WHAT
On January 1, 2023, an amendment to the Illinois Pharmacy Practice Act, IL HB4430, became effective, which expanded the definition of “practice of pharmacy” to include the initiation, dispensing, or administration of drugs, laboratory tests, assessments, referrals, and consultations for HIV preexposure prophylaxis (PrEP) and postexposure prophylaxis (PEP).
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 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.1,2
According to IL HB4430, pharmacists are authorized to initiate PrEP and PEP by providing consultations and ordering HIV tests. They can also make referrals for patients to seek additional services for care and treatment. The act states 3:
“A pharmacist may provide initial assessment and dispensing of prophylaxis drugs for PEP and PrEP. If a patient’s HIV test results are reactive, the pharmacist shall refer the patient to an appropriate healthcare professional or clinic. If the patient’s HIV results are nonreactive, the pharmacist may initiate HIV PrEP or PEP to eligible patients.”
The bill can be found here: https://www.ilga.gov/ legislation/102/HB/PDF/10200HB4430lv.pdf.3
COMPREHENSIVE MONOGRAPH MEETS ALL OF YOUR BOARD OF PHARMACY REQUIREMENTS TO PRESCRIBE P rEP/PEP!
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 Illinois had an overall high rate (10/100,000 population) of people newly diagnosed with HIV. Cook County had the highest rate of newly diagnosed people in the state, 19/100,000 population, according to preliminary 2021 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 atrisk 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.1
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.1,2
WHO
Illinois-licensed pharmacists may dispense PrEP and PEP without prior authorization from a physician; however, pharmacy technicians are not authorized to dispense PrEP and PEP in Illinois.
HOW Standing Order
Pharmacists must have a standing order from a physician who is licensed to practice medicine in all its branches, or the medical director of the county or local health department, which allows
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.1,7 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
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 1 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 day-to-day practice. Finally, this state primer on Illinois PrEP/PEP practice contains state-specific policies and procedures necessary for Illinois pharmacists that would not be included in the US-based, comprehensive monograph.
Training
Pharmacists must complete an educational training program that is accredited by the Accreditation Council for Pharmacy Education related to the initiation, dispensing, or administration of drugs, laboratory tests, assessments, referrals, and consultations for HIV PrEP and PEP.
the pharmacist to offer care to patients who are seeking HIV care and medication. The legislation of HB4430 elaborates that the standing order must be consistent with the current version of the guidelines of the CDC, guidelines of the US Preventive Services Task Force, or generally
Example of a Standing Order
Test Results
Pharmacists may order and receive results of clinical laboratory tests.
The legislation does not specify what type of HIV test is required but it states that pharmacists must follow current guidelines. According to the CDC 2021 updated guidelines on PrEP for HIV prevention, the preferred test to be performed before initiating PrEP is an HIV antigen/antibody fourth-generation test.1
A pharmacist may provide initial assessment and dispensing of PrEP and PEP based on patient’s HIV test results. If reactive, the pharmacist must refer the patient to an appropriate healthcare professional or clinic. If nonreactive, the pharmacist may initiate HIV PrEP or PEP.
Communication With Patient’s Primary Healthcare Provider
A pharmacist must communicate the services provided under the provisions to the:
• Patient
• Patient’s primary healthcare provider or other healthcare provider or clinic, if known
If the patient does not give the name of a healthcare provider, the pharmacist must:
• Give the patient a list of primary healthcare providers or clinics in the area
However, the patient does not need to have a primary healthcare provider before PrEP and PEP can be prescribed, nor does the pharmacist need to coordinate care with a patient’s primary healthcare provider.
Sharing of Information
Pharmacists must document and retain the documentation of PrEP and PEP services in a confidential manner consistent with state HIV confidentiality requirements. The confidentiality requirements are outlined in the Public Health (410 ILCS 305) AIDS Confidentiality Act.11 Documentation and retention must take place in a private manner.
Sharing of information, as authorized in Section 2.1 of the Department of Public Health Act, is not prohibited.12
recognized evidence-based clinical guidelines. Although the legislation in HB4430 states that a standing order should come from a physician or a regional jurisdiction (ie, the county health department) rather than a statewide order, it does not specify whether a standing order must name the specific pharmacist(s) it applies to.
Reimbursement and Payment
The Illinois Public Aid Code was amended to allow HIV PrEP and PEP provided by a pharmacist to be covered by healthcare plans if:
• The pharmacist meets the requirements in the Pharmacy Practice Act
• The healthcare plan provides coverage for the same services provided by other healthcare professionals
• The pharmacist is included in the health plan’s network
• The reimbursement has been negotiated between the pharmacist and the health plan
REFERENCES
1. 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 August 10, 2023.
2. 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 10, 2023.
3. Illinois General Assembly. HB4430 Enrolled. https://www.ilga.gov/legislation/102/ HB/PDF/10200HB4430lv.pdf. Accessed August 10, 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 Living With HIV, 2020. https://map.aidsvu.org/map. Accessed July 20, 2023.
Subject to federal approval by the Centers for Medicare and Medicaid Services (CMS), Illinois Medicaid coverage is expanded to include PrEP and PEP services by pharmacists. The legislation also specifies that when these services are provided by a pharmacist, the care must be covered and reimbursed by insurance.3 Under this coverage expansion, patient care services ordered and administered by a pharmacist shall be covered and reimbursed at no less than 85% of the rate that the services are covered and reimbursed when ordered or administered by physicians.3
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. Illinois General Assembly. Public Health (410 ILCS 305) AIDS Confidentiality Act. https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1550&ChapterID=35. Accessed August 20, 2023.
12. Illinois General Assembly. Executive Branch (20 ILCS 2305/) Department of Public Health Act. (Part 1). https://www.ilga.gov/legislation/ilcs/ilcs3. asp?ActID=330&ChapterID=5. Accessed August 20, 2023.