February 2016 Florida Pharmacy Journal by Florida Pharmacy Today

The Official Publication Of The Florida Pharmacy Association FEB. 2016

FIRST IN ITS CLASS:

Treatment for Irritable Bowel Syndrome Diarrhea (IBS-D) hallmark symptoms

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florida PHARMACY TODAY Departments

VOL. 79 | NO. 2 FEBRUARY 2016 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

4 Calendar 4 Advertisers 5 President’s Viewpoint 7 Executive Insight 17 FPA News & Notes 29 Buyer’s Guide

9 10 18 21 23

Former FPA Treasurer to Receive Leadership Mentor Award First in its Class: Treatment for Irritable Bowel Syndrome Diarrhea (IBS-D) hallmark symptoms

Maitland Pharmacist Elected as FPA President-Elect FPA Member Profile Peggyann Zaenger, BS, PharmD

FPA 126th Annual Meeting and Convention

FEBRUARY 2016

Mission Statements:

FPA Calendar 2015-16

FEBRUARY 28

Award Nominations Due MARCH

4 - 7

APhA Annual Meeting Baltimore, MD

Legislative Session ends

19-20 FPA Committee and Council Meetings Orlando 25

Good Friday - FPA Office Closed

Easter - FPA Office Closed APRIL

4-5

Florida Board of Pharmacy Meeting Altamonte Springs

of the Florida Pharmacy Today Journal MAY

1 - 3

NASPA Leadership Retreat

Deadline for FPA Resolutions

Deadline for Vice Speaker and Director nominations

FPA Leadership Retreat

21-22 FPA CE Conference Jacksonville 24 - 25 NCPA Congressional Summit JUNE 6/30 - 7/3 FPA Annual Meeting, Ft. Lauderdale, Florida 10

Last day for convention pre-registration

15 - 17 FPA Clinical Conference Tampa 23

Advisory Council on Pharmacy Practice

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............................... 15 KAHAN HEIMBERG, PLC................................. 8 PHARMACISTS MUTUAL................................ 2 PHARMACY QUALITY COMMITMENT..... 19

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 |

FLORIDA PHARMACY TODAY

E-MAIL YOUR SUGGESTIONS/IDEAS TO dave@fiorecommunications.com

The President’s Viewpoint TIM ROGERS, RPh, FPA PRESIDENT

Why Are Pharmacists Nice People?

remember the days when pharmacists were the No. 1 respected profession. Some polls may not have us at the top anymore, but we are still pretty darned close. Why is it that our patients and neighbors feel that way about pharmacists? I think I know. For decades, no, for centuries, the pharmacist has been that person who was accessible by everyone to ask for their “sage” advice. In the days of olde, there was a pharmacy on practically every block in the city, and people in the country knew where the closest one was. The pharmacist, “Doc,” was the one who had the wisdom and experience to help identify problems or alleviate unwarranted fears. We were the oracle of knowledge in all health matters, the counselor to the young mother with the sick child, and the advisor to the caretakers of the sick and elderly. We made up the potions and filled the doctor’s prescription that healed and alleviated symptoms. Let’s fast-forward to more modern times. So many people count on having access to “their” pharmacist. Besides being the provider of medications, the pharmacist is their counselor and confidant in all medical matters. People put their trust in us. This trust has made the pharmacist an essential part of our community. We have repaid this trust by stepping out from behind the counter and taking on the role of a community humanitarian. Be it the Mom-and-Pop corner drug store or a member of today’s chain pharmacies, the pharmacist has become involved in helping people in every aspect of life. We have become and are expected to be aiding not only people, but the community. We are out there serving on the PTA, being scout leaders, working to help the

Boys and Girls Club and sponsoring Little League baseball teams. We work to support the different charities that fight child abuse, breast cancer and we support the March of Dimes. The practice of our profession has stitched a fabric of service and caring to others. Is it pharmacy that has turned us into this

For decades, no, for centuries, the pharmacist has been that person who was accessible by everyone to ask for their “sage” advice. In the days of olde, there was a pharmacy on practically every block in the city, and people in the country knew where the closest one was.

Tim Rogers, RPh 2015-2016 FPA President

to those who follow us to be the loving and caring people that we are. I guess that is why we have been held in such high esteem by our communities and why we have been and will continue to remain among the most respected professions. Tim Rogers, RPh FPA President

caring-for-everyone persona, or is it the persona of caring for others that has turned us toward the practice of pharmacy? Now that I’m in my fifth decade of practice, and having watched and worked with hundreds of pharmacists, I believe that it is a little bit of both. The only fear I have is that the business of pharmacy, with all the stress and strains that go with it, could change that feeling. But no, I believe that we will continue to help others and that we will act as mentors and role models FEBRUARY 2016

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

SAVE THE DATES FPA Management of Pulmonary Disorders Conference April 15-17, 2016 Offering Continuing Education Credits for: ■■ General Pharmacy ■■ Consultant Pharmacy ■■ Laboratory Data ■■ Medication Errors ■■ Controlled Substance Grand Hyatt Tampa Bay 2900 Bayport Drive Tampa, FL 33607 For Room Reservation Call: (813) 874-1234 (888) 421-1442 Deadline: March 25, 2016

FPA Regulatory and Law Conference May 21-22, 2016 Offering Continuing Education Credits for: ■■ General Pharmacy ■■ Consultant Pharmacy ■■ Medication Errors ■■ Controlled Substance Omni Jacksonville Hotel 245 Water Street Jacksonville, Florida 32202 For Room Reservation Call: (800) THE-OMNI Deadline: April 29, 2016

6 |

FLORIDA PHARMACY TODAY

Executive Insight BYAMANDA MICHAELQ.JACKSON, RPH BY GUEST COLUMNIST RHODES, PHARMD CANDIDATE 2016

NAPLEX, MPJE… and PCOA?

ou are probably familiar with the NAPLEX (North American Pharmacist Licensure Examination) and MPJE (Multistate Pharmacy Jurisprudence Examination), but have you heard of the PCOA? As a fourthyear pharmacy student, I hadn’t until late last year when one of my professors told us we should be thankful to be P4s because, starting in 2016, P3s at my school would be required to take a new standardized exam – the PCOA. In addition to the relief I felt, a swirl of questions rushed through my mind: What is the PCOA? What is its purpose? How is it formatted? Intrigued, I did some research. PCOA stands for Pharmacy Curriculum Outcomes Assessment. It is administered by the National Association of Boards of Pharmacy (NABP) four times a year at sites designated by participating pharmacy schools. It is now required for all students nearing the completion of their didactic curriculum (P3s or equivalent) but may be taken by students in all four professional years.1 It is provided at no cost to the former, $75 per student for the latter.2 Its purpose is to provide pharmacy schools a way to assess their students’ academic progress.1 The computer-based assessment is composed of 225 questions from four content areas: clinical sciences, pharmaceutical sciences, administrative sciences and basic biomedical sciences. Clinical science takes up the biggest portion of the assessment at 32 percent and covers literature evaluation, drug information, clinical pathophysiology, pharmacokinetics, pharmacogenomics, population health and medication therapy management. Pharmaceutical science is the second biggest portion, making up 30 percent of the assess-

ment. Topics include medicinal chemistry, pharmacology, toxicology, dosage forms, compounding and dietary supplements. Social, behavioral, and administrative science make up 22 percent and covers health care systems, economics, pharmacy management, research design, ethics and law. Basic biomedical science makes up the least at 16 percent, covering physiology, biochemistry, microbiology, genetics and immunology.3 Within four weeks from the

The computer-based assessment is composed of 225 questions from four content areas: clinical sciences, pharmaceutical sciences, administrative sciences and basic biomedical sciences. last day of the testing window in which the student takes the assessment, individual reports are sent to the pharmacy school. They include the individual’s scores and national percentiles for the four content areas and total assessment.4 The school also receives a report of its overall performance compared to national results.5 Pharmacy outcome assessments are not a recent development. The Ba-

Amanda Q. Rhodes

sic Pharmaceutical Sciences Examination fell out of use in the 1980s. It had been used by some schools, but was never shown to correlate to student performance on experiential rotations, nor with clinical coursework.6 According to a 2006 study by Kirschenbaum, about half of U.S. pharmacy programs used some form of end-of-year examination. It also suggested that a validated, standardized assessment tool from a centralized source would let schools benchmark results and make the assessment process less formidable.7 Studies have shown that the PCOA is one such tool.6 In 2008, the NABP began administering the PCOA to select schools. The PCOA will be sure to have an impact on pharmacy schools. Information provided by individual student reports has been utilized in cases of academic dismissal and/or suspension. The assessment also allows students to practice taking standardized tests. To

See Executive Insight continued on p. 9 FEBRUARY 2016 |

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

A Pharmacist And A Lawyer Board of Pharmacy Licensure Disciplinary Proceedings Compounding Violations, DEA Investigations Mergers and Acquisitions Pharmacy Risk Assessment/Management Evaluations KAHAN ◆ HEIMBERG, PLC

Pharmacist Attorney Brian A. Kahan, R.Ph., J.D. Licensed Florida Pharmacist and Attorney

STATEWIDE REPRESENTATION 561-392-9000 bkahan@kahanlaw.com 2300 N.W. Corporate Blvd., Suite 123 Boca Raton, FL 33431 The hiring of a lawyer is an important decision that should not be based solely upon advertisements. Before you decide, ask us to send you free written information about our qualifications and experience.

Executive Insight continued from p. 7

encourage student performance, some programs have offered scholarship money to high performers. Others have incorporated individual results into a class grade. Because the PCOA can be used as a diagnostic tool to identify areas of weakness, schools can recommend individuals to complete remedial classes.8 Even though the PCOA became mandatory this year, it has been around for almost a decade. I didn’t take the assessment at any point in my pharmacy school career, but I almost wish I had. It would have been interesting to see how I measured up to my peers across the country. More importantly, the individual score report would have provided me with feedback on my strengths and weakness—something especially valuable now that my NAPLEX is around the corner.

References

1. PCOA for schools. National Association of Boards of Pharmacy. 2016. Available at: http://www.nabp. net/programs/assessment/pcoa/ pcoa-for-schools. Accessed Jan 25, 2016. 2. Catizone CA. Registration and administration guide for schools and colleges of pharmacy. National Association of Boards of Pharmacy. 2015. Available at: http://www. nabp.net/system/rich/rich_files/ rich_files/000/001/245/original/ pcoa-20school-20guide-final-01132016. pdf. Accessed January 25, 2016. 3. Content areas for students. National Association of Boards of Pharmacy. 2016. Available at: http://www.nabp. net/programs/assessment/pcoa-forstudents/content-areas-for-students. Accessed Jan 25, 2016. 4. FAQs for students. National Association of Boards of Pharmacy. 2016. Available at: http://www.nabp. net/programs/assessment/pcoa-forstudents/faqs-for-students. Accessed Jan 25, 2016. 5. Score reports for schools. National Association of Boards of Pharmacy.

2016. Available at: http://www.nabp. net/programs/assessment/pcoa-forschools/score-reports-for-schools. Accessed Jan 25, 2016. 6. Scott DM, Bennett LL, Ferrill MJ, Brown DL. Pharmacy curriculum outcomes assessment for individual student assessment and curricular evaluation. Am J Pharm Educ. Dec 2010;74(10): 183. 7. Plaza CM. Progress examinations in pharmacy education. Am J Pharm Educ. 2007;71(4): 66. 8. Gortney JS, Bray BS, Salinitri FD. Implementation and use of the Pharmacy Curriculum Outcomes Assessment at US schools of pharmacy. Am J Pharm Educ. Nov 2015;79(9): 137.

Former FPA Treasurer to Receive Leadership Mentor Award The American Pharmacists Association announced that FPA member Michael A. Moné will be the recipient of the Gloria Niemeyer Francke Leadership Mentor Award. This award recognizes an individual who has promoted and encouraged pharmacists to attain leadership positions within pharmacy through example as role model and mentor. The pharmacist for whom the award is named – Gloria Niemeyer Francke, PharmD – personally exemplified the award’s criteria. Francke, 1986 APhA Honorary President and 1987 Remington Honor Medalist, inspired and mentored future leaders throughout her illustrious pharmacy career. Michael was past treasurer of the Florida Pharmacy Association and also served as Speaker of the House of Delegates. This award will be presented to Michael at the APhA annual meeting in Baltimore, Maryland.

FEBRUARY 2016

Eluxadoline (VIBERZI ) ®

First in its Class: Treatment for Irritable Bowel Syndrome Diarrhea (IBS-D) hallmark symptoms PRIMARY AUTHOR: JAMAL BROWN, PHARM.D.

Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tampa, Florida jamal.brown@famu.edu 813-975-6557 Campus Office

CORRESPONDING AUTHOR: CRYSTAL PARKE, PHARM.D.

Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Tampa, Florida crystal.parke@famu.edu 813-975-6557 Campus Office ADDITIONAL AUTHOR: JUAN F. MOSLEY II, PHARM.D., CPH, AAHIVP

Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Crestview Education Center Crestview, Florida juan.mosley@famu.edu 153 W. Woodruff Ave. Crestview, FL 32536 850-689-7870 Campus Fax 850-449-0869 Mobile Office

FLORIDA PHARMACY TODAY

ADDITIONAL AUTHOR: LILLIAN L. SMITH, PHARM.D., CPH, MBA

Assistant Professor of Pharmacy Practice Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Crestview Education Center Crestview, Florida lillian.smith@famu.edu 153 W. Woodruff Ave. Crestview, FL 32536 850-689-7870 Campus Fax 850-689-7916 Mobile Office ADDITIONAL AUTHOR: THUY HANG T. DO PHARM.D. CANDIDATE

Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Crestview Education Center Crestview, Florida thuy1.hangdo@famu.edu 153 W. Woodruff Ave. Crestview, FL 32536 ADDITIONAL AUTHOR: WILLIAM T. BENTON III PHARM.D. CANDIDATE

Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Crestview Education Center Crestview, Florida taylor1.benton@famu.edu 153 W. Woodruff Ave. Crestview, FL 32536

ADDITIONAL AUTHOR: YASMIN A. ARAFA PHARM.D. CANDIDATE

Florida Agricultural and Mechanical University College of Pharmacy and Pharmaceutical Sciences Crestview Education Center Crestview, Florida yasmin1.arafa@famu.edu 153 W. Woodruff Ave. Crestview, FL 32536 Keywords: eluxadoline, IBS-D, diarrhea, gastrointestinal Disclosure: The authors report no financial or commercial relationships in regard to this article Acknowledgement: Dr. Brown and Dr. Parke (corresponding author: crystal.parke@ famu.edu) are Assistant Professors of Pharmacy Practice at the Florida Agricultural and Mechanical University, College of Pharmacy and Pharmaceutical Sciences, in Tampa, Florida. Dr. Mosley and Dr. Smith are Assistant Professors of Pharmacy Practice at the Florida Agricultural and Mechanical University, College of Pharmacy and Pharmaceutical Sciences, in Crestview, Florida. Thuy Hang T. Do, William T. Benton III, and Yasmin A. Arafa are doctor of pharmacy candidates at that institution.

Abstract INTRODUCTION

It is estimated that two out of every 10 people in the United States suffer from irritable bowel syndrome with diarrhea (IBS-D). Common symptoms associated with IBS-D include diarrhea, abdominal pain and bloating. Unfortunately, treatment options for managing this debilitating condition are very limited.1 Eluxadoline is a new treatment option for managing IBS-D in adults, which was FDA approved based on the results of two phase III clinical trials. DISCUSSION

Eluxadoline provides specific therapy due to its distinctive mechanism of action. It provides mixed activity of the opioid receptors in the nervous system directed at decreasing bowel movements.2 The most common side effects of eluxadoline are constipation and abdominal pain, but more serious side effects can occur. Due to the opioid receptor involvement, there is potential for abuse of eluxadoline. It is currently pending DEA review as a controlled substance. CONCLUSION

Eluxadoline was designed to treat the most bothersome symptoms associated with IBS-D, providing a new and effective therapy option. Eluxadoline provides patients with the option of controlling IBS-D as monotherapy, as opposed to the common need for multiple medications to control IBS-D symptoms.

Introduction Irritable bowel syndrome with diarrhea (IBS-D) is a common condition affecting nearly 15 million people in the United States. It is estimated that two out of every 10 people suffer from irritable bowel syndrome. Women are affected more than men by about a 2:1 ratio.1 The most common symptoms include diarrhea, abdominal pain and bloating. These symptoms can have a major impact on people in their everyday lives. Treatment options for managing this debilitating ailment are very limited.1 Current treatment options for IBS-D include: diphenoxylate/atropine, loperamide, dicyclomine and belladonna alkaloids. These drugs provide short-term relief of symptoms, but they are frequently used incorrectly as long-term management. Although the absolute cause of IBS-D is unknown, there is proof of possible origins involving deranged brain-gut signaling, hypersensitivity of visceral sensory afferent fibers, genetic alterations and food sensitivity. Treatment for IBS currently targets the serotonergic and opioidergic system.1 On May 27, 2015, the FDA announced the approval of eluxadoline, a new therapeutic drug for managing IBS-D in adults. This innovative drug provides specific therapy for the vari-

ety of symptoms associated with IBS-D. The unique mechanism of eluxadoline provides mixed activity of the opioid receptors in the nervous system directed at decreasing bowel movements.2 The dose indicated for irritable bowel syndrome in adults is 100mg twice a day with food. The most common side effects associated with eluxadoline include constipation and abdominal pain; however, more serious side effects involving spasms in the sphincter of Oddi can occur. Eluxadoline was designed to treat the most bothersome symptoms associated with IBS-D, providing physicians with a new therapy option established by evidence-based trials.2 Indication and Usage Eluxadoline is indicated for treatment in adults with irritable bowel syndrome with diarrhea (IBS-D).3 Clinical Pharmacology MECHANISM OF ACTION

Eluxadoline works by targeting receptors in the central nervous system that specifically result in a reduction of bowel movements. It is a locally acting mixed mu-opioid receptor agonist, delta opioid receptor antagonist and kappa opioid receptor agonist. The multiple opioid activity is designed to treat the symptoms of IBS-D while reducing constipation that occurs with unopposed mu-opioid receptor agonists.4 Pharmacodynamics CARDIAC ELECTROPHYSIOLOGY (QTC)

The effect of eluxadoline on cardiac repolarization was tested in a thorough QTc study. Eluxadoline did not produce QTc prolongation at supra-therapeutic doses 10 times the maximum recommended dose.4 Pharmacokinetics Following oral administration, the time to maximum plasma concentration of eluxadoline 100 mg was approximately 1.5 hours with food and two hours while fasting. The mean peak plasma concentration (Cmax) is two to four nanograms/milliliter (ng/ml) and one to two ng/mL when taken with a highfat meal. The total systemic exposure (AUC) of eluxadoline was 12 to 22 nanograms x hours/milliliters (ngxhr/mL), which was decreased by 60 percent when taken with a high-fat meal. Eluxadoline has linear pharmacokinetics and did not exhibit any accumulation upon repeated dosing of twice a day (the standard dose). The variability of eluxadoline pharmacokinetic parameters ranges from 51 percent to 98 percent.4 ABSORPTION AND DISTRIBUTION

The mean absolute bioavailability of eluxadoline has not been determined. The median Tmax value was 1.5 hours, with a range of one to eight hours under fed conditions and two hours, with a range of half an hour to six hours, under fasting conditions. The administration of eluxadoline with a high-fat meal (containing approximately 50 percent calories from fat of 800 to 1000 total calories) decreased the Cmax of FEBRUARY 2016 |

eluxadoline by 50 percent and AUC by 60 percent. The total body distribution of eluxadoline consisted of 81 percent plasma protein binding of eluxadoline.4 METABOLISM AND ELIMINATION

The exact mechanism by which eluxadoline is metabolized has yet to be established. There is evidence that glucuronidation can occur to form an acyl glucuronide metabolite. The mean plasma elimination half-life of eluxadoline ranges from about 3.7 to six hours. Following a single oral dose of 300 mg of eluxadoline in healthy male subjects, 82.2 percent of the total radioactivity was recovered in feces within 336 hours and less than 1 percent was recovered in urine within 192 hours. Eluxadoline does not require any renal dose adjustments. In the case of mild to moderate hepatic impairment, the dose should be reduced to 75 mg twice daily. Use with severe hepatic impairment is contraindicated.4 Principal Clinical Trial Eluxadoline was FDA approved based on two phase III, double-blind, placebo-controlled clinical trials consisting of 2,415 patients randomly assigned to receive either eluxadoline 75 mg twice daily, eluxadoline 100 mg twice daily or placebo over 26 weeks of treatment.2 Patients recorded daily symptoms and stool consistency. The primary outcome was a composite response over 12 or 26 weeks demonstrating improvement in abdominal pain and stool consistency over baseline. A patient had to have improvement in both categories on the same day to be a daily responder.5 INCLUSION AND EXCLUSION CRITERIA:

1. Inclusion criteria: Patients had to have diagnosed IBS-D as defined by Rome III, a two-week baseline of Bristol stool score > 5.5, worst abdominal pain >3.0 and global symptom score* of > 2.0. Additional requirements included diary compliance and no rescue-use medications during baseline.5 2. Exclusion criteria: Prior pancreatitis, alcohol abuse, cholecystitis in the past six months, sphincter of Oddi* dysfunction, IBD, intestinal obstruction, GI infection or diverticulitis* within three months, Lipase > two times upper limit of normal and ALT or AST > three times upper limit of normal. 5 PRIMARY COMPOSITE ENDPOINTS:3

To be a responder, a patient must meet both responder criteria on >50 percent of days: ■■ Daily pain responder: worst abdominal pain scores in the past 24 hours improved by ≥30 percent compared to average baseline pain ■■ Daily stool consistency responder: Bristol Stool Score of <5

TABLE 1: ENROLLMENT AND BASELINE CHARACTERISTICS Trial 1 Screened

2832

2521

Randomized

1281

1146

Mean Age

44.9

45.9

Female

838

756

>65 years of age

115

126

*Cholecystectomy

272

224

Used loperamide in prior year

466

408

Results: Overall response rates were compared for patients who met the daily response criteria for at least 50 percent of the days during the 12- or 26-week study period. Results of both trials revealed eluxadoline being more effective than placebo at controlling the primary outcome measures of abdominal pain and stool consistency.5 Each study revealed statistically significant improvements in responder rates through 12 weeks. Pooled results also showed eluxadoline having better results for the 26-week study duration. The results were statistically significant for both males and females.5 The most common adverse events reported in patients taking eluxadoline were constipation and nausea, with both occurring in less than 10% of patients. During the first week of treatment, eight patients receiving eluxadoline had hepatobiliary sphincter of Oddi spasm. All of these patients had a prior cholecystectomy, so further inquiry in this patient population is required.5 See tables 2 and 3 below for detailed results. TABLE 2: INDIVIDUAL COMPONENTS OF THE PRIMARY ENDPOINT 1 Pain responder (30% improvement)

Weeks 1-12 Weeks 1-26

FLORIDA PHARMACY TODAY

% Responders

P value

% Responders

P value

100 mg

46.8%

0.069

34.7%

<0.001

PBO

42.3%

100 mg

48.3%

PBO

44.0%

21.5% 0.086

36.8%

<0.001

23.9%

Trial 1

Weeks 1-26 |

Stool Consistency Responder

TABLE 3: ADEQUATE RELIEF OF IBS SYMPTOMS: 50% RESPONDER ANALYSIS

Weeks 1-12

Trial 2

% Responders

P value

% Responders

P value

100 mg

54.2%

0.002

58.4%

0.011

PBO

43.8%

100 mg

49.5%

PBO

40.0%

49.2% 0.005

53.7% 43.7%

0.006

Adverse Drug Effects The efficacy and safety of eluxadoline in IBS-D patients was established in the two aforementioned studies above.6 Adverse reactions were not present at baseline. Sphincter of Oddi spasm presenting with abdominal pain was the most common side effect, occurring in two of the 807 (0.2 percent) patients receiving 75 mg twice daily, and in eight out of 1032 (0.8 percent) patients receiving eluxadoline 100 mg twice daily.6 No cases of sphincter of Oddi spasm were present at the one month post baseline mark, demonstrating that this is a transient side effect. All side effects resolved upon discontinuation of eluxadoline.6 The most common adverse reactions of eluxadoline reported in > 2 percent of patients include the following: constipation, nausea and abdominal pain. Other adverse reactions to eluxadoline are included in Table 4. TABLE 4. COMMON ADVERSE REACTIONS IN THE PLACEBO-CONTROLLED STUDIES IN IBS-D PATIENTS VIBERZI 100 MG TWICE DAILY

VIBERZI 75 MG TWICE DAILY

PLACEBO

(N= 1032) %

(N=807) %

(N=975) %

Constipation

Abdominal Pain**

ADVERSE REACTIONS

Nausea

Upper Respiratory Tract Infection

Vomiting

Abdominal Distention

Nasopharyngitis Bronchitis Dizziness

Flatulence Rash***

Increased ALT Fatigue

Viral gastroenteritis

3 3 3 3 3 3 2 1

4 3 3 3 3 2 3 3

3 2 2 2

Drug Interactions Evaluation and caution should be practiced when administering oral drugs concomitantly with eluxadoline. Eluxadoline has the potential to interact with organic anion-transporting polypeptide (OATP1B1) inhibitors by increasing the drug concentrations of eluxadoline. Drugs in the OATP1B1 class include: cyclosporine, gemfibrozil, atazanavir, lopinavir, ritonavir, saquinavir, tipranavir and eltrombopag. 6 Eluxadoline has the potential to interact with strong CYP inhibitors, increasing the exposure to eluxadoline. It is important to monitor patients for impaired mental or physical abilities needed to perform potentially hazardous activities such as operating machinery or driving. Examples of strong CYP inhibitors include: ciprofloxacin, gemfibrozil, fluconazole, clarithromycin, paroxetine and bupropion.6 The potential for eluxadoline to interact with drugs that increase the risk for constipation could potentially be hazardous by causing impaction. It is important to avoid the use of other drugs that cause constipation such as: loperamide (chronic use), alosetron, anticholinergics and opioids. If constipation does occur, stop the drug immediately to prevent serious adverse events.6

Evaluation and caution should be practiced when administering oral drugs concomitantly with eluxadoline. Eluxadoline has the potential to interact with organic anion-transporting polypeptide (OATP1B1) inhibitors by increasing the drug concentrations of eluxadoline.

2 1 2 2

* Reported in > 2% of VIBERZI-treated patients at either dose and at an incidence greater than in placebo-treated patients **“Abdominal Pain” term includes: abdominal pain, abdominal pain lower, and abdominal pain upper *** “Rash” term includes: dermatitis, dermatitis allergic, rash, rash erythematous, rash generalized, rash maculopapular, rash papular, rash pruritic, urticaria and idiopathic urticaria

Contraindications: Eluxadoline has an absolute contraindication in patients with known or suspected biliary obstruction, alcoholism, pancreatitis, a history of pancreatitis or a suspected duct obstruction. Eluxadoline should be used with caution with patients that consume three or more alcoholic beverages a day or have GI obstruction, GI perforation, chronic constipation, sequelae* from constipation, or mechanical gastrointestinal obstruction. 6 Warning and Precautions: Eluxadoline interacts with the mu-opioid receptor by way of antagonism, increasing the chances of causing sphincter of Oddi spasms that ultimately result in pancreatitis. If this occurs or is suspected, discontinue therapy immediately. Patients without a gallbladder are at an increased risk and alternative therapy should be considered.4 FEBRUARY 2016

Eluxadoline may also increase the risk of non-sphincter of Oddi spasm-related pancreatitis. Instruct patients that if they have pain radiating to the lower back and abdominal area to seek medical attention. This could potentially be a serious side effect. Dosage and Administration Eluxadoline 100 mg twice a day with food is the recommended dose for adults. The recommended dosage for patients without a gallbladder, patients who are unable to tolerate the 100 mg dose, patients receiving concomitant OATP1B1 inhibitors or patients who have mild or moderate hepatic impairment is 75 mg twice daily with food.3 Eluxadoline should be discontinued in patients who develop severe constipation for more than four days. If a dose of eluxadoline is missed, take the next scheduled dose. It is not recommended to take more than one dose at the time.6 Cost No cost information is yet available, as ViberziÂŽ was recently approved by the FDA and has not been released into the market by Actavis Pharmaceuticals, Inc. P & T Committee Considerations Irritable bowel syndrome related diarrhea is a condition that affects over 15 million people in the United States alone.1 The recent approval of eluxadoline by the FDA provides prescribers with the first mixed opioid receptor activity option of medication. Eluxadolineâ&#x20AC;&#x2122;s unique mechanism of action makes it the first in its class and differentiates it from other treatment options for IBS-D such as diphenoxylate/atropine, loperamide, dicyclomine, hyoscyamine and belladonna alkaloids.1 Generally, clinicians first prescribe an antispasmodic agent such as hyoscyamine and dicyclomine. These drugs work by relaxing smooth muscle in the gut, which reduces pain from gas and bloating. In patients with long-term diarrhea, the two most commonly prescribed drugs are the antidiarrheal agents loperamide and diphenoxylate/atropine. Loperamide is an opioid antimotility drug that is used for diarrhea; however, it is limited in use due to side effects. Loperamide often

Eluxadolineâ&#x20AC;&#x2122;s unique mechanism of action makes it the first in its class and differentiates it from other treatment options for IBS-D such as diphenoxylate/ atropine, loperamide, dicyclomine, hyoscyamine and belladonna alkaloids.

FLORIDA PHARMACY TODAY

causes drowsiness and rebound constipation and is contraindicated in patients with hepatic impairment. This drug generally works well in the acute setting, but in long-term use it appears to require strict monitoring. Diphenoxylate/atropine is a combination product consisting of the antidiarrheals diphenoxylate and the anticholinergic atropine. Diphenoxylate/ atropine is often prescribed acutely for diarrhea but its use for long-term therapy is debatable. The drug is a controlled

This drug generally works well in the acute setting, but in long-term use it appears to require strict monitoring. Diphenoxylate/atropine is a combination product consisting of the antidiarrheals diphenoxylate and the anticholinergic atropine. substance in many states due to the potentiation effect in relation to other drugs. When diphenoxylate is taken with opiates, barbiturates or alcohol, the effects of the medication may increase, potentially leading to respiratory depression. Diphenoxylate/atropine is also contraindicated in patients with hepatic disease. These drugs are routinely prescribed as longterm therapy because of limited options, but in general, these drugs are a short-term solution. It is imperative to express concern over eluxadoline being a new drug and that the longterm safety of this drug has not been established. It is therefore premature to recommend the use of eluxadoline for routine use in the patient population. With the prevalence of IBS-D, it would be advisable to monitor the follow-up studies and results that occur with eluxadoline and possibly reconsider this in the future for use in patients that present with persistent irritable bowel syndrome induced diarrhea. The unknown cost of the medication at the current time, potential unknown side effect profile, potential for abuse leading to dependency and the drug interaction profile make eluxadoline a high-risk drug until a prescribing history can be established. While clinical trials regarding eluxadoline show minimal risk, the use of eluxadoline in the inpatient setting was not examined thoroughly. Most of the studies focused on outpatient individuals for a relatively short amount of time. The benefits of eluxadoline have not shown to be remarkably superior to other treatment options, and the availability of generic substitutes for current treatment make eluxadoline superiority inconclusive. Although eluxadoline did prove to be efficacious in test, it should be used on a limited basis at this time until further prescribing parameters and a safety profile are established.

Conclusion The mixed opioid receptor activity of eluxadoline has shown to be effective in treating patients with irritable bowel syndrome diarrhea.1 It does, however, have potential risks, including pancreatitis, drug dependence (schedule pending DEA review) and multiple drug interactions with commonly prescribed medications.6 One of the major benefits of eluxadoline is that it eliminates polypharmacy* for IBS-D. The patient may only need to take one drug for symptom control as opposed to taking multiple medications to control symptoms. Clinical trials demonstrated that once prescribing guidelines and long term safety are established, it could potentially be a major breakthrough for sufferers of irritable bowel syndrome induced diarrhea. The medication has shown both advantages and disadvantages and is a viable option for patients who have exhausted more economically feasible options with no relief. TABLE 5. GLOSSARY OF TERMS TABLE

References

1. Actavis Receives FDA Approval for VIBERZI (eluxadoline) for the Treatment of Irritable Bowel Syndrome. (n.d.). Retrieved July 6, 2015. 2. Bokic T, Storr M, Schicho R. Potential Causes and Present Pharmacotherapy of Irritable Bowel Syndrome: An Overview. Pharmacology. 2015 Jul 1;96(1-2):76-85. 3. Davenport JM, et al. Effect of uptake transporters OAT3 and OATP1B1 and efflux transporter MRP2 on the pharmacokinetics of eluxadoline. J Clin Pharmacol. 2014 Dec 10. 4. Dove LS, Lembo A, Randall CW, Fogel R, Andrae D, Davenport JM, McIntyre G, Almenoff JS, Covington PS. Eluxadoline benefits patients with irritable bowel syndrome with diarrhea in a phase 2 study. Gastroenterology. 2013 Aug;145(2):329-38.e1. 5. Covington P, Andre D, Davenport M, et al. Eluxadoline for the treatment of diarrhea-predominant irritable bowel syndrome: results of 2 randomized, double-blind, placebo-controlled phase III clinical trials of efficacy and safety. Presented as part of Digestive Disease Week; May 3–6, 2014; Chicago, Illinois. Available at http://files.shareholder.com/downloads/ABEA4H9PM3/3238878290x0x752274/f0470ebb-e052-4c0c-ad2923093ccbc694/View%20presentation. Accessed July 4, 2015. 6. Fujita W, et al. Molecular characterization of eluxadoline as a potential ligand targeting mu-delta opioid receptor heteromers. Biochem Pharmacol. 2014 Dec 1;92(3):448-56. 7. Highlights of Prescribing Information. (n.d.). Retrieved July 6, 2015, from http://www.actavis.com/Actavis/media/ PDFDocuments/VIBERZI_PI.pdf

Rome III Criteria

A diagnostic system developed to classify functional gastrointestinal disorders (FGIDs), such as irritable bowel syndrome.

Bristol stool score

A medical tool created to classify the form of feces into seven categories.

Global symptom score

An overall symptom scale that uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem.

Sphincter of Oddi dysfunction

A condition where the sphincter muscle does not properly open, which prevents bile and pancreatic juice from flowing through and causes a backup of digestive juices.

Diverticulitis

Inflammation in one or more small pouches forming the wall of the colon in the digestive tract.

Cholecystectomy

Surgical removal of the gallbladder

Impaction

A solid, immobile bulk of feces that develops in the rectum as a result of chronic constipation.

• DOH Investigations

Sequelae

A condition that results due to a previous disease or injury.

• Medicare/Medicaid Defense

Polypharmacy

The use of four or more medications by a patient.

• Contract Litigation

Representing Health Care Professionals

• Licensure Discipline • Administrative Hearings George F. Indest III, J.D., M.P.A., LL.M.

1101 Douglas Avenue Altamonte Springs, FL 32714 Telephone: (407) 331-6620 www.TheHealthLawFirm.com

FEBRUARY 2016

HELP SUPPORT THE ADOPT-A-STUDENT PROGRAM Florida Pharmacy Association (FPA) 126th Annual Meeting & Convention June 30-July 3, 2016 Marriott Harbor Beach Resort & Spa – Ft. Lauderdale, Florida Again this year, students from Florida Colleges of Pharmacy will be “Adopted” for the FPA Annual Meeting and Convention. Pharmacy students will benefit from the interaction with practicing pharmacists, learn first hand how FPA actually operates and how they can become involved in their chosen profession. As you remember, college students are on a tight budget and most of them cannot afford to attend convention. Here is how you can help! Be a Bronze, Silver or Gold Sponsor! The donation amounts are Bronze ($150), Silver ($250), and Gold ($500) Level Mentor Sponsors and will help offset the costs of the AAS program. You also have the option to give any amount you prefer. The FPA offers Adopted students complimentary registration, which includes tickets to the Exhibit Hall, Student Luncheon, Awards Banquet, President’s Breakfast, hotel accommodations for 3 nights at the host hotel, and special programs designed for them. Your generous support of the FPA’s programs and services are keys to our success in advocating for our profession, supporting our pharmacy students and promoting quality patient care services. Thank you for giving back to your profession. Make a contribution yourself, ask your local unit association or get together with friends to Adopt-A-Student. Remember, these are the future leaders of pharmacy! Mentor Program. Each of the adopted students will be assigned a pharmacist who may invite them to attend meetings, CE programs, and share their knowledge and pharmacy experience with them. If you plan to attend the convention and would like to be a mentor, please contact the FPA office. Please donate online or complete the form below and fax or mail with your check to: Florida Pharmacy Association 610 North Adams Street Tallahassee, FL 32301 Fax: (850)561-6758 Please make your check payable to the Florida Pharmacy Foundation Sponsor Name: _________________________________________________________________________ Address: ______________________________________________________________________________ City: _______________________________________ State: __________ Zip: _______________________ Phone: ____________________________________ Amount of Contribution: _______________________ Charge to the following (please circle): AMEX

DISCOVER

MASTERCARD

VISA

Account #:_____________________________________Security Code: ________ Exp. Date: __________ Signature: _____________________________________________________________________________ q Yes, I would like to serve as a Mentor. q Contact me with more information on Mentoring. Contributions to the Florida Pharmacy Association Foundation are tax deductible as a charitable contribution for federal income tax purposes. Consult your CPA for complete details. 16

FLORIDA PHARMACY TODAY

FPA News & Notes 2016 Pharmacist Legislative Days a Success On Jan. 19-20, 2016, Florida’s capital city was visited by nearly 350 pharmacist, student and pharmacy technician advocates. During this two-day event, there was a briefing on various pharmacy issues being considered by the Legislature, numerous visits with legislators at the Capitol and tours of the Capitol Museum and Governor’s Mansion. Participants also connected at the FPA office for a reception on Jan. 19. This event was facilitated to help educate members of the Florida House and Senate and their staff on the important role that pharmacists play in health care. Access to Pharmacist Services Act Legislation Shelved HB 547, sponsored by Representative Narain, is currently tabled with SB 692, sponsored by Senator Grimsley, withdrawn from consideration. These bills, if approved by the Legislature and signed into law by the governor, would have clarified many of the services that pharmacists in this state could provide, including health and wellness, medication therapy management and the ability to initiate, modify and discontinue prescription drug therapy under a collaborative arrangement with a physician. These bills, supported by both FPA and FSHP, are being withdrawn from further consideration this session at the request of FSHP to allow for our organizations to dialog with the leadership of the Florida Medical Association and address their concerns. Two Hour Controlled Substance CE Available from FPA New Board of Pharmacy rules require Florida licensed pharmacists to complete an approved CE program related to controlled substance dispensing by the end of the current biennial renewal period (September 2017). The rule was revised substantially as a result of several months of discussions within the Controlled Substance Standards Committee during which a considerable amount of public testimony was heard on access issues. Elements of the CE program must be related to prescription validation processes for controlled substances and should include the following: 1. Ensuring access to controlled substances for all patients with a valid prescription; 2. Use of the Prescription Drug Monitoring Program’s Database; 3. Assessment of prescriptions for appropriate therapeutic value;

4. Detection of prescriptions not based on a legitimate medical purpose; and, 5. The laws and rules related to the prescribing and dispensing of controlled substances. The Florida Pharmacy Association presented its first program at January’s law conference in Sandestin and will be making it available at each of our conferences statewide as well as the annual meeting in Ft. Lauderdale and the Southeastern Gathering in Sandestin this coming August. The program will need to be completed once each biennial renewal period and can be included in the 30 hours of CE for the “PS” license. We hope to have a home study program available in the near future, so continue to watch Stat News, Florida Pharmacy Today and the FPA website for more information. Broward County Pharmacy Student Receives National Scholarship The America n Pharmacists Association Foundation announced that FPA student member Farima Fakheri Raof will be the recipient of the Gloria Francke scholarship. Student scholarships are awarded to recognize exceptional demonstration of leadership skills and academics through active involvement in the APhA Academy of Student Pharmacists (APhA-ASP). The recipients will be recognized at the APhA Foundation Contributors’ Breakfast during the 2016 APhA Annual Meeting and Exposition in Baltimore on Monday, March 7. A video will honor the recipients during the APhA-ASP Opening General Session on Friday, March 4. The scholarships recognize those students who choose to invest their time through active involvement in their school’s APhA-ASP chapter. These exceptional students help shape the future of the pharmacy profession while managing the demands of a full-time curriculum. Raof is an FPA member and student at Nova Southeastern University College of Pharmacy in Davie, Fla., and is president of their APhA-ASP chapter. She is an active member of the FPA Student Affairs Council.

FEBRUARY 2016

Florida Pharmacy Foundation News Tampa Pharmacy Student Winner of FPA Student Leadership Scholarship University of South Florida student and FPA member Benjamin Groves is the recipient of the 2016 FPA Terry Gubbins Student Leadership Scholarship. This prestigious award recognizes Ben’s involvement in FPA as well as school and community activities and his demonstrated sense of passion for the profession. Groves is originally from Port Orange, Fla., and is

a third-year pharmacy student at the USF College of Pharmacy in Tampa. Groves has been very active with FPA, currently serving as a member of the Public Affairs Council. He previously served on the Organization Affairs Council and as a Florida Legislative Days Health Fair liaison. He remains active on campus, serving as chapter president for APhA-ASP at USF College of Pharmacy, vice-president of operations of the Delta Mu Chapter of Phi Lambda Sigma Pharmacy Leadership Society, and as a student delegate. Upon graduation, he plans to pursue a combined, two-year healthsystem pharmacy administration residency with a master’s degree. Groves extends his sincere appreciation to the Florida Pharmacy Association and Terry Gubbins for their continued support of the profession of pharmacy and their investment into future pharmacy leaders. The Terry Gubbins Student Leadership award, established in 2014 by Terry Gubbins, former FPA Chairman of the Board, recognizes and celebrates outstanding leadership through school activities, public service and community as well as professional involvement. The Terry Gubbins Student Leadership Scholarship is given once a year at the Florida Pharmacists Legislative Days, where the recipient is recognized with a $1,000 check and a plaque.

Maitland Pharmacist Elected as FPA President-Elect Pharmacist Suzanne Wise of Maitland was elected president-elect of the Florida Pharmacy Association. Wise will begin her term as president-elect at the 126th Annual Meeting and Convention on July 3, 2016, at the Harbor Beach Marriott Resort and Spa in Ft. Lauderdale. Wise earned her PharmD and MBA from the University of Florida in 2009. She has been an active member of FPA since 2004. She has held various leadership positions in both the FPA and the America Pharmacists Association. Wise also serves as a mentor and preceptor for pharmacy students as a University of Florida College of Pharmacy adjunct faculty member. In 2010, she was awarded the FPA Distinguished Young Pharmacist of the Year, and in 2012, Suzy was recognized with an Outstanding Young Alumni Award from the University of Florida. “The profession of pharmacy is ever-changing, which provides Florida pharmacists an opportunity to shape the future of the profession and healthcare in Florida,” said Wise. “The key to continuing to drive positive change in the profession is the involvement of the members of the Florida Pharmacy Association. As your president-elect, I will work to increase not only FPA membership, but member engagement. Together, we can increase the involvement of pharmacists, student pharmacists and technicians in defining the future of pharmacy.”

FLORIDA PHARMACY TODAY

“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

FEBRUARY 2016

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

FLORIDA PHARMACY TODAY

FPA Member Profile

Peggyann Zaenger, BS, PharmD

THE STATS Hometown: Toledo, Ohio Employer: Halliday’s & Koivisto’s Pharmacy, Jacksonville (Retiring 2/29/2016)

Why do you value your FPA Membership? Access to timely information, quality CEs and comradery of pharmacists from all walks of practice.

What are some thoughts you have on pharmacy as a profession right now? I would still choose pharmacy as my profession. I practiced in academia for the majority of my professional years. Tremendous opportunities for daily personal education. I do not believe that our profession is still the No. 1 respected profession.

What are you most excited about regarding the future of pharmacy? Ability to receive payment for counseling activities.

What do you wish everybody knew about pharmacy? How long a pharmacist studies at the college level, plus the large number of hours required each year to remain active. Also that pharmacists don’t set the cost of the majority of filled prescriptions. Copays are dictated by insurers.

What got you interested in pharmacy in the first place?

My mom was a registered nurse working as an IV therapist as part of a hospital pharmacy. Lots of pharmacists hung out at my childhood home. I listened to them talk about what they did and wanted to do what they did. They all loved their jobs.

What do you think your patients would say about you and your practice? They like that I will always take time to answer their questions. I will not let them buy products that I feel are not appropriate for them. That they love when I make home visits.

What is the most humorous thing that has ever happened to you? Being roasted and toasted by 30 physicians when I retired from 28 years as the associate director of a family practice residency program.

FEBRUARY 2016

CALL FOR ABSTRACTS FOR POSTER PRESENTATIONS For Florida Pharmacy Students

FLORIDA PHARMACY ASSOCIATION 126th ANNUAL MEETING AND CONVENTION

June 29-July 3, 2016 Marriott Harbor Beach Resort & Spa ♦ Ft. Lauderdale, Florida Poster Session: Friday, July 1, 2016 ♦ 11:00AM-1:00PM

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:

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 22

FLORIDA PHARMACY TODAY

FEBRUARY 2016

FLORIDA PHARMACY TODAY

FEBRUARY 2016

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.

FLORIDA PHARMACY TODAY

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.

A W A R D S

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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:

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

FEBRUARY 2016

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”

FEBRUARY 2016