BILL ANALYSIS �
SB 1438
Page 1
Date of Hearing: June 24, 2014
ASSEMBLY COMMITTEE ON JUDICIARY
Bob Wieckowski, Chair
SB 1438 (Pavley) - As Amended: June 11, 2014
PROPOSED CONSENT
SENATE VOTE : 31-0
SUBJECT : CONTROLLED SUBSTANCES: OPIOID ANTAGONISTS
KEY ISSUE : SHOULD IT BE CLARIFIED THAT PEACE OFFICERS ARE
INCLUDED AMONG THOSE PERSONS WHO UNDER EXISTING LAW ARE ALLOWED
TO ADMINISTER THE DRUG NALOXONE TO SOMEONE AT-RISK FOR AN OPIOID
OVERDOSE WITHOUT BEING SUBJECT TO CRIMINAL OR CIVIL LIABILITY,
AS LONG AS CERTAIN CONDITIONS ARE MET?
SYNOPSIS
This bill, sponsored by the California Professional
Firefighters, seeks to clarify that, under a recently enacted
2013 law, peace officers are among those persons authorized to
possess and administer opioid antagonists, a category of drugs
used to treat opiate-related drug overdose quite effectively.
Proponents contend it is important to remove any ambiguity about
the application of the law to peace officers because of their
frequent role as first responders in medical emergencies. The
bill also clarifies the associated protections from civil and
criminal liability that extend to peace officers who properly
exercise this authority. With respect to liability, existing
law limits liability for any person who possesses or distributes
naloxone if it was done pursuant to a prescription or standing
order by an authorized licensed health care professional. Under
this bill, peace officers would be included in the group of
persons who may possess and distribute naloxone pursuant to a
prescription or standing order, therefore removing any doubt
that under the new law they would not be liable in a civil
action or subject to criminal prosecution or professional review
for such acts carried out pursuant to the statute. Among other
things, this bill directs the Emergency Medical Service
Authority (EMSA) to develop standards and promulgate regulations
allowing all prehospital emergency care personnel to administer
naloxone. According to the sponsor, this is intended to ensure
that all state EMT's will be trained in the use of naloxone as
SB 1438
Page 2
part of their basic scope of practice. The bill was previously
approved by the Assembly Health Committee by a 17-0 vote, and
before that was approved by the Senate without receiving a
single "no" vote. In addition to the firefighters, the bill is
supported by California sheriffs, emergency physicians,
pharmacists, and the Drug Policy Alliance. The bill currently
has no registered opposition and will be referred to
Appropriations Committee should it pass this Committee.
SUMMARY : Clarifies the authority of peace officers to possess
and administer opioid antagonists to persons at risk for or
experiencing an opiate-related overdose, and clarifies the
applicable protections from liability for such acts. Further
requires the development of training and other standards for the
administration of naloxone by emergency medical technicians
(EMTs) and other prehospital emergency care personnel.
Specifically, this bill :
1)Clarifies that peace officers are among those persons to whom
an authorized licensed health care provider may issue a
prescription or standing order for the distribution or
administration of an opioid antagonist to a person at risk of
an opioid-related overdose.
2)Clarifies that peace officers are among those persons who are
not subject to professional review, liable in a civil action,
or subject to criminal prosecution for possession or
distribution of an opioid antagonist pursuant to a
prescription or standing order issued by an authorized
licensed health care provider.
3)Requires the Emergency Medical Services Authority (EMSA), to
develop, and after approval by the Commission on Emergency
Medical Services (Commission), to adopt training and standards
for all prehospital emergency care personnel regarding the use
and administration of naloxone and other opioid antagonists.
Allows EMSA to adopt existing training and standards for
prehospital emergency care personnel regarding the statewide
use and administration of naloxone or another opioid
antagonist to satisfy this requirement.
4)Provides that the above training shall satisfy the training
requirement (pursuant to Civil Code Section 1722(d)(1)) for
every person who is prescribed or possesses an opioid
antagonist pursuant to a standing order-training that
SB 1438
Page 3
otherwise must be provided by an authorized opioid overdose
prevention and treatment training program.
5)Requires EMSA, on or before July 1, 2015, to develop, and
after approval by the Commission, to adopt regulations that
include administration of naloxone in EMT-I certification
training substantially similar to the training currently
required for EMT-II certification.
6)Requires the Attorney General, in order to encourage research
on misuse and abuse of controlled substances, to authorize
hospitals and trauma centers to share data on controlled
substance overdose trends with local law enforcement agencies
and local emergency medical services agencies, provided that
such data is shared with complete patient confidentiality and
is limited to the number of overdoses and the substances
suspected as the primary cause of the overdoses.
EXISTING LAW :
1)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. (Civil Code Section 1714.22(b).)
2)Permits a licensed health care provider to issue a standing
order for the distribution of an opioid antagonist to a person
at risk of an opioid-related overdose, by a family member,
friend, or other person in a position to assist the person at
risk, or a standing order for the administration of the drug
by a family member, friend, or other person in a position to
assist a person experiencing or reasonably suspected of
experiencing an opioid overdose. (Civil Code Section
1714.22(c).)
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, except that a person who is prescribed naloxone
directly from a licensed prescriber, and not through a
standing order, is not required to receive such training.
(Civil Code Section 1714.22(d).)
4)Provides that a licensed health care provider who acts with
SB 1438
Page 4
reasonable care shall not be subject to professional review,
be liable in a civil action, or be subject to criminal
prosecution for issuing a prescription or standing order for
an opioid antagonist pursuant to these provisions. (Civil
Code Section 1714.22(e).)
5)Provides that a person who possesses or distributes an opioid
antagonist pursuant to a prescription or standing order shall
not be subject to professional review, be liable in a civil
action, or be subject to criminal prosecution for this
possession or distribution. Further provides that a person
not otherwise licensed to administer an opioid antagonist, but
who has received training through an overdose prevention and
treatment training program, shall not be subject to
professional review, be liable in a civil action, or be
subject to criminal prosecution for administering an opioid
antagonist to a person who is experiencing or is suspected of
experiencing an overdose, provided that the person
administering the drug acts with reasonable care in good faith
and not for compensation. (Civil Code Section 1714.22(f).)
6)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, and
requires EMSA to promulgate regulations for use by all
prehospital emergency care personnel. (Health & Safety Code
Section 1797.197.)
7)Requires the Attorney General to encourage research on the
misuse and abuse of controlled substances, and permits the
Attorney General to: (1) develop new and improved approaches
and techniques to strengthen enforcement of the Controlled
Substances Act; and (2) enter into contracts with agencies or
other parties to conduct demonstrations or special projects
that bear directly on the misuse and abuse of controlled
substances. (Health & Safety Code Section 11601.)
FISCAL EFFECT : As currently in print this bill is keyed fiscal.
COMMENTS : This bill, sponsored by the California Professional
Firefighters, seeks to remove ambiguity in existing law by
expressly authorizing peace officers to possess and administer
opioid antagonists-- a class of drugs used to treat
opiate-related drug overdose--and clarifying the associated
SB 1438
Page 5
protections from liability that extend to peace officers who
properly exercise this authority. According to the author:
SB 1438 intends to expand the pool of emergency
responders allowed to carry and administer the drug
naloxone, a drug that helps resuscitate victims from
life-threatening opiate-overdoses. 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 EMT-IIs (now known as "Advanced 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. SB 635 (Ammiano), 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 the ability
of law enforcement and other first responders to carry
and administer the drug.
Background on properties of naloxone, a common opioid
antagonist : Opioid antagonists are a group of drugs routinely
used in hospitals and in pre-hospital settings (i.e. by
paramedics in the field) on patients who are suspected to be
overdosing on opioids such as heroin, methadone, or oxycodone.
The most common type of opioid antagonist is known as naloxone
hydrochloride (or its brand name "Narcan"), and is approved by
the federal Food and Drug Administration for the treatment of an
opioid overdose. (Hereafter, this analysis will use the term
"naloxone" interchangeably with the term "opioid antagonist.")
Opioid overdoses are characterized by central nervous system and
respiratory depression, leading to coma and death. Naloxone,
like other opioid antagonists, has the ability to counteract
depression of the central nervous and respiratory system caused
by an opioid overdose. Once administered, naloxone takes effect
after around two minutes, with effects lasting around 45
minutes, potentially saving the person's life. A New York Times
SB 1438
Page 6
article published August 21, 2005 ("The Shot That Saves") noted:
If given early enough, naloxone can prevent damage to
the brain caused by lack of oxygen and leave the victim
unharmed. According to research . . . at least 75
percent of overdose deaths involve multiple drugs,
usually mixtures of heroin and other depressants like
alcohol. Removing the opioid from the mix with
naloxone is often enough to revive victims.
Naloxone itself is virtually harmless. Its most common
side effects are withdrawal symptoms like nausea,
shakiness and agitation in those who are physically
dependent on opioids. While uncomfortable, these
symptoms are not dangerous. Rarely, seizures can occur,
but this risk is far lower than the risk to those who
are not treated. The drug has no effect on those who
haven't taken opioids.
Naloxone is typically administered by injection into a vein or
muscle, with intravenous injection providing for the fastest
action. Some overdose prevention programs use syringes fitted
with atomizers to enable 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.
Background on the opioid overdose epidemic . 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. It is important to note that most opioid-related
overdoses do not occur in injection drug users of heroin or
commonly perceived "street drugs." In fact, 2009 data indicates
that approximately 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.
SB 1438
Page 7
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.
History of the SB 767 pilot overdose prevention project in
California. In 2008, the Legislature approved and the Governor
signed the Overdose Treatment Liability Act (SB 767
(Ridley-Thomas) Ch. 477, Stats. 2007) which established a
three-year pilot overdose prevention project. Scheduled to
sunset on January 1, 2016, the Act grants limited immunity from
civil and criminal penalties to licensed health care providers
in seven counties for prescribing, dispensing, or distributing
naloxone, when acting with reasonable care and in conjunction
with a local opioid overdose prevention and treatment training
program. AB 2145 (Ammiano), Ch. 545, Stats. 2010, extended the
sunset to 2016, and extended liability protection to third party
administrators of naloxone.
Before the prevention project reached its 2016 sunset date
however, additional data reported by participating pilot
counties indicated quite strongly that the project had achieved
a high rate of success in preventing overdose, coupled with the
near total lack of any adverse events associated with
administration of naloxone. Consequently, AB 635 (Ammiano) was
introduced in 2013 to expand the overdose prevention program
statewide and remove the sunset date. Proponents of the bill
argued convincingly that the pilot project data demonstrated
that naloxone prescription is safe and effective in saving lives
without producing significant adverse events, thus justifying
removal of the sunset date and expansion of the program. AB 635
was unanimously approved by the Legislature and was signed into
law (Ch. 707, Stats. 2013) by Governor Brown. This bill is
follow-up legislation to AB 635, and seeks to clarify perceived
ambiguity in the statute and to revise training and standards
requirements for certain emergency medical personnel.
This bill clarifies provisions authorizing persons to possess
and administer naloxone, and providing conditional protection
from liability. Existing law, Civil Code Section 1714.22,
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
SB 1438
Page 8
person at risk of overdose. (Italics added.) Other provisions
offer the same authorization with respect to the issuance of
standing orders for distribution and administration. Although
current law arguably already covers peace officers through the
umbrella category "other person in a position to assist the
person at risk of overdose," proponents contend it is necessary
to expressly clarify that peace officers may carry and
administer naloxone pursuant to the statute.
According to the author, it is important to remove any ambiguity
about the application of the law to peace officers because of
their frequent role as first responders in medical emergencies.
For example, the author states that "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."
Advocates for expansion of naloxone use contend that because
naloxone cannot be self-administered by the person experiencing
the overdose, it is recommendable to extend protection from
liability to third parties who are trained to administer
naloxone, or else they may avoid employing naloxone in an
emergency even when it is available.
With respect to liability for possession of naloxone, existing
law reasonably limits liability for any person who possesses or
distributes naloxone if it was done pursuant to a prescription
or standing order by an authorized licensed health care
professional. Under this bill, peace officers would be included
in the group of persons who may possess and distribute naloxone
pursuant to a prescription or standing order, and who therefore
would not be liable in a civil action or subject to criminal
prosecution or professional review.
Development of standards and training requirements. This bill,
among other things, directs the Emergency Medical Service
Authority (EMSA) to develop standards and promulgate regulations
allowing all prehospital emergency care personnel to administer
naloxone. According to the bill's sponsor, the CA Professional
Firefighters, the bill will ensure that all state EMTs will be
SB 1438
Page 9
trained in the use of naloxone as part of their basic scope of
practice-in contrast to the current state of affairs where
reportedly only three county local EMS agencies have authorized
naloxone administration as part of their optional scope.
Without these provisions, they contend, first responders across
California would be put in the "untenable" situation of being
prohibited from administering naloxone because their county had
not authorized naloxone administration as part of their optional
scope of practice even though lay people would in many cases be
allowed to under the law. The scope of practice issue for EMTs
and other emergency care personnel was previously heard in the
Assembly Health Committee, whose jurisdiction more appropriately
covers that issue, and the bill was approved unanimously before
being referred to this Committee for analysis of the
liability-related issues.
REGISTERED SUPPORT / OPPOSITION :
Support
California Professional Firefighters (sponsor)
California Chapter of the American College of Emergency
Physicians
California Opioid Maintenance Providers
California Pharmacists Association
California State Sheriff's Association
Drug Policy Alliance
Emergency Medical Services Administrators Association of
California (EMSAAC)
San Diego County Sheriff's Department
Opposition
None on file
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334