Providing PEP/PrEP in the Pharmacy Setting: Nevada Edition

PHARMACY PrEP EDUCATION A “HOW TO” SERIES SPANNING POLICY TO PRACTICE

PROVIDING PrEP IN THE PHARMACY SETTING NEVADA EDITION

WHAT On April 22, 2022, the Nevada State Board of Pharmacy (NSBP) notified pharmacists and technicians that through State Senate Bill 325 (SB325), approved during the 2021 legislative session...

Pharmacists are authorized to prescribe, dispense, and administer drugs to prevent the acquisition of HIV and to perform certain tests.

The language of the bill can be found here: https:// www.leg.state.nv.us/App/NELIS/REL/81st2021/ Bill/7959/Text.1 Preexposure prophylaxis (PrEP) is the use of specific combinations of antiretroviral agents to reduce the risk of HIV infection, and postexposure prophylaxis (PEP) utilizes specific combinations of antiretroviral agents to prevent infection in appropriately identified and evaluated HIV-negative people who have had a single high-risk HIV exposure.2,3

This activity is jointly provided by Global Education Group and Integritas Communications.

This activity is supported by an educational grant from Gilead Sciences, Inc.

PROVIDING PrEP IN THE PHARMACY SETTING: NEVADA EDITION

WHY Almost 1.1 million people in the United States are living with HIV today, with 13% of HIV-infected individuals unaware of their infection. Latest estimates from the Centers for Disease Control and Prevention (CDC) indicate that there were 30,635 new HIV infections in the United States in 2020.4,5 Nevada has the highest rate (14.9/100,000 population) of new HIV infections in the Western United States,4 and Clark County, the most populous county in Nevada, has the highest rate overall. In 2018, the CDC estimated that while one in five people living with HIV in Clark County is unaware of their status, only 11% had been tested in the past year.6 PrEP is intended for HIV-negative individuals who are at risk of infection through sexual intercourse or injection drug use, including sexually active men who have sex with men (MSM), heterosexual men and women, and transgender individuals. Prescribing PEP should be considered an emergency intervention; PEP is not a substitute for appropriate, continuous use of PrEP in conjunction with behavioral risk reduction. It can be thought of as similar to dispensing the morning-after contraceptive pill.3 Individuals who continue to engage in high-risk behavior after receiving PEP or who have received multiple courses of PEP should probably transition to PrEP.7

Although highly effective, HIV PrEP remains underutilized in the United States.8 As 85% to 90% of PrEP medications are filled at community pharmacies, pharmacists have the capability to help end the HIV epidemic by 2030.9,10 Pharmacists have the legal authority in most states to prescribe and dispense PrEP in collaboration with other clinicians, and educating pharmacists for this role is vitally important11 Pharmacists should be aware of the recently updated national guidelines and recommendations for PrEP implementation, titled Preexposure Prophylaxis for the Prevention of HIV Infection in the US—2021 Update: A Clinical Practice Guideline.7 In addition, the monograph and CE activity, PEP/PrEP in the Pharmacy Setting: A Comprehensive User Guide, presents the clinical and administrative tasks necessary to implement PrEP and PEP in day-to-day practice. Finally, this state primer on Nevada PEP/PrEP practice contains those policies and procedures necessary for Nevada pharmacists that would not be included in the US-based, comprehensive monograph.

HOW Required Training and Insurance12

In order to increase access to PrEP/PEP, SB 325 required the NSBP to establish a protocol requiring pharmacists who wish to prescribe, dispense, administer PrEP and PEP drugs to: 1. Complete a training course concerning the prescribing, dispensing, and administering of drugs approved by the United States Food and Drug Administration (FDA) for preventing the acquisition of HIV. The course must be approved by the Accreditation Council for Pharmacy Education (ACPE) or offered by a college of pharmacy or department of pharmacy at a university accredited by the ACPE.13 a. A training course to consider is PEP/PrEP in the Pharmacy Setting: A Comprehensive User Guide. This 2.0 contact hour ACPE-accredited activity is a downloadable and printable monograph. It includes “how-to” clinical information, efficacy and safety data, workflow suggestions, and resources necessary for pharmacists to assess patients, and initiate and monitor patients on PEP/PrEP for HIV prevention (link to this Monograph is at the end of this Primer).

2. Maintain and keep proof of completion of the training while the pharmacist prescribes, dispenses, or administers such drugs and for at least 2 years after prescribing, dispensing, and administering 3. Maintain professional liability insurance coverage of at least $1,000,000

2

For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources

PrEP Initiation and Management12

Once a pharmacist has completed the aforementioned, the pharmacist must: 1. Complete an assessment of the patient, which includes a. HIV test

b. Renal function test c. Hepatitis B test

d. Evaluation for any signs and symptoms of acute HIV infection (AHI)

2. Counsel the patient and provide information about the drug dispensed or administered including13 a. Proper administration and storage of the drug b. Proper dosage

c. Drug effectiveness

d. Potential side effects

e. The need to be regularly tested for HIV infection f. The need to adhere to treatment

g. The inability of the drug to prevent other sexually transmitted infections (STIs)

3. Comply with the CDC guidelines for PrEP and PEP, Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. A Clinical Practice Guideline7 and Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV—United States, 20163

Providing PrEP to Continue a Patient’s Current Treatment12

A pharmacist may prescribe, dispense, or administer up to a 30-day supply of an FDA-approved drug for PrEP in order to continue the patient’s treatment without completing the required laboratory testing if the pharmacist: 1. Makes a good faith effort to obtain and review the laboratory history of the patient 2. Completes an assessment of the patient

3. Reviews potential side effects with the patient

4. Determines that the risk associated with continuing the treatment outweighs the risk of discontinuing treatment

PEP Initiation, Management, and PEP-to-PrEP12

A pharmacist may prescribe, dispense, or administer an FDA-approved drug for PEP to prevent the acquisition of HIV immediately upon the request of a patient who has recently been exposed to HIV. Once the PEP regimen is completed, before continuation of treatment using such drugs beyond the initial prescribing, dispensing, or administering, complete an assessment of the patient including: 1. HIV test (to confirm HIV-negative)

2. Pregnancy test, if the patient is a woman of childbearing age 3. Liver function

4. Renal function

5. STI testing/screening 6. Hepatitis B

7. Hepatitis C

Patients who test positive for HIV should be referred for HIV treatment. Patients who test negative for HIV but are still at risk for acquiring HIV should be counseled to transition to PrEP.

Monitoring and Follow-up for Patients Initiating PEP and PrEP12

A pharmacist who prescribes, dispenses, or administers an FDA-approved drug for preventing the acquisition of HIV must implement a plan for monitoring the patient, which should include support and ongoing assessment and clinical management as stated in the 2021 Updated CDC PrEP Clinical Practice Guidelines and the 2016 Updated Guidelines for PEP.3,7

3

PROVIDING PrEP IN THE PHARMACY SETTING: NEVADA EDITION

Other Administrative Issues

Reporting Communicable Diseases12,13

In addition, pharmacists are required to comply with the provisions of chapter 441A of NRS and chapter 441A of NAC concerning the reporting of cases of communicable diseases.

In Person or TelePrEP Care12,13

You will be considered as having a therapeutic relationship with a patient if you assess or examine that patient in person or via telehealth or any other electronic method (either within or even outside of Nevada or the United States) within the immediately preceding 6 months of diagnosing, dispensing, or prescribing PrEP or PEP.

Resource Pacific AETC: AIDS Education & Training Center Program has a Practice Transformation program that implements interventions and systems change in clinical settings to improve patient outcomes along the HIV prevention and care continuum. This includes support for clinics addressing both HIV and substance use in rural settings. Pacific AETC provides online and on-demand learning, capacitybuilding assistance, and links to local AETC partners on the West Coast. https://paetc.org

REFERENCES 1.

Nevada Legislature. 81st (2021) Session. SB325. https://www.leg.state.nv.us/App/ NELIS/REL/81st2021/Bill/7959/Text. Accessed June 8, 2022.

2.

CDC. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP).

Updated September 2020. https://www.cdc. gov/hiv/clinicians/prevention/prepand-pep.html. Accessed May 24, 2022.

3.

CDC. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV—United States, 2016. https:// www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines. pdf. Accessed May 24, 2022.

9.

4.

Centers for Disease Control and Prevention (CDC). HIV Surveillance Report.

Diagnoses of HIV Infection in the United States and Dependent Areas, 2020; vol 33. Published May 2022. https://www.cdc.gov/hiv/pdf/library/reports/surveillance/ cdc-hiv-surveillance-report-2020-updated-vol-33.pdf. Accessed June 13, 2022.

10. HIV.gov. Overview: what is ending the HIV epidemic in the U.S.? Updated June 2021. https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/overview.

Accessed May 24, 2022.

5.

CDC. HIV basics: U.S. statistics. Updated June 2, 2021. https://www.hiv.gov/hivbasics/overview/data-and-trends/statistics. Accessed June 13, 2022.

6.

Nevada Dept Health and Human Services, Division of Public and Behavioral Health.

Technical bulletin. July 9, 2021. https://bop.nv.gov/uploadedFiles/bopnvgov/ content/Resources/ALL/TB_PrEP.PEP_FINAL.pdf. Accessed June 8, 2021.

12. Nevada State Board of Pharmacy. Notice to pharmacists and technicians April 22, 2022. https://bop.nv.gov/uploadedFiles/bopnvgov/content/home/features/ SB%20325%20PREP%20and%20PEP%20Notice%2004.22.2022.pdf. Accessed June 1, 2022.

TO” EDUCATION A “HOW PHARMACY PrEPG POLICY TO PRACTICE SERIES SPANNIN

ski, Melissa Badow PharmD, MPH,BCIDP, FCCP, FIDSA, P BCPS, AAHIV Professor

Clinical Associate Diseases Section of Infectious Pharmacotherapy Practice of Pharmacy Department Illinois at Chicago University of College of Pharmacy Chicago, Illinois

HOW TO OBTAIN CREDIT

questionnaire, complete the preactivity the score of 70% on Participants must receive a minimum evaluation online at complete and the program raph. posttest, and complete m/PrEPpharmacyMonog

www.ExchangeCME.co Estimated time

to complete this

activity is 2 hours.

, Shauna Applin ARNP, CNM, AAHIVMs

HIV Clinical Director Provider Lead Adult Medicine Care Community Health Medical Center Hilltop Regional Tacoma, Washington

Group and

by Global Education jointly provided This activity is Sciences, Inc. Integritas Communications. grant from Gilead an educational supported by This activity is

7.

US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. A Clinical Practice Guideline. https:// www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-guidelines-2021.pdf. Accessed May 24, 2022.

8.

Smith DK, et al. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-1295.

Highleyman L. PrEP use growing in US, but not reaching all those in need.

Aidsmap. 2018. https://www.aidsmap.com/news/mar-2018/prep-use-growingus-not-reaching-all-those-need#:~:text=The%20CDC%20estimates%20that%20 85,the%20entire%20four%2Dyear%20period. Accessed May 24, 2022.

11. Tung EL, et al. Sex Health. 2018;15(6):556-561.

13. Nevada State Board of Pharmacy. Approved regulation R039-21. April 11, 2022. https://www.leg.state.nv.us/Register/2021Register/R039-21AP.pdf. Accessed June 8, 2022.

CALLING ALL PHARMACISTS!

COMPREHENSIVE MONOGRAPH MEETS ALL OF YOUR BOARD OF PHARMACY REQUIREMENTS TO PRESCRIBE PEP/PrEP!

Providing PEP/PrEP in the Pharmacy Setting: A Comprehensive User Guide is an electronic/downloadable monograph that delivers 2.0 contact hours (0.20 CEUs) from the Accreditation Council for Pharmacy Education. It imparts in-depth HIV preexposure and postexposure prophylaxis (PrEP and PEP) content, fulfilling most state Board of Pharmacy training requirements for pharmacists wishing to become PrEP and PEP providers. The monograph includes clinical and behavioral aspects of HIV prevention and supports pharmacists now challenged to come up to speed on guidelines and protocols for HIV PrEP and PEP.

www.ExchangeCME.com/PrEPpharmacyMonograph

Clinical Resource Center

For additional resources for pharmacists and your patients, visit the Clinical Resource Center at:

www.ExchangeCME.com/PrEPPharmacyResources