ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 1 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S 1 An act relating to HIV infection prevention drugs; 2 providing a short title; creating s. 465.1861, F.S.; 3 defining terms; authorizing licensed pharmacists to 4 screen adults for HIV exposure and provide the results 5 to such adults, with advice to consult with or seek 6 treatment from a physician; authorizing pharmacists to 7 dispense HIV preexposure prophylaxis drugs pursuant to 8 a prescription; authorizing pharmacists to order and 9 dispense HIV postexposure prophylaxis drugs pursuant 10 to a written collaborative practice agreement with a 11 physician; specifying requirements for the practice 12 agreements; requiring the supervising physician to 13 review the pharmacist's records a nd actions in 14 accordance with the practice agreement; requiring 15 pharmacists who enter into such practice agreements to 16 submit the agreements to the Board of Pharmacy; 17 requiring such pharmacists to provide certain written 18 information when dispensing such dr ugs to patients; 19 requiring pharmacists to comply with certain 20 procedures under certain circumstances; requiring 21 pharmacists, before ordering and dispensing HIV 22 postexposure prophylaxis drugs, to be certified by the 23 Board of Pharmacy; specifying minimum req uirements for 24 the certification; requiring certain pharmacies to 25 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 2 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S submit an access-to-care plan to the Board of Pharmacy 26 and the Department of Health annually; authorizing the 27 board to fine or place certain prohibitions on a 28 pharmacy that does not comply wi th the requirements 29 for access-to-care plans; specifying requirements for 30 the plans; requiring the board to adopt rules; 31 providing an effective date. 32 33 Be It Enacted by the Legislature of the State of Florida: 34 35 Section 1. This act may be cited as th e "John W. Rheay 36 Act." 37 Section 2. Section 465.1861, Florida Statutes, is created 38 to read: 39 465.1861 Ordering and dispensing HIV infection prevention 40 drugs.— 41 (1) As used in this section, the term: 42 (a) "HIV" means the human immunodeficiency virus. 43 (b) "HIV infection prevention drug" means preexposure 44 prophylaxis, postexposure prophylaxis, and any other drug 45 approved by the United States Food and Drug Administration for 46 the prevention of HIV infection. 47 (c) "Postexposure prophylaxis" means a drug o r drug 48 combination that meets the clinical eligibility recommendations 49 of the United States Centers for Disease Control and Prevention 50 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 3 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S guidelines for antiretroviral treatment following potential 51 exposure to HIV. 52 (d) "Preexposure prophylaxis" means a drug or drug 53 combination that meets the clinical eligibility recommendations 54 of the United States Centers for Disease Control and Prevention 55 guidelines for antiretroviral treatment for the prevention of 56 HIV transmission. 57 (2) A pharmacist may screen an adult for HIV exposure and 58 provide the results to the adult, with the advice that the 59 patient should seek further medical consultation or treatment 60 from a physician. 61 (3) A pharmacist may dispense HIV preexposure prophylaxis 62 drugs pursuant to a valid prescripti on issued by a licensed 63 health care practitioner authorized by law to prescribe such 64 drugs. 65 (4) A pharmacist who is certified under subsection (6) may 66 order and dispense HIV postexposure prophylaxis drugs pursuant 67 to a written collaborative practice agre ement between the 68 pharmacist and a physician licensed under chapter 458 or chapter 69 459. 70 (a) A written collaborative practice agreement between a 71 pharmacist and a physician under this section must include, at a 72 minimum, all of the following: 73 1. Terms and conditions relating to the screening for HIV 74 and the ordering and dispensing of HIV postexposure prophylaxis 75 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 4 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S drugs by the pharmacist. Such terms and conditions must be 76 appropriate for the pharmacist's training. 77 2. Specific categories of pat ients the pharmacist is 78 authorized to screen for HIV and for whom the pharmacist may 79 order and dispense HIV postexposure prophylaxis drugs. 80 3. A requirement that the pharmacist maintain records for 81 any HIV postexposure prophylaxis drugs ordered and dispe nsed 82 under the collaborative practice agreement. 83 4. The physician's instructions for obtaining relevant 84 patient medical history for the purpose of identifying 85 disqualifying health conditions, adverse reactions, and 86 contraindications to the use of HIV pos texposure prophylaxis 87 drugs. 88 5. A process and schedule for the physician to review the 89 pharmacist's records and actions under the practice agreement. 90 6. Evidence of the pharmacist's current certification by 91 the board as provided in subsection (6). 92 7. Any other requirements as established by the board with 93 the approval of the Board of Medicine and the Board of 94 Osteopathic Medicine. 95 (b) A physician who has entered into a written 96 collaborative practice agreement pursuant to this section is 97 responsible for reviewing the pharmacist's records and actions 98 to ensure compliance with the agreement. 99 (c) The pharmacist shall submit a copy of the written 100 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 5 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S collaborative practice agreement to the board. 101 (5) A pharmacist who orders and dispenses HIV postexposure 102 prophylaxis drugs pursuant to subsection (4) must provide the 103 patient with written information advising the patient to seek 104 follow-up care from his or her primary care physician. If the 105 patient indicates that he or she lacks regular access to primary 106 care, the pharmacist must comply with the procedures of the 107 pharmacy's approved access -to-care plan as provided in 108 subsection (7). 109 (6) To provide services under a collaborative practice 110 agreement pursuant to this section, a pharmacist must be 111 certified by the board, according to rules adopted by the board. 112 To be certified, a pharmacist must, at a minimum, meet all of 113 the following criteria: 114 (a) Hold an active and unencumbered license to practice 115 pharmacy under this chapter. 116 (b) Be engaged in the active pra ctice of pharmacy. 117 (c) Have earned a degree of doctor of pharmacy or have 118 completed at least 3 years of experience as a licensed 119 pharmacist. 120 (d) Maintain at least $250,000 of liability coverage. A 121 pharmacist who maintains liability coverage pursuant to s. 122 465.1865 or s. 465.1895 satisfies this requirement. 123 (e) Have completed a course approved by the board, in 124 consultation with the Board of Medicine and the Board of 125 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 6 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S Osteopathic Medicine, which includes, at a minimum, instruction 126 on all of the following : 127 1. Performance of patient assessments. 128 2. Point-of-care testing procedures. 129 3. Safe and effective treatment of HIV exposure with HIV 130 infection prevention drugs, including, but not limited to, 131 consideration of the side effects of the drug dispensed and the 132 patient's diet and activity levels. 133 4. Identification of contraindications. 134 5. Identification of patient comorbidities in individuals 135 with HIV requiring further medical evaluation and treatment, 136 including, but not limited to, cardiovascular dis ease, lung and 137 liver cancer, chronic obstructive lung disease, and diabetes 138 mellitus. 139 (f) Any other criteria as established by the board with 140 the approval of the Board of Medicine and the Board of 141 Osteopathic Medicine. 142 (7)(a) A pharmacy in which a phar macist is providing 143 services under a written collaborative practice agreement 144 pursuant to subsection (4) must submit an access -to-care plan to 145 the board and department annually. If the board or the 146 department determines that a pharmacy has failed to submit an 147 access-to-care plan required under this section or if a 148 pharmacy's access-to-care plan does not comply with this section 149 or applicable rules of the board, the board must notify the 150 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 7 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S pharmacy of its noncompliance and the pharmacy must submit an 151 access-to-care plan that brings the pharmacy into compliance 152 according to parameters provided in board rule. The board may 153 fine a pharmacy that fails to comply with this paragraph or may 154 prohibit such pharmacy from allowing its pharmacists to screen 155 adults for HIV exposure or order and dispense HIV postexposure 156 prophylaxis drugs under a collaborative practice agreement until 157 the pharmacy complies with this paragraph. 158 (b) An access-to-care plan shall assist patients in 159 gaining access to appropriate care settings wh en they present to 160 a pharmacist for HIV screening and indicate that they lack 161 regular access to primary care. An access -to-care plan must 162 include, but need not be limited to: 163 1. Procedures to educate such patients about care that 164 would be best provided i n a primary care setting and the 165 importance of receiving regular primary care. 166 2. The pharmacy's plan for collaborative partnership with 167 one or more nearby federally qualified health centers, county 168 health departments, or other primary care settings. The goals of 169 such partnership must include, but need not be limited to, 170 protocols for identifying and appropriately referring a patient 171 who has presented to the pharmacist for HIV screening or access 172 to HIV infection prevention drugs and indicates that he or she 173 lacks regular access to primary care. 174 (8) The board shall adopt rules to implement this section. 175 ENROLLED CS/CS/HB 159, Engrossed 2 2024 Legislature CODING: Words stricken are deletions; words underlined are additions. hb0159-05-er Page 8 of 8 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S Section 3. This act shall take effect July 1, 2024. 176