BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1438
AUTHOR: Pavley
AMENDED: April 10, 2014
HEARING DATE: April 24, 2014
CONSULTANT: Diaz
SUBJECT : Controlled substance: opioid antagonists.
SUMMARY : Adds peace officers to existing law regarding the use
and administration of an opioid antagonist. Requires the
Emergency Medical Services Authority to develop training and
standards and to promulgate regulations for the use and
administration of naloxone hydrochloride by all prehospital
emergency care personnel. Allows local emergency medical
services agencies to develop training and standards and to
promulgate regulations for the use and administration of
naloxone hydrochloride by prehospital emergency care personnel
under their jurisdiction in lieu of those developed by the
Emergency Medical Services Authority. Authorizes hospitals and
trauma centers to share information, as specified, regarding
controlled substances overdose trends.
Existing law:
Civil Code
1.Defines "opioid antagonist" as naloxone hydrochloride
(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
Continued---
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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 the Emergency Medical Services Authority (EMSA) to
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. Requires EMSA to promulgate
regulations for use by all prehospital emergency care
personnel.
6.Requires the Attorney General to 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.
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.Allows a local emergency medical services agency to 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.
4.Authorizes hospitals and trauma centers to share information
with local law enforcement and local emergency medical
services agencies about controlled substance overdose trends.
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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.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, California and
the nation are in the midst of a drug abuse crisis.
Prescription opioid and heroin abuse have precipitated a
public health epidemic marked by a spike in fatal overdoses.
While naloxone, an opiate antidote that reverses opiate
overdoses, has been used by paramedics and emergency medical
technicians (EMTs) in the state (now known as "Advanced EMTs")
to save lives for the last few decades, 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 emergency medical technicians 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. 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.
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.
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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. 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 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 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
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to naloxone does not promote increased drug use or risk-taking
behavior that results in unintended overdoses.
5.Double referral. This bill has been double referred. Should it
pass out of this committee, it will be referred to Senate
Public Safety Committee.
6.Related 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 devices furnished to the patient.
Prohibits a pharmacist from permitting a person to waive the
consultation. Requires a pharmacist to complete a training
program on the use of opioid antagonists prior to furnishing
naloxone. This bill is currently in the Assembly
Appropriations Committee.
7.Prior legislation. 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.
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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. Required EMSA to develop guidelines relating to
the county certification programs.
SB 1134 (Escutia) of 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) of 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 was
never heard in the Senate Health and Human Services Committee.
8. Support. DPA writes in support that SB 1438 is an
urgently needed measure to allow first responders to
administer 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.
9. Policy Comment.
a. Local EMS agencies. 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
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Administration's Opioid Overdose Prevention Toolkit.
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.
(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.
( 3 4 ) 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.
SUPPORT AND OPPOSITION :
Support: California State Sheriffs' Association
Drug Policy Alliance
California Chapter of the American College of
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Emergency Physicians (prior version)
Oppose: None received
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