Providing PEP/PrEP in the Pharmacy Setting: Illinois Edition by Integritas Communications

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!

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/PEP IN THE PHARMACY SETTING ILLINOIS EDITION STATE PrEP/PEP PRIMER www.ExchangeCME.com/PrEPPharmMonograph

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CALLING

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

2 PROVIDING PrEP IN THE PHARMACY SETTING: ILLINOIS EDITION For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources

WHY

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.

Pharmacist shall educate the patient that if their HIV test is positive, they should discontinue taking PEP and seek care from a medical provider for treatment. Emphasize the importance of receiving follow-up care from a medical provider to allow for: - Signs and symptoms of acute HIV infection - Full evaluation of the exposure - Receipt of HIV testing - Information on resources available for HIV exposure Inform the patient of the importance of completing the full 28-day course of PEP therapy unless directed otherwise by a medical provider Patients who report intravenous drug use should be assessed for their interest in substance use disorder treatment and information on services should be made available for those who desire treatment. Information on safer syringe use should be shared for those who continue to inject or who are at risk for relapse. Notification Pharmacists choosing to dispense PEP under the authority of this standing order shall notify the patient’s primary care provider within 72 hours of providing therapy Notification should include the pharmacist’s name and NPI #, and the pharmacy/practice name and phone number, exposure history and medicines dispensed. If the patient does not have a primary care provider, the pharmacist shall counsel he patient regarding the benefits of establishing a relationship with a primary care provider, and provide information regarding primary care providers, including private practices federally qualified health centers, free clinics, or local health departments serving the area in which the patient is located. Approved by: ___ _________________________________ Date signed: ____3-28-22 Elizabeth Cuervo Tilson, MD, MPH NPI: 1760540421 (Legal Authority Session Law 2021 State Health Director according to his/her discretion. This order shall remain in effect until the later of described in Section 4(a) Session Law 2021 - If it is learned that the individual was a victim of sexual assault, refer to person to an emergency department or other medical facility specially trained for victims of sexual assault - In these instances, PEP may be initiated without delay, if no other contraindication, with referral for specialty care Contraindication s Patient self-reports, or if a point-of-care HIV test is positive > 72 hours since exposure Known or suspected reduced renal unction Precautions Pregnancy (known or suspected) and breastfeeding Follow the guidance given in the sections below for each of these considerations Safety Evaluation Obtain a list of all current medications the individual seeking PEP therapy is taking and perform a drug-drug interaction review - If no clinically-significant drug interactions between current medications and PEP: Proceed to dispense PEP therapy - If clinically-significant drug interactions between current medications and PEP: Step 1: Contact patient-authorized medical provider for guidance If the authorized medical provider is not available: Step 2: Contact the National Clinician Consultation Center (NCCC) Post-Exposure Prophylaxis Hotline at (888) 448-4911 If further guidance on dispensing PEP for this individual based on drug interactions is unavailable via the authorized provider or the NCCC PEP Hotline then Step 3: Refer the individual seeking PEP therapy to the Emergency Department or other medical provider If individual seeking PEP therapy is breastfeeding follow Step 1-3 as outlined in this section Medication Dispensing 28-Day Regimen (See ‘How Supplied’ Below) Alternative 28-Day Regimen (See ‘How Supplied’ Below) Individuals 13 years and older (Including Pregnant Patients) tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg once daily tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg once daily darunavir 800 mg AND ritonavir 100 mg once daily accordance with manufacturer requirements. Some products require dispensing in day supply is allowed pursuant Refills None. No limit on how many courses per patient per year (see Patient Education section for addressing risk mitigation). Patient Education Patient Education Medication Education - When 30-day supply is dispensed, emphasize the minimum treatment duration is 28 days. - Drug information sheets that include side effects and adverse drug events for each medication dispensed should be given at the time medication is dispensed and patient should be counseled on what to do if they experience an adverse drug event. - An offer to counsel should be made in accordance with standard North Carolina pharmacy practice Risk Mitigation - Educational material on PEP should be provided - Educational material on behaviors to avoid HIV exposure should be offered - Pre-exposure Prophylaxis (PrEP) Education This should be considered when: An individual who reports behaviors or situation that place them at risk for frequently occurring HIV exposure (e.g. injection drug use, sex without condoms or other high-risk sexual behavior ● More than 1 course of PEP therapy has been dispensed within a year If appropriate, written/verbal education on PrEP and the benefits to use should be provided HIV testing Each patient who receives PEP therapy shall be educated on the importance of having a test to determine their HIV infection status Pharmacist shall educate the patient on self-test HIV kit and local HIV testing site options. North Carolina State Health Director’s Standing Order for Post Exposure Prophylaxis (PEP) for Human Immunodeficiency Virus (HIV) March 28, 2022 Pursuant to S.L. 2021-110, this standing order, signed by the North Carolina State Health Director, authorizes immunizing pharmacists practicing pharmacy in the state of North Carolina and licensed by the North Carolina Board of Pharmacy to dispense, deliver, or administer PEP therapy products as directed below. HIV PEP Dispensing Protocol Exposure Timeline Communicate with the patient to identify when the exposure took place Assess the length of time since the exposure took place to determine if initiation of PEP is recommended or if the patient should be referred to a medical care provider as outlined in the Eligibility & Risk Screening section - 72 hours or less: continue screening process - Greater than 72 hours: screening process should stop, but provide education on the lack of evidence on effectiveness of PEP initiation after 72 hours and refer patient to a medical care provider for HIV screening Discuss with the patient the effectiveness of PEP based on time of initiation since exposure Time Since Exposure (Hours) CDC Guidelines Efficacy Evaluation 0-72 Effective More than 72 No Evidence Supporting Efficacy Eligibility & Risk Screening For individuals age 13 years or older who voluntarily request Post-Exposure Prophylaxis and meet criteria for PEP initiation. https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf This standing order may be used for persons < 18 years of age with a parent or legal guardian consent. The patient should be provided the Pharmacist-Initiated HIV Post-Exposure Prophylaxis Patient Questionnaire to screen the patient and to determine if an exposure occurred which would meet the criterial for PEP initiation - High risk: PEP is recommended Intercourse (receptive or insertive) with a person known to be HIV positive Needle sharing with a person known to be HIV positive Injuries with exposure to potentially infectious fluids (through eye, mucous membrane, percutaneous, or non-intact skin) of a person known to be HIV positive - Lower risk: recommendation of PEP should be evaluated on a case-by-case basis Intercourse (receptive or insertive) with a person with an unknown HIV status Mouth to vagina, penis, or anus contact (insertive or receptive) with a person known to be HIV positive Injuries with exposure to potentially infectious fluids (through eye, mucous membrane, percutaneous, or non-intact skin) of a person with unknown HIV status - For exposures determined to be lower risk, these additional risk factors should be assessed and the presence would weigh in favor of dispensing PEP therapy: Non-intact oral mucosa (i.e. cuts, sores) The presence of blood If either party had a genital ulcer If either party had a sexually transmitted infection If the other person had a detectable HIV viral load (>200 copies/mL) ▪ Determination of HIV status - Patient should be provided the Pharmacist-Initiated HIV Post-Exposure Prophylaxis Patient Questionnaire to selfreport if they have ever tested positive for HIV - All persons considered for PEP who do not self-report they have tested positive in the past should have determination of their HIV infection status by HIV testing, preferably by using rapid combined Ag/Ab or antibody blood tests including a rapid self-test. - If rapid HIV blood test results are unavailable, and PEP is otherwise indicated, it may be initiated without delay but should be discontinued if the patient is later determined to have HIV infection Sexual Assault

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.

4 PROVIDING PrEP IN THE PHARMACY SETTING: ILLINOIS EDITION For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources