Florida 2023 2023 Regular Session

Florida Senate Bill S0542 Analysis / Analysis

Filed 03/07/2023

                    The Florida Senate 
BILL ANALYSIS AND FISCAL IMPACT STATEMENT 
(This document is based on the provisions contained in the legislation as of the latest date listed below.) 
Prepared By: The Professional Staff of the Committee on Education Postsecondary  
 
BILL: SB 542 
INTRODUCER:  Senator Boyd 
SUBJECT:  Emergency Opioid Antagonists 
DATE: March 6, 2023 
 
 ANALYST STAFF DIRECTOR  REFERENCE  	ACTION 
1. Brick Bouck HE Favorable 
2.     JU  
3.     RC  
 
I. Summary: 
The bill requires each Florida College System institution and state university to store a supply of 
emergency opioid antagonists in each residence hall or dormitory residence owned or operated 
by the institution in the event of an opioid overdose. The emergency opioid antagonist must be 
easily accessible to campus law enforcement officers who are trained in the administration of 
emergency opioid antagonists and provides immunity from civil or criminal liability for 
administering an emergency opioid antagonist in accordance with the bill. 
 
The bill takes effect July 1, 2023. 
II. Present Situation: 
Opioid Epidemic 
An opioid overdose may cause a person to lose consciousness, stop breathing, and die.
1
 In 2017, 
the number of overdose deaths involving opioids was 6 times higher nationwide than it was in 
1999.
2
 In that same year in Florida, opioids killed 4,280 people, including 25 children under the 
age of 18, indicating a 9 percent increase in the overall death toll over the preceding year.
3
 As a 
                                                
1
 U.S. Food & Drug Administration, Statement From FDA Commissioner Scott Gottlieb, M.D., on Unprecedented New 
Efforts to Support Development of Over-The-Counter Naloxone to Help Reduce Opioid Overdose Deaths (Jan. 17, 2019), 
https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-
efforts-support-development-over (last visited Mar. 2, 2023). 
2
 National Institute on Drug Abuse, Drug Overdose Death Rates, https://nida.nih.gov/research-topics/trends-
statistics/overdose-death-rates (last visited Mar. 1, 2023). 
3
 Florida Department of Law Enforcement, Medical Examiners Commission, Drugs Identified in Deceased Persons by 
Florida Medical Examiners, 2017 Annual Report (Nov. 2018), available at https://www.fdle.state.fl.us/MEC/Publications-
and-Forms/Documents/Drugs-in-Deceased-Persons/2017-Annual-Drug-Report.aspx, at ii. 
REVISED:   BILL: SB 542   	Page 2 
 
result of the opioid epidemic, Governor Scott declared Florida to be in a state of emergency.
4
 
Subsequent Executive Orders extended the state of emergency through April 2, 2019.
5
 
 
On April 1, 2019, Governor DeSantis created a Statewide Task Force on Opioid Abuse to 
research and assess the nature of opioid drug abuse in Florida and develop a statewide strategy to 
identify best practices to combat the opioid epidemic through education, treatment, prevention, 
recovery, and law enforcement.
6
 Deaths from opioid overdoses in Florida increased by 6 percent 
from 2020 to 2021, to 6,442.
7
 
 
Emergency Opioid Antagonists 
An emergency opioid antagonist is a drug such as naloxone hydrochloride or any similarly acting 
drug that blocks the effects of opioids administered from outside the body and that is approved 
by the United States Food and Drug Administration for the treatment of an opioid overdose. 
Naltrexone is another commonly used opioid antagonist.
8
 Naloxone is a well-established 
essential medicine for the treatment of a life-threatening opioid overdose in emergency 
medicine.
9
 Naloxone is a safe antidote to a suspected overdose and can save a life when given in 
time.
10
 Research shows that when naloxone and overdose education are available to community 
members, overdose deaths decrease in those communities.
11
  
 
Administration 
Laypersons administering naloxone have a 75 to 100 percent success rate in reversing the effects 
of an opioid overdose.
12
 Naloxone may be administered to a person through a vein, through a 
muscle, or through the nasal passage, and is FDA-approved for the use in an opioid overdose and 
                                                
4
 Office of the Governor, Executive Order Number 17-146, May 3, 2017 (Opioid Epidemic). 
5
 Office of the Governor, Executive Order Number 19-36, February 1, 2019 (Opioid Epidemic Extension). 
6
 Office of the Governor, Executive Order Number 19-97, April 1, 2019 ((Establishing the Office of Drug Control and the 
Statewide Task Force on Opioid Abuse to Combat Florida's Substance Abuse Crisis). 
7
 FDLE, Medical Examiners Commission, Drugs Identified in Deceased Persons by Florida Medical Examiners: 2021 
Annual Report, available at https://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-in-Deceased-
Persons/2021-Annual-Drug-Report-FINAL. 
8
 Theriot, Jonathan, et. al., Opioid Antagonists (last updated July 19, 2022), 
https://www.ncbi.nlm.nih.gov/books/NBK537079/#:~:text=3%5D%5B4%5D-
,The%20two%20most%20commonly%20used%20centrally%20acting%20opioid%20receptor%20antagonists,depression%2
0associated%20with%20opioid%20use. (last visited Mar. 1, 2023). 
9
 John Strang et al., Take-Home Naloxone for the Emergency Interim Management of Opioid Overdose: The Public Health 
Application of an Emergency Medicine, 79(13) Drugs 1395-1418 (2019), available at 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728289/. 
10
 U.S. Department of Health and Human Services, Office of the Surgeon General, U.S. Surgeon General’s Advisory on 
Naloxone and Opioid Overdose (Apr. 5, 2018), available at https://www.hhs.gov/surgeongeneral/priorities/opioids-and-
addiction/naloxone-advisory/index.html (last visited Mar. 2, 2023). 
11
 Id. 
12
 Rachael Rzasa Lynn and J. L. Galinkin, Naloxone dosage for opioid reversal: current evidence and clinical implications, 
9(1) Therapeutic Advances in Drug Safety 63-88 (2018), available at 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753997/.  BILL: SB 542   	Page 3 
 
the reversal of respiratory depression associated with opioid use.
13
 Naltrexone is available in 
both oral and long-acting injectable formulations.
14
  
 
Naloxone may cost less than a dollar per unit for a simple vial, to several thousand dollars for 
certain intramuscular auto-injectors.
15
 On average, Naloxone costs approximately $30 per carton, 
which includes two doses of Narcan.
16
 The Florida Department of Children and Families, as part 
of its overdose prevention program, purchases Narcan at $75 per carton.
17
 Emergent Biosolutions 
has produced an FDA- approved naloxone nasal spray called Narcan.
18
 Emergent Biosolutions 
offers up to two free cartons of Narcan to degree-granting postsecondary institutions.
19
  
 
Regulation 
Naloxone and naltrexone are derivatives of thebaine,
20
 a Schedule II controlled substance in 
Florida.
21
 Schedule II substances may only be dispensed with a prescription from a licensed 
health care practitioner,
22
 but emergency responders, crime lab personnel, and personnel of a law 
enforcement agency are authorized by law to possess, store, and administer emergency opioid 
antagonists as necessary and are immune from any civil liability or criminal liability as a result 
of administering an emergency opioid antagonist.
23
 The U.S. Surgeon General has developed 
standards to encourage the distribution of over-the-counter naloxone.
24
  
 
Subject to statutory exceptions, it is illegal for a drug manufacturer or wholesale distributor in 
Florida to distribute a prescription drug to a person without a prescription.
25
 One such statutory 
exception authorizes a public school to purchase a supply of epinephrine auto-injectors from a 
                                                
13
 Jonathan Theriot, et. al., Opioid Antagonists, (last updated July 23, 2021), StatPearls Pub. 2022-Jan, available at 
https://www.ncbi.nlm.nih.gov/books/NBK537079/#:~:text=3%5D%5B4%5D-
,The%20two%20most%20commonly%20used%20centrally%20acting%20opioid%20receptor%20antagonists,depression%2
0associated%20with%20opioid%20use. (last visited Mar. 2, 2023). 
14
 Id. 
15
 John Strang et al., Take-Home Naloxone for the Emergency Interim Management of Opioid Overdose: The Public Health 
Application of an Emergency Medicine, 79(13) Drugs 1395-1418 (2019), available at 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6728289/. 
16
 Florida Department of Education, 2023 Staff Analysis of HB 39 (Jan. 11, 2023). 
17
 Email, Florida Department of Children and Families (Mar. 6, 2023). 
18
 Id. Emergent Biosolutions bought Adapt Pharma, who originally produced Narcan. 
19
 Emergent Biosolutions, Free Narcan Nasal Spray to Eligible Schools, available at https://californiamat.org/wp-
content/uploads/2022/01/Schools.PP-NAR4-US-00483-Professional-Educator-One-Pager-2021-Update.pdf.  
20
 National Center for Biotechnology Information, PubChem Compound Summary for CID 5284596, Naloxone, PubChem 
https://pubchem.ncbi.nlm.nih.gov/compound/Naloxone (last visited Mar. 2, 2023); and Sun Dongbang, et al., Assymetric 
synthesis of naltrexone, Chem Sci 2018 Oct 23 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6326069/ (last visited 
Mar. 1, 2023). 
21
 Section 893.03(2)(a)1.s., F.S. 
22
 Section 893.04(1)(f), F.S. “Practitioner” means a physician licensed under chapter 458, a dentist licensed under chapter 
466, a veterinarian licensed under chapter 474, an osteopathic physician licensed under chapter 459, an advanced practice 
registered nurse licensed under chapter 464, a naturopath licensed under chapter 462, a certified optometrist licensed under 
chapter 463, a psychiatric nurse as defined in s. 394.455, F.S., a podiatric physician licensed under chapter 461, or a 
physician assistant licensed under chapter 458 or chapter 459, provided such practitioner holds a valid federal controlled 
substance registry number. Section 893.02(23), F.S. 
23
 Section 381.887, F.S. 
24
 U.S. Food & Drug Administration, supra note 1. 
25
 Section 499.005(14), F.S.  BILL: SB 542   	Page 4 
 
wholesale distributor or manufacturer.
26
 In addition, a manufacturer or wholesale distributor of 
naloxone may sell a prescription drug to: 
 A licensed pharmacist or any person under the licensed pharmacist's supervision while acting 
within the scope of the licensed pharmacist's practice; 
 A licensed practitioner authorized by law to prescribe prescription drugs or any person under 
the licensed practitioner's supervision while acting within the scope of the licensed 
practitioner's practice; 
 A qualified person who uses prescription drugs for lawful research, teaching, or testing, and 
not for resale; 
 A licensed hospital or other institution that procures such drugs for lawful administration or 
dispensing by practitioners; 
 An officer or employee of a federal, state, or local government; or 
 A person that holds a valid permit issued by the Department of Business and Professional 
Regulation, which authorizes that person to possess prescription drugs.
27
 
 
The Good Samaritan Act 
The Good Samaritan Act provides that any person, including those licensed to practice medicine, 
who gratuitously and in good faith renders emergency care or treatment either in direct response 
to emergency situations outside of a hospital, doctor's office, or other place having proper 
medical equipment, without objection of the injured victim or victims are immune from liability 
for any civil damages as a result of such care or treatment or as a result of any act or failure to act 
in providing or arranging further medical treatment where the person acts as an ordinary 
reasonably prudent person would have acted under the same or similar circumstances.
28
 
 
Dormitories and Residence Halls 
All 12 state universities in the State University System of Florida own or operate a residence hall 
or dormitory available to students. In the 28 state colleges in the Florida College System, there 
are 12 residence halls or dormitories available to students. However, only three of these 
residence halls or dormitories are owned or operated by a state college. They are located at 
Chipola College, College of the Florida Keys, and Florida Gateway College.
29
 
III. Effect of Proposed Changes: 
SB 542 requires each Florida College System (FCS) institutions and state university to have a 
supply of emergency opioid antagonists with an autoinjection or intranasal application delivery 
system in each residence hall or dormitory residence owned or operated by the institution for the 
administration of emergency opioid antagonists to a person believed to be experiencing an opioid 
overdose. The bill defines an “emergency opioid antagonist” to mean naloxone hydrochloride or 
any similarly acting drug that blocks the effects of opioids administered from outside the body 
and that is approved by the United States Food and Drug Administration for the treatment of an 
opioid overdose. The emergency opioid antagonist must be placed in a clearly marked location 
                                                
26
 Section 1002.20(3)(i), F.S. 
27
 Section 499.03(1), F.S. 
28
 Section 768.13(2)(a), F.S. 
29
 Florida Department of Education, 2023 Staff Analysis of HB 39 (Jan. 11, 2023).  BILL: SB 542   	Page 5 
 
within each residence hall or dormitory residence in a manner that is easily accessible to campus 
law enforcement officers who are trained in the administration of emergency opioid 
antagonists.
30
 
 
The bill provides civil and criminal immunity to any campus law enforcement officer trained in 
the administration of emergency opioid antagonists, and the institution that employs such officer, 
who administers or attempts to administer an emergency opioid antagonist as authorized under 
laws related to emergency treatment for suspected opioid overdose and the Good Samaritan Act. 
 
The bill requires the State Board of Education and the Board of Governors to adopt rules and 
regulations, in cooperation with the Department of Health, to administer requirements related to 
the supply and administration of emergency opioid antagonists pursuant to the bill. 
 
The bill encourages public and private partnerships to cover the cost associated with the purchase 
and placement of such emergency opioid antagonists. 
 
Providing increased access to an emergency opioid antagonist through a dormitory or residence 
hall accessible by law enforcement trained in its use may help decrease the risk of death for FCS 
institution and state university students and others who experience an opioid overdose. 
 
The bill takes effect July 1, 2023. 
IV. Constitutional Issues: 
A. Municipality/County Mandates Restrictions: 
None. 
B. Public Records/Open Meetings Issues: 
None. 
C. Trust Funds Restrictions: 
None. 
D. State Tax or Fee Increases: 
None. 
E. Other Constitutional Issues: 
None. 
                                                
30
 Campus law enforcement may include personnel employed by the institution, or county or municipal officers who act as 
campus law enforcement on a contractual basis.  BILL: SB 542   	Page 6 
 
V. Fiscal Impact Statement: 
A. Tax/Fee Issues: 
None. 
B. Private Sector Impact: 
None. 
C. Government Sector Impact: 
The bill does not require the appropriation of state funds. Florida College System 
institutions and state universities that secure a supply of emergency opioid antagonists 
may incur costs related to the purchase and storage of the emergency opioid antagonist. 
The costs are indeterminate. 
VI. Technical Deficiencies: 
None. 
VII. Related Issues: 
None. 
VIII. Statutes Affected: 
This bill substantially amends s. 1004.0971 of the Florida Statutes. 
IX. Additional Information: 
A. Committee Substitute – Statement of Changes: 
(Summarizing differences between the Committee Substitute and the prior version of the bill.) 
None. 
B. Amendments: 
None. 
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.