April 2021 Florida Pharmacy Today

The Official Publication Of The Florida Pharmacy Association APR. 2021

RUXOLITINIB (JAKAFI®) FOR TREATMENT OF STEROID-REFRACTORY ACUTE GRAFT-VERSUS-HOST DISEASE IN ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER

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florida PHARMACY TODAY Departments 4 Calendar 4 Advertisers

VOL. 84 | NO. 4 APRIL 2021 THE OFFICIAL PUBLICATION OF THE FLORIDA PHARMACY ASSOCIATION

Features

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5 Executive Insight 6 Call for Resolutions 14 Call for Abstracts

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Ruxolitinib (Jakafi®) For Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease In Adult and Pediatric Patients 12 Years and Older

The 131st Annual Florida Pharmacy Association Meeting and Convention

APRIL 2021

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Mission Statements:

FPA Calendar 2021

Florida Pharmacy Today Journal MAY 9

JULY

Last day to submit resolutions to the House of Delegates

15-16 Clinical Conference

5

FPA Office Closed for Independence Day

7-11

131st Annual FPA Meeting and Convention Ponte Vedra

24 - 25 NASPA Leadership Conference 31

Memorial Day - FPA office Closed JUNE

8

Last day to submit items of new business to the House of Delegates

8

Last day to register for the House of Delegates summer session

9-10

Board of Pharmacy Meeting Orlando

AUGUST 1-4

38th Annual SE Gatherin, Henderson Beach Spa and Resort Destin

22

FPA Board of Directors Meeting

FOR A COMPLETE CALENDAR OF EVENTS GO TO WWW.FLORIDAPHARMACY.ORG

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 two-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 Sept. 30, 2021, or prior to licensure renewal. Consultant pharmacists and technicians will need to renew their licenses and registrations by Dec. 31, 2022.

For the 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.floridapharmacy.org CONTACTS FPA — Michael Jackson (850) 222-2400

FSHP — Tamekia Bennett (850) 906-9333 UF — Emely McKitrick (352) 273-5169

The Florida Pharmacy Today Journal is a peer-reviewed journal which serves as a medium through which the Florida Pharmacy Association can communicate with the profession on advances in the sciences of pharmacy, socio-economic issues bearing on pharmacy and newsworthy items of interest to the profession. As a self-supported journal, it solicits and accepts advertising congruent with its expressed mission.

Florida Pharmacy Today Board of Directors The mission of the Florida Pharmacy Today Board of Directors is to serve in an advisory capacity to the managing editor and executive editor of the Florida Pharmacy Today Journal in the establishment and interpretation of the Journal’s policies and the management of the Journal’s fiscal responsibilities. The Board of Directors also serves to motivate the Florida Pharmacy Association members to secure appropriate advertising to assist the Journal in its goal of self-support.

Advertisers APMS..................................................................... 7 KAHAN............................................................... 10 MICRO MERCHANTS........................................ 2 PQC...................................................................... 20 PHARMACISTS MUTUAL.............................. 17

Note: The views of the authors do not necessarily represent the views or NSU — Carsten Evans (954) 262-1300 opinions of the Florida Pharmacy Association, Florida Pharmacy Today or any related entities.

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.

FAMU — Dr. Selika Sampson (850) 599-3301

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FLORIDA PHARMACY TODAY

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Executive Insight

BY MICHAEL JACKSON, RPH MICHAEL JACKSON, BPHARM, EVP & CEO, FLORIDA PHARMACY ASSOCIATION

F

There is No Doubt.

This Profession is Ready and Able

or a number of years we have preached and advocated to anyone listening that the profession of pharmacy is considerably more than what is perceived by the public. We are not just purveyors of product. We are health care providers who make a difference every day in the lives of the patients that we serve.

No one can question anymore the qualifications of a pharmacist and what they can do to help improve health quality and save costs. Regardless of what society may think, we have now proven that pharmacists are essential health care providers.

Take for example the current pandemic that we are still fighting through.

When many health facilities, businesses and entertainment venues sealed their entrances or transitioned to digital services, pharmacies were still providing full service, face-to-face care.

Our colleagues extended their vast skills to assist with COVID-19 testing and vaccine administration. It is very clear that the other side of the pandemic, that we are working to get to, will come from what our state’s pharmacists will be asked to do today. That has been proven in several states who commissioned their pharmacists to be vaccination centers.

Last year, the Florida Legislature, after many years of resistance, made aggressive changes in the Pharmacy Practice Act opening new pathways for patient care services by pharmacists. Our colleagues have been given a wonderful opportunity to transition our practice beyond our wildest dreams to levels of care that we have been trained to provide. All it takes is completion of approved training programs that are under development.

I can share with you my own personal experience with my pharmacist and technician colleagues who left no doubt that we belong on the patient care frontline and not just an afterthought.

This month while beginning my presentation and legislative update in Tampa, I experienced a medical emergency. I was about 25% into my lecture, felt lightheaded and in the next moment woke up on the floor of the meeting ballroom looking up at the ceiling. I was surrounded by FPA leadership, pharmacists and technicians who rushed to my side to assist. I was told that CPR was performed as a precaution as there was no pulse.

I am convinced that the action of these volunteer pharmacists and technician members were instrumental in helping me to recover. They took immediate action without hesitation and without fear and used their training and experience to help their association manager to get back on his feet.

The story doesn’t end there as I was transported to St. Joe’s Hospital for observation. I applaud the team at St. Joe’s for their professionalism and their hard work to continue to address my medical crisis. I was excited to see a representative from the hospital pharmacy in the emergency room perform a pharmacy consultation with me. This is how coordinated care works best, with interdisciplinary collaboration among health care providers.

To all the pharmacists attending our April Tampa meeting and also participating by our streamed webinar, I can share with you that because of your care and your concerns, I am recovering nicely back here in Tallahassee. To our great FPA staff that kept our conference going in my absence, a special acknowledgment of thanks for your dedication to the

Michael Jackson, B.Pharm

FPA. To our other members who heard about what happened to me in Tampa and have reached out with your concerns and prayers, I send a general note of thanks and appreciation. I am the son of a former Western Pennsylvania steelworker and am made of some really tuff stuff.

This experience convinces me that there is no question that this profession is ready and able to take on any health care role that we have been trained for.

I challenge anyone who says otherwise.

Congress will now have an opportunity to recognize pharmacists by supporting a new bill designating us as providers. The Congressional House of Delegates has just received The Pharmacy and Medically Underserved Areas Enhancement Act. Ask your congressman to support this legislation. The FPA has fought for provider status recognition, and you all have proven it is earned and deserved. n APRIL 2021

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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

Continuing Education Coordinator 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.................................... Eric Jakab, Gainesville Secretary............................. Julie Burger, Pensacola Member.........................Michael Finnick, Jacksonville Member.............David Mackarey, Boynton Beach Member....................................... Matt Schneller, Tampa Member............................Teresa Tomerlin, Rockledge Member...................................... Greta Pelegrin, Hialeah Technician Member..........Julie Burger, Pensacola Executive Editor.......Michael Jackson, Tallahassee Managing Editor...................Dave Fiore, Tallahassee Journal Reviewer........................... Dr. Melissa Ruble Journal Reviewer....................................Dr. Angela Hill This is a peer-reviewed publication. . ©2021 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 ASSOCIATION

610 N. Adams St. • Tallahassee, FL 32301 850/222-2400 • FAX 850/561-6758 Web address: www.floridapharmacy.org.

CALL FOR RESOLUTIONS TO THE 2021 HOUSE OF DELEGATES The House of Delegates Board of Directors will meet in May 2021 to review and approve resolutions for the Annual Meeting. The deadline for submitting resolutions is May 9, 2021! PLEASE NOTE THIS DEADLINE. The last day to submit items of new business is June 8, 2021.

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

Protect your patients.

Protect your pharmacy.

ERR ORS C A N I NJ U R E PATIE NTS AND P U T YO UR PHAR M ACY I N F IN AN C IAL J EOPAR DY.

The PQC+ QA program can improve efficiency and increase patient safety as well as help you meet accreditation, credentialing, PBM and state Quality Assurance requirements.

• Training, Quality Assurance CE, and resources • Patient Safety Organization protection for your QA work • Practical tools to collect and analyze patient safety data

Learn more at www.medicationsafety.org or call us at (866) 365-7472.

The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

Ruxolitinib (Jakafi®) For Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease In Adult and Pediatric Patients 12 Years and Older

Gervin Robertson, Pharm.D., MBA, MHA

Cynthia R. Hall, Pharm.D., J.D., M.S.

Gervin Robertson, Pharm.D., MBA, MHA, Division Director of Pharmacy Services Cynthia R. Hall, Pharm.D., J.D., M.S. (Health Care Ethics), Assistant Professor of Pharmacy Practice Wender Beldor, Pharm.D., John Cunningham, Pharm.D., Martina Nasri, Pharm.D., Austin Smith, Pharm.D., Samuel Wells, Pharm.D. Drs. Beldor, Cunningham, Nasri, Smith, and Wells were Doctor of Pharmacy Candidates at the writing of this manuscript.

Florida A&M University College of Pharmacy and Pharmaceutical Sciences 153 W. Woodruff Ave. Crestview, Fl 32539 850-599-3369 cynthia.hall@famu.edu Please send all correspondence to gervin.robertson@famu.edu 8 |

FLORIDA PHARMACY TODAY

Introduction Specialty therapeutic agents continue to evolve and advance the options for the management of rare diseases which have been neglected as a part of pharmaceutical research and development.

Currently, innovative technological advancements have made drug discovery more appealing in the rare diseases’ spectrum. Regulators continue to incentivize researchers to pursue unmet needs, new drug targets are increasingly being found, and the industry is investing greater resources in rare disease research with many positive results. As the pharmacies of the future are becoming more prevalently specialty in nature and accessible, the role of the pharmacist and education directed toward specialty product advancement must meet the demand. The increasing patient outcomes as represented by new drugs and indications, need for improved ambulatory clinical management, and increasing financial impact of specialty drugs necessitates the following introduction of a new indication on an older drug used for a rare disease state.

Graft-versus-host disease (GVHD) is a condition that can occur after allogeneic hematopoietic stem cell transplantation in patients with hematologic malignancies.1 Allogeneic transplantation involves the transfer of cells from a donor to a recipient. GVHD occurs when the cells from a donor see the cells of the recipient as foreign and attacks them.1,2 GVHD is one of the leading causes of adverse events and death post-allogeneic stem cell transplant.2 There are two main categories of GVHD: acute graft-versus-host disease (aGVHD) and chronic graft-versus-host disease

(cGVHD).1-3 Some patients may develop one type, both types, or neither, but cGVHD is more likely to occur when a patient develops aGVHD initially.

Acute GVHD is defined as GVHD occurring within 100 days after transplant. 2 The symptoms experienced may include: rash, burning and redness of the skin, nausea, vomiting, abdominal cramps, loss of appetite, jaundice.1,2 Chronic GVHD occurs after 100 days, and even months or years the transplant and may involve serious effects adversely affecting a patient’s skin, gut, liver, mouth, eyes, lungs, joints, and genitalia.2,3 It is estimated that up to 70% of transplant recipients will develop aGVHD and 40% develop cGVHD post-transplant.4 Risk factors for aGVHD include HLA mismatch, use of stem cells from peripheral-blood instead of bone marrow, use of an unrelated donor or a donor of a different sex.1,3,4 Acute GVHD is graded based on severity of symptomatology. Grade I represents the mild form of aGVHD and is generally treated with topical steroids.3,5,6 Grade II is considered moderate, Grade III is severe, and Grade IV is very severe. Grades II-IV are treated with systemic steroids and other immunosuppressant agents.3,5,6 Grades II-IV aGVHD are initially treated with glucocorticoid therapy such as methylprednisolone or prednisone.5-7 However, resistance to steroids may occur, and when it does, prognosis is usually poor with survival rates ranging from 5 to 30%.3 Other immune-suppressing drugs must be added when response is inadequate to corticosteroids. These drugs included antithymocyte globulin, my-

cophenolate mofetil, tacrolimus, daclizumab, etanercept, and thalidomide, among others.5-7 However, no second line therapy had been recommended over another in the treatment of steroid-refractory aGVHD.5 This review will discuss the safety and effectiveness of ruxolitinib (Jakafi®, Incyte) approved in 2019 by the Food and Drug Administration for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.

Pharmacology and Pharmacodynamics Ruxolitinib is classified as a kinase inhibitor.8,9 As an inhibitor of Janus Associated Kinases (JAK1/JAK2), ruxolitinib mediates various cytokines and growth factors involved in immune functioning and in the formation of blood cells from stem cells.9 Spoerl et al. demonstrated in a mouse model of aGVHD that ruxolitinib inhibits STAT3 phosphorylation.8 STAT3 induces the proliferation of proinflammatory cytokines important for GVHD pathogenesis.8 Thus, Ruxolitinib, through the regulation of the JAK-STAT signaling pathway, plays a role in decreasing the expression of cytokines and immune-cell infiltrates leading to improved symptomatology and improved organ functioning in GVHD.8,9 Pharmacokinetics A summary of pharmacokinetic for concomitant use is listed in Table 1.

Table 1

Absorption

■ ■ ■

Tmax: 1 to 2 hours Bioavailability (oral): 95% Effect of Food: No effect on absorption

Distribution

■

Protein Binding (albumin): 97%

Metabolism

■

Primarily via CYP3A4 2 Active Metabolites 1 Major Metabolite Substrate of CYP3A and CYP2C9

■ ■ ■

Excretion

■ ■ ■ ■ ■

Elimination Half Life

■ ■

Renal: 74% (mostly as metabolites) Fecal: 22% (mostly as metabolites) Dialyzable: No (hemodialysis) Total Body Clearance: 11.9 L/hr (acute graft-versus-host disease) Ruxolitinib: 3 hours Ruxolitinib plus metabolites: 5.8 hours

Mean ruxolitinib maximal plasma concentrations (Cmax) and AUC increased proportionally over a single dose range of 5 mg to 200 mg. Mean ruxolitinib Cmax ranged from 205 nM to 7,100 nM and AUC ranged from 862 nM*hr to 30,700 nM*hr over a single dose range. The AUC of ruxolitinib and its active metabolites increased by 1.6-fold in subjects with

RISK FACTORS FOR AGVHD INCLUDE HLA MISMATCH, USE OF STEM CELLS FROM PERIPHERAL-BLOOD INSTEAD OF BONE MARROW, USE OF AN UNRELATED DONOR OR A DONOR OF A DIFFERENT SEX. ESRD after dialysis compared with normal renal function (CrCl 90mL/min or greater).9 Following oral administration of a single dose of ruxolitinib 25mg, the AUC of ruxolitinib increased in subjects with mild impairment (Child-Pugh A) by 1.9-fold, moderate impairment (Child-Pugh B) by 1.3-fold, and severe impairment (Child-Pugh C) hepatic impairment by 1.7fold compared with normal hepatic function. Following oral administration of a single dose of ruxolitinib 25 mg, the total AUC of ruxolitinib and its active metabolites increased by 1.3, 1.5-, and 1.9-fold in subjects with mild, moderate, and severe renal impairment.9 The absorption of ruxolitinib achieves Cmax within one to two hours post-dose. The oral absorption of ruxolitinib is estimated to be at least 95% according to a mass balance study in humans. There were no clinically relevant changes in absorption from administration of ruxolitinib with a high-fat, high calorie meal (approximately 800 to 1,000 calories of which 50% were derived from fat).9 Ruxolitinib may be administered with or without food. Ruxolitinib is not removed by dialysis; however some active metabolites of ruxolitinib may be removed by the process. Administer ruxolitinib only after dialysis. Hemodialysis is not expected to enhance the elimination of ruxolitinib.9 Clinical Efficacy A study was conducted in order to determine the efficacy of ruxolitinib with patients presenting with Steroid-Refractory Acute Graft-Versus-Host Disease. This study is known as the REACH1 trial and it was an open-label, single-cohort, multicenter study of ruxolitinib for the treatment of patients with steroid-refractory acute GVHD Grades 2 to 4 occurring after allogeneic hematopoietic stem cell transplantation.11 Ruxolitinib was administered at a dose of 5mg twice daily, and the dose could be increased to 10mg twice daily after 3 days in the absence of toxicity.11 The primary endpoint was overall response rate (ORR) at Day-28, defined as the proportion of patients having complete response (CR), very good partial response, or partial response (PR). The key secondary endpoint of the REACH1 trial was 6-month duration of response, defined as the time from first response to GVHD progression or death.11 In this first prospective trial of ruxolitinib in patients presenting with Steroid-Refractory aGVHD, treatment with ruxolitinib resulted in an overall response in 54.9% of patients

by Day-28.11 The best overall response rate (ORR) at any time was 73.2%.11 The Day-28 overall response rate (ORR) for paAPRIL 2021

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tients with Grade 2 SR aGVHD was 100%, for Grade 3 SR aGVHD the ORR was 40.7%, for Grade 4 SR aGVHD the ORR was 44.4%. The median duration of response, calculated from Day-28 response to progression (progression defined as worsening by one stage in any organ without improvement in other organs in comparison to prior response assessment) was 16 days.11 The median time from Day-28 response to either death or the need for a new treatment for aGVHD was 173 days.11 The responses to ruxolitinib were rapid and strong; allowing most patients to achieve a sustained reduction to their corticosteroid dose. The adverse effect profiles of the patients were consistent with expectations for SR aGVHD and the use of ruxolitinib. The conclusion of the trial found that ruxolitinib represented a promising therapeutic strategy for the management of patients presenting with SR aGVHD. A new phase 3 trial is underway to determine the efficacy of ruxolitinib versus the best available therapy for the treatment of SR aGVHD.11 Common Adverse Events In patients that have graft-versus-host disease, the most common adverse effect is hematological related and includes thrombocytopenia and anemia. The incidence rate of these adverse effects is greater than 20%, so it is imperative to make to make a note of this when considering ruxolitinib.12 The most common non-hematological adverse effects are bruising, dizziness, and headache. The incidence rate of these adverse

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effects is greater than 10%. For patients that have acute graft versus host disease, the most common adverse effects that is hematological are anemia, thrombocytopenia, and neutropenia.12 These adverse effects have a high incidence rate of greater than 50%. Lastly, the most common non-hematologic adverse effects are infections and edema. The incidence rate of these adverse effects is also greater than 50%.

Hypersensitivity Reactions Reactions indicative of a hypersensitivity reaction such as hives, difficulty breathing, angioedema, or swelling of the throat have occurred. Ruxolitinib should be discontinued immediately if one of these clinically significant reactions develop.

Immunogenicity No studies have shown immunogenicity in patients taking ruxolitinib.

Contraindications Ruxolitinib has no contraindications.

Precautions Before a patient begins ruxolitinib it is pertinent to make sure the patient does not have any hematological conditions such as thrombocytopenia, anemia, or neutropenia.14 You can manage these conditions by dose reduction, or interruption, or transfusion. There is a risk of infection while on ruxolitinib.

We need to assess the patient for signs of infection and initiate appropriate treatment. Serious infections should be resolved before starting therapy. If a patient were to interrupt therapy due to one of the conditions aforementioned or if complete discontinuation were to occur, we would manage with supportive care and consider resuming treatment. There is a risk of non-melanoma skin cancer, so it is best to perform periodic skin examination. Lipid elevations have also been seen. Assessing lipid levels every 8-12 weeks from the start of therapy as needed is recommended.14 Dosages A summary of dosing parameters are listed in table 2, table 3, and table 4.

Ruxolitnib comes in the following dosage strengths: ■ 5 mg tablets - round and white with “INCY” on one side and “5” on the other.14 ■ 10 mg tablets - round and white with “INCY” on one side and “10” on the other.14 ■ 15 mg tablets - oval and white with “INCY” on one side and “15” on the other.14 ■ 20 mg tablets - capsule-shaped and white with “INCY” on one side and “20” on the other.14 ■ 25 mg tablets - oval and white with “INCY” on one side and “25” on the other.14 ■ Ruxolitnib needs to be stored at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)14

BEFORE A PATIENT BEGINS RUXOLITINIB IT IS PERTINENT TO MAKE SURE THE PATIENT DOES NOT HAVE ANY HEMATOLOGICAL CONDITIONS SUCH AS THROMBOCYTOPENIA, ANEMIA, OR NEUTROPENIA.

Table 3

Renal and Hepatic Impairment Dose Modifications for Renal Impairment14 Renal Impairment Status

Platelet Count

Recommended Starting Dosage

Moderate (CrCl 30 to 59 mL/min) or Severe (CrCl 15 to 29 mL/min)

Any

5 mg once daily

ESRD (CrCl less than 15 mL/min) on dialysis

Any

5 mg once after dialysis session

Patients with acute GVHD

Table 4

Dose Modifications for Hepatic Impairment14

Table 2

Acute Graft Versus Host Disease Dose Modification Guidelines for Patients with Acute Graft Versus Host Disease14 Laboratory Parameter

Dosing Recommendations

■

Clinically significant

■

Reduce dose by 1 dose level.

When platelets recover to previous values, dosing may return to prior dose level.

■

ANC less than 1 × 109/L considered related to ruxolitinib

■

Hold ruxolitinib for up to 14 days; resume at 1 dose level lower upon recovery.

■

Total Bilirubin elevation, no liver GVHD

■

3.0−5.0 × ULN: Continue ruxolitinib at 1 dose level lower until recovery. >5.0−10.0 × ULN: Hold ruxolitinib for up to 14 days until bilirubin ≤ 1.5 × ULN; resume at current dose upon recovery.

Total bilirubin > 10.0 × ULN: Hold ruxolitinib for up to 14 days until bilirubin ≤ 1.5 × ULN; resume at 1 dose level lower upon recovery.

■

■

■

■

Total Bilirubin elevation, liver GVHD

■

>3.0 × ULN: Continue ruxolitinib at 1 dose level lower until recovery.

Hepatic Impairment Status

Platelet Count

Recommended Starting Dosage

Patients with acute GVHD Mild, Moderate, or Severe based on NCI criteria

Any

No dose modification needed

Any

Monitor blood counts more frequently for toxicity and consider 5 mg once daily

Stage 3 or 4 liver GVHD

Ruxolitinib is dosed orally and can be administered with or without food. If a dose is missed, the patient should not take an additional dose but should resume at the next scheduled dose. If patients are unable to ingest tablets, ruxolitinib can be administered through a nasogastric tube by suspending one tablet in approximately 40 mL of water with stirring for approximately 10 minutes.14 Within 6 hours after the tablet has dispersed, the suspension can be administered through a nasogastric tube using an appropriate syringe. The tube should be rinsed with approximately 75 mL of water.14 Drug Interactions A summary of drug interactions is listed in table 5.

Ruxolitinib has interactions with strong CYP3A4 inhibitors or fluconazole. When on both fluconazole and ruxolitinib, avoid doses of greater than 200 mg except in patients with graft-versus-host disease and adjust the dosage when on less than 200 mg of fluconazole.14 Table 5

Dose Modifications for Concomitant Use with Strong CYP3A4 Inhibitors or Fluconazole14 For patients with acute GVHD: Ketoconazole

5 mg once daily

Other CYP3A4 inhibitors

No dose adjustment

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Cost Ruxolitinib lowest dose is 5mg oral tablet twice a day which retails for over $13,500 for 60 tablets (1 month supply). A patient on this medication would be paying roughly $162,000 annually without any copay assistance.13 P&T Committee Considerations Ruxolitinib was the first drug approved to treat steroidrefractory graft-versus-host disease. Other treatments have been mostly supportive to control the symptoms of the disease. As one of the only drugs to treat this condition it is advantageous to have this drug available to help treat patients with this debilitating disease.15 Ruxolitinib also has the ability to lower symptom profiles of patients with graft-versus-host disease. Also, the drug can improve patient quality of life by increasing exercise tolerance and improving overall health.

The primary disadvantage of ruxolitinib it the risk of dose dependent thrombocytopenia. Though ruxolitinib has this very serious adverse effect, it can be avoided by individualizing the dose to the patient. Also, thrombocytopenia can be reversed after several weeks of the drug being discontinued.

Another disadvantage of the drug is the price with patients having to pay over $162,000 annually. However, the cost of the drug would make it hard to afford for most patients, so a cost benefit analysis should be performed.

Role of the Pharmacist The role of the pharmacist in GVHD specialty therapeutics management should bridge the continuity of care, with an emphasis on addressing gaps in the medication access process; thus, the pharmacist is involved with all aspects of patient care—from specialty pharmacy operations to clinical monitoring after initiation.

The pharmacist’s role in medication access is also pivotal in overseeing insurance coverage and medication dispensing, or prior authorization processes. The pharmacist can streamline the handoff from the health system to specialty pharmacy. In the event that insurance coverage cannot be obtained, the pharmacist is positioned to identify and discusses alternative options to another formulary agent or enrolling patients in the medication assistance program.

As the population of patients who require specialty pharmacy services through outpatient prescriptions increases and the therapies become more complex, the need for individuals who specialize in various areas of ambulatory pharmacy practice continue to grow. Innovative practice models for new specialized ambulatory clinical pharmacists must evolve, and the services provided must document the value of the pharmacist monitoring the continued efficacy, improved patient outcomes, and cost effectiveness to third party payors.

Conclusion This review was focused on the safety and effectiveness of ruxolitinib; a kinase inhibitor which was approved by the food and drug administration for the treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older in May 2019.1,9,13 Ruxolitinib is 12

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FLORIDA PHARMACY TODAY

dosed orally and can be administered with or without food, but it is an expensive medication. Ruxolitinib may be used for patients who have been off of a corticosteroid for 6 months.

When discontinuing ruxolitinib, it should be tapered off by one dose level approximately every 8 weeks and if signs or symptoms recur after discontinuation, then treatment options should be considered.13 References

1. Graft Versus Host Disease (GvHD). (n.d.). Accessed 11/14/2020 https://my.clevelandclinic.org/health/ diseases/10255-graft-vs-host-disease-an-overview-in-bonemarrow-transplant 2. Gknation. (2015, February 26). Graft-Versus-Host Disease.

Accessed 11/14/2020 https://www.lls.org/treatment/typesof-treatment/stem-cell-transplantation/graft-versus-hostdisease 3. Robert Zeiser, M.D., and Bruce R. Blazar, M.D.Acute Graftversus-Host Disease — Biologic Process, Prevention, and Therapy N Engl J Med 2017;377:2167-79. DOI: 10.1056/ NEJMra1609337 4. Tompa, R., & Fred Hutch News Service. (2015, April 21). Life with graft-vs.-host disease: When the transplant is just the beginning. Accessed 11/14/2020 https://www.fredhutch. org/en/news/center-news/2015/04/tackling-graft-vs-hostdisease.html 5. First- and Second-Line Systemic Treatment of Acute Graftversus-Host Disease: Recommendations of the American Society of Blood and Marrow Transplantation Paul J. Martin,1 J. Douglas Rizzo,2 John R. Wingard,3 Karen Ballen,4 Peter T. Curtin,5 Corey Cutler,6 Mark R. Litzow,7 Yago Nieto,8 Bipin N. Savani,9 Jeffrey R. Schriber,10 Paul J. Shaughnessy,11 Donna A. Wall,12 Paul A. Carpenter1 Biol Blood Marrow Transplant 18: 1150-1163 (2012) 2012 American Society for Blood and Marrow Transplantation https:// higherlogicdownload.s3.amazonaws.com/ASBMT/43a1f41f55cb-4c97-9e78-c03e867db505/UploadedImages/Systemic_ Treatment_of_aGVHD_.pdf 6. Diagnosis and management of acute graft-versus-host disease Fiona L. Dignan,1,2 Andrew Clark,3 Persis Amrolia,4 Jacqueline Cornish,5 Graham Jackson,6 Prem Mahendra,7 Julia J. Scarisbrick,8 Peter C. Taylor,9 Nedim Hadzic,10 Bronwen E. Shaw1,11 and Michael N. Potter1 o 2012 Blackwell Publishing Ltd, British Journal of Haematology http://content. guidelinecentral.com/guideline/get/pdf/3731 Accessed 11/14/2020 7. Stöppler, M. C. (n.d.). Graft Versus Host Disease Symptoms, Prognosis & GVHD Treatment. https://www.medicinenet. com/graft_versus_host_disease_gvhd/article.htm 8. Activity of therapeutic JAK 1/2 blockade in graft-versus-host disease 9. Silvia Spoerl, Nimitha R. Mathew, Michael Bscheider, Annette Schmitt-

131st Annual Meeting and Convention Schedule

July 7 – 11, 2021 Sawgrass Marriott Golf Resort & Spa 1000 PGA Tour Boulevard Ponte Vedra Beach, FL APRIL 2021

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Keynote Speaker Scott Knoer, MS, PharmD, FASHP, is the 13th Executive Vice President and Chief Executive Officer of the American Pharmacists Association. He received his BA in psychology from Creighton University in 1988 and his PharmD from the University of Nebraska in 1996. He completed a 2-year administrative residency with a concurrent MS degree in hospital pharmacy from the University of Kansas in 1998.

Before his current leadership role at APhA, Dr. Knoer was the Chief Pharmacy Officer at the Cleveland Clinic from 2011 to 2020, where he led an international pharmacy enterprise with a $1.4 billion dollar drug budget and 1,558 FTEs in 18 hospitals with facilities in Ohio, Florida, and Nevada; Toronto; London; and Abu Dhabi.

After graduation from pharmacy school, he was an Operations Manager at the University of Texas Medical Branch at Galveston for 3 years. Moving to Minnesota, he was the Director of Pharmacy at the University of Minnesota Medical Center, Fairview, for a decade before being recruited to the Cleveland Clinic in 2011.

Dr. Knoer has served the profession extensively through involvement in professional organizations at the local, state, and national levels. He is published widely on a variety of pharmacy and leadership topics. He is a frequent invited lecturer to state, national, and international audiences. He is often quoted as a health care expert on a broad array of topics in newspaper, radio, and television outlets.

Dr. Knoer is a passionate advocate for patients and the profession of pharmacy. He has successfully lobbied boards of pharmacy in Ohio and Minnesota to allow the advancement of pharmacy practice, and he has led initiatives that changed Ohio and federal law related to the elevation of pharmacy practice and reducing the impact of drug shortages.

Accommodations

ROOM RATES: $179 plus tax based on single/double occupancy. The room reservation deadline is Friday, June 11, 2021 or when room block is full.

Thereafter, reservations may be taken on a space available or rate available basis. There is an optional resort fee. Self-parking is discounted to $10 per day. Please be sure to ask for the Florida Pharmacy Association group rate. All reservations must be accompanied by a first night room deposit or guaranteed with a major credit card. The check-in time is 4:00pm and the checkout time is 11:00 am.

Social Distanced Special Events FPPC Reception: Attend this reception to support your Political Action Committee.

House of Delegates: Serving in the House of Delegates? Make sure you register!

President’s 250 Club: Contribute to the president’s club and be invited to a private reception.

Exhibits: Participate in the grand opening reception in the exhibit hall! Visit with exhibitors, introduce yourself, tell them you appreciate them and invite them back next year! The exhibitors are a very important part of FPA’s convention. Companies send their representatives to educate you about their products and services at great expense. Please show them your appreciation!

Poster Presentations: Browse submissions from all pharmacy professionals. Contact the FPA office for more information if you would like to submit a poster presentation.

Foundation Celebration Event: Recognize 2021 Foundation Donors and Student Award Recipients.

FIPN Breakfast: Enjoy breakfast with other Florida independent pharmacy owners. RSVP at 850-656-0100.

Awards Event: Honor outstanding practitioners during the awards presentation.

Installation of Officers: Attend the installation of NEW officers on Sunday morning!

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FLORIDA PHARMACY TODAY

Wednesday, July 7 2:00pm-4:00pm 4:00pm-5:00pm 5:00pm-6:00pm 6:00pm-7:00pm 7:00pm 7:30pm

FPA Registration Desk Opens HOD Board of Directors Meeting Florida Pharmacist Political Committee (FPPC) Meeting Budget & Finance Committee Meeting Florida Pharmacy Foundation Annual Meeting Florida Pharmacy Association Officer’s Meeting

Thursday, July 8 5 hrs of GCE/TECH 7:00am 7:30am 7:45am-9:15am

Registration Desk Opens Welcome and Introductions Education: 1.5 hrs GCE/TECH

Legislative Update 2021

Michael Jackson, BPharm, CPh, Executive Vice President and CEO, Florida Pharmacy Association Upon completion of this activity, pharmacists will be able to: Describe the recent and proposed changes to Florida laws related to the practice of pharmacy; Execute changes within the pharmacy to maintain compliance with current Florida laws; Explain how revisions to the pharmacy practice act and rules may help technicians in their efforts to support pharmacist services. UAN: 0165-0000-21-032-L03-P Upon completion of this activity, technicians will be able to: Recognize the recent and proposed changes to Florida laws related to the practice of pharmacy; Identify changes within the pharmacy to maintain compliance with current Florida laws; Explain how revisions to the pharmacy practice act and rules may help technicians in their efforts to support pharmacist services. UAN: 0165-0000-21-032-L03-T 8:00am-10:00am

Delegate Registration

9:20am-10:50am Education: 1.5 hr GCE/TECH New Drug Update 2020-2021 Shawn Bridley, PharmD, BCGP, CPh, cMTM, MHP, Board Certified Geriatric Pharmacist, Owner, Care Dynamics Senior Care Upon completion of this activity, pharmacists will be able to: Briefly discuss updated CDC Immunization recommendations; Describe the current information concerning newly FDA approved medications; Discuss (pharmacology, pharmacokinetics, efficacy and safety data, drug interactions, dosing, monitoring, and cost) in the selection of evidence-based pharmacotherapy. UAN: 0165-0000-21-033-L01-P Upon completion of this activity, technicians will be able to: Recognize new drugs released in 2020-2021; Identify indications of newly released drugs; Identify recommendations by the CDC for immunizations. UAN: 0165-0000-21-033-L01-T 11:00am-1:00pm

FPA House of Delegates and Annual Business Meeting

12:00pm-1:00pm

Lunch On Your Own

1:00pm-2:00pm

Education: 1 hr GCE/TECH

Bypassing Burnout: Establishing Resiliency as a Journey Instead of a Destination

Stacey D. Curtis, PharmD, Clinical Assistant Professor, Pharmacotherapy and Translational Research, University of Florida College of Pharmacy Upon completion of this activity, participants will be able to: Define the signs and symptoms of burnout; Describe methods to mitigate burnout and improve well-being; Discuss the characteristics of resiliency; Develop individual intentional practices to foster resiliency and well-being; Identify strategies that improve positive change within organizations to influence resiliency and well-being. UAN: 0165-0000-21-034-L04-P Upon completion of this activity, technicians will be able to: Define the signs and symptoms of burnout; Describe methods to mitigate burnout and improve well-being; Discuss the characteristics of resiliency; Develop individual intentional practices to foster resiliency and well-being; Identify strategies that improve positive change within organizations to influence resiliency and well-being. UAN: 0165-0000-21-034-L04-T 2:05pm-3:05pm

Education: 1 hr GCE/TECH

Keynote Address: Empowering Pharmacists to Care for Patients

Scott Knoer, M.S., Pharm.D., FASHP, Executive Vice President and CEO, American Pharmacists Association Upon completion of this activity, pharmacists will be able to: Identify significant disruptive innovations that will impact healthcare; Describe the need for payment reform and provider status at the national and state levels; Describe the importance of advocacy in professional advancement. UAN: 0165-0000-21-035-L04-P Upon completion of this activity, technicians will be able to: Identify significant disruptive innovations that will impact healthcare; Describe the importance of changing financial reimbursement models for pharmacy services; Describe the importance of technician certification. UAN: 0165-0000-21-035-L04-T 3:30pm-5:30pm

House of Delegates Reconvenes

6:00pm-7:00pm

FPPC RECEPTION

8:00pm

President’s 250 Club

CONTINUING EDUCATION CODE KEY:

GCE = General

RC = Recertification Consultant

TECHA=P RTechnician IL 2021

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Friday July 9 6 hrs GCE/TECH/RC 7:00am 7:45am-9:15am

Registration Desk Opens Education: 1.5 hrs GCE/TECH/RC

Pharmacist in Action During the COVID-19 Pandemic Crisis

Kathleen Jodoin, PharmD, BCPS, Pharmacy Clinical Coordinator, Mount Sinai Medical Center Upon completion of this activity, pharmacists will be able to: Discuss SARS-CoV-2 transmission and explain the severity of its progression; Describe the evolution of treatment options and identify emerging treatment strategies for COVID-19; Discuss the available COVID-19 vaccine options and high risk patient populations recommended for vaccination; Identify sedation strategies in the ICU that clinicians may utilize in the treatment of COVID-19 positive patients; Identify drug shortage challenges facing health-systems due to COVID-19; Identify leadership and logistical strategies to successfully communicate changes and overcome operational hurdles during a pandemic crisis. UAN: 0165-0000-21-036-L01-P Upon completion of this activity, technicians will be able to: Define COVID-19; Review the Coronaviridae virus and discuss factors and disease progression; Identify potential prevention and treatment options for COVID-19. UAN: 0165-0000-21-036-L01-T 9:00am-11:00am

Journal Board Meeting

9:20am-10:50am

Education: 1.5 hrs GCE/TECH/RC

The Impact of COVID on the Mind, Mood, and Memory

Angela Hill, Pharm.D., CRPh, Professor & Associate Dean of Clinical Affairs, Project Director, WE-CARE, Taneja College of Pharmacy, University of South Florida Upon completion of this activity, pharmacists will be able to: Describe the prevalence of mood disorders and suicide associated with past and current epidemics and pandemics; Discuss the impact of COVID infection on the brain and its functions; Explain the risk factors and implications of COVID infection for Alzheimer’s disease and other memory impairing disorders; Develop competency in selecting, and monitoring the newer antidepressants based on select patient characteristics; Provide recommendations for counseling patients with depression through case-based discussions; Choose resources for health professionals and the public to assist with mood, memory, and mind issues. UAN: 0165-0000-21-037-L01-P* Upon completion of this activity, technicians will be able to: Recognize the prevalence of mood disorders and suicide associated with past and current epidemics and pandemics; Discuss the impact of COVID infection on the brain and its functions; List the risk factors of COVID infection for Alzheimer’s disease and other memory impairing disorders. UAN: 0165-0000-21-038-L04-T 11:00am-1:00pm

Exhibit Hall Grand Opening

11:00am-1:00pm

Poster Presentations

12:00pm-1:00pm

Lunch On Your Own

1:00pm-2:30pm

Local Unit Leaders Meeting

1:00pm-2:30pm

Education: 1.5 hrs GCE/TECH/RC

Anticoagulation in the Time of COVID

Katherine Vogel Anderson, Pharm.D., BCACP, Associate Professor, Faculty Senate Chair, University of Florida Colleges of Pharmacy and Medicine Department of Pharmacotherapy and Translational Research, Division of General Internal Medicine Upon completion of this activity, pharmacists will be able to: Discuss thromboembolism risk associated with COVID-19; Provide recommendations for anticoagulation therapy in the management of COVID-19; Review available evidence regarding anticoagulation therapy for COVID-19 patients.

UAN: 0165-0000-21-039-L01-P Upon completion of this activity, technicians will be able to: Review thromboembolism risk for patients with COVID-19; Discuss anticoagulant drugs, dosages, and regimens used in the treatment of COVID-19; Determine risks and benefits of using anticoagulation therapy in treating COVID-19.

UAN: 0165-0000-21-039-L01-T 2:35pm-4:05pm

Education: 1.5 hrs GCE/TECH/RC

Nutrition and Supplements to Support the Immune System

Lynn Lafferty, PharmD, ND, MBA, DACBN, Endowed Professor, Assistant Professor of Pharmacy Practice Nova Southeastern College of Pharmacy Upon completion of this activity, pharmacists will be able to: Review Biochemical and Physiological Principals of the Immune System; Discuss how Clinical and Functional Nutrition enhances the Immune System; Recite the tenets of Herbal Medicine and Supplementation Practices; Discuss how to incorporate nutrition into pharmacy practice. UAN: 0165-0000-21-040-L01-P Upon completion of this activity, technicians will be able to: Recognize the principals of clinical and functional nutrition; List the tenets of herbal medicine; List ways to incorporate nutrition into pharmacy practice. UAN: 0165-0000-21-040-L01-T 7:00pm 16

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FLORIDA PHARMACY TODAY

Foundation Celebration Student Awards

Saturday July 10 6 hrs of GCE/TECH/RC 6:30am-7:30am

Florida Independent Pharmacy Owner Breakfast RSVP 850-656-0100

7:00am

Registration Desk Opens

7:45am-9:15am

Education 1.5 hrs GCE/TECH/RC

Keeping Up with Immunizations: Helping Your Community

Elias B. Chahine, PharmD, FCCP, FASCP, FFSHP, BCPS, BCIDP, FSHP President-Elect, Professor of Pharmacy Practice Gregory School of Pharmacy, Palm Beach Atlantic University Upon completion of this activity, pharmacists will be able to: Assess adult patients for risk factors for common vaccine-preventable diseases; Distinguish between the various available vaccines for influenza; pneumococcal disease; herpes zoster; tetanus diphtheria pertussis; hepatitis A; hepatitis B; and human papillomavirus; Design a patient-specific immunization regimen on the basis of age, risk factors, and comorbid conditions; Describe the role of pharmacists and pharmacy technicians in immunization advocacy and delivery; Delineate strategies for effectively addressing pseudo-science and vaccine hesitancy. UAN: 0165-0000-21-041-L06-P* Upon completion of this activity, technicians will be able to: List for risk factors for common vaccine-preventable diseases; Identify the various available vaccines for influenza; pneumococcal disease; herpes zoster; tetanus diphtheria pertussis; hepatitis A; hepatitis B; and human papillomavirus; Describe the role of pharmacists and pharmacy technicians in immunization advocacy and delivery; State two strategies for addressing vaccine hesitancy.

UAN: 0165-0000-21-042-L06-T 9:20am-10:50am

Education 1.5 hrs GCE/TECH/RC

MTM and Pharmacists - #1 Clinical Service We Should Be Known For

Jonathan G. Marquess, PharmD, CDCES, FAPhA, President/CEO, The Institute for Wellness and Education, Inc Upon completion of this activity, pharmacists will be able to. State the core elements of medication therapy management (MTM) services and summarize changes to MTM criteria; Outline the key habits to be covered in a medication therapy management session; Access tools and resources available for pharmacist to develop and provide MTM services; List barriers to providing MTM services in a pharmacy; Review cases that utilize MTM for patients with diabetes that is recommended and needed for patient and provider success. UAN: 0165-0000-21-043-L04-P Upon completion of this activity, technicians will be able to: Identify the core elements of medication therapy management (MTM) services; Recognize tools and resources available in the pharmacy to provide MTM services; List barriers to providing MTM services in a pharmacy. UAN: 0165-0000-21-043-L01-T 11:00am-1:00pm

Exhibit Hall Opens

12:00pm-1:00pm

Lunch On Your Own

1:00pm-2:30pm

Education: 1.5 hrs GCE/TECH/RC

Test and Treat: Florida Pharmacy Practice and Physician Collaboration

Daniel E. Buffington, PharmD, MBA, FAPhA, President, Clinical Pharmacology Services, Inc. Upon completion pharmacists will be able to: Review of Florida regulations concerning pharmacists and pharmacy practice; Outline the existing scope of practice and recent legislative additions to pharmacy practice (i.e., Chronic Care Management, Test & Treat, and Consultant Pharmacist licensure, etc.); Demonstrate the design, implementation, and utilization of various Physician and Pharmacist practice agreements. UAN: 0165-0000-21-044-L04-P Upon completion technicians will be able to: Define Collaborative Practice Agreements; Recognize Florida rules concerning pharmacists and pharmacy practice; Recognize recent legislative changes to the practice of pharmacy. UAN: 0165-0000-21-044-L04-T 2:35pm-4:05pm

Education 1.5 hrs GCE/TECH/RC

Prescription Department Manager: Role and Responsibilities

Mark W. Mikhael Pharm. D., ProHealth Pharmacy Solutions, Chief Pharmacy Officer Upon completion of this activity, pharmacists will be able to: Discuss the responsibilities of the Prescription Department Manager (PDM); Identify training that may help the PDM; Describe common misunderstandings regarding the role of the PDM; Discuss the consequences for not following the rules.

UAN: 0165-0000-21-045-L03-P Upon completion of this activity, technicians will be able to: Recognize the responsibilities of the Prescription Department Manager (PDM); Identify training that may help the PDM; List the consequences for not following the rules. UAN: 0165-0000-21-045-L03-T 5:00pm-6:00pm

Past Presidents Reception (Invitation Only)

7:00pm

Masquerade Ball Awards Banquet

CONTINUING EDUCATION CODE KEY:

GCE = General

RC = Recertification Consultant

TECH = Technician APRIL 2021

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Sunday July 11 5 hrs of GCE/TECH 6:45am-7:45am 7:00am 7:45am-9:45am

Sunday Morning Worship Registration Desk Opens Education: 2 hrs GCE/TECH

Reducing Medication Errors through Implementing a Continuous Quality Improvement Program

Michael Jackson, BPharm, CPh, Executive Vice President and CEO, Florida Pharmacy Association Upon completion of this activity, pharmacists will be able to: Define elements of a Continuous Quality Improvement (CQI) Program; Restructure a pharmacy practice to address quality related events; Discuss how to use Root Cause Analysis (RCA) to prevent errors; Implement an action plan to address quality of care in pharmacies with a goal towards error reduction and prevention; Recite quality improvement regulations for Florida pharmacies; Implement programs to improve patient safety in pharmacy health care systems. UAN: 0165-0000-21-046-L05-P Upon completion of this activity, technicians will be able to: Define CQI; Discuss RCA; List most common medication errors; Employ techniques to reduce medication errors by using CQI. UAN: 0165-0000-21-046-L05-T 9:50am-10:50am

Education: 1 hr GCE/TECH

HIV/AIDS Update 2021

Briana Journee, PharmD, MPh, Assistant Professor, Florida A & M University, College of Pharmacy Upon completion of this activity, pharmacists will be able to: Review current modes of transmission; Identify high risk behaviors; Discuss the pharmacist role in providing care for HIV infected patients; Describe the mechanism of actions of antivirals; Describe the rationale behind combination therapies; Interpret current Florida law on HIV/AIDS. UAN: 0165-0000-21-047-L02-P Upon completion technicians will be able to: Define HIV and AIDS; List methods of transmission of HIV/AIDS; Identify high risk behaviors; Recognize current Florida law on HIV/AIDS. UAN: 0165-0000-21-047-L02-T 10:55am-11:15am

Installation of Officers

11:15am-11:25am

Break

11:25am-1:25pm

Education: 2 hrs GCE/TECH

Validation and Counseling of Prescriptions for Controlled Substance and Opioids

Joseph Cammilleri, PharmD, BCACP, CPE, Ambulatory Care Clinical Pharmacist, Pain Management, PGY2 Pain/Palliative Care Program Director, UF Health Upon completion of this activity, participants will be able to: Describe how to ensure access to controlled substances for all patients with a valid prescription; Use the Prescription Drug Monitoring Program’s Database; Assess prescriptions for appropriate therapeutic value; Detect prescriptions that are not based on a legitimate medical purpose; Discuss the laws and rules related to the prescribing and dispensing of controlled substances; Discuss proper patient storage and disposal of controlled substances; Discuss protocols for addressing and resolving problems recognized during the drug utilization review; Provide education on section 381.887, F.S., emergency treatment for suspected opioid overdoses and on the State Surgeon General’s Statewide Standing Order for Naloxone; Counsel patients with opioid prescriptions; and Provide available treatment resources for opioid physical dependence, addiction, misuse, or abuse. UAN: 0165-0000-21-048-L03-P* Upon completion technicians will be able to: Use the Prescription Drug Monitoring Program’s\Database; Assess prescriptions for appropriate and accurate information; Recognize the laws and rules related to the prescribing and dispensing of controlled substances. UAN: 0165-0000-21-048-L03-T*

COVID Waiver: It is our desire to bring to you an outstanding convention and educational experience while helping everyone to stay safe during this current pandemic. If you, or a member of your party, have traveled to areas where COVID-19 is spreading, or you have been in contact with individuals who have COVID 14 days prior to the convention, we ask that you not participate in this event. By registering for and attending the FPA’s Annual Meeting and Convention, you are acknowledging that an inherent risk of exposure to COVID-19 exists in any public place where people are present. By attending the Annual Meeting and Convention, you and any guests voluntarily assume all risks related to exposure to COVID-19 and agree not to hold the Florida Pharmacy Association and its related event organizers liable for any illness or injury. Participants must agree to the above disclaimer along with wearing masks, exercising social distance, following local health guidelines, and having temperature taken in order to participate at the FPA Annual Meeting and Convention. If you are showing symptoms of possible COVID-19, we will be unable to admit you to the meeting.

The Florida Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Up to 22 contact hours are available upon successful completion of attendance and evaluation from Thursday-Sunday. Statements of continuing pharmacy education credit will available for you to download and print in four weeks. The FPA is also a Florida Department of Health approved provider of continuing education. This is an ACPE application* and knowledge based activity. Speakers have no relevant financial relationship to the activities.

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FLORIDA PHARMACY TODAY

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Life and disability insurance are written through PMC Advantage Insurance Services, Inc., a wholly-owned subsidiary of Pharmacists Mutual Insurance Company.

APRIL 2021

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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