Providing PEP/PrEP in the Pharmacy Setting: Illinois Edition

STATE PrEP/PEP PRIMER

PROVIDING PrEP/PEP IN THE PHARMACY SETTING ILLINOIS EDITION

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 states3: “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

CALLING ALL PHARMACISTS! Launch Date: August

3, 2023

Expiration Date:

August 3, 2024

Target Audience

the activity addresses design of this pharmacists involved The educational and community needs of clinical for HIV. patients at risk in the care of

HOW TO OBTAIN CREDIT

questionnaire, complete the preactivity the score of 70% on Participants must receive a minimum evaluation online at complete and the program . posttest, and complete PrEPPharmMonograph

www.ExchangeCME.com/activity is 2 hours.

Estimated time

to complete this

Arsalan “RC” PharmD, MBA

Shah,

of Pharmacy Senior Director Central City Concern Portland, Oregon

Group and

by Global Education jointly provided This activity is Sciences, Inc. Integritas Communications. grant from Gilead an educational supported by This activity is

COMPREHENSIVE MONOGRAPH MEETS ALL OF YOUR BOARD OF PHARMACY REQUIREMENTS TO PRESCRIBE PrEP/PEP! www.ExchangeCME.com/PrEPPharmMonograph

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 IN THE PHARMACY SETTING: ILLINOIS EDITION

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 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

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.

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.

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.

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 2

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

For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources

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.

Example of a Standing Order

▪

Notification

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.

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 the 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 2021-110 HouseBill 96 This order is effective immediately upon signing and may be revised or revoided by the State Health Director according to his/her discretion. This order shall remain in effect until the later of the development of the protocols described in Section 4(a) Session Law 2021-110 HouseBill 96 or January 1, 2023.

Contraindication s Precautions Safety Evaluation

Medication Dispensing

- 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 ▪ Patient self-reports, or if a point-of-care HIV test is positive ▪ > 72 hours since exposure ▪ Known or suspected reduced renal function ▪ Pregnancy (known or suspected) and breastfeeding ▪ Follow the guidance given in the sections below for each of these considerations ▪ 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.

28-Day Regimen Alternative 28-Day Regimen (See ‘How Supplied’ Below) (See ‘How Supplied’ Below) Individuals 13 years and older (Including Pregnant Patients) tenofovir disoproxil fumarate 300 mg with emtricitabine tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg once daily 200 mg once daily plus plus raltegravir 400 mg twice daily OR dolutegravir* 50 mg daily darunavir 800 mg AND ritonavir 100 mg once daily

How Supplied

(*Do not use dolutegravir in patients who are pregnant or have the potential to become pregnant)

Medications should be dispensed in accordance with manufacturer requirements. Some products require dispensing in unopened original containers, which may require the dispensing of a 30-day supply. A 30-day supply is allowed pursuant to this standing order.

Refills None. No limit on how many courses per patient per year (see Patient Education section for addressing risk mitigation).

North Carolina State Health Director’s Standing Order for Patient ▪ Medication Education Post Exposure Prophylaxis for Human Immunodeficiency Virusduration (HIV) is 28 days.

Education - When 30-day supply is(PEP) dispensed, emphasize the minimum treatment March 28, side 2022 - Drug information sheets that include 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 Patient Education adverse drug event.

- An offersigned to counsel made in accordance with standard Northimmunizing Carolina pharmacy practice Pursuant to S.L. 2021-110, this standing order, by theshould Northbe Carolina State Health Director, authorizes pharmacists practicing ▪ Risk Mitigation pharmacy in the state of North Carolina and licensed by the North Carolina Board of Pharmacy to dispense, deliver, or administer PEP therapy - Educational material on PEP should be provided products as directed below.

- Educational material on behaviors to avoid HIV exposure should be offered - Pre-exposure Prophylaxis Education HIV PEP(PrEP) Dispensing Protocol ▪ toThis should be considered when: Exposure ▪ Communicate with the patient identify when the exposure took place ● Antook individual who reports behaviors that place them riskpatient for frequently Timeline ▪ Assess the length of time since the exposure place to determine if initiationorofsituation PEP is recommended or ifatthe occurring HIV exposure (e.g. injection drug use, section sex without condoms or other high-risk should be referred to a medical care provider as outlined in the Eligibility & Risk Screening sexual behavior - 72 hours or less: continue screening process More than stop, 1 course PEP therapy has on been within aon year - Greater than 72 hours: screening ●process should but of provide education thedispensed lack of evidence ▪ If appropriate, education on PrEP andprovider the benefits to use should be provided effectiveness of PEP initiation after 72 hourswritten/verbal and refer patient to a medical care for HIV screening ▪ HIVthe testing ▪ Discuss with patient the effectiveness of PEP based on time of initiation since exposure ▪ Each patient who receives PEP therapy shall educated Efficacy on the importance Time Since Exposure (Hours) CDCbeGuidelines Evaluation of having a test to 0-72 determine their HIV infection status.

Effective ▪ 72 Pharmacist shall educate the patient on self-test HIV kitSupporting and local HIV testing site options.

More than No Evidence 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

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

3

PROVIDING PrEP IN THE PHARMACY SETTING: ILLINOIS EDITION

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

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

• The reimbursement has been negotiated between the pharmacist and the health plan

REFERENCES 1.

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 August 10, 2023.

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.

4

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.

For PEP/PrEP clinical resources, including practice guidelines, organizations, patient resources, and suggested readings, visit ExchangeCME.com/PrEPPharmacyResources