WHAT
In January 2022, an amendment to the Utah State Pharmacy Practice Act, 58-17b-627(3)(a), which had been approved in the 2021 legislative session, became effective.
The language of the bill can be found here: https://le.utah.gov/xcode/Title58/Chapter17B/5817b-P6.html?v=C58-17b-P6_1800010118000101.1
Pre-exposure prophylaxis (PrEP) is the use of specific combinations of antiretroviral agents to
reduce the risk of HIV infection in appropriately identified and evaluated HIV-negative people, and post-exposure prophylaxis (PEP) uses specific combinations of antiretroviral agents to prevent infection in appropriately identified and evaluated HIV-negative people who have had a single exposure that presents a substantial risk for HIV acquisition. 2,3
WHY
Approximately 1.2 million people in the United States are living with HIV today, with 13% of individuals unaware of their positive HIV status. Latest data from the Centers for Disease Control and Prevention (CDC) indicate that there were 36,136 new reported HIV infections in the United States in 2021.4,5 While Utah overall had a low rate (5/100,000 population) of new HIV infections, Salt Lake County (the most populous county in Utah) had the highest rate, 7.9/100,000 population, according to preliminary 2020 data.6
PrEP is intended for HIV-negative individuals who are at risk of infection through sexual intercourse or injection drug use. An individual is considered at risk if they engage in vaginal or anal sex, including men who have sex with men, heterosexual men and women, and transgender individuals and/or they inject substances.2
In contrast, although PEP is also for HIV-negative individuals who are at risk, 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. Offer PrEP to individuals who continue to be at risk of acquiring HIV after receiving PEP or who have received multiple PEP prescriptions within a short time frame.2,3
HOW
Although PrEP is highly effective and can reduce the risk of acquiring HIV by 99% when taken as prescribed, it remains underutilized in the United States.2,7 Because 85% to 90% of PrEP prescriptions are filled at community pharmacies, pharmacists have the capability to help end the HIV epidemic by 2030.8,9 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.10
PrEP Initiation and Follow-Up Care
Pharmacists should be aware of the recently updated CDC guidelines and recommendations for PrEP implementation, titled Preexposure Prophylaxis for the Prevention of HIV Infection in the US—2021 Update: A Clinical Practice Guideline. 2 In addition, the monograph and CE activity, PEP/PrEP in the Pharmacy Setting: A Comprehensive User Guide 2023, present the clinical and administrative tasks necessary to implement PrEP and PEP in dayto-day practice. Finally, this state primer on Utah PEP/PrEP practice contains state-specific policies and procedures necessary for Utah pharmacists that would not be included in the US-based, comprehensive monograph.
A pharmacist may prescribe a prescription drug or device within the scope of the pharmacist’s training and experience and must follow Section 627 of the Utah Pharmacy Practice Act, Prescription of Drugs or Devices by a Pharmacist. In order to help pharmacists comply with Utah Code § 58-17b-627, and in accordance with the 2021 updated CDC PrEP guidelines, the Utah Guidance for Pre-Exposure and PostExposure Prophylaxis of HIV is a protocol that was developed for prescribing pharmacists. The protocol outlines the indications, baseline laboratory testing, prescribing, and follow-up requirements for pharmacists prescribing PrEP and PEP. The Utah guidance can be found here: https://www.dopl.utah.gov/ wp-content/uploads/2022/09/utah-guidance-for-pre-exposure-and-post-exposure-prophylaxis-of-hiv. pdf, and includes the following screening and notification forms for both PrEP and PEP to assist pharmacists with initiating and prescribing11:
• Self-Screening Patient Intake Form
• Assessment and Treatment Care Pathway
• Provider Fax
Oral PrEP Initiation and Management
1. Assessment of HIV and sexually transmitted infection (STI) risk factors:
– Screening forms are provided to guide the evaluation of patients’ risk of acquiring HIV.
– The patient should complete the Pre-Exposure Prophylaxis (PrEP) Self-Screening Patient Intake Form. The pharmacist must complete the section in the Pre-Exposure Prophylaxis (PrEP) Assessment and Treatment Care Pathway on Background Information/HIV and STI Risk Factors.
2. Once the pharmacist and patient have completed the aforementioned, the pharmacist must ensure that the appropriate laboratory tests are complete. The following tests and checks are listed in the Pre-Exposure Prophylaxis (PrEP) Assessment and Treatment Care Pathway:
a. HIV test antigen/antibody (fourth-generation) test
b. Syphilis/Treponemal antibody
c. Hepatitis B surface antigen test
d. Gonorrhea/Chlamydia test
e. Renal function test
f. Evaluation for any signs and symptoms of an STI not otherwise specified
g. Ask if the patient had condomless sex in the past 2 weeks
Positive, Reactive, or Indeterminate Results
– Do not prescribe PrEP if the HIV antibody/antigen fourth-generation test result is reactive or indeterminate.
– A reactive treponemal antibody test result should be referred to the county health department or the patient’s primary care provider for follow-up and confirmatory testing.
– A positive hepatitis B surface antigen indicates either acute or chronic hepatitis B and the patient should be referred to the county health department or a specialist physician.
– All reactive or indeterminate chlamydia and/or gonorrhea results must be referred to the county health department or the patient’s healthcare provider for evaluation and treatment.
– Renal function as indicated by estimated creatinine clearance (eCrCl):
• >60 mL/min/1.73 m2 denotes kidney function adequate for PrEP
• 30-60 mL/min/1.73 m2: only tenofovir alafenamide/emtricitabine (TAF/FTC) is indicated
• <30 mL/min/1.73 m2: refer for evaluation/follow-up
Note: Concurrent nonsteroidal anti-inflammatory drug (NSAID) use would favor TAF/FTC.
3. Complete the Medical History checklist in the Pre-Exposure Prophylaxis (PrEP) Assessment and Treatment Care Pathway, which reviews referral conditions and considerations for pharmacist prescribing of PREP. If a patient has 1 or more contraindications that are listed on the checklist, the pharmacist must refer the patient to a specialist for consultation or management of PrEP.
4. Provide a 90-day prescription of oral PrEP medication to the patient that includes information about the drug dispensed or administered. A sample prescription form is included in the Pre-Exposure Prophylaxis (PrEP) Assessment and Treatment Care Pathway.
The pharmacist must notify the patient’s primary care or other healthcare provider about the prescription or, if the patient does not have a healthcare provider, provide written notification to the patient. A sample Provider Notification form is included in the Pre-Exposure Prophylaxis (PrEP) Assessment and Treatment Care Pathway.
5. Monitor PrEP by conducting and/or reviewing results of HIV testing, STI testing, and baseline testing as part of the patient assessment. The patient’s healthcare provider may take over management of the patient’s PrEP at any time.
PEP Initiation and Follow-Up Care
1. Assessment of risk of acquiring HIV:
– Screening forms are provided to guide the evaluation of patients’ risk of acquiring HIV.
– The patient should complete the Post-Exposure Prophylaxis (PEP) Self-Screening Patient Intake Form. The form includes questions about the possible exposure to HIV and about the patient’s medical history.
2. The pharmacist must complete the Post-Exposure Prophylaxis (PEP) of Human Immunodeficiency Virus (HIV) Assessment and Treatment Care Pathway on Background Information/HIV and STI Risk Factors. The pathway includes an algorithm with a series of questions about the patient’s potential exposure and medical history and determines whether PEP prescription is recommended, depending on the answers.
Pharmacist Mandatory Follow-Up
The pharmacist must do the following:
1. Contact the patient’s primary care provider or other appropriate provider to send written notification of PEP prescription and to facilitate establishing care for baseline testing, such as renal function, HIV Ag/Ab fourth-generation test, liver function, and hepatitis B serology.
2. Provide a written individualized care plan to the patient.
3. Contact the patient approximately 1 month after the initial prescription to advocate for appropriate provider follow-up after completing the regimen.
The Post-Exposure Prophylaxis (PEP) of Human Immunodeficiency Virus (HIV) Assessment and Treatment Care Pathway provides a sample PEP prescription form and a take-home Patient Information form that includes details about the medication prescribed and dosing regimen, the importance of adherence to the regimen, potential common side effects, and notification to avoid taking NSAIDs while taking PEP.
The notification also provides details about follow-up and next steps, including what laboratory tests must be completed by the patient’s healthcare provider. The notification recommends that if a patient feels they may still be at risk of HIV infection after completing a course of PEP, they should speak with their healthcare provider about transitioning to PrEP.
Finally, the Post-Exposure Prophylaxis (PEP) of Human Immunodeficiency Virus (HIV) Assessment and Treatment Care Pathway provides a Provider Notification form, with details about the PEP prescription and the recommended follow-up labs at 6 weeks and 3 months after PEP initiation.
REFERENCES
1. Utah State Legislature. Regulation of the Practice of Pharmacy Operating Standards. https://le.utah.gov/xcode/Title58/Chapter17B/58-17b-P6.html?v=C5817b-P6_1800010118000101. Accessed August 16, 2023.
2. Centers for Disease Control and Prevention. 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 June 7, 2023.
3. Centers for Disease Control and Prevention, US Department of Health and Human Services. 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-npepguidelines.pdf. Accessed August 16, 2023.
4. Centers for Disease Control and Prevention. HIV Surveillance Report. https://www.cdc. gov/hiv/library/reports/hiv-surveillance/vol-34/index.html. Accessed July 20, 2023.
5. HIV.gov. U.S. Statistics. https://www.hiv.gov/hiv-basics/overview/data-and-trends/ statistics/. Accessed July 20, 2023.
6. AIDSVu. Rates of Persons Newly Diagnosed With HIV, 2020. https://map.aidsvu. org/map. Accessed July 20, 2023.
7. Mayer KH, Agwu A, Malebranche D. Barriers to the wider use of pre-exposure prophylaxis in the United States: a narrative review. Adv Ther. 2020;37(5):1778-1811.
8. Highleyman L. PrEP use growing in US, but not reaching all those in need. https:// www.aidsmap.com/news/mar-2018/prep-use-growing-us-not-reaching-all-thoseneed. Accessed July 20, 2023.
9. HIV.gov. What is ending the HIV epidemic in the US? https://www.hiv.gov/federalresponse/ending-the-hiv-epidemic/overview. Accessed July 20, 2023.
10. Tung EL, Thomas A, Eichner A, Shalit P. Implementation of a community pharmacybased pre-exposure prophylaxis service: a novel model for pre-exposure prophylaxis care. Sex Health. 2018;15(6):556-561.
11. State of Utah Department of Commerce Division of Occupational and Professional Licensing. Utah Guidance for Pre-Exposure and Post-Exposure Prophylaxis of HIV. https://www.dopl.utah.gov/wp-content/uploads/2022/09/utah-guidance-for-preexposure-and-post-exposure-prophylaxis-of-hiv.pdf. Accessed July 23, 2023.