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.