Florida Senate - 2024 COMMITTEE AMENDMENT
Bill No. SB 1320
Ì587166EÎ587166
LEGISLATIVE ACTION
Senate . House
Comm: WD .
01/29/2024 .
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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 the state to
31 prescribe such drugs.
32 (4) A pharmacist may order and dispense HIV postexposure
33 prophylaxis drugs only pursuant to a collaborative practice
34 agreement between the pharmacist and a physician licensed under
35 chapter 458 or chapter 459 who practices medicine or osteopathic
36 medicine in the same geographic area as the pharmacist. As used
37 in this subsection, the term “geographic area” means the county
38 or counties, or any portion of the county or counties, within
39 which the pharmacist and the physician provide health care
40 services.
41 (5) A pharmacist who orders and dispenses HIV postexposure
42 prophylaxis drugs pursuant to subsection (4) shall provide the
43 patient with written information advising the patient to seek
44 follow-up care from his or her primary care physician. If the
45 patient indicates that he or she lacks regular access to primary
46 care, the pharmacist must comply with the procedures of the
47 pharmacy’s approved access-to-care plan as provided in
48 subsection (7).
49 (6) Before ordering or dispensing HIV postexposure
50 prophylaxis drugs under this section, a pharmacist must be
51 certified by the board, according to the rules adopted by the
52 board, in consultation with the Board of Medicine and the Board
53 of Osteopathic Medicine. To be certified, a pharmacist must, at
54 a minimum, meet all of the following criteria:
55 (a) Hold an active and unencumbered license to practice
56 pharmacy under this chapter.
57 (b) Be engaged in the active practice of pharmacy.
58 (c) Have earned a degree of doctor of pharmacy or have
59 completed at least 3 years of experience as a licensed
60 pharmacist.
61 (d) Maintain at least $250,000 of liability coverage. A
62 pharmacist who maintains liability coverage pursuant to s.
63 465.1865 or s. 465.1895 satisfies this requirement.
64 (e) Have completed a course approved by the board, in
65 consultation with the Board of Medicine and the Board of
66 Osteopathic Medicine, which includes, at a minimum, instruction
67 on all of the following:
68 1. Performance of patient assessments.
69 2. Point-of-care testing procedures.
70 3. Safe and effective treatment of HIV exposure with HIV
71 infection prevention drugs, including, but not limited to,
72 consideration of the side effects of the drug dispensed and the
73 patient’s diet and activity levels.
74 4. Identification of contraindications.
75 5. Identification of patient comorbidities in individuals
76 with HIV requiring further medical evaluation and treatment,
77 including, but not limited to, cardiovascular disease, lung and
78 liver cancer, chronic obstructive lung disease, and diabetes
79 mellitus.
80 (7) The board shall adopt by rule reasonable and fair
81 minimum standards to ensure that all pharmacies that provide
82 adult screening for HIV exposure submit to the department for
83 approval an access-to-care plan (ACP) for assisting patients to
84 gain access to appropriate care settings when they present to
85 the pharmacy for HIV screening and indicate that they lack
86 regular access to primary care.
87 (a) An ACP must include:
88 1. Procedures to educate such patients about care that
89 would be best provided in a primary care setting and the
90 importance of receiving regular primary care.
91 2. A collaborative partnership with one or more nearby
92 federally qualified health centers, county health departments,
93 or other primary care settings. The goals of such partnership
94 must include, but need not be limited to, identifying patients
95 who have presented to the pharmacy for HIV screening or access
96 to HIV infection prevention drugs, and, if such a patient
97 indicates that he or she lacks regular access to primary care,
98 proactively seeking to establish a relationship between the
99 patient and a federally qualified health center, county health
100 department, or other primary care setting so that the patient
101 develops a medical home at such setting for primary health care
102 services. A pharmacy that establishes one or more collaborative
103 partnerships under this subparagraph may not enter into an
104 arrangement relating to such partnership which would prevent a
105 federally qualified health center, county health department, or
106 other primary care setting from establishing collaborative
107 partnerships with other pharmacies.
108 (b) Effective July 1, 2025, a pharmacy’s ACP must be
109 approved by the department before the pharmacy may receive
110 initial licensure or licensure renewal occurring after that
111 date. A pharmacy with an approved ACP must submit data to the
112 department regarding the implementation and results of its plan
113 as part of the licensure renewal process, or as directed by the
114 department, before each licensure renewal.
115 (8) The board shall adopt rules to implement this section.
116 Section 2. This act shall take effect July 1, 2024.
117
118 ================= T I T L E A M E N D M E N T ================
119 And the title is amended as follows:
120 Delete everything before the enacting clause
121 and insert:
122 A bill to be entitled
123 An act relating to HIV infection prevention drugs;
124 creating s. 465.1861, F.S.; defining terms;
125 authorizing pharmacists to screen adults for HIV
126 exposure and provide the results to such adults, with
127 advice to seek consultation or treatment from a
128 physician; authorizing pharmacists to dispense HIV
129 preexposure prophylaxis drugs only pursuant to a
130 prescription; authorizing pharmacists to order and
131 dispense HIV postexposure prophylaxis drugs only
132 pursuant to a collaborative practice agreement with a
133 physician; defining the term “geographic area”;
134 requiring such pharmacists to provide certain written
135 information when dispensing such drugs to patients;
136 requiring pharmacists to comply with certain
137 procedures under certain circumstances; requiring
138 pharmacists to be certified by the Board of Pharmacy
139 before ordering or dispensing HIV postexposure
140 prophylaxis drugs; requiring the board, in
141 consultation with the Board of Medicine and the Board
142 of Osteopathic Medicine, to adopt rules for such
143 certification; specifying minimum requirements for the
144 certification; requiring the board to adopt by rule
145 certain minimum standards to ensure that pharmacies
146 providing adult screenings for HIV exposure submit to
147 the department for approval an access-to-care plan
148 (ACP) for a specified purpose; specifying requirements
149 for ACPs; requiring that, beginning on a specified
150 date, such ACPs be approved before a license may be
151 issued or renewed; requiring such pharmacies to submit
152 specified data to the department as part of the
153 licensure renewal process and update their ACPs as
154 needed, or as directed by the department, before each
155 licensure renewal; requiring the board to adopt rules;
156 providing an effective date.