BILL ANALYSIS Ó
SENATE COMMITTEE ON PUBLIC SAFETY
Senator Loni Hancock, Chair S
2013-2014 Regular Session B
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SB 1438 (Pavley) 8
As Amended: April 10, 2014
Hearing date: April 29, 2014
Civil Code and Health and Safety Code
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OPIOID ANTAGONISTS
HISTORY
Source: Author
Prior Legislation: AB 635 (Ammiano) - Ch. 707, Stats. 2013
SB 767 (Ridley-Thomas) - Ch. 477, Stats. 2007
SB 1695 (Escutia), Chapter 678, Statutes of 2002
Support: Drug Policy Alliance; California State Sheriffs'
Association; Emergency Medical Services
Administrators' Association of California; California
Chapter of the American College of Emergency
Physicians Association
Opposition:None known
KEY ISSUES
SHOULD PEACE OFFICERS BE SPECIFICALLY ADDED TO THE LIST OF PERSONS -
SUCH AS FAMILY MEMBERS OF AN OVERDOSE VICTIM - AUTHORIZED TO
ADMINISTER AN OPIOID ANTAGONIST TO REVERSE AN OVERDOSE?
SHOULD THE STATE EMERGENCY MEDICAL SERVICES AUTHORITY DEVELOP
STANDARDS AND PUBLISH REGULATIONS FOR ADMINISTRATION OF THE OPIOID
ANTAGONIST NALOXONE BY ALL PREHOSPITAL EMERGENCY CARE PERSONNEL?
SHOULD LOCAL EMERGENCY MEDICAL SERVICE AGENCIES BE AUTHORIZED TO
DEVELOP THEIR OWN STANDARDS AND REGULATIONS IN LIEU OF ADOPTION OR
USE OF THE STATE STANDARDS?
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PURPOSE
The purposes of this bill are to 1) specifically include peace
officers in a list of persons, including family members of a
person at risk of an opioid overdose, authorized to administer
the opioid antagonist naloxone; 2) direct the State Emergency
Medical Services Authority to develop standards and promulgate
regulations for administration of naloxone by all prehospital
emergency care personnel; and 3) authorize local emergency
medical agencies to adopt their own standards and promulgate
regulations for administration of naloxone by prehospital
emergency care personnel under jurisdiction of the local agency.
Existing law (Civil Code § 1714.22) provisions relevant to this
bill:
An opioid antagonist is defined as naloxone
hydrochloride (naloxone) that is approved by the Federal
Food and Drug Administration (FDA) for the treatment of an
opioid overdose.
A licensed health care provider who is authorized to
prescribe naloxone to prescribe and dispense or distribute
the medication to a person at risk of an overdose or to a
family member, friend, or other person in a position to
assist the person at risk of overdose. A licensed health
care provider to issue standing orders for these purposes.
A person who is prescribed or possesses naloxone
pursuant to a standing order to receive training by an
overdose prevention and treatment training program, as
specified. A person who is prescribed naloxone directly
from a licensed prescriber, and not through a standing
order, is not subject to the training requirement.
A health care provider who acts with reasonable care in
issuing a prescription for naloxone and any person who
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possesses, distributed, or administers naloxone, with
reasonable care, from professional review, civil action, or
criminal prosecution.
Relevant Health and Safety Code Provisions in Existing Law
The Emergency Medical Services Authority (EMSA) shall
establish training and standards for all prehospital
emergency care personnel, as defined, regarding the
characteristics and method of assessment and treatment of
anaphylactic reactions and the use of epinephrine. EMSA
shall promulgate regulations for use by all prehospital
emergency care personnel. (Health & Saf. Code § 1797.197.)
The Attorney General shall encourage research on the
misuse and abuse of controlled substances. Allows the
Attorney General to develop new and improved approaches,
techniques, systems, equipment, and devices to strengthen
enforcement of the Controlled Substances Act, and to enter
into contracts entities, as specified, to conduct
demonstrations or special projects that bear directly on
the misuse and abuse of controlled substances. (Health &
Saf. Code § 11601.)
This bill adds peace officers to the list of people who can
receive a prescription for an opioid antagonist for the purpose
of assisting a person at risk of an opioid-related overdose.
This bill adds peace officers to the list of people who can
receive standing orders for the distribution of an opioid
antagonist for this purpose.
This bill requires EMSA to establish training and standards for
all prehospital emergency care personnel on the use and
administration of naloxone and other opioid antagonists and to
promulgate regulations for this purpose.
This bill allows EMSA to designate existing training and
standards for this purpose.
This bill allows a local emergency medical services agency to
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develop training and standards and to promulgate regulations for
prehospital emergency medical care personnel under its
jurisdiction who use and administer naloxone in lieu of those
developed by EMSA.
This bill authorizes hospitals and trauma centers to share
information with local law enforcement and local emergency
medical services agencies about controlled substance overdose
trends. Specifies that this information shall only include the
number of overdoses and the substances suspected as the primary
cause of the overdoses and shall ensure patient confidentiality.
RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION
For the last several years, severe overcrowding in California's
prisons has been the focus of evolving and expensive litigation
relating to conditions of confinement. On May 23, 2011, the
United States Supreme Court ordered California to reduce its
prison population to 137.5 percent of design capacity within two
years from the date of its ruling, subject to the right of the
state to seek modifications in appropriate circumstances.
Beginning in early 2007, Senate leadership initiated a policy to
hold legislative proposals which could further aggravate the
prison overcrowding crisis through new or expanded felony
prosecutions. Under the resulting policy, known as "ROCA"
(which stands for "Receivership/ Overcrowding Crisis
Aggravation"), the Committee held measures that created a new
felony, expanded the scope or penalty of an existing felony, or
otherwise increased the application of a felony in a manner
which could exacerbate the prison overcrowding crisis. Under
these principles, ROCA was applied as a content-neutral,
provisional measure necessary to ensure that the Legislature did
not erode progress towards reducing prison overcrowding by
passing legislation, which would increase the prison population.
In January of 2013, just over a year after the enactment of the
historic Public Safety Realignment Act of 2011, the State of
California filed court documents seeking to vacate or modify the
federal court order requiring the state to reduce its prison
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population to 137.5 percent of design capacity. The State
submitted that the, ". . . population in the State's 33 prisons
has been reduced by over 24,000 inmates since October 2011 when
public safety realignment went into effect, by more than 36,000
inmates compared to the 2008 population . . . , and by nearly
42,000 inmates since 2006 . . . ." Plaintiffs opposed the
state's motion, arguing that, "California prisons, which
currently average 150% of capacity, and reach as high as 185% of
capacity at one prison, continue to deliver health care that is
constitutionally deficient." In an order dated January 29,
2013, the federal court granted the state a six-month extension
to achieve the 137.5 % inmate population cap by December 31,
2013.
The Three-Judge Court then ordered, on April 11, 2013, the state
of California to "immediately take all steps necessary to comply
with this Court's . . . Order . . . requiring defendants to
reduce overall prison population to 137.5% design capacity by
December 31, 2013." On September 16, 2013, the State asked the
Court to extend that deadline to December 31, 2016. In
response, the Court extended the deadline first to January 27,
2014 and then February 24, 2014, and ordered the parties to
enter into a meet-and-confer process to "explore how defendants
can comply with this Court's June 20, 2013 Order, including
means and dates by which such compliance can be expedited or
accomplished and how this Court can ensure a durable solution to
the prison crowding problem."
The parties were not able to reach an agreement during the
meet-and-confer process. As a result, the Court ordered
briefing on the State's requested extension and, on February 10,
2014, issued an order extending the deadline to reduce the
in-state adult institution population to 137.5% design capacity
to February 28, 2016. The order requires the state to meet the
following interim and final population reduction benchmarks:
143% of design bed capacity by June 30, 2014;
141.5% of design bed capacity by February 28, 2015; and,
137.5% of design bed capacity by February 28, 2016.
If a benchmark is missed the Compliance Officer (a position
created by the February 10, 2016 order) can order the release of
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inmates to bring the State into compliance with that benchmark.
In a status report to the Court dated February 18, 2014, the
state reported that as of February 12, 2014, California's 33
prisons were at 144.3 percent capacity, with 117,686 inmates.
8,768 inmates were housed in out-of-state facilities.
The ongoing prison overcrowding litigation indicates that prison
capacity and related issues concerning conditions of confinement
remain unresolved. While real gains in reducing the prison
population have been made, even greater reductions may be
required to meet the orders of the federal court. Therefore,
the Committee's consideration of ROCA bills -bills that may
impact the prison population - will be informed by the following
questions:
Whether a measure erodes realignment and impacts the
prison population;
Whether a measure addresses a crime which is directly
dangerous to the physical safety of others for which there
is no other reasonably appropriate sanction;
Whether a bill corrects a constitutional infirmity or
legislative drafting error;
Whether a measure proposes penalties which are
proportionate, and cannot be achieved through any other
reasonably appropriate remedy; and,
Whether a bill addresses a major area of public safety
or criminal activity for which there is no other
reasonable, appropriate remedy.
COMMENTS
1. Need for This Bill
According to the author:
California and the nation are in the midst of a drug
abuse crisis. Addiction to heroin and other opiates -
including prescription pain-killers - is impacting the
lives of Californians across the state. Drug
overdoses are now the most common cause of accidental
death, with an estimated 16,651 fatalities linked to
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opioid painkillers in 2010. While heroin overdoses
have increased nationwide, prescription opioids, such
as Vicodin and OxyContin, have caused more deaths than
heroin and cocaine overdoses combined.
This bill would expand the pool of emergency
responders who carry the drug naloxone that helps
resuscitate victims from an opiate overdose. While
naloxone, an opiate antidote that reverses opiate
overdoses, has been used by paramedics and advanced
emergency medical technicians (EMTs) to save lives for
the last few decades in the state, current law is
unclear about the ability of other first emergency
responders, such as law enforcement, to use this
medication.
Recently, California has taken several steps to
prevent overdose fatalities. Legislation enacted last
year expanded the use of naloxone for health care
providers, family, friends and other persons who may
assist overdose victims, but the law has been
interpreted to lack specific clarity about law
enforcement's ability to carry and administer the
drug.
While paramedics and EMTs are often the first to
respond to a medical emergency, some localities report
that peace officers are increasingly the first to
encounter an overdose victim. A recent internal
survey within the San Diego Sheriff's Department found
that Sheriff's deputies responded to over 200
overdose-related emergency calls in the first nine
months of 2013, and in over 50 percent of those cases,
the Sheriff's deputy was the first emergency responder
on the scene.
Last month, in recognition of the nationwide surge in
opiate overdoses, U.S. Attorney General Eric Holder
echoed the plea made by the director of the White
House Office of National Drug Control Policy, to train
and equip law enforcement officers with naloxone.
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First responder expansion might not be needed in every
jurisdiction, but communities should assess their
current resources and local needs. In Ventura County,
a portion of which the author represents, from
2008-2011, opioid overdoes-related emergency room
visits increased 49 percent, and accidental
opioid-related deaths increased 35 percent in the same
time frame. The rising rates in the County propelled
the start of an organization called "Not One More" by
two mothers who lost their children to drug overdoses.
They now provide community training on the use of
naloxone and some off-duty police have attended the
recent trainings. Since their last training, new
trainees have already been credited with saving two
lives.
SB 1438 is intended to save lives by making naloxone
available to all first responders, including law
enforcement personnel. When a person overdoses,
unless these is rapid action to reverse the opioid's
effects, getting the overdose victim to a hospital is
frequently too late.
2. Deaths Related to Opioid Overdose
According to the Centers for Disease Control and Prevention
(CDC), there were nearly 37,000 drug overdose deaths in the
United States in 2008 and approximately 4,300 drug poisoning
deaths in California. Counties experiencing the highest numbers
of overdose deaths were Alameda, Fresno, Kern, Los Angeles,
Orange, Riverside, Sacramento, San Bernardino, San Diego, San
Francisco, and Santa Clara. In 2009, 28,754 (91 percent) of all
unintentional poisoning deaths were caused most commonly by
prescription opioids, which include such drugs as methadone,
hydrocodone (Vicodin), and oxycodone (Oxycontin), followed by
cocaine and heroin.
3. Naloxone Background
According to the FDA, naloxone, which is not a controlled
substance, rapidly reverses the effects of opioid overdose and
is the standard treatment for overdose, which is characterized
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by decreased breathing or heart rate or loss of consciousness.
The National Institute on Drug Abuse's Web site states that, as
of March 2014, 17 states have passed laws that allow for wider
prescribing of naloxone to those who can help prevent overdoses,
such as family and friends of drug addicts and a wide array of
emergency personnel, like police and firefighters. Some
overdose prevention programs use syringes fitted with atomizers
to enable the medication to be sprayed into the nose.
In April 2014, the FDA announced the approval of a new hand-held
auto-injector to reverse opioid overdose. The medication is
injected into the muscle or under the skin. The new device
provides verbal instruction, similar to an automated
defibrillator. The FDA granted a fast-track designation, which
is designed to facilitate development and to expedite the review
of drugs to treat serious conditions and fill unmet medical
need, according to the FDA's Web site.
4. Results of Naloxone Distribution and Administration
A 2012 CDC report on programs known to distribute naloxone
documented the reversal of more than 10,000 heroin overdoses.
The programs provided opioid overdose education and naloxone to
drug users and to those who might be present during a drug
overdose in order to help reduce overdose deaths. However, of
the 48 programs that responded, nearly half reported problems in
obtaining naloxone related to cost and a shortage of supply.
According to the Drug Policy Alliance's (DPA) Web site, naloxone
has been safely and effectively used for more than 40 years in
ambulances and emergency rooms across the country. Naloxone has
no potential for abuse and side effects are rare. DPA also
cites ongoing research showing that expanding access to naloxone
does not promote increased drug use or risk-taking behavior that
results in unintended overdoses.
5. Related Pending and Prior Legislation
AB 1535 (Bloom) would authorize a pharmacist to furnish naloxone
if the pharmacist provides a consultation to ensure the
education of the person to whom the drug is furnished and
notification to the patient's primary care provider of drugs or
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devices furnished to the patient. The bill would prohibit a
pharmacist from permitting a person to waive the consultation
and requires a pharmacist to complete a training program on the
use of opioid antagonists prior to furnishing naloxone. AB 1535
is currently in the Assembly Appropriations Committee.
AB 635 (Ammiano), Chapter 707, Statutes of 2013, expanded the
program in AB 2145 (Ammiano) Chapter 545, Statues of 2010
statewide, deleted the sunset date and the reporting
requirements and modified the limited liability provisions for
both licensed health care professionals who prescribe, dispense,
or distribute naloxone and unlicensed persons who act with
reasonable care to administer naloxone to a person who is
experiencing or is suspected to be experiencing an overdose.
AB 2145 (Ammiano) extended the sunset date of the seven-county
pilot program established under SB 767 (Ridley-Thomas), Chapter
477, Statutes of 2007, to January 1, 2016, extended to January
1, 2015, the deadline for the requirement of local health
jurisdictions operating an overdose prevention program to
report, as specified, to the Senate and Assembly Committees on
Judiciary and added immunity for unlicensed trained people who
administer an opioid antidote in emergency situations during
which they believe that a person is experiencing a drug
overdose.
SB 767 (Ridley-Thomas) established a seven-county pilot program
until January 1, 2010, in which licensed health care providers
were given immunity from civil liability or criminal prosecution
when they prescribed naloxone to a person in connection with an
opioid overdose prevention and training program on how to
recognize and respond to an opiate overdose. SB 767 required
local health jurisdictions operating an overdose prevention
program to report, as specified, to the Senate and Assembly
Committees on Judiciary by January 1, 2010.
SB 1695 (Escutia), Chapter 678, Statutes of 2002, authorized
counties to establish training and certification programs to
permit an EMT-I to administer naloxone by means other than
intravenous injection if he or she has completed training and
passed a test. SB 1695 required EMSA to develop guidelines
relating to the county certification programs.
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6. Amendment accepted by Author in Health Committee to be Taken
in Public Safety
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The Senate Health Committee suggested an amendment to prevent
conflicts in the provisions concerning standards and regulations
developed by the California EMSA and local emergency medical
service authorities. The author agreed to take the amendments
in this committee. The Senate Health Committee analysis
described the amendment as follows:
This bill allows a local EMS agency to develop
training, standards, and regulations for prehospital
emergency medical care personnel for the use and
administration of naloxone, in lieu of those developed
by the EMSA. To help prevent a conflict, Committee
staff suggests the following amendment to ensure that
both local EMS agency and EMSA training, standards,
and regulations are in line with best practices in the
Substance Abuse and Mental Health Administration's
Opioid Overdose Prevention Toolkit.
The amendments are in bold italics:
Section 1797.197 of the Health and Safety Code:
(a) The authority shall establish training and
standards for all prehospital emergency care
personnel, as defined pursuant to in paragraph (2) of
subdivision (a) of Section 1797.189, regarding the
characteristics and method of assessment and treatment
of anaphylactic reactions and the use of epinephrine.
The authority shall promulgate regulations regarding
these matters for use by all prehospital emergency
care personnel.
(b) (1) The authority shall establish training and
standards for all prehospital emergency care
personnel, as defined in paragraph (2) of subdivision
(a) of Section 1797.189, regarding the use and
administration of naloxone hydrochloride and other
opioid antagonists. The authority shall promulgate
regulations regarding these matters for use by all
prehospital emergency care personnel. The authority
may designate existing training and standards for the
use and administration of naloxone hydrochloride or
another opioid antagonist to satisfy the requirements
of this section.
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(2) A local EMS agency may develop its own training
and standards, and may promulgate regulations, in lieu
of the training and standards and regulations
developed by the authority pursuant to paragraph (1),
for the purpose of considering local need, regarding
the use and administration of naloxone hydrochloride
and other opioid antagonists by prehospital emergency
care personnel under the jurisdiction of that local
EMS agency.
(3) The training, standards, and regulations in
paragraphs (1) and (2) of subdivision (b) shall be in
line with best practices in the Substance Abuse and
Mental Health Services Administration's Opioid
Overdose Prevention Toolkit.
(34) The training described in paragraphs (1) and (2)
shall satisfy the requirements of paragraph (1) of
subdivision (d) of Section 1714.22 of the Civil Code.
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