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The Florida Senate

CS/CS/HB 159 — HIV Infection Prevention Drugs

by Health & Human Services Committee; Healthcare Regulation Subcommittee; and Reps. Franklin, Trabulsy, and others (CS/CS/SB 1320 by Appropriations Committee on Health and Human Services; Health Policy Committee; and Senator Calatayud)

This summary is provided for information only and does not represent the opinion of any Senator, Senate Officer, or Senate Office.

Prepared by: Health Policy Committee (HP)

The bill authorizes licensed pharmacists, after meeting specified requirements, to screen adults for HIV exposure and provide the results of the screening to the adult, with the advice that the patient should seek further medical consultation or treatment from a physician.

The bill defines related terms as follows:

  • “HIV infection prevention drug” means preexposure prophylaxis, postexposure prophylaxis, and any other drug approved by the U.S. Food and Drug Administration for the prevention of HIV infection.
  • “Preexposure prophylaxis” means a drug or drug combination that meets the clinical eligibility recommendations of the U.S. Centers for Disease Control and Prevention (CDC) guidelines for antiretroviral treatment for the prevention of HIV transmission.
  • “Postexposure prophylaxis” means a drug or drug combination that meets the clinical eligibility recommendations of CDC guidelines for antiretroviral treatment following potential exposure to HIV.

The bill establishes a process whereby a pharmacist may become certified by the Board of Pharmacy (BOP) to order and dispense postexposure prophylaxis (PEP) drugs under a written collaborative practice agreement (CPA) with an allopathic or osteopathic physician. The bill does not authorize a pharmacist to order and dispense preexposure prophylaxis drugs under such a CPA.

The bill requires that for a pharmacist to be certified, he or she must:

  • Hold an active and unencumbered license to practice pharmacy;
  • Be engaged in the active practice of pharmacy;
  • Have earned a doctorate of pharmacy degree or have completed at least three years of experience as a licensed pharmacist;
  • Maintain at least $250,000 of liability coverage; and
  • Have completed a course approved by the BOP, in consultation with the Board of Medicine (BOM) and the Board of Osteopathic Medicine (BOOM), which includes specified criteria required by statute, plus any other criteria established by the BOP with the approval of the BOM and the BOOM.

The bill requires the written CPA to include:

  • Terms and conditions relating to the pharmacist’s screening for HIV and the ordering and dispensing of HIV PEP drugs;
  • Specific categories of patients the pharmacist is authorized to screen and may order and dispense HIV PEP drugs;
  • A requirement that the pharmacist maintain records for any HIV PEP drugs ordered and dispensed under the CPA;
  • The physician’s instructions for obtaining relevant patient medical history for the purpose of identifying disqualifying health conditions, adverse reactions, and contraindications to the use of HIV PEP drugs;
  • A process and schedule for the physician to review the pharmacist’s records and actions under the CPA;
  • Evidence of the pharmacist’s current certification by the BOP; and
  • Any other requirements established by the BOP with the approval of the BOM and the BOOM.

The bill requires a pharmacist participating in a CPA to submit a copy of the CPA to the BOP.

The bill requires a pharmacist who orders and dispenses HIV PEP drugs under a CPA to provide the patient with written information to advise the patient to seek follow-up care from the patient’s primary care physician. If the patient indicates that he or she lacks regular access to primary care, the bill requires the pharmacist to comply with the procedures of the pharmacy’s access-to-care plan (ACP).

The bill requires that a pharmacy wherein a pharmacist is providing services under a CPA to submit an ACP to the BOP and the Department of Health (DOH) annually. The ACP must assist patients in gaining access to appropriate care settings when they otherwise lack such access. The bill requires that the ACP must include, but need not be limited to:

  • Procedures to educate such patients about care that would be best provided in a primary care setting and the importance of receiving regular primary care; and
  • The pharmacy’s plan for collaborative partnership with one or more nearby federally qualified health centers, county health departments, or other primary care settings. The goals of such partnership must include, but need not be limited to, protocols for identifying and appropriately referring a patient who has presented to the pharmacist for HIV screening or access to HIV infection prevention drugs and indicates that he or she lacks regular access to primary care.

The bill requires that if the BOP or the DOH determines that a pharmacy has failed to submit an ACP required under the bill or if a pharmacy’s ACP does not comply with the bill or applicable BOP rules, the BOP must notify the pharmacy of its noncompliance and the pharmacy must submit an ACP that brings the pharmacy into compliance according to parameters provided in BOP rule. The BOP may fine a pharmacy that fails to comply with this requirement or may prohibit such pharmacy from allowing its pharmacists to screen adults for HIV exposure or order and dispense HIV PEP drugs under a CPA until the pharmacy complies.

The bill requires the BOP to adopt rules to implement the bill.

If approved by the Governor, or allowed to become law without the Governor’s signature, the bill takes effect July 1, 2024.  

Vote: Senate 39-0; House 113-0