Florida 2024 Regular Session

Florida House Bill H0159 Latest Draft

Bill / Enrolled Version Filed 03/06/2024

                                    
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CS/CS/HB 159, Engrossed 2 	2024 Legislature 
 
 
 
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      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 
 
 
 
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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          
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CS/CS/HB 159, Engrossed 2 	2024 Legislature 
 
 
 
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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          
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CS/CS/HB 159, Engrossed 2 	2024 Legislature 
 
 
 
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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          
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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          
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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 
 
 
 
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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 
 
 
 
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 Section 3.  This act shall take effect July 1, 2024. 176