PROVIDING PrEP IN THE PHARMACY SETTING OREGON EDITION
WHAT In 2021, the Oregon Board of Pharmacy (OBOP) granted authority to prescribe preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP) to pharmacists who complete continuing education (CE) on HIV prevention medications. 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 appropriately identified and evaluated HIV-negative people who have had a single high-risk HIV exposure.1,2 In June 2021, Oregon House Bill 2958 was signed into law, allowing pharmacists to prescribe, dispense, and administer drugs to prevent the acquisition of HIV (both PrEP and PEP) and to perform certain tests. HB 2958 went into effect in late September 2021. 3 The language of the bill can be found here: MeasureDocument/HB2958olis.oregonlegislature.gov/liz/2021R1/Downloads/https://4
PrEP EDUCATION A “HOW TO” SERIES SPANNING POLICY TO PRACTICE
This activity is jointly provided by Global Education Group and Integritas Communications. This activity is supported by an educational grant from Gilead Sciences, Inc.
PHARMACY
Pharmacist Participation3
While HB 2958 creates the pathway for any licensed and practicing pharmacist in Oregon to prescribe PrEP/PEP, the opt-in decision to do so is solely the pharmacist’s. Pharmacists should take into account factors such as staffing, financial viability, and the capacity of physical space to honor patient confidentiality when deciding to prescribe.
• The Oregon State University College of Pharmacy is in the process of creating a 2-hour, online, ACPE-accredited course designed to meet the Oregon Board of Pharmacy’s training program criteria
2 PROVIDING PrEP IN THE PHARMACY SETTING: OREGON EDITION For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources
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 Oregon, the rate of new HIV diagnosis among those ≥13 years of age was 5.0/100,000 population.5
Although Black and Latinx communities account for about 15% of the state population, they account for about 30% of all people with new diagnoses of HIV. 3
HOW Required Training3 In order to start prescribing PrEP and PEP, the OBOP requires that pharmacists “complete a comprehensive training program related to the prescribing and dispensing of HIV prevention medications, to include related trauma informed care.” It is the responsibility of the pharmacist to determine if a training program meets these criteria prior to participating.
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. 2 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
• 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 (a link to the Monograph is at the end of this Primer).
Insurance3
The law requires insurers to reimburse pharmacists for their time prescribing PrEP and PEP at the same rate they would reimburse any other health care provider. HB 2958 made counseling for and prescribing PrEP and PEP billable services for pharmacists, which may provide a critical financial incentive to offer PEP and PrEP.
WHY 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 important.11 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.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. Finally, this state primer on Oregon PEP/PrEP practice contains those policies and procedures necessary for Oregon pharmacists that would not be included in the US-based, comprehensive monograph.
Training Options
a.
1. PEP Self-Screening Patient Intake Form a. Basic patient information b. Assessment to determine the details and risk level of the exposure to HIV c. Medical history
1. PrEP Self-Screening Patient Intake Form
Record Keeping12 Pharmacists are required to maintain all records associated with prescribing and other related activities for a minimum of 10 years. Copies must be made available to the patient and provider upon request. Pharmacy records must be retained and made available to the Board for inspection upon request. Records must be stored on-site for at least 1 year, and then may be stored securely off-site, as long as they can be retrieved within 3 business days. Records and documentation can be written, electronic, or a combination of the two.
a. Basic patient information b. HIV risk assessment c. Medical history d. Patient acknowledgment of risk and responsibilities in relation to screening
3. PEP Prescription a. Optional prescription form 4. Patient Information, PEP for HIV a. Detailed patient handout explaining the medication and directions, and follow-up and next steps
3. PrEP Prescription a. Optional prescription form 4. PrEP Provider Notification Form a. Notification to the patient’s provider that they are taking PrEP b. Summary of treatment regimen c. Test results HIV PEP Protocol
PrEP & PEP Statewide Drug Therapy Management Protocols13
2. PrEP Assessment and Treatment Care Pathway Risk factors that may indicate the patient is a for PrEP to initiating PrEP
good candidate
3
b. Laboratory tests necessary prior
The OBOP has developed 2 statewide drug therapy management protocols, one for PrEP and one for PEP, for pharmacists to use when assessing patients and prescribing medication. HIV PrEP Protocol
and frequency thereafter c. Referral conditions and considerations d. Considerations for selecting the appropriate oral PrEP regimen
2. PEP HIV Assessment and Treatment Care Pathway a. Specific questions and information about the exposure b. Approved PEP regimen c. Counseling points d. Pharmacist mandatory follow-up
5. Provider Notification, PEP for HIV a. Notification to the patient’s provider that they are taking PEP b. Specific drug regimen c. Drug safety information, potential contraindications and drug-drug-interactions d. Recommended labs to be ordered at 6 weeks and/or 3 months after the initiation of PEP Protocol.pdfresourcePDF/prep/OR_PrEP_https://exchangecme.com/ Download a printable version of the OBOP HIV PrEP Protocol Protocol.pdfresourcePDF/prep/OR_PEP_https://exchangecme.com/ Download a printable version of the OBOP HIV PEP Protocol
HB 2958 also requires insurers to cover PEP and at least 1 form of PrEP without prior authorization and regardless of whether the prescribing pharmacist is in-network. Health Maintenance Organizations (eg, Kaiser Permanente) are exempt from the prohibition on network restrictions).
Pharmacists are subject to state reporting laws for positive results on any test they order or perform, including HIV tests. Any positive test results for chlamydia, gonorrhea, HIV, hepatitis B, or syphilis are required to be reported to the patient’s local health department or the Oregon Health Authority within 1 business day. Patients should be referred to their primary care provider or local health department for follow-up care and treatment if the results for any of these infections are positive or indeterminate.
PrEP Prescribing3,13 Pharmacists completing a training program can prescribe up to a 90-day prescription of PrEP.
For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources
Positive Test Results
1. HIV antigen/antibody (Ag/Ab) (4th gen) — every 90 days 2. Syphilis/treponemal antibody — every 90-180 days depending on risk 3. Chlamydia/gonorrhea (urinalysis, pharyngeal, and/or rectal depending on sexual behaviors) — every 90-180 days depending on risk 4. Hepatitis B surface antigen — at initial intake only 5. Hepatitis C surface antigen — at initial intake and annually thereafter 6. Creatinine clearance — at initial intake and annually thereafter
PrEP Labs and Initiation3,13
The prescribing pharmacist is required to:
• Pharmacists can prescribe tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and tenofovir alafenamide (TAF)/FTC, but at this time they are not allowed to administer cabotegravir long-acting injectable for PrEP
• If all labs are complete, the pharmacist may prescribe PrEP
1. Identify a provider for patient follow-up and communicate appropriate follow-up instructions to that provider
2. Contact the patient 1 month after prescribing to advocate for appropriate provider follow-up If an HIV test is not performed by the prescribing pharmacist, one should be conducted by the provider to which the patient is referred along with all other labs associated with PEP follow-up
• If just the HIV test is complete, and the results are nonreactive (ie, the patient is HIV-negative) the pharmacist may prescribe PrEP, but the patient needs to complete all other required labs and bring them in to the pharmacy within 30 days
PEP Labs and Initiation3,13 Labs for Prescribing PEP Pharmacists have the option of performing a fourth-generation point-of-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.
• In addition, a pharmacist may prescribe, dispense, and administer up to a 30-day supply of a PrEP therapy to a patient based solely on a negative HIV test, however, the patient must complete and bring in the results of all required labs within 30 days3,12
• If the HIV test has been performed and the results are reactive or indeterminate, the pharmacist may not prescribe PrEP, and the patient should be referred to a health care provider
Although Oregon pharmacists do not have independent statutory authority to order, perform, and receive the results of clinical laboratory tests, authority can be granted as part of a statewide drug therapy management protocol. Both the PrEP and PEP protocols give pharmacists authority to perform fourth-generation point-of-care HIV tests.12 Community pharmacies must have a CLIA waiver in order to perform CLIA waived fourth-generation point-of-care HIV tests on-site. Labs for Prescribing PrEP
4 PROVIDING PrEP IN THE PHARMACY SETTING: OREGON EDITION
The OBOP protocol states that the required laboratory tests for PrEP initiation and/or management include the list below. Results from HIV tests performed elsewhere must have been performed within a 14-day period prior to prescribing and dispensing.
• The exposure occurred >72 hours ago; PEP is time sensitive and must be started as soon as possible
PEP Prescribing and Follow-up3,13
• Treponema pallidum antibody as appropriate
• Pregnancy test as appropriate
Oregon AIDS Education & Training Center (AETC) manages Oregon’s PrEP prescriber list and offers free trainings and resources to health care professionals in Oregon and southwest Washington. https://www.oraetc.org/
• The patient has a history of known hepatitis B infection
PEP Follow-up13 The prescribing pharmacist is required to
• Hepatitis B surface antigen and surface antibody • Hepatitis C antibody
Pharmacists completing a training program can prescribe a 30-day prescription of PEP. PEP Should NOT Be Initiated if
5
1. Contact the patient: a. Provide a written individualized care plan to each patient b. 1 month after prescribing to advocate for appropriate provider follow-up after completion of the regimen
• HIV antigen/antibody test
2. Notify the patient’s health care provider: a. Provide written notification of the PEP prescription b. Facilitate establishing care for baseline testing c. Recommend they see the patient within 1-2 weeks of starting HIV PEP d. Recommend ordering the following labs at 6 weeks after starting HIV PEP
• Hepatitis C antibody Resources
• Sexually transmitted infection (STI) screening e. Recommend ordering the following labs at 3 months after starting PEP
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
• HIV antigen/antibody test
For one-on-one education and technical assistance related to pharmacist-prescribed PrEP and PEP in Oregon, pharmacists can schedule a brief virtual check-in with Oregon AETC faculty. To utilize this free resource, visit: https://www.oraetc.org/prescriber-support and schedule with Devon Flynn, PharmD. To locate county-specific resources relevant to patients accessing PrEP and PEP in pharmacy settings, visit: https://www.oraetc.org/pep and https://www.oraetc.org/prep
• Metabolic panel
Providing PEP/PrEP in the Pharmacy
12. Oregon Laws. Oregon Board of Pharmacy Rule 855-020-0110. Prescribing practices. https://oregon.public.law/rules/oar_855020-0110. Accessed June 13, 2022.
CEUs)
13. Oregon Board of Pharmacy. Public Health & Pharmacy Formulary Advisory Committee. HIV PEP/HIV PrEP Protocols. https://www.oregon. gov/pharmacy/Pages/PFAC.aspx. Accessed June 24, 2022. Setting: A Comprehensive User Guide (0.20 from the Accreditation Council for 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. Participants must complete the preactivity questionnaire, complete and receive minimum score 70% on the posttest,and complete the program evaluation online www.ExchangeCME.com/PrEPpharmacyMonograph Estimated complete hours. Melissa Badowski PharmD, MPH, FCCP, FIDSA, BCIDP, BCPS, AAHIVP Clinical SectionAssociateInfectious Diseases DepartmentPharmacotherapyofPharmacy Practice University of Illinois Chicago College of Pharmacy Chicago, Illinois Shauna Applin ARNP, AAHIVMsCNM, ClinicalMedicine 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 provided Education IntegritasCommunications.supported grant Sciences,
8. Smith DK, et al. MMWR Morb Mortal Wkly Rep. 2015;64(46):12911295.
1. CDC. Pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP). Updated September 2020. 24,gov/hiv/clinicians/prevention/prep-and-pep.html.https://www.cdc.AccessedMay2022.
REFERENCES
10. HIV.gov. Overview: what is ending the HIV epidemic in the U.S.? Updated June 2021. ending-the-hiv-epidemic/overview.https://www.hiv.gov/federal-response/AccessedMay24,2022.
PROVIDING PrEP IN THE PHARMACY SETTING: OREGON EDITION CALLING ALL PHARMACISTS! COMPREHENSIVE MONOGRAPH MEETS ALL OF YOUR BOARD 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
9. Highleyman L. PrEP use growing in US, but not reaching all those in need. aidsmap. 2018. entire%20four%2Dyear%20period.need#:~:text=The%20CDC%20estimates%20that%2085,the%20mar-2018/prep-use-growing-us-not-reaching-all-those-https://www.aidsmap.com/news/AccessedMay24,2022.
Pharmacy Education.
11. Tung EL, et al. Sex Health. 2018;15(6):556-561.
is an electronic/downloadable monograph that delivers 2.0 contact hours
4. Oregon Legislative Assembly. House Bill 2958. ment/HB2958.oregonlegislature.gov/liz/2021R1/Downloads/MeasureDocuhttps://olis.AccessedJune10,2022.
2. CDC. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupa tional Exposure to HIV—United States, 2016. Accessedhiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf.https://www.cdc.gov/2016.May24,2022.
3. Oregon Statewide PrEP/PEP Workgroup. Pharmacist prescribed PrEP and PEP in Oregon. Draft. September 30, 2021. pdf.Overview_of_Pharmacist_Prescribed_PrEP_and_PEP_in_Oregon.TITIS/HIVPREVENTION/Documents/PrEP%20and%20PEP/oregon.gov/oha/PH/DISEASESCONDITIONS/HIVSTDVIRALHEPAhttps://www.AccessedJune10,2022.
5. CDC. HIV Surveillance Report. Diagnoses of HIV Infection in the United States and Dependent Areas, 2020; vol 33. Published May 2022. Junecdc-hiv-surveillance-report-2020-updated-vol-33.pdf.https://www.cdc.gov/hiv/pdf/library/reports/surveillance/Accessed13,2022.
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.
7. US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States—2021 Update. A Clinical Practice Guideline. prep/cdc-hiv-prep-guidelines-2021.pdf.https://www.cdc.gov/hiv/pdf/risk/AccessedMay24,2022.
