Florida Senate - 2024 CS for CS for SB 1320
By the Appropriations Committee on Health and Human Services;
the Committee on Health Policy; and Senator Calatayud
603-03116-24 20241320c2
1 A bill to be entitled
2 An act relating to HIV infection prevention drugs;
3 creating s. 465.1861, F.S.; defining terms;
4 authorizing pharmacists to screen adults for HIV
5 exposure and provide the results to such adults, with
6 advice to seek consultation or treatment from a
7 physician; authorizing pharmacists to dispense HIV
8 preexposure prophylaxis drugs only pursuant to a
9 prescription; authorizing pharmacists to order and
10 dispense HIV postexposure prophylaxis drugs only
11 pursuant to a written collaborative practice agreement
12 with a physician; defining the term “geographic area”;
13 specifying requirements for the practice agreements;
14 requiring the supervising physician to review the
15 pharmacist’s actions in accordance with the practice
16 agreement; requiring pharmacists who enter into such
17 practice agreements to submit the agreements to the
18 Board of Pharmacy; requiring pharmacists who enter
19 into such practice agreements to provide evidence of
20 certain certification to their supervising physician;
21 requiring such pharmacists to provide certain written
22 information when dispensing such drugs to patients;
23 requiring pharmacists to comply with certain
24 procedures under certain circumstances; requiring that
25 pharmacists, before ordering and dispensing HIV
26 postexposure prophylaxis drugs, be certified by the
27 Board of Pharmacy in accordance with rules adopted by
28 the board and approved by the Board of Medicine and
29 the Board of Osteopathic Medicine; specifying minimum
30 requirements for the certification; requiring the
31 board to adopt by rule certain minimum standards to
32 ensure that pharmacies providing adult screenings for
33 HIV exposure submit to the Department of Health for
34 approval an access-to-care plan (ACP) for a specified
35 purpose; specifying requirements for ACPs; requiring
36 that, beginning on a specified date, such ACPs be
37 approved before a license may be issued or renewed;
38 requiring such pharmacies to submit specified data to
39 the department as part of the licensure renewal
40 process and, or as directed by the department, before
41 each licensure renewal; requiring the board to adopt
42 rules; providing an effective date.
43
44 Be It Enacted by the Legislature of the State of Florida:
45
46 Section 1. Section 465.1861, Florida Statutes, is created
47 to read:
48 465.1861 Ordering and dispensing HIV drugs.—
49 (1) As used in this section, the term:
50 (a) “HIV” means the human immunodeficiency virus.
51 (b) “HIV infection prevention drug” means preexposure
52 prophylaxis, postexposure prophylaxis, and any other drug
53 approved by the United States Food and Drug Administration for
54 the prevention of HIV infection as of March 8, 2024.
55 (c) “HIV postexposure prophylaxis drug” means a drug or
56 drug combination that meets the clinical eligibility
57 recommendations of the United States Centers for Disease Control
58 and Prevention guidelines for antiretroviral treatment following
59 potential exposure to HIV issued as of March 8, 2024.
60 (d) “HIV preexposure prophylaxis drug” means a drug or drug
61 combination that meets the clinical eligibility recommendations
62 of the United States Centers for Disease Control and Prevention
63 guidelines for antiretroviral treatment for the prevention of
64 HIV transmission issued as of March 8, 2024.
65 (2) A pharmacist may screen an adult for HIV exposure and
66 provide the results to that adult, with the advice that the
67 patient should seek further medical consultation or treatment
68 from a physician.
69 (3) A pharmacist may dispense HIV preexposure prophylaxis
70 drugs only pursuant to a valid prescription issued by a licensed
71 health care practitioner authorized by the laws of this state to
72 prescribe such drugs.
73 (4) A pharmacist may order and dispense HIV postexposure
74 prophylaxis drugs only pursuant to a written collaborative
75 practice agreement between the pharmacist and a physician
76 licensed under chapter 458 or chapter 459 who practices medicine
77 or osteopathic medicine in the same geographic area as the
78 pharmacist. As used in this subsection, the term “geographic
79 area” means the county or counties, or any portion of the county
80 or counties, within which the pharmacist and the physician
81 provide health care services.
82 (a) The written collaborative practice agreement must
83 include particular terms and conditions imposed by the
84 supervising physician relating to the screening for HIV and the
85 ordering and dispensing of HIV postexposure prophylaxis drugs
86 under this section. The terms and conditions of the practice
87 agreement must be appropriate for the pharmacist’s training, and
88 the supervising physician is responsible for reviewing the
89 pharmacist’s actions in accordance with the practice agreement.
90 A pharmacist who enters into such a practice agreement with a
91 supervising physician must submit the agreement to the board.
92 (b) At a minimum, a written collaborative practice
93 agreement must include all of the following:
94 1. Specific categories of patients the pharmacist is
95 authorized to screen for HIV and for whom the pharmacist may
96 order and dispense HIV postexposure prophylaxis drugs.
97 2. The physician’s instructions for obtaining relevant
98 patient medical history for the purpose of identifying
99 disqualifying health conditions, adverse reactions, and
100 contraindications to the use of HIV postexposure prophylaxis
101 drugs.
102 3. A requirement that the pharmacist maintain records for
103 any HIV postexposure prophylaxis drugs ordered and dispensed
104 under the collaborative practice agreement.
105 4. A process and schedule for the physician to review the
106 pharmacist’s records and actions under the collaborative
107 practice agreement.
108 5. Any other requirements as established by the board, with
109 the approval of the Board of Medicine and the Board of
110 Osteopathic Medicine.
111 (c) A pharmacist authorized to screen for HIV and order and
112 dispense HIV postexposure prophylaxis drugs pursuant to a
113 written collaborative practice agreement must provide his or her
114 supervising physician with evidence of current certification by
115 the board as provided in subsection (6).
116 (5) A pharmacist who orders and dispenses HIV postexposure
117 prophylaxis drugs pursuant to subsection (4) must provide the
118 patient with written information advising the patient to seek
119 follow-up care from his or her primary care physician. If the
120 patient indicates that he or she lacks regular access to primary
121 care, the pharmacist must comply with the procedures of the
122 pharmacy’s approved access-to-care plan as provided in
123 subsection (7).
124 (6) Before ordering or dispensing HIV postexposure
125 prophylaxis drugs under this section, a pharmacist must be
126 certified by the board, according to the rules adopted by the
127 board and approved by the Board of Medicine and the Board of
128 Osteopathic Medicine. To be certified, a pharmacist must, at a
129 minimum, meet all of the following criteria:
130 (a) Hold an active and unencumbered license to practice
131 pharmacy under this chapter.
132 (b) Be engaged in the active practice of pharmacy.
133 (c) Have earned a degree of doctor of pharmacy or have
134 completed at least 3 years of experience as a licensed
135 pharmacist.
136 (d) Maintain at least $250,000 of liability coverage. A
137 pharmacist who maintains liability coverage pursuant to s.
138 465.1865 or s. 465.1895 satisfies this requirement.
139 (e) Have completed a course approved by the board, in
140 consultation with the Board of Medicine and the Board of
141 Osteopathic Medicine, which includes, at a minimum, instruction
142 on all of the following:
143 1. Performance of patient assessments.
144 2. Point-of-care testing procedures.
145 3. Safe and effective treatment of HIV exposure with HIV
146 infection prevention drugs, including, but not limited to,
147 consideration of the side effects of the drug dispensed and the
148 patient’s diet and activity levels.
149 4. Identification of contraindications.
150 5. Identification of patient comorbidities in individuals
151 with HIV requiring further medical evaluation and treatment,
152 including, but not limited to, cardiovascular disease, lung and
153 liver cancer, chronic obstructive lung disease, and diabetes
154 mellitus.
155 (7) The board shall adopt by rule reasonable and fair
156 minimum standards to ensure that all pharmacies that provide
157 adult screening for HIV exposure submit to the department for
158 approval an access-to-care plan (ACP) for assisting patients to
159 gain access to appropriate care settings when they present to
160 the pharmacy for HIV screening and indicate that they lack
161 regular access to primary care.
162 (a) An ACP must include:
163 1. Procedures to educate such patients about care that
164 would be best provided in a primary care setting and the
165 importance of receiving regular primary care.
166 2. A collaborative partnership with one or more nearby
167 federally qualified health centers, county health departments,
168 or other primary care settings. The goals of such partnership
169 must include, but need not be limited to, identifying patients
170 who have presented to the pharmacy for HIV screening or access
171 to HIV infection prevention drugs, and, if such a patient
172 indicates that he or she lacks regular access to primary care,
173 proactively seeking to establish a relationship between the
174 patient and a federally qualified health center, county health
175 department, or other primary care setting so that the patient
176 develops a medical home at such setting for primary health care
177 services. A pharmacy that establishes one or more collaborative
178 partnerships under this subparagraph may not enter into an
179 arrangement relating to such partnership which would prevent a
180 federally qualified health center, county health department, or
181 other primary care setting from establishing collaborative
182 partnerships with other pharmacies.
183 (b) Effective July 1, 2025, a pharmacy’s ACP must be
184 approved by the department before the pharmacy may receive
185 initial licensure or licensure renewal occurring after that
186 date. A pharmacy with an approved ACP must submit data to the
187 department regarding the implementation and results of its plan
188 as part of the licensure renewal process, or as directed by the
189 department, before each licensure renewal.
190 (8) The board shall adopt rules to implement this section.
191 Section 2. This act shall take effect July 1, 2024.