The Official Publication Of The Florida Pharmacy Association JAN. 2016
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florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers 5 President’s Viewpoint 7 Executive Insight 14 FPA News & Notes 29 Buyer’s Guide
VOL. 79 | NO. 1 JANUARY 2016 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION
Features
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Telemedicine by Health Care Clinicians
ANDEXANET ALFA: Investigational Factor Xa Inhibitor Antidote FPA 126th Annual Meeting and Convention
JANUARY 2016
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Mission Statements:
FPA Calendar 2015-16
JANUARY 31
Last day to submit election ballots FEBRUARY
of the Florida Pharmacy Today Journal APRIL
15 - 17 FPA Clinical Conference Tampa MAY
9-10
Board of Pharmacy meeting Jacksonville
1 - 3
NASPA Leadership Retreat
28
Awards Nomination Due
6
Deadline for FPA Resolutions
6
Deadline for Vice Speaker and Director nominations
MARCH 4 - 7
APhA Annual Meeting Baltimore, MD
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Legislative Session ends
19-20 FPA Committee and Council Meetings Orlando 25
Good Friday - FPA Office Closed
27
Easter - FPA Office Closed
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.com Events calendar subject to change CE CREDITS (CE cycle) The Florida Board of Pharmacy requires 10 hours’ LIVE Continuing Education as part of the required 30 hours’ general education needed every license renewal period. There is a new 2 hour CE requirement for pharmacists on the dispensing of controlled substances effective this biennial renewal period. Pharmacists should have satisfied all continuing education requirements for this biennial period by September 30, 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
The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.
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 executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.
Advertisers THE HEALTH LAW FIRM............................... 13 KAHAN HEIMBERG, PLC............................... 20 PHARMACISTS MUTUAL.............................. 13 Rx OWNERSHIP.................................................. 2
CONTACTS FPA — Michael Jackson (850) 222-2400 FSHP — Tamekia Bennett (850) 906-9333 U/F — Art Wharton (352) 273-6240 FAMU — Leola Cleveland (850) 599-3301 NSU — Carsten Evans (954) 262-1300 DISCLAIMER Articles in this publication are designed to provide accurate and authoritative information with respect to the subject matter covered. This information is provided with the understanding that neither Florida Pharmacy Today nor the Florida Pharmacy Association is engaged in rendering legal or other professional services through this publication. If expert assistance or legal advice is required, the services of a competent professional should be sought. The use of all medications or other pharmaceutical products should be used according to the recommendations of the manufacturers. Information provided by the maker of the product should always be consulted before use. 4 |
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E-MAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com
The President’s Viewpoint TIM ROGERS, RPh, FPA PRESIDENT
I
Water the Grass
know that the title might seem a little 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 pharmacist, I pride myself as an amateur “farmercist,” in that I enjoy making things grow. For many years I’ve planted 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 germinate, grass grows, and soon, in the big picture, you have a yard. 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. 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 pharmacy 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 observations 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,
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. 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 association is perceived to offer, such as continuing education, interaction with other pharmacists and technicians and sources of information about the profession and where it’s going. As a rebuttal to this, I say, that is all good, but we shouldn’t confine our information to just one source. Younger pharmacists have grown
Tim Rogers, RPh 2015-2016 FPA President
up relying on e-information and might not see the benefit of attending meetings or seeing live presentations to pharmacists and technicians and interacting with these people. It is through interactions like this that we find out what others in our profession are doing, 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 changes to our profession, others, such as insurance companies, lawyers and physicians, will have the only voice that is heard. In the last 40 years, I have seen the profession go from manual typewriters to computers, from being primarily 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 JANUARY 2016
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2015-16 FPA Board of Directors The Florida Pharmacy Association gratefully acknowledges the hard work and dedication of the following members of the FPA leadership who work diligently all year long on behalf of our members.
Suzanne Kelley..................................................................................................Board Chair Timothy Rogers..........................................................................................FPA President Alexander Pytlarz.................................................................................... FPA Treasurer Scott Tomerlin...........................................................................................President-Elect Jackie Donovan........................................................................Speaker of the House Carol Motycka................................................................Vice Speaker of the House Thomas Johns......................................................................................... FSHP President Jennifer Raquipo................................................................................. Region 1 Director Michael Hebb.........................................................................................Region 2 Director Tom Cuomo.............................................................................................Region 3 Director Linda Lazuka.........................................................................................Region 4 Director Robert Parrado...................................................................................Region 5 Director Luther Laite IV.....................................................................................Region 6 Director David Mackarey.................................................................................. Region 7 Director Humberto Martinez..........................................................................Region 8 Director Mitchell Fingerhut.............................................................................Region 9 Director
Florida Pharmacy Today Journal Board Chair.............................................................. Carol Motycka, motycka@cop.ufl.edu Vice Chair....................................................Cristina Medina, cmmedina@cvs.com Treasurer....................Stephen Grabowski, sgrabowski@seniormmc.com Secretary.............. Verender Gail Brown, brownvgrx4304@hotmail.com Member.................................................Joseph Koptowsky, docjik1215@aol.com Member.............................. Rebecca Poston, Rebecca.Poston@flhealth.gov Member.................................................Patricia Nguebo, notablep@hotmail.com Member................................................................Norman Tomaka, FLRX9@aol.com Member........................................................................Stuart Ulrich, Stuarx@aol.com Member............................................................. Don Bergemann, don@bceinfo.com Executive Editor................Michael Jackson, mjackson@pharmview.com Managing Editor...................Dave Fiore, dave@fiorecommunications.com Journal Reviewer....................... Dr. Melissa Ruble, mruble@health.usf.edu Journal Reviewer....................................Dr. Angela Hill, ahill2@health.usf.edu
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might be able to provide better healthcare 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 associations 2. Rejuvenate and modernize our existing associations to meet everyone’s needs 3. Encourage the younger pharmacists 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 associations are not just a source of CE, but a venue for fellowship, education, advocacy, opportunity, a think tank that will look to the future and something that we cannot afford not to belong to The FPA and our unit associations have much more to offer, such as: continuing education statewide, home study programs, career center services, fellowship, pharmacy resources, current and meaningful information, advocacy for our profession and our patient’s health and much more. So, let us plant the seeds of the future for pharmacy and nurture and encourage all of them to grow so the future will be greener and better place for all. n
Executive Insight BY MICHAEL JACKSON, BY GUEST COLUMNIST JUSTIN DOROTHEO, PPHARM RPH D. CANDIDATE AND FPA INTERN
Pharmacists Prescribing Birth Control in the New Year 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 Oregon HB 2879 and HB 3343, state law now authorizes Oregon pharmacists to prescribe and dispense oral and transdermal contraceptives to women aged 18 years or older and those younger than 18 who have received a previous prescription for oral or transdermal birth control from a physician.1 In addition, the law also allows for the pharmacist to dispense a 12-month supply at once instead of a single-month or threemonth supply.2 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. Oregon, however, remains the first state to effectuate such a law, as California’s SB 493, signed into law in 2013, allows for pharmacist to have this authority but currently lacks the implementation of appropriate measures to do so. With this change in Oregon, many supporters say the state is moving toward initiatives to allow over-the-counter availability of contraceptives, a highly 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 responsibility. Before women in Oregon who seek birth control can obtain a prescription, they must fill out a health questionnaire and receive regular
blood pressure checks. Once the pharmacist 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 consultant pharmacist for the Oregon State Board of Pharmacy, explains in Phar-
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. 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 Journal of the American Pharmacist Association (JAPhA) in 2006. This study sought to establish a collaborative drug therapy protocol to screen and counsel women for safe use of hormonal contraceptives prescribed by community
Justin R. Dorotheo
pharmacists. In addition to administering the questionnaire, the law mandates pharmacists who wish to prescribe birth control attend a five-hour requisite continuing education (CE) course to help better prepare them for prescribing birth control. PUBLIC RESPONSE Although widely supported, one popular morning television show expressed doubt on whether pharmacists had the expertise to care for patients in regards to contraception. In response, the American Society of Health-Systems Pharmacists (ASHP) published a statement online, saying: “Pharmacists are the medication-use experts and are specifically trained to help patients use their medications safely and apSee Executive Insight continued on p. 9 JANUARY 2016 |
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FPA STAFF Executive Vice President/CEO Michael Jackson (850) 222-2400, ext. 200
Director of Continuing Education Tian Merren-Owens, ext. 120 Controller Wanda Hall, ext. 211
Educational Services Office Assistant Stacey Brooks, ext. 210 Coordinator of Membership Christopher Heil, ext. 110
FLORIDA PHARMACY TODAY BOARD Chair..................................... Carol Motycka, St. Augustine Vice Chair................................Cristina Medina, Hollywood Treasurer...............................Stephen Grabowski, Tampa Secretary.........................Verender Gail Brown, Orlando Member..................................... Joseph Koptowsky, Miami Member..............................Rebecca Poston, Tallahassee Member.............................................. Patricia Nguebo, Ocala Member................................. Norman Tomaka, Melbourne Member..............................Stuart Ulrich, Boynton Beach Member.......................Don Bergemann, Tarpon Springs Executive Editor.........Michael Jackson, Tallahassee Managing Editor.........................Dave Fiore, Tallahassee
This is a peer-reviewed publication. ©2016, FLORIDA PHARMACY JOURNAL, INC. ARTICLE ACCEPTANCE: The Florida Pharmacy Today is a publication that welcomes articles that have a direct pertinence to the current practice of pharmacy. All articles are subject to review by the Publication Review Committee, editors and other outside referees. Submitted articles are received with the understanding that they are not being considered by another publication. All articles become the property of the Florida Pharmacy Today and may not be published without written permission from both the author and the Florida Pharmacy Today. The Florida Pharmacy Association assumes no responsibility for the statements and opinions made by the authors to the Florida Pharmacy Today. The Journal of the Florida Pharmacy Association does not accept for publication articles or letters concerning religion, politics or any other subject the editors/ publishers deem unsuitable for the readership of this journal. In addition, The Journal does not accept advertising material from persons who are running for office in the association. The editors reserve the right to edit all materials submitted for publication. Letters and materials submitted for consideration for publication may be subject to review by the Editorial Review Board. FLORIDA PHARMACY TODAY, Annual subscription - United States and foreign, Individual $36; Institution $70/year; $5.00 single copies. Florida residents add 7% sales tax. FLORIDA PHARMACY ASSOCIATION
610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web Address: http://www.pharmview.com 8 | FLORIDA PHARMACY TODAY
SAVE THE DATE 126TH ANNUAL MEETING AND CONVENTION OF THE FLORIDA PHARMACY ASSOCIATION Marriott Harbor Beach 3030 Holiday Drive Fort Lauderdale, Florida 33316 June 30 - July 3, 2016
Executive Insight continued from p. 7
propriately… Today’s pharmacists are trained and licensed to provide a number of additional services, including initiating and modifying drug therapy, conducting health and wellness testing, helping patients manage chronic conditions, administering immunizations and helping patients understand and manage their medications… 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 Association (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-counter (OTC).5 A January 2016 statement from Dr. Mark DeFracesco, current president of ACOG, has most recently expressed that the law change in Oregon 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 reproductive health… Requiring a pharmacist to prescribe and dispense oral contraceptives 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 areas of Oregon who sometimes “wait up to 18 weeks to see a provider.”1 MORAL CONSCIENCE With these recent changes in Oregon 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 conscience. In answering these questions,
the president of the Christian Pharmacy Fellowship International (CPFI), pharmacist Fred Eckel, shared these words on the matter: “Some pharmacists may have moral concerns with birth control medications. Because, in this case, the Oregon legislation is permissive, I do not see that [these laws] create a moral dilemma, because a pharmacist who may not be comfortable prescribing oral contraceptives 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, saying “the real question is, are pharmacists equipped to handle this responsibility? 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 nation that pharmacists are more than capable of delivering the needs of women in access to care. Despite the remaining 48 states still without legislation expanding this pharmacist role in health care, there is no doubt that these changes 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: Gilchrist, A. How Oregon Pha r mac i st s A re Presc r ib ing Birth Control. Pharmacy Times. http://www.pharmacytimes.com/resource-centers/womens-health/howoregon-pharmacists-are-prescribingbirth-control. Published January 4, 2016. Accessed January 6, 2016. Liss-Schultz, N. Oregon Residents Can Now Get Birth Control Prescription Without Doctor’s Visit. RH Reality Check. http://rhrealitycheck.org/
article/2015/06/30/oregon-residentscan-now-get-birth-control-prescription-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 Obstetricians 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-Statementon-Pharmacist-Prescribing-Laws. Published January 4, 2016. Accessed January 8, 2016. Eckel F. President of Christian Pharmacist Fellowship International (CPFI): Oregon Pharmacists and Birth Control. 2016 n References
1 http://www.pharmacytimes.com/ resource-centers/womens-health/ how-oregon-pharmacists-areprescribing-birth-control 2 http://rhrealitycheck.org/ article/2015/06/30/oregonresidents-can-now-get-birth-controlprescription-without-doctors-visit/ 3 http://www.ashp.org/menu/News/ NewsCapsules/Article.aspx?id=1592 4 http://www.acog.org/Resources-AndPublications/Committee-Opinions/ Committee-on-Gynecologic-Practice/ Over-the-Counter-Access-to-OralContraceptives 5 http://www.acog.org/About-ACOG/ News-Room/Statements/2016/ ACOG-Statement-on-PharmacistPrescribing-Laws 6 Eckel F. President of Christian Pharmacist Fellowship International (CPFI): Oregon Pharmacists and Birth Control. 2016
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Telemedicine by Health Care Clinicians Antonio J. Carrion Primary Author Assistant Professor of Pharmacy Practice Florida A&M University College of Pharmacy and Pharmaceutical Sciences Jamal A. Brown Corresponding Author Assistant Professor of Pharmacy Practice Florida A&M University College of Pharmacy and Pharmaceutical Sciences Jamal.brown@famu.edu (813) 540-3268
Today’s means of daily communication have been altered and expanded through the advancement and use of technology (Santamore, W. P., 2008). With the employment of digital personal assistants, cellular phones, the Internet, text messaging, interactive voice response, and email, telemedicine can be provided through a wide range of technologies and applications (Grisby, 1998). Telemedicine utilizes telecommunication technology to transfer medical data from one location to another, with the distance between locations being either a few or thousands of miles away (Brown N., 2007). Telemedicine began more than 40 years ago, when the National Aeronautics and Space Administration (NASA) started monitoring the physiologic status of astronauts during missions while working in space (Bashur, A., 1997). During the late 1960s and 1970s, advances in communication technology provided the basis for NASA-funded telemedicine programs to 10
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be developed and used by other areas of medicine (Bashur, A., 1997). Many programs demonstrated that telemedicine could be used effectively for consultative, diagnostic and educational purposes, especially for rural populations where access to quality healthcare is limited by geography and/or a lack of adequate medical services and providers (Brown, N., 2007). Throughout the 1980s and 1990s, further enhancement of computer technology systems expanded the use of telemedicine by specialties such as cardiology, oncology, radiology, psychiatry and surgery (Brown, N., 2007). By the late 1990s, telemedicine programs were being initiated by home healthcare agencies, correctional facilities, and researchers all over the globe (Brown, N., 2007). Today, we see pharmacists utilizing telemedicine in the ambulatory care setting to manage chronic disease states and even provide counseling and drug information in retail pharmacy settings. Even though telemedicine can be very
beneficial in various aspects of medical care, there are several issues surrounding the emergence of telemedicine. The purpose of this article is to discuss the financial cost, resistance to implementation, education, training, confidentiality and the roll of the pharmacist in telemedicine. Financial Cost The financial cost of implementing a telemedicine-based healthcare system is a major limiting factor in regards to the future of telemedicine. As a multimillion-dollar investment with no reimbursement currently available, many institutions or hospital systems may not be able to institute their own telemedicine-based system (Witzke, A. K., 2007). Through collaborative partnerships between hospitals, alternative models have been established as a possibility for reducing the expenses associated 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 quality of care are benefits that outweigh the expense of telemedicine realization. The maintenance cost of a telemedicine infrastructure remains the greatest expense 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 Universal Service Program and provides rural health care providers with discounts on telecommunication charges (Myers, M. K., 2003). In addition, other federal funds have been appropriated to aid rural programs with the expenditure of maintaining the telemedicine infrastructure (Myers, M. K., 2003). Because of the high costs of equipping and using an interactive telemedicine system (especially the cost of broadbandwidth transmission media), many telemedicine providers are moving toward more cost-effective systems, such as desktop store-and-forward systems (Grisby, J., 1998).
Implementation Resistance Fear of being replaced by computer technology is a concern some healthcare providers have voiced for many years. Physicians mostly rely on the presence of patients to provide certain clinical information and to perform 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 being provided by nurses and physicians, not to replace the human interaction and healing touch that can only be provided by bedside caregivers (Witzke, A. K., 2007). For the most part, physicians tend to be more resistant than nurses to telemedicine management of their patients (Celi, L. A., 2001). This resistance and lack of cooperation can limit the effectiveness of telemedicine and potentially negatively impact the patient’s quality of care. Educating for Use Educational training is a key concern during implementation of telemedicine (Witzke, A. K., 2007). An important step in the planning process is the establishment of a system super user group that includes healthcare professional representation 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 information technology system, as well as time spent reviewing and learning operational guidelines or changes to the proposed workflow of the facility using it. Not only must the providers be educated, but the patients must also receive instruction on the usage of the systems. Clearly, training is important, but for those individuals with limited mobility or severe chronic diseases, access must be considered and is very essential in the success of the system (Santamore, W. P., 2008). Future telemedicine systems will more than likely have multiple means of connectivity (i.e. cellular phones, Internet, text messaging, interactive 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 experience from healthcare providers and patients (Witzke, A. K., 2007). Confidentiality & Security Finally, the issue of confidentiality and security of electronic transmission of medical information remains a prominent concern. The current medical record system is already insecure, but there are additional concerns surrounding the ability of electronic medical record systems to maintain an appropriate level of security (Grisby, J., 1998). In general, electronic records are more secure than paper-based charts, but there is the associated risk of unauthorized persons obtaining access to confidential data (Grisby, J., 1998). The breaches of security may lead to inappropriate disclosure of individual 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 diagnosis to marketers, may even be facilitated by the use of electronic databases (Grisby, J., 1998). With the introduction of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), standards have been set forth that govern electronic data exchange, protect the privacy of health information and secure electronic signatures (Myers, M. K., 2003). With HIPAA, the challenge for telemedicine providers will be in how to deal with multiple state privacy provisions and federal provisions, which may be in conflict and prevent the integration 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, pharmacists are used to provide clinical services such as managing chronic disease states through telemedicine for patients that live in rural areas or face transportation barriers to care. Systems such as the Veterans Health Administration JANUARY 2016 |
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(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 telehealth program, CCHT, introduced in 2003 in the USA, was created to remotely manage the care of older adults with chronic disease, avoiding long-term admission to hospitals or other care institutions. (Darkins, A., 2008) The introduction of this program has led to decreased utilization of health care resources with a 19.7 percent reduction 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 reduction), hypertension (30.3 percent reduction) and CHF (25.9 percent reduction). (Barr, P., 2010) In the Hyperlink study performed in MinneapolisSt Paul, a pharmacist-ran hypertension clinic compared outcomes of telemedicine and telephone monitoring vs. patients seen by their physician without 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 visits when compared to the patient group only receiving primary care visits. (Kerby, 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 community 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 interaction 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 12
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such technology available, pharmacists in the future have the opportunity to complete MTM visits, patient education consultations and even verify medications through video technology. (Castel, C., 2015). Conclusion Telemedicine will inevitably alter the delivery of patient care outside of the hospital setting and has the potential to improve the efficiency of healthcare delivery in general. (Santamore, W. P., 2008). Already, these technologies are starting to be used clinically and will impact on the patient-provider relationship (Santamore, W. P., 2008). Pharmacists must continue to stay involved with the implementation of services and expansion of diverse roles within our profession. While enhancing patient satisfaction through the flexibility of communication and improved access to health information, the benefits of linking appropriate medical specialists to patients in need of their services have been the incentive for the continual growth and use of telemedicine technology (Bashur, A., 2007). Telemedicine has the potential in reducing time and cost in patient transfers, assisting connections between clinical researchers and improving the education of medical personnel, which are all major problems in the healthcare arena. The patient’s concerns, perceptions and needs must be addressed to achieve optimal technology utilization and patient benefit, which will eventually fall on the shoulders of healthcare providers. Current 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 responsibilities. Pharmacists should use telemedicine opportunities to further improve outcomes and decrease hospitalization rates in the outpatient setting. To ensure the success and not represent a diminishing percentage of use, telemedicine users must be properly educated, be willing to accept the telemedicine initiative, maintain confidentiality and politic for necessary funds that will drive the telehealth movement in the
next few years. References
Barr, 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-directconsumer-telehealth-providersincrease-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 ClusterRandomized 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/walgreensvp-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.
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FPA News & Notes Board of Pharmacy Rule on CS Dispensing Pending Last month, the Florida Board of Pharmacy announced 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 Standards Committee where a considerable amount of public 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 prescription. 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 concerns that may be apparent. There is additional language added to the rule that should help alleviate fear from enforcement 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 September 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 support 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 providers are running into when ordering controlled substances. The recommendation by the wholesaler advisory council is not binding on the Department. FPA Advocates for Healthiest Weight Florida The Florida Department of Health is promoting a campaign 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 program is a public-private collaboration bringing togeth-
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er state agencies, local governments, businesses, schools, nonprofits, faith-based groups and health care professionals 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.HealthyPromiseFL.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 business 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 received are used to cover reporting costs to the state and direct fundraising expenses. The Florida Pharmacist Political 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 Legislative Affairs, Bill Eley for making this contribution possible. We have several ways that you can make a contribution to FPPC. You can go online at Pharmview.com, select the contribution option when renewing your membership dues or you can download a contribution form that is available on the FPA website.
Florida Pharmacist Services Access Bill TP’d House bill 547 entitled Access to Pharmacy Services Act was filed that makes certain modifications to the pharmacy practice act. This FPA, FSHP and Florida Independent Pharmacy Network supported bill revises the definition of “practice of the profession of pharmacy” 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 patient’s drug therapy. ■■ Collaborate with a patient’s health care provider, the provider’s authorized agent, or other persons specifically authorized by the patient regarding the patient’s health care status, in addition to the patient’s drug therapy. ■■ Dispense medications, including vaccines, in addition to the administration of such medications. ■■ This legislation also changes the consultant pharmacist 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 therapy or protocol with one or more health care providers ■■ Allow those serving in the capacity as a consultant pharmacist or doctor of pharmacy under the consultant licensure section to perform medication management, patient health and wellness assessments, counseling and referrals related to medications and health care services This 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 FPA On December 5 the FPA sent to the membership a special Stat News action alert for those providing services to Florida Medicaid. As you are aware, the Florida 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. Several plans have already provided notices to their patients 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 provider. 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 issue 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 information 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 Guidance At a recent Board of Pharmacy meeting a number of pharmacies that closed were being disciplined because of failure to comply with rule 64B16-28.202. When a pharmacy permit makes a determination to end activity there are steps that need to be complied with. Those steps are as follows: Prior to closure of a pharmacy the permittee shall notify the Board of Pharmacy in writing as to the effective
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date of closure, and shall: A. Return the pharmacy permit to the Board of Pharmacy office or arrange with the local Bureau of Investigative 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 permittee shall: A. Physically deliver the prescription files to a pharmacy operating within reasonable proximity of the pharmacy being closed and within the same locality. This delivery of prescription files may occur prior to the return of the pharmacy permit to the Board of Pharmacy 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 prescription 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 prescriptions in separate files so as to prevent intermingling with the transferee pharmacy’s prescription files. There are similar kinds of tasks that must be performed 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.
In MemoriAm 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, director 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 activation 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.
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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
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ANDEXANET ALFA: Investigational Factor Xa Inhibitor Antidote
Lena Charafi PharmD Candidate 2016 University of Florida College of Pharmacy The topic of anticoagulation became very popular in recent years due to an increase in incidence of venous thromboembolism (VTE) among the U.S. population. Non-vitamin K oral anticoagulants, such as dabigatran, rivaroxaban, apixaban, and edoxaban, became the new generation of medications for treatment and prophylaxis of VTE. It has been estimated that in five years, over 20 million patients will receive Factor Xa inhibitors for anticoagulation purposes. These agents have shown in multiple randomized, controlled trials to be as effective as warfarin, have lower rates of bleeding and have less drugdrug and drug-food interactions. They have a more predictable anticoagulant effect, which allows a fixed dose regimen. However, one big disadvantage of using newer anticoagulant agents is the absence of an antidote to reverse anticoagulation in the case of a life-threatening bleeding episode or emergency surgery. Andexanet alfa is an investigational new medication that has the potential to become the first universal antidote to reverse the anticoagulant activity of Factor Xa inhibitors. The United States Food and Drug Administration (FDA) has recognized the lack of an effective reversal agent for Factor Xa 18
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inhibitors. In February of 2015, the FDA granted an orphan drug designation to andexanet alfa for being a novel antidote to Factor Xa inhibitors. Background Andexanet alfa is an injectable medication that has a very fast onset of action and a short duration of action. It has been recently developed by Portola Pharmaceuticals. Andexanet alfa has a unique mechanism of action. It is a recombinant protein and has a structure very similar to Factor Xa, but it is catalytically inactive. It binds to Factor Xa inhibitors but does not cause the anticoagulant effect. Andexanet alfa underwent multiple preclinical studies that provided substantial evidence supporting the safety, efficacy and rapid onset of action of andexanet alfa. The most recent studies were two Phase III trials, ANNEXAR and ANNEXA-A, that looked at the
safety and efficacy of andexanet alfa to reverse anticoagulant effects of apixaban or rivaroxaban in older, healthy volunteers. Each study consisted of two parts. In the first part of each study, the effect of a single bolus of andexanet alfa was evaluated in healthy volunteers who had been given rivaroxaban 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 Studies ANNEXA-R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of Factor Xa Inhibitors – Rivaroxaban) is a randomized, double-blind, placebo-controlled Phase III study that evaluated the safety and efficacy of andex-
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 administered 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 anti-Factor Xa levels as the primary endpoint. Secondary endpoints included: 1) occurrence of 80 percent or greater reduction 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 significantly and immediately reversed the anticoagulation activity of rivaroxaban. Anti-Factor Xa activity was rapidly reduced within 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 percent reduction in anti-Factor Xa activity from baseline to nadir, 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. However, 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 completed 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 volunteers were given 20 mg of rivaroxaban once daily for four days and then randomized in a 2:1 ratio to receive either an andexanet 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 Anticoagulant 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-
Looking at the safety profile of the study drug, andexanet alfa was shown to be well-tolerated. 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 second group was a placebo group (n=9). The efficacy of andexanet alfa was evaluated using an anti-Factor Xa levels as the primary endpoint. Secondary endpoints included: 1) occurrence of 80 percent or greater reduction in anti-Factor Xa activity from baseline to nadir, 2) change in free apixaban con-
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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 reversed by 94 percent two to five minutes after completion of a bolus. Looking at the secondary endpoints, the number of
Portola Pharmaceuticals conducted multiple preclinical and clinical studies that demonstrated safety and efficacy of andexanet alpha. subjects who achieved the occurrence of greater than 80 percent reversal was 100 percent in andexanet alfa group and zero percent in the placebo group, the change in free apixaban 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 outcomes with statistical significance. Looking at the safety findings of the study, andexanet alfa was well tolerated. All 33 subjects completed the study with-
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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 volunteers 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 administered as a 400 mg IV bolus followed by a continuous infusion of 4 mg/min for 120 minutes. The second group received a placebo treatment. The efficacy of andexanet alfa treatment was evaluated using the percent change in antiFactor 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 anti-Factor Xa activity from baseline to post-bolus nadir, 2) occurrence 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 postinfusion, 5) occurrence of thrombin generation post-infusion above the lower limit of derived normal range. Researchers showed that the mean percent change in antiFactor 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 andexanet 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 andexanet 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. Conclusion Portola Pharmaceuticals conducted multiple preclinical and clinical studies that demonstrated safety and efficacy of andexanet alpha. The data from both Phase III studies indicates that they achieved all of the primary and secondary endpoints with statistical significance. These findings are consistent 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. Reversal 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.
Some of the limitations of the studies include a small sample size, which could possibly mean that the results do not have sufficient power to detect a difference 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 different doses of andexanet alpha may be required for the two direct Factor Xa inhibitors apixaban and rivaroxaban. The dosing could be difficult to remember in an emergency bleed situation. Another important consideration is that andexanet alpha is a recombinant protein, and as with all structurally modified 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 reaction.
The topic of anticoagulation became very popular in recent years due to an increase in incidence of venous thromboembolism (VTE) among the U.S. population. 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):1628. 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 breakthroughdesignated 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. ANNEXAâ&#x201E;˘-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 Oâ&#x20AC;&#x2122;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.
2 016 FPA CAN DID A TE S
Online Voting is Open for the Election of FPA Officers and Regional Directors 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.
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C A L L
F O R
APhA Foundation and NASPA Bowl of Hygeia Awarded to a pharmacist for outstanding community service above and beyond professional duties. The use of the following selection criteria is required: ■■ The recipient must be a Florida licensed pharmacist and a member of FPA. ■■ ■■ T recipient has not previously received the award. ■■ two on its award committee or an officer of the association in other than an ex officio capacity. ■■ has compiled an outstanding record of community service, which, apart from his/her specific identification as a pharmacist, reflects well on the profession. James H. Beal Award Awarded to the "Pharmacist of the Year." The criteria established for this award is that the recipient be a Florida registered pharmacist and a member of FPA, who has rendered outstanding service to pharmacy within the past five years. Criteria: ■■ must be a Florida registered pharmacist and a member of the FPA. ■■ has rendered outstanding service to pharmacy within the past five years. Technician of the Year Award Awarded annually to a Florida pharmacy 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 technician practice.
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N O M I N A T I O N S ■■ Candidate must have demonstrated
contributions to the Florida Pharmacy Association and/or other pharmacy organizations. ■■ Candidate must have demonstrated commitment to community service. ■■ Candidate is not a past recipient of this award. R.Q. Richards Award This award is based on outstanding achievement in the field of pharmaceutical public relations in Florida. Criteria: ■■ recipient must be a Florida registered pharmacist and a member of the FPA. ■■ has displayed outstanding achievement in the field of pharmaceutical public relations in Florida. Frank Toback/AZO Consultant Pharmacist Award Criteria: ■■ Candidate must be an FPA member, registered with the Florida Board of Pharmacy as a consultant pharmacist 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 period 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 actively involved in a project that has or could potentially be of benefit to members of the profession.
F P A
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 Award Interamerican Pharmacists Association created this award to honor the memory of Roman M. Corrons who inspired and motivated countless pharmacists to participate actively and aspire to take on leadership roles in their profession. Roman was always there with guidance and support that motivated pharmacists and encouraged visionary leadership, approachable active membership and succession planning. This award recognizes the motivators among us who inspire others to continue to advance the profession. Criteria: ■■ The recipient must be a Florida Licensed Pharmacist and a member of the FPA. ■■ Candidate should motivate others to excel within the profession by encouraging them to be leaders. ■■ Candidate is not necessarily an association 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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Criteria: ■■ The recipient must be an FPA member. ■■ The recipient must serve as a role model for the profession of pharmacy. Upsher Smith Excellence in Innovation Award Awarded to honor practicing pharmacists who have demonstrated innovation in pharmacy practice that has resulted in improved patient care. Criteria: ■■ The recipient has demonstrated innovative pharmacy practice resulting in improved patient care. ■■ The recipient should be a practicing pharmacist within the geographic area represented by the presenting Association.
Qualified Nominee: A pharmacist practicing within the geographic area represented by the presenting Association. Cardinal Generation Rx Award The Cardinal Health Generation Rx Champions Award recognizes a pharmacist who has demonstrated excellence in community-based prescription drug abuse prevention. The award is intended to recognize outstanding efforts within the pharmacy community to raise awareness of this serious public health problem. It is also intended to encourage 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 implementation of prevention programs ■■ Innovation and creativity in the creation and implementation of prevention activities ■■ Scope/magnitude of prescription drug abuse efforts ■■ Demonstrated impact of prescription drug abuse prevention efforts
DEADLINE FOR NOMINATIONS: FEBRUARY 28, 2016 FPA AWARDS NOMINATION FORM I AM PLEASED TO SUBMIT THE FOLLOWING NOMINATION:
NOMINATED BY:
Name:
Name:
Address:
Date Submitted: Signature:
FOR THE FOLLOWING AWARD: (Nomination Deadline February 28, 2016) APhA Foundation and NASPA Bowl of Hygeia James H. Beal Award
Please describe briefly below the nominee's accomplishments, indicating why you feel he or she should receive this award. (Attach additional sheets if necessary.)
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
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
JANUARY 2016
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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 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 st
nd
□YES □NO
rd
Awards:
Posters will be eligible for 1 , 2 , and 3 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:
College:
□YES
□NO
_____________________________________________________________________________
ABSTRACT FORMAT 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 DEADLINE DATE: FRIDAY, MAY 6, 2016 28
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FLORIDA PHARMACY TODAY
florida BUYER’S GUIDE PHARMACY TODAY
ADVERTISERS: This is a special section designed to give your company more exposure and to act as an easy reference for the pharmacist.
PHARMACY RESOURCES PPSC Retail Pharmacy Purchasing Program (888) 778-9909
LEGAL ASSISTANCE Kahan ◆ Heimberg, PLC Brian A. Kahan, R.Ph., Attorney at Law (561) 392-9000 The Health Law Firm George F. Indest III, J.D., M.P.A., LL.M. (407) 331-6620
PHARMACEUTICAL WHOLESALER McKesson Drug Company Jim Springer (800) 804-4590 FAX: (863) 616-2953
FREQUENTLY CALLED NUMBERS AHCA MEDICAID PHARMACY SERVICES 2727 Mahan Drive Tallahassee, FL 32308 (850) 412-4166 www.fdhc.state.fl.us/medicaid/ pharmacy AMERICAN PHARMACISTS ASSOCIATION (APhA) Washington, D.C. (800) 237-2742 www.pharmacist.com AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS Bethesda, MD (301) 657-3000 www.ashp.com/main.htm DRUG INFORMATION CENTER Palm Beach Atlantic University (561) 803-2728 druginfocenter@pba.edu FLORIDA BOARD OF PHARMACY 4052 Bald Cypress Way Bin #C04 Tallahassee, FL 32399-3254 (850) 245-4292 www.doh.state.fl.us/mqa FLORIDA POISON INFORMATION CENTER NETWORK (800) 222-1222 www.fpicn.org NATIONAL COMMUNITY PHARMACISTS ASSOCIATION 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 (703) 683-3619 fax info@ncpanet.org
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 Referral 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.
RECOVERING PHARMACISTS NETWORK OF FLORIDA (407) 257-6606 “Pharmacists Helping Pharmacists”
JANUARY 2016
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“I’M ALWAYS WATCHING OUT FOR MY PATIENTS, BUT WHO’S WATCHING OUT FOR ME?”
WE ARE. 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
Call toll free (866) 365-7472 or visit www.pqc.net PQC IS BROUGHT TO YOU BY YOUR STATE PHARMACY ASSOCIATION
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FLORIDA PHARMACY TODAY