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The Official PublicationOf The Florida Pharmacy Association

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J A N U A R Y 2 0 1 6 | 3

VOL. 79 | NO. 1JANUARY 2016THE OFFICIAL PUBLICATION OF THEFLORIDA PHARMACY ASSOCIATIONP H A R M A C Y T O D A Y

florida

Departments 4 Calendar

4 Advertisers

5 President’s Viewpoint

7 Executive Insight

14 FPA News & Notes

29 Buyer’s Guide

Features

Telemedicine by Health Care Clinicians

ANDEXANET ALFA: Investigational Factor Xa Inhibitor Antidote

FPA 126th Annual Meeting and Convention

10

18

26

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:of the Florida Pharmacy Today JournalThe Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Phar-macy 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.

of the 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 execu-tive editor of the Florida Pharmacy Today Journal in the establishment and interpreta-tion of the Journal’s policies and the manage-ment 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.

AdvertisersTHE HEALTH LAW FIRM .............................. 13KAHAN HEIMBERG, PLC .............................. 20PHARMACISTS MUTUAL ............................. 13Rx OWNERSHIP ................................................. 2

2015-16

FPA CalendarJANUARY

31 Last day to submit election ballots

FEBRUARY

9-10 Board of Pharmacy meetingJacksonville

28 Awards Nomination Due

MARCH

4 - 7 APhA Annual MeetingBaltimore, MD

11 Legislative Session ends

19-20 FPA Committee and Council Meetings Orlando

25 Good Friday - FPA Office Closed

27 Easter - FPA Office Closed

APRIL

15 - 17 FPA Clinical ConferenceTampa

MAY

1 - 3 NASPA Leadership Retreat

6 Deadline for FPA Resolutions

6 Deadline for Vice Speaker and Director nominations

21-22 FPA CE Conference Jacksonville

JUNE

6/30 - 7/3 FPA Annual Meeting, Ft. Lauderdale, Florida

For a complete calendar of events go to www.pharmview.comEvents 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, 2017 or prior to licensure renewal. Consultant pharmacists and technicians will need to review their licenses and registrations by December 31, 2016.

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

CONTACTSFPA — Michael Jackson (850) 222-2400FSHP — Tamekia Bennett (850) 906-9333U/F — Art Wharton (352) 273-6240FAMU — 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.

J A N U A R Y 2 0 1 6 | 5

E-MAIL YOURSUGGESTIONS/IDEAS TO

dave@fiorecommunications.com

Water the Grass

I know that the title might seem a lit-tle strange for an article found in the FPA journal, written by the FPA

president, but don’t think that I may have hit my head a little too hard. Just bear with me for a few sentences.

In addition to my work as a phar-macist, I pride myself as an amateur “farmercist,” in that I enjoy making things grow. For many years I’ve plant-ed potatoes, tomatoes, corn, squash and even some grasses. As I am sure most of you know, when you plant grass seeds, you need to supply them with plenty of water and eventually a little fertilizer to assure that they grow into something useful, something to be proud of, which will continue to grow. Pretty basic concept, no? The seeds ger-minate, grass grows, and soon, in the big picture, you have a yard.

In my more than 40 years in phar-macy, and especially my years in dif-ferent leadership roles, I have noticed a trend that I find disturbing. What is it? It is apathy or ignorance in the bene-fit to us and the profession by being in-volved in different professional organi-zations. Let me list a few observations and try to figure out the cause.

■ There has been a decline in the number of county or local pharma-cy unit associations.

■ There has been an increase in the average pharmacist’s age in these associations.

■ There has been a decrease in the number of pharmacists stepping up to take leadership roles.

■ And because of this, there has been a decrease in the advancement of pharmacy in Florida.Now, I will say that these observa-

tions are mine, and some of you may have different views. Here are some of the reasons that I think may contribute to these observations.

New pharmacists come out of school owing a lot of money. Most of my students come out owing between $100,000 and $200,000 in student loans, and the job market for pharmacists is not as good as it used to be. In fact, many pharmacists are having trouble finding a full-time job. With this said,

if you find a job, you want to work hard at it, keep it and be able to repay your debts.

Many of today’s employers provide advantages that belonging to a local as-sociation is perceived to offer, such as continuing education, interaction with other pharmacists and technicians and sources of information about the pro-fession and where it’s going. As a re-buttal to this, I say, that is all good, but we shouldn’t confine our information to just one source.

Younger pharmacists have grown

up relying on e-information and might not see the benefit of attending meet-ings or seeing live presentations to pharmacists and technicians and inter-acting with these people. It is through interactions like this that we find out what others in our profession are do-ing, how they do it and what we need to be involved with in order to have a voice in the changes that come to our profession. If we don’t guide the chang-es to our profession, others, such as in-surance companies, lawyers and phy-sicians, will have the only voice that is heard.

In the last 40 years, I have seen the profession go from manual typewrit-ers to computers, from being primar-ily a purveyor of product to being a purveyor of information about drugs and disease states, from a profession of medication to a profession of total healthcare. I can guarantee you that there will be tremendous changes in the profession in the next 10 to 20 years. Let’s make those changes ourselves, so they benefit our profession, so that we

The President’s Viewpoint

In my more than 40 years in pharmacy, and especially my years in

different leadership roles, I have noticed a trend that I find disturbing.

What is it? It is apathy or ignorance in the benefit to us and the profession

by being involved in different professional

organizations.

TIM ROGERS, RPh, FPA PRESIDENT

Tim Rogers, RPh 2015-2016 FPA President

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 Kelley .................................................................................................Board ChairTimothy Rogers .........................................................................................FPA PresidentAlexander Pytlarz ................................................................................... FPA TreasurerScott Tomerlin ..........................................................................................President-ElectJackie Donovan .......................................................................Speaker of the HouseCarol Motycka ...............................................................Vice Speaker of the HouseThomas Johns ........................................................................................ FSHP PresidentJennifer Raquipo ................................................................................ Region 1 DirectorMichael Hebb ........................................................................................Region 2 DirectorTom Cuomo ............................................................................................Region 3 DirectorLinda Lazuka ........................................................................................Region 4 DirectorRobert Parrado ..................................................................................Region 5 DirectorLuther Laite IV ....................................................................................Region 6 DirectorDavid Mackarey ................................................................................. Region 7 DirectorHumberto Martinez .........................................................................Region 8 DirectorMitchell Fingerhut ............................................................................Region 9 Director

Florida Pharmacy Today Journal Board

Chair.............................................................. Carol Motycka, motycka@cop.ufl.eduVice Chair ...................................................Cristina Medina, cmmedina@cvs.com Treasurer ...................Stephen Grabowski, sgrabowski@seniormmc.comSecretary .............Verender Gail Brown, brownvgrx4304@hotmail.comMember ................................................Joseph Koptowsky, docjik1215@aol.comMember ............................. Rebecca Poston, Rebecca.Poston@flhealth.govMember ................................................Patricia Nguebo, notablep@hotmail.comMember ...............................................................Norman Tomaka, FLRX9@aol.comMember .......................................................................Stuart Ulrich, Stuarx@aol.comMember ............................................................ Don Bergemann, don@bceinfo.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

2015-16 FPA Board of Directors might be able to provide better health-care to our patients. More seasoned pharmacists must encourage younger pharmacists to participate by showing them the advantages of membership and acting as their mentors in roles of leadership.

This is what I would like to see us do:1. Start new local associations2. Rejuvenate and modernize our ex-

isting associations to meet every-one’s needs

3. Encourage the younger pharma-cists to join and take on leadership roles

4. Find out what others expect us to supply and make it available

5. Let everyone know that our asso-ciations are not just a source of CE, but a venue for fellowship, educa-tion, advocacy, opportunity, a think tank that will look to the future and something that we cannot afford not to belong toThe FPA and our unit associations

have much more to offer, such as: con-tinuing education statewide, home study programs, career center services, fellowship, pharmacy resources, cur-rent and meaningful information, ad-vocacy for our profession and our pa-tient’s health and much more.

So, let us plant the seeds of the fu-ture for pharmacy and nurture and en-courage all of them to grow so the fu-ture will be greener and better place for all. ■

J A N U A R Y 2 0 1 6 | 7

See Executive Insight continued on p. 9

Transdermal & Oral Contraceptives available OTC? Not exactly

As of January 1, 2016, pharmacists in Oregon are ringing in the New Year with permission to write prescriptions for birth control. Introduced with Or-egon HB 2879 and HB 3343, state law now authorizes Oregon pharmacists to prescribe and dispense oral and trans-dermal contraceptives to women aged 18 years or older and those young-er than 18 who have received a previ-ous prescription for oral or transdermal birth control from a physician.1 In addi-tion, the law also allows for the phar-macist to dispense a 12-month supply at once instead of a single-month or three-month supply.2

Introduction of this new law means Oregon joins California as one of two states in the U.S. that permit pharma-cists to prescribe birth control. Oregon, however, remains the first state to effec-tuate such a law, as California’s SB 493, signed into law in 2013, allows for phar-macist to have this authority but cur-rently lacks the implementation of ap-propriate measures to do so.

With this change in Oregon, many supporters say the state is moving to-ward initiatives to allow over-the-coun-ter availability of contraceptives, a high-ly controversial and charged debate.

ROLE OF THE PHARMACIST

It should not be overlooked that in this unique expansion to the role of pharmacists comes a great deal of re-sponsibility. Before women in Oregon who seek birth control can obtain a pre-scription, they must fill out a health questionnaire and receive regular

blood pressure checks. Once the phar-macist determines there is an absence of contraindications and that the use of contraceptives will be effective and safe, then a prescription can be written by the pharmacist.1

Fiona Karbowicz, RPh, a consul-tant pharmacist for the Oregon State Board of Pharmacy, explains in Phar-

macy Times that the questionnaire was derived from an algorithm in a birth control direct-access study conducted by researchers from the University of Washington and published in the Jour-nal of the American Pharmacist As-sociation (JAPhA) in 2006. This study sought to establish a collaborative drug therapy protocol to screen and counsel women for safe use of hormonal con-traceptives prescribed by community

pharmacists.In addition to administering the

questionnaire, the law mandates phar-macists who wish to prescribe birth control attend a five-hour requisite con-tinuing education (CE) course to help better prepare them for prescribing birth control.

PUBLIC RESPONSE

Although widely supported, one popular morning television show ex-pressed doubt on whether pharmacists had the expertise to care for patients in regards to contraception. In response, the American Society of Health-Sys-tems Pharmacists (ASHP) published a statement online, saying:

“Pharmacists are the medication-use ex-perts and are specifically trained to help pa-tients use their medications safely and ap-

Pharmacists Prescribing Birth Control in the New Year

Executive Insight

Introduction of this new law

means Oregon joins California as one of two states in the U.S. that

permit pharmacists to prescribe birth

control.

BY MICHAEL JACKSON, RPHBY GUEST COLUMNIST JUSTIN DOROTHEO, PPHARM D. CANDIDATE AND FPA INTERN

Justin R. Dorotheo

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. 120Controller

Wanda Hall, ext. 211 Educational Services Office Assistant

Stacey Brooks, ext. 210Coordinator of Membership

Christopher Heil, ext. 110

FLORIDA PHARMACY TODAY BOARDChair..................................... Carol Motycka, St. AugustineVice Chair ...............................Cristina Medina, HollywoodTreasurer ..............................Stephen Grabowski, TampaSecretary ........................Verender Gail Brown, OrlandoMember .................................... Joseph Koptowsky, MiamiMember .............................Rebecca Poston, TallahasseeMember .............................................Patricia Nguebo, OcalaMember ................................Norman Tomaka, MelbourneMember .............................Stuart Ulrich, Boynton BeachMember ......................Don Bergemann, Tarpon SpringsExecutive Editor ........Michael Jackson, TallahasseeManaging Editor ........................Dave Fiore, Tallahassee

This is a peer-reviewed publication. ©2016, 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

SAVE THE DATE126TH ANNUAL MEETING

AND CONVENTION OF THE FLORIDA PHARMACY

ASSOCIATION

Marriott Harbor Beach3030 Holiday Drive

Fort Lauderdale, Florida 33316

June 30 - July 3, 2016

J A N U A R Y 2 0 1 6 | 9

propriately… Today’s pharmacists are trained and licensed to provide a number of additional services, including initiat-ing and modifying drug therapy, conduct-ing health and wellness testing, helping patients manage chronic conditions, ad-ministering immunizations and helping pa-tients understand and manage their medi-cations… Pharmacists are highly educated and trained healthcare professionals who are willing and able to provide vital care for those in need.”4

SUPPORT FOR EXPANDED ACCESS

It’s no secret that there has long been support for legislation such as this in regard to expanding access to health care services to women. Organizations such as the American Medical Associa-tion (AMA) in 2013 and the American College of Obstetrics and Gynecology (ACOG) as far back as 2012 have long endorsed their support for increased access to contraception, with goals to move these medications over-the-coun-ter (OTC).5 A January 2016 statement from Dr. Mark DeFracesco, current president of ACOG, has most recently expressed that the law change in Ore-gon is not enough:

“Birth control is an essential part of women’s health care, and OTC status would help more women benefit from the ability to control their own repro-ductive health… Requiring a pharma-cist to prescribe and dispense oral con-traceptives only replaces one barrier — a physician’s prescription — with another.”6

However, Oregon State Board of Pharmacy executive director Marcus Watt also believes this law will greatly benefit women living in more rural ar-eas of Oregon who sometimes “wait up to 18 weeks to see a provider.”1

MORAL CONSCIENCEWith these recent changes in Ore-

gon law regarding pharmacists, some are asking if this is the right direction for pharmacy practice and if the law change will put some pharmacists in a position in violation with their con-science. In answering these questions,

the president of the Christian Phar-macy Fellowship International (CPFI), pharmacist Fred Eckel, shared these words on the matter:

“Some pharmacists may have mor-al concerns with birth control medica-tions. Because, in this case, the Oregon legislation is permissive, I do not see that [these laws] create a moral dilem-ma, because a pharmacist who may not be comfortable prescribing oral contra-ceptives does not have to participate. This new opportunity is consistent with the expanded role being proposed for pharmacists, so the debate should focus on whether it is an appropriate role for pharmacists rather that any moral issue.”

Eckel also reflected a very similar stance to that of ASHP’s statement, say-ing “the real question is, are pharma-cists equipped to handle this respon-sibility? Without a doubt, using today’s curriculum, pharmacists are more than well equipped to take on this role in healthcare management.” 6

These recent changes in Oregon and previously in California show the na-tion that pharmacists are more than ca-pable of delivering the needs of women in access to care. Despite the remain-ing 48 states still without legislation ex-panding this pharmacist role in health care, there is no doubt that these chang-es in Oregon were accomplished due to the power of advocacy and the voice of pharmacists and pharmacy students fighting for the ability and recognition for pharmacy legislation designed to increase patient access and utilize the trained skills of today’s pharmacists.

Resources:G i l c h r i s t , A . H o w O r e -

gon Pharmacists Are Prescr ib-ing Birth Control. Pharmacy Times. http://www.pharmacytimes.com/re-source-centers/womens-health/how-oregon-pharmacists-are-prescribing-birth-control. Published January 4, 2016. Accessed January 6, 2016.

Liss-Schultz, N. Oregon Residents Can Now Get Birth Control Prescrip-tion Without Doctor’s Visit. RH Real-ity Check. http://rhrealitycheck.org/

article/2015/06/30/oregon-residents-can-now-get-birth-control-prescrip-tion-without-doctors-visit/. Published June 30, 2015. Accessed January 6, 2016.

News Capsules: ASHP Responds to “Good Morning America” Segment on Oregon Pharmacists Prescribing Oral Contraceptives. American Society of Health-System Pharmacists (ASHP). http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=1592. Published January 5, 2016. Accessed January 8, 2016.

Over-the-counter access to oral contraceptives. Committee Opinion No. 544. American College of Obstetri-cians and Gynecologists. Obstet Gynecol 2012:120;1527-31.

Newsroom: Statements: 2016: ACOG Statement on Pharmacist Prescribing Laws. American Congress of Obstetricians and Gynecologists (ACOG). http://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-on-Pharmacist-Prescribing-Laws. Pub-lished January 4, 2016. Accessed Janu-ary 8, 2016.

Eckel F. President of Christian Phar-macist Fellowship International (CPFI): Oregon Pharmacists and Birth Control. 2016 ■

References1 http://www.pharmacytimes.com/

resource-centers/womens-health/how-oregon-pharmacists-are-prescribing-birth-control

2 http://rhrealitycheck.org/article/2015/06/30/oregon-residents-can-now-get-birth-control-prescription-without-doctors-visit/

3 http://www.ashp.org/menu/News/NewsCapsules/Article.aspx?id=1592

4 http://www.acog.org/Resources-And-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Over-the-Counter-Access-to-Oral-Contraceptives

5 http://www.acog.org/About-ACOG/News-Room/Statements/2016/ACOG-Statement-on-Pharmacist-Prescribing-Laws

6 Eckel F. President of Christian Pharmacist Fellowship International (CPFI): Oregon Pharmacists and Birth Control. 2016

Executive Insight continued from p. 7

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

Antonio J. CarrionPrimary AuthorAssistant Professor of Pharmacy PracticeFlorida A&M University College of Pharmacy and Pharmaceutical Sciences

Jamal A. BrownCorresponding AuthorAssistant Professor of Pharmacy PracticeFlorida A&M University College of Pharmacy and Pharmaceutical SciencesJamal.brown@famu.edu(813) 540-3268

Today’s means of daily communi-cation have been altered and expand-ed through the advancement and use of technology (Santamore, W. P., 2008). With the employment of digital person-al assistants, cellular phones, the Inter-net, text messaging, interactive voice re-sponse, and email, telemedicine can be provided through a wide range of tech-nologies and applications (Grisby, 1998). Telemedicine utilizes telecommuni-cation technology to transfer medical data from one location to another, with the distance between locations being ei-ther a few or thousands of miles away (Brown N., 2007).

Telemedicine began more than 40 years ago, when the National Aero-nautics and Space Administration (NASA) started monitoring the physi-ologic status of astronauts during mis-sions while working in space (Bashur, A., 1997). During the late 1960s and 1970s, advances in communication technology provided the basis for NA-SA-funded telemedicine programs to

be developed and used by other areas of medicine (Bashur, A., 1997). Many programs demonstrated that telemedi-cine could be used effectively for con-sultative, diagnostic and educational purposes, especially for rural popula-tions where access to quality healthcare is limited by geography and/or a lack of adequate medical services and pro-viders (Brown, N., 2007). Throughout the 1980s and 1990s, further enhance-ment of computer technology systems expanded the use of telemedicine by specialties such as cardiology, oncolo-gy, radiology, psychiatry and surgery (Brown, N., 2007). By the late 1990s, tele-medicine programs were being initiat-ed by home healthcare agencies, cor-rectional facilities, and researchers all over the globe (Brown, N., 2007). To-day, we see pharmacists utilizing tele-medicine in the ambulatory care set-ting to manage chronic disease states and even provide counseling and drug information in retail pharmacy settings. Even though telemedicine can be very

Telemedicine by Health Care Clinicians

J A N U A R Y 2 0 1 6 | 11

beneficial in various aspects of medical care, there are several issues surround-ing the emergence of telemedicine. The purpose of this article is to discuss the financial cost, resistance to implementa-tion, education, training, confidentiali-ty and the roll of the pharmacist in tele-medicine.

Financial CostThe financial cost of implementing a

telemedicine-based healthcare system is a major limiting factor in regards to the future of telemedicine. As a multi-million-dollar investment with no re-imbursement currently available, many institutions or hospital systems may not be able to institute their own telemedi-cine-based system (Witzke, A. K., 2007). Through collaborative partnerships between hospitals, alternative mod-els have been established as a possibil-ity for reducing the expenses associat-ed with telemedicine usage (Witzke, A. K., 2007). Although a costly investment, many administrators of institutions feel that safety, improved clinical outcomes and an overall improvement in quali-ty of care are benefits that outweigh the expense of telemedicine realization. The maintenance cost of a telemedicine in-frastructure remains the greatest ex-pense to those organizations promoting and developing telemedicine programs (Myers, M. K., 2003).

The Telecommunications Act of 1996 made the Federal Communications Commission accountable for the Uni-versal Service Program and provides rural health care providers with dis-counts on telecommunication charges (Myers, M. K., 2003). In addition, other federal funds have been appropriated to aid rural programs with the expen-diture of maintaining the telemedicine infrastructure (Myers, M. K., 2003). Be-cause of the high costs of equipping and using an interactive telemedicine system (especially the cost of broad-bandwidth transmission media), many telemedicine providers are moving to-ward more cost-effective systems, such as desktop store-and-forward systems (Grisby, J., 1998).

Implementation ResistanceFear of being replaced by computer

technology is a concern some health-care providers have voiced for many years. Physicians mostly rely on the presence of patients to provide cer-tain clinical information and to per-form necessary interventions, which is limited by the inability to physically touch the patients (Witzke, A. K., 2007). The addition of telemedicine systems is merely intended to enhance the care be-ing provided by nurses and physicians, not to replace the human interaction and healing touch that can only be pro-vided by bedside caregivers (Witzke, A. K., 2007). For the most part, physicians tend to be more resistant than nurses to telemedicine management of their pa-tients (Celi, L. A., 2001). This resistance and lack of cooperation can limit the ef-fectiveness of telemedicine and poten-tially negatively impact the patient’s quality of care.

Educating for UseEducational training is a key concern

during implementation of telemedicine (Witzke, A. K., 2007). An important step in the planning process is the establish-ment of a system super user group that includes healthcare professional repre-sentation from each of the telemedicine monitoring units (Witzke, A. K., 2007). Training and education for providers should primarily be focused on time for hands-on practice with a new informa-tion technology system, as well as time spent reviewing and learning opera-tional guidelines or changes to the pro-posed workflow of the facility using it. Not only must the providers be educat-ed, but the patients must also receive instruction on the usage of the systems. Clearly, training is important, but for those individuals with limited mobil-ity or severe chronic diseases, access must be considered and is very essen-tial in the success of the system (Santa-more, W. P., 2008). Future telemedicine systems will more than likely have mul-tiple means of connectivity (i.e. cellular phones, Internet, text messaging, inter-active voice response, e-mail) to more comprehensively address access issues and resolve other related access issues (Santamore, W. P., 2008). During the

post implementation period, users must have the ability to assess any ongoing learning needs and communicate any changes to processes as the program grows and changes with gained experi-ence from healthcare providers and pa-tients (Witzke, A. K., 2007).

Confidentiality & SecurityFinally, the issue of confidentiali-

ty and security of electronic transmis-sion of medical information remains a prominent concern. The current medi-cal record system is already insecure, but there are additional concerns sur-rounding the ability of electronic med-ical record systems to maintain an ap-propriate level of security (Grisby, J., 1998). In general, electronic records are more secure than paper-based charts, but there is the associated risk of un-authorized persons obtaining access to confidential data (Grisby, J., 1998). The breaches of security may lead to inappropriate disclosure of individu-al patient information to persons who are unauthorized to receive it. Certain types of disclosure, such as the sale of lists of patients with a specific diagno-sis to marketers, may even be facilitated by the use of electronic databases (Gris-by, J., 1998). With the introduction of the Health Insurance Portability and Ac-countability Act of 1996 (HIPAA), stan-dards have been set forth that govern electronic data exchange, protect the privacy of health information and se-cure electronic signatures (Myers, M. K., 2003). With HIPAA, the challenge for telemedicine providers will be in how to deal with multiple state privacy pro-visions and federal provisions, which may be in conflict and prevent the inte-gration of telemedicine services (Myers, M. K., 2003).

Role of the Pharmacist Pharmacists play an important role

in the successful implementation of telemedicine in the health care arena. In the ambulatory care setting, phar-macists are used to provide clinical ser-vices such as managing chronic disease states through telemedicine for patients that live in rural areas or face transpor-tation barriers to care. Systems such as the Veterans Health Administration

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

(VHA) have successfully implemented telemedicine into their practice model, allowing for patients to be seen more frequently and produce better health outcomes. The VHA national home tele-health program, CCHT, introduced in 2003 in the USA, was created to remote-ly manage the care of older adults with chronic disease, avoiding long-term ad-mission to hospitals or other care insti-tutions. (Darkins, A., 2008)

The introduction of this program has led to decreased utilization of health care resources with a 19.7 percent re-duction in hospital admissions and a 25.3 percent decrease in bed days of care. Patients with the most common conditions reported large decreases in hospitalization: DM (20.4 percent re-duction), hypertension (30.3 percent reduction) and CHF (25.9 percent re-duction). (Barr, P., 2010) In the Hyper-link study performed in Minneapolis-St Paul, a pharmacist-ran hypertension clinic compared outcomes of telemedi-cine and telephone monitoring vs. pa-tients seen by their physician with-out tele-monitoring. The results of this study show that hypertensive patients were able to achieve and maintain high adherence to both the tele-monitoring and the phone case management vis-its when compared to the patient group only receiving primary care visits. (Ker-by, T.,2012)

Pharmacists in the retail setting also have great opportunities for integration with telemedicine. According to Adam Pellegrini, Walgreen’s VP for digital health, “Telehealth and telemedicine represent a significant opportunity for pharmacists and providers to partner on cutting-edge healthcare models. We hope that telehealth and telemedicine will extend the role of the communi-ty pharmacist. Our Pharmacy Chat is a prime example of this, as we do almost 9,000 to 10,000 chats per week with our patients on anything from drug in-teraction to just questions about their medications.” (Johnsen, M., 2015). CVS Health has already piloted programs including telehealth physician health care, and the company is exploring the allowance of MinuteClinic providers to consult with telehealth physicians to expand the scope of care offered. With

such technology available, pharmacists in the future have the opportunity to complete MTM visits, patient education consultations and even verify medica-tions through video technology. (Cas-tel, C., 2015).

ConclusionTelemedicine will inevitably alter

the delivery of patient care outside of the hospital setting and has the poten-tial to improve the efficiency of health-care delivery in general. (Santamore, W. P., 2008). Already, these technolo-gies are starting to be used clinically and will impact on the patient-provid-er relationship (Santamore, W. P., 2008). Pharmacists must continue to stay in-volved with the implementation of ser-vices and expansion of diverse roles within our profession. While enhancing patient satisfaction through the flexibil-ity of communication and improved ac-cess to health information, the benefits of linking appropriate medical special-ists to patients in need of their services have been the incentive for the continu-al growth and use of telemedicine tech-nology (Bashur, A., 2007). Telemedicine has the potential in reducing time and cost in patient transfers, assisting con-nections between clinical researchers and improving the education of medi-cal personnel, which are all major prob-lems in the healthcare arena. The pa-tient’s concerns, perceptions and needs must be addressed to achieve optimal technology utilization and patient ben-efit, which will eventually fall on the shoulders of healthcare providers. Cur-rent efforts to develop a coverage and payment policy for telemedicine should focus on the use of interactive video consultation and those services being provided by healthcare professionals outside of their required duties and re-sponsibilities. Pharmacists should use telemedicine opportunities to further improve outcomes and decrease hospi-talization rates in the outpatient setting. To ensure the success and not represent a diminishing percentage of use, tele-medicine users must be properly edu-cated, be willing to accept the telemed-icine initiative, maintain confidentiality and politic for necessary funds that will drive the telehealth movement in the

next few years.

ReferencesBarr, P., Mcelnay, J., & Hughes, C. (2010).

Connected health care: The future of health care and the role of the pharmacist. Journal of Evaluation in Clinical Practice, 58

Bashur, A., Lovett, J. (1997). Assessment of Telemedicine: Results of the Initial Experience. Aviation Space and Environmental Medicine, 48, 65-70.

Brown, Nancy (1995). A Brief History of Telemedicine. Telemedicine Information Exchange: Telemedicine and Telehealth Articles. Available at: http://tie.telemed.org/articles.asp. Accessed April 1, 2010.

Castel, C. (2015). CVS Health to Partner with Direct-to-Consumer Telehealth Providers to Increase Access to Physician Care. Retrieved December 10, 2015, from https://www.cvshealth.com/content/cvs-health-partner-direct-consumer-telehealth-providers-increase-access-physician-care

Celi, L. A., Hassan, E., Marquardt. C., Breslow, M., Rosenfeld, B. (2001). The eICU: It’s Not Just Telemedicine. Critical Care, 29, N183-N189.

Darkins, A., Ryan, P., Kobb, R., Foster, L., Edmonson, E., Wakefield, B. & Lancaster, A. E. (2008) Care coordination/home telehealth: the systematic implementation of health informatics, home telehealth, and disease management to support the care of veteran patients with chronic conditions. Telemedicine and E-Health, 14 (10), 1118–1126.

Grigsby, J., Sanders, J. H. (1998). Telemedicine: Where It Is and Where It’s Going.Annals of Internal Medicine, 129, 123-127.

Kerby, T., Asche, S., Maciosek, M., O’Connor, P., Sperl-Hillen, J., & Margolis, K. (2012). Adherence to Blood Pressure Telemonitoring in a Cluster-Randomized Clinical Trial. The Journal of Clinical Hypertension, 668-674.

Johnsen, M. (2015). Walgreens VP digital health talks telemedicine. Retrieved December 10, 2015, from http://www.drugstorenews.com/article/walgreens-vp-digital-health-talks-telemedicine

Myers, Mary K. (2003). Telemedicine: An Emerging Health Care Technology. Health Care Manager, 22, 219-223.

Santamore, W. P., Homko, C. J. (2008). Understanding How the Patient Interacts With Internet Intervention is Key to Advancing Telemedicine. Journal of Cardiovascular Nursing, 23, 472-473.

Witzke, Anita K. (2007). Trends in Telemedicine. Men in Nursing, 2, 46-54.

J A N U A R Y 2 0 1 6 | 13

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

Board of Pharmacy Rule on CS Dispensing Pending

Last month, the Florida Board of Pharmacy an-nounced rule 64B16-27.831 related to the standards for the dispensing of controlled substances that took effect on December 24, 2015. The rule is a result of several months of discussions within the Controlled Substance Stan-dards Committee where a considerable amount of pub-lic testimony was heard on access issues. Key things in the revised rule include guidance on what a pharmacist must do prior to prior to refusing to dispense a prescrip-tion. Members should be aware that the rule does not require a prescription to be dispensed rather it puts in place actions that need to take place to alleviate any con-cerns that may be apparent. There is additional language added to the rule that should help alleviate fear from en-forcement agencies as well as additional language that prohibits licensees or persons from interfering with the professional judgment of a pharmacist. There is also new CE requirements that pharmacists must complete before the end of the current biennial renewal which ends Sep-tember 30, 2017. FPA will be working to get this program ready for the membership as soon as possible. For more information please review the rule at this link.

NOTE: During the Board of Pharmacy’s Controlled Substance Standards Committee meeting in December, the Department was urged to reach out to the medical boards to learn of what actions that they are taking to deal with the prescribing of controlled substances in this state. It was also revealed that the wholesale advisory council has recommended to the Department of Business and Professional Regulation that there should be sup-port for changes to Florida Statutes 499.0121 that requires a review of wholesaler customer orders that are greater than 5,000 dosage units of any one controlled substance. The FPA believes that this could be the first step in trying to deal with supply problems that some pharmacy pro-viders are running into when ordering controlled sub-stances. The recommendation by the wholesaler adviso-ry council is not binding on the Department.

FPA Advocates for Healthiest Weight FloridaThe Florida Department of Health is promoting a cam-

paign to help our state become healthier through weight control. The Florida Pharmacy Association has been asked to become involved in this program through our member advocacy. The Healthiest Weight Florida pro-gram is a public-private collaboration bringing togeth-

er state agencies, local governments, businesses, schools, nonprofits, faith-based groups and health care profes-sionals to assist Floridians make informed choices about healthy eating and active living. Please consider visiting this web site for more information. There is even a web site hosted by the Florida Department of Health where you can post your healthy promise. Visit www.Healthy-PromiseFL.com to make your pledge.

APCI Supports Florida Pharmacist Political Committee

The Florida Pharmacist Political Committee was formed by volunteer members of the FPA to facilitate a means for all of us to pool our resources and have a greater reach to candidates who have or will have an understanding of what is best for the practice and busi-ness of pharmacy. Since August of 2013 the Committee has raised nearly $100,000 of which 90 percent are direct campaign contributions. Ten percent of contributions re-ceived are used to cover reporting costs to the state and direct fundraising expenses. The Florida Pharmacist Po-litical Committee is pleased to share with members that American Pharmacy Cooperative has made a generous contribution of $15,000 to help in our efforts to fight for pharmacy. We thank APCI and their Director of Legisla-tive Affairs, Bill Eley for making this contribution possi-ble. We have several ways that you can make a contribu-tion to FPPC. You can go online at Pharmview.com, select the contribution option when renewing your member-ship dues or you can download a contribution form that is available on the FPA website.

FPA News & Notes

J A N U A R Y 2 0 1 6 | 15

Florida Pharmacist Services Access Bill TP’dHouse bill 547 entitled Access to Pharmacy Servic-

es Act was filed that makes certain modifications to the pharmacy practice act. This FPA, FSHP and Florida In-dependent Pharmacy Network supported bill revises the definition of “practice of the profession of pharma-cy” to allow a pharmacist to:

■ Consult on the therapeutic values and interactions of patent or proprietary products and health and wellness assessments and patient care relating to medication therapy management.

■ Manage, in addition to monitor and review, a pa-tient’s drug therapy.

■ Collaborate with a patient’s health care provider, the provider’s authorized agent, or other persons spe-cifically authorized by the patient regarding the pa-tient’s health care status, in addition to the patient’s drug therapy.

■ Dispense medications, including vaccines, in addi-tion to the administration of such medications.

■ This legislation also changes the consultant pharma-cist licensure section where consultant pharmacists and doctors of pharmacy would be able to:

■ Order and evaluate clinical testing in more settings than nursing homes or in home health care facilities

■ Initiate, modify, discontinue and administer drugs within the framework of a drug management thera-py or protocol with one or more health care provid-ers

■ Allow those serving in the capacity as a consultant pharmacist or doctor of pharmacy under the consul-tant licensure section to perform medication man-agement, patient health and wellness assessments, counseling and referrals related to medications and health care servicesThis bill also includes in the pharmacy practice act

that a health insurer or benefit plan may reimburse for those services. This legislation was heard in the House Health Quality Committee however due to a number of last minute amendments placed onto the bill during the meeting and objections from the medical associations a decision was made to postpone further action. The FPA and FSHP have already met with the Florida Medical Association and is working on a number of changes to the bill which may give it an opportunity for a hearing when the legislative session starts next month.

FPPC Supporting Legislative Campaigns

L to R: Representative Travis Cummings, Representative Matt Hudson, FPA’s Michael Jackson and Representative Cary Pigman

Network Closures Concerning FPAOn December 5 the FPA sent to the membership a

special Stat News action alert for those providing ser-vices to Florida Medicaid. As you are aware, the Flori-da Medicaid program has transitioned to managed care. In that process changes were made to the Florida laws that govern the Medicaid program that allows plans to define what their pharmacy networks should be. Sev-eral plans have already provided notices to their pa-tients that only certain pharmacies would be allowed to participate in their networks. The FPA believes that this is an unworkable solution for care of patients who may be transportation challenged or are being provided customized services from their current pharmacy pro-vider. To correct this issue will require action from the Florida Legislature who will need to hear from you and your patients. If you have not taken action yet on this is-sue please do so now. Your state representative and state senator is now in your district and now is the best time to tell them what is needed. Talking points and informa-tion that you need on this issue is available through this link. You are free to pass this message on to others and get them involved as well.

Closing a Pharmacy GuidanceAt a recent Board of Pharmacy meeting a number

of pharmacies that closed were being disciplined be-cause of failure to comply with rule 64B16-28.202. When a pharmacy permit makes a determination to end activ-ity there are steps that need to be complied with. Those steps are as follows:

Prior to closure of a pharmacy the permittee shall no-tify the Board of Pharmacy in writing as to the effective

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

date of closure, and shall:A. Return the pharmacy permit to the Board of Pharma-

cy office or arrange with the local Bureau of Investiga-tive Services of the Department to have the pharmacy permit returned to the Board of Pharmacy;

B. Advise the Board of Pharmacy which permittee is to receive the prescription files;

On the date of closure of a pharmacy the former per-mittee shall:

A. Physically deliver the prescription files to a pharma-cy operating within reasonable proximity of the phar-macy being closed and within the same locality. This delivery of prescription files may occur prior to the re-turn of the pharmacy permit to the Board of Pharma-cy office; and

B. Affix a prominent sign to the front entrance of the pharmacy advising the public of the new location of the former permittee’s prescription files or otherwise provide a means by which to advise the public of the new location of their prescription files.After the closing of a pharmacy, the custody of the pre-

scription files of the pharmacy shall be transferred to the new permittee, unless the former permittee and the new permittee inform the Board in writing that custody of the prescription files have been or are to be transferred to a

pharmacy other than the new permittee.

A pharmacy receiving custody of prescription files from another pharmacy shall maintain the delivered pre-scriptions in separate files so as to prevent intermingling with the transferee pharmacy’s prescription files.

There are similar kinds of tasks that must be per-formed if the pharmacy also has a DEA license. That is included in the Code of Federal Regulations Part 1301.52.

If you are a prescription department manager of a pharmacy that is closing and ceasing to operate it is a good idea to make sure that the above issues are being taken care of.

Col. Charles Melvin “Chuck” Shoff (USAF, retired), 77, resident of Fort Walton Beach, Florida, passed away at his home on Dec. 11, 2015. He is survived by his wife, son and sister.

Chuck was born on Aug. 20, 1938, in Youngstown, Ohio. He earned a bachelor’s degree in Pharmacy from Ohio Northern University in 1961. Shortly thereafter, Chuck was drafted into the USAF and stationed in Evreux, France. He ultimately served 31 total years through a combination of both active and reserve duty. After France, Chuck was stationed to Hurlburt Field, Florida, where he transitioned to reserve status and became an active pharmacist.

Chuck lived a full life both professionally and otherwise, serving as an Okaloosa County Hospital pharmacist, di-rector of pharmacy at Fort Walton Beach Medical Center, a consultant pharmacist for several local facilities and past president of the Florida Society of Health-System Pharmacists. He maintained reserve military status (to include ac-tivation during Desert Storm), was past chairman of the local YMCA board, an active adult leader in the Boy Scouts, a member of the police pension board, an avid snow skier, an active member of Shalimar United Methodist Church, and always there to help anyone in need, regardless of status.

Chuck lived the short dash of life fully without fear, but always maintained a sense of compassion for his fellow man. To share memories, express condolences and sign the guestbook, click here.

In MemoriAm

J A N U A R Y 2 0 1 6 | 17

CALL FOR RESOLUTIONS TO THE 2016 HOUSE OF DELEGATES

The House of Delegates Board of Directors will meet in May 2016 to review and approve resolutions for the Annual Meeting. The deadline for submitting resolutions is May 6, 2016! PLEASE NOTE THIS DEADLINE.

The following information will be needed when submitting resolutions:

1. Name of organization: The name of the organization submitting the resolutions(s);2. Name and telephone number of individuals: A contact in the event clarification or further

information is needed; 3. Problem: A statement of the problem addressed by the resolution;4. Intent: A statement of what passage of the resolution will accomplish;5. Resolution Format: Please type and use double spacing.

TITLE OF RESOLUTION

NAME OF ORGANIZATION

WHEREAS , AND

WHEREAS :

THEREFORE BE IT

RESOLVED (THAT THE FPA OR SUBDIVISION OF FPA)

CONTACT NAME AND PHONE #:

PROBLEM:

INTENT:

Return this form to: Membership Coordinator, Florida Pharmacy Association, 610 North Adams Street, Tallahassee, Florida 32301 or fax (850) 561-6758

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

Lena CharafiPharmD Candidate 2016University of Florida College of Pharmacy

The topic of anticoagulation became very popular in recent years due to an increase in incidence of venous throm-boembolism (VTE) among the U.S. pop-ulation. Non-vitamin K oral anticoagu-lants, such as dabigatran, rivaroxaban, apixaban, and edoxaban, became the new generation of medications for treat-ment and prophylaxis of VTE. It has been estimated that in five years, over 20 million patients will receive Factor Xa inhibitors for anticoagulation pur-poses. These agents have shown in mul-tiple randomized, controlled trials to be as effective as warfarin, have low-er rates of bleeding and have less drug-drug and drug-food interactions. They have a more predictable anticoagulant effect, which allows a fixed dose regi-men. However, one big disadvantage of using newer anticoagulant agents is the absence of an antidote to reverse anti-coagulation in the case of a life-threat-ening bleeding episode or emergency surgery. Andexanet alfa is an investi-gational new medication that has the potential to become the first universal antidote to reverse the anticoagulant ac-tivity of Factor Xa inhibitors. The Unit-ed States Food and Drug Administra-tion (FDA) has recognized the lack of an effective reversal agent for Factor Xa

inhibitors. In February of 2015, the FDA granted an orphan drug designation to andexanet alfa for being a novel anti-dote to Factor Xa inhibitors.

BackgroundAndexanet alfa is an injectable med-

ication that has a very fast onset of ac-tion and a short duration of action. It has been recently developed by Porto-la Pharmaceuticals. Andexanet alfa has a unique mechanism of action. It is a re-combinant protein and has a structure very similar to Factor Xa, but it is cat-alytically inactive. It binds to Factor Xa inhibitors but does not cause the antico-agulant effect.

Andexanet alfa underwent multiple preclinical studies that provided sub-stantial evidence supporting the safe-ty, efficacy and rapid onset of action of andexanet alfa. The most recent stud-ies were two Phase III trials, ANNEXA-R and ANNEXA-A, that looked at the

safety and efficacy of andexanet alfa to reverse anticoagulant effects of apixa-ban or rivaroxaban in older, healthy vol-unteers. Each study consisted of two parts. In the first part of each study, the effect of a single bolus of andex-anet alfa was evaluated in healthy vol-unteers who had been given rivaroxa-ban or apixaban. In the second part of each study, the ability of andexanet alfa to sustain reversal of the anticoagulant effects of apixaban and rivaroxaban was evaluated by administering a bolus plus continuous infusion of andexanet alfa to healthy volunteers who have been given rivaroxaban or apixaban.

Most Recent StudiesANNEXA-R (Andexanet Alfa a Nov-

el Antidote to the Anticoagulant Effects of Factor Xa Inhibitors – Rivaroxaban) is a randomized, double-blind, place-bo-controlled Phase III study that eval-uated the safety and efficacy of andex-

ANDEXANET ALFA: Investigational Factor Xa Inhibitor Antidote

J A N U A R Y 2 0 1 6 | 19

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anet alfa in reversing anticoagulant effects of rivaroxaban in healthy volunteers who were 50 to 75 years old. The study consisted of two parts. In Part 1, 41 healthy volunteers were given 20 mg of rivaroxaban once daily for four days and then randomized in a 2:1 ratio to receive either andexanet alfa ad-ministered as an 800 mg IV bolus (n=27) or a placebo (n=14). Participants and care providers were kept blind to treatment. Researchers evaluated the efficacy of andexanet alfa using an-ti-Factor Xa levels as the primary endpoint. Secondary end-points included: 1) occurrence of 80 percent or greater reduc-tion in anti-Factor Xa activity from baseline to nadir (smaller value of two or five minutes after the end of bolus), 2) change in free rivaroxaban concentration from baseline to nadir, 3) change in thrombin generation from baseline to peak and 4) occurrence of thrombin generation above the lower limit of derived normal range.

Results showed that researchers were able to achieve the primary outcome with statistical significance (p<0.001). The mean percent change in anti-Factor Xa levels from baseline to nadir was 92 percent. In this study, andexanet alfa significant-ly and immediately reversed the anticoagulation activity of ri-varoxaban. Anti-Factor Xa activity was rapidly reduced with-in two to five minutes after the administration of the bolus. The study also met all the secondary outcomes with statistical significance. Twenty-six out of 27 subjects in the andexanet alfa study group achieved a greater than or equal to 80 per-cent reduction in anti-Factor Xa activity from baseline to na-dir, the mean change in free rivaroxaban concentration from baseline to nadir was 3.9 ng/mL in the andexanet alfa group, and ETP (Endogenous Thrombin Potential) was significantly greater in andexanet alfa group compared to placebo. How-ever, 22 hours after the end of andexanet alfa bolus, thrombin generation restored to baseline range in 26 out of 27 subjects.

Looking at the safety profile of the study drug, andexanet alfa was shown to be well-tolerated. All 41 subjects complet-ed the study (14 in the placebo group and 27 in the andexanet alfa group). No serious adverse events or thrombotic events were reported in any subject. Researchers did not report any premature discontinuation from the study.

In the second part of the ANNEXA-R study, healthy volun-teers were given 20 mg of rivaroxaban once daily for four days and then randomized in a 2:1 ratio to receive either an andex-anet alfa 800 mg IV bolus followed by a continuous infusion of 8 mg/min for 120 minutes or a placebo. The data from this part of the study has not been presented at this time.

ANNEXA-A (Andexanet Alfa: A Novel Antidote to the An-ticoagulant Effects of Factor Xa Inhibitors – Apixaban) is the randomized, double-blind, placebo-controlled Phase III study that assessed the safety and efficacy of andexanet alfa in re-

versing apixaban-induced anticoagulation in older, healthy volunteers. Similar to ANNEXA-R, the study consisted of two parts. In the first part of the study, 33 healthy volunteers (aged 50 to 73) were given 5 mg of apixaban twice daily for four days and then randomized in a 3:1 ratio to two groups. The first group was a study group that received andexanet alfa administered as a 400 mg IV bolus (n=24) and the sec-ond group was a placebo group (n=9). The efficacy of andex-anet alfa was evaluated using an anti-Factor Xa levels as the primary endpoint. Secondary endpoints included: 1) occur-rence of 80 percent or greater reduction in anti-Factor Xa ac-tivity from baseline to nadir, 2) change in free apixaban con-

Looking at the safety profile of the study drug, andexanet alfa was shown to be well-tolerated.

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

centration from baseline to nadir, and 3) change in thrombin generation from baseline to peak (largest value of two, five or 10 minutes after the end of bolus).

Study results demonstrated that research was able to achieve primary endpoint with statistical significance (p<0.0001) and the anticoagulant activity of apixaban was re-versed by 94 percent two to five minutes after completion of a bolus. Looking at the secondary endpoints, the number of

subjects who achieved the occurrence of greater than 80 per-cent reversal was 100 percent in andexanet alfa group and zero percent in the placebo group, the change in free apixa-ban concentration from baseline to nadir was 1.8 ng/mL in andexanet alfa group and thrombin generation was greater in the andexanet alfa group but returned to baseline in all of the subjects. Furthermore, the study met all the secondary out-comes with statistical significance.

Looking at the safety findings of the study, andexanet alfa was well tolerated. All 33 subjects completed the study with-

out any premature discontinuation (9 in the placebo group and 24 in the andexanet alfa group). No serious adverse events, thrombotic events or antibodies to Factor X or Xa were reported by study subjects.

In the second part of the ANNEXA-A study, 32 healthy vol-unteers received 5 mg of apixaban twice daily for four days and then randomized in a 3:1 ratio to two groups. The first group was a study group and received andexanet alfa ad-ministered as a 400 mg IV bolus followed by a continuous infusion of 4 mg/min for 120 minutes. The second group re-ceived a placebo treatment. The efficacy of andexanet alfa treatment was evaluated using the percent change in anti-Factor Xa activity from baseline to post-infusion nadir, which was determined to be the primary endpoint. The secondary endpoints set by the researchers were 1) percent change in an-ti-Factor Xa activity from baseline to post-bolus nadir, 2) oc-currence of 80 percent or greater reduction in anti-Factor Xa activity from baseline to post- infusion nadir, 3) change in free apixaban concentration from baseline to post-infusion nadir, 4) change in thrombin generation from baseline to peak post-infusion, 5) occurrence of thrombin generation post-infusion above the lower limit of derived normal range.

Researchers showed that the mean percent change in anti-Factor Xa from baseline to post-infusion nadir was 92 percent, mean percent change in anti-Factor Xa activity from baseline to post-bolus nadir was 93 percent, all of the subjects in an-dexanet alfa group achieved 80 percent or greater reduction in anti-Factor Xa activity and thrombin generation returned to the baseline range in 100 percent of the subjects. Indeed, the study met all of the primary and secondary endpoints with statistical significance.

In addition, all 32 subjects completed the study (24 in the andexanet alfa group and 8 in the placebo group). Some of the reported side effects included mild infusion-related reactions, which occurred in four subjects in the andexanet alfa group and two subjects in the placebo group. One subject in the an-dexanet alfa group discontinued the treatment due to mild hives during the infusion. No other serious adverse effects, thrombotic events or formation of antibodies to factor X or factor Xa were reported.

ConclusionPortola Pharmaceuticals conducted multiple preclinical

and clinical studies that demonstrated safety and efficacy of andexanet alpha. The data from both Phase III studies in-dicates that they achieved all of the primary and secondary endpoints with statistical significance. These findings are con-sistent with the mechanism of action of andexanet alfa, which involves high-affinity binding to the factor Xa inhibitor and reducing unbound plasma levels of the anticoagulant. Rever-sal of the anticoagulant effect was attained within two to five minutes after administration of the bolus, and was sustained during the continuous infusion. In addition, bolus or bolus plus infusion regimen could provide flexibility for rapid and sustained reversal in apixaban-treated bleeding patients The duration of reversal effect after discontinuation of andexanet alfa infusion is consistent with the half-life of andexanet alfa.

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Portola Pharmaceuticals conducted multiple preclinical and clinical studies that demonstrated safety and efficacy of andexanet alpha.

J A N U A R Y 2 0 1 6 | 21

Members voting in the FPA election are encouraged to go to www.pharmview.com and sign in with your username and password. Once signed in you will see the menu item for the 2016 FPA election of officers. Voting is now done online and only takes a few minutes.

Online Voting is Open for the Election of FPA Officers and Regional Directors

2016 FPA CANDIDATES

Some of the limitations of the stud-ies include a small sample size, which could possibly mean that the results do not have sufficient power to detect a dif-ference between the study groups and the placebo, and the study may turn out to be falsely negative, leading to a type II error. Also, looking at the data from Phase III trials, we can assume that dif-ferent doses of andexanet alpha may be required for the two direct Factor Xa in-hibitors apixaban and rivaroxaban. The dosing could be difficult to remember in an emergency bleed situation. An-other important consideration is that andexanet alpha is a recombinant pro-tein, and as with all structurally mod-ified proteins, immunogenicity might become an issue. However, andexanet alfa molecule has less steric hindrance compared to Factor Xa molecule and, therefore, lesser risk of immunologic re-action.

References: Portola Pharmaceuticals. Portola

Pharmaceuticals Announces phase 3 ANNEXA-A study of andexanet alfa and Eliquis met primary and secondary endpoints with high statistical significance [press release]. Oct. 1, 2014. b Web. Jun. 9, 2015.

Portola announces full results from positive phase 3 ANNEXA(TM)-R study demonstrating that andexanet alfa rapidly and significantly reversed anticoagulant effect of factor Xa inhibitor Xarelto(r) [news release]. San Francisco, CA; June 22, 2015. Web. Jun. 24, 2015.

Portola, Bristol-Myers Squibb and Pfizer Announce Full Results of Second Part of Phase 3 ANNEXA-A(TM) Study

Demonstrating That Investigational andexanet Alfa Sustained Reversal of Anticoagulant Effect of Factor Xa Inhibitor Eliquis (apixaban) [news release]. San Francisco, CA; Mar. 2, 2015. Web. Jun. 9, 2015.

Shah N, Rattu M. Reversal agents for anticoagulants: focus on andexanet alfa. Am Med Stud Res J. 2014;1(1):16-28.

Mo Y, Yam FK. Recent advances in the development of specific antidotes for target-specific oral anticoagulants. Pharmacotherapy. 2015 Feb. 3.

Portola Pharmaceuticals, Inc. receives FDA orphan drug designation for andexanet alfa, its breakthrough-designated factor Xa inhibitor antidote [Internet]. Centennial (CO): Biospace; 2015 Feb 26. Web. Jun. 9, 2015.

Crowther M, Gold AM, Levy GG, Lu G, Leeds J, Wiens BL, et al. ANNEXA™-R: a phase 3 randomized, double-blind, placebo-controlled trial, demonstrating reversal of rivaroxaban-induced anticoagulation in older subjects by andexanet alfa (PRT064445), a universal antidote for factor Xa (fXa) inhibitors [presentation slides]. 2015. (Presented at American College of Cardiology 64th Annual Scientific Session & Expo; Mar 14-16, 2015; San Diego, California). Web. Jun. 9, 2015

O’Riordan, M. Positive Results for Factor Xa Inhibitor Antidote: ANNEXA-A. Medscape multispecialty: news & perspective. New York. Oct 1 2014. Web. Jun. 9, 2015.

A study in older subject to evaluate the safety and ability of andexanet alfa to reverse the anticoagulation effect of rivaroxaban. ClinicalTrials.gov. National Library of Medicine (US). Identifier NCT02220725. Aug 2014. Web. Jun. 11, 2015.

Chu S, Boucher M, Spry C. Antidote treatments for the reversal of direct oral anticoagulants [Issues in emerging health technologies, Issue 138]. Ottawa: CADTH; 2015. Web. Jun. 11, 2015.

Enriquez, Andres, Gregory Y H Lip and Adrian Baranchuk. Anticoagulation reversal in the era of the non-vitamin K oral anticoagulants. Europace. 2015. Web. Jun. 11, 2015.

Lu G, Deguzman FR, Hollenbach. A specific antidote for reversal of anticoagulation by direct and indirect inhibitors of coagulation factor Xa. Nature Medicine Mar. 2013. Web. Jun. 8, 2015.

Siegal DM, Curnutte JT, Connolly SJ, et al. andexanet alfa for the reversal of factor Xa inhibitor activity. N Engl J Med. Nov 11, 2015. Web. Nov. 12, 2015.

Connors, Jean M. Antidote for Factor Xa Anticoagulants. N Engl J Med. Nov 11, 2015. Web. Nov. 12, 2015.

The topic of anticoagulation becamevery popular in recent years due to an increase in incidence of venous thromboembolism (VTE) among the U.S. population.

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APhA Foundation and NASPA Bowl of Hygeia

Awarded to a pharmacist for out-standing community service above and beyond professional duties. The use of the following selection criteria is re-quired:

■ The recipient must be a Florida li-censed pharmacist and a member of FPA.

■ The recipient must be living. Awards are not presented posthumously.

■ The recipient has not previously re-ceived the award.

■ The recipient is not currently serving nor has he/she served within the immediate past two years on its award committee or an officer of the association in other than an ex offi-cio capacity.

■ The recipient has compiled an out-standing record of community ser-vice, which, apart from his/her spe-cific identification as a pharmacist, reflects well on the profession.

James H. Beal AwardAwarded to the "Pharmacist of the

Year." The criteria established for this award is that the recipient be a Flori-da registered pharmacist and a mem-ber of FPA, who has rendered outstand-ing service to pharmacy within the past five years.Criteria:

■ The recipient must be a Florida reg-istered pharmacist and a member of the FPA.

■ The recipient has rendered outstand-ing service to pharmacy within the past five years.

Technician of the Year AwardAwarded annually to a Florida phar-

macy technician who is recognized for his/her outstanding performance and achievement during his/her career.

Criteria: ■ Candidate must be a member of the

Florida Pharmacy Association for at least two years.

■ Candidate must have demonstrated contributions and dedication to the advancement of pharmacy techni-cian practice.

■ Candidate must have demonstrated contributions to the Florida Pharma-cy Association and/or other phar-macy organizations.

■ Candidate must have demonstrated commitment to community service.

■ Candidate is not a past recipient of this award.

R.Q. Richards AwardThis award is based on outstanding

achievement in the field of pharmaceu-tical public relations in Florida.Criteria:

■ The recipient must be a Florida reg-istered pharmacist and a member of the FPA.

■ The recipient has displayed out-standing achievement in the field of pharmaceutical public relations in Florida.

Frank Toback/AZO Consultant Pharmacist AwardCriteria:

■ Candidate must be an FPA member, registered with the Florida Board of Pharmacy as a consultant pharma-cist in good standing.

■ Candidate should be selected based on their outstanding achievements in the field of consultant pharmacy.

DCPA Sidney Simkowitz Pharmacy Involvement Award

Presented annually to a Florida pharmacist who has been active at the local and state pharmacy association level in advancement of the profession of pharmacy in Florida.Criteria:

■ A minimum of five years of active involvement in and contributions to the local association and FPA.

■ Candidate must have held office at local level pharmacy association.

■ Member in good standing for a pe-riod of at least five years in the FPA and must have served as a member or chairman of a committee of the association.

■ Candidate must have been active-ly involved in a project that has or could potentially be of benefit to members of the profession.

Pharmacists Mutual Companies Distinguished Young Pharmacist Award

Awarded to a young pharmacist for their involvement and dedication to the practice of pharmacy.Criteria:

■ Licensed to practice for nine years or fewer.

■ Licensed to practice in the state in which selected.

■ Participation in national pharmacy association, professional programs, and/or community service.

IPA Roman Maximo Corrons Inspiration & Motivation AwardInteramerican Pharmacists Associa-tion created this award to honor the memory of Roman M. Corrons who in-spired and motivated countless phar-macists to participate actively and as-pire to take on leadership roles in their profession. Roman was always there with guidance and support that moti-vated pharmacists and encouraged vi-sionary leadership, approachable active membership and succession planning. This award recognizes the motivators among us who inspire others to contin-ue to advance the profession.Criteria:

■ The recipient must be a Florida Li-censed Pharmacist and a member of the FPA.

■ Candidate should motivate others to excel within the profession by en-couraging them to be leaders.

■ Candidate is not necessarily an asso-ciation officer, but guides, supports and/or inspires others.

A brief description on the candidate’s motivational/inspirational skills must accompany the nomination.

The Jean Lamberti Mentorship Award

The Jean Lamberti Mentorship Award was established in 1998 to honor those pharmacists who have taken time to share their knowledge and experience with pharmacist candidates. The award is named in honor of long time FPA member Jean Lamberti for her effort in working with pharmacy students.

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DEADLINE FOR NOMINATIONS: FEBRUARY 28, 2016

Criteria: ■ The recipient must be an FPA mem-

ber. ■ The recipient must serve as a role

model for the profession of pharmacy.

Upsher Smith Excellence in Innovation Award

Awarded to honor practicing phar-macists who have demonstrated inno-vation in pharmacy practice that has re-sulted in improved patient care.Criteria:

■ The recipient has demonstrated inno-vative pharmacy practice resulting in improved patient care.

■ The recipient should be a practic-ing pharmacist within the geograph-ic area represented by the presenting Association.

Qualified Nominee: A pharmacist prac-ticing within the geographic area repre-sented by the presenting Association.

Cardinal Generation Rx AwardThe Cardinal Health Generation Rx

Champions Award recognizes a phar-macist who has demonstrated excellence in community-based prescription drug abuse prevention. The award is intend-ed to recognize outstanding efforts with-in the pharmacy community to raise awareness of this serious public health problem. It is also intended to encour-age educational prevention efforts aimed at patients, youth and other members of the community.

The nominee must be a pharmacist who is a member of the state association. Self-nominations are allowed. Applica-

tions will be evaluated based upon the following criteria:

■ Commitment to community-based educational prevention efforts aimed at prescription drug abuse

■ Involvement of other community groups in the planning and imple-mentation of prevention programs

■ Innovation and creativity in the cre-ation and implementation of preven-tion activities

■ Scope/magnitude of prescription drug abuse efforts

■ Demonstrated impact of prescription drug abuse prevention efforts

I AM PLEASED TO SUBMIT THE FOLLOWING NOMINATION:

Name:

Address:

FOR THE FOLLOWING AWARD:

(Nomination Deadline February 28, 2016)

APhA Foundation and NASPA Bowl of Hygeia

James H. Beal Award

R.Q. Richards Award

Frank Toback/AZO Consultant Pharmacist Award

DCPA Sydney Simkowitz Award

Pharmacists Mutual Co. Distinguished Young Pharmacist Award

IPA Roman Maximo Corrons Inspiration & Motivation Award

The Jean Lamberti Mentorship Award

Upsher Smith Excellence in Innovation Award

Cardinal Generation Rx Award

NOMINATED BY:

Name:

Date Submitted:

Signature:

Please describe briefly below the nominee's accomplishments, indicating why you feel he or she should receive this award. (Attach additional sheets if necessary.)

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F P A A W A R D S N O M I N A T I O N F O R M

MAIL NOMINATONS TO: Annual Awards, Florida Pharmacy Association, 610 N. Adams St., Tallahassee, FL 32301(850) 222-2400 FAX (850) 561-6758 DEADLINE FOR NOMINATIONS IS FEBRUARY 28, 2016

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The FPA Poster Presentations are open to PHARMACY STUDENTS ONLY. Complete and submit this COVERSHEET for each abstract submission. Submissions must be received no later than Friday, May 6, 2016. Abstracts will NOT be accepted after this date. Mail or E-mail this application along with the abstract submission to:

Tian Merren Owens, MS, PharmD, Director of Continuing Education Florida Pharmacy Association

610 N. Adams Street Tallahassee, FL 32301

tmerren@pharmview.com PLEASE TYPE Contact Information: Presenter's Name (MUST BE A STUDENT):________________________________________________________________

□Entry Level Pharm.D. □ Post B.S. Pharm.D. Address: ________________________________________________________________________________________ City, State, Zip: ___________________________________________________________________________________ Telephone No: _____________________E-Mail Address: _________________________________________________ Abstract Title: ____________________________________________________________________________________

Poster Type: □Clinical Research

□Basic Science Research

□Translational Research (Basic Science and Clinical Research) Primary Author: __________________________________________________________________________________

(Students must be listed first to be considered for the Award. Presenter will be notified by mail of acceptance).

Co-Author(s): _________________________________________________________ Student □YES □NO

Awards: Posters will be eligible for 1st, 2nd, and 3rd place prizes to be presented at Convention. (Only one prize is given for each winning poster)

Free Registration: Three entry level students from each Florida College of Pharmacy will be eligible for a

complimentary Florida Pharmacy Association Convention Student registration. (Student Registration does not include CE or hotel accommodations)

I am interested in being considered for this registration: □YES □NO College: _____________________________________________________________________________

The abstract form submitted should be the equivalent of one page. The abstract should include: Title (Include authors’ names and name of College of Pharmacy), Purpose, Methods, Results, and Conclusions.

Abstracts will not be accepted if it is not in this format. Do not include figures or graphs.

Please direct all questions and concerns to: Tian Merren Owens ♦ (850) 222-2400 ext. 120 ♦ tmerren@pharmview.com

CALL FOR ABSTRACTS FOR POSTER PRESENTATIONS

For Florida Pharmacy Students FLORIDA PHARMACY ASSOCIATION

���th ANNUAL MEETING AND CONVENTION June ���July �� ����

Marriott Harbor Beach Resort � Spa ♦ Ft� Lauderdale� Florida

Poster Session� Friday� July �� ���� ♦ �����AM�����PM

ABSTRACT FORMAT

DEADLINE DATE: FRIDAY, MAY 6, 2016

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PHARMACY RESOURCES

PPSCRetail Pharmacy Purchasing Program(888) 778-9909

LEGAL ASSISTANCE

Kahan ◆ Heimberg, PLCBrian A. Kahan, R.Ph., Attorney at Law(561) 392-9000

The Health Law FirmGeorge F. Indest III, J.D., M.P.A., LL.M. (407) 331-6620

PHARMACEUTICAL WHOLESALER

McKesson Drug CompanyJim Springer(800) 804-4590 FAX: (863) 616-2953

BUYER’S GUIDEADVERTISERS: This is a special section designed to give your company more exposure and to act as an easy reference for the pharmacist.

P H A R M A C Y T O D A Yflorida

Advertising in Florida Pharmacy Today

Display Advertising: please call (850) 264-5111 for a media kit and rate sheet. Buyers’ Guide: A signed insertion of at least 3X per year, 1/3 page or larger display ad, earns a placement in the Buyers’ Guide. A screened ad is furnished at additional cost to the advertiser. Professional Refer-ral Ads: FPA Members: $50 per 50 words; Non-members: $100 per 50 words; No discounts for advertising agencies. All Professional Referral ads must be paid in advance, at the time of ad receipt.

AHCA MEDICAID PHARMACY SERVICES2727 Mahan DriveTallahassee, FL 32308(850) 412-4166www.fdhc.state.fl.us/medicaid/pharmacy

AMERICAN PHARMACISTSASSOCIATION (APhA)Washington, D.C. (800) 237-2742www.pharmacist.com

AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTSBethesda, MD (301) 657-3000www.ashp.com/main.htm

DRUG INFORMATION CENTERPalm Beach Atlantic University(561) 803-2728druginfocenter@pba.edu

FLORIDA BOARD OF PHARMACY4052 Bald Cypress WayBin #C04Tallahassee, FL 32399-3254(850) 245-4292www.doh.state.fl.us/mqa

FLORIDA POISON INFORMATION CENTER NETWORK(800) 222-1222www.fpicn.org

NATIONAL COMMUNITY PHARMACISTS ASSOCIATION 100 Daingerfield Road Alexandria, VA 22314(703) 683-8200(703) 683-3619 faxinfo@ncpanet.org

RECOVERING PHARMACISTS NETWORK OF FLORIDA(407) 257-6606 “Pharmacists Helping Pharmacists”

FREQUENTLY CALLED NUMBERS

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

We are the Alliance for Patient Medication Safety (APMS), a federally listed Patient Safety Organization. Our Pharmacy Quality Commitment (PQC) program:

• Helps you implement and maintain a continuous quality improvement program

• Offers federal protection for your patient safety data and your quality improvement work

• 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

WE ARE.

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