual convention at the Kingston Plantation. It is located on the Grand Strand which are miles of wide-open beaches. The Plantation has great ocean vistas, 9 pools, Caribbean Family Water Playground and a new Lazy River. Beyond the Plantation are thousands of great places to eat and many places to enjoy the nightlife. There are tons of things that
This year’s convention will be filled with opportunities to complete your CPE requirements before the year-end deadline. Our CPE Planning Committee headed by Liza Chapman, Pharm.D., has been working hard to provide CPE with content that can meet the needs of all areas of practice. We will also have a special 3-hour CPE opportunity for those that need to get the new CPE mandate on disaster preparedness. There are two Certificate Programs, one for diabetes and another for immunizations. Register early - spaces are limited for these programs which will take place on Friday. We will have special entertainment at our Opening General
The Georgia Pharmacy Journal
individuals and families can do. Water slides, amusement parks, and putt-putt golf abound.
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May 2010
Session - Don Yeager, “New York Times best selling author� and cancer survivor, and an outstanding motivational speaker. I have had a chance to hear him and he really brings an inspirational message. You don’t want to miss this special event.
Pharm PAC would like to encourage you to make a contribution today and help pharmacy look forward to a bright future in the state of Georgia.
Our convention schedule has been altered to allow you to have more time for an evening with your family and friends. Our Sunday evening outdoor party has been taken out of the schedule to make time for this. Later that evening we will have entertainment, beginning with a desert reception starting at 9:30 p.m. Kevin Lupine, hypnotist, will be with us again. I’m sure many of you can remember how much fun this show was when our own, Dean Stone, R.Ph., became the star of the show with his antics while he was hypnotized! Wait till you see what Jack Dunn, R.Ph., will be like!
Name: ________________________________ Address: _______________________________ _____________________________________ Phone Number: __________________________ Email Address: __________________________ Contribution: $__________________________
Don’t procrastinate, go now to www.gpha.org or call 404419-8116 to register for a great convention. While you are registering don’t forget that GPhA has a lot of active student pharmacists members who could use a sponsor to help them attend the convention.
(Circle the Pledge Level to which you wish to belong.) $1 - $250 - Patriot $251 - $500 - Representative $501 - $1000 - Senator $1001+ - Governor’s Circle
I’m looking forward to seeing you in Myrtle Beach, S.C.
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Sustainers Circle: When you check this box and provide valid credit card information you are making a 5 year commitment to make the same contribution for the next 5 years. Your credit card will automatically be charged annually on the date of your initial contribution.
.FMWJO . (PMETUFJO 1 $ " 5 5 0 3 / &@@@ : "5 - "8 3PTXFMM 4USFFU .BSJFUUB (FPSHJB
Contributions or gifts to Pharm PAC are not deductible as charitable contributions for Federal income tax purposes.
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Name on the Credit Card:
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_____________________________________ Credit Card Number: _____________________________________
„ 'PSNFS "TTJTUBOU "UUPSOFZ (FOFSBM GPS UIF 4UBUF PG (FPSHJB BOE $PVOTFM GPS QSPGFTTJPOBM MJDFOTJOH CPBSET JODMVEJOH UIF (FPSHJB #PBSE PG 1IBSNBDZ BOE UIF (FPSHJB %SVHT BOE /BSDPUJDT "HFODZ
CSV#: ________ Expiration Date: ____________ Signature: ______________________________ Contributions made to Pharm PAC are not tax deductible.
Detach this form and complete it and return it to:
Pharm PAC, 50 Lenox Pointe, NE Atlanta, GA 30324 You may also donate online.
„ 'PSNFS "ENJOJTUSBUJWF -BX +VEHF GPS UIF 0GGJDF PG 4UBUF "ENJOJTUSBUJWF )FBSJOHT The Georgia Pharmacy Journal
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May 2010
EXECUTIVE VICE PRESIDENT’S EDITORIAL Jim Bracewell Executive Vice President / CEO
A Tribute: George Sidney Anderson Early one morning a few years ago, I was on the road to a pharmacy meeting and stopped at a Hardees Restaurant. I went in for a cup of coffee and sausage biscuit to go.
they had offended him. He showed compassion for his fellow staff at GPhA and was quick to offer help and sympathy when needed.
A young lady with a cheerful voice and bright smile took my order and placed it on the counter. I gave her a five dollar bill and she gave me my change. As I stepped away to leave I noticed that she had given me too much change from my five dollars.
To me, Sid’s wisdom from years of experience was most valuable to me and my work with him. I could readily seek his council and I did so frequently. Sid liked to arrive early in the morning for work to avoid the traffic so he and I had many early morning conversations before the business day got started.
I turned back and said, “Lady, I think you gave me too much change.”
It was in those morning talks where Sid helped me grow personally so much. He knew pharmacy in Georgia. Best of all he knew the pharmacists in Georgia. He knew their names. He knew their families. He knew their store and their business. While Sid was not a pharmacist, I often think what a great hometown pharmacist he would have made.
She replied, with a smile, “No sir, our morning coffee is free to senior citizens.” It was clear to me that my age as a senior citizen was showing. She did not ask my age, she did not ask if I was a senior nor did she even ask if I wanted the senior discount. She looked at me and without asking knew I deserved a senior discount.
George Sidney Anderson has made a mark on the profession of pharmacy in Georgia that will be long remembered. On behalf of the Georgia Pharmacy Association, I hope Mary and Sid’s family will accept our sincere sympathy at his passing and our enduring love for his friendship and contribution to us.
There are benefits to growing older and senior discounts are most obvious. Growing older is not an option for us, but growing wiser is.
We wish Sid Godspeed in his new life. Age does not make a man or woman wise, kind, or caring. Those are traits that must be nurtured each day. Sid Anderson was known as a wise, kind, and caring prince of a man. Sid cared deeply about his family. If you were not speaking about pharmacy, the conversation would quickly include a reference to Mary, his wife, whom he loved dearly. He cared about his family and showed great pride when speaking of his two daughters, their husbands, and, of course, his grandchildren. Sid was known for his kindness. It is difficult to think of Sid commenting negatively about anyone no matter how much
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May 2010
GPHA MEMBER NEWS
Welcome to GPhA! The following is a list of new members who have joined Georgia’s premier professional pharmacy association! Devon Amponin, Savannah David Allen Childers, C.Ph.T., Canton Margarete Sydney Cowie, B.S., Savannah Quynh N. Do, Lawrenceville Seritha Carol Gilbert, B.S., Bonaire Barbie J. Gleaton, Pooler Matthew DeWitt Hurd, Pharm.D., Lawrenceville Christine McFayden Klein, Pharm.D., Atlanta
Nancy Eva Montgomery, Macon Steven J. Pabst, B.S., Savannah Shante Noelle Pool, Pharm.D., Fayetteville Christopher Michael Rankin, Richmond Hill Matthew Glenn Reed, Waycross Melissa Beth Usry, Pharm.D., Thomson Jennifer Smith Wells, Pharm.D., Bogart
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. There is also a print application on page 30 of the Journal. 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. GPhA early bird registration will be $295 for a GPhA member until May 9, 2010. Hotel rooms fill quickly so 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.
2010 Convention Room Block Expires May 24, 2010 Embassy Suites Hotel Oceanfront Suite – King $234.00 Oceanview Suite $174.00 Embassy suites are two-rooms with in room microwave and refrigerator and rate includes a complimentary buffet breakfast and complimentary manager’s reception (5:30 – 7:30pm daily- based on single/double occupancy). Brighton Tower Condo Two Bedroom Oceanview $220.00 Three Bedroom Oceanview $262.00 Does not include complimentary buffet breakfast or reception The units are a typical condo set up with living room, dining, full kitchen and a patio area. Units are individually owned and will vary in decoration. Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens. Plantation Villa One Bedroom Resort view $164 Two Bedroom Resort view $174 Villas have full living area and full kitchens. Does not include complimentary buffet breakfast or reception Daily maid service includes only removing trash, vacuuming, making beds with existing linens and replacing bath linens. Call for Reservations: 1-800-876-0010 - Tell reservations the Group Code: GPA 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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May 2010
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Mercer University College of Pharmacy and Health Sciences Monday, June 28, 2010, at the Pirate’s Cove 205 Main Street, North Myrtle Beach, SC 29582-3020 7:30 p.m.
I will attend the Alumni Dinner for alumni spouses and friends of Mercer University College of Pharmacy and Health Sciences. Please make ______ reservations at $35.00 per person. _______ 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:
Class/Year:
________________
_____________________________________________________
______________________________________________________________________
_____________________ State: ___________
Zip code:
_____________________
Work Phone: _________________________ Home Phone: __________________________ Mail registration form with check, payable to Mercer University to Sharon Lim Harle, Office of Alumni Services, Mercer University, 3001 Mercer University Drive, Atlanta, GA 30341. For more information please call (678) 547-6420 or e-mail to lim_s@mercer.edu.
University of Georgia College of Pharmacy Monday, June 28, 2010, at the Rioz Brazilian Steakhouse 2920 Hollywood Drive, Myrtle Beach, SC 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. _______ 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:
Class/Year:
________________
_____________________________________________________
______________________________________________________________________
_____________________ State: ___________
Zip code:
_____________________
Work Phone: _________________________ Home Phone: __________________________ Mail registration form with check, payable to UGA Foundation, by Friday, June 25, 2010, to Sheila Roberson, College of Pharmacy Alumni Director, University of Georgia, College of Pharmacy, Athens, GA 30602. For more information please call 706.542.5303. The Georgia Pharmacy Journal
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May 2010
GPhA LEGISLATIVE UPDATE
GPhA Government Affairs Legislative Update Information current as of April 16, 2010. If you have any questions please email Stuart Griffin at sgriffin@gpha.org. his is an excerpt from the weekly email legislative update for the Georgia Pharmacy Association with distribution to members of the Georgia Pharmacy Association every Friday during the legislative session. If you have questions about anything below you can email Stuart Griffin, Director of Government Affairs, at sgriffin@gpha.org. If you would like to receive the Pharm-O-Gram please call Kelly McLendon at 404-419-8116 or email her at kmclendon@gpha.org.
SB195 is similar to our Drug Update bill that we pass each year but SB195 comes from the Secretary of State and codifies in law what is consistent with present-day technology for licensing requirements and other items that fall under the purview of the Secretary of State's office. We are using SB195 as a vehicle to carry language that makes digital signatures, used in an eprescribing fax, legal prescriptions. We are also using SB195 as a vehicle to carry language that allows the digital print out of the phrase 'Brand Necessary' legal.
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The Lt. Governor's office has appointed the conferees to work out the final details of this bill. The bill should reach final passage within the next week. Pharmacy Benefits Manager Regulation: SB310 Sponsors: Hawkins (R-Gainesville), Murphy (R-Cumming), Goggans (R-Douglas), Carter (R-Pooler), Williams (R-Lyons) & Hudgens (R-Hull) Passed Senate 53-0 on March 8, 2010 Currently in House Rules Position - Support
Vehicles for Immunosuppressant and Epilepsy Carve-Out: SB56 and SB49 Sponsors: SB56 - Butler (D-Stone Mountain), Seay (DRiverdale), Adelman (D-Decatur), Brown (D-Macon), Reed & Tate (D-Atlanta) SB49 - Hawkins (R-Gainesville), Thomas (R-Dalton), Hudgens (R-Hull), Cowsert (R-Athens), Butterworth (RCornelia) & Harp (R-Midland) Waiting on Agree/Disagree in Senate Position - Oppose with Current Language
SB310 is the same bill we passed in 2009 that was vetoed by the Governor. SB310 requires any Pharmacy Benefit Manger operating in the state of Georgia to be licensed with the Georgia Department of Insurance. The bill also requires PBMs to adhere to the 'Pharmacy Audit Bill of Rights' along with other purposes.
SB56 and SB49 were both bills with subject matter not related to carve-out legislation until immunosuppressant and epilepsy carve-out language were added to the bill during the end of the 2009 legislative session. With the current carve-out language, we are opposing and observing any movement of SB56 & SB49.
The House Insurance Committee attached language to SB310 and then passed the bill unanimously through the committee. We have been told the PBM bill will be passed through the House Rules Committee for a final vote on the bill Wednesday, April 21st. SB310 will then need to go back to the Senate for a final agree.
SB56 has been stripped of its carve-out language. A conference committee will be formed by the Lieutenant Governor's office for further action.
Drug Update: SB353 Sponsors: Carter (R-Pooler) & Thomas (R-Dalton) Passed House on April 12, 2010 for final passage on April 12, 2010 Position - Support
Secretary of State's Modernization Bill: SB195 Sponsors: Chance (R-Tyrone), Staton (R-Macon), Shafer (RDuluth) & Pearson (R-Dawson) Passed Senate and Amended in House in 2009 - Senate Disagree - House Insisted Position - Support
SB353 is our annual drug update bill that updates Schedule I, II, IV and V controlled substances.
Continued on page 16
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May 2010
Pharmacy-Based Immunization Program Friday, June 25, 2010 (8:30 a.m. - 6:30 p.m.) Embassy Suites & Conference Center at Kingston Plantation 9800 Queensway Blvd Myrtle Beach, SC 29572
For further CPE details and to registration online go to www.gpha.org or you can register by calling Kelly McLendon at 404-419-8116. For questions regarding this program please call Mary Ellen Chapman at 404-419-8126 or email her at mechapman@gpha.org. Member Type GPhA Non-Member GPhA Members Pharmacy School Student
Cost $495 $400 $175
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. Pharmacy-Based Immunization Delivery certificate training program is a Practice-based activity conducted in two parts – a self-study learning component and a live training seminar. A Certificate of Achievement will be awarded to participants who successfully complete all program components. Key learning objectives for the live training seminar: • Identify opportunities for pharmacists to become involved in immunization delivery. • Describe how vaccines evoke an immune response and provide immunity. • Identify the vaccines available on the U.S. market for each vaccine-preventable disease and classify each vaccine as live attenuated or inactivated. • Outline the target groups for vaccination based on the Advisory Committee for Immunization Practices recommendations. • Review patients’ medical and immunization histories and determine vaccine recommendations based on current immunization schedules. • Outline the steps involved in establishing a pharmacy-based immunization delivery program. • Discuss the legal, regulatory, and liability issues involved with pharmacy-based immunization programs. • Describe the signs and symptoms of adverse reactions that can occur after vaccination and the emergency procedures for management of patients with adverse reactions to vaccination. • Describe the appropriate technique for administration of the live attenuated influenza vaccine. • Demonstrate appropriate intramuscular and subcutaneous injection technique for adult immunization. For a more complete list of program learning objectives, please go to APhA’s website, www.pharmacist.com/ctp. This is a Practice Based CPE Activity. The target audience for this Activity is Pharmacists. Continuing Pharmacy Education (CPE) Credit CPN: 202-0014: Expiration Date: 12/31/10 Successful completion of the live seminar component involves passing the final exam with a grade of 70% or higher and demonstrating competency in 2 intramuscular and 1 subcutaneous injection. Successful completion of this component will result in 8.0 contact hours of continuing pharmacy education credit (0.80 CEU). ACPE UAN: Live-202-999-09-001-L01-P Successful completion of the self-study component involves passing the self-study assessment questions with a grade of 70% or higher and will result in 12.0 contact hours of continuing pharmacy education credits (1.2 CEU). ACPE UAN: SS-202-999-09-002-H01-P 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 in-part by an educational grant from VaxServe.
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May 2010
Pharmaceutical Care for Patients With Diabetes A Certificate Program for Pharmacists Hosted by GPhA Friday, June 25, 2010 12:30 - 6:30 p.m. Embassy Suites Conference Center Kingston Plantation 9800 Queensway Blvd Myrtle Beach, SC 29572 To learn more about this program go to www.gpha.org. For questions regarding registration, call Kelly McLendon at 404-419-8116. If there are questions about this program contact Mary Ellen Chapman at 404-419-8126 or mechapman@gpha.org. Pharmaceutical Care for Patients with Diabetes is an innovative and intensive practice-based activity that focuses on the pharmacist's role in the area of diabetes management. The program, which emphasizes a health care team approach, seeks to foster the implementation of pharmaceutical care interventions that will promote disease self-management. Goals of the program: • Provide comprehensive instruction in the pathophysiology of diabetes • Teach current approaches to the medical management of diabetic patients • Introduce pharmacists to their role as a diabetes educator • Provide pharmacists with information about becoming a Certified Diabetes Educator, and about other diabetes management-related credentialing opportunities Pharmaceutical Care for Patients with Diabetes certificate training program is conducted in three parts - a self-study learning component, web-based case studies and key concepts, and a live training seminar. A Certificate of Achievement will be awarded to participants who successfully complete all program components. Key learning objectives for the live training seminar are: • Discuss medications used to treat diabetes • Conduct a comprehensive patient self-management assessment • Describe the elements of a diabetes self-management education program • Develop a documentation and record-keeping system • Provide diabetes self-care instruction, including use of devices, products, and equipment • Design and implement a pharmacy-based diabetes education program For additional event and CPE details visit www.gpha.org. 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. Program Materials: The American Pharmacists Association will provide online access to the self-study materials by issuing a voucher code. Voucher code will be provided within 30 days of the scheduled program. Seminar binders, which include all handouts and case studies will be provided at the live seminar.
No refunds will be issued; however, timely notification of cancellation may allow another pharmacist to participate in this program. The Georgia Pharmacy Journal
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May 2010
Continued from page 13
medication therapy experts and as vital components in the welfare of their patients.
Flu-mist: HB1154 Sponsors: Jerguson (R-Holly Springs) Passed Senate on April 13, 2010 for final passage Position - Support
Sharps Waste: HB504 Sponsors: Wilkinson (R-Fulton County), Cooper (RMarietta), Mitchell (D-Stone Mountain), Mayo (D-Decatur) & Henson (D-Stone Mountain) House Health & Human Services Position - Compromise without legislation
HB1154 was changed slightly in the Senate to reflect changes desired by the House. Now that the bill has passed both the House and Senate, it must now go back to the House for an agreement and final passage.
HB504 requires the pharmacist to supply the patient with a sharps waste container to dispose of their sharps waste after use.
Patient Safety Act: SB418 Sponsors: Carter (R-Pooler), Hawkins (R-Gainesville), Harp (R-Midland), Thomas (R-Dalton) & Goggans (R-Douglas), Passed the Senate 49-9 on March 24, 2010 Currently in House Health and Human Services and will be heard on Monday, April 19 at 2:00 p.m. Position - Support
This issue has been resolved without a mandate. We have reached an agreement with the sponsors of this legislation through a House Resolution (HR 1946). We plan to start a program to educate communities regarding Sharps Waste and the correct disposal of sharps.
SB418 establishes a program for the monitoring of prescribing and dispensing Schedule II, III, IV, or V controlled substances by the Georgia Drugs and Narcotics Agency. SB418 requires dispensers to submit certain information regarding the dispensing of such controlled substances. Brand and Generic Information on Label: HB194 Sponsors: Millar (R-Dunwoody), Cooper (R-Marietta), Rice (R-Norcross) & Hugley (D-Columbus) Agreed by House for Final passage on April 14, 2010 Position - Neutral
Lawyer and Pharmacist Leroy Toliver, Pharm.D., R.Ph., J.D.
HB194 requires the pharmacist to print on the prescription label the name of the brand when a brand is prescribed and substituted with a generic. The bill allows exemptions for inpatient hospital dispensing and specialty packaging as defined by the Board of Pharmacy.
• Professional Licensure Disciplinary Proceedings • Medicaid Recoupment Defense • Challenges in Medicaid Audits • OIG List Problems • SCX or Other Audits
Safe Medication Practice Act: HB361 Sponsors: Stephens (R-Savannah) Passed Senate for final passage on April 13, 2010 Position - Support
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.
HB361 was introduced during the 2009 Legislative Session by Rep. Ron Stephens. HB361 specifically focuses on pharmacy practiced in an institutional setting. The bill codifies the importance of the pharmacist's involvement in medication therapy management. HB361 also codifies the importance of the collaboration between the pharmacist, physician and other clinical practitioners.
Toliver and Gainer, LLP 942 Green Street, SW Conyers, GA 30012-5310 altoliver@aol.com 770.929.3100
Although the bill only pertains to pharmacists in an institutional setting, the bill is very important for the practice of pharmacy as a whole as it recognizes pharmacists as highly trained
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May 2010
MEMBER NEWS
APhA Announces Candidate for Trustee, Jonathan Marquess Information about each candidate will appear on APhA’s web page in early April.
he American Pharmacists Association (APhA) has announced its slate of candidates for President-elect, Trustees and Honorary President for elections to be held in the spring of 2010. Association members will have the opportunity to meet the candidates at APhA’s Annual Meeting and Exposition in Washington, DC, March 12-15, 2010.
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Jonathan G. Marquess, Pharm.D., CDE, CPT, of Acworth, Georgia is one of the candidates for Trustee. He is is the owner of three community pharmacies and is President and CEO of The Institute for Wellness and Education. He chaired the APhA New Practitioner Advisory Committee and served as President of APhA-ASP. He has been involved in many community-based research projects, including the APhA Foundation’s Diabetes Ten City Challenge. About the American Pharmacists Association (APhA) The American Pharmacists Association, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 practicing pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in advancing the profession. APhA, dedicated to helping all pharmacists improve medication use and advance patient care, is the first-established and largest association of pharmacists in the United States. APhA members provide care in all practice settings, including community pharmacies, health systems, long-term care facilities, managed care organizations, hospice settings, and the uniformed services.
Ballots for APhA's upcoming elections will be mailed to members in May, along with ballots for candidates for the executive committees and sections of the APhA Academy of Pharmacy Practice and Management (APhA-APPM) and the APhA Academy of Pharmaceutical Research and Science (APhA-APRS). Members will have the opportunity to vote online or by mail.
GEORGIA CAMPUS – PHILADELPHIA COLLEGE OF OSTEOPATHIC MEDICINE
PCOM School of Pharmacy – Georgia Campus SHAPING PHARMACY EDUCATION FOR TOMORROW’S LEADERS PCOM is proud to offer a new Doctor of Pharmacy (PharmD) degree. Providing future pharmacists with the tools for community and hospital practices, long-term and managed care consulting, pharmacy management, research and academia. PCOM School of Pharmacy – Georgia Campus is now accepting applications. For more information, e-mail us at PharmDAdmissions@pcom.edu or apply now at www.pcom.edu Philadelphia College of Osteopathic Medicine’s Doctor of Pharmacy program has applied for accreditation status by the Accreditation Council for Pharmacy Education, 20 North Clark Street, Suite 2500, Chicago, IL 60602-5109, 312/644-3575; FAX 312/664-4652, Web site, www.acpe-accredit.org. For an explanation of ACPE accreditation process, consult the Office of the Dean, or ACPE.
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Considered one of the greatest challenges on the East Coast — a par 72 triumph — Moorland is the most challenging of the three courses at Legends Resort. It was designed by golf architect P. B. Dye and opened in 1990. It offers deep bunkers, elevation changes, multi-level fairways and greens, as well as signature bulkheads. It is a course reminiscent of the PGA West Stadium Course. This controversial course is definitely a “target” golf course. It will cause golfers to constantly use every ounce of skill and luck in their possession. Moorland earned its designation as one of the “Top 10 New Courses of 1990” by Golf Digest. Play the 245 yard par-4 16th and see for yourself why the large bunker guarding the green is appropriately named “Hell’s Half Acre.”
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MEMBER NEWS
Former GPhA President, Winston “Rusty” O. Bullard, Dies The Times-Herald newspaper for Newnan - Coweta County reported on March 29, 2010 that Winston "Rusty" O. Bullard, age 79, died at his Newnan home on Sunday, March 28, 2010. He was born in Columbia County, Ga. to the late Oscar Clark Bullard and Annie Haynes Bullard. He received his degree from Mercer School of Pharmacy and became a small business owner and Pharmacist in East Point, where he opened Bullard's Pharmacy. He also served on the board of Trustees for Mercer University. In his spare time he enjoyed the outdoors, quail hunting with his bird dogs, Mississippi Jake and Jenny. He served in the early 1980's as the President for the Georgia Pharmaceutical Association. He was a Deacon and taught Sunday school for Dogwood Hills Baptist Church. He relocated to Newnan in 1980 and became a member of First Baptist Church of Newnan where he loved to work at the AO Mission Center. He was actively involved with the East Point Rotary Club.
from 6 until 8 p.m. on Monday evening. In lieu of flowers, memorial contributions can be made to The AO Mission Center, 15 W. Washington Street, Newnan, Ga. 30263. Condolences may be expressed online at www.mckoon.com.
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In addition to his parents, he is preceded in death by sister Jean Crawford. He and his wife Iris Browning Bullard celebrated their 53rd happy wedding anniversary on March 17, just before he went to the hospital and under hospice care.
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In addition to his wife, he is survived by son Mike Thomas and his wife Betty of Sharpsburg; daughters Sabrina Frazier and her husband Alan of Peachtree City, Sabra Hatley and her husband Bill of Haines City, FL.; grandchildren Lee Thomas and his wife Sonia of Sharpsburg, Clint Thomas and his wife Amber of Newnan, Amanda and Erica Frazier of Peachtree City, Branson, Breckon and Bryan Hatley of Haines City, FL.; great-grandchildren Sydney Ethan, Andrew and Kai Thomas; sisters Marjorie Hood, Ruth Gary; brothers John Bullard, Ralph Bullard.
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The funeral service was held on Tuesday, March 30, 2010 at 2 p.m. in the Chapel of McKoon Funeral Home, Dr. Jimmy Patterson and Rev. Jerry Walker officiated. Interment followed at Forest Lawn Memorial Gardens at Red Oak in College Park, Ga. The family received visitors The Georgia Pharmacy Journal
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Continuing Education for Pharmacists Oral anticoagulation without protimes: A review of two emerging agents that may come to market. Lindsay Davis, Pharm.D. (Acute Care Pharmacy Resident, Phoenix VA Medical Center, Phoenix, AZ)
Goals: The goals of this lesson are to provide an overview of two emerging oral anticoagulants and address their potential place in therapy should they be approved by the FDA for the U.S. market. Published clinical trial data will be presented to assess the safety and efficacy of these agents compared to currently available anticoagulants. Objectives: At the conclusion of this lesson, successful participants should be able to: Review elements of the clotting cascade and clotting terminology. List the most common indications for anticoagulation therapy. Identify reasons why new oral anticoagulants could be beneficial in clinical practice. Define the mechanism of action of the two emerging anticoagulants discussed. Based on presented clinical trial data, be able to describe the benefits and risks associated with each new agent. INTRODUCTION Anticoagulants are essential components in the medical management of conditions including the prevention and treatment of thromboembolic disorders such as deep vein thrombosis and pulmonary embolism and in the prevention of cardioembolic events such as stroke from atrial fibrillation. These conditions carry with them significant morbidity and mortality. For patients requiring long-term anticoagulation therapy there is only one oral anticoagulant available on the U.S. market, warfarin, which has many challenges associated with its use. All other available anticoagulants require either intravenous or subcutaneous administration which can be inconvenient or worrisome to patients. New oral anticoagulants are being developed that will hopefully be more efficacious than those currently available while maintaining favorable pharmacokinetic and safety profiles. Due to the inherent risks of interfering with the body’s clotting system, no anticoagulant will be without risk. That said, the goal of anticoagulation therapy is to minimize risk and maximize safety while reducing complications of clot formation within the body. INDICATIONS FOR ANTICOAGULATION THERAPY Common indications for anticoagulation therapy include prevention of cardioembolic stroke in patients with atrial fibrillation or mechanical heart valve prosthesis, and in the treatment and prevention of venous thromboembolism (VTE) which consists of deep vein thrombosis (DVT) and pulmonary embolism (PE). The vast majority of the patient population undergoing anticoagulation therapy falls into one of these categories. The emerging anticoagulants referred to in this article will be discussed in terms of the risks and benefits of these novel agents as they relate to these disease states. COAGULATION CASCADE The human body utilizes an elaborate system of proteins & feedback mechanisms to maintain homeostasis in regard to bleeding and clotting. This coagulation system relies on communication of tissues and coagulant proteins (clotting factors) that provide both a means to repair wounds (fibrin clot formation) and degrade clots once the tissues have been fully repaired (fibrinolysis).1 The clotting and fibrinolytic system is an intricate series of successive protein activation and is called the “coagulation cascade�, see Figure 1. The coagulation cascade consists of two primary pathways, the intrinsic and extrinsic pathways, which both lead to the final common pathway and ultimately fibrin clot (thrombus) formation.1 Inhibition of the activity or production of clotting factors results in disruption of the coagulation cascade and decreased thrombus formation. Current and emerging anticoagulants alter different steps within the clotting cascade either by decreasing the production of clotting factors (e.g. warfarin), through indirect inhibition of clotting factors (e.g. heparin, low-molecular weight heparins, fondaparinux), or through direct inhibition of clotting factors (e.g. direct thrombin inhibitors, direct factor Xa inhibitors).1 Simply stated, anticoagulants slow the rate of coagulation. Two common misconceptions about anticoagulation therapy are that anticoagulants completely prevent clotting from occurring and that anticoagulant therapy causes bleeding.
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Figure 1 – Coagulation Cascade
Adapted from figure 1 in Reference 1. MECHANISM OF ACTION OF CURRENTLY AVAILABLE ANTICOAGULANTS Currently the US market has nine FDA approved agents for anticoagulation therapy, each with differing indications and limitations (Tables 1 and 2). Table 1: FDA approved anticoagulants
Warfarin depletes vitamin K dependent clotting factors II, VII, IX, and X thereby effectively inhibiting both the intrinsic and extrinsic pathways of coagulation.1 Since 1954, the vitamin K antagonist (VKA) warfarin has been and remains the only available oral anticoagulant on the U.S. market. Challenges associated with use of warfarin include the need to individualize the dosage due to its unpredictable anticoagulant effect, multiple food & drug interactions, and narrow therapeutic window.1 Warfarin therapy requires regular monitoring of the patient’s international normalized ratio (INR) to maintain safety and efficacy. This monitoring requires trained medical professionals who are diligent with, at minimum, monthly follow-up with patients. Heparin potentiates the actions of antithrombin III. Antithrombin III inactivates thrombin (factor IIa) and factors IXa, Xa, XIa, and XIIa.1 The actions of heparin inhibit the propagation of the intrinsic and final common pathways of the coagulation cascade. Drawbacks to the use of unfractionated heparin (UFH) include route of administration (intravenous or subcutaneous) and unpredictable anticoagulant effect due to unspecific binding.1 The unpredictable anticoagulant effect of UFH requires regular monitoring of the activated partial thromboplastin time (aPTT) and careful dose titration by skilled providers.1 Additionally, heparin carries the paradoxical risk of thrombosis called heparin-induced thrombocytopenia (HIT).1 Low-molecular weight heparins (LMWHs) such as enoxaparin, dalteparin, and tinzaparin cause antithrombin IIImediated inhibition of factor Xa and, to a lesser extent, inhibition of thrombin (factor IIa)1. Limitations to The Georgia Pharmacy Journal
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anticoagulation treatment with LMWHs include the requirement of subcutaneous administration, risk of accumulation of drug with renal impairment, and risk of HIT.1 The indirect factor Xa inhibitor, fondaparinux, exerts its anticoagulant effects through antithrombin III mediated selective inhibition of factor Xa.1 Limitations to fondaparinux include requirement of subcutaneous administration and the risk of drug accumulation with renal impairment.1
Table 2: Limitations of current anticoagulants
Adapted from table 1 in Reference 1. EMERGING ANTICOAGULANT AGENTS As discussed, there are many limitations and undesirable attributes to the currently available anticoagulants on the U.S. market today. A novel oral anticoagulant that could provide equivalent or superior efficacy and similar or enhanced safety would be a beneficial addition to current therapy options. An agent that does not require regular measurement of clotting times (e.g. INR, aPTT) would also be preferable. Table 3 lists desired attributes for newly developed anticoagulants. Dabigatran and rivaroxaban are two oral anticoagulants that are being developed for the treatment of various clotting disturbances. According to ClinicalTrials.gov there are currently 19 trials involving dabigatran and 25 trials involving rivaroxaban in various stages of completion.2 These agents are being studied for the prevention of cardioembolic stroke due to atrial fibrillation, in the treatment and prevention of venous thromboembolism, and in the medical management of acute coronary syndrome. Even though these agents have not been approved by the FDA and are therefore not available in the U.S. at this time, there are several published clinical trials that offer insight into the possible risks and benefits of their use. Table 3: Desired attributes for newly developed anticoagulants
DABIGATRAN Dabigatran is an oral direct thrombin inhibitor.3 It was approved for use in Europe and Canada in 2008 for venous thromboembolism (VTE) prophylaxis in elective total hip and total knee replacement (THR/TKR) under the brand names of Pradax速 and Pradaxa速, respectively.4 Dabigatran binds specifically to thrombin and has little effect on other clotting factors.4 By binding to the active site of thrombin, dabigatran inhibits the conversion of fibrinogen to fibrin, The Georgia Pharmacy Journal
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thereby blocking the final step of the coagulation cascade and thus fibrin clot formation. Dabigatran has a unique pharmacokinetic profile (see Figure 1). Dabigatran etexilate is given orally and is converted into its active metabolite, dabigatran, after absorption from the gastrointestinal tract. The bioavailability of dabigatran is very poor and absorption is dependent upon an acidic environment.3 To overcome this, the manufacturer designed a capsule containing pellets with a tartaric acid core and coated with dabigatran etexilate.5 This creates an acidic microenvironment that improves dissolution and absorption of the drug independent of gastric pH.5 The prodrug dabigatran etexilate is hepatically converted into two active metabolites, dabigatran glucuronide which is excreted through the biliary system, and dabigatran which is renally eliminated.5 Because of the extensive renal elimination of dabigatran, it is contraindicated in patients with severe renal impairment.4 The onset of effect for dabigatran is within 1 hour of dosing and the anticoagulant effect parallels plasma concentrations.4 As a result of the quick onset of effect, anticoagulant therapy with dabigatran would not require bridge therapy with heparins or fondaparinux when immediate anticoagulation is critical. Figure 2: Pharmacokinetic profile for dabigatran
Adapted from text in Reference 4. The RE-LY trial was a non-inferiority trial comparing warfarin and dabigatran for stroke prevention in patients with atrial fibrillation (AF).6 Adjusted dose warfarin with a goal INR of 2-3 was compared to two different dosages of dabigatran, 110mg bid and 150mg bid (Table 4). There were over 18,000 patients enrolled in this study. Median follow up time for this trial was 2 years. For the primary outcome of stroke or systemic embolism dabigatran showed noninferiority (or equivalence) to warfarin for both dosages and superiority with the higher dosage of 150mg bid. The rate of stroke or systemic embolism per year was 1.69% for warfarin, 1.53% for dabigatran 110mg, and 1.11% for dabigatran 150mg. Major bleeding was no different between warfarin (3.36%/yr) and the 150mg dose dabigatran (3.11%/yr) but was significantly less for the 110mg dose of dabigatran (2.71%/yr). Although there was no difference in major bleeding between dabigatran and warfarin at the 150mg dosage, there was a significant increase in GI bleeding with this dosage of dabigatran compared to warfarin, 1.51%/yr and 1.02%/yr respectively. Furthermore there was an increased rate of drug discontinuation with dabigatran (14.5%/yr for 110mg dose, 15.5%/yr for 150mg dose) over warfarin (10.2%/yr), mainly due to an increase in dyspepsia. The authors postulate that the increase in dyspepsia and potentially the increased risk of GI bleeding can be attributed to the required acidic microenvironment utilized in the capsule to aid in drug absorption.6 There was an increased rate of myocardial infarction (MI) with both dosages of dabigatran (0.72%/yr for 110mg dose, 0.74%/yr for 150mg dose) compared to warfarin (0.53%/yr) with the difference in rate of MI with the 150mg dosage being statistically significant. The investigators suggest that this may be due to the protective nature of warfarin against MI and not as a result of dabigatran causing MI.6 Overall this study found a decrease in death from any cause with the use of dabigatran versus warfarin with a more pronounced effect with the higher dosage of dabigatran. It is important to note that patients with severe renal or hepatic dysfunction were excluded from this trial, so more data are needed to determine the effect of dabigatran on this subset of patients. Currently there is an ongoing trial, named RELY-ABLE, which has an estimated completion date of July 2011 that is a long term extension of the RE-LY trial to evaluate long-term safety of this agent.7 In conclusion, the results of the RE-LY trial support the use of The Georgia Pharmacy Journal
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dabigatran for stroke prevention in patients with atrial fibrillation. Table 4: Results of RE-LY trial
Dabigatran has also been studied for the use of VTE prophylaxis in total hip and total knee replacement (THR/TKR). The RE-NOVATE, RE-MODEL, and RE-MOBILIZE trials evaluated enoxaparin versus dabigatran at doses of 150mg or 220mg once daily (Table 5).8 It is helpful to be familiar with the two different dosage regimens for enoxaparin that were used in these trials. In Europe enoxaparin is used for VTE prophylaxis for THR/TKR at a dosage of 40mg SQ once daily started 12 hours prior to surgery.9 In the U.S., enoxaparin is used for VTE prophylaxis for TKR at an approved dosage of 30mg SQ twice daily starting 12 – 24 hours after surgery.9 Both dosage regimens are approved for VTE prophylaxis in THR in the U.S. When evaluating the outcomes of these trials, it is important to keep in mind the regimen that is used for enoxaparin for this indication in the U.S. as this will most closely mirror the true effects in the U.S. patient population. It is also important to be familiar with duration of anticoagulation therapy used for prophylaxis in these trials. The CHEST 2008 Guidelines recommend at least 10 days but up to 35 days of anticoagulation therapy for VTE prophylaxis in THR and at least 10 days of prophylaxis for TKR.1 The first two trials, RE-NOVATE and REMODEL, provided prophylaxis for 6 – 10 days, meaning that not all patients met the 10 day minimum recommended by CHEST.8 Together, these trials enrolled over 8,000 patients.7 In the RE-NOVATE trial, enoxaparin 40mg daily was compared to dabigatran 150mg or 220mg once daily for VTE prophylaxis in THR. Dabigatran was shown to be noninferior (equal) to enoxaparin for this indication. The primary outcome of VTE and all-cause mortality occurred in 6.7% of patients in the enoxaparin group, 8.6% in the dabigatran 150mg group, and 6.0% in the dabigatran 220mg group. In the RE-MODEL trial, enoxaparin 40mg daily was compared to dabigatran for VTE prophylaxis in TKR. Dabigatran was also shown to be non-inferior (equal) to enoxaparin for this indication. The primary outcome of VTE and all-cause mortality occurred in 37.7% of patients in the enoxaparin group, 40.5% in the dabigatran 150mg group, and 36.4% in the dabigatran 220mg group. The results and data gained from these two trials aided in the approval of this medication in Europe and Canada. In the RE-MOBILIZE trial, U.S. enoxaparin dosing of 30mg twice daily was compared to dabigatran for VTE prophylaxis in TKR. For the primary endpoint of VTE and all-cause mortality, both dosages of dabigatran were found to be inferior to enoxaparin (dabigatran 150mg 33.7%, dabigatran 220mg 31.1%, and warfarin 25.3%). Major bleeding was not significantly different among any dosage regimen for enoxaparin or dabigatran across all three studies. In conclusion, dabigatran may be useful in the prophylaxis of VTE in THR/TKR with more data being needed comparing the U.S. enoxaparin dosage regimen with dabigatran and appropriate lengths of treatment. No difference in bleeding rates, hepatic enzyme elevation, or acute coronary syndrome between enoxaparin and dabigatran was found in any of these three trials.
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Table 5: Results of RE-NOVATE, RE-MODEL, & RE-MOBILIZE
RIVAROXABAN Rivaroxaban is a direct factor Xa inhibitor.3 It was also approved for use in Europe and Canada in 2008 for VTE prophylaxis in elective THR and TKR, under the brand name Xarelto速.4 Rivaroxaban is different than fondaparinux in that rivaroxaban is a direct inhibitor of factor Xa and does not require antithrombin III to exert its effects. Therefore, rivaroxaban can be referred to as an antithrombin III independent inhibitor of factor Xa. Rivaroxaban inhibits both free and unbound factor Xa and by doing so prevents the conversion of prothrombin to thrombin and preventing thrombus formation.1 Rivaroxaban is given orally and is 80% bioavailable.3 It is hepatically metabolized by the cytochrome P450 enzymes CYP3A4 and CYP2J2, which means that drugs that inhibit these enzymes may cause plasma drug levels to rise.3 Twothirds of rivaroxaban is excreted via the kidneys, therefore it can be expected that either dosage adjustments or contraindications for use in impaired renal function will be warranted.4 Peak plasma concentrations are achieved within 3 hours and the half-life is 9 hours.4 As a result of its quick onset of effect, anticoagulant therapy with rivaroxaban would not require bridge therapy with heparins or fondaparinux when immediate anticoagulation is critical. The RECORD trials are Phase III clinical trials conducted comparing enoxaparin to rivaroxaban for VTE prophylaxis in total hip and knee replacement.3 The RECORD 1 trial enrolled over 4,500 patients and showed rivaroxaban as having superior efficacy over enoxaparin at the dosage of 40mg SQ once daily for the prevention of VTE in THR, 3.7% vs. 1.1% respectively.10 There was no difference in rate of major bleeding between the two groups. The trials RECORD 3 and RECORD 4 compared enoxaparin to rivaroxaban for the prevention of VTE in total knee replacement.9,11 RECORD 3 used the European enoxaparin dosing of 40mg SQ once daily and RECORD 4 used the US enoxaparin dosing of 30mg SQ twice daily. Both the RECORD 3 and RECORD 4 trials showed a statistically significant decrease (superiority) in risk of VTE and all-cause mortality with rivaroxaban versus enoxaparin with no difference in major bleeding.9,11 There are concerns that rivaroxaban may cause drug-induced liver injury and clinically relevant non-major bleeding.12 Rivaroxaban was submitted for approval to the FDA for the indication of VTE prophylaxis in total hip and knee replacement based on the findings of these trials. The FDA advisory panel preliminarily approved rivaroxaban in March 2009, however in May 2009 the FDA sought further information regarding safety data.12 At this time, approval of rivaroxaban is still pending FDA review.
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Table 6: Results of REORD 1, RECORD 3, & RECORD 4 trials
CONCLUSIONS In summary, anticoagulation therapy is an integral part of care for the treatment and prevention of venous thromboembolism and in the prevention of stroke in patients with mechanical heart valve prosthesis or in those with atrial fibrillation. Warfarin, the mainstay of long-term oral anticoagulation therapy, requires close monitoring but has been shown to be very effective when used with care. Other currently available anticoagulants are limited by their need for parenteral administration. There is an enormous amount of data that remains to be gathered, published, and evaluated regarding these two emerging agents, dabigatran and rivaroxaban. Early evidence indicates potential promise for the use of these agents in prevention of cardioembolic stroke in atrial fibrillation and/or VTE prophylaxis in total hip and knee replacement surgeries. In addition to efficacy, long-term safety must be established before either of these agents might be (safely) approved for use in the U.S. market. REFERENCES 1. Lassen MR, Laux V. Emergence of new oral antithrombotics: a critical appraisal of their clinical potential. Vascular Health and Risk Management. 2008; 4(6): 1373-86. 2. ClinicalTrials.gov. Accessed via the internet on 01/18/2010. 3. Karthikeyan G, Eikelboom JW, Hirsh J. New oral anticoagulants: not quite there. Pol Arch Med Wewn. 2009; 199(1-2): 53-9. 4. Eriksson BI, Quinlan DJ, Weitz JI. Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor Xa inhibitors in development. Clin Pharmacokinet. 2009; 48(1): 1-22. 5. Stangier J. Clinical pharmacokinetics and pharmacodynamics of the oral direct thrombin inhibitor dabigatran etexilate. Clin Pharmacokinet. 2008; 47(5): 285-95. 6. Connolly S, Ezekowitz MD, Yusuf S. Dabigatran versus warfarin in patients with atrial fibrillation. NEJM. 2009; 361(12): 1139-51. 7. RELY-ABLE Long term multi-center extension of dabigatran treatment in patient with atrial fibrillation who completed RE-LY trial. NCT00808067. ClinicalTrials.gov. Accessed via the internet on 01/18/2010. 8. Weitz JI, Hirsh J, Samama MM. New antithrombotic drugs. CHEST. 2008; 133(6): 247s-248s. 9. Lassen MR, Ageno W, Borris LC, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. NEJM. 2008; 358(26): 2776-86. 10. Eriksson BI, Borris LC, Friedman RJ, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. NEJM. 2008; 358(26): 2765-75. 11. Turpie AG, Lassen MR, Davidson BL, et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD 4): a randomized trial. Lancet. 2009; 373: 1673-80. 12. Stiles S. FDA puts rivaroxaban decision on hold, seeks further information. Accessed via the internet at http://www.theheart.org/article/974923.do on 01/02/2010.
Reprinted with permission of the author. No financial support was received for this activity. This coninuing education activity may appear in other state pharmacy association Journals.
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Continuing Education for Pharmacists Quiz and Evaluation Oral anticoagulation without protimes: A review of two emerging agents that may come to market. 1. Anticoagulation therapy: a. completely prevents clot formation b. makes patients bleed c. results in coagulation d. slows the rate of coagulation
7. All of the following are true EXCEPT: a. Clinical trials have found dabigatran to have equivalent efficacy compared to enoxaparin (40 mg once daily) for VTE prophylaxis in total hip replacement and total knee replacement. b. Clinical trials have found dabigatran to have equivalent efficacy compared to enoxaparin (30mg twice daily) for VTE prophylaxis in total hip replacement. c. Dabigatran is approved for VTE prophylaxis in total hip and total knee replacement in Europe and Canada. d. The RE-LY trial found that dabigatran was noninferior (equivalent) to warfarin for the prevention of cardioembolic stroke in atrial fibrillation.
2. The only oral anticoagulant available on the U.S. market today is: a. enoxaparin b. dabigatran c. warfarin d. fondaparinux 3. Venous thromboembolism (VTE) includes both: a. deep vein thrombosis (DVT) and pulmonary embolism (PE) b. deep vein thrombosis (DVT) and ischemic stroke c. ischemic stroke and pulmonary embolism (PE) d. atherosclerotic plaque and pulmonary embolism (PE)
8. Rivaroxaban’s mechanism of action is a: a. Direct thrombin inhibitor b. Antithrombin III dependent inhibitor of thrombin c. Direct Factor Xa inhibitor d. Antithrombin III dependent inhibitor of factor Xa
4. Indications for anticoagulation therapy include: a. treatment of venous thromboembolism (VTE) b. prevention of VTE in orthopedic surgery c. prevention of stroke in atrial fibrillation d. all of the above
9. The RECORD trials found that rivaroxaban has ______ efficacy for the prevention of venous thromboembolism in total knee and total hip replacement as compared to enoxaparin. a. Inferior b. Equivalent c. Superior d. Indeterminant
5. Desirable attributes for newly developed anticoagulants include all of the following EXCEPT: a. Oral administration b. Targets multiple clotting factors c. Low risk of bleeding d. Available antidote
10. The FDA advisory panel requested further safety data prior to the approval of rivaroxaban likely to assess what concerns: a. Hepatotoxicity and dyspepsia b. Hepatotoxicity and increased bleeding risk c. Pulmonary toxicity and increased bleeding risk d. Pulmonary toxicity and dyspepsia
6. Dabigatran’s mechanism of action is a: a. Direct thrombin inhibitor b. Antithrombin III dependent inhibitor of thrombin c. Direct Factor Xa inhibitor d. Antithrombin III dependent inhibitor of factor Xa
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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.
Oral anticoagulation without protimes: A review of two emerging agents that may come to market. This lesson is a knowledge-based CPE activity and is targeted to pharmacists. GPhA code: J10-05 ACPE#: 0142-0000-10-105-H01-P Contact Hours: 1.0 (0.1 CEU) Release Date: 05/01/2010 Expiration Date: 05/01/2013 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.
A A A A A
B B B B B
C C C C C
D D D D D
6. A B C D 7. A B C D 8. A B C D 9. A B C D 10. A B C D
Activity Evaluation: must be completed for credit Please rate the following items on a scale from 1 (poor) to 5 (excellent)as to how well the activity: 1. 2. 3. 4. 5. 6. 7. 8.
Met my educational needs: Relates to pharmacy practice: Achieves the stated learning objectives: Faculty presented the information: Teaching methods conveyed information: Post-test aided in assessing my grasp of the information: Avoided any bias or commercial bias: How long did it take to complete this activity?
1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 1 2 3 4 5 _______________________
A passing grade of 70% is required for each examination. A person who fails the exam may resubmit the quiz only once at no additional charge. Please check here if you are indicating a change of address â
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Name: ____________________________________________________________________________ License Number(s) and State(s): ___________________ Email Address: ___________________________ Address: __________________________________________________________________________ City: _________________ State: __________ Zip: __________ Remove this page from the Journal and mail this completed quiz and evaluation to: GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324. The Georgia Pharmacy Journal
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May 2010
GEORGI A PH ARM ACY ASSOCI ATION, I NC Membership Application Member # Member Name
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Membership Categories (select one): Active Pharmacist $175.00 Joint (husband and wife) $262.50 nd New Graduate, 2 year $120.00 st New Graduate, 1 year $60.00
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Academy Member (select one): ACP, Consultant Pharmacists
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404-364-5021 fax ~ GPhA · 50 Lenox Pointe NE · Atlanta, GA 30324 ~ 404-231-5074 phone www.GPhA.org
2009 - 2010 GPhA BOARD OF DIRECTORS
The Georgia Pharmacy Journal Editor:
Jim Bracewell jbracewell@gpha.org
Managing Editor & Designer:
Kelly McLendon kmclendon@gpha.org
The Georgia Pharmacy Journal® (GPJ) is the official publication of the Georgia Pharmacy Association, Inc. (GPhA). Copyright © 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.
ARTICLES AND ARTWORK Those who are interested in writing for this publication are encouraged to request the official GPJ Guidelines for Writers. Artists or photographers wishing to submit artwork for use on the cover should call, write or e-mail the editorial offices as listed above.
SUBSCRIPTIONS AND CHANGE OF ADDRESS The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate for non-members is $50.00 per year domestic and $10.00 per single copy; international rates $65.00 per year and $20.00 single copy. Subscriptions are not available for non-GPhA member pharmacists licensed and practicing in Georgia. The Georgia Pharmacy Journal® (GPJ) (ISSN 1075-6965) is published monthly by the GPhA, 50 Lenox Pointe NE, Atlanta, GA 30324. Periodicals postage paid at Atlanta, GA and additional offices. POSTMASTER: Send address changes to The Georgia Pharmacy Journal®, 50 Lenox Pointe, NE, Atlanta, GA 30324.
ADVERTISING Advertising copy deadline and rates are available at www.gpha.org upon request. All advertising and production orders should be sent to the GPhA headquarters as listed above.
GPhA HEADQUARTERS 50 Lenox Pointe, NE Atlanta, Georgia 30324 Office: 404.231.5074 Fax: 404.237.8435
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Don Davis Gina Ryan Johnson Meagan Spencer Barbee Rusty Fetterman Garrick Schenck Daniel Forrister Lance Faglie
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The Georgia Pharmacy Journal
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May 2010