Florida Senate - 2024 COMMITTEE AMENDMENT
Bill No. SB 1320
Ì157278PÎ157278
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
01/30/2024 .
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The Committee on Health Policy (Calatayud) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 465.1861, Florida Statutes, is created
6 to read:
7 465.1861 Ordering and dispensing HIV drugs.—
8 (1) As used in this section, the term:
9 (a) “HIV” means the human immunodeficiency virus.
10 (b) “HIV infection prevention drug” means preexposure
11 prophylaxis, postexposure prophylaxis, and any other drug
12 approved by the United States Food and Drug Administration for
13 the prevention of HIV infection as of March 8, 2024.
14 (c) “HIV postexposure prophylaxis drug” means a drug or
15 drug combination that meets the clinical eligibility
16 recommendations of the United States Centers for Disease Control
17 and Prevention guidelines for antiretroviral treatment following
18 potential exposure to HIV issued as of March 8, 2024.
19 (d) “HIV preexposure prophylaxis drug” means a drug or drug
20 combination that meets the clinical eligibility recommendations
21 of the United States Centers for Disease Control and Prevention
22 guidelines for antiretroviral treatment for the prevention of
23 HIV transmission issued as of March 8, 2024.
24 (2) A pharmacist may screen an adult for HIV exposure and
25 provide the results to that adult, with the advice that the
26 patient should seek further medical consultation or treatment
27 from a physician.
28 (3) A pharmacist may dispense HIV preexposure prophylaxis
29 drugs only pursuant to a valid prescription issued by a licensed
30 health care practitioner authorized by the laws of this state to
31 prescribe such drugs.
32 (4) A pharmacist may order and dispense HIV postexposure
33 prophylaxis drugs only pursuant to a written collaborative
34 practice agreement between the pharmacist and a physician
35 licensed under chapter 458 or chapter 459 who practices medicine
36 or osteopathic medicine in the same geographic area as the
37 pharmacist. As used in this subsection, the term “geographic
38 area” means the county or counties, or any portion of the county
39 or counties, within which the pharmacist and the physician
40 provide health care services.
41 (a) The written collaborative practice agreement must
42 include particular terms and conditions imposed by the
43 supervising physician relating to the screening for HIV and the
44 ordering and dispensing of HIV postexposure prophylaxis drugs
45 under this section. The terms and conditions of the practice
46 agreement must be appropriate for the pharmacist’s training, and
47 the supervising physician is responsible for reviewing the
48 pharmacist’s actions in accordance with the practice agreement.
49 A pharmacist who enters into such a practice agreement with a
50 supervising physician must submit the agreement to the board.
51 (b) At a minimum, a written collaborative practice
52 agreement must include all of the following:
53 1. Specific categories of patients the pharmacist is
54 authorized to screen for HIV and for whom the pharmacist may
55 order and dispense HIV postexposure prophylaxis drugs.
56 2. The physician’s instructions for obtaining relevant
57 patient medical history for the purpose of identifying
58 disqualifying health conditions, adverse reactions, and
59 contraindications to the use of HIV postexposure prophylaxis
60 drugs.
61 3. A process and schedule for the physician to review the
62 pharmacist’s actions under the practice agreement.
63 4. Any other requirements as established by the board in
64 consultation with the Board of Medicine and the Board of
65 Osteopathic Medicine.
66 (c) A pharmacist authorized to screen for HIV and order and
67 dispense HIV postexposure prophylaxis drugs pursuant to a
68 written collaborative practice agreement must provide his or her
69 supervising physician with evidence of current certification by
70 the board as provided in subsection (6).
71 (5) A pharmacist who orders and dispenses HIV postexposure
72 prophylaxis drugs pursuant to subsection (4) must provide the
73 patient with written information advising the patient to seek
74 follow-up care from his or her primary care physician. If the
75 patient indicates that he or she lacks regular access to primary
76 care, the pharmacist must comply with the procedures of the
77 pharmacy’s approved access-to-care plan as provided in
78 subsection (7).
79 (6) Before ordering or dispensing HIV postexposure
80 prophylaxis drugs under this section, a pharmacist must be
81 certified by the board, according to the rules adopted by the
82 board, in consultation with the Board of Medicine and the Board
83 of Osteopathic Medicine. To be certified, a pharmacist must, at
84 a minimum, meet all of the following criteria:
85 (a) Hold an active and unencumbered license to practice
86 pharmacy under this chapter.
87 (b) Be engaged in the active practice of pharmacy.
88 (c) Have earned a degree of doctor of pharmacy or have
89 completed at least 3 years of experience as a licensed
90 pharmacist.
91 (d) Maintain at least $250,000 of liability coverage. A
92 pharmacist who maintains liability coverage pursuant to s.
93 465.1865 or s. 465.1895 satisfies this requirement.
94 (e) Have completed a course approved by the board, in
95 consultation with the Board of Medicine and the Board of
96 Osteopathic Medicine, which includes, at a minimum, instruction
97 on all of the following:
98 1. Performance of patient assessments.
99 2. Point-of-care testing procedures.
100 3. Safe and effective treatment of HIV exposure with HIV
101 infection prevention drugs, including, but not limited to,
102 consideration of the side effects of the drug dispensed and the
103 patient’s diet and activity levels.
104 4. Identification of contraindications.
105 5. Identification of patient comorbidities in individuals
106 with HIV requiring further medical evaluation and treatment,
107 including, but not limited to, cardiovascular disease, lung and
108 liver cancer, chronic obstructive lung disease, and diabetes
109 mellitus.
110 (7) The board shall adopt by rule reasonable and fair
111 minimum standards to ensure that all pharmacies that provide
112 adult screening for HIV exposure submit to the department for
113 approval an access-to-care plan (ACP) for assisting patients to
114 gain access to appropriate care settings when they present to
115 the pharmacy for HIV screening and indicate that they lack
116 regular access to primary care.
117 (a) An ACP must include:
118 1. Procedures to educate such patients about care that
119 would be best provided in a primary care setting and the
120 importance of receiving regular primary care.
121 2. A collaborative partnership with one or more nearby
122 federally qualified health centers, county health departments,
123 or other primary care settings. The goals of such partnership
124 must include, but need not be limited to, identifying patients
125 who have presented to the pharmacy for HIV screening or access
126 to HIV infection prevention drugs, and, if such a patient
127 indicates that he or she lacks regular access to primary care,
128 proactively seeking to establish a relationship between the
129 patient and a federally qualified health center, county health
130 department, or other primary care setting so that the patient
131 develops a medical home at such setting for primary health care
132 services. A pharmacy that establishes one or more collaborative
133 partnerships under this subparagraph may not enter into an
134 arrangement relating to such partnership which would prevent a
135 federally qualified health center, county health department, or
136 other primary care setting from establishing collaborative
137 partnerships with other pharmacies.
138 (b) Effective July 1, 2025, a pharmacy’s ACP must be
139 approved by the department before the pharmacy may receive
140 initial licensure or licensure renewal occurring after that
141 date. A pharmacy with an approved ACP must submit data to the
142 department regarding the implementation and results of its plan
143 as part of the licensure renewal process, or as directed by the
144 department, before each licensure renewal.
145 (8) The board shall adopt rules to implement this section.
146 Section 2. This act shall take effect July 1, 2024.
147
148 ================= T I T L E A M E N D M E N T ================
149 And the title is amended as follows:
150 Delete everything before the enacting clause
151 and insert:
152 A bill to be entitled
153 An act relating to HIV infection prevention drugs;
154 creating s. 465.1861, F.S.; defining terms;
155 authorizing pharmacists to screen adults for HIV
156 exposure and provide the results to such adults, with
157 advice to seek consultation or treatment from a
158 physician; authorizing pharmacists to dispense HIV
159 preexposure prophylaxis drugs only pursuant to a
160 prescription; authorizing pharmacists to order and
161 dispense HIV postexposure prophylaxis drugs only
162 pursuant to a written collaborative practice agreement
163 with a physician; defining the term “geographic area”;
164 specifying requirements for the practice agreements;
165 requiring the supervising physician to review the
166 pharmacist’s actions in accordance with the practice
167 agreement; requiring pharmacists who enter into such
168 practice agreements to submit the agreements to the
169 Board of Pharmacy; requiring pharmacists who enter
170 into such practice agreements to provide evidence of
171 certain certification to their supervising physician;
172 requiring such pharmacists to provide certain written
173 information when dispensing such drugs to patients;
174 requiring pharmacists to comply with certain
175 procedures under certain circumstances; requiring
176 pharmacists to be certified by the Board of Pharmacy
177 before ordering or dispensing HIV postexposure
178 prophylaxis drugs; requiring the board, in
179 consultation with the Board of Medicine and the Board
180 of Osteopathic Medicine, to adopt rules for such
181 certification; specifying minimum requirements for the
182 certification; requiring the board to adopt by rule
183 certain minimum standards to ensure that pharmacies
184 providing adult screenings for HIV exposure submit to
185 the Department of Health for approval an access-to
186 care plan (ACP) for a specified purpose; specifying
187 requirements for ACPs; requiring that, beginning on a
188 specified date, such ACPs be approved before a license
189 may be issued or renewed; requiring such pharmacies to
190 submit specified data to the department as part of the
191 licensure renewal process and, or as directed by the
192 department, before each licensure renewal; requiring
193 the board to adopt rules; providing an effective date.