Sponsored by:
Senator VIN GOPAL
District 11 (Monmouth)
SYNOPSIS
Authorizes pharmacists to dispense HIV prophylaxis without individual prescription under certain circumstances; mandates prescription benefits coverage.
CURRENT VERSION OF TEXT
As introduced.
An Act concerning pharmacists and supplementing P.L.2003, c.280 (C.45:14-40 et seq.), P.L.1997, c.192 (C.26:2S-1 et seq.), and P.L.1968, c.413 (C.30:4D-1 et seq.).
Be It Enacted by the Senate and General Assembly of the State of New Jersey:
1. As used in this act:
CDC PEP guidelines means the Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV United States, 2016, or any subsequent guidelines, published by the federal Centers for Disease Control and Prevention.
CDC PReP guidelines means the 2017 Preexposure Prophylaxis for the Prevention of HIV Infection in the United States 2017 Update: A Clinical Practice Guideline, or any subsequent guidelines, published by the federal Centers for Disease Control and Prevention.
HIV means the human immunodeficiency virus.
HIV preexposure prophylaxis means a fixed-dose combination of tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), or another drug or drug combination determined by the State Board of Pharmacy to meet the same clinical eligibility recommendations provided in the CEC PReP guidelines.
HIV postexposure prophylaxis means: tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with either raltegravir (400mg), taken twice daily, or dolutegravir (50mg), taken once daily; tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg), taken once daily, in combination with darunavir (800mg) and ritonavir (100mg), taken once daily; or another drug or drug combination determined by the State Board of Pharmacy to meet the same clinical eligibility recommendations provided in the CEC PRP guidelines.
2. a. Notwithstanding any other provision of law to the contrary, a pharmacist may initiate and furnish HIV preexposure prophylaxis or HIV postexposure prophylaxis to a patient without an individual prescription pursuant to a standing order issued to the pharmacist by the Commissioner of Health or, if the commissioner is not a duly licensed physician, the Deputy Commissioner for Public Health Services. A standing order shall be issued to a pharmacist upon request, provided that the pharmacist satisfies the training requirements set forth in subsection b. of this section and certifies that the pharmacist will adhere to the requirements set forth in subsection c. of this section concerning the protocols for initiating and furnishing HIV preexposure prophylaxis and the requirements set forth in subsection d. of this section concerning the protocols for initiating and furnishing HIV postexposure prophylaxis to patients without an individual prescription. In no case shall a patient be authorized to waive the consultation required pursuant to subsection c. or subsection d. of this section.
b. A pharmacist shall not be authorized to furnish HIV preexposure prophylaxis or HIV postexposure prophylaxis to a patient without an individual prescription unless the pharmacist completes a training program, approved by the State Board of Pharmacy in consultation with the Department of Health, concerning the use of HIV preexposure prophylaxis and HIV postexposure prophylaxis. At a minimum, the training program shall include information about financial assistance programs available to patients to assist with the costs of HIV preexposure prophylaxis and HIV postexposure prophylaxis.
c. A pharmacist shall furnish at least a 30-day supply, and up to a 60-day supply, of HIV preexposure prophylaxis to a patient without an individual prescription if the following requirements are met:
(1) The patient is HIV-negative, as documented by a negative HIV test result obtained within the previous seven days from an HIV antigen/antibody test or antibody-only test or from a rapid, point-of-care fingerstick blood test approved by the federal Food and Drug Administration. If the patient does not provide evidence of a negative HIV test in accordance with this paragraph, the pharmacist shall order an HIV test. If the test results are not ordered directly to a pharmacist, the pharmacist shall verify the test results to the pharmacist s satisfaction. If the patient tests positive for HIV infection, the pharmacist or person administering the test shall direct the patient to a primary care provider, provide the patient with information and resources concerning treatment providers and HIV treatment clinics in the region, and shall take all other actions required under State and federal law in response to a positive test for HIV;
(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reported checklist of acute HIV infection signs and symptoms;
(3) The patient does not report taking any contraindicated medications, and the pharmacist reviews the patient s prescription monitoring information to confirm no contraindicated prescriptions have been issued or dispensed to the patient in the past six months;
(4) The patient has not been furnished with HIV preexposure prophylaxis without an individual prescription within the past two years;
(5) The pharmacist provides counseling to the patient on the ongoing use of HIV preexposure 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 diseases, and pregnancy for individuals of child-bearing capacity. The pharmacist shall notify the patient that the patient will not be eligible to continue receiving HIV preexposure prophylaxis unless the patient is seen by a primary care provider and issued a prescription for the HIV preexposure prophylaxis, and that the patient may be furnished with no more than a 60-day supply of HIV preexposure prophylaxis by a pharmacist without an individual prescription within any given two year period;
(6) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient s record in the record system maintained by the pharmacy, and includes the dispensation of the HIV preexposure prophylaxis in the prescription monitoring database established pursuant to P.L.2007, c.244 (C.45:1-45 et al.) with a note indicating the HIV preexposure prophylaxis was provided without an individual prescription pursuant to this section; and
(7) The pharmacist notifies the patient s primary care provider that the pharmacist furnished the patient with HIV preexposure prophylaxis pursuant to this section. If the patient does not have a primary care provider, or refuses to consent to the pharmacist providing notice to the primary care provider pursuant to this paragraph, the pharmacist shall provide the patient with a list of physicians and surgeons, clinics, or other health care service providers to contact regarding ongoing care for HIV preexposure prophylaxis. The Department of Health shall publish and maintain a current list of providers for pharmacists to use for the purposes of this paragraph, which list may be made available on the department s Internet website.
d. A pharmacist shall furnish a complete course of HIV postexposure prophylaxis