Amendment 1

FILED ON: 6/24/2022

SENATE . . . . . . . . . . . . . . No. 2955

The Commonwealth of Massachusetts

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In the One Hundred and Ninety-Second General Court
(2021-2022)

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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:

SECTION 1. Section 1 of chapter 94C, as appearing in the 2020 Official Edition, is hereby amended by inserting after the definition of “Extended-release long-acting opioid in a non-abuse deterrent form” the following 2 definitions:-

“HIV”, human immunodeficiency virus.

“HIV prevention drug”, a drug approved by the United States Food and Drug Administration for the prevention of HIV, including, but not limited to, pre-exposure prophylaxis.

SECTION 2. Said section 1 of said chapter 94C, as so appearing, is hereby further amended by inserting after the definition of “Practitioner” the following definition:-

“Pre-exposure prophylaxis”, a drug or drug combination that is taken or administered to reduce the risk of HIV acquisition and meets the same clinical eligibility recommendations provided in current guidelines of the federal Centers for Disease Control and Prevention.

SECTION 3. Said chapter 94C is hereby further amended by inserting after section 21B the following section:-

Section 21C. (a) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs in accordance with regulations promulgated by the department as set forth in this section.

(b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs according to United States Food and Drug Administration guidance and product labeling if the patient:

(i) is HIV negative, as documented by a negative HIV test result obtained within the previous 7 days from an HIV antigen and antibody test or antibody-only test or from a rapid, point-of-care fingerstick blood test approved by the United States Food and Drug Administration; provided, however, that if the patient does not provide evidence of a negative HIV test in accordance with this clause, the pharmacist may order an HIV test prior to prescribing, dispensing or administering the drugs; provided further, that if the test results are not transmitted directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction prior to prescribing, dispensing or administering the drugs; and provided further, that if the patient tests positive for HIV infection, the pharmacist or person administering the test shall direct the patient to a primary care provider and provide the patient with a list of providers and clinics in the region;

(ii) does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms; and

(iii) does not report taking any contraindicated medication.

(i) provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, which may include education about side effects, safety during pregnancy and breastfeeding, adherence to recommended dosing and the importance of timely testing and treatment, as applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and pregnancy for individuals of child-bearing capacity;

(ii) notify the patient that the patient is required to be seen by a primary care provider to receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not furnish a 60-day supply of pre-exposure prophylaxis to a single patient more than once every 2 years:

(iii) document, to the extent possible, the services provided to the patient by the pharmacist in the patient’s record in the record system maintained by the pharmacy and maintain records of pre-exposure prophylaxis furnished to each patient; and

(iv) notify the patient’s primary care provider that the pharmacist completed the requirements specified in this subsection; provided, however, that if the patient does not have a primary care provider or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care service providers to contact regarding ongoing care for pre-exposure prophylaxis.

SECTION 4. The department of public health shall promulgate regulations to establish statewide drug therapy protocols for prescribing, dispensing and administering pre-exposure prophylaxis and other HIV prevention drugs approved by the United States Food and Drug Administration that are consistent with federal Centers for Disease Control and Prevention guidelines not later than 6 months after the effective date of this act. The regulations shall include, but not be limited to, rules stating that a pharmacist shall not furnish a 60-day supply of pre-exposure prophylaxis to a single patient more than once every 2 years.