The Expanding Role of the Pharmacist in HIV Prevention

Jointly provided by Postgraduate Institute for Medicine and Integritas Communications This activity is supported by an independent educational grant from Gilead Sciences, Inc.

FACULTY PREAMBLE SLIDES RESOURCE CENTER

CME/MEDICAL COMMUNICATIONS INQUIRIES

info@integritasgrp.com integritasgrp.com 2

FACULTY FACULTY

RICHARD A. ELION, MD

Clinical Professor of Medicine George Washington University School of Medicine Codirector, HIV/HCV Program Providence Hospital Washington, DC

Richard A. Elion, MD, is a Clinical Professor of Medicine at George Washington University School of Medicine and Health Sciences (GW) and an Adjunct Professor in the Milken Institute School of Public Health at GW as well. Codirector of the HIV/HCV clinical and research program at Providence Hospital, he also serves as Vice President of Strategy for Trio Health.

Dr. Elion has had an active clinical practice for more than 30 years and has been the principal investigator of numerous clinical trials, including the newly formed AIDS Clinical Trials Group site in Washington, DC, and the Multicenter AIDS Cohort Study in conjunction with Johns Hopkins University, Baltimore, Maryland. A founding member of the American Academy of HIV Medicine and a past board member of the HIV Medicine Association (HIVMA), a division of the Infectious Diseases Society of America (IDSA), he is working on various HIV prevention projects with the Department of Health and working to convert a citywide sexually transmitted disease (STD) program into a center for prevention studies. Dr. Elion has also been an active investigator in HIV prevention and pre-exposure prophylaxis (PrEP) and was the principal investigator in the PrEP demonstration project recently published in the Journal of the American Medical Association.

Dr. Elion has also been active in hepatitis C virus (HCV) treatment for more than 20 years, both in clinical care and in research. He has published on the pivotal trials of some of the new direct-acting antiviral agents for HCV, and worked closely to develop clinical and research protocols for HCV during his tenure as Director of Research at Whitman Walker Health in Washington, DC. He currently focuses on both mono- and dual-infected patients in his clinical work.

Dr. Elion graduated from the Temple University School of Medicine in Philadelphia, Pennsylvania, did his residency at Duke University Medical Center, Durham, North Carolina.

He received his master’s degree in counseling and spiritual psychology from the University of Santa Monica, California.

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FACULTY

JAMES D. SCOTT, BS, MEd, PharmD

Associate Dean Experiential and Professional Affairs Professor, Pharmacy Practice and Administration Western University of Health Sciences Pomona, California

James D. Scott, BS, MEd, PharmD, received his PharmD in 1994 from the University of Florida. He completed a 1-year clinical residency in Geriatric Pharmacotherapy in 1995 at the VA Medical Center in Gainesville, Florida. In 1997, he completed a 2-year fellowship in Infectious Diseases Pharmacotherapy at the University of Illinois at Chicago. He is certified by the American Academy of HIV Medicine as an HIV expert.

From July 1997 through April 2000, Dr. Scott was Director of Infection Management at the Clinical Pharmacokinetics Laboratory in Buffalo, New York. He joined Western University in May of 2000. He oversees the Office of Experiential Education of the PharmD curriculum, offering training and development programs for adjunct faculty/preceptors, providing focused resources and support to affiliated teaching sites, and implementing evaluation and quality assurance measures. His current research, clinical practice, and academic interests focus on HIV pharmacotherapy and adherence counseling. His recent research projects have included retrospective analyses evaluating the use and efficacy of HIV therapies, pharmacokinetic studies, and prospective investigator-initiated clinical trials.

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ELYSE TUNG, PharmD, BCACP FACULTY

Clinical Assistant Professor University of Washington School of Pharmacy Director of Clinical Services Kelley-Ross Pharmacy at the Polyclinic Seattle, Washington

Elyse Tung, PharmD, BCACP, is the Director of Clinical Services at Kelley-Ross Pharmacy in Seattle, Washington. Since 2009, she has worked on establishing innovative pharmacy practices including the first PrEP clinic managed by a pharmacist in a community pharmacy setting in 2015. Her previous experience also includes establishing a pharmacist-managed anemia clinic, travel clinic, and a transitions-of-care clinic in a senior care center. In 2014 she received the Washington State Pharmacy Association Innovative Pharmacy Practice Award.

Dr. Tung is also a Clinical Assistant Professor at the University of Washington School of Pharmacy. Prior to accepting this position, she completed her pharmacy practice residency at Swedish Medical Center in Seattle, and worked at Overlake Senior Care Center in Bellevue, Washington.

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TARGET AUDIENCE

This activity is intended for pharmacists engaged in the care of patients at risk for HIV.

EDUCATIONAL OBJECTIVES

After completing this activity, the participant should be better able to: •• Provide proactive, universal HIV-risk screening, identify patients at substantial risk for HIV acquisition, and determine PrEP eligibility

PREAMBLE

•• Create open patient-provider dialogue and engage the patient as an active, educated participant in clinical decision-making, ongoing patient-centric monitoring, and comprehensive risk-reduction strategies •• Counsel patients regarding PrEP efficacy, safety, and optimal use, and offer treatmentadherence counseling to patients receiving PrEP •• Provide ongoing guideline-based clinical and laboratory monitoring for patients receiving PrEP

STATEMENT OF NEED/PROGRAM DESCRIPTION

The most recent estimates from the Centers for Disease Control and Prevention (CDC) state that approximately 37,000 people in the United States become infected with HIV each year.1 To reduce the number of new infections, health care providers should be prepared to discuss the potential benefits of preexposure prophylaxis (PrEP) with adults who are at particularly high risk for acquiring HIV.2 The United States Public Health Service (USPHS) and the CDC have published clinical practice guidelines on identifying candidates and prescribing medication approved by the US Food and Drug Administration for HIV PrEP.3 During this Interactive Exchange™ program, expert faculty will review these guidelines with a focus on how pharmacists can facilitate patient engagement and retention in HIV-prevention services.4 Key topics will include recommendations on universal HIV testing, cohorts at substantial risk for HIV acquisition, criteria for PrEP eligibility, and practical approaches to monitoring PrEP outcomes and adherence.1 Faculty will also discuss the growing evidence pool supporting pharmacy-based programs to highlight opportunities for program attendees to play increasingly central roles in the prevention of new HIV infections.5

REFERENCES

1. CDC. CDC fact sheet: HIV incidence: estimated annual infections in the U.S., 2008–2014. Overall and by transmission route. https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/hiv-incidence-fact-sheet_508.pdf.

Updated February 2017. Accessed October 31, 2017.

2. Drugs@FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021752s053lbl.pdf. Accessed October 31, 2017.

3. CDC. USPHS Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2014. https://www. cdc.gov/hiv/pdf/prepguidelines2014.pdf. Accessed October 31, 2017.

4. CDC. Effectiveness of Prevention Strategies to Reduce the Risk of Acquiring or Transmitting HIV. https://www.cdc. gov/hiv/risk/estimates/preventionstrategies.html. Updated March 2017. Accessed October 31, 2017.

5. CDC. Innovative CDC effort expands HIV testing into pharmacies. http://www.cdc.gov/nchhstp/newsroom/2012/ nhtdpressrelease2012.html. Published June 2012. Accessed October 31, 2017.

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10:45 am– 11:35 am

Registration and Preactivity Outcomes Assessment

11:35 am– 11:40 am

Video Presentation: Putting the PrEP Into HIV Prevention Richard A. Elion, MD

11:40 am– 11: 50 am

PrEPping Pharmacists Elyse Tung, PharmD, BCACP

11: 50 am– 12:15 pm

What Is PrEP and Who Needs It? James D. Scott, BS, MEd, PharmD

12:15 pm– 12:30 pm

The Pharmacist as a PrEP Manager and Educator Elyse Tung, PharmD, BCACP

12:30 pm– 12:45 pm

Choose-a-Case™

12:45 pm– 1:00 pm

Postactivity Outcomes Assessment and Ask the Experts Question & Answer

PREAMBLE

PROGRAM AGENDA

CONTINUING PHARMACY EDUCATION

Postgraduate Institute for Medicine is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Postgraduate Institute for Medicine designates this continuing education activity for 1.5 contact hours (0.15 CEUs) of the Accreditation Council for Pharmacy Education.

Universal Activity Number - 0809-9999-17-947-L02-P Type of Activity: Application Pharmacists have up to 30 days to complete the evaluation and claim credit for participation so that information can be submitted to CPE Monitor as required.

DISCLOSURE OF CONFLICTS OF INTEREST

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are positioned to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in health care and not a specific proprietary business interest of a commercial interest.

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FACULTY Richard A. Elion, MD Consulting fees: Gilead Sciences, Inc.; ViiV Healthcare Fees for non-CME/CE services: Gilead Sciences, Inc.; Janssen Pharmaceuticals, Inc. Contracted research: Gilead Sciences, Inc. James D. Scott, BS, MEd, PharmD

Has nothing to disclose.

Elyse Tung, PharmD, BCACP

Honoraria: Gilead Sciences, Inc. Fees for non-CME/CE services: Gilead Sciences, Inc.

PREAMBLE

PLANNERS AND MANAGERS The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP, have nothing to disclose. The Integritas Communications planners and managers, Jim Kappler, PhD, and Jeanette Ruby, MD, have nothing to disclose.

DISCLOSURE OF UNLABELED USE

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

DISCLAIMER

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

REQUEST FOR CREDIT

For Pharmacists: Upon receipt of the completed activity evaluation form, you will receive an email from CEcertificate@pimed.com (within 3 weeks) with a link and directions to submit your credit to the NABP CPE Monitor Service.

Food and beverage are no longer provided at Midday Symposia. This ASHP policy considers the varied internal policies of commercial supporters related to the Physician Payments Sunshine Act. You are welcome to bring your lunch to the session.

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CLINICAL PRACTICE GUIDELINES Laboratory Testing for the Diagnosis of HIV Infection: Updated Recommendations.

Centers for Disease Control and Prevention, 2014. »» https://stacks.cdc.gov/view/cdc/23447

STD and HIV Screening Recommendations.

Centers for Disease Control and Prevention, 2017.

»» https://www.cdc.gov/std/prevention/screeningreccs.htm

US Public Health Service: Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2014. A Clinical Practice Guideline.

Centers for Disease Control and Prevention, 2014.

»» https://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

ASHP Guidelines on Pharmacist Involvement in HIV Care.

Schafer JJ, et al. Am J Health Syst Pharm. 2016;73(7):468-494.

»» https://www.researchgate.net/publication/299358491_ASHP_Guidelines_ on_Pharmacist_Involvement_in_HIV_Care

CLINICAL RESOURCES PrEP Kit. AIDS United, 2015.

RESOURCE CENTER

»» https://www.aidsunited.org/data/files/Site_18/PrEP_Kit_Dec15_final.pdf

HIV in the United States by Geographic Distribution.

Centers for Disease Control and Prevention, 2017.

»» https://www.cdc.gov/hiv/statistics/overview/geographicdistribution.html

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Provider Information Sheet—PrEP During Conception, Pregnancy, and Breastfeeding.

Centers for Disease Control and Prevention.

»» https://www.cdc.gov/hiv/pdf/prep_gl_clinician_factsheet_pregnancy_ english.pdf

State HIV Laws.

Centers for Disease Control and Prevention, 2017. »» https://www.cdc.gov/hiv/policies/law/states/

Taking a Sexual History.

NYC Health, 2015.

»» https://www1.nyc.gov/assets/doh/downloads/pdf/csi/csi-prep-pep-sexhistory.pdf

Transgender Health Learning Center.

University of California, San Francisco, 2017.

»» http://transhealth.ucsf.edu/trans?page=lib-00-00

HIV Drug Interactions.

University of Liverpool (Web site), 2017.

»» http://www.hiv-druginteractions.org/checker

Centers for Disease Control and Prevention (CDC): HIV Basics The CDC is a division within the US Department of Health and Human Services (DHHS), the principal agency for protecting the health of all Americans. This comprehensive site provides extensive links to topics across the HIV-care continuum, including PrEP. »» https://www.cdc.gov/hiv/basics/index.html

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RESOURCE CENTER

PATIENT RESOURCES

Positively Aware Positively Aware, created by TPAN (Test Positive Aware Network), is a source of HIV-treatment news for consumers, as well as an educational tool for HIV caregivers. The site features PrEP resources, including videos for MSM and transgender people. »» https://www.positivelyaware.com/

PrEP for U.S. Women: A Collection of Resources HIVE provides preconception and prenatal resources for women and couples affected by HIV. »» https://www.hiveonline.org/prep4women/

PrEP Locator PrEP Locator is an online directory of public and private-practice providers of HIV preexposure prophylaxis (PrEP) in the United States.

The site includes a map-based widget for ease of locating PrEP services. »» https://preplocator.org/

SMARTPHONE APPS (FREE)

Mango Health — Medicine Manager, Pill Reminder

iPhone »» https://itunes.apple.com/us/app/mango-health-medication-manager/id560657279?mt=8 Android »» https://play.google.com/store/apps/details?id=com.mangohealth.mango&hl=en

Medisafe Pill Reminder, Rx & Medicine Tracker

RESOURCE CENTER

iPhone »» https://itunes.apple.com/il/app/id573916946?mt=8

Android »» https://play.google.com/store/apps/details?id=com.medisafe.android.client

SUGGESTED READING HIV providers’ likelihood to prescribe pre-exposure prophylaxis (PrEP) for HIV prevention differs by patient type: a short report.

Adams LM, Balderson BH. AIDS Care. 2016;28(9):1154-1158. »» https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4974057/pdf/nihms806492.pdf

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Antiretroviral prophylaxis for HIV prevention in heterosexual men and women.

Baeten JM, et al. N Engl J Med. 2012;367(5):399-410. »» http://www.nejm.org/doi/full/10.1056/NEJMoa1108524#t=article

Pharmacists as providers of HIV preexposure prophylaxis.

Bruno C, Saberi P. Int J Clin Pharm. 2012;34(6):803-806. »» https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3501608/pdf/nihms415425.pdf

Effectiveness of prevention strategies to reduce the risk of acquiring or transmitting HIV. Centers for Disease Control and Prevention, 2017. »» https://www.cdc.gov/hiv/risk/estimates/preventionstrategies.html

Innovative CDC effort expands HIV testing into pharmacies.

Centers for Disease Control and Prevention, 2012. »» https://www.cdc.gov/nchhstp/newsroom/2012/nhtdpressrelease2012.html

Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial.

Choopanya K, et al. Lancet. 2013;381(9883):2083-2090. »» http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61127-7/abstract

Behavioral HIV risk reduction among people who inject drugs: meta-analytic evidence of efficacy.

RESOURCE CENTER

Copenhaver MM, et al. J Subst Abuse Treat. 2006;31(2):163-171. »» http://www.colby.edu/psych/wp-content/uploads/sites/50/2014/08/Copenhaver-et-al.-2006.pdf

Pharmacist-provided rapid HIV testing in two community pharmacies.

Darin KM, et al. J Am Pharm Assoc (2003). 2015;55(1):81-88. »» http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.670.7159&rep=rep1&type=pdf

Integrating antiretroviral strategies for human immunodeficiency virus prevention: post- and pre-exposure prophylaxis and early treatment.

Grant RM, Smith DK. Open Forum Infect Dis. 2015;2(4):ofv126. »» https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4621406/pdf/ofv126.pdf

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Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.

Grant RM, et al. N Engl J Med. 2010;363(27):2587-2599. »» http://www.nejm.org/doi/full/10.1056/NEJMoa1011205#t=article

MSM estimation state profiles.

Grey J, Emory Coalition for Applied Modeling for Prevention (CAMP). »» http://www.emorycamp.org/item.php?i=50

Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic openlabel randomised trial.

McCormack S, et al. Lancet. 2016;387(10013):53-60. »» http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(15)00056-2.pdf

Exploratory survey of Florida pharmacists’ experience, knowledge, and perception of HIV pre-exposure prophylaxis.

RESOURCE CENTER

Shaeer KM, et al. J Am Pharm Assoc (2003). 2014;54(6):610-617. »» https://www.ncbi.nlm.nih.gov/pubmed/?term=Shaeer+KM%2C+et+al.+J+Am+Pharm+Assoc.+2014%3B54(6)%3A610-617

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Please visit the CLINICAL RESOURCE CENTER for additional information and resources

www.ExchangeCME.com/PrEPRESOURCES17

© 2017 Integritas Communications.

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