SENATE . . . . . . . . . . . . . . No. 2480 The Commonwealth of Massachusetts _______________ In the One Hundred and Ninety-Third General Court (2023-2024) _______________ SENATE, October 19, 2023. The committee on Senate Ways and Means, to whom was referred the Senate Bill enabling pharmacists to prescribe, dispense and administer PrEP (Senate, No. 1353),- reports, recommending that the same ought to pass with an amendment substituting a new draft with the same title (Senate, No. 2480). For the committee, Michael J. Rodrigues 1 of 4 FILED ON: 10/19/2023 SENATE . . . . . . . . . . . . . . No. 2480 The Commonwealth of Massachusetts _______________ In the One Hundred and Ninety-Third General Court (2023-2024) _______________ An Act enabling pharmacists to prescribe, dispense and administer PrEP. Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority of the same, as follows: 1 SECTION 1. Section 1 of chapter 94C of the General Laws, as appearing in the 2022 2Official Edition, is hereby amended by inserting after the definition of “Extended-release long- 3acting opioid in a non-abuse deterrent form” the following 2 definitions:- 4 “HIV”, human immunodeficiency virus. 5 “HIV prevention drug”, a drug approved by the United States Food and Drug 6Administration for the prevention of HIV, including, but not limited to, pre-exposure 7prophylaxis. 8 SECTION 2. Said section 1 of said chapter 94C, as so appearing, is hereby further 9amended by inserting after the definition of “Practitioner” the following definition:- 10 “Pre-exposure prophylaxis”, a drug or drug combination that is taken or administered to 11reduce the risk of HIV contraction and meets the same clinical eligibility recommendations 12provided in current guidelines of the federal Centers for Disease Control and Prevention. 2 of 4 13 SECTION 3. Said chapter 94C is hereby further amended by inserting after section 21B 14the following section:- 15 Section 21C. (a) A licensed pharmacist may prescribe, dispense or administer HIV 16prevention drugs in accordance with regulations promulgated by the department and United 17States Food and Drug Administration guidance and product labeling; provided, however, that a 18pharmacist shall not furnish a 60-day supply of pre-exposure prophylaxis to a single patient more 19than once every 2 years; and provided further, that the patient: 20 (i) is HIV negative, as documented by a negative HIV test result obtained within the 21previous 7 days from an HIV antigen and antibody test or antibody-only test or from a rapid, 22point-of-care fingerstick blood test approved by the United States Food and Drug 23Administration; provided, however, that if the patient does not provide evidence of a negative 24HIV test in accordance with this clause, the pharmacist may order an HIV test prior to 25prescribing, dispensing or administering the drugs; provided further, that if the test results are not 26transmitted directly to the pharmacist, the pharmacist shall verify the test results to the 27pharmacist’s satisfaction prior to prescribing, dispensing or administering the drugs; and 28provided further, that if the patient tests positive for HIV infection, the pharmacist or person 29administering the test shall direct the patient to a primary care provider and provide the patient 30with a list of providers and clinics in the region; 31 (ii) does not report any signs or symptoms of acute HIV infection on a self-reported 32checklist of acute HIV infection signs and symptoms; and 33 (iii) does not report taking any contraindicated medication. 3 of 4 34 (c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs 35shall: 36 (i) provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, 37which may include education about side effects, safety during pregnancy and breastfeeding, 38adherence to recommended dosing and the importance of timely testing and treatment, as 39applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and 40pregnancy for individuals of child-bearing capacity; 41 (ii) notify the patient that the patient is required to be seen by a primary care provider to 42receive subsequent prescriptions for pre-exposure prophylaxis; 43 (iii) document, to the extent possible, the services provided to the patient by the 44pharmacist in the patient’s record in the record system maintained by the pharmacy and maintain 45records of pre-exposure prophylaxis furnished to each patient; and 46 (iv) notify the patient’s primary care provider that the pharmacist completed the 47requirements specified in this subsection; provided, however, that if the patient does not have a 48primary care provider or refuses consent to notify the patient’s primary care provider, the 49pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care 50service providers to contact regarding ongoing care for pre-exposure prophylaxis. 51 SECTION 4. Not later than 6 months after the effective date of this act, the department of 52public health shall promulgate regulations to establish statewide drug therapy protocols for 53prescribing, dispensing and administering pre-exposure prophylaxis and other HIV prevention 54drugs approved by the United States Food and Drug Administration that are consistent with 55federal Centers for Disease Control and Prevention guidelines. The regulations shall include, but 4 of 4 56not be limited to, rules stating that a pharmacist shall not furnish a 60-day supply of pre-exposure 57prophylaxis to a single patient more than once every 2 years.