JUNE 2019

The Official PublicationOf The FloridaPharmacy Association

LEGISLATIVE REPORT

“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”

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• Helps you implement and maintain a continuous quality improvement program

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• Assists with quality assurance requirements found in network contracts, Medicare Part D, and state regulations

• Provides tools, training and support to keep your pharmacy running efficiently and your patients safe

PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION

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Call toll free (866) 365-7472 or visit www.pqc.net

J U N E 2 0 1 9 | 3

VOL. 82 | NO. 6JUNE 2019THE OFFICIAL PUBLICATION OF THEFLORIDA PHARMACY ASSOCIATIONP H A R M A C Y T O D A Y

florida

FeaturesDepartments

4 Calendar

4 Advertisers

5 President’s Viewpoint

7 Executive Insight

26 Buyer's Guide

Andexanet alfa (ANDEXXA): A Novel Antidote which Reverses Bleeding in Patients Treated with Factor Xa Inhibitors

Cultivating a Pipeline of Leadership in Florida

End of Legislative Session Report: A Recap of 2019

Perceptions to Possibilities: Going Beyond Prescriptions

10

16

18

22Correction: In the May 2019 issue of Florida Pharmacy Today, the Larkin University College of Pharmacy was mistakenly identified as the Larkin Health Sci-ences Institute College of Pharmacy. We regret the error and apologize to the College’s students, faculty, alumni and friends.

4 | F L O R I D A P H A R M A C Y T O D A Y

E-MAIL YOURSUGGESTIONS/IDEAS TO

dave@fiorecommunications.com

MissionStatements:Florida Pharmacy Today Journal

The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a me-dium through which the Florida Pharmacy Association can communicate with the profes-sion on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the pro-fession. 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 Jour-nal 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 ap-propriate advertising to assist the Journal in its goal of self-support.

AdvertisersAMERICAN ASSOCIATED PHARMACIES ..... 15KAHAN & ASSOCIATES ................................ 14PQC ....................................................................... 2PARTNERSHIP FOR SAFE MEDICINES ........ 9PHARMACISTS MUTUAL ............................. 25

2019

FPA Calendar

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) 222-2400FSHP — Tamekia Bennett (850) 906-9333UF — Emely McKitrick (352) 273-5169FAMU — Leola Cleveland (850) 599-3301NSU — Carsten Evans (954) 262-1300

DISCLAIMER Articles in this publication are designed to provide accurate and authoritative infor-mation 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.

JULY

4 Independence Day - FPA Office Closed

10-14 129th Annual FPA Meeting and ConventionFt. Lauderdale

AUGUST

2 FPA Governmental Affairs Committee MeetingOrlando

4-7 36th Annual Southeastern Gatherin'Destin

15-16 Florida Board of Pharmacy MeetingTampa

16-17 Southeastern Officers ConferenceAtlanta

24-25 FPA Councils and Committee Meetings; FPA Board of Directors Meeting

SEPTEMBER

7-8 Regulatory and Law ConferenceMiami

OCTOBER

5-6 Florida Board of Pharmacy MeetingTampa

8-9 Florida Board of Pharmacy MeetingFort Lauderdale

12-13 FPA Midyear Clinical ConferenceKissimmee

26-29 NCPA Annual ConferenceSan Diego, California

FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW.PHARMVIEW.COM

Events calendar subject to change

Note: The views of the authors do not necessarily represent the views or opinions of the Florida Pharmacy As-sociation, Florida Pharmacy Today or any related entities.

The Power of Reflection

J U N E 2 0 1 9 | 5

E-MAIL YOURSUGGESTIONS/IDEAS TO

dave@fiorecommunications.com

The Power of ReflectionIt 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 Stra-tegic 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 pow-erful 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 sys-tem of accountability to servant leaders with an awareness of service and duty to the profession, our members and our patients. It was absolutely the pas-sion of the Councils, Committees and Subcommittees that drove our success during the 2018-2019 service year. Our Strategic Plan was a success in mov-ing our Association in a stronger direc-tion and we accomplished a great deal. More than tangible things or deliver-ables to hold, we showed a presence and it’s caused a stir among the mem-bership. This is a very good thing and we know that the movement for con-tinued change and transformation will continue.

We had many performance indica-tors – working through our strategic plan priorities, goals and objectives. I have so much respect for the owner-ship each of the Council chairs and co-chairs 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 ele-vate 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 re-turn 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 surren-der, they thrived and I look forward to seeing advancement of our Association and our strategic plan from the founda-tions they set.

I am excited for the transformation of our leadership, and I thank those who served this year who have com-pleted their terms: Susy Wize as chair-man of the Board, Jeanette Connelly as speaker of the House, Ashley Huff as treasurer, Joy Wright as Region 1 direc-tor, Dean Pedalino as Region 3 direc-tor, Melissa Ruble as Region 5 director and Mitchell Fingerhut as Region 9 di-

rector. I want to thank the chairs and co-chairs of our Councils and Commit-tees: Eric Larson and Bill Mincey for GAC, Bert Martinez and James Alcorn for Organizational Affairs, Raul Correa and David Pino for Public Affairs, Sar-ah Haley and Charlie Brown for Mem-bership Affairs, Pooja Patel and Car-

The President’s ViewpointANGELA S. GARCIA, PHARMD/MPH, CPH

Angela S. Garcia, PharmD, MPH, CPh

6 | F L O R I D A P H A R M A C Y T O D A Y

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 ChairAngela Garcia ..............................................................................................FPA PresidentAshley Huff ................................................................................................... FPA TreasurerDavid Mackarey ......................................................................................President-ElectJeanette Connelly ..................................................................Speaker of the HouseGary Koesten .................................................................Vice Speaker of the HouseSandy Estrada ........................................................................................ FSHP PresidentJoyanna Wright .................................................................................. Region 1 DirectorNeil Barnett ...........................................................................................Region 2 DirectorDean Pedalino ......................................................................................Region 3 DirectorCheryl Rouse ........................................................................................Region 4 DirectorMelissa Ruble .......................................................................................Region 5 DirectorBarbara Beadle ..................................................................................Region 6 DirectorPaul Delisser ......................................................................................... Region 7 DirectorRamy Gabriel ........................................................................................Region 8 DirectorMitchell Fingerhut ............................................................................Region 9 DirectorJulie Burger. ......................................................................................Technician Member

Florida Pharmacy Today Journal Board

Chair.............................................................. Carol Motycka, motycka@cop.ufl.eduVice Chair ...................................................Cristina Medina, cmmedina@cvs.com Treasurer ........................................................Eric Jakab, ericjakab@hotmail.comMember ................................................. Michael Finnick, michaelfinnick@ufl.eduMember ......................................................Matt Schneller, schnem18@gmail.comMember .........................................Teresa Tomerlin, teresapharmd@cfl.rr.comMember ...........................................Greta Pelegrin, gretapelegrin@yahoo.comTechnician Member .......................Julie Burger, julieburger133@gmail.comExecutive Editor ...............Michael Jackson, mjackson@pharmview.comManaging Editor ..................Dave Fiore, dave@fiorecommunications.comJournal Reviewer ...................... Dr. Melissa Ruble, mruble@health.usf.eduJournal Reviewer ...................................Dr. Angela Hill, ahill2@health.usf.edu

2018-19 FPA Board of Directors 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 mecha-nism of our Association this year. With-out their dedication, the Power of WE wouldn’t have been embraced.

What we did not accomplish is a per-fect place to reflect and determine what the barriers were, and once identified, how we remove those barriers to al-low other leadership teams the ability to progress further. We will be conduct-ing 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 gover-nance and ensuring our leadership is ed-ucated about their roles, our duties and strengthening the leadership. Instilling a cornerstone of transparency and ac-countability will give us the greatest op-portunity for a deep-rooted strength. Removing the misinformation, misper-ceptions and misguided efforts will help our Association rise to the level we should be functioning – our greatest ca-pacity as leaders for the profession in Florida. This new awareness, education and new approach to leadership by the BOD will translate to a stronger leader-ship core built on the principles of our duty to serve, and this will be the first step back toward the trust our member-ship 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 in-coming president, David “Chachi” Mac-keray and his leadership team. Partner-ing with our President-elect Joe Scuro to help cultivate a continuum of integ-rity and transformative leadership will undoubtedly reestablish trust and ac-countability and recruit the member-ship 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 prac-tice of pharmacy. If we build strong, we stay strong. n

J U N E 2 0 1 9 | 7

Direct and indirect remuneration (DIR) fee is a term given to ac-tion 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 like-ly expanding into the commercial mar-ket place, which is beyond the Medicare program. The DIR fee system was creat-ed by the Center for Medicare and Med-icaid Services to address prescription drug cost variances between gross pre-scription drug costs of Medicare Part D plans that were not captured at the point of sale and any pricing conces-sions. 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 ma-jor disruption and cash flow challeng-es. As per a survey conducted by NCPA on 640 community pharmacists, 87 per-cent of pharmacists said DIR fees signif-icantly affected their pharmacy’s abili-ty to provide patient care and remain in business.

Pharmacy advocates have been working hard with the Center for Medi-care and Medicaid Services (CMS) to re-form this totally nontransparent and onerous system of pharmacy reim-bursement through rulemaking. Sad-ly, 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 Unit-ed States to fix this problem. Bills were filed during the previous Congressio-nal 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 administra-tion 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

members who had been asked to con-tact their Congressman and ask that they support that letter (see June 5, 2019, Stat News).

For the current Congressional ses-sion, there are several bills addressing the DIR debacle. S 988 and HR 803 will do the following:

n Boost transparency in drug pricing. Prohibiting these retroactive phar-macy fees will make Medicare Plan Finder more accurate and allow bet-ter CMS oversight.

n Give seniors reduced cost-shar-ing and greater budget predictabil-ity. Beneficiaries who use their drug plan to fill prescriptions are pun-ished 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.

n Preserve access to independent com-munity pharmacies. Locally owned pharmacies provide enhanced pa-tient care and are often located in underserved rural and inner city ar-eas. The number of U.S. indepen-dent community pharmacies has declined the past five years and a re-cent study estimated 3 million ru-ral residents are at risk of losing the

Relief Needed on DIR Fees. Congress, Where Are You?

Executive InsightBY MICHAEL JACKSON, RPHMICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION

Michael Jackson, B.Pharm

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.

8 | F L O R I D A P H A R M A C Y T O D A Y

Executive Vice President/CEOMichael Jackson

(850) 222-2400, ext. 200Director of Continuing Education

Tian Merren-Owens, ext. 120 Educational Services Office Assistant

Stacey Brooks, ext. 210Coordinator of Membership

Christopher Heil, ext. 110Accounting Coordinator

Ashley Gandy ext. 211

FLORIDA PHARMACY TODAY BOARDChair..................................... Carol Motycka, St. AugustineVice Chair ...............................Cristina Medina, HollywoodTreasurer ..........................................Eric Jakab, Gainesville Member ..............................Michael Finnick, JacksonvilleMember ..............................................Matt Schneller, TampaMember ..................................Teresa Tomerlin, RockledgeMember .............................................Greta Pelegrin, HialeahTechnician Member ................Julie Burger, PensacolaExecutive Editor ........Michael Jackson, TallahasseeManaging Editor ........................Dave Fiore, Tallahassee

This is a peer-reviewed publication. ©2019 FLORIDA PHARMACY JOURNAL, INC.ARTICLE ACCEPTANCE: The Florida Phar-macy 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 Re-view 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 sub-scription - United States and foreign, Indi-vidual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax.

FLORIDA PHARMACY ASSOCIATION

610 N. Adams St. • Tallahassee, FL 32301850/222-2400 • FAX 850/561-6758

Web Address: http://www.pharmview.com

FPA STAFF only pharmacy in their community with the next nearest pharmacy over 10 miles away, a trend exacerbated by pharmacy DIR fees.

n 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 subsi-dies, manufacturer coverage gap discount payments and plan bids.” Accord-ing 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 provid-ers 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

References1. Looking Beneath the Surface of DIR, Goar Alvarez, PharmD, Ranga Narla, PharmD,

LeanneLai, PhD and Alberto Wertheimer, PhD – Florida Pharmacy Today, October 20182. https://www.ncpanet.org/advocacy/federal-advocacy/pharmacy-dir-fees

JOIN TODAY!

J U N E 2 0 1 9 | 9

10 | F L O R I D A P H A R M A C Y T O D A Y

Andexanet alfa (ANDEXXA): A Novel Antidote which Reverses Bleeding in Patients Treated with Factor Xa InhibitorsBy 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 profes-sor of pharmacy practice of the Florida A&M University College of Pharma-cy’s Durell Peaden Jr. Center. In addi-tion to teaching and training doctor of pharmacy students, Dr. Larose-Pierre has been an active member of multiple professional organizations. In her pro-fessional affiliations and in academia,

she remains a strong advocate for pharmacy students’ in-volvement in community activities and research in areas in-cluding pharmacy practice, critical care, infectious disease, immunization, medication therapy management and screen-ing of patients for chronic diseases (i.e hypertension, diabetes mellitus, coagulopathies).

Chenita Carter, Pharm.D., M.S., is an assistant professor of pharmacy prac-tice at Florida A&M University’s Col-lege of Pharmacy and Pharmaceutical Sciences. Dr. Carter received her Doc-tor of Pharmacy degree from FAMU and completed PGY1 residency at Sa-cred Heart Hospital in Pensacola, Flor-ida. She earned a Master of Science de-gree 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 re-search interests include asthma, COPD, pediatrics, medica-tion therapy management, anticoagulation and substance abuse.

Laura Simmons, Pharm.D., received her Doctor of Pharmacy degree from Florida A&M University’s College of Pharmacy and Pharmaceutical Scienc-es. 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 volun-teers as a middle school girls’ basket-

ball coach in the Gulf Breeze area. Her research interests in-clude anticoagulation, asthma, COPD and hyperlipidemia.

Marlon S. Honeywell, Pharm.D., is executive associate dean of Florida A&M University’s College of Pharma-cy and Pharmaceutical Sciences. He re-ceived a Bachelor of Science in phar-macy 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 residen-cy 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 pre-sented at numerous podium and poster sessions and pub-lished over 70 manuscripts for various journals. Additionally, he has contributed textbook chapters to “Remington: The Sci-ence and Practice of Pharmacy and Pharmacotherapy: Prin-ciples and Practice.” He currently contributes to a bimonth-ly 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.

J U N E 2 0 1 9 | 11

ABSTRACTCoagulation 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 thromboem-bolism (VTE), characterized as deep vein thrombosis (DVT) and pulmonary edema (PE). These diseases can lead to major complications, such as cerebrovascular and/or cardiovascu-lar accidents and death. Treatment for coagulation disorders leading to VTE is imperative to prevent these life-threaten-ing complications. Drugs that are most frequently used for VTE include antiplatelet drugs such as aspirin, oral antico-agulants such as warfarin, parenteral anticoagulants such as heparin and direct thrombin inhibitors (DTIs) such as bivali-rudin and argatroban, and direct factor Xa inhibitors. While these agents inhibit coagulation through different mecha-nisms, they are found to be effective and likely to be used ei-ther as initial or alternative therapy in patients with VTE. Di-rect 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 for-mation. These agents are currently used, either as initial or as alternative therapy, because they show better efficacy as an-ticoagulants, 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 pre-vent life-threatening bleeding, a specific antidote has been de-veloped and approved by the FDA to reverse the effect of two factor Xa inhibitors, rivaroxaban and apixaban.

INTRODUCTIONDirect factor Xa (FXa) inhibitors, such as rivaroxaban, apix-

aban, edoxaban and betrixaban, have become an integral part of anticoagulation in the prophylaxis and treatment of throm-boembolism. 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 coagula-tion. When Factor X is activated, it becomes factor Xa, which stimulates clot formation, platelet activation and endothe-lial activation resulting in thrombus formation, platelet ag-gregation and potentially thromboembolism. Because FXa appears to be the primary site of stimulation of thrombin pro-duction, the inhibitors of FXa are more effective at preventing thrombin formation and therefore decreasing or inhibiting coagulation.1-2 These direct oral anticoagulants have superi-or 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 speci-ficity 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 ad-dition, Thrombin is believed to have pro-inflammatory ef-

fects.5 Therefore, the effects of anti-Xa agents may affect oth-er roles of thrombin apart from the inhibition of coagulation, leading to maintenance of hemostasis. Despite superior safe-ty 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 pro-thrombin 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 ef-fective in the reversal of FXa-inhibitor-induced bleeding, the immediate concern is that factor Xa inhibitors lack a specif-ic 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 re-sume. Although intended for direct and indirect factor Xa in-hibitors, Andexxa® is only FDA approved to reverse antico-agulation due to life-threatening or uncontrolled bleeding in patients treated with rivaroxaban or apixaban.8 Andexxa is reported to reduce unbound apixaban and rivaroxaban signif-icantly (>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 poten-tial benefit, this article shall review clinical information ger-mane to the use of this agent.

PHARMACOLOGYFactor Xa is believed to be the most important enzyme re-

sponsible for the synthesis of thrombin, the factor most re-sponsible 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. An-dexanet alfa is a recombinant-modified, human FXa protein, also known as inactivated-zhzo, which binds to and seques-

12 | F L O R I D A P H A R M A C Y T O D A Y

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 molec-ular weight heparin (LMSH) and vitamin K antagonist war-farin.1 It has a stronger affinity for FXa inhibitors than en-dogenous FXa and can overcome competition to temporarily reverse the anticoagulant effects of rivaroxaban and apixa-ban.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 pre-vent the cleavage of prothrombin to thrombin, averting such procoagulant effects.8

PHARMACOKINETICSHealthy patients were used to assess the pharmacokinet-

ic parameters for andexanet alfa. The onset of action of an-dexanet 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.

PHARMACODYNAMICSAndexanet alfa binds to FXa inhibitors and impedes the

activity of Tissue Factor Pathway Inhibitor (TFPI).8 TFPI, un-der normal conditions, is an endogenous inhibitor of FXa and can decrease thrombin generation. By inhibiting TFPI, throm-bin is generated, increasing the procoagulant effect.4,7 Al-though an elevation in Tissue Factor-initiated thrombin gen-eration 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, includ-ing 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 con-tinued approximately two hours after completion of the con-tinuous 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 pre-viously administered rivaroxaban or apixaban. Dosing for an-dexanet alfa may be seen in Table 1. Patients who received ≤10 mg of rivaroxiban or ≤5 mg of apixaban should be dosed us-ing the low-dose regimen while those who received >10 mg of rivaroxiban and >5 mg of apixaban should receive the high-dose regimen of andexanet. 8 The time of the last dose of the FXa inhibitor also is taken into consideration in order to initi-ate the dose of andexanet. Patients who received the FXa in-hibitor >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 regi-men 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 shak-en) for approximately three to five minutes, until complete dissolution occurs. An intravenous bolus should be admin-istered 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 manufactur-er reports an estimated risk of birth defects to be 2-4 percent and associated risk of miscarriage to be 15-20 percent.8

CLINICAL TRIALSANNEXA-A and ANNEXA-R were two parallel, phase III

clinical trials that initially solidified safety and efficacy. Vol-unteers 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 FXa Inhibitor Last Dose <8 Hours or Unknown ≥8 Hours

Rivaroxaban≤ 10mg Low Dose Regimen

Low Dose Regimen

> 10mg/ Unknown High Dose Regimen

Apixaban≤ 5mg Low Dose Regimen

> 5mg/Unknown High Dose Regimen

J U N E 2 0 1 9 | 13

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 depend-ing 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 an-nounced a preliminary success rate of 83 percent. According to preliminary results of ANNEXA-4, there are no differenc-es 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 al-lowed 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 an-tibodies, the immune response did not neutralize the drug nor cross-react with endogenous FX or FXa.8 This low im-munogenicity profile was determined after a single IV infu-sion and no data exists about subsequent exposures to andex-anet alfa.11 The most common adverse event reported was an infusion-related reaction in 18 percent of patients. How-ever, 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 PRECAUTIONSAndexanet alfa has a black box warning for thromboem-

bolic risks, ischemic risks, cardiac arrest and sudden deaths.8 Table 3 depicts the reported adverse reactions seen in AN-NEXA-A AND ANNEXA-R studies. No thrombotic events or severe adverse events were reported in healthy volunteers.6

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*

Infusion-related 18% 6%

UTI ≥5% —

Pneumonia ≥5% —

Immunogenicity (low titers of anti-andexxa antibodies) 17% 2%

GI Disorders <0.1% (Apixaban only) — *The manufacturer reports that all other adverse reactions occurred more frequently in the placebo group than with andexxa.8

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.

14 | F L O R I D A P H A R M A C Y T O D A Y

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ANNEXA-4 denotes that 18 percent of patients suffered a thromboembolic event, ischemic event, cardiac event or sud-den death following treatment. Patients should be monitored for signs and symptoms of thromboembolic incidents and re-sumed on anticoagulant therapy promptly when medically appropriate.8

STORAGEAndexanet alfa is supplied in a carton of four single-use vi-

als 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

COSTThe cost of andexanet alfa therapy for the high- and low-

dose protocols are approximately $59,400 (18 vials) and $29,700 (nine vials), respectively.11 The cost per the 100 mg-vi-al is approximately $3,300. When the 100 mg-vial is used, a to-tal 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 mg-vials are required to complete the treatment in the low-dose group versus nine of the 200 mg-vials in the high-dose treat-ment group.8

REFERENCESMANN 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 NIH1. 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 meta-analysis. 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.1538-7836.2007.02473.X. WILEY ONLINE LIBRARY. KATOH, H., NOZUE, T. & MICHISHITA, I. ANTI-INFLAMMATORY EFFECT OF FACTOR-XA INHIBITORS IN JAPANESE PATIENTS WITH ATRIAL FIBRILLATION. HEART VESSELS 32: 1130-1136. DOI:10.1007/S00380-017-0962-Y3. 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

DisclosureThe authors of this manuscript have no potential conflicts of interest in the creation of this article.

J U N E 2 0 1 9 | 15

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16 | F L O R I D A P H A R M A C Y T O D A Y

Objectives: To determine if pharmacists believe

their role in health care is expanding to provide lifestyle modification counseling to patients with hypertension and/or cor-onary heart disease (CHD). Preparedness and confidence were measured, as well as pharmacists’ perceived efficacy. Major barriers to this type of patient-pharma-cist counseling were additionally investi-gated.

Methods: Through the Florida Pharmacy Associ-

ation (FPA) email database, Florida phar-macists were asked to take part in a sur-vey to determine their preparedness to counsel patients on lifestyle modifica-tions, 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 sur-vey 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 re-sponse questions requiring categoriza-tion. The remaining seven questions were short answer or multiple choice catego-ries. Cohen’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 respon-dents were community-pharmacy based (n=59). On average, respondents rated that

Perceptions to Possibilities: Going Beyond Prescriptions

Emily N. Bennett, B.S., Pharm.D. Candidate 2022College of Pharmacy, University of FloridaLake Nona, Florida

William E. Haley, Ph.D.ProfessorSchool of Aging Studies, University of South FloridaTampa, Florida

Adrian N.S. Badana, MPH, CPH Ph.D. Fellow, Aging StudiesSchool of Aging Studies, University of South FloridaTampa, Florida

Wendy H. Updike, Pharm.D., BCPS, CDE (corresponding au-thor)Clinical Assistant ProfessorCollege of Pharmacy, University of South Florida12901 Bruce B. Downs Blvd., MDC 30Tampa, Florida 33612 E-mail address: wupdike@health.usf.edu

the role of the pharmacist is probably ex-panding to encompass patient-centered counseling regarding lifestyle modifi-cation (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 confi-dence for counseling on diet were posi-tively correlated (p < 0.0001), as well as preparedness and confidence for coun-seling on aerobic exercise (p < 0.0001). When asked whose role lifestyle modi-fication counseling should be, 33.9 per-cent of pharmacists said they believe the role belongs to a multitude of health professionals, with 63 percent of those including pharmacists. There was a sig-nificant, positive association for how confident pharmacists felt in their abil-ity to counsel patients with hyperten-sion/CHD on diet changes (such as the Mediterranean diet) and the total ses-sions they have counseled patients re-garding lifestyle modifications (p = 0.018). Pharmacists who reported that they felt more confident tended to re-

port that they had more counseling ses-sions with patients. In addition, there was a significant, positive association for how prepared pharmacists felt in their ability to counsel patients with hy-pertension/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 com-pared to confidence to counsel on incor-porating 30 minutes of daily aerobic ex-ercise (p = 0.058) and preparedness to counsel on aerobic exercise (p = 0.038). Regardless of predicted positive out-comes to pharmacist-patient counsel-ing, 77.2 percent of pharmacists listed at least one possible barrier to their suc-cess 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 modifi-

cation counseling may be an invaluable tool in the management of coronary heart disease and hypertension, and a majority of pharmacists are support-ive of their expanding role within the health care setting. While pharmacists realize the importance of providing lifestyle modification education to pa-tients, many agree that it should contin-ue to be a multidisciplinary approach to improve patient care. Numerous barri-ers remain, however, that require fur-ther attention before pharmacists can be used to their full potential and abil-ity, especially in the community-phar-macy setting.

Table 1: Pharmacists’ 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

18 | F L O R I D A P H A R M A C Y T O D A Y

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-

islature also had to train a historic number of freshman legis-lators 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 Repub-licans and 17 Democrats.

The legislative agenda was focused mainly on the priori-ty initiatives of the governor, Cabinet, Senate president and House speaker. Gov. Ron DeSantis’ priorities for this ses-sion included increasing the environmental budget for Ev-erglades’ restoration and clean water efforts, addressing the $5.4 billion in insured losses from Hurricane Michael, and al-lowing patient access to smokable medical marijuana. Senate President Bill Galvano’s priority was a transportation infra-structure 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 accom-plished 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-

End of Legislative Session Report: A Recap of 2019 By Michael Jackson and Adams St, Advocates

Total Bills Filed 3,052 Total Bills Filed 3,192 Total Bills Filed 3,491Total Bills Passed 249 Total Bills Passed 200 Total Bills Passed 194

Percentage Passed 8% Percentage Passed 6% Percentage Passed 5.50%

2017 Legislative Session 2018 Legislative Session 2019 Legislative Session

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.

J U N E 2 0 1 9 | 19

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 ap-propriations 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 constitution-al 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 re-storing voting rights to felons; and the governor’s controver-sial Canadian Drug Importation bill.

Major Policy/Budget Initiatives Passed This Year n $121.5 million tax cut package n Revamp teacher bonuses and increase school choice fund-

ing n Massive Hurricane Michael Recovery Funding from both

federal and state, which led to cuts elsewhere n Water Quality Improvement and Everglades Restoration,

which received a historic $656 million in recurring fund-ing

n 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

n Public safety legislation, including the Marjory Stoneman Douglas bill that allows teachers to carry guns

n Allowing smokable marijuana n Major CON (Certificate of Need) application changes n Controversial legislation banning sanctuary cities n Implementation of Amendment 4 – restoring felons vot-

ing rights n Very first “Tele-Health” legislation, which will for the first

time allow doctors from other states to provide telemedi-cine 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 ma-jor issues. The major high priority issues of interest included:

n PBM – Network Adequacy Inclusion, Transparency

Spread Pricing, Audit protection n Telehealth/Telepharmacy n Remote Supervision n Point of Care/Test and Treat n Collaborative Practice Agreements – FSHP collaboration n Patient Access for Pharmacy of Choice: Advocate for pa-

tient access to their pharmacy of choice (no closed net-works or mail order restrictions)

Priority Bills and Session Accomplishments

PRACTICE OF PHARMACY (HB 111 REP. PLACENSIA AND REP. SIROIS/SB 300 SEN. BRANDES)

n These bills would have allowed a pharmacist to enter into a protocol agreement with a doctor to test and treat pa-tients for influenza and streptococcus, and to also enter into a collaborative practice agreement to assist in drug therapy and chronic disease management.

n 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.

n 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)

n These bills would have allowed a consultant pharmacist to enter into a collaborative practice agreement to assist in drug therapy and chronic disease management.

n 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.

n 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)

n These bills would have allowed a pharmacy to use an au-tomated system for outpatient dispensing and deploy a machine that need not be located in a community phar-macy as long as it was under the supervision of a Florida licensed pharmacist. Controlled substances would not be allowed in these machines.

n Despite opposing testimony, the bill passed the House, but was never heard in the Senate.

20 | F L O R I D A P H A R M A C Y T O D A Y

n 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)

n These bills would require pharmacists and doctors to elec-tronically generate and transmit prescriptions for medici-nal drugs.

n ASA and FPA met with both sponsors to discuss the fee issue charged to pharmacies for receiving electronic pre-scriptions. Also raised were challenges that pharmacists had to deal with when receiving an electronic prescrip-tion that could not be filled by the pharmacy and possible steering of patients by PBMs.

n Due to concerns from FPA membership, ASA negotiat-ed with Sen. Bean to file an amendment to include a lat-er date for implementation (7/31/2021) and limit to those doctors’ offices that have EHR systems.

n 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.

n Ultimately, HB 831 was adopted and has been signed by the governor.

PRESCRIPTION DRUG MONITORING PROGRAM(HB 1253 REP. MARIANO/SB 1700 SEN. LEE)

n These bills would allow the attorney general to access in-formation in the PDMP.

n Specifically, this would allow the AG to petition a court for access to data necessary to support potential fraud or for civil litigation

n Attorney General Ashley Moody made this her priority legislation in order to support her opioid lawsuit against several large business interests.

n There were strong attempts by the chains to kill this bill, but ASA/FPA helped members to understand the privacy

protections in place to protect patient information and the bill passed both chambers.

n The AG stated that passage of this bill saves the state mil-lions in litigation costs and two to three years of lost litiga-tion resolution.

n HB1253 was approved by the House and Senate with no objection and is headed to the governor’s desk.

PRESCRIPTION DRUG MONITORING PROGRAMHB 375 REP. PIGMAN/SB 592 SEN. ALBRITTON

n These bills were filed to allow for the interchange of pre-scription drug monitoring program data with other states, districts, territories, the Veterans Administration, Depart-ment of Defense and Indian Health Services.

n The exchange of information with these other entities would be permissible so long as the restrictions and re-quirements are compatible with Florida laws.

n HB375, which has been signed by the governor, also in-cludes an exemption for prescribers and dispensers from having to query the PDMP database for patients in a li-censed hospice when prescribing or dispensing a “nono-pioid controlled substance.”

PHARMACY BENEFIT MANAGERS (HB 271 REP. SANTIAGO/SB 906 SEN. WRIGHT)

n These bills would have done many things outside the scope of enforcing PBM regulation, audits, transparency and oversight.

n While neither bill was heard, the issue was raised and therefore brought up in discussions during several com-mittees and on the floor, and it is now becoming the focus of political agendas.

n ASA had many meetings regarding pharmacy benefit managers, including successfully feeding members ques-tions to ask in committee and on the floor.

n ASA had several positive meetings with AHCA Secretary Mary C. Mayhew and her staff about conducting an audit for the Medicaid PBMs.

n ASA convinced Sen. Doug Broxson – chair of the Banking and Insurance Committee – to make this issue his com-mittee’s priority next session.

n 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)

n 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 major-ity of the members, the executive order now has the gov-ernor 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.

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.

J U N E 2 0 1 9 | 21

CANADIAN DRUG IMPORTATION PROGRAM(HB 19 REP. LEEK/SB 1528 SEN. BEAN)

n 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.

n The House version was a much broader program allow-ing for importation from not only Canada but other coun-tries as well.

n We were able to get the Senate to agree to a more restrict-ed 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.

n 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.

n Drugs that are to be imported are those expected to gen-erate cost savings. Controlled substances, biological prod-ucts, drugs inhaled during surgery and injectable drugs are excluded from the importation program.

n Pharmacies that participate in the Canadian and interna-tional import program are required to file reports with the state and are limited to who these medications can be dispensed to.

n The program will not begin until permission is granted by the federal government.

n 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)

n These bills defined the practice of telehealth in the state of Florida and allows doctors licensed in other states to pro-vide telemedicine without needing a Florida license.

n It will allow pharmacists in other states to provide tele-health services, but only through a Florida-licensed phar-macy.

n HB23 passed both chambers and will be signed by the governor.

PRESCRIPTION DRUG FORMULARY CONSUMER PROTECTION(HB 1362 REP. WILLIAMSON/SB 1180 SEN. MAYFIELD)

n 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.

n This bill passed the Senate but stalled in the House.

CONTINUING EDUCATION FOR HEALTH CARE PROFESSIONALS

n 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 main-tain their vaccination credential. As a freshman member of the Legislature, Rep. Sirois quickly stood out as a cham-pion 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.

n The amendment did not pass, but began a discussion to be addressed next session.

STATE HEMP PROGRAMSB 1020 SEN. BRADLEY

n This legislation would allow for the retail sale of hemp and hemp products under the Department of Agriculture.

n Revises the definition of cannabis under F.S. 893 to ex-clude hemp and industrial hemp.

n 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)

n Requires health care licensees (including pharmacists) to complete continuing education on human trafficking.

n Continuing education is required to be completed by Jan-uary 1, 2021 and must be 1 hour

n Course content must include sex trafficking and labor traf-ficking, how to identify individuals who may be victims of human trafficking, how to report cases of human traf-ficking and resources available to victims

n Requires Department of Health licenses or certificate holders to post in their place of work assessable to em-ployees a sign in English and Spanish the following in-formation: "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, re-tail work, restaurant work, or any other activity, call the National Human Trafficking Resource Center at 888-373-7888 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. Com-mittee weeks for the 2020 session will likely start as early as September, as the 2020 Ssssion will begin early January and end early March.

22 | F L O R I D A P H A R M A C Y T O D A Y

As we celebrated the 50th anni-versary of the American Pharmacists Association – Academy of Student Pharmacists (APhA-ASP) in Seattle, Washington, March 21-25, I can hon-estly say we stood out among the other states across the country with example after example of excellence in leader-ship. In just about every circle I work in or around, I hear pharmacists express-ing their concerns for the future of the profession. I can honestly say, the lead-ership for the profession of pharma-cy in Florida is changing and we have an amazing opprtunity. Our duty is to reach out to them, cultivate strong in-tegrity in leadership and move them past what we accomplished.

Anyone attending the American Pharmacists Association (APhA) An-nual Convention in Seattle and attend-ing the APhA-Academy of Student Pharmacists (ASP) Student Pharmacist Programming, HOD and Awards Ses-sions, would walk away feeling a sense of comfort knowing we have a pipe-line 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, indi-vidual mentoring and advocacy for the profession.

At the APhA Annual, it was a show-case of just how incredible our APhA-ASP chapters are across the state and the leadership that is available to our Association as they graduate and en-ter the profession. A special thank you to each of our seven college of pharma-cy ASP chapter advisers for investing in their student leadership and chapter members. Advisers have worked to ele-vate them as up and coming leaders by encouraging their involvement and in-novations in various patient care proj-ects and fostering opportunities for ad-vocacy in the profession. A very special

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 stu-dents that served at the national lev-el, 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 presi-dent-elect and, although she didn’t win the seat this year, we know she’s go-ing to run again for a national position. Her message rang out among the en-tire 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 APhA-ASP Parliamentarian Dr. Michael Moné. I myself was moved to tears. Our stu-dents 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 Leader-ship Award. Two of the four were our very own FPA student leaders Vivian Nguyen (UF Jacksonville) and Jaim-ie Myers (USF Tampa). It was incredi-ble 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. Vivi-an Nguyen also received the Sam Kaly-an Scholarship. We have seen both of them unite not only their own APhA-ASP chapters, but work in unison with

Cultivating a Pipeline of Leadership in FloridaBy FPA President Angela Garcia, PharmD, MPH, CPh

J U N E 2 0 1 9 | 23

the other chapters across the state in FPA advocacy and leadership events through their active work in the Coun-cils. 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 host-ed local patient counseling events to identify their top student candidates who will go on to compete at the na-tional level during the Annual Conven-tion at APhA. Our state with seven col-leges of pharmacy has an advantage for representation and we are very ex-cited when our schools facilitate the ac-tivities and help represent clinical excel-lence for our state. For the second year in a row, the National Patient Counsel-ing Competition included a Florida can-didate. 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 Flor-ida student placed in the Top 10, and certainly never back to back. We cele-brate the excellence of these students in patient counseling and chalk this up as one more data point for amazing student leadership. We’re looking for-ward to the FPA Annual Convention and Expo in Fort Lauderdale, July 11-14, where all seven schools will send stu-dents to compete in our statewide Pa-tient Counseling Competition. We love the spirit of competition and simultane-ous support they give each other, not only over the summer but also all year long.

Chapter AwardsWith regard to patient care and the

bread and butter of patient engage-ment – our students have the opportu-nity to engage in several Patient Care Projects including Operation Immuni-zation, Operation Diabetes, Operation Heart, Generation Rx and OTC Medica-tion Safety. Recently added is the Wom-en’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 Univer-sity of Florida received a national rec-ognition for their Operation Diabetes Patient Care Projects combined across their three campuses (Gainesville, Jack-sonville and Orlando), which is a great honor and recognition.

PharmFlix is one of the most awe-some challenges each school has every year and the work they produce is so in-spiring. Most of the students have their PharmFlix videos uploaded to YouTube, but we will be showcasing those along with the FPA Advocacy Video Chal-lenge for members to see throughout the Annual Convention. Student chap-ters must produce a video featuring their APhA-ASP chapter members us-ing the annual theme for the event. This year, in celebration of the 50th anniver-sary, 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 resolu-tions passed in the “big house” APhA HOD. We also know that the USF Col-lege of Pharmacy submitted a Resolu-tion for the FPA HOD (as a New Busi-ness item), so we hope to see their advocacy continue and to see addition-al schools prepare strong resolutions submissions. During their HOD, the APhA-ASP students supported their re-gions and the state to ensure a consis-tent message on what their priorities were as they plan and prepare for en-try into the profession. The University of Florida won the Back the PAC fund-raiser 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. How-ever, have you ever thought about the fact there are also conveniently sev-en schools and colleges of pharma-cy across the state of Florida? Could there be something to the magic of sev-en? Could it be a coincidence or stroke of luck? You decide! What we do know is that the FPA continues to need spon-sorship of students to support the pro-gramming this summer and for our membership to reach out to mentors and lead our student pharmacists as they enter the profession as new prac-titioners.

For those of you who can, we always encourage the Adopt A Student pro-gram (whether you can attend the an-nual or not) or to make a donation to the Adopt A Student Program. We need pharmacists to participate in the stu-dent 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 on-line to pharmview.com and look for the FPA Annual and Convention portal. We need to support the programs and ex-periences that foster our students’ de-velopment 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 phar-macist, 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 genera-tion of pharmacists. WE are responsible to cultivate new leaders for the profes-sion by promoting them instead of our-selves. WE are here to support change and invest in new approaches to learn-ing 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 be-yond what we achieved. WE invest in greatness.

24 | F L O R I D A P H A R M A C Y T O D A Y

129th Annual Meeting and Convention

JULY 10–14, 2019Marriott Harbor Beach

Resort and SpaFort Lauderdale, FL

J U N E 2 0 1 9 | 25

Norman “Hoot” 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 � lm known as

Black Hawk Down.In August of 2001, Dr. Hooten retired from active duty. He brie� y 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 e� ort 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 A� airs Medical Center followed by a Postgraduate Year Two (PGY2) psychiatric pharmacy resident at the West Palm Beach Veterans A� airs 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 � nd ways to give back to the Veteran community that has given so much to our great nation. He currently practices at the Orlando Veterans A� airs Medical Center where his primary area of interest is working with Veterans who su� er with chronic service related pain and substance abuse.

Keynote Speaker

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 fi nancial relationship to the activities.

26 | F L O R I D A P H A R M A C Y T O D A Y

Thank You For Attending the129th Annual

Meeting & Convention!See You Next Year!

130th Annual ConventionJW Marriott Marco Island Beach ResortMarco Island, FL

July 8 – 12, 2020

Save the Date!Save the Date!

Accommodations

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.

Special EventsFPPC 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!

Marriott Harbor Beach Resort & Spa3030 Holiday Drive • Ft. Lauderale, FL 33316

(800) 222-6543 or (954) 525-4000

J U N E 2 0 1 9 | 27

FPA 129th Annual Meeting and Convention July 10-14, 2019 Ft. Lauderdale, FL ,

Participant Information

Name: _____________________________________________________

Badge Name: _______________________________________________

Mailing Address: ____________________________________________

City, State, Zip: _____________________________________________

Phone: (W) (H)_______________________

Fax: ______________________________________________________

License: PS________________ PU_________ Other State________

1

2

3

5

FPA Polo Shirt (Deadline is June 7, 2019)

Quantity Price M/F Size Amount

Yes ______ @ $35 ______ ______ $_______

8

Participant Information

Name _______________________________________________

Address______________________________________________

City, State, Zip_________________________________________

Phone___ ________________________

Email________________________________________________

Practice Setting________________________________________

License: PS______________ PU _____________RPT_________

NABP e-profile#__________________ Date of Birth___________

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_

FPA Member $345 $430 $_______

Non Member $525 $610 $_______

Pharmacist BEST Value $540 $625 $_______

Member Technician $155 $185 $_______

Non Member Technician $175 $210 $_______

Technician BEST Value $185 $220 $_______

Student $150 $170 $_______

Handbooks $40 N/A $_______

(BEST Value includes Registration & Membership)

2

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.

Daily Education Registration Daily registration does not include admittance to functions or handbooks. Handouts will be posted on our website July 10.

Before June 21 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 Friday Saturday Sunday

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 $_____

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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.

Quantity Price Amount

Exhibit Hall @ $30 $______

Awards Event @ $80 $______

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6

Payment Total Enclosed: $______

Check (To: FPA) AMEX Discover MasterCard Visa

Account # ____________________________________________

Security Code _________________ Expiration Date __________

Billing Address ________________________________________

Signature ____________________________________________

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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

House of Delegates Before June 12 Amount

House of Delegates $165 ______ (Non-convention registrants)

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28 | F L O R I D A P H A R M A C Y T O D A Y

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