Florida Statutes 465.1861 – Ordering and dispensing HIV infection prevention drugs
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(1) As used in this section, the term:
(a) “HIV” means the human immunodeficiency virus.
Terms Used In Florida Statutes 465.1861
- Administration: means the obtaining and giving of a single dose of medicinal drugs by a legally authorized person to a patient for her or his consumption. See Florida Statutes 465.003
- Board: means the Board of Pharmacy. See Florida Statutes 465.003
- Department: means the Department of Health. See Florida Statutes 465.003
- Dispense: means the transfer of possession of one or more doses of a medicinal drug by a pharmacist to the ultimate consumer or her or his agent. See Florida Statutes 465.003
- drugs: means those substances or preparations commonly known as "prescription" or "legend" drugs which are required by federal or state law to be dispensed only on a prescription, but shall not include patents or proprietary preparations as hereafter defined. See Florida Statutes 465.003
- Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
- Pharmacist: means any person licensed pursuant to this chapter to practice the profession of pharmacy. See Florida Statutes 465.003
- Pharmacy: includes a community pharmacy, an institutional pharmacy, a nuclear pharmacy, a special pharmacy, and an Internet pharmacy. See Florida Statutes 465.003
- Prescription: includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of the state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. See Florida Statutes 465.003
(b) “HIV infection prevention drug” means preexposure prophylaxis, postexposure prophylaxis, and any other drug approved by the United States Food and Drug Administration for the prevention of HIV infection.
(c) “Postexposure prophylaxis” means a drug or drug combination that meets the clinical eligibility recommendations of the United States Centers for Disease Control and Prevention guidelines for antiretroviral treatment following potential exposure to HIV.
(d) “Preexposure prophylaxis” means a drug or drug combination that meets the clinical eligibility recommendations of the United States Centers for Disease Control and Prevention guidelines for antiretroviral treatment for the prevention of HIV transmission.
(2) A pharmacist may screen an adult for HIV exposure and provide the results to the adult, with the advice that the patient should seek further medical consultation or treatment from a physician.
(3) A pharmacist may dispense HIV preexposure prophylaxis drugs pursuant to a valid prescription issued by a licensed health care practitioner authorized by law to prescribe such drugs.
(4) A pharmacist who is certified under subsection (6) may order and dispense HIV postexposure prophylaxis drugs pursuant to a written collaborative practice agreement between the pharmacist and a physician licensed under chapter 458 or chapter 459.
(a) A written collaborative practice agreement between a pharmacist and a physician under this section must include, at a minimum, all of the following:
1. Terms and conditions relating to the screening for HIV and the ordering and dispensing of HIV postexposure prophylaxis drugs by the pharmacist. Such terms and conditions must be appropriate for the pharmacist’s training.
2. Specific categories of patients the pharmacist is authorized to screen for HIV and for whom the pharmacist may order and dispense HIV postexposure prophylaxis drugs.
3. A requirement that the pharmacist maintain records for any HIV postexposure prophylaxis drugs ordered and dispensed under the collaborative practice agreement.
4. 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 postexposure prophylaxis drugs.
5. A process and schedule for the physician to review the pharmacist’s records and actions under the practice agreement.
6. Evidence of the pharmacist’s current certification by the board as provided in subsection (6).
7. Any other requirements as established by the board with the approval of the Board of Medicine and the Board of Osteopathic Medicine.
(b) A physician who has entered into a written collaborative practice agreement pursuant to this section is responsible for reviewing the pharmacist’s records and actions to ensure compliance with the agreement.
(c) The pharmacist shall submit a copy of the written collaborative practice agreement to the board.
(5) A pharmacist who orders and dispenses HIV postexposure prophylaxis drugs pursuant to subsection (4) must provide the patient with written information advising the patient to seek follow-up care from his or her primary care physician. If the patient indicates that he or she lacks regular access to primary care, the pharmacist must comply with the procedures of the pharmacy‘s approved access-to-care plan as provided in subsection (7).
(6) To provide services under a collaborative practice agreement pursuant to this section, a pharmacist must be certified by the board, according to rules adopted by the board. To be certified, a pharmacist must, at a minimum, meet all of the following criteria:
(a) Hold an active and unencumbered license to practice pharmacy under this chapter.
(b) Be engaged in the active practice of pharmacy.
(c) Have earned a degree of doctor of pharmacy or have completed at least 3 years of experience as a licensed pharmacist.
(d) Maintain at least $250,000 of liability coverage. A pharmacist who maintains liability coverage pursuant to s. 465.1865 or s. 465.1895 satisfies this requirement.
(e) Have completed a course approved by the board, in consultation with the Board of Medicine and the Board of Osteopathic Medicine, which includes, at a minimum, instruction on all of the following:
1. Performance of patient assessments.
2. Point-of-care testing procedures.
3. Safe and effective treatment of HIV exposure with HIV infection prevention drugs, including, but not limited to, consideration of the side effects of the drug dispensed and the patient’s diet and activity levels.
4. Identification of contraindications.
5. Identification of patient comorbidities in individuals with HIV requiring further medical evaluation and treatment, including, but not limited to, cardiovascular disease, lung and liver cancer, chronic obstructive lung disease, and diabetes mellitus.
(f) Any other criteria as established by the board with the approval of the Board of Medicine and the Board of Osteopathic Medicine.
(7)(a) A pharmacy in which a pharmacist is providing services under a written collaborative practice agreement pursuant to subsection (4) must submit an access-to-care plan to the board and department annually. If the board or the department determines that a pharmacy has failed to submit an access-to-care plan required under this section or if a pharmacy’s access-to-care plan does not comply with this section or applicable rules of the board, the board must notify the pharmacy of its noncompliance, and the pharmacy must submit an access-to-care plan that brings the pharmacy into compliance according to parameters provided in board rule. The board may fine a pharmacy that fails to comply with this paragraph or may prohibit such pharmacy from allowing its pharmacists to screen adults for HIV exposure or order and dispense HIV postexposure prophylaxis drugs under a collaborative practice agreement until the pharmacy complies with this paragraph.
(b) An access-to-care plan shall assist patients in gaining access to appropriate care settings when they present to a pharmacist for HIV screening and indicate that they lack regular access to primary care. An access-to-care plan must include, but need not be limited to:
1. 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.
2. 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.
(8) The board shall adopt rules to implement this section.