FL
Florida House Bill H0159

Florida 2024 Regular Session

Florida House Bill H0159 Compare Versions

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1010 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
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14+A bill to be entitled 1
1515 An act relating to HIV infection prevention drugs; 2
1616 providing a short title; creating s. 465.1861, F.S.; 3
1717 defining terms; authorizing licensed pharmacists to 4
18-screen adults for HIV exposure and provide the results 5
19-to such adults, with advice to consult with or seek 6
20-treatment from a physician; authorizing pharmacists to 7
21-dispense HIV preexposure prophylaxis drugs pursuant to 8
22-a prescription; authorizing pharmacists to order and 9
23-dispense HIV postexposure prophylaxis drugs pursuant 10
24-to a written collaborative practice agreement with a 11
25-physician; specifying requirements for the practice 12
26-agreements; requiring the supervising physician to 13
27-review the pharmacist's records a nd actions in 14
28-accordance with the practice agreement; requiring 15
29-pharmacists who enter into such practice agreements to 16
30-submit the agreements to the Board of Pharmacy; 17
31-requiring such pharmacists to provide certain written 18
32-information when dispensing such dr ugs to patients; 19
33-requiring pharmacists to comply with certain 20
34-procedures under certain circumstances; requiring 21
35-pharmacists, before ordering and dispensing HIV 22
36-postexposure prophylaxis drugs, to be certified by the 23
37-Board of Pharmacy; specifying minimum req uirements for 24
38-the certification; requiring certain pharmacies to 25
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18+screen for HIV exposure and order and dispense HIV 5
19+infection prevention drugs under a collaborative 6
20+practice agreement; requiring pharmacists to be 7
21+certified by the Board of Pharmacy before ordering and 8
22+dispensing HIV infection prevention drugs; requiring 9
23+the board, in consultation with the Board of Medicine 10
24+and the Board of Osteopathic Medicine, to adopt rules 11
25+for such certification; specifying minimum 12
26+requirements for the certification; requiring the 13
27+board to adopt rules; providing an effective date. 14
28+ 15
29+Be It Enacted by the Legislature of the State of Florida: 16
30+ 17
31+ Section 1. This act may be cited as the "John W. Rheay 18
32+Act." 19
33+ Section 2. Section 465.1861, Florida Statutes, is created 20
34+to read: 21
35+ 465.1861 Ordering and dispensing HIV infection prevention 22
36+drugs.— 23
37+ (1) As used in this section, the term: 24
38+ (a) "HIV" means the human immunodeficiency virus. 25
39+
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4747 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
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51-submit an access-to-care plan to the Board of Pharmacy 26
52-and the Department of Health annually; authorizing the 27
53-board to fine or place certain prohibitions on a 28
54-pharmacy that does not comply wi th the requirements 29
55-for access-to-care plans; specifying requirements for 30
56-the plans; requiring the board to adopt rules; 31
57-providing an effective date. 32
58- 33
59-Be It Enacted by the Legislature of the State of Florida: 34
60- 35
61- Section 1. This act may be cited as th e "John W. Rheay 36
62-Act." 37
63- Section 2. Section 465.1861, Florida Statutes, is created 38
64-to read: 39
65- 465.1861 Ordering and dispensing HIV infection prevention 40
66-drugs.— 41
67- (1) As used in this section, the term: 42
68- (a) "HIV" means the human immunodeficiency virus. 43
69- (b) "HIV infection prevention drug" means preexposure 44
70-prophylaxis, postexposure prophylaxis, and any other drug 45
71-approved by the United States Food and Drug Administration for 46
72-the prevention of HIV infection. 47
73- (c) "Postexposure prophylaxis" means a drug o r drug 48
74-combination that meets the clinical eligibility recommendations 49
75-of the United States Centers for Disease Control and Prevention 50
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51+ (b) "HIV infection prevention drug" means preexposure 26
52+prophylaxis, postexposure prophylaxis, and any other drug 27
53+approved by the United States Food and Drug Administration for 28
54+the prevention of HIV infection. 29
55+ (c) "Postexposure prophylaxis" means a drug or drug 30
56+combination that meets the clinical eligibility recommendations 31
57+of the United States Centers for Disease Contro l and Prevention 32
58+guidelines for antiretroviral treatment following potential 33
59+exposure to HIV. 34
60+ (d) "Preexposure prophylaxis" means a drug or drug 35
61+combination that meets the clinical eligibility recommendations 36
62+of the United States Centers for Disease Cont rol and Prevention 37
63+guidelines for antiretroviral treatment for the prevention of 38
64+HIV transmission. 39
65+ (2) A pharmacist may screen an adult for HIV exposure and 40
66+provide the results to the adult, with the advice that the 41
67+patient should seek further medical co nsultation or treatment 42
68+from a physician. 43
69+ (3) A pharmacist may dispense HIV preexposure prophylaxis 44
70+drugs pursuant to a valid prescription issued by a licensed 45
71+health care practitioner authorized by law to prescribe such 46
72+drugs. 47
73+ (4) A pharmacist who is certified under subsection (6) may 48
74+order and dispense HIV postexposure prophylaxis drugs pursuant 49
75+to a written collaborative practice agreement between the 50
76+
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8484 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
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88-guidelines for antiretroviral treatment following potential 51
89-exposure to HIV. 52
90- (d) "Preexposure prophylaxis" means a drug or drug 53
91-combination that meets the clinical eligibility recommendations 54
92-of the United States Centers for Disease Control and Prevention 55
93-guidelines for antiretroviral treatment for the prevention of 56
94-HIV transmission. 57
95- (2) A pharmacist may screen an adult for HIV exposure and 58
96-provide the results to the adult, with the advice that the 59
97-patient should seek further medical consultation or treatment 60
98-from a physician. 61
99- (3) A pharmacist may dispense HIV preexposure prophylaxis 62
100-drugs pursuant to a valid prescripti on issued by a licensed 63
101-health care practitioner authorized by law to prescribe such 64
102-drugs. 65
103- (4) A pharmacist who is certified under subsection (6) may 66
104-order and dispense HIV postexposure prophylaxis drugs pursuant 67
105-to a written collaborative practice agre ement between the 68
106-pharmacist and a physician licensed under chapter 458 or chapter 69
107-459. 70
108- (a) A written collaborative practice agreement between a 71
109-pharmacist and a physician under this section must include, at a 72
110-minimum, all of the following: 73
111- 1. Terms and conditions relating to the screening for HIV 74
112-and the ordering and dispensing of HIV postexposure prophylaxis 75
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88+pharmacist and a physician licensed under chapter 458 or chapter 51
89+459. 52
90+ (a) A written collaborative practice agreement between a 53
91+pharmacist and a physician under this section must include, at a 54
92+minimum, all of the following: 55
93+ 1. Terms and conditions relating to the screening for HIV 56
94+and the ordering and dispensing of HIV postexposure prophylaxis 57
95+drugs by the pharmacist. Such terms and conditions must be 58
96+appropriate for the pharmacist's training. 59
97+ 2. Specific categories of patients the pharmacist is 60
98+authorized to screen for HIV and for whom the pharmacist may 61
99+order and dispense HIV postexposure pr ophylaxis drugs. 62
100+ 3. The physician's instructions for obtaining relevant 63
101+patient medical history for the purpose of identifying 64
102+disqualifying health conditions, adverse reactions, and 65
103+contraindications to the use of HIV postexposure prophylaxis 66
104+drugs. 67
105+ 4. A process and schedule for the physician to review the 68
106+pharmacist's actions under the practice agreement. 69
107+ 5. Evidence of the pharmacist's current certification by 70
108+the board as provided in subsection (6). 71
109+ 6. Any other requirements as established by th e board in 72
110+consultation with the Board of Medicine and the Board of 73
111+Osteopathic Medicine. 74
112+ (b) A physician who has entered into a written 75
113+
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121121 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
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125-drugs by the pharmacist. Such terms and conditions must be 76
126-appropriate for the pharmacist's training. 77
127- 2. Specific categories of pat ients the pharmacist is 78
128-authorized to screen for HIV and for whom the pharmacist may 79
129-order and dispense HIV postexposure prophylaxis drugs. 80
130- 3. A requirement that the pharmacist maintain records for 81
131-any HIV postexposure prophylaxis drugs ordered and dispe nsed 82
132-under the collaborative practice agreement. 83
133- 4. The physician's instructions for obtaining relevant 84
134-patient medical history for the purpose of identifying 85
135-disqualifying health conditions, adverse reactions, and 86
136-contraindications to the use of HIV pos texposure prophylaxis 87
137-drugs. 88
138- 5. A process and schedule for the physician to review the 89
139-pharmacist's records and actions under the practice agreement. 90
140- 6. Evidence of the pharmacist's current certification by 91
141-the board as provided in subsection (6). 92
142- 7. Any other requirements as established by the board with 93
143-the approval of the Board of Medicine and the Board of 94
144-Osteopathic Medicine. 95
145- (b) A physician who has entered into a written 96
146-collaborative practice agreement pursuant to this section is 97
147-responsible for reviewing the pharmacist's records and actions 98
148-to ensure compliance with the agreement. 99
149- (c) The pharmacist shall submit a copy of the written 100
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125+collaborative practice agreement pursuant to this section is 76
126+responsible for reviewing the pharmacist's actions to en sure 77
127+compliance with the agreement. 78
128+ (c) The pharmacist shall submit a copy of the written 79
129+collaborative practice agreement to the board. 80
130+ (5) A pharmacist who orders and dispenses HIV postexposure 81
131+prophylaxis drugs pursuant to subsection (4) must provid e the 82
132+patient with written information advising the patient to seek 83
133+follow-up care from his or her primary care physician. If the 84
134+patient indicates that he or she lacks regular access to primary 85
135+care, the pharmacist must comply with the procedures of the 86
136+pharmacy's approved access -to-care plan as provided in 87
137+subsection (7). 88
138+ (6) To provide services under a collaborative practice 89
139+agreement pursuant to this section, a pharmacist must be 90
140+certified by the board, according to rules adopted by the board 91
141+in consultation with the Board of Medicine and the Board of 92
142+Osteopathic Medicine. To be certified, a pharmacist must, at a 93
143+minimum, meet all of the following criteria: 94
144+ (a) Hold an active and unencumbered license to practice 95
145+pharmacy under this chapter. 96
146+ (b) Be engaged in the active practice of pharmacy. 97
147+ (c) Have earned a degree of doctor of pharmacy or have 98
148+completed at least 3 years of experience as a licensed 99
149+pharmacist. 100
150+
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158158 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
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162-collaborative practice agreement to the board. 101
163- (5) A pharmacist who orders and dispenses HIV postexposure 102
164-prophylaxis drugs pursuant to subsection (4) must provide the 103
165-patient with written information advising the patient to seek 104
166-follow-up care from his or her primary care physician. If the 105
167-patient indicates that he or she lacks regular access to primary 106
168-care, the pharmacist must comply with the procedures of the 107
169-pharmacy's approved access -to-care plan as provided in 108
170-subsection (7). 109
171- (6) To provide services under a collaborative practice 110
172-agreement pursuant to this section, a pharmacist must be 111
173-certified by the board, according to rules adopted by the board. 112
174-To be certified, a pharmacist must, at a minimum, meet all of 113
175-the following criteria: 114
176- (a) Hold an active and unencumbered license to practice 115
177-pharmacy under this chapter. 116
178- (b) Be engaged in the active pra ctice of pharmacy. 117
179- (c) Have earned a degree of doctor of pharmacy or have 118
180-completed at least 3 years of experience as a licensed 119
181-pharmacist. 120
182- (d) Maintain at least $250,000 of liability coverage. A 121
183-pharmacist who maintains liability coverage pursuant to s. 122
184-465.1865 or s. 465.1895 satisfies this requirement. 123
185- (e) Have completed a course approved by the board, in 124
186-consultation with the Board of Medicine and the Board of 125
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162+ (d) Maintain at least $250,000 of liability coverage. A 101
163+pharmacist who maintains liabi lity coverage pursuant to s. 102
164+465.1865 or s. 465.1895 satisfies this requirement. 103
165+ (e) Have completed a course approved by the board, in 104
166+consultation with the Board of Medicine and the Board of 105
167+Osteopathic Medicine, which includes, at a minimum, instructio n 106
168+on all of the following: 107
169+ 1. Performance of patient assessments. 108
170+ 2. Point-of-care testing procedures. 109
171+ 3. Safe and effective treatment of HIV exposure with HIV 110
172+infection prevention drugs, including, but not limited to, 111
173+consideration of the side effec ts of the drug dispensed and the 112
174+patient's diet and activity levels. 113
175+ 4. Identification of contraindications. 114
176+ 5. Identification of patient comorbidities in individuals 115
177+with HIV requiring further medical evaluation and treatment, 116
178+including, but not limit ed to, cardiovascular disease, lung and 117
179+liver cancer, chronic obstructive lung disease, and diabetes 118
180+mellitus. 119
181+ (7)(a) A pharmacy in which a pharmacist is providing 120
182+services under a written collaborative practice agreement 121
183+pursuant to subsection (4) must submit an access-to-care plan to 122
184+the board and department annually. 123
185+ (b) An access-to-care plan shall assist patients in 124
186+gaining access to appropriate care settings when they present to 125
187+
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195195 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
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199-Osteopathic Medicine, which includes, at a minimum, instruction 126
200-on all of the following : 127
201- 1. Performance of patient assessments. 128
202- 2. Point-of-care testing procedures. 129
203- 3. Safe and effective treatment of HIV exposure with HIV 130
204-infection prevention drugs, including, but not limited to, 131
205-consideration of the side effects of the drug dispensed and the 132
206-patient's diet and activity levels. 133
207- 4. Identification of contraindications. 134
208- 5. Identification of patient comorbidities in individuals 135
209-with HIV requiring further medical evaluation and treatment, 136
210-including, but not limited to, cardiovascular dis ease, lung and 137
211-liver cancer, chronic obstructive lung disease, and diabetes 138
212-mellitus. 139
213- (f) Any other criteria as established by the board with 140
214-the approval of the Board of Medicine and the Board of 141
215-Osteopathic Medicine. 142
216- (7)(a) A pharmacy in which a phar macist is providing 143
217-services under a written collaborative practice agreement 144
218-pursuant to subsection (4) must submit an access -to-care plan to 145
219-the board and department annually. If the board or the 146
220-department determines that a pharmacy has failed to submit an 147
221-access-to-care plan required under this section or if a 148
222-pharmacy's access-to-care plan does not comply with this section 149
223-or applicable rules of the board, the board must notify the 150
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232-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
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236-pharmacy of its noncompliance and the pharmacy must submit an 151
237-access-to-care plan that brings the pharmacy into compliance 152
238-according to parameters provided in board rule. The board may 153
239-fine a pharmacy that fails to comply with this paragraph or may 154
240-prohibit such pharmacy from allowing its pharmacists to screen 155
241-adults for HIV exposure or order and dispense HIV postexposure 156
242-prophylaxis drugs under a collaborative practice agreement until 157
243-the pharmacy complies with this paragraph. 158
244- (b) An access-to-care plan shall assist patients in 159
245-gaining access to appropriate care settings wh en they present to 160
246-a pharmacist for HIV screening and indicate that they lack 161
247-regular access to primary care. An access -to-care plan must 162
248-include, but need not be limited to: 163
249- 1. Procedures to educate such patients about care that 164
250-would be best provided i n a primary care setting and the 165
251-importance of receiving regular primary care. 166
252- 2. The pharmacy's plan for collaborative partnership with 167
253-one or more nearby federally qualified health centers, county 168
254-health departments, or other primary care settings. The goals of 169
255-such partnership must include, but need not be limited to, 170
256-protocols for identifying and appropriately referring a patient 171
257-who has presented to the pharmacist for HIV screening or access 172
258-to HIV infection prevention drugs and indicates that he or she 173
259-lacks regular access to primary care. 174
260- (8) The board shall adopt rules to implement this section. 175
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269-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
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273- Section 3. This act shall take effect July 1, 2024. 176
199+a pharmacist for HIV screening and indicate that they lack 126
200+regular access to primary care. An access -to-care plan must 127
201+include: 128
202+ 1. Procedures to educate such patients about care that 129
203+would be best provided in a primary care setting and the 130
204+importance of receiving regular primary care. 131
205+ 2. The pharmacy's plan for collabor ative partnership with 132
206+one or more nearby federally qualified health centers, county 133
207+health departments, or other primary care settings. The goals of 134
208+such partnership must include, but need not be limited to, 135
209+protocols for identifying and appropriately ref erring a patient 136
210+who has presented to the pharmacist for HIV screening or access 137
211+to HIV infection prevention drugs and indicates that he or she 138
212+lacks regular access to primary care. 139
213+ (8) The board shall adopt rules to implement this section. 140
214+ Section 3. This act shall take effect July 1, 2024. 141