PROVIDING PrEP IN THE PHARMACY SETTING VIRGINIA EDITION
This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from Gilead Sciences, Inc.
WHAT In 2021, the Virginia Board of Pharmacy (VBOP) granted authority to pharmacists to prescribe HIV preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to persons 18 years of age or older. PrEP is the use of specific combinations of antiretroviral agents to reduce the risk of HIV infection, and PEP utilizes specific combinations of antiretroviral agents to prevent infection in those who have had a high-risk HIV exposure in the previous 72 hours.1-4
PHARMACY PrEP EDUCATION A “HOW TO” SERIES SPANNING POLICY TO PRACTICE
Although highly effective, HIV PrEP remains underutilized in the United States.7 As 85% to 90% of PrEP medications are filled at community pharmacies, pharmacists have the capability to help end the HIV epidemic by 2030.8,9
Training Option
• A training course to consider is the 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 Monograph is at the end of this Primer).
HIV PrEP Process Elements
1. PrEP Self-Screening Patient Intake Form a. Basic patient information b. HIV risk assessment c. Medical history d. Patient acknowledgment of risk and responsibilities vis-à-vis screening and medication use
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 Pharmacistsimportant.10should 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 1 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.
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 morningafter contraceptive pill.2 Individuals who continue to engage in high-risk behavior after receiving PEP or who have received multiple courses of PEP should receive counseling about transitioning to PrEP.1
PROVIDING PrEP IN THE PHARMACY SETTING: VIRGINIA EDITION
PrEP & PEP Standardized Patient Assessment Process Elements3,4 As part of the HIV PrEP/PEP statewide protocol, the VBOP has developed 2 sets of Standardized Patient Assessment Process Elements, one for PrEP and one for PEP, for pharmacists to use when assessing patients and prescribing medication. A pharmacy may create and use an electronic format for these forms as long as they are identical to the originals put forth by the VBOP. Here’s a brief summary of each form:
Finally, this state primer on Virginia PEP/PrEP practice contains those policies and procedures necessary for Virginia pharmacists that would not be included in the national, comprehensive monograph.
HOW Required Training3,4 In order to start prescribing PrEP and PEP, the VBOP requires that pharmacists “be knowledgeable of the manufacturer’s instructions for use and complete a comprehensive training program related to the prescribing and dispensing of HIV prevention medications, to include related trauma informed care.” The intention of including “trauma-informed care” is to acknowledge that those who may have experienced trauma may require additional support services.
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 2020.5,6 In the state of Virginia, the rate of new HIV diagnosis among those ≥13 years of age was 8.7/100,000. In the United States, half of all new diagnoses occur in the South.5
regimen
a.
HIV test
Protocol.pdfresourcePDF/prep/VA_PEP_https://exchangecme.com/ Download a printable version of the VBOP HIV PEP
is complete, and the results are nonreactive (ie,
the patient needs to complete all other required labs and bring them to the pharmacy within 30 days. •
appropriate
steps
4. Provider Notification, PEP for HIV Notification to the patient’s provider that the patient is taking PEP Recommended labs to be ordered at 6 3 after the initiation of PEP for Prescribing PrEP
exposure
Form a. Basic patient information b. Assessment to determine the details and risk level of the exposure to
The VBOP protocol states that the required laboratory tests for PrEP initiation and/or include: If If just the HIV test the patient is HIV-negative) but If the has the
all labs are complete, the pharmacist may prescribe PrEP; the next labs are due in 90 days •
3
Protocol.pdfresourcePDF/prep/VA_PrEP_https://exchangecme.com/
treatment regimen c.
1. HIV antigen/antibody (Ag/Ab) (fourth generation [gen]) – the HIV test must be performed within the 14 days prior to prescribing and dispensing 2. Syphilis/treponemal antibody 3. Chlamydia/gonorrhea (urinalysis, pharyngeal, and/or rectal depending on sexual behavior) 4. Hepatitis B surface antigen 5. Hepatitis C surface antigen 6. Renal function/creatinine clearance •
Elements
b.
a.
necessary
been performed and the results are reactive or indeterminate,
initiating
months
regimen c. Counseling points d. Pharmacist mandatory follow-up
management
pharmacist may not prescribe PrEP and the patient should be referred to a health care provider
Download a printable version of the VBOP HIV PrEP
the pharmacist may prescribe PrEP,
Protocol
2. PEP HIV Assessment and Treatment Care Pathway information about the and Recommended PEP
Protocol
1. PEP Self-Screening Patient Intake HIV
patient risk factors b.
c. Medical history
b. Specific drug regimen c. Drug safety information, potential contraindications, and drug-drug-interactions d.
3. Patient Information, PEP for HIV Detailed patient handout explaining the medication directions, and follow-up and next
a.
b. Summary
3. PrEP Provider Notification Form Notification to the patient’s provider that the patient is taking PrEP of Test results HIV PEP Process
and
c. Referral conditions and considerations d.
weeks and
PrEP Initiation and Management1,3 Labs
a.
2. PrEP Assessment and Treatment Care Pathway Risk factors that may indicate the patient is a good candidate for PrEP Laboratory tests prior to PrEP Considerations for selecting the oral PrEP
a. Specific questions and
3. Pregnancy Medical Conditions in Which the Pharmacist Must Refer the Patient
1. Hepatitis B surface antigen
PEP Should NOT Be Initiated If1
3. Chlamydia (referral for evaluation and treatment)
2. Reactive treponemal antibody test (referral for follow-up and confirmatory testing)
If any of the following tests is positive, the patient should be referred to county health or a specialist physician
• The exposure occurred >72 hours ago; PEP is time sensitive and must be started as soon as possible
• The patient has a history of known hepatitis B infection In each of these situations the patient should be referred to a local health care provider, emergency department, urgent care, infectious disease specialist, or public health clinic
4. Gonorrhea (referral for evaluation and treatment)
• 1 month after prescribing; advocate for appropriate provider follow-up after completion of the regimen
1. HIV Ag/Ab (fourth gen) test (patient should be referred for confirmatory testing; pharmacist may not prescribe PrEP)
• Determine whether the patient has a health care provider for follow-up, or refer directly to another provider or public health department for follow-up
If any of the following tests is reactive or indeterminate, the results must be referred to the county health department or the patient’s health care provider
HIV Test If it’s unknown whether the patient is HIV positive, pharmacists have the option of performing a fourth-gen pointof-care HIV finger-stick test when prescribing PEP. However, the PEP protocol does not require that an HIV test be performed by a pharmacist in order to prescribe.
The patient should be referred for evaluation and management to a health care provider or appropriate specialist.
• Impaired kidney function (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2)
PEP Initiation and Management4
PEP Follow-up The prescribing pharmacist is required to Contact the patient: • Counsel the patient about: follow-up testing for HIV, renal function, hepatic function, hepatitis B and C, and sexually transmitted infections proper use of medication, dosing schedule, and potential side effects the importance of medication adherence with respect to PEP efficacy signs and symptoms of acute HIV infection using condoms and not sharing injection equipment emergency contraception (if appropriate)
2. Hepatitis C surface antigen
• Provide a written individualized care plan to each patient
4 PROVIDING PrEP IN THE PHARMACY SETTING: VIRGINIA EDITION
• Presence of hepatitis B virus infection
• Comorbid nephrotoxic medications
• The patient is <18 years of age
For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources
If the patient has one or more of the following conditions, then the pharmacist is not authorized to initiate treatment.
5. CDC. HIV Surveillance Report. Diagnoses of HIV Infection in the United States and Dependent Areas, 2020; vol 33. Published May surveillance-report-2020-updated-vol-33.pdf.https://www.cdc.gov/hiv/pdf/library/reports/surveillance/cdc-hiv-2022.AccessedJune13,2022.
• Recommend ordering the following labs at 3 months after starting PEP HIV Hepatitisantigen/antibodyCantibody
• Provide written notification of the PEP prescription
9. HIV.gov. Overview: what is ending the HIV epidemic in the U.S.? Updated June 2021. the-hiv-epidemic/overview.https://www.hiv.gov/federal-response/ending-AccessedMay24,2022.
and surface antibody
HIV Hepatitisantigen/antibodyBsurfaceantigen
Hepatitis C antibody Metabolic panel
2. Centers for Disease Control and Prevention (CDC). Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV— United States, 2016. cdc-hiv-npep-guidelines.pdf.https://www.cdc.gov/hiv/pdf/programresources/2016.AccessedMay24,2022.
10. Tung EL, et al. Sex Health. 2018;15(6):556-561.
• Recommend in-person follow-up within 1-2 weeks of starting HIV PEP
1. US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. A Clinical Practice Guideline. guidelines-2021.pdf.https://www.cdc.gov/hiv/pdf/risk/prep/cdc-hiv-prep-AccessedMay24,2022.
7. Smith DK, et al. MMWR Morb Mortal Wkly Rep. 2015;64(46):1291-1295.
8. Highleyman L. PrEP use growing in US, but not reaching all those in need. aidsmap. 2018. period.CDC%20estimates%20that%2085,the%20entire%20four%2Dyear%20prep-use-growing-us-not-reaching-all-those-need#:~:text=The%20https://www.aidsmap.com/news/mar-2018/AccessedMay24,2022.
REFERENCES
5
6. CDC. HIV basics: U.S. statistics. Updated June 2, 2021. https://www. hiv.gov/hiv-basics/overview/data-and-trends/statistics. Accessed June 13, 2022.
Resource
MidAtlantic AETC: AIDS Education & Training Center Program serves Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, and West Virginia through its central office and partners. This regional office provides assistance with capacity-building, training, and technical services. https://aidsetc.org/aetc-program/midatlantic-aetc
4. Virginia Board of Pharmacy. Preventive Care. HIV Post-exposure prophylaxis (PEP) statewide protocol. Accessedpharmacy/docs/protocols/PEPCombinedProtocol12-22-2021.pdf.https://www.dhp.virginia.gov/June24,2022.
• Recommend ordering the following labs at 6 weeks after starting HIV PEP
Notify the health care provider
Treponema pallidum antibody as appropriate Pregnancy test as appropriate STI screening
3. Virginia Board of Pharmacy. Preventive Care. HIV Pre-exposure prophylaxis (PrEP) statewide protocol. Accessedpharmacy/docs/protocols/PrEPCombinedProtocol12-22-2021.pdf.https://www.dhp.virginia.gov/June24,2022.
contact hours
OF PHARMACY REQUIREMENTS TO PRESCRIBE PEP/PrEP! For additional resources for pharmacists and your patients, visit the Clinical Resource Center at: Clinical Resource Center www.ExchangeCME.com/PrEPPharmacyResourceswww.ExchangeCME.com/PrEPpharmacyMonograph Participants must complete the preactivity questionnaire, complete and receive a minimum score of 70% on the posttest, and complete the program evaluation online at www.ExchangeCME.com/PrEPpharmacyMonograph Estimated time to complete this activity is 2 hours. Melissa Badowski PharmD, MPH, FCCP, FIDSA, BCIDP, BCPS, AAHIVP Clinical Associate Professor Section of Infectious Diseases DepartmentPharmacotherapyofPharmacy Practice University of Illinois at Chicago College of Pharmacy Chicago, Illinois Shauna Applin, ARNP, AAHIVMsCNM, HIV Clinical Director Adult Medicine Lead Provider Community Health Care Hilltop Regional Medical Center Tacoma, Washington HOW TO OBTAIN CREDIT PHARMACY PrEP EDUCATION A “HOW TO” SERIES SPANNING POLICY TO PRACTICE This activity jointly provided by Global Education Group and Integritas Communications. This activity supported by educational grant from Gilead Sciences, Inc.
to become
electronic/downloadable monograph
pharmacists
PROVIDING PrEP IN THE PHARMACY SETTING: VIRGINIA EDITION
Providing PEP/PrEP in the Pharmacy Setting: A Comprehensive User Guide is an that delivers 2.0 (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 training requirements for pharmacists wishing PrEP and PEP providers. The includes aspects of HIV supports now challenged to come up to speed on protocols for HIV PrEP and PEP. ALL OF YOUR BOARD
monograph
clinical and behavioral
of Pharmacy
prevention and
guidelines and
CALLING ALL PHARMACISTS! COMPREHENSIVE MONOGRAPH MEETS
