Florida Senate - 2021 SB 1442 By Senator Boyd 21-01592-21 20211442__ Page 1 of 10 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to substance abuse prevention; 2 amending s. 381.887, F.S.; revising provisions 3 relating to the prescribing, ordering, and dispensing 4 of emergency opioid antagonists to certain persons; 5 requiring the Department of Health to develop and 6 implement a statewide awareness campaign to educate 7 the public regarding opioid overdoses and the safe 8 storage and administration of emergency opioid 9 antagonists; authorizing licensed pharmacists to 10 dispense an emergency opioid antagonist to certain 11 persons without a prescription, under certain 12 circumstances; authorizing certain persons dispensed 13 opioid antagonists without a prescription to store and 14 possess and, in certain emergency situations, to 15 administer opioid antagonists; providing certain 16 authorized persons immunity from civil and criminal 17 liability for administering emergency opioid 18 antagonists under certain circumstances; authorizing 19 personnel of law enforcement agencies and other 20 agencies and certain other persons to administer 21 emergency opioid antagonists under certain 22 circumstances; creating s. 381.888, F.S.; defining 23 terms; requiring the department, in coordination with 24 the Board of Pharmacy, to establish and administer the 25 At-home Drug Deactivation and Disposal System Program 26 for a specified purpose; providing requirements for 27 the at-home drug deactivation and disposal systems; 28 requiring the department, in coordination with the 29

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 2 of 10 CODING: Words stricken are deletions; words underlined are additions. board, to develop relevant educational materials and a 30 plan for distribution of the at-home drug deactivation 31 and disposal systems and educational materials; 32 requiring the department, in consultation with the 33 board, to adopt rules; amending s. 401.253, F.S.; 34 requiring certain health care facilities, basic life 35 support services, or advanced life support services to 36 report incidents involving a suspected or actual 37 overdose of a controlled substance; conforming 38 provisions to changes made by the act; amending ss. 39 456.44 and 465.0276, F.S.; requiring prescribing and 40 dispensing practitioners to concurrently prescribe or 41 dispense an at-home drug deactivation and disposal 42 system along with certain controlled substances; 43 providing an effective date. 44 45 Be It Enacted by the Legislature of the State of Florida: 46 47

Section 1. Subsections (2), (3), and (4) of

section 48 381.887, Florida Statutes, are amended to read: 49 381.887 Emergency treatment for suspected opioid overdose.— 50 (2)(

a) The purpose of this

section is to provide for the 51 prescribing, ordering, and dispensing prescription of emergency 52 opioid antagonists an emergency opioid antagonist to patients, 53 and caregivers, and any other persons who may come into contact 54 with a controlled substance or a person who is at risk of 55 experiencing an opioid overdose and to encourage the 56 prescribing, ordering, and dispensing prescription of emergency 57 opioid antagonists by authorized health care practitioners. 58

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b) The Department of Health shall develop and implement a 59 statewide awareness campaign to educate the public regarding the 60 risk factors of opioid overdoses, the signs and symptoms of 61 opioid overdoses, and how to respond to such overdoses, 62 including the safe storage and administration of emergency 63 opioid antagonists. 64 (3)(

a) An authorized health care practitioner may prescribe 65 and dispense an emergency opioid antagonist to a patient or 66 caregiver for use in accordance with this section, and 67 pharmacists may dispense an emergency opioid antagonist pursuant 68 to such a prescription or pursuant to paragraph (

b) a non-69 patient-specific standing order for an autoinjection delivery 70 system or intranasal application delivery system, which must be 71 appropriately labeled with instructions for use. Such patient or 72 caregiver is authorized to store and possess approved emergency 73 opioid antagonists and, in an emergency situation when a 74 physician is not immediately available, administer the emergency 75 opioid antagonist to a person believed in good faith to be 76 experiencing an opioid overdose, regardless of whether that 77 person has a prescription for an emergency opioid antagonist. 78 (

b) A pharmacist licensed under

chapter 465 may order or 79 dispense an emergency opioid antagonist without a prescription 80 to any person who is at risk of an opioid overdose due to his or 81 her medical condition or history, is a caregiver of someone who 82 is at risk of an opioid overdose, is in a position to assist 83 another person who is at risk of an opioid overdose, or may come 84 into contact with a controlled substance. Such patient or 85 caregiver is authorized to store and possess approved emergency 86 opioid antagonists and, in an emergency situation when a 87

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 4 of 10 CODING: Words stricken are deletions; words underlined are additions. physician is not immediately available, to administer the 88 emergency opioid antagonist to a person believed in good faith 89 to be experiencing an opioid overdose, regardless of whether 90 that person has a prescription for an emergency opioid 91 antagonist. 92

(4) The following persons are authorized to possess, store, 93 and administer emergency opioid antagonists as clinically 94 indicated and are immune from any civil liability or criminal 95 liability as a result of administering an emergency opioid 96 antagonist: 97 (

a) Emergency responders, including, but not limited to, 98 law enforcement officers, paramedics, and emergency medical 99 technicians. 100 (

b) Crime laboratory personnel for the statewide criminal 101 analysis laboratory system as described in s. 943.32, including, 102 but not limited to, analysts, evidence intake personnel, and 103 their supervisors. 104 (

c) Personnel of a law enforcement agency or other agency, 105 including, but not limited to, correctional probation officers 106 and child protective investigators who, while acting within the 107 scope or course of employment, come into contact with a 108 controlled substance or a person who is at risk of experiencing 109 an opioid overdose. 110 (

d) A person who is dispensed an emergency opioid 111 antagonist pursuant to paragraph (3)(

b) and comes into contact 112 with a controlled substance or a person who is at risk of 113 experiencing an opioid overdose. 114

Section

Section 381.888, Florida Statutes, is created to 115 read: 116

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 5 of 10 CODING: Words stricken are deletions; words underlined are additions. 381.888 At-home Drug Deactivation and Disposal System 117 Program.— 118

(1) DEFINITIONS.—As used in this section, the term: 119 (a) “Board” means the Board of Pharmacy. 120 (b) “Department” means the Department of Health. 121 (c) “Nonretrievable” has the same meaning as provided in 21 122 C.F.R. s. 1300.05(b), as that definition exists on the effective 123 date of this act. 124 (d) “Pharmacy” has the same meaning as provided in s. 125 465.003(11). 126 (e) “Program” means the At-home Drug Deactivation and 127 Disposal System Program. 128

(2) PROGRAM ESTABLISHED.— 129 (

a) The department, in coordination with the board, shall 130 establish and administer the At-home Drug Deactivation and 131 Disposal System Program for the purpose of identifying and 132 distributing a suitable at-home drug deactivation and disposal 133 system that pharmacies must co-dispense with each opioid 134 prescription. The at-home drug deactivation and disposal system 135 must permanently render the active pharmaceutical ingredient 136 nonretrievable, nonusable, and fully nontoxic at the point it 137 enters the state’s municipal waste systems. 138 (

b) The department, in coordination with the board, shall 139 develop relevant educational materials and a plan for 140 distribution of the at-home drug deactivation and disposal 141 systems and educational materials to pharmacies in this state. 142

(3) RULEMAKING AUTHORITY.—The department, in consultation 143 with the board, shall adopt rules to administer the program. 144

Section 3. Paragraph (

a) of subsection (1) and subsections 145

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 6 of 10 CODING: Words stricken are deletions; words underlined are additions. (3) and (5) of

section 401.253, Florida Statutes, are amended to 146 read: 147 401.253 Reporting of controlled substance overdoses.— 148 (1)(

a) A health care facility, a basic life support 149 service, or an advanced life support service that which treats 150 and releases, or transports to a medical facility, a person in 151 response to an emergency call for a suspected or actual overdose 152 of a controlled substance must may report such incidents to the 153 department.

Such reports must be made using the Emergency 154 Medical Service Tracking and Reporting System or other 155 appropriate method with secure access, including, but not 156 limited to, the Washington/Baltimore High Intensity Drug 157 Trafficking Overdose Detection Mapping Application Program or 158 other program identified by the department in rule. If a health 159 care facility, a basic life support service, or an advanced life 160 support service reports such incidents, it must shall make its 161 best efforts to make the report to the department within 120 162 hours after it responds to the incident. 163

(3) A health care facility, a basic life support service, 164 or an advanced life support service that reports information to 165 or from the department pursuant to this

section in good faith is 166 not subject to civil or criminal liability for making the 167 report. 168

(5) The department shall produce a quarterly report to the 169 Statewide Drug Policy Advisory Council, the Department of 170 Children and Families, and the Florida FUSION Center summarizing 171 the raw data received pursuant to this section. Such reports 172 shall also be made immediately available to the county-level 173 agencies described in paragraph (1)(b). The Statewide Drug 174

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 7 of 10 CODING: Words stricken are deletions; words underlined are additions. Policy Advisory Council, the Department of Children and 175 Families, and the department may use these reports to maximize 176 the utilization of funding programs for health care facilities, 177 licensed basic life support service providers, or advanced life 178 support service providers, and for the dissemination of 179 available federal, state, and private funds for local substance 180 abuse services in accordance with s. 397.321(4). 181

Section 4. Subsection (6) of

section 456.44, Florida 182 Statutes, is amended to read: 183 456.44 Controlled substance prescribing.— 184

(6) EMERGENCY OPIOID ANTAGONIST.—For the treatment of pain 185 related to a traumatic injury with an Injury Severity Score of 9 186 or greater, a prescriber who prescribes a

Schedule II controlled 187 substance listed in s. 893.03 or 21 U.S.C. s. 812 must 188 concurrently prescribe an emergency opioid antagonist, as 189 defined in s. 381.887(1), and an at-home drug deactivation and 190 disposal system pursuant to s. 381.888. 191

Section 5. Paragraph (

b) of subsection (1) of

section 192 465.0276, Florida Statutes, is amended to read: 193 465.0276 Dispensing practitioner.— 194 (1) 195 (

b) A practitioner registered under this

section may not 196 dispense a controlled substance listed in

Schedule II or 197

Schedule III as provided in s. 893.03. This paragraph does not 198 apply to: 199 1. The dispensing of complimentary packages of medicinal 200 drugs which are labeled as a drug sample or complimentary drug 201 as defined in s. 499.028 to the practitioner’s own patients in 202 the regular course of her or his practice without the payment of 203

Florida Senate - 2021 SB 1442 21-01592-21 20211442__ Page 8 of 10 CODING: Words stricken are deletions; words underlined are additions. a fee or remuneration of any kind, whether direct or indirect, 204 as provided in subsection (4). 205 2. The dispensing of controlled substances in the health 206 care system of the Department of Corrections. 207 3. The dispensing of a controlled substance listed in 208

Schedule II or

Schedule III in connection with the performance 209 of a surgical procedure. 210 a. For an opioid drug listed as a

Schedule II controlled 211 substance in s. 893.03 or 21 U.S.C. s. 812: 212 (

I) For the treatment of acute pain, the amount dispensed 213 pursuant to this subparagraph may not exceed a 3-day supply, or 214 a 7-day supply if the criteria in s. 456.44(5)(

a) are met. 215 (II) For the treatment of pain other than acute pain, a 216 practitioner must indicate “NONACUTE PAIN” on a prescription. 217 (III) For the treatment of pain related to a traumatic 218 injury with an Injury Severity Score of 9 or greater, a 219 practitioner must concurrently prescribe an emergency opioid 220 antagonist, as defined in s. 381.887(1), and an at-home drug 221 deactivation and disposal system pursuant to s. 381.888. 222 b. For a controlled substance listed in

Schedule III, the 223 amount dispensed pursuant to this subparagraph may not exceed a 224 14-day supply. 225 c. The exception in this subparagraph does not allow for 226 the dispensing of a controlled substance listed in

Schedule II 227 or

Schedule III more than 14 days after the performance of the 228 surgical procedure. 229 d. For purposes of this subparagraph, the term “surgical 230 procedure” means any procedure in any setting which involves, or 231 reasonably should involve: 232

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I) Perioperative medication and sedation that allows the 233 patient to tolerate unpleasant procedures while maintaining 234 adequate cardiorespiratory function and the ability to respond 235 purposefully to verbal or tactile stimulation and makes intra- 236 and postoperative monitoring necessary; or 237 (II) The use of general anesthesia or major conduction 238 anesthesia and preoperative sedation. 239 4. The dispensing of a controlled substance listed in 240

Schedule II or

Schedule III pursuant to an approved clinical 241 trial. For purposes of this subparagraph, the term “approved 242 clinical trial” means a clinical research study or clinical 243 investigation that, in whole or in part, is state or federally 244 funded or is conducted under an investigational new drug 245 application that is reviewed by the United States Food and Drug 246 Administration. 247 5. The dispensing of methadone in a facility licensed under 248 s. 397.427 where medication-assisted treatment for opiate 249 addiction is provided. 250 6. The dispensing of a controlled substance listed in 251

Schedule II or

Schedule III to a patient of a facility licensed 252 under

part IV of

chapter 400. 253 7. The dispensing of controlled substances listed in 254

Schedule II or

Schedule III which have been approved by the 255 United States Food and Drug Administration for the purpose of 256 treating opiate addictions, including, but not limited to, 257 buprenorphine and buprenorphine combination products, by a 258 practitioner authorized under 21 U.S.C. s. 823, as amended, to 259 the practitioner’s own patients for the medication-assisted 260 treatment of opiate addiction. 261

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Section 6. This act shall take effect July 1, 2021. 262