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 Appropriations Subcommittee on Health and Human Services
BILL: PCS/SB 544 (455298)
INTRODUCER: Appropriations Subcommittee on Health and Human Services and Senator Boyd
SUBJECT: Drug-related Overdose Prevention
DATE: January 21, 2022
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Looke Brown HP Favorable
2. Howard Money AHS Fav/CS
3. AP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
PCS/SB 544 amends section 381.887, Florida Statutes, to expand access to emergency opioid
antagonists by:
Allowing pharmacists to order, as well as dispense, emergency opioid antagonists with an
autoinjection delivery system or intranasal delivery system;
Providing that specified persons who are authorized to possess, store, and administer
emergency opioid antagonists are immune from any civil or criminal liability resulting from
the administration of such emergency opioid antagonists; and
Adding specified personnel of a law enforcement agency or other agencies to the list of
persons who are authorized to possess, store, and administer emergency opioid antagonists.
The bill also amends section 395.1041, Florida Statutes, to require hospital emergency
departments, urgent care centers, and basic (BLS) and advanced life support (ALS) providers to
report the treatment of actual or suspected overdose victims under certain circumstances.
The bill amends section 381.981, Florida Statutes, requiring the Florida Public Health Institute,
Inc., to include emergency opioid antagonists as part of substance abuses in their statutorily
required health awareness campaigns.
The Department of Health (department) will incur costs for ongoing maintenance, additional
storage and software licensing for their reporting systems for hospital emergency departments,
REVISED: BILL: PCS/SB 544 (455298) Page 2
urgent care centers and life support services to report data which can be absorbed within existing
resources.
The bill provides an effective date of July 1, 2022.
II. Present Situation:
History of the Opioid Crisis in Florida
According to the National Institute on Drug Abuse:
1
“In the late 1990s, pharmaceutical companies reassured the medical community that patients
would not become addicted to prescription opioid pain relievers, and health care providers
began to prescribe them at greater rates” and
“This subsequently led to widespread diversion and misuse of these medications before it
became clear that these medications could indeed be highly addictive.”
Between the early 2000s and the early 2010s, Florida was infamous as the “pill mill capital” of
the country. At the peak of the pill mill crisis, doctors in Florida bought 89 percent of all the
oxycodone sold in the country.
2
Between 2009 and 2011, the Legislature enacted a series of reforms to combat prescription drug
abuse. These reforms included strict regulation of pain management clinics; creating the
Prescription Drug Monitoring Program (PDMP); and stricter regulation on selling, distributing,
and dispensing controlled substances.
3
“In 2016, the opioid prescription rate was 75 per
100 persons in Florida. This rate was down from a high of 83 per 100.”
4
As reported at the time by the Florida Attorney General’s Opioid Working Group:
Drug overdose is now the leading cause of non-injury related death in the
United States. Since 2000, drug overdose death rates increased by 137
percent, including a 200 percent increase in the rate of overdose deaths
involving opioids. In 2015, over 52,000 deaths in the U.S. were attributed
to drug poisoning, and over 33,000 (63 percent) involved an opioid. In
2015, 3,535 deaths occurred in Florida where at least one drug was
identified as the cause of death. More specifically, 2,535 deaths were
caused by at least one opioid in 2015. Stated differently, seven lives per
day were lost to opioids in Florida in 2015. Overall, the state had a rate of
opioid-caused deaths of 13 per 100,000. The three counties with the
1
National Institute on Drug Abuse, Opioid Overdose Crisis (Rev. Jan. 2019), available at https://www.drugabuse.gov/drugs-
abuse/opioids/opioid-overdose-crisis (last visited Nov. 29, 2021).
2
Lizette Alvarez, Florida Shutting ‘Pill Mill’ Clinics, The New York Times (Aug. 31, 2011), available at
http://www.nytimes.com/2011/09/01/us/01drugs.html (last visited Nov. 29, 2021).
3
See Chapters 2009-198, 2010-211, and 2011-141, Laws of Fla.
4
Attorney General’s Opioid Working Group, Florida’s Opioid Epidemic: Recommendations and Best Practices, 7 (Mar. 1,
2019), available at https://myfloridalegal.com/webfiles.nsf/WF/TDGT-
B9UTV9/$file/AG+Opioid+Working+Group+Report+Final+2-28-2019.pdf (last visited Nov. 29, 2021). BILL: PCS/SB 544 (455298) Page 3
highest opioid death rate were Manatee County (37 per 100,000), Dixie
County (30 per 100,000), and Palm Beach County (22 per 100,000).
5
Early in 2017, the federal Centers for Disease Control and Prevention (CDC) declared the opioid
crisis an epidemic.
6
Shortly thereafter, on May 3, 2017, Governor Rick Scott signed Executive
Order 17-146 declaring the opioid epidemic a public health emergency in Florida.
7
House Bill 21 (2018)
In 2018, the Florida Legislature passed CS/CS/HB 21 (Chapter 2018-13, Laws of Florida) to
combat the opioid crisis. CS/CS/HB 21:
Required additional training for practitioners on the safe and effective prescribing of
controlled substances;
Restricted the duration of prescriptions for Schedule II opioid medications to three days or up
to seven days if medically necessary;
Reworked the PDMP statute to require that prescribing practitioners check the PDMP prior
to prescribing a controlled substance and to allow the integration of PDMP data with
electronic health records and the sharing of PDMP data between Florida and other states; and
Provided for additional funding for treatment and other issues related to opioid abuse.
Status of the Opioid Crisis after HB 21
There is some evidence that the passage of HB 21 reduced opioid use in Florida. For example,
one study that reviewed pharmacy prescriptions claims for a health plan serving more than
45,000 Floridians found that on average, the number of enrollees per month that began opioid
use between April of 2019 and August of 2019 dropped from 5.5 per 1,000 patients to 4.6 per
1,000 patients.
8
Unfortunately, with the onset of the COVID-19 pandemic, the incidence of opioid use disorder
and resulting overdose deaths has once again risen. A report from Project Opioid details
provisional data from the department showing that deaths from drug overdoses have increased by
43 percent between 2019 and 2020, from 56 deaths per 100,000 in 2019 to 94 deaths per 100,000
in 2020. 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.
9
5
Id.
6
See Exec. Order No. 17-146, available at https://www.flgov.com/wp-content/uploads/2017/05/17146.pdf. (last visited Mar.
12, 2021).
7
Id.
8
Juan M. Hincapie-Castillo, et al., Changes in Opioid Use After Florida’s Restriction Law for Acute Pain Prescriptions,
JAMA Netw Open. 2020 Feb; 3(2): e200234, available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7049083/, (last
visited Nov. 29, 2021).
9
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 Nov. 29, 2021). BILL: PCS/SB 544 (455298) Page 4
Opioid Antagonists
Opioid receptor antagonists block one or more of the opioid receptors in the central or peripheral
nervous system. The two most commonly used, centrally-acting opioid receptor antagonists are
naloxone and naltrexone. Naloxone comes in intravenous, intramuscular, and intranasal
formulations and is FDA-approved for the use in an opioid overdose and the reversal of
respiratory depression associated with opioid use. Naltrexone is available in both oral and long-
acting injectable formulations and is FDA-approved for the treatment of opioid and/or alcohol
maintenance treatment. The most commonly used peripheral opioid receptor antagonist is
methylnaltrexone, which is a potent competitive antagonist acting at the digestive tract and is
also FDA-approved for the treatment of opioid-induced constipation.
10
The Florida Public Health Institute, Inc.
The Florida Public Health Institute (Institute) is a not-for-profit corporation established by
s. 381.98, F.S., with the purpose of advancing the knowledge and practice of public health,
including promoting health awareness in Florida. The Institute is tasked with procuring funds to
complement, supplement, and enhance the missions of the various organizations, entities, and
departments that provide public health initiatives by serving as the lead corporation in the state
for promoting public health awareness. The Institute is required to enter into partnerships with
providers of continuing education for health care practitioners, including, but not limited to,
hospitals and state and local medical organizations, to ensure that practitioners are aware of the
most recent and complete diagnostic and treatment tools.
Additionally, s. 381.981, F.S., requires the Institute to, in consultation with the department,
coordinate monthly health awareness campaigns with national, state, and local health care
organizations and government entities, targeting a wide range of the public, including: parents;
teachers and other school employees; students in 4th through 12th grades, colleges, and
universities; state agency employees; county and local government employees; patients of county
health departments; Medicaid recipients; health care professionals and providers; and the public
in general. The health campaigns must include the following diseases in at least one monthly
campaign every 24 months:
Cancer, including breast, prostate, cervical, ovarian, colorectal, and skin cancer and
leukemia.
Heart disease.
Stroke.
Lung disease, including asthma and smoking-relating disease.
Neurological disorders and disease, including Alzheimer's disease, Parkinson's disease, and
epilepsy.
Gastrointestinal disease.
Kidney disease.
Diabetes.
10
Opioid Antagonists, Theriot, Jonathan, et. al., (last updated July 23, 2021), 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 Nov. 29, 2021). BILL: PCS/SB 544 (455298) Page 5
Liver disease.
Autoimmune disorders.
Birth defects and prenatal care.
Obesity and malnutrition.
Sexually transmissible disease.
Hepatitis A, hepatitis B, and hepatitis C.
Arthritis.
Vaccine-preventable diseases.
Infectious diseases, including HIV/AIDS.
Substance abuse.
Mental illness.
Lupus.
Osteoporosis.
III. Effect of Proposed Changes:
This bill amends s. 381.887, F.S., to:
Include the prescribing, ordering and dispensing of emergency opioid antagonists within the
purpose of the section, which is to provide for the emergency treatment for suspected opioid
overdose;
Authorize a pharmacist to order, and dispense pursuant to that order, an emergency opioid
antagonist with an autoinjection delivery system or intranasal application delivery system to
a patient or caregiver;
11
Add personnel of a law enforcement agency or other agencies to the list of persons
authorized to possess, store, and administer emergency opioid antagonists under the section.
The bill specifies that such personnel includes, but is not limited to, correctional probation
officers and child protective investigators who, while acting within the scope or course of
employment, come into contact with controlled substances or persons at risk of experiencing
an opioid overdose; and
Provide immunity from any civil or criminal liability to the listed persons authorized to
possess, store, and administer emergency opioid antagonists under the section for the
administering of emergency opioid antagonists.
12
The bill amends s. 381.981, F.S., requiring the Florida Public Health Institute, Inc., to include
emergency opioid antagonists as part of substance abuses in their statutorily required health
awareness campaigns.
The bill also amends s. 395.1041, F.S., to require a hospital emergency department or urgent care
center to report the treatment of a person in response to an actual or suspected overdose to the
department if the patient was not transported to the hospital by a BLS or ALS provider and to
require a BLS or ALS provider to report when it treats and releases or transports to a medical
11
Section 381.887, F.S., defines “patient” as a person who is at risk of experiencing an opioid overdose, and defines
“caregiver” as a family member, friend, or person in a position to have recurring contact with a person at risk of experiencing
an opioid overdose.
12
These persons include emergency responders as well as crime laboratory personnel for the statewide criminal analysis
laboratory system and their supervisors. BILL: PCS/SB 544 (455298) Page 6
facility a person in response to an emergency call for a suspected or actual overdose of a
controlled substance. The provider must use an appropriate reporting method with secure access,
including, but not limited to, the Washington/Baltimore High Intensity Drug Trafficking
Overdose Detection Mapping Application Program or other program identified by the
department rule and must use its best effort to report such incidents within 120 hours of
discovering the incident.
The bill provides an effective date of July 1, 2022.
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.
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
PCS/SB 544 may have an indeterminate negative fiscal impact on BLS providers, ALS
providers, hospital emergency departments, and urgent care centers that are required to
report specified incidents of treatment of patients suffering from suspected or actual
overdoses of controlled substances.
C. Government Sector Impact:
The Department of Health has existing reporting systems for hospital emergency
departments, urgent care centers and life support services to report data; however, BILL: PCS/SB 544 (455298) Page 7
ongoing maintenance, additional data storage and software licensing will be needed. The
cost is estimated to be $64,000 recurring and can be absorbed with existing resources.
13
VI. Technical Deficiencies:
None.
VII. Related Issues:
None.
VIII. Statutes Affected:
This bill substantially amends the following sections of the Florida Statutes: 381.887, 381.981,
and 395.1041.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
Recommended CS by Appropriations Subcommittee on Health and Human Services
on January 19, 2022:
The committee substitute:
Removes the requirement that the Florida Public Health Institute, Inc., in
consultation with the Department of Health (department), educate the public
regarding the use of emergency opioid antagonists as part of its statutory duty to
educate the public regarding substance abuse; however, the Florida Public Health
Institute must include emergency opioid antagonists in their educational information
about preventing, detecting, treating, and curing disease awareness campaigns.
Modifies the list of persons authorized to possess, store, and administer emergency
opioid antagonists to include personnel of a law enforcement agency or other agency
and that such personnel include, but is not limited to, correctional probation officers
and child protective investigators.
Removes the technical adjustments to s. 401.253, F.S.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.
13
Department of Health, Senate Bill 544, 2022 Agency Legislative Analysis (January 11, 2022) (on file with the Senate
Appropriations Subcommittee on Health and Human Services).