HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 783 Emergency Opioid Antagonists
SPONSOR(S): Health & Human Services Committee, Healthcare Regulation Subcommittee, Caruso
TIED BILLS: IDEN./SIM. BILLS: SB 704
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Healthcare Regulation Subcommittee 14 Y, 0 N, As CS Osborne McElroy
2) Health Care Appropriations Subcommittee 13 Y, 0 N Fontaine Clark
3) Health & Human Services Committee 18 Y, 0 N, As CS Osborne Calamas
SUMMARY ANALYSIS
Opioids are psychoactive substances which are highly effective pain relievers. Opioids are commonly
prescribed to treat acute and chronic pain; however, while highly effective, they are also highly addictive and
an overabundance of opioids in the body can lead to a fatal overdose. More than 106,000 Americans died from
drug-involved overdose in 2021, including illicit drugs and prescription opioids. In 2021, there were 6,442
opioid overdose deaths reported in Florida, a 22% increase from 2019.
Opioid antagonists are used to treat opioid overdoses to counteract the life-threatening depression of the
central nervous system and respiratory system that results from an opioid overdose. Under current law, a
pharmacist is authorized to order and dispense an emergency opioid antagonist to a patient or caregiver
without a prescription or a non-patient-specific standing order being in place. Emergency responders, crime
laboratory personnel, and personnel of a law enforcement agency or another agency who, if they are likely to
come in contact with a controlled substance or persons at risk of an overdose, are authorized to possess,
store, and administer emergency opioid antagonists.
In September 2022, the Department of Health (DOH) issued a statewide Standing Order for Naloxone, an
emergency opioid antagonist. The Standing Order authorizes pharmacists to dispense certain naloxone
formulations to emergency responders for administration to persons exhibiting signs of opioid overdose. Under
the Standing Order, emergency responders, including law enforcement, firefighters, paramedics, and
emergency medical technicians, can go to a pharmacy or community-based program for training on opioid
antagonist administration and receive an opioid antagonist without a patient-specific prescription.
CS/CS/HB 783 revises the definitions of the terms “authorized health care practitioner,” and “caregiver,” in the
context of emergency opioid antagonist administration. The changes broaden the definitions of these terms to
eliminate unintended restrictions on how and by whom emergency opioid antagonists may be dispensed,
possessed, and administered.
The bill creates the Statewide Council on Opioid Abatement within the Department of Children and Families for
the purpose of enhancing the development and coordination of state and local efforts to abate the opioid
epidemic and to support the victims of the opioid crisis.
The bill has an indeterminate, negative fiscal impact on the Department of Children and Families and the
Department of Legal Affairs.
The bill provides an effective date of July 1, 2023.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
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DATE: 4/18/2023
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Opioids are psychoactive substances derived from the opium poppy, or their synthetic analogues. 1
Opioids are highly effective pain relievers, and as such are commonly used to treat acute and chronic
pain. An individual experiences pain because of a series of electrical and chemical exchanges across
the individual’s peripheral nerves, spinal cord, and brain. 2 Opioid receptors occur naturally and are
distributed widely throughout the central nervous system and in peripheral sensory and autonomic
nerves and modulate the body’s perception of pain.3 Opioids bind to specific opioid receptors, disrupt
the transmission of pain signals through the central nervous system and reduce the perception of pain.4
Opioids include prescription medications used to treat pain, as well as illegal drugs. Opioids include:5
Buprenorphine (Subutex, Suboxone),
Codeine,
Fentanyl (Duragesic, Fentora),
Heroin,
Hydrocodone (Vicodin, Lortab, Norco),
Hydromorphone (Dilaudid, Exalgo),
Meperidine,
Methadone,
Morphine,
Oxycodone (OxyContin, Percodan, Percocet),
Oxymorphone,
Tramadol, and
U-47700.
Opioids can create a euphoric feeling because they affect the regions of the brain involved with
pleasure and reward, which can lead to abuse.6 In 2019, an estimated 62 million people used opioids
for non-medical reasons worldwide.7 Opioids are commonly misused, with an estimated 36.3 million
people worldwide suffering from drug use disorders.8 Continued use of opioids can lead to the
development of tolerance and psychological and physical dependence.9 This dependence is
characterized by a strong desire to take opioids, impaired control over opioid use, persistent opioid use
1 World Health Organization, Opioid Overdose, available at https://www.who.int/news-room/fact-sheets/detail/opioid-overdose (last
visited March 20, 2023).
2
Medical News Today, What is pain, and how do you treat it? (Sept. 7, 2020), available at
https://www.medicalnewstoday.com/articles/145750#:~:text=People%20feel%20pain%20when%20specific,immediate%20contraction%
20of%20the%20muscles (last visited March 20, 2023).
3 Gjermund Henriksen, Frode Willoch, Imaging of Opioid Receptors in the Central Nervous System, Brain (2008) 131 (5): 1171-1196.
4 Id.
5
U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, SAMHSA Opioid
Overdose Toolkit: Facts for Community Memb ers (2018), available at https://store.samhsa.gov/sites/default/files/d7/priv/sma18-
4742.pdf (last visited March 20, 2023).
6 National Institute on Drug Abuse, How Do Opioids Affect the Brain and Body?, (June 2020), available at
http://www.drugabuse.gov/publications/research-reports/prescription-drugs/opioids/how-do-opioids-affect-brain-body (last visited March
20, 2023).
7 Florida Department of Law Enforcement, Drugs Identified in Deceased Persons b y Florida Medical Examiners 2019 Report, (Nov.
2020), available at https://www.fdle.state.fl.us/MEC/Publications-and-Forms/Documents/Drugs-in-Deceased-Persons/2019-Annual-
Drug-Report.aspx#:~:text=%E2%9C%93%20The%20most%20frequently%20occurring,)%20and%20oxycodone%20(1%2C181 ) (last
visited March 20, 2023).
8 United Nations Office on Drugs and Crime, World Drug Report 2021, Glob al Overview: Drug Demand and Drug Supply (Jun. 2021),
available at https://www.unodc.org/res/wdr2021/field/WDR21_Booklet_2.pdf (last visited March 20, 2023).
9 Supra, note 4.
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despite harmful consequences, a higher priority given to opioid use than to other activities and
obligations, and a physical withdrawal reaction when opioids are discontinued. 10
Opioid Overdose
An overabundance of opioids in the body can lead to a fatal overdose. The opioid receptors that are
located in major pain pathways, thus enabling opioids to alleviate the sensation of pain, are also found
in the respiratory control centers of the brain.11 Opioids disrupt the transmission of signals for
respiration in the identical manner as they disrupt the transmission of pain signals. This leads to a
reduction, and possible cessation, of an individual’s respiration. Oxygen starvation will eventually stop
vital organs like the heart and brain and can lead to unconsciousness, coma, and possible death. 12
Within 3-5 minutes without oxygen, brain damage starts to occur, soon followed by death.13
However, a person’s breathing will commonly slow gradually over time and breathing may not stop until
minutes to hours after the drug or drugs were used.14 An opioid overdose can be identified by a
combination of three signs and symptoms referred to as the “opioid overdose triad”:15
Pinpoint pupils;
Unconsciousness; and
Respiratory depression.
More than 106,000 Americans died from drug-involved overdose in 2021, including illicit drugs and
prescription opioids.16 Opioid-involved overdose deaths increased from 21,088 in 2010 to 47,600 in
2017; the rate of such deaths remained relatively consistent for the next two years with 49,860 opioid-
involved overdose deaths in 2019.17 This was followed by a sharp increase in opioid-involved overdose
deaths associated with the COVID-19 pandemic beginning in 2020.18 Nationally, there were 63,630
reported opioid-involved overdose deaths in 2020 and 80,411 in 2021. 19
The graph below demonstrates the total number of U.S. overdose deaths involving any opioid20 from
1999 to 2021.21
10 Supra, note 1.
11 Pattinson, K.T.S., Opioids and the Control of Respiration, BJA, Vol. 100, Issue 6, Pages 747-758, available at
https://doi.org/10.1093/bja/aen094.
12 Harm Reduction Coalition, Guide to Developing and Managing Overdose Prevention and Take-Home Naloxone Projects, (Aug. 31,
2020), available at http://harmreduction.org/our-work/overdose-prevention/ (last visited March 20, 2023).
13 Id.
14 Id.
15 Supra, note 1.
16 National Institute on Drug Abuse, Overdose Death Rates, available at https://www.drugabuse.gov/drug-topics/trends-
statistics/overdose-death-rates (last visited March 20, 2023).
17 Id.
18 Ghose, R., Forati, A.M. & Mantsch, J.R. Impact of the COVID-19 Pandemic on Opioid Overdose Deaths: A Spatiotemporal Analysis.
J Urban Health 99, 316–327 (2022), available at https://doi.org/10.1007/s11524-022-00610-0 (last visited March 27, 2023).
19 Supra, note 16.
20 Any opioid includes prescription opioids (natural and semi -synthetic opioids and methadone), heroin and synthetic opioids other than
methadone (primarily fentanyl).
21 Supra, note 16.
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Opioid Deaths in the United States, 1999-202122
Prior to the COVID-19 pandemic, the increase in opioid overdose deaths can be outlined in three
distinct waves:
The first wave began with increased prescribing of opioids in the 1990s, with overdose deaths
involving prescription opioids increasing since at least 1999.
The second wave began in 2010, with rapid increase in overdose deaths involving heroin.
The third wave began in 2013, with significant increases in overdose deaths involving synthetic
opioids, particularly those involving illicitly manufactured fentanyl. The market for illicitly
manufactured fentanyl continues to change, and the drug can be found in combination with
heroin, counterfeit pills, and cocaine.23
In 2021, there were 6,442 opioid overdose deaths reported in Florida, a 22% increase from 2019. 24
There were an additional 50,803 all-drug, non-fatal overdoses resulting in an emergency department
visit in 2021.25 Additionally, fentanyl, an extremely potent opioid drug, is the leading cause of overdose
deaths in Florida, and the incidence of fentanyl overdose deaths increased by 38 percent from 2,348 in
2019 to 3,244 in 2020.26
Opioid Antagonists
An opioid antagonist, such as Narcan or Naloxone, is a drug that blocks the effects of exogenously
administered opioids. Opioid antagonists are used in opioid overdoses to counteract life-threatening
depression of the central nervous system and respiratory system, allowing an overdose victim to
breathe normally.27 This occurs because opioid antagonists create a stronger bond with opioid
22 Supra, note 16.
23
Centers for Disease Control and Prevention, Understanding the Opioid Overdose Epidemic, available at
https://www.cdc.gov/opioids/basics/epidemic.html (last visited March 20, 2023).
24 Florida Department of Health, FL Health Charts: Sub stance Use Dashb oard, available at
https://www.flhealthcharts.gov/ChartsDashboards/rdPage.aspx?rdReport=SubstanceUse.Overdose (last visited March 20, 2023).
25 Id.
26 Project Opioid, A Pandemic Fueling an Epidemic in Florida in 2020, available at https://projectopioid.org/wp-
content/uploads/2020/12/PO-2020-Data-Study-Final_New-Section.pdf (last visited March 20, 2023).
27 Harm Reduction Coalition, Understanding Naloxone, (Sept. 8, 2020), available at http://harmreduction.org/issues/overdose-
prevention/overview/overdose-basics/understanding-naloxone/ (last visited March 20, 2023).
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receptors than opioids. This forces the opioids from the opioid receptors and allows the transmission of
signals for respiration to resume.28 This effect lasts only for a short period of time,29 with the narcotic
effect of the opioids returning if still present in large quantities in the body. In this scenario, additional
doses of an opioid antagonist would be required, which is why it is generally recommended that anyone
who has experienced an overdose seek medical attention.
Opioid antagonists, such as naloxone, have no potential for abuse 30 and will not cause harm if
mistakenly administered to a person who is not overdosing on an opioid.31
Dispensing of Opioid Antagonists
Under current law, an authorized health care practitioner may prescribe and dispense an emergency
opioid antagonist to a patient or caregiver without a prescription or a non-patient specific standing order
being in place.32 A pharmacist licensed under Ch. 465, F.S, is authorized to order and dispense an
emergency opioid antagonist to a patient or caregiver without a prescription or a non-patient specific
standing order being in place.33 A “patient” means any person at risk of experiencing an opioid
overdose, and a “caregiver” means a family member, friend, or person in a position to have recurring
contact with a person at risk of experiencing an opioid overdose. 34
Under current law, emergency responders, crime laboratory personnel, and personnel of a law
enforcement agency or another agency who are likely to come in contact with a controlled substance or
persons at risk of an overdose, are authorized to possess, store, and administer emergency opioid
antagonists. Such individuals are immune from civil liability for administering an emergency opioid
antagonist in accordance with the Good Samaritans Act. 35
In September 2022, the State Surgeon General issued a statewide Standing Order for Naloxone
(Standing Order).36 The Standing Order authorizes pharmacists to dispense certain naloxone
formulations to emergency responders for administration to persons exhibiting signs of opioid
overdose. Under the Standing Order, emergency responders, including law enforcement, firefighters,
paramedics, and emergency medical technicians, can go to a pharmacy or community-based program
for training on opioid antagonist administration and receive an opioid antagonist without a patient-
specific prescription.37
Multistate Opioid Lawsuit and Settlement
28 Supra, note 11.
29
The half-life for a common opioid antagonist in adults ranged from 30 to 81 minutes. Acute opiate withdrawal is a pote ntial side-effect
of naloxone; however, this would be time limited to the half-life of naloxone.
30 Supra, note 27.
31 Centers for Disease Control and Prevention, 5 Things to Know Ab out Naloxone, (Oct. 25, 2022), available at
https://www.cdc.gov/drugoverdose/featured-
topics/naloxone.html#:~:text=Naloxone%20is%20safe.,Small%2C%20constricted%20%E2%80%9Cpinpoint%20pupils%E2%80%9D
(last visited March 20, 2023).
32 S. 381.887, F.S. An “authorized health care practitioner” means a licensed practitioner who is authorized to prescribe drugs under
Florida law.
33 S. 381.887, F.S.
34 Id.
35 S. 381.887(5), F.S.; see also s. 768.13, F.S. The Good Samaritans Act provides civil immunity to any person, including licensed
medical professionals, who gratuitously and in good faith renders emergency care or treatment in direct response to an emergency
situation.
36 Florida Department of Health, Statewide Standing Order for Naloxone, (Sep. 30, 2022), available at
https://www.floridahealth.gov/licensing-and-regulation/ems-system/_documents/standing-order-naloxone.pdf (last visited March 20,
2023).
37 Id.
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In 2018, Attorney General Pam Bondi filed a lawsuit against multiple opioid manufacturers and
distributors. The suit was later expanded to include the pharmacies CVS and Walgreens .38 The
complaint alleged that the defendants caused the opioid crisis by, among other things:39
Engaging in a campaign of misrepresentations and omissions about opioid use designed to
increase opioid prescriptions and opioid u