The Official Publication Of The Florida Pharmacy Association JUNE 2019
LEGISLATIVE REPORT
“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”
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florida PHARMACY TODAY Departments 4 Calendar
VOL. 82 | NO. 6 JUNE 2019 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION
Features
4 Advertisers 5 President’s Viewpoint
7 Executive Insight
26 Buyer's Guide
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Andexanet alfa (ANDEXXA): A Novel Antidote which Reverses Bleeding in Patients Treated with Factor Xa Inhibitors Perceptions to Possibilities: Going Beyond Prescriptions End of Legislative Session Report: A Recap of 2019 Cultivating a Pipeline of Leadership in Florida
Correction: In the May 2019 issue of Florida Pharmacy Today, the Larkin University College of Pharmacy was mistakenly identified as the Larkin Health Sciences Institute College of Pharmacy. We regret the error and apologize to the College’s students, faculty, alumni and friends.
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FPA Calendar 2019
Florida Pharmacy Today Journal
JULY 4
Independence Day FPA Office Closed
10-14 129th Annual FPA Meeting and Convention Ft. Lauderdale AUGUST 2
FPA Governmental Affairs Committee Meeting Orlando
4-7
36th Annual Southeastern Gatherin' Destin
15-16 Florida Board of Pharmacy Meeting Tampa
SEPTEMBER 7-8
Regulatory and Law Conference Miami OCTOBER
5-6
Florida Board of Pharmacy Meeting Tampa
8-9
Florida Board of Pharmacy Meeting Fort Lauderdale
12-13 FPA Midyear Clinical ConferenceKissimmee 26-29 NCPA Annual Conference San Diego, California
16-17 Southeastern Officers Conference Atlanta 24-25 FPA Councils and Committee Meetings; FPA Board of Directors Meeting
FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW. PHARMVIEW.COM
Events calendar subject to change
CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE Continuing Education as part of the required 30 hours’ general education needed every license renewal period. There is a new 2 hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists should have satisfied all continuing education requirements for this biennial period by September 30, 2019 or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by December 31, 2020. For Pharmacy Technician Certification Board Application, Exam Information and Study materials, please contact the FPA office. For more information on CE programs or events, please contact the Florida Pharmacy Association at (850) 222-2400 or visit our website at www.pharmview.com CONTACTS FPA — Michael Jackson (850) 222-2400
FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169
FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300
Mission Statements:
Note: The views of the authors do not necessarily represent the views or opinions of the Florida Pharmacy Association, Florida Pharmacy Today or any related entities.
The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.
Florida Pharmacy Today Board of Directors The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.
Advertisers AMERICAN ASSOCIATED PHARMACIES...... 15 KAHAN & ASSOCIATES................................. 14 PQC........................................................................ 2 PARTNERSHIP FOR SAFE MEDICINES......... 9 PHARMACISTS MUTUAL.............................. 25
DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association is engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by the maker of the product should always be consulted before use.
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FLORIDA PHARMACY TODAY
E-MAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com
The President’s Viewpoint ANGELA S. GARCIA, PHARMD/MPH, CPH
The Power of Reflection It is finally the time to close out the year and reflect on The Power of WE. The Association has come to a point in time where a rebranding was aligned with the timing of a new five-year Strategic Plan. The Power of WE comes from realignment of the priority to serve the membership and fulfill the purpose of our Association as leaders, rather than to serve the “self” or the “ME.” Flipping the ME upside down gives us the WE and we are very powerful when we embrace the WE and move in unison toward service. We had to till the ground, break up the old boys’ mentality and way of doing and shift the focus of our leadership from perceptions of power without a system of accountability to servant leaders with an awareness of service and duty to the profession, our members and our patients. It was absolutely the passion of the Councils, Committees and Subcommittees that drove our success during the 2018-2019 service year. Our Strategic Plan was a success in moving our Association in a stronger direction and we accomplished a great deal. More than tangible things or deliverables to hold, we showed a presence and it’s caused a stir among the membership. This is a very good thing and we know that the movement for continued change and transformation will continue. We had many performance indicators – working through our strategic plan priorities, goals and objectives. I have so much respect for the ownership each of the Council chairs and cochairs took, and how they poured their passion into leading their respective teams. What carries great meaning for me, is that they all knew I wanted to be out of their way to allow them to elevate to the level of leadership, mentor-
ship and guidance they were capable of. To empower and surrender control over to your team brings waves of return not otherwise available if they are restricted or micromanaged. Each of the chairs and co-chairs were selected because of their expertise, experience and ability to lead, and stepping out of their roles allowed them to achieve all their accomplishments this year. Some tasks were started, some finished and others deferred to address priorities the teams identified. Through surrender, they thrived and I look forward to seeing advancement of our Association and our strategic plan from the foundations they set. I am excited for the transformation of our leadership, and I thank those who served this year who have completed their terms: Susy Wize as chairman of the Board, Jeanette Connelly as speaker of the House, Ashley Huff as treasurer, Joy Wright as Region 1 director, Dean Pedalino as Region 3 director, Melissa Ruble as Region 5 director and Mitchell Fingerhut as Region 9 di-
Angela S. Garcia, PharmD, MPH, CPh
rector. I want to thank the chairs and co-chairs of our Councils and Committees: Eric Larson and Bill Mincey for GAC, Bert Martinez and James Alcorn for Organizational Affairs, Raul Correa and David Pino for Public Affairs, Sarah Haley and Charlie Brown for Membership Affairs, Pooja Patel and Car-
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2018-19 FPA Board of Directors The Florida Pharmacy Association gratefully acknowledges the hard work and dedication of the following members of the FPA leadership who work diligently all year long on behalf of our members.
Suzanne Wise.....................................................................................................Board Chair Angela Garcia...............................................................................................FPA President Ashley Huff.................................................................................................... FPA Treasurer David Mackarey.......................................................................................President-Elect Jeanette Connelly...................................................................Speaker of the House Gary Koesten..................................................................Vice Speaker of the House Sandy Estrada......................................................................................... FSHP President Joyanna Wright................................................................................... Region 1 Director Neil Barnett............................................................................................Region 2 Director Dean Pedalino.......................................................................................Region 3 Director Cheryl Rouse.........................................................................................Region 4 Director Melissa Ruble........................................................................................Region 5 Director Barbara Beadle...................................................................................Region 6 Director Paul Delisser.......................................................................................... Region 7 Director Ramy Gabriel.........................................................................................Region 8 Director Mitchell Fingerhut.............................................................................Region 9 Director Julie Burger........................................................................................Technician Member
Florida Pharmacy Today Journal Board Chair.............................................................. Carol Motycka, motycka@cop.ufl.edu Vice Chair....................................................Cristina Medina, cmmedina@cvs.com Treasurer.........................................................Eric Jakab, ericjakab@hotmail.com Member.................................................. Michael Finnick, michaelfinnick@ufl.edu Member.......................................................Matt Schneller, schnem18@gmail.com Member..........................................Teresa Tomerlin, teresapharmd@cfl.rr.com Member............................................Greta Pelegrin, gretapelegrin@yahoo.com Technician Member........................Julie Burger, julieburger133@gmail.com Executive Editor................Michael Jackson, mjackson@pharmview.com Managing Editor...................Dave Fiore, dave@fiorecommunications.com Journal Reviewer....................... Dr. Melissa Ruble, mruble@health.usf.edu Journal Reviewer....................................Dr. Angela Hill, ahill2@health.usf.edu
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men Aceves for Educational Affairs, Luther Laite for Professional Affairs and Genevieve Hale and Joseph Shoyoye for Student Affairs Council. I appreciate the dedication and effort of our technicians and student pharmacists to carry out the tasks and be the operations mechanism of our Association this year. Without their dedication, the Power of WE wouldn’t have been embraced. What we did not accomplish is a perfect place to reflect and determine what the barriers were, and once identified, how we remove those barriers to allow other leadership teams the ability to progress further. We will be conducting a lot of leadership development as I transition into the next service term as chairman of the Board of Directors. We will be embracing best practice for BOD meetings, realigning with good governance and ensuring our leadership is educated about their roles, our duties and strengthening the leadership. Instilling a cornerstone of transparency and accountability will give us the greatest opportunity for a deep-rooted strength. Removing the misinformation, misperceptions and misguided efforts will help our Association rise to the level we should be functioning – our greatest capacity as leaders for the profession in Florida. This new awareness, education and new approach to leadership by the BOD will translate to a stronger leadership core built on the principles of our duty to serve, and this will be the first step back toward the trust our membership needs to have in us. I am excited to step away from the service term of president and into the service term of chairman of the BOD, and I look forward to supporting our incoming president, David “Chachi” Mackeray and his leadership team. Partnering with our President-elect Joe Scuro to help cultivate a continuum of integrity and transformative leadership will undoubtedly reestablish trust and accountability and recruit the membership growth. It is through the Power of WE that we brought about change, and we will continue to grow ourselves and bring in a pipeline of new leadership to carry us into the next phase of the practice of pharmacy. If we build strong, we stay strong. n
Executive Insight BY MICHAEL JACKSON, RPH MICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION
D
Relief Needed on DIR Fees. Congress, Where Are You?
irect and indirect remuneration (DIR) fee is a term given to action taken by Medicare Part D plans through its contracted PBMs to collect money from providers to offset patient costs. The use of DIR fees is likely expanding into the commercial market place, which is beyond the Medicare program. The DIR fee system was created by the Center for Medicare and Medicaid Services to address prescription drug cost variances between gross prescription drug costs of Medicare Part D plans that were not captured at the point of sale and any pricing concessions. It is in this determination of the DIR fee where pharmacy providers are struggling to understand. This entire system of retrospectively adjusting fees to pharmacy providers is creating a major disruption and cash flow challenges. As per a survey conducted by NCPA on 640 community pharmacists, 87 percent of pharmacists said DIR fees significantly affected their pharmacy’s ability to provide patient care and remain in business. Pharmacy advocates have been working hard with the Center for Medicare and Medicaid Services (CMS) to reform this totally nontransparent and onerous system of pharmacy reimbursement through rulemaking. Sadly, CMS in its recent release of the rule failed miserably to address this issue. It is clear that we have to now rely upon Congress and the president of the United States to fix this problem. Bills were filed during the previous Congressional session to correct this problem (H.R. 5951 and S. 3308). Congress failed to take action on those bills and we now have to work with a new Congress. A letter from 28 members of the U.S. Sen-
ate was sent to the Trump administration on June 7, 2019, asking for action on this issue. Neither of Florida’s two senators were listed on that letter. The House of Representatives is preparing a similar letter to the President and FPA
As per a survey conducted by NCPA on 640 community pharmacists, 87 percent of pharmacists said DIR fees significantly affected their pharmacy’s ability to provide patient care and remain in business.
Michael Jackson, B.Pharm
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members who had been asked to contact their Congressman and ask that they support that letter (see June 5, 2019, Stat News). For the current Congressional session, there are several bills addressing the DIR debacle. S 988 and HR 803 will do the following:
Boost transparency in drug pricing. Prohibiting these retroactive pharmacy fees will make Medicare Plan Finder more accurate and allow better CMS oversight. Give seniors reduced cost-sharing and greater budget predictability. Beneficiaries who use their drug plan to fill prescriptions are punished the most by pharmacy DIR fees. This is because retroactive fees lead to inflated drug costs that are the basis for beneficiary cost-sharing amounts. Preserve access to independent community pharmacies. Locally owned pharmacies provide enhanced patient care and are often located in underserved rural and inner city areas. The number of U.S. independent community pharmacies has declined the past five years and a recent study estimated 3 million rural residents are at risk of losing the JUNE 2019 |
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FPA STAFF Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200
Director of Continuing Education Tian Merren-Owens, ext. 120
Educational Services Office Assistant Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110 Accounting Coordinator Ashley Gandy ext. 211
FLORIDA PHARMACY TODAY BOARD Chair..................................... Carol Motycka, St. Augustine Vice Chair................................Cristina Medina, Hollywood Treasurer...........................................Eric Jakab, Gainesville Member............................... Michael Finnick, Jacksonville Member...............................................Matt Schneller, Tampa Member...................................Teresa Tomerlin, Rockledge Member..............................................Greta Pelegrin, Hialeah Technician Member.................Julie Burger, Pensacola Executive Editor.........Michael Jackson, Tallahassee Managing Editor.........................Dave Fiore, Tallahassee
This is a peer-reviewed publication. ©2019 FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. FLORIDA PHARMACY ASSOCIATION
610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web Address: http://www.pharmview.com 8 |
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only pharmacy in their community with the next nearest pharmacy over 10 miles away, a trend exacerbated by pharmacy DIR fees. Address the concerns of CMS and MedPAC. CMS has noted “variations in the treatment of costs and price concessions affect beneficiary cost sharing, CMS payments to plans, federal reinsurance and low-income cost-sharing subsidies, manufacturer coverage gap discount payments and plan bids.” According to MedPAC’s 2015 Report to Congress, “MedPAC sees insurers gaming the system to hold premiums down and maximize enrollment.”
It is very clear that the current system of reimbursement for pharmacy providers is being gamed at the expense of our industry and also the patients we serve. No other industry that we are aware of is compensated in this manner and this has to be fixed now. We elected our Florida members of Congress to look out for our interests and the interests of the patients that we serve. Where are they? n References
1. Looking Beneath the Surface of DIR, Goar Alvarez, PharmD, Ranga Narla, PharmD, LeanneLai, PhD and Alberto Wertheimer, PhD – Florida Pharmacy Today, October 2018 2. https://www.ncpanet.org/advocacy/federal-advocacy/pharmacy-dir-fees
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Andexanet alfa (ANDEXXA): A Novel Antidote which Reverses Bleeding in Patients Treated with Factor Xa Inhibitors By Margareth Larose-Pierre, Pharm.D., Chenita Carter, Pharm.D., Laura Simmons, Pharm.D., and Marlon S. Honeywell, Pharm.D. Margareth Larose-Pierre, Pharm.D., is associate dean and associate professor of pharmacy practice of the Florida A&M University College of Pharmacy’s Durell Peaden Jr. Center. In addition to teaching and training doctor of pharmacy students, Dr. Larose-Pierre has been an active member of multiple professional organizations. In her professional affiliations and in academia, she remains a strong advocate for pharmacy students’ involvement in community activities and research in areas including pharmacy practice, critical care, infectious disease, immunization, medication therapy management and screening of patients for chronic diseases (i.e hypertension, diabetes mellitus, coagulopathies). Chenita Carter, Pharm.D., M.S., is an assistant professor of pharmacy practice at Florida A&M University’s College of Pharmacy and Pharmaceutical Sciences. Dr. Carter received her Doctor of Pharmacy degree from FAMU and completed PGY1 residency at Sacred Heart Hospital in Pensacola, Florida. She earned a Master of Science degree in pharmaceutical outcomes and policy from the University of Florida in 2015. She also works as a career coach for third-year pharmacy students. Her research interests include asthma, COPD, pediatrics, medication therapy management, anticoagulation and substance abuse.
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Laura Simmons, Pharm.D., received her Doctor of Pharmacy degree from Florida A&M University’s College of Pharmacy and Pharmaceutical Sciences. She graduated summa cum laude in May 2019. Dr. Simmons currently works as a pharmacist intern for CVS Pharmacy in Gulf Breeze, Florida. She also volunteers as a middle school girls’ basketball coach in the Gulf Breeze area. Her research interests include anticoagulation, asthma, COPD and hyperlipidemia. Marlon S. Honeywell, Pharm.D., is executive associate dean of Florida A&M University’s College of Pharmacy and Pharmaceutical Sciences. He received a Bachelor of Science in pharmacy from FAMU in 1995 and was licensed to practice pharmacy that same year. He subsequently graduated with the Doctor of Pharmacy degree in 1997. Honeywell completed a residency in home health care and infusion in 1998; and a fellowship in 1999 in ambulatory and community health, with a concentration in hypertensive care. As a professor of pharmacy practice, Dr. Honeywell presented at numerous podium and poster sessions and published over 70 manuscripts for various journals. Additionally, he has contributed textbook chapters to “Remington: The Science and Practice of Pharmacy and Pharmacotherapy: Principles and Practice.” He currently contributes to a bimonthly column, “The Diagnostic Spotlight,” in US Pharmacist. During his tenure, he also has been an investigator in several grants, which collectively total more than $450,000. Honeywell has been honored as the Teacher of the Year in 2009, 2008, 2006, 2004, 2002 and 2001. Furthermore, he earned the university’s Superior Accomplishment Award in 2003 and was listed in Who’s Who Among America’s Teachers® in 2002 and 2007.
ABSTRACT Coagulation disorders and/or thromboembolic disorders affect 1-2 per 1,000 Americans each year according to the CDC and approximately 60,000-100,000 die of venous thromboembolism (VTE), characterized as deep vein thrombosis (DVT) and pulmonary edema (PE). These diseases can lead to major complications, such as cerebrovascular and/or cardiovascular accidents and death. Treatment for coagulation disorders leading to VTE is imperative to prevent these life-threatening complications. Drugs that are most frequently used for VTE include antiplatelet drugs such as aspirin, oral anticoagulants such as warfarin, parenteral anticoagulants such as heparin and direct thrombin inhibitors (DTIs) such as bivalirudin and argatroban, and direct factor Xa inhibitors. While these agents inhibit coagulation through different mechanisms, they are found to be effective and likely to be used either as initial or alternative therapy in patients with VTE. Direct factor Xa inhibitors, such as apixaban and rivaroxaban, are newer oral and parenteral agents that inhibit factor Xa, one of the factors involved in both the intrinsic and extrinsic pathways of the coagulation cascade leading to thrombus formation. These agents are currently used, either as initial or as alternative therapy, because they show better efficacy as anticoagulants, but they are not without side effects. The most common adverse reactions associated with these agents is bleeding, which can become life-threatening. Kcentra® (Prothrombin Complex Concentrate, human) was approved by the U.S. Food and Drug Administration in April 2013 for urgent reversal of warfarin effects and has been the antidote used up to this point to counteract the effect of factor Xa inhibitors but it lacks specificity for the factor Xa. To prevent life-threatening bleeding, a specific antidote has been developed and approved by the FDA to reverse the effect of two factor Xa inhibitors, rivaroxaban and apixaban. INTRODUCTION Direct factor Xa (FXa) inhibitors, such as rivaroxaban, apixaban, edoxaban and betrixaban, have become an integral part of anticoagulation in the prophylaxis and treatment of thromboembolism. These agents leads to anticoagulation by virtue of their inhibition of Factor Xa. Factor X is involved in both the intrinsic pathway and the extrinsic pathway of coagulation. When Factor X is activated, it becomes factor Xa, which stimulates clot formation, platelet activation and endothelial activation resulting in thrombus formation, platelet aggregation and potentially thromboembolism. Because FXa appears to be the primary site of stimulation of thrombin production, the inhibitors of FXa are more effective at preventing thrombin formation and therefore decreasing or inhibiting coagulation.1-2 These direct oral anticoagulants have superior efficacy, enhanced safety profiles and less of a monitoring burden when compared to vitamin k antagonists (VKA) like warfarin.3 Their superiority is believed to lie in their specificity and their effect on both pathways of the coagulation cascade.4 Thrombin also is involved in anticoagulation and anti-inflammation through its activation of protein C. In addition, Thrombin is believed to have pro-inflammatory ef-
fects.5 Therefore, the effects of anti-Xa agents may affect other roles of thrombin apart from the inhibition of coagulation, leading to maintenance of hemostasis. Despite superior safety outcomes when compared to warfarin, major bleeding is still a concern and has been recorded at an annual rate of 2.1 to 3.5 percent in patients with atrial fibrillation who have been prescribed factor Xa inhibitors.3-6 Previously, a four-factor prothrombin complex concentrate (Kcentra®) has been used to reverse major bleeding events by providing factors II, VII, IX and X to affected patients.7 Though Kcentra® is 69 percent effective in the reversal of FXa-inhibitor-induced bleeding, the immediate concern is that factor Xa inhibitors lack a specific reversal agent for significant, life-threatening bleeding or emergency surgical procedures. ANDEXANET ALFA (ANDEXXA®) Approved in May 2018, andexanet alfa (Andexxa®) became the first agent to offer specific reversal of direct and indirect FXa inhibitors, thereby allowing normal coagulation to resume. Although intended for direct and indirect factor Xa inhibitors, Andexxa® is only FDA approved to reverse anticoagulation due to life-threatening or uncontrolled bleeding in patients treated with rivaroxaban or apixaban.8 Andexxa is reported to reduce unbound apixaban and rivaroxaban significantly (>90 percent) within 2-5 minutes after administration of a single IV bolus dose.6 Preliminary research suggests that andexanet’s ability to bind to enoxaparin and fondaparinux may eventually broaden FDA approval to low molecular weight heparins and indirect FXa inhibitors.9 Given its potential benefit, this article shall review clinical information germane to the use of this agent. PHARMACOLOGY Factor Xa is believed to be the most important enzyme responsible for the synthesis of thrombin, the factor most responsible for clot formation and platelet aggregation.1 Drugs used to inhibit the effects of FXa are currently frequently used to treat patients with thromboembolic disorders. Andexanet alfa is a recombinant-modified, human FXa protein, also known as inactivated-zhzo, which binds to and sequesJUNE 2019 |
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ters FXa inhibitors.8 Preliminary studies show that andexanet reversed the inhibition of FXa inhibitors on a dose-dependent basis and decreased the clotting time in patients receiving these agents.9 Andexanet also may decrease clotting time and bleeding in patients anticoagulated with heparin, low molecular weight heparin (LMSH) and vitamin K antagonist warfarin.1 It has a stronger affinity for FXa inhibitors than endogenous FXa and can overcome competition to temporarily reverse the anticoagulant effects of rivaroxaban and apixaban.10 Additionally, andexanet alfa mimics native FXa, raising apprehension of its innate potential to exhibit procoagulant activity. For this reason, the protein has been modified to prevent the cleavage of prothrombin to thrombin, averting such procoagulant effects.8 PHARMACOKINETICS Healthy patients were used to assess the pharmacokinetic parameters for andexanet alfa. The onset of action of andexanet after completion of the bolus administration is about two minutes. The volume of distribution is approximately 5L, which is similar to blood volume. Elimination half-life for ranges from five to seven hours, with a total body clearance of approximately 4.3L/hr.8 The anti-FXa activity returns to normal in approximately two hours after discontinuation of the drug. PHARMACODYNAMICS Andexanet alfa binds to FXa inhibitors and impedes the activity of Tissue Factor Pathway Inhibitor (TFPI).8 TFPI, under normal conditions, is an endogenous inhibitor of FXa and can decrease thrombin generation. By inhibiting TFPI, thrombin is generated, increasing the procoagulant effect.4,7 Although an elevation in Tissue Factor-initiated thrombin generation was apparent, the binding of TFPI was not found to affect hemostasis in animal models.6,8 Three tests were used to measure the drug’s effects, including anti-FXa activity, the free fraction of FXa inhibitors and thrombin generation. The anti-FXa activity was utilized as the primary pharmacodynamic outcome. Dosing requires a bolus and a continuous infusion for up to two hours. A decrease in
anti-FXa activity was seen two minutes post-bolus and continued approximately two hours after completion of the continuous infusion.8 DOSAGE AND ADMINISTRATION Dosage has been categorized into two regimens, a low dose and a high dose, based on the dose and time of the previously administered rivaroxaban or apixaban. Dosing for andexanet alfa may be seen in Table 1. Patients who received ≤10 mg of rivaroxiban or ≤5 mg of apixaban should be dosed using the low-dose regimen while those who received >10 mg of rivaroxiban and >5 mg of apixaban should receive the highdose regimen of andexanet. 8 The time of the last dose of the FXa inhibitor also is taken into consideration in order to initiate the dose of andexanet. Patients who received the FXa inhibitor >eight hours should receive the low-dose and those who receive the last dose of the FXa inhibitor <eight hours prior to andexanet should receive the high-dose regimen. When the dose and time are unknown, the high-dose regimen is recommended. For reconstitution, the manufacturer recommends slowly adding 10 mL of sterile water for injection to the 100 mg vial of andexanet alfa. The solution should be swirled (not shaken) for approximately three to five minutes, until complete dissolution occurs. An intravenous bolus should be administered at a rate of 30 mg/minute. After the bolus, andexanet alfa should be infused between 4 and 8 mg/min for up to 120 minutes.8 The use of andexanet alfa in pregnancy and lactation and pediatric populations has not been studied. The manufacturer reports an estimated risk of birth defects to be 2-4 percent and associated risk of miscarriage to be 15-20 percent.8 CLINICAL TRIALS ANNEXA-A and ANNEXA-R were two parallel, phase III clinical trials that initially solidified safety and efficacy. Volunteers were older, healthy adults, randomized in a trial of apixaban or placebo or rivaroxaban or placebo. Following the bolus, primary outcomes of these trials were a 94 percent and 92 percent reduction in anti-FXa activity in the apixaban-
Table 1: Andexanet Alfa Dosing8 Regimen
IV Bolus (30mg/min)
IV Infusion
Low Dose
400mg
4mg/min up to 120 min
High Dose
800mg
8mg/min up to 120 min
FXa Inhibitor Rivaroxaban Apixaban 12
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FXa Inhibitor Last Dose
<8 Hours or Unknown
≤ 10mg
Low Dose Regimen
> 10mg/ Unknown
High Dose Regimen
≤ 5mg
Low Dose Regimen
> 5mg/Unknown
High Dose Regimen
FLORIDA PHARMACY TODAY
≥8 Hours
Low Dose Regimen
Table 2: Efficacy of Andexanet alfa versus Placebo in Reversing Anti-FXa activity6 Studies
Percent Thrombin generation after 2-10 minutes
P Values
Apaxiban
Rivaroxiban
Placebo
Annexa-A (Bolus)
94±2%
—
21±9%
P<0.001
Annexa-A (B+I)
92±3%
—
33±6%
P<0.001
Annexa-R (Bolus)
—
92±3%
18±15%
P<0.001
Annexa-R (B+I)
—
97±2%
45±12%
P<0.001
B+I = Bolus + Infusion
Table 3: Adverse Reactions Reported with Andexanet During ANNEXA-A and ANNEXA-R6,8* Adverse reactions
% occurrence with Andexxa
% occurrence with Placebo*
UTI
≥5%
—
Pneumonia
≥5%
—
Immunogenicity (low titers of anti-andexxa antibodies)
17%
2%
<0.1% (Apixaban only)
—
Infusion-related
GI Disorders
18%
6%
*The manufacturer reports that all other adverse reactions occurred more frequently in the placebo group than with andexxa.8
treated and rivaroxaban-treated arms, respectively.6 (See Table 2) The effect of andexanet in restoring thrombin generation persisted for approximately two hours and/or until the end of the infusion and returned to placebo level gradually depending on the half-life of apixaban and rivaroxaban respectively. Currently, ANNEXA-4 is an ongoing, prospective trial, which attempts to reaffirm effectiveness and safety in patients experiencing an acute major bleed. The trial is scheduled to be completed in November 2022.12 ANNEXA-4 investigators announced a preliminary success rate of 83 percent. According to preliminary results of ANNEXA-4, there are no differences in safety, efficacy and pharmacokinetics in patients older than 65 years of age when compared to younger patients. The aforesaid results from phase II and phase III clinical trials allowed the drug to be fast-tracked for approval.11 Andexanet has not been studied in the pediatric population. There are clinical concerns that stem from the potential for immunogenicity. Although the ANNEXA trials deter-
mined that approximately 6 percent of patients developed antibodies, the immune response did not neutralize the drug nor cross-react with endogenous FX or FXa.8 This low immunogenicity profile was determined after a single IV infusion and no data exists about subsequent exposures to andexanet alfa.11 The most common adverse event reported was an infusion-related reaction in 18 percent of patients. However, according to the last report from the ANNEXA-4 trial, no infusion reactions had been noted.8,12 Results confirmed pneumonia and urinary tract infections as the most common adverse reactions (≥5 percent).8 WARNINGS AND PRECAUTIONS Andexanet alfa has a black box warning for thromboembolic risks, ischemic risks, cardiac arrest and sudden deaths.8 Table 3 depicts the reported adverse reactions seen in ANNEXA-A AND ANNEXA-R studies. No thrombotic events or severe adverse events were reported in healthy volunteers.6
ANNEXA-4 INVESTIGATORS ANNOUNCED A PRELIMINARY SUCCESS RATE OF 83 PERCENT. ACCORDING TO PRELIMINARY RESULTS OF ANNEXA-4, THERE ARE NO DIFFERENCES IN SAFETY, EFFICACY AND PHARMACOKINETICS IN PATIENTS OLDER THAN 65 YEARS OF AGE WHEN COMPARED TO YOUNGER PATIENTS. JUNE 2019
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ANNEXA-4 denotes that 18 percent of patients suffered a thromboembolic event, ischemic event, cardiac event or sudden death following treatment. Patients should be monitored for signs and symptoms of thromboembolic incidents and resumed on anticoagulant therapy promptly when medically appropriate.8 STORAGE Andexanet alfa is supplied in a carton of four single-use vials and each vial contains 100 mg. Unopened vials should be refrigerated (2°C to 8°C). Reconstituted vials are stable for 8 hours at room temperature and 24 hours under refrigeration. Reconstituted bags are stable for 8 hours at room temperature and 16 hours under refrigeration when compared to the vials.8 COST The cost of andexanet alfa therapy for the high- and lowdose protocols are approximately $59,400 (18 vials) and $29,700 (nine vials), respectively.11 The cost per the 100 mg-vial is approximately $3,300. When the 100 mg-vial is used, a total of nine vials is required in patients receiving the low dose of andexanet alfa and 18 vials in patients receiving the high dose. A 200 mg-vial also is available and five of the 200 mgvials are required to complete the treatment in the low-dose group versus nine of the 200 mg-vials in the high-dose treatment group.8
A Pharmacist And A Lawyer Licensure Disciplinary Proceedings Insurance Company/PBM Audits and Appeals Purchase & Sales of Pharmacies Regulatory Compliance Consultants Business Operations Consultants
REFERENCES
MANN KG, BRUMMEL K, BUTENAS S. WHAT IS ALL THAT THROMBIN FOR? FIRST PUBLISHED: 20 JUNE 2003. J THROMB HAEMOST. 2003 JUL;1(7):1504-14..HTTPS://DOI. ORG/10.1046/J.1538-7836.2003.00298.X. PUBMED.GOV. US NATIONAL LIBRARY OF MEDICINE NIH 1. Bauer KA - 2011. Recent progress in anticoagulant therapy: oral direct inhibitors of thrombin and factor Xa. J. Thromb Haemost. 2011 Jul;9(s1):12-19 https://www.ncbi.nlm.nih.gov/ pubmed/21781237 2. Makam RCP, Hoaglin DC, McManus DD, et al. Efficacy and safety of direct oral anticoagulants approved for cardiovascular indications: Systematic review and metaanalysis. PLoS One. 2018;13(5):e0197583. Published 2018 May 24. doi: 10.1371/journal.pone.0197583 ANSELL J. FACTOR XA OR THROMBIN: IS FACTOR XA A BETTER TARGET? FIRST PUBLISHED 09 JULY 2007. J THROMB HAEMOST. 2007 JUL;5(S1):60-64. DOI: 10.1111/J.15387836.2007.02473.X. WILEY ONLINE LIBRARY. KATOH, H., NOZUE, T. & MICHISHITA, I. ANTIINFLAMMATORY EFFECT OF FACTOR-XA INHIBITORS IN JAPANESE PATIENTS WITH ATRIAL FIBRILLATION. HEART VESSELS 32: 1130-1136. DOI:10.1007/S00380-017-0962-Y 3. Siegal DM, Curnutte JT, Connolly SJ, et al. Andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med 2015; 373:2413-2424. Doi:10.1056/NEJMoa1510991 4. Piran S, Khatib R, Schulman S, et al. Management of direct factor Xa inhibitor-related major bleeding with prothrombin complex concentrate: a meta-analysis. Blood Adv. 2019;3(2):158-167. doi: 10.1182/bloodadvances.2018024133. 5. Andexxa. [Package insert]. San Francisco, CA: Portola Pharmaceuticals, Inc.; 2018. 6. Lu G, DeGuzman FR, Hollenbach SJ, et al. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nat Med 2013;19:446-451. 7. Rogers KC, Finks SH. A new option for reversing the anticoagulant effect of factor Xa inhibitors: andexanet alfa (ANDEXXA). Am J Med, 132 (2019), pp. 38-41. https://doi. org/10.1016/j.amjmed.2018.06.028 8. Powell J, Taylor J, Garland SG. (2019). Andexanet alfa: A Novel Factor Xa Inhibitor Reversal Agent. Ann Pharmacother. 2019 Feb 27. 1060028019835209. Doi:10.1177/1060028019835209 9. Connolly SJ, Milling TJ, Eikelboom JW, et al. Andexanet alfa for acute major bleeding associated with factor Xa inhibitors. N Engl J Med 2016; 375:1131-1141. DOI: 10.1056/NEJMoa1607887
KAHAN & ASSOCIATES, PLLC
Pharmacist Attorney Brian A. Kahan, R.Ph., J.D. Licensed Florida Pharmacist and Attorney
STATEWIDE REPRESENTATION 561-392-9000 bkahan@kahanlaw.com 2300 N.W. Corporate Blvd., Suite 123 Boca Raton, FL 33431 The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience.
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Disclosure The authors of this manuscript have no potential conflicts of interest in the creation of this article.
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Perceptions to Possibilities: Going Beyond Prescriptions Emily N. Bennett, B.S., Pharm.D. Candidate 2022 College of Pharmacy, University of Florida Lake Nona, Florida William E. Haley, Ph.D. Professor School of Aging Studies, University of South Florida Tampa, Florida Adrian N.S. Badana, MPH, CPH Ph.D. Fellow, Aging Studies School of Aging Studies, University of South Florida Tampa, Florida Wendy H. Updike, Pharm.D., BCPS, CDE (corresponding author) Clinical Assistant Professor College of Pharmacy, University of South Florida 12901 Bruce B. Downs Blvd., MDC 30 Tampa, Florida 33612 E-mail address: wupdike@health. usf.edu
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Objectives: To determine if pharmacists believe their role in health care is expanding to provide lifestyle modification counseling to patients with hypertension and/or coronary heart disease (CHD). Preparedness and confidence were measured, as well as pharmacistsâ&#x20AC;&#x2122; perceived efficacy. Major barriers to this type of patient-pharmacist counseling were additionally investigated. Methods: Through the Florida Pharmacy Association (FPA) email database, Florida pharmacists were asked to take part in a survey to determine their preparedness to counsel patients on lifestyle modifications, confidence levels when counseling, perceived patient follow-through, current counseling practice and possible barriers
to counseling. Participants were given the opportunity upon completion of the survey to enter themselves in a drawing for one $50 Visa gift card. The questionnaire consisted of 20 questions where nine were multiple choice questions in Likert scale format, while three were extended response questions requiring categorization. The remaining seven questions were short answer or multiple choice categories. Cohenâ&#x20AC;&#x2122;s kappa statistic was used to determine the reliability of categorization for the extended response questions. Results: The questionnaire was fully completed by 149 pharmacists of the 7,349 who were emailed the link to participate through the FPA database. The majority of respondents were community-pharmacy based (n=59). On average, respondents rated that
Table 1: Pharmacistsâ&#x20AC;&#x2122; perceived barriers to successful lifestyle management counseling (115 participants out of 149). Barrier
Number of Pharmacists
Lack of Time (too busy or no opportunities during work hours)
62
Patient Complications (unwilling, not receptive, offended, cultural differences)
22
Compensation Issues (lack of incentives, no payment model)
21
Lack of Resources (lack of staff, space, patient information, current guidelines)
19
Lack of Respect/Status
10
Other Responsibilities
9
Lack of Corporate Support (employer expectations)
6
Outside Scope of Practice
4
Pharmacist is Unwilling
3
Lack of Training
2
No Barriers
2
Uncategorized (unsure)
1
the role of the pharmacist is probably expanding to encompass patient-centered counseling regarding lifestyle modification (M = 4.05, SD = 1.06) and that the conversations of lifestyle modification should likely be a part of their role (M = 4.13, SD = 0.86). Preparedness and confidence for counseling on diet were positively correlated (p < 0.0001), as well as preparedness and confidence for counseling on aerobic exercise (p < 0.0001). When asked whose role lifestyle modification counseling should be, 33.9 percent of pharmacists said they believe the role belongs to a multitude of health professionals, with 63 percent of those including pharmacists. There was a significant, positive association for how confident pharmacists felt in their ability to counsel patients with hypertension/CHD on diet changes (such as the Mediterranean diet) and the total sessions they have counseled patients regarding lifestyle modifications (p = 0.018). Pharmacists who reported that they felt more confident tended to re-
port that they had more counseling sessions with patients. In addition, there was a significant, positive association for how prepared pharmacists felt in their ability to counsel patients with hypertension/CHD on diet changes and the total sessions they have counseled regarding lifestyle modification (p = 0.014). Similar positive correlations were seen for total counseling sessions compared to confidence to counsel on incorporating 30 minutes of daily aerobic exercise (p = 0.058) and preparedness to counsel on aerobic exercise (p = 0.038). Regardless of predicted positive outcomes to pharmacist-patient counseling, 77.2 percent of pharmacists listed at least one possible barrier to their success in providing adequate counseling to patients. The Top 3 barriers included: lack of time, patient complications and compensation issues. See Table 1 for a complete list of pharmacist-perceived barriers that were expressed.
Conclusions: Pharmacist-patient lifestyle modification counseling may be an invaluable tool in the management of coronary heart disease and hypertension, and a majority of pharmacists are supportive of their expanding role within the health care setting. While pharmacists realize the importance of providing lifestyle modification education to patients, many agree that it should continue to be a multidisciplinary approach to improve patient care. Numerous barriers remain, however, that require further attention before pharmacists can be used to their full potential and ability, especially in the community-pharmacy setting.
End of Legislative Session Report: A Recap of 2019
By Michael Jackson and Adams St, Advocates
islature also had to train a historic number of freshman legislators entering session for the first time. The Florida House of Representatives started with 41 new members of the 120 total – 71 Republicans and 46 Democrats. The Florida Senate saw 9 new members this year. Out of 40 total members – 23 Republicans and 17 Democrats.
THE FLORIDA HOUSE OF REPRESENTATIVES STARTED WITH 41 NEW MEMBERS OF THE 120 TOTAL – 71 REPUBLICANS AND 46 DEMOCRATS. THE FLORIDA SENATE SAW 9 NEW MEMBERS THIS YEAR. OUT OF 40 TOTAL MEMBERS – 23 REPUBLICANS AND 17 DEMOCRATS.
The 2019 legislative session marks the first year with the members of the new administration in their current roles. This year, the state of Florida elected a new governor and Cabinet – attorney general, chief financial officer, Department of Agriculture and Consumer Services commissioner – all with their own agendas. The Legislature changed leadership as well, with a new speaker of the House, Senate president, and committee chairmen and committee structures. The Leg-
2017 Legislative Session Total Bills Filed 3,052 Total Bills Passed 249 Percentage Passed 8% 18
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The legislative agenda was focused mainly on the priority initiatives of the governor, Cabinet, Senate president and House speaker. Gov. Ron DeSantis’ priorities for this session included increasing the environmental budget for Everglades’ restoration and clean water efforts, addressing the $5.4 billion in insured losses from Hurricane Michael, and allowing patient access to smokable medical marijuana. Senate President Bill Galvano’s priority was a transportation infrastructure project that included creating a multiuse toll road corridor. Speaker Jose Oliva’s priority primarily focused on a major health care agenda, saying “All conversations around health care should center on cost, access and equality.” The House speaker and Senate president repeatedly agreed that their goal was to pass fewer bills this year than ever before in an effort to limit government and regulation. They accomplished this goal by passing the fewest bills in the last three years. The total number of bills filed was 3,491 and only 194 bills passed both chambers and went to the governor. Inter-
2018 Legislative Session Total Bills Filed 3,192 Total Bills Passed 200 Percentage Passed 6%
2019 Legislative Session Total Bills Filed 3,491 Total Bills Passed 194 Percentage Passed 5.50%
estingly, most of the bills enrolled were designated House bills – 133 – and only 61 were Senate bills. The two chambers passed the FY 19-20 budget totaling $91.1 billion. It is $1.8 billion more than the current year appropriations and $24.4 billion more than the budget signed by Gov. Charlie Crist 10 years ago. While they ultimately agreed on allocations, they did not finish on time and had to extend session by one day. While the budget was their constitutional responsibility, many issues took up time and energy that directly impacted vulnerable Floridians. These included: massive hurricane recovery efforts; addressing violence and mental health issues in schools; tax cuts; toxic algae blooms; banning local government regulation; preventing sanctuary cities in Florida from providing protection for immigrants; implementing a controversial constitutional amendment restoring voting rights to felons; and the governor’s controversial Canadian Drug Importation bill. Major Policy/Budget Initiatives Passed This Year ■■ $121.5 million tax cut package ■■ Revamp teacher bonuses and increase school choice funding ■■ Massive Hurricane Michael Recovery Funding from both federal and state, which led to cuts elsewhere ■■ Water Quality Improvement and Everglades Restoration, which received a historic $656 million in recurring funding ■■ Canadian importation program to reduce prescription drug costs. Florida will be one of the first states in the country to ask for federal waivers to support this initiative ■■ Public safety legislation, including the Marjory Stoneman Douglas bill that allows teachers to carry guns ■■ Allowing smokable marijuana ■■ Major CON (Certificate of Need) application changes ■■ Controversial legislation banning sanctuary cities ■■ Implementation of Amendment 4 – restoring felons voting rights ■■ Very first “Tele-Health” legislation, which will for the first time allow doctors from other states to provide telemedicine without having a Florida license Last year, FPA leadership put together an advocacy plan that included preferred priority projects. The intent was to create a focused campaign addressing the issues that were most important. Weekly briefings were facilitated with the Governmental Affairs Council to provide updates on session initiatives. Our work this session touched on each of the major issues. The major high priority issues of interest included: ■■ PBM – Network Adequacy Inclusion, Transparency
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Spread Pricing, Audit protection Telehealth/Telepharmacy Remote Supervision Point of Care/Test and Treat Collaborative Practice Agreements – FSHP collaboration Patient Access for Pharmacy of Choice: Advocate for patient access to their pharmacy of choice (no closed networks or mail order restrictions)
Priority Bills and Session Accomplishments PRACTICE OF PHARMACY (HB 111 REP. PLACENSIA AND REP. SIROIS/SB 300 SEN. BRANDES) ■■
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These bills would have allowed a pharmacist to enter into a protocol agreement with a doctor to test and treat patients for influenza and streptococcus, and to also enter into a collaborative practice agreement to assist in drug therapy and chronic disease management. Through its advocacy plan, Adams St. Advocates (ASA) helped this legislation successfully pass the House bill through all three committees of reference and off the House floor with a final vote of 99 Yeas and 16 Nays. Unfortunately, the Senate never gave either of these bills a hearing and they were withdrawn at the end of the 2019 session.
CONSULTANT PHARMACISTS (HB 833 REP. BYRD/SB 1050 SEN. DIAZ) ■■
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These bills would have allowed a consultant pharmacist to enter into a collaborative practice agreement to assist in drug therapy and chronic disease management. ASA supported the successful passage of HB 833 through all three committees of reference and off the House floor with a final vote of 112 Yeas and 4 Nays. Unfortunately, the Senate never gave either of these bills a hearing and they were withdrawn at the end of the 2019 session.
AUTOMATED PHARMACY SYSTEMS (HB 687 REP. WILLHITE/SB 1170 SEN. BRANDES) ■■
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These bills would have allowed a pharmacy to use an automated system for outpatient dispensing and deploy a machine that need not be located in a community pharmacy as long as it was under the supervision of a Florida licensed pharmacist. Controlled substances would not be allowed in these machines. Despite opposing testimony, the bill passed the House, but was never heard in the Senate. JUNE 2019
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The House tried to amend it on to another bill and it flipped from House to Senate multiple times. Largely due to intense lobbying from FPA members and ASA’s work with key senators, the Senate refused to hear the bill as amended and the bill died the last day of session.
MANDATORY ELECTRONIC PRESCRIBING (HB 831 REP. MARIANO/SB 1192 SEN. BEAN) ■■
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These bills would require pharmacists and doctors to electronically generate and transmit prescriptions for medicinal drugs. ASA and FPA met with both sponsors to discuss the fee issue charged to pharmacies for receiving electronic prescriptions. Also raised were challenges that pharmacists had to deal with when receiving an electronic prescription that could not be filled by the pharmacy and possible steering of patients by PBMs. Due to concerns from FPA membership, ASA negotiated with Sen. Bean to file an amendment to include a later date for implementation (7/31/2021) and limit to those doctors’ offices that have EHR systems. According to reports filed by the Agency for Health Care Administration, over 10 million e-prescriptions monthly were processed in Florida by the end of 2018. The number of e-prescribing physicians has increased to over 50,000. Ultimately, HB 831 was adopted and has been signed by the governor.
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PRESCRIPTION DRUG MONITORING PROGRAM HB 375 REP. PIGMAN/SB 592 SEN. ALBRITTON ■■
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These bills would allow the attorney general to access information in the PDMP. Specifically, this would allow the AG to petition a court for access to data necessary to support potential fraud or for civil litigation Attorney General Ashley Moody made this her priority legislation in order to support her opioid lawsuit against several large business interests. There were strong attempts by the chains to kill this bill, but ASA/FPA helped members to understand the privacy
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GOV. RON DESANTIS’ PRIORITIES FOR THIS SESSION INCLUDED INCREASING THE ENVIRONMENTAL BUDGET FOR EVERGLADES’ RESTORATION AND CLEAN WATER EFFORTS, ADDRESSING THE $5.4 BILLION IN INSURED LOSSES FROM HURRICANE MICHAEL, AND ALLOWING PATIENT ACCESS TO SMOKABLE MEDICAL MARIJUANA. 20
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These bills were filed to allow for the interchange of prescription drug monitoring program data with other states, districts, territories, the Veterans Administration, Department of Defense and Indian Health Services. The exchange of information with these other entities would be permissible so long as the restrictions and requirements are compatible with Florida laws. HB375, which has been signed by the governor, also includes an exemption for prescribers and dispensers from having to query the PDMP database for patients in a licensed hospice when prescribing or dispensing a “nonopioid controlled substance.”
PHARMACY BENEFIT MANAGERS (HB 271 REP. SANTIAGO/SB 906 SEN. WRIGHT)
PRESCRIPTION DRUG MONITORING PROGRAM (HB 1253 REP. MARIANO/SB 1700 SEN. LEE) ■■
protections in place to protect patient information and the bill passed both chambers. The AG stated that passage of this bill saves the state millions in litigation costs and two to three years of lost litigation resolution. HB1253 was approved by the House and Senate with no objection and is headed to the governor’s desk.
These bills would have done many things outside the scope of enforcing PBM regulation, audits, transparency and oversight. While neither bill was heard, the issue was raised and therefore brought up in discussions during several committees and on the floor, and it is now becoming the focus of political agendas. ASA had many meetings regarding pharmacy benefit managers, including successfully feeding members questions to ask in committee and on the floor. ASA had several positive meetings with AHCA Secretary Mary C. Mayhew and her staff about conducting an audit for the Medicaid PBMs. ASA convinced Sen. Doug Broxson – chair of the Banking and Insurance Committee – to make this issue his committee’s priority next session. ASA is assisting in drafting a letter requesting a study from the Banking and Insurance Committee to help guide policy changes.
STATEWIDE TASKFORCE ON OPIOID DRUG ABUSE (HB 875 REP. SIROIS/SB 1658 SEN. SIMPSON) ■■
These bills would have created an Opioid Task Force, however the bill was ultimately withdrawn when the governor signed an executive order creating it. While the original bill had the attorney general appointing a majority of the members, the executive order now has the governor appointing a majority of the members. The task force has 21 (including the chair) and includes two at-large members appointed by the governor and three at-large members appointed by the attorney general, among other agency personnel.
CANADIAN DRUG IMPORTATION PROGRAM (HB 19 REP. LEEK/SB 1528 SEN. BEAN) ■■
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These bills allowed for the importation of prescription drugs from Canada. This issue was the governor’s priority in an effort to reduce prescription drug costs. Florida will be one of the first states in the country to ask for federal waivers to support this initiative. The House version was a much broader program allowing for importation from not only Canada but other countries as well. We were able to get the Senate to agree to a more restricted version of importation through Canada only. However, the broader House version that allowed for international entities to ship drugs into Florida as well was adopted by the legislature. The Agency for Health Care Administration will contract with a vendor who will be responsible for ensuring that imported drugs are safe and in compliance with federal laws. Drugs that are to be imported are those expected to generate cost savings. Controlled substances, biological products, drugs inhaled during surgery and injectable drugs are excluded from the importation program. Pharmacies that participate in the Canadian and international import program are required to file reports with the state and are limited to who these medications can be dispensed to. The program will not begin until permission is granted by the federal government. HB19 was ultimately approved by the House and Senate and has been signed by the governor.
TELEHEALTH (HB 23 REP. YARBOROUGH/SB 1526 SEN. HARRELL) ■■
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These bills defined the practice of telehealth in the state of Florida and allows doctors licensed in other states to provide telemedicine without needing a Florida license. It will allow pharmacists in other states to provide telehealth services, but only through a Florida-licensed pharmacy. HB23 passed both chambers and will be signed by the governor.
PRESCRIPTION DRUG FORMULARY CONSUMER PROTECTION (HB 1362 REP. WILLIAMSON/SB 1180 SEN. MAYFIELD) ■■
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This “bait-and-switch” bill would prohibit PBMs and health plans from switching the drug formulary from name-brand drugs to cheaper, generic drugs mid-year causing patient distress. This bill passed the Senate but stalled in the House.
CONTINUING EDUCATION FOR HEALTH CARE PROFESSIONALS ■■
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Rep. Sirois filed an amendment to his HB 549 to remove the requirement that FMA must be the exclusive provider of pharmacy education for pharmacists wishing to maintain their vaccination credential. As a freshman member of the Legislature, Rep. Sirois quickly stood out as a champion for pharmacy issues and took it upon himself to look for ways to benefit the profession, including ways that weren’t originally part of our advocacy plan. The amendment did not pass, but began a discussion to be addressed next session.
STATE HEMP PROGRAM SB 1020 SEN. BRADLEY ■■ ■■ ■■
This legislation would allow for the retail sale of hemp and hemp products under the Department of Agriculture. Revises the definition of cannabis under F.S. 893 to exclude hemp and industrial hemp. SB1020 passed both the House and Senate with only one dissenting vote in the House. This legislation is headed to the governor’s desk.
CONTINUING EDUCATION OF HEALTH CARE PRACTITIONERS ON HUMAN TRAFFICKING (HB 851 REP. FITZENHAGEN AND OTHERS) ■■ ■■ ■■
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Requires health care licensees (including pharmacists) to complete continuing education on human trafficking. Continuing education is required to be completed by January 1, 2021 and must be 1 hour Course content must include sex trafficking and labor trafficking, how to identify individuals who may be victims of human trafficking, how to report cases of human trafficking and resources available to victims Requires Department of Health licenses or certificate holders to post in their place of work assessable to employees a sign in English and Spanish the following information: "If you or someone you know is being forced to engage in an activity and cannot leave, whether it is prostitution, housework, farm work, factory work, retail work, restaurant work, or any other activity, call the National Human Trafficking Resource Center at 888373-7888 or text INFO or HELP to 233-733 to access help and services. Victims of slavery and human trafficking are protected under United States and Florida law."
ASA monitored an additional 92 pharmacy-related bills throughout the 2019 session that ultimately didn’t pass. Committee weeks for the 2020 session will likely start as early as September, as the 2020 Ssssion will begin early January and end early March.
JUNE 2019
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Cultivating a Pipeline of Leadership in Florida By FPA President Angela Garcia, PharmD, MPH, CPh As we celebrated the 50th anniversary of the American Pharmacists Association – Academy of Student Pharmacists (APhA-ASP) in Seattle, Washington, March 21-25, I can honestly say we stood out among the other states across the country with example after example of excellence in leadership. In just about every circle I work in or around, I hear pharmacists expressing their concerns for the future of the profession. I can honestly say, the leadership for the profession of pharmacy in Florida is changing and we have an amazing opprtunity. Our duty is to reach out to them, cultivate strong integrity in leadership and move them past what we accomplished. Anyone attending the American Pharmacists Association (APhA) Annual Convention in Seattle and attending the APhA-Academy of Student Pharmacists (ASP) Student Pharmacist Programming, HOD and Awards Sessions, would walk away feeling a sense of comfort knowing we have a pipeline of leaders that are ready to take this profession and this state by force. The passion burns so brightly within all of them; every student brings something unique to the table, which makes you realize how blessed you are when you share their journey through leadership experiences, patient care outreach, individual mentoring and advocacy for the profession. At the APhA Annual, it was a showcase of just how incredible our APhAASP chapters are across the state and the leadership that is available to our Association as they graduate and enter the profession. A special thank you to each of our seven college of pharmacy ASP chapter advisers for investing in their student leadership and chapter members. Advisers have worked to elevate them as up and coming leaders by encouraging their involvement and innovations in various patient care projects and fostering opportunities for advocacy in the profession. A very special 22
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thank you to our deans for recognizing the impact that APhA-ASP has on our students as the future of our profession. It’s important to recognize two students that served at the national level, Shannon Stitsworth (UF) and Doug Tran (UF), as well as the two that are going to begin their year of service on National Standing Committees, Ian Floresta (UF) and Jaimie Myers (USF). Kathryn Albert, a second-year student and president-elect at the USF College of Pharmacy ran for national president-elect and, although she didn’t win the seat this year, we know she’s going to run again for a national position. Her message rang out among the entire delegation – the attending student body, faculty, APhA-ASP leadership and pharmacists sitting in the audience – to find their passion in pharmacy. It was a beautifully delivered speech and was recognized for the impact it made on everyone, including a statement of support by former FPA Speaker of the
House and Parliamentarian, and APhAASP Parliamentarian Dr. Michael Moné. I myself was moved to tears. Our students across the state are nothing short of amazing and the risks they take to seek a position is at a level many of us have never pursued. This year, four students from across the country were nominated for the APhA-ASP National Student Leadership Award. Two of the four were our very own FPA student leaders Vivian Nguyen (UF Jacksonville) and Jaimie Myers (USF Tampa). It was incredible to see 50 percent of the recognized leadership belonged to our state and, knowing both Vivian and Jaimie well, it’s very clear that their ability to lead others and lead them into leadership is what makes their recognitions at the national-level so well deserved. Vivian Nguyen also received the Sam Kalyan Scholarship. We have seen both of them unite not only their own APhAASP chapters, but work in unison with
the other chapters across the state in FPA advocacy and leadership events through their active work in the Councils. Both have been nominated for the Terry Gubbins Leadership Award along with John Hirschman and Elizabeth Davis. We look forward to recognizing that student this year. Across the country, 141 schools hosted local patient counseling events to identify their top student candidates who will go on to compete at the national level during the Annual Convention at APhA. Our state with seven colleges of pharmacy has an advantage for representation and we are very excited when our schools facilitate the activities and help represent clinical excellence for our state. For the second year in a row, the National Patient Counseling Competition included a Florida candidate. This year, Ashley Beachy from LECOM Bradenton placed in the Top 10 and last year in 2018, Jaimie Myers from the University of South Florida placed. It has been a long time since a Florida student placed in the Top 10, and certainly never back to back. We celebrate the excellence of these students in patient counseling and chalk this up as one more data point for amazing student leadership. We’re looking forward to the FPA Annual Convention and Expo in Fort Lauderdale, July 11-14, where all seven schools will send students to compete in our statewide Patient Counseling Competition. We love the spirit of competition and simultaneous support they give each other, not only over the summer but also all year long. Chapter Awards With regard to patient care and the bread and butter of patient engagement – our students have the opportunity to engage in several Patient Care Projects including Operation Immunization, Operation Diabetes, Operation Heart, Generation Rx and OTC Medication Safety. Recently added is the Women’s Health Initiative, which many of
our schools and colleges were already involved with innovative projects. Each school has a patient care curriculum to base their learning and outreach upon, but schools and colleges are given the freedom to innovate their approaches to patient care and outreach. The University of Florida received a national recognition for their Operation Diabetes Patient Care Projects combined across their three campuses (Gainesville, Jacksonville and Orlando), which is a great honor and recognition. PharmFlix is one of the most awesome challenges each school has every year and the work they produce is so inspiring. Most of the students have their PharmFlix videos uploaded to YouTube, but we will be showcasing those along with the FPA Advocacy Video Challenge for members to see throughout the Annual Convention. Student chapters must produce a video featuring their APhA-ASP chapter members using the annual theme for the event. This year, in celebration of the 50th anniversary, their theme was “Celebrating 50 years.” The USF College of Pharmacy was a finalist in this event, which is a first for their chapter and campus. Policy in the APhA-ASP HOD was action packed, and the USF College of Pharmacy had their resolution pass, which was actually aligned to resolutions passed in the “big house” APhA HOD. We also know that the USF College of Pharmacy submitted a Resolution for the FPA HOD (as a New Business item), so we hope to see their advocacy continue and to see additional schools prepare strong resolutions submissions. During their HOD, the APhA-ASP students supported their regions and the state to ensure a consistent message on what their priorities were as they plan and prepare for entry into the profession. The University of Florida won the Back the PAC fundraiser as the top school in the country for the amount raised per APhA-ASP member. Call me crazy, but we all know about
the Seven Wonders of the World. However, have you ever thought about the fact there are also conveniently seven schools and colleges of pharmacy across the state of Florida? Could there be something to the magic of seven? Could it be a coincidence or stroke of luck? You decide! What we do know is that the FPA continues to need sponsorship of students to support the programming this summer and for our membership to reach out to mentors and lead our student pharmacists as they enter the profession as new practitioners. For those of you who can, we always encourage the Adopt A Student program (whether you can attend the annual or not) or to make a donation to the Adopt A Student Program. We need pharmacists to participate in the student mentoring program and events, and to carry that mentoring beyond the Annual year round. Please contact the FPA staff (tmerren@pharmview. com) for more information or go online to pharmview.com and look for the FPA Annual and Convention portal. We need to support the programs and experiences that foster our students’ development in leadership, advocacy and patient care. This is one place where the return on investment pays off; support the pipeline of leadership for student pharmacist members of the FPA. If we reflect on the oath of a pharmacist, we see common themes with our strategic plan: to hold ourselves to a higher standard of practice and pay it forward by training the next generation of pharmacists. WE are responsible to cultivate new leaders for the profession by promoting them instead of ourselves. WE are here to support change and invest in new approaches to learning and patient care practice models. This is how we carry out The Power of WE in leadership. WE bring the next generation up and promote them beyond what we achieved. WE invest in greatness.
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129th Annual Meeting and Convention JULY 10â&#x20AC;&#x201C;14, 2019 Marriott Harbor Beach Resort and Spa Fort Lauderdale, FL 24
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FLORIDA PHARMACY TODAY
Keynote Speaker Norman â&#x20AC;&#x153;Hootâ&#x20AC;? Hooten Dr. Hooten is a 20-year veteran of the U.S. Army. He has more than 20 years of experience training military special operations and law enforcement personnel and 14 years of experience in Counter-Terrorism operations while serving in the U.S. Army Delta Force. Dr. Hooten has a distinguished service history in joint, combined, interagency and international operations. He was a key contributor to the success of Operation Just Cause in Panama as well as operations in Lebanon, the Balkans, and Operation Restore Hope in Mogadishu, Somalia. As a DELTA Force Assault Team Leader in Somalia he and his teammates played a critical role in the rescue and recovery of the crew members of the Black Hawk helicopter that crashed on October 3rd, 1993. The incident was later the subject of the feature film known as
Black Hawk Down. In August of 2001, Dr. Hooten retired from active duty. He briefly attended Pharmacy School at Campbell University in Buies Creek North Carolina. On September 11th, 2001, Dr. Hooten was recalled from pharmacy school to active service in the US Army. He subsequently played a critical role in the national effort to establish aviation security protocols and served as the National Supervisory Training Coordinator for the Federal Air Marshal Service Global Response Team. In February of 2009 he assumed duties as the Deputy Director of the King Abdullah Special Operations Training Center (KASOTC) in Amman, Jordan where he led an international team of subject matter experts in the design and development of protocols, tactics, techniques, and procedures for international counter terrorism operations. He served in this capacity for 3 years. During his Army career, Dr. Hooten realized the impact that pharmacists could have with active duty military and Veterans; he subsequently returned to pharmacy school at Palm Beach Atlantic University in West Palm Beach, Florida where he graduated in 2016. Upon graduation, he completed a Postgraduate Year One (PGY1) pharmacy residency at the Orlando Veterans Affairs Medical Center followed by a Postgraduate Year Two (PGY2) psychiatric pharmacy resident at the West Palm Beach Veterans Affairs Medical Center. Dr. Hooten has a passion for the role pharmacists can play in the management of pain and substance use disorders in Veterans and is committed to having a positive impact in this area of pharmacy practice. After completing his residency training, Dr. Hooten wished to continue to find ways to give back to the Veteran community that has given so much to our great nation. He currently practices at the Orlando Veterans Affairs Medical Center where his primary area of interest is working with Veterans who suffer with chronic service related pain and substance abuse.
The Florida Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Up to 23 contact hours are available upon successful completion of attendance and evaluation from Thursday-Sunday. Statements of continuing pharmacy education credit will available for you to download and print in four weeks. The FPA is also a Florida Department of Health approved provider of continuing education. This is an ACPE knowledge based activity. Speakers have no relevant financial relationship to the activities.
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Marriott Harbor Beach Resort & Spa
3030 Holiday Drive • Ft. Lauderale, FL 33316 (800) 222-6543 or (954) 525-4000
ROOM RATES: $189 plus tax based on single/ double occupancy. The room reservation deadline is Friday, June 21, 2019 or when room block is full. Thereafter, reservations may be taken on a space available or rate available basis. There is an optional resort fee. Self-parking is discounted to $12 per day. Please be sure to ask for the Florida Pharmacy Association group rate. All reservations must be accompanied by a first night room deposit or guaranteed with a major credit card. The check-in time is 4:00pm and the checkout time is 11:00 am. Room reservations can be made by calling (800) 222-6543 or (954) 525-4000.
Accommodations Special Events FPPC RECEPTION: Attend this reception to support your Political Action Committee. HOUSE OF DELEGATES: Be a delegate or observer and see how important member participation is to the direction of the Association. RECOGNITION OF FPPC DONORS: Contribute to the FPPC and be invited to a private reception. EXHIBITS: Participate in the grand opening reception in the exhibit hall! Visit with exhibitors, introduce yourself, shake their hands, tell them you appreciate them and invite them back next year! The exhibitors are a very important part of FPA’s convention. Companies send their representatives to educate you about their products and services at great expense. Please show them your appreciation! POSTER PRESENTATIONS: Browse submissions from pharmacy students. Contact the FPA office for more information if you would like to submit a poster presentation. RECEPTIONS: Enjoy catching up with your colleagues as the Universities entertain their alumni and friends followed by a night of Karaoke Fun! STUDENT EVENTS: Participate in the Adopt-A-Student Mentor Social. Students will benefit from interacting with practicing pharmacists, attending student focused continuing education programs and learning firsthand about the FPA and how involvement can improve their chosen profession. Call the FPA office and offer to mentor or sponsor a student. FUN RUN WALK: Exercise is good for the soul. Incorporate health and fitness while at the FPA convention. Please register early to reserve your space. AWARDS EVENT: Honor outstanding practitioners during the awards presentation. INSTALLATION OF OFFICERS: Attend the installation of NEW officers on Sunday morning!
Save the Date! 130th Annual Convention JW Marriott
Marco Island Beach Resort
Thank You For Attending the
129th Annual Meeting & Convention! 26
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See You Next Year!
FLORIDA PHARMACY TODAY
Marco Island, FL
July 8 – 12, 2020
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FPA 129th Annual Meeting and Convention July 10-14, 2019 Ft. Lauderdale, FL
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55Daily Education Registration
Participant Information Participant Information
Daily registration does not include admittance to functions or handbooks. Handouts will be posted on our website July 10.
Name: _____________________________________________________ Name _______________________________________________ Address______________________________________________ Badge Name: _______________________________________________ City, State, Zip_________________________________________ Mailing Address: ____________________________________________ Phone___ ________________________ City, State, Zip: _____________________________________________ Email________________________________________________ Phone: (W) (H)_______________________ Practice Setting________________________________________ License: PS______________ PU _____________RPT_________ Fax: ______________________________________________________ NABP Date of Birth___________ License:e-profile#__________________ PS________________ PU_________ Other State________ Emergency Contact Name/Number_________________________
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Full Package Registration
Full package registration includes Educational Programs Thursday-Sunday, House of Delegates on Friday, Exhibit Hall Friday and Saturday, and Awards Event on Saturday. Handbooks are not included in full package registration. Handouts will be available the week of the convention on our website, www.pharmview.com. Before June 21
Onsite
Amount_
$345
$430
$_______
Non Member
$525
$610
$_______
Pharmacist BEST Value
$540
$625
$_______
Member Technician
$155
$185
$_______
Non Member Technician
$175
$210
$_______
Technician BEST Value
3Student
Handbooks
$185
$220
$_______
$150
$170
$_______
$40
N/A
$_______
(BEST Value includes Registration & Membership) Please indicate below which functions you will attend. Tickets will be provided upon request during the pre-registration process and placed in your packet. If no boxes are selected, we will assume you will not attend any of the events listed below and tickets will not be available onsite. Please see box 6 for additional tickets.
House of Delegates (Friday)
Exhibit Hall (Friday and/or Saturday)
Awards Event (Saturday)
I will not attend any of these functions.
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House of Delegates
House of Delegates (Non-convention registrants)
Onsite
Amount
FPA Member
$165
$185
$_______
Non Member
$215
$235
$_______
Member Technician
$65
$85
$_______
Non Member Technician
$90
$110
$_______
Handbooks
$40
N/A
$_______
Please select the day(s) you will attend: Thursday
2FPA Member
3
Before
June 21
6
Friday
Saturday
Sunday
Additional Tickets
The following events are included in the Full Registration Package if requested. However, you must purchase additional tickets for guests who are NOT registered. Price
Amount
Exhibit Hall
Quantity
@ $30
$______
Awards Event
@ $80
$______
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Special Events Registration
The events listed below must be purchased individually and are not included in any other registration packages. Quantity
Price
Amount
FPPC Reception _________ @ N/C (Complimentary event, indicate if attending)
$_____
Christian Fellowship
$_____
_________
@ N/C
(Complimentary event, indicate if attending) Poster Presenter
_________
@ $25
$_____
Student Awards Event
_________
@ $50
$_____
8
FPA Polo Shirt (Deadline is June 7, 2019) Quantity Price
9
Yes
______ @ $35
Payment
M/F ______
Size ______
Amount $_______
Total Enclosed: $______
Check (To: FPA) AMEX Discover MasterCard Visa Account # ____________________________________________ Security Code _________________ Expiration Date __________
Before June 12
Amount
$165
______
Billing Address ________________________________________ Signature ____________________________________________
Four Ways to Register
Mail: FPA, 610 North Adams Street, Tallahassee, FL 32301 Phone: 850-222-2400 Fax: 850-561-6758 Web: www.pharmview.com
Schedule Subject to Change
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