Maine Revised Statutes Title 32 Sec. 13786-E – Prescribing, dispensing and administering HIV prevention drugs
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1. Definitions. As used in this section, unless the context otherwise indicates, the following terms have the following meanings.
A. “CDC guidelines” means guidelines related to nonoccupational exposure to potential HIV infection, or any subsequent guidelines, published by the federal Department of Health and Human Services, Centers for Disease Control and Prevention. [PL 2021, c. 265, §6 (NEW).]
B. “HIV prevention drug” means a preexposure prophylaxis drug, post-exposure prophylaxis drug or other drug approved for the prevention of HIV infection by the federal Food and Drug Administration. [PL 2021, c. 265, §6 (NEW).]
C. “Post-exposure prophylaxis drug” means a drug or drug combination that meets the clinical eligibility recommendations provided in CDC guidelines following potential exposure to HIV infection. [PL 2021, c. 265, §6 (NEW).]
D. “Preexposure prophylaxis drug” means a drug or drug combination that meets the clinical eligibility recommendations provided in CDC guidelines to prevent HIV infection. [PL 2021, c. 265, §6 (NEW).]
[PL 2021, c. 265, §6 (NEW).]
Terms Used In Maine Revised Statutes Title 32 Sec. 13786-E
- Board: means the Maine Board of Pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A
- Collaborative practice agreement: means a written and signed agreement between one or more pharmacists with training and experience relevant to the scope of the collaborative practice and a practitioner that supervises or provides direct consultation to the pharmacist or pharmacists engaging in collaborative drug therapy management that:
A. See Maine Revised Statutes Title 32 Sec. 13702-ADepartment: means the Department of Professional and Financial Regulation. See Maine Revised Statutes Title 32 Sec. 13702-A dispensing: means the preparation and delivery of a prescription drug in a suitable container appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug pursuant to a lawful order of a practitioner. See Maine Revised Statutes Title 32 Sec. 13702-A Drug: means :
A. See Maine Revised Statutes Title 32 Sec. 13702-AEvidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other. Person: means an individual, corporation, partnership, association or any other legal entity. See Maine Revised Statutes Title 32 Sec. 13702-A Pharmacist: means an individual provider of health care services licensed by this State to engage in the practice of pharmacy. See Maine Revised Statutes Title 32 Sec. 13702-A Pharmacy: means :
A. See Maine Revised Statutes Title 32 Sec. 13702-APractitioner: means an individual who is licensed, registered or otherwise authorized in the appropriate jurisdiction to prescribe and administer drugs in the course of professional practice. See Maine Revised Statutes Title 32 Sec. 13702-A Prescription drug order: means a lawful written or oral order of a practitioner for a drug or device. See Maine Revised Statutes Title 32 Sec. 13702-A
2. Authorization. Notwithstanding any provision of law to the contrary and as authorized by the board in accordance with rules adopted under subsection 3, a pharmacist may prescribe, dispense and administer HIV prevention drugs pursuant to a standing order or collaborative practice agreement or to protocols developed by the board for when there is no prescription drug order, standing order or collaborative practice agreement in accordance with the requirements in this subsection and may also order laboratory testing for HIV infection as necessary.
A. Before furnishing an HIV prevention drug to a patient, a pharmacist shall complete a training program approved by the board on the use of protocols developed by the board for prescribing, dispensing and administering an HIV prevention drug, on the requirements for any laboratory testing for HIV infection and on guidelines for prescription adherence and best practices to counsel patients prescribed an HIV prevention drug. [PL 2021, c. 265, §6 (NEW).]
B. A pharmacist shall dispense or administer a preexposure prophylaxis drug in at least a 30-day supply, and up to a 60-day supply, as long as all of the following conditions are met:
(1) The patient tests negative for HIV infection, as documented by a negative HIV test result obtained within the previous 7 days. If the patient does not provide evidence of a negative HIV test result in accordance with this subparagraph, the pharmacist shall order an HIV test. If the test results are not transmitted directly to the 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 and provide a list of primary care providers and clinics within a reasonable travel distance of the patient’s residence;
(2) The patient does not report any signs or symptoms of acute HIV infection on a self-reporting checklist of acute HIV infection signs and symptoms;
(3) The patient does not report taking any contraindicated medications;
(4) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on the ongoing use of a preexposure prophylaxis drug. The pharmacist shall notify the patient that the patient must be seen by a primary care provider to receive subsequent prescriptions for a preexposure prophylaxis drug and that a pharmacist may not dispense or administer more than a 60-day supply of a preexposure prophylaxis drug to a single patient once every 2 years without a prescription;
(5) The pharmacist documents, to the extent possible, the services provided by the pharmacist in the patient’s record in the patient profile record system maintained by the pharmacy. The pharmacist shall maintain records of preexposure prophylaxis drugs dispensed or administered to each patient;
(6) The pharmacist does not dispense or administer more than a 60-day supply of a preexposure prophylaxis drug to a single patient once every 2 years, unless otherwise directed by a practitioner; and
(7) The pharmacist notifies the patient’s primary care provider that the pharmacist completed the requirements specified in this paragraph. 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, clinics or other health care providers to contact regarding follow-up care. [PL 2021, c. 265, §6 (NEW).]
C. A pharmacist shall dispense or administer a complete course of a post-exposure prophylaxis drug as long as all of the following conditions are met:
(1) The pharmacist screens the patient and determines that the exposure occurred within the previous 72 hours and the patient otherwise meets the clinical criteria for a post-exposure prophylaxis drug under CDC guidelines;
(2) The pharmacist provides HIV testing to the patient or determines that the patient is willing to undergo HIV testing consistent with CDC guidelines. If the patient refuses to undergo HIV testing but is otherwise eligible for a post-exposure prophylaxis drug under this subsection, the pharmacist may dispense or administer a post-exposure prophylaxis drug;
(3) The pharmacist provides counseling to the patient, consistent with CDC guidelines, on the use of a post-exposure prophylaxis drug. The pharmacist shall also inform the patient of the availability of a preexposure prophylaxis drug for persons who are at substantial risk of acquiring HIV; and
(4) The pharmacist notifies the patient’s primary care provider of the dispensing or administering of the post-exposure prophylaxis drug. 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, clinics or other health care providers to contact regarding follow-up care. [PL 2021, c. 265, §6 (NEW).]
[PL 2021, c. 265, §6 (NEW).]
3. Rules; protocols. The board by rule shall establish standards for authorizing pharmacists to prescribe, dispense and administer HIV prevention drugs in accordance with subsection 2, including adequate training requirements and protocols for when there is no prescription drug order, standing order or collaborative practice agreement. Rules adopted under this subsection are routine technical rules as defined in Title 5, chapter 375, subchapter 2?A.
[PL 2021, c. 265, §6 (NEW).]
SECTION HISTORY
PL 2021, c. 265, §6 (NEW).