Florida Senate - 2021 SB 1442
By Senator Boyd
21-01592-21 20211442__
1 A bill to be entitled
2 An act relating to substance abuse prevention;
3 amending s. 381.887, F.S.; revising provisions
4 relating to the prescribing, ordering, and dispensing
5 of emergency opioid antagonists to certain persons;
6 requiring the Department of Health to develop and
7 implement a statewide awareness campaign to educate
8 the public regarding opioid overdoses and the safe
9 storage and administration of emergency opioid
10 antagonists; authorizing licensed pharmacists to
11 dispense an emergency opioid antagonist to certain
12 persons without a prescription, under certain
13 circumstances; authorizing certain persons dispensed
14 opioid antagonists without a prescription to store and
15 possess and, in certain emergency situations, to
16 administer opioid antagonists; providing certain
17 authorized persons immunity from civil and criminal
18 liability for administering emergency opioid
19 antagonists under certain circumstances; authorizing
20 personnel of law enforcement agencies and other
21 agencies and certain other persons to administer
22 emergency opioid antagonists under certain
23 circumstances; creating s. 381.888, F.S.; defining
24 terms; requiring the department, in coordination with
25 the Board of Pharmacy, to establish and administer the
26 At-home Drug Deactivation and Disposal System Program
27 for a specified purpose; providing requirements for
28 the at-home drug deactivation and disposal systems;
29 requiring the department, in coordination with the
30 board, to develop relevant educational materials and a
31 plan for distribution of the at-home drug deactivation
32 and disposal systems and educational materials;
33 requiring the department, in consultation with the
34 board, to adopt rules; amending s. 401.253, F.S.;
35 requiring certain health care facilities, basic life
36 support services, or advanced life support services to
37 report incidents involving a suspected or actual
38 overdose of a controlled substance; conforming
39 provisions to changes made by the act; amending ss.
40 456.44 and 465.0276, F.S.; requiring prescribing and
41 dispensing practitioners to concurrently prescribe or
42 dispense an at-home drug deactivation and disposal
43 system along with certain controlled substances;
44 providing an effective date.
45
46 Be It Enacted by the Legislature of the State of Florida:
47
48 Section 1. Subsections (2), (3), and (4) of section
49 381.887, Florida Statutes, are amended to read:
50 381.887 Emergency treatment for suspected opioid overdose.—
51 (2)(a) The purpose of this section is to provide for the
52 prescribing, ordering, and dispensing prescription of emergency
53 opioid antagonists an emergency opioid antagonist to patients,
54 and caregivers, and any other persons who may come into contact
55 with a controlled substance or a person who is at risk of
56 experiencing an opioid overdose and to encourage the
57 prescribing, ordering, and dispensing prescription of emergency
58 opioid antagonists by authorized health care practitioners.
59 (b) The Department of Health shall develop and implement a
60 statewide awareness campaign to educate the public regarding the
61 risk factors of opioid overdoses, the signs and symptoms of
62 opioid overdoses, and how to respond to such overdoses,
63 including the safe storage and administration of emergency
64 opioid antagonists.
65 (3)(a) An authorized health care practitioner may prescribe
66 and dispense an emergency opioid antagonist to a patient or
67 caregiver for use in accordance with this section, and
68 pharmacists may dispense an emergency opioid antagonist pursuant
69 to such a prescription or pursuant to paragraph (b) a non
70 patient-specific standing order for an autoinjection delivery
71 system or intranasal application delivery system, which must be
72 appropriately labeled with instructions for use. Such patient or
73 caregiver is authorized to store and possess approved emergency
74 opioid antagonists and, in an emergency situation when a
75 physician is not immediately available, administer the emergency
76 opioid antagonist to a person believed in good faith to be
77 experiencing an opioid overdose, regardless of whether that
78 person has a prescription for an emergency opioid antagonist.
79 (b) A pharmacist licensed under chapter 465 may order or
80 dispense an emergency opioid antagonist without a prescription
81 to any person who is at risk of an opioid overdose due to his or
82 her medical condition or history, is a caregiver of someone who
83 is at risk of an opioid overdose, is in a position to assist
84 another person who is at risk of an opioid overdose, or may come
85 into contact with a controlled substance. Such patient or
86 caregiver is authorized to store and possess approved emergency
87 opioid antagonists and, in an emergency situation when a
88 physician is not immediately available, to administer the
89 emergency opioid antagonist to a person believed in good faith
90 to be experiencing an opioid overdose, regardless of whether
91 that person has a prescription for an emergency opioid
92 antagonist.
93 (4) The following persons are authorized to possess, store,
94 and administer emergency opioid antagonists as clinically
95 indicated and are immune from any civil liability or criminal
96 liability as a result of administering an emergency opioid
97 antagonist:
98 (a) Emergency responders, including, but not limited to,
99 law enforcement officers, paramedics, and emergency medical
100 technicians.
101 (b) Crime laboratory personnel for the statewide criminal
102 analysis laboratory system as described in s. 943.32, including,
103 but not limited to, analysts, evidence intake personnel, and
104 their supervisors.
105 (c) Personnel of a law enforcement agency or other agency,
106 including, but not limited to, correctional probation officers
107 and child protective investigators who, while acting within the
108 scope or course of employment, come into contact with a
109 controlled substance or a person who is at risk of experiencing
110 an opioid overdose.
111 (d) A person who is dispensed an emergency opioid
112 antagonist pursuant to paragraph (3)(b) and comes into contact
113 with a controlled substance or a person who is at risk of
114 experiencing an opioid overdose.
115 Section 2. Section 381.888, Florida Statutes, is created to
116 read:
117 381.888 At-home Drug Deactivation and Disposal System
118 Program.—
119 (1) DEFINITIONS.—As used in this section, the term:
120 (a) “Board” means the Board of Pharmacy.
121 (b) “Department” means the Department of Health.
122 (c) “Nonretrievable” has the same meaning as provided in 21
123 C.F.R. s. 1300.05(b), as that definition exists on the effective
124 date of this act.
125 (d) “Pharmacy” has the same meaning as provided in s.
126 465.003(11).
127 (e) “Program” means the At-home Drug Deactivation and
128 Disposal System Program.
129 (2) PROGRAM ESTABLISHED.—
130 (a) The department, in coordination with the board, shall
131 establish and administer the At-home Drug Deactivation and
132 Disposal System Program for the purpose of identifying and
133 distributing a suitable at-home drug deactivation and disposal
134 system that pharmacies must co-dispense with each opioid
135 prescription. The at-home drug deactivation and disposal system
136 must permanently render the active pharmaceutical ingredient
137 nonretrievable, nonusable, and fully nontoxic at the point it
138 enters the state’s municipal waste systems.
139 (b) The department, in coordination with the board, shall
140 develop relevant educational materials and a plan for
141 distribution of the at-home drug deactivation and disposal
142 systems and educational materials to pharmacies in this state.
143 (3) RULEMAKING AUTHORITY.—The department, in consultation
144 with the board, shall adopt rules to administer the program.
145 Section 3. Paragraph (a) of subsection (1) and subsections
146 (3) and (5) of section 401.253, Florida Statutes, are amended to
147 read:
148 401.253 Reporting of controlled substance overdoses.—
149 (1)(a) A health care facility, a basic life support
150 service, or an advanced life support service that which treats
151 and releases, or transports to a medical facility, a person in
152 response to an emergency call for a suspected or actual overdose
153 of a controlled substance must may report such incidents to the
154 department. Such reports must be made using the Emergency
155 Medical Service Tracking and Reporting System or other
156 appropriate method with secure access, including, but not
157 limited to, the Washington/Baltimore High Intensity Drug
158 Trafficking Overdose Detection Mapping Application Program or
159 other program identified by the department in rule. If a health
160 care facility, a basic life support service, or an advanced life
161 support service reports such incidents, it must shall make its
162 best efforts to make the report to the department within 120
163 hours after it responds to the incident.
164 (3) A health care facility, a basic life support service,
165 or an advanced life support service that reports information to
166 or from the department pursuant to this section in good faith is
167 not subject to civil or criminal liability for making the
168 report.
169 (5) The department shall produce a quarterly report to the
170 Statewide Drug Policy Advisory Council, the Department of
171 Children and Families, and the Florida FUSION Center summarizing
172 the raw data received pursuant to this section. Such reports
173 shall also be made immediately available to the county-level
174 agencies described in paragraph (1)(b). The Statewide Drug
175 Policy Advisory Council, the Department of Children and
176 Families, and the department may use these reports to maximize
177 the utilization of funding programs for health care facilities,
178 licensed basic life support service providers, or advanced life
179 support service providers, and for the dissemination of
180 available federal, state, and private funds for local substance
181 abuse services in accordance with s. 397.321(4).
182 Section 4. Subsection (6) of section 456.44, Florida
183 Statutes, is amended to read:
184 456.44 Controlled substance prescribing.—
185 (6) EMERGENCY OPIOID ANTAGONIST.—For the treatment of pain
186 related to a traumatic injury with an Injury Severity Score of 9
187 or greater, a prescriber who prescribes a Schedule II controlled
188 substance listed in s. 893.03 or 21 U.S.C. s. 812 must
189 concurrently prescribe an emergency opioid antagonist, as
190 defined in s. 381.887(1), and an at-home drug deactivation and
191 disposal system pursuant to s. 381.888.
192 Section 5. Paragraph (b) of subsection (1) of section
193 465.0276, Florida Statutes, is amended to read:
194 465.0276 Dispensing practitioner.—
195 (1)
196 (b) A practitioner registered under this section may not
197 dispense a controlled substance listed in Schedule II or
198 Schedule III as provided in s. 893.03. This paragraph does not
199 apply to:
200 1. The dispensing of complimentary packages of medicinal
201 drugs which are labeled as a drug sample or complimentary drug
202 as defined in s. 499.028 to the practitioner’s own patients in
203 the regular course of her or his practice without the payment of
204 a fee or remuneration of any kind, whether direct or indirect,
205 as provided in subsection (4).
206 2. The dispensing of controlled substances in the health
207 care system of the Department of Corrections.
208 3. The dispensing of a controlled substance listed in
209 Schedule II or Schedule III in connection with the performance
210 of a surgical procedure.
211 a. For an opioid drug listed as a Schedule II controlled
212 substance in s. 893.03 or 21 U.S.C. s. 812:
213 (I) For the treatment of acute pain, the amount dispensed
214 pursuant to this subparagraph may not exceed a 3-day supply, or
215 a 7-day supply if the criteria in s. 456.44(5)(a) are met.
216 (II) For the treatment of pain other than acute pain, a
217 practitioner must indicate “NONACUTE PAIN” on a prescription.
218 (III) For the treatment of pain related to a traumatic
219 injury with an Injury Severity Score of 9 or greater, a
220 practitioner must concurrently prescribe an emergency opioid
221 antagonist, as defined in s. 381.887(1), and an at-home drug
222 deactivation and disposal system pursuant to s. 381.888.
223 b. For a controlled substance listed in Schedule III, the
224 amount dispensed pursuant to this subparagraph may not exceed a
225 14-day supply.
226 c. The exception in this subparagraph does not allow for
227 the dispensing of a controlled substance listed in Schedule II
228 or Schedule III more than 14 days after the performance of the
229 surgical procedure.
230 d. For purposes of this subparagraph, the term “surgical
231 procedure” means any procedure in any setting which involves, or
232 reasonably should involve:
233 (I) Perioperative medication and sedation that allows the
234 patient to tolerate unpleasant procedures while maintaining
235 adequate cardiorespiratory function and the ability to respond
236 purposefully to verbal or tactile stimulation and makes intra-
237 and postoperative monitoring necessary; or
238 (II) The use of general anesthesia or major conduction
239 anesthesia and preoperative sedation.
240 4. The dispensing of a controlled substance listed in
241 Schedule II or Schedule III pursuant to an approved clinical
242 trial. For purposes of this subparagraph, the term “approved
243 clinical trial” means a clinical research study or clinical
244 investigation that, in whole or in part, is state or federally
245 funded or is conducted under an investigational new drug
246 application that is reviewed by the United States Food and Drug
247 Administration.
248 5. The dispensing of methadone in a facility licensed under
249 s. 397.427 where medication-assisted treatment for opiate
250 addiction is provided.
251 6. The dispensing of a controlled substance listed in
252 Schedule II or Schedule III to a patient of a facility licensed
253 under part IV of chapter 400.
254 7. The dispensing of controlled substances listed in
255 Schedule II or Schedule III which have been approved by the
256 United States Food and Drug Administration for the purpose of
257 treating opiate addictions, including, but not limited to,
258 buprenorphine and buprenorphine combination products, by a
259 practitioner authorized under 21 U.S.C. s. 823, as amended, to
260 the practitioner’s own patients for the medication-assisted
261 treatment of opiate addiction.
262 Section 6. This act shall take effect July 1, 2021.