BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1438|
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THIRD READING
Bill No: SB 1438
Author: Pavley (D), et al.
Amended: 5/6/14
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 4/24/14
AYES: Hernandez, Morrell, Beall, De León, DeSaulnier, Evans,
Monning, Nielsen, Wolk
SENATE PUBLIC SAFETY COMMITTEE : 6-0, 4/29/14
AYES: Hancock, Anderson, Knight, Liu, Mitchell, Steinberg
NO VOTE RECORDED: De León
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SUBJECT : Controlled substances: opioid antagonists
SOURCE : Author
DIGEST : This bill clarifies that peace officers are included
among the persons authorized to receive and distribute opioid
antagonists, as specified. Requires the Emergency Medical
Services Authority (EMSA) to establish training and standards,
and promulgate regulations, for all prehospital emergency care
personnel regarding the use and administration of naloxone
hydrochloride (naloxone) and other opioid antagonists.
Notwithstanding that requirement, this bill also authorizes a
local emergency medical services (EMS) agency to establish
training and standards, and promulgate regulations, in lieu of
those developed and promulgated by EMSA, as specified.
CONTINUED
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Clarifies that both of those types of trainings satisfy
specified requirements allowing for immunity from criminal and
civil liability for administering an opioid antagonist.
Additionally, permits the Attorney General (AG), to authorize
hospitals and trauma centers to share information with local law
enforcement agencies and local EMS agencies. Limits the data
that may be provided by hospitals and trauma centers to the
number of overdoses and the substances suspected as the primary
cause of the overdoses.
ANALYSIS :
Existing law:
Civil Code
1.Defines "opioid antagonist" as naloxone that is approved by
the federal Food and Drug Administration (FDA) for the
treatment of an opioid overdose.
2.Allows 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. Allows a licensed health care
provider to issue standing orders for these purposes.
3.Requires 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. Specifies that a person who is prescribed naloxone
directly from a licensed prescriber, and not through a
standing order, is not subject to the training requirement.
4.Exempts a health care provider who acts with reasonable care
in issuing a prescription for naloxone and any person who
possesses, distributed, or administers naloxone, with
reasonable care, from professional review, civil action, or
criminal prosecution.
Health and Safety Code
5.Requires EMSA to establish training and standards for all
prehospital emergency care personnel, as defined, regarding
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the characteristics and method of assessment and treatment of
anaphylactic reactions and the use of epinephrine. Requires
EMSA to promulgate regulations for use by all prehospital
emergency care personnel.
6.Requires the AG to encourage research on the misuse and abuse
of controlled substances. Allows the AG 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.
This bill:
1.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.
Adds peace officers to the list of people who can receive
standing orders for the distribution of an opioid antagonist
for this purpose.
2.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. Allows EMSA to
designate existing training and standards for this purpose.
3.Permits a local EMS agency, notwithstanding (2) above, to
develop its own training and standards, and to promulgate
regulations, in lieu of the training and standards and
regulations developed by EMSA, for the purpose of considering
local need, regarding the use and administration of naloxone
and other opioid antagonists by prehospital emergency care
personnel under the jurisdiction of that local EMS agency.
4.Permits the AG to authorize hospitals and trauma centers to
share information with local law enforcement and local EMS
agencies about controlled substance overdose trends.
Specifies that this information is limited to the number of
overdoses and the substances suspected as the primary cause of
the overdoses and requires the information to be shared in a
matter that ensures patient confidentiality.
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5.Requires the training, standards, and regulations described in
(1) and (2) above to be in line with best practices in the
Substance Abuse and Mental Health Services Administration's
Opioid Overdose Prevention Toolkit.
6.Clarifies that the training described in (1) and (2) satisfy
the requirements allowing for immunity from criminal and civil
liability for administering an opioid antagonist, as
specified.
Background
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%) 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.
Naloxone . 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 by decreased breathing or heart rate or loss of
consciousness. The National Institute on Drug Abuse's Internet
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 to 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
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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 Internet Web site.
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's) Internet 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.
Prior Legislation
AB 635 (Ammiano, Chapter 707, Statutes of 2013) expanded the
program in AB 2145 (Ammiano, Chapter 545, Statutes 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.
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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. 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/she has completed training and
passed a test. Required EMSA to develop guidelines relating to
the county certification programs.
SB 1134 (Escutia, 2001) contained, among other things, the
provisions in SB 1695 above. SB 1134 was vetoed by Governor
Davis who cited cost reasons related to provisions in the bill
that required grants for drug overdose prevention programs.
SB 851 (Oller, 2001) required the EMSA to develop and implement
procedures and protocols to permit EMT-I's in Sierra County to
obtain training and certification to safely administer emergency
medical procedures, including naloxone, that are outside of
their scope of practice. This bill died in the Senate Health
and Human Services Committee.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 5/19/14)
California Chapter of the American College of Emergency
Physicians
California Pharmacists Association
California State Sheriffs' Association
Drug Policy Alliance
Emergency Medical Services Administrators' Association of
California
ARGUMENTS IN SUPPORT : The DPA writes that this bill is an
urgently needed measure to allow first responders to administer
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opiate overdose reversal medication, naloxone, to a person at
risk of a fatal overdose. Naloxone has been extensively
researched and widely used by a number of health care entities
for decades and several states have already expanded usage to
peace officers with no reports of negative outcomes for patient
safety. DPA believes this bill is part of a comprehensive
strategy to combat the epidemic of opiate overdoses in
California.
JL:e 5/20/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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