BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1438|
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UNFINISHED BUSINESS
Bill No: SB 1438
Author: Pavley (D), et al.
Amended: 8/22/14
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
SENATE FLOOR : 31-0, 5/23/14
AYES: Anderson, Beall, Block, Cannella, Corbett, Correa, De
León, DeSaulnier, Gaines, Galgiani, Hernandez, Hill, Huff,
Jackson, Knight, Lara, Leno, Lieu, Liu, Mitchell, Monning,
Morrell, Nielsen, Padilla, Pavley, Roth, Steinberg, Torres,
Vidak, Walters, Wolk
NO VOTE RECORDED: Berryhill, Calderon, Evans, Fuller, Hancock,
Hueso, Wright, Wyland, Yee
ASSEMBLY FLOOR : 78-0, 8/27/14 - See last page for vote
SUBJECT : Controlled substances: opioid antagonists
SOURCE : California Professional Firefighters
San Diego County Sheriffs' Department
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DIGEST : This bill requires the Emergency Medical Services
Authority (EMSA) to develop and adopt training and standards for
all prehospital emergency care personnel regarding the use and
administration of naloxone hydrochloride (naloxone) and other
opioid antagonists and to include the administration of naloxone
in the training and scope of practice, consistent with current
law, for emergency medical technician I (EMT-I) certification.
Requires the Attorney General (AG) to authorize hospitals and
trauma centers to share data on controlled substance overdose
trends with local law enforcement agencies and local emergency
medical services (EMS) agencies, as specified.
Assembly Amendments (1) delete provisions related to including
peace officers among those authorized to distribute opioid
antagonists; (2) remove the authorization for, at the EMS
medical director's discretion, pertinent training to satisfy
training requirements, and instead authorize the EMS medical
director to approve or conduct a trial study of the use and
administration of naloxone; (3) require EMSA to develop and
adopt regulations to include the administration of naloxone in
the training and scope of practice of EMT-I certification; and
(4) make other technical changes.
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
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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
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.Requires EMSA to develop and adopt training and standards, and
promulgate regulations, for all prehospital emergency medical
care personnel, as defined, regarding the use and
administration of naloxone hydrochloride (naloxone) and other
opioid antagonists.
2.Authorizes EMSA to adopt existing training and standards for
prehospital emergency medical care personnel regarding the
statewide use and administration of naloxone or another opioid
antagonist.
3.Authorizes the medical director of a local EMS agency, to
approve or conduct a trial study of the use and administration
of naloxone or other opioid antagonists by any level of
prehospital emergency medical care personnel, and authorizes
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the training received by prehospital emergency medical care
personnel specific to the use and administration of naloxone
or other opioid antagonists during this trial study to be used
towards satisfying the training requirements established by
EMSA.
4.Specifies that both of those types of trainings satisfy
specified requirements allowing for immunity from criminal and
civil liability for administering an opioid antagonist.
5.Requires EMSA to develop and adopt regulations to include the
administration of naloxone in the training and scope of
practice of emergency medical technician-I (EMT-I)
certification, on or before July 1, 2016.
6.Requires these regulations to be substantially similar to
certain regulations that authorize an EMT-I to receive
training for naloxone administration without having to
complete the entire emergency medical technician-II (EMT-II)
certification course.
7.Permits the Attorney General, in connection with that
research, and in furtherance of the enforcement of the act, to
authorize hospitals and trauma centers to share information
with local law enforcement agencies, EMSA, and local EMS
agencies about controlled substances.
8.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.
9.Requires that the information shared be shared in a manner
that ensures complete patient confidentiality.
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
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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
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
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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 851 (Oller, 2001) required the EMSA to develop and implement
procedures and protocols to permit EMT-Is in Sierra County to
obtain training and certification to safely administer emergency
medical procedures, including naloxone, that are outside of
their scope of practice. The bill died in the Senate Health and
Human Services Committee.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Assembly Appropriations Committee:
One-time staff costs, not likely to exceed $100,000 for EMSA
to issue regulations.
Local and private costs will be incurred as well. Local and
private EMS agencies who have not adopted naloxone
administration on a voluntary basis will incur costs for
policy development and revising training curriculum.
EMT-Is will incur a cost of $50-80 each for the additional
training. These costs are not state-reimbursable.
SUPPORT : (Verified 8/27/14)
California Professional Firefighters (co-source)
San Diego County Sheriffs' Department (co-source)
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CAL FIRE
California Chapter of the American College of Emergency
Physicians Association
California Opioid Maintenance Providers
California Pharmacists Association
California Society of Addiction Medicine
California State Sheriffs' Association
Drug Policy Alliance
Pacific Clinics
OPPOSITION : (Verified 8/27/14)
Emergency Medical Directors' Association of California
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
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 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. Pacific Clinics writes in support that this bill
will better equip existing prehospital personnel who are
frequently first responders to opioid overdoses. Pacific
Clinics further states that this bill ensures that EMSA and
local EMS agencies are authorized to develop training protocols
so that prehospital personnel have the appropriate knowledge to
use and administer naloxone.
ARGUMENTS IN OPPOSITION : The Emergency Medical Services
Administrators Association (EMSAAC) and the Emergency Medical
Directors Association of California, Inc. (EMDAC) oppose this
bill and state that adding naloxone to the EMT basic scope of
practice adds ongoing costs for (1) adding naloxone instruction
in EMT courses; (2) verifying the knowledge/skills on naloxone
administration by recertifying EMTs; (3) initial purchase,
re-supply, and replacements of expiring naloxone auto-injectors
by EMT providers; and (4) increased EMS system monitoring,
oversight and quality assurance. In addition EMSAAC/EMDAC state
that requiring EMSA to develop and adopt regulations to include
the administration of naloxone usurps the medical direction of
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the scope of practice of prehospital personnel currently
provided for in existing law.
ASSEMBLY FLOOR : 78-0, 08/27/14
AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Gorell, Gray, Grove, Hagman, Hall, Roger Hernández, Holden,
Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,
Maienschein, Mansoor, Medina, Melendez, Mullin, Muratsuchi,
Nazarian, Nestande, Olsen, Pan, Patterson, Perea, John A.
Pérez, V. Manuel Pérez, Quirk, Quirk-Silva, Rendon,
Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner,
Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, Atkins
NO VOTE RECORDED: Harkey, Vacancy
JL:e 8/27/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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