BILL ANALYSIS
AB 2145
Page 1
Date of Hearing: April 13, 2010
ASSEMBLY COMMITTEE ON JUDICIARY
Mike Feuer, Chair
AB 2145 (Ammiano) - As Introduced: February 18, 2010
SUBJECT : DRUG OVERDOSE TREATMENT: LIABILITY
KEY ISSUES :
1)SHOULD THE EXISTING PILOT PROGRAM FOR OPIOID ANTAGONIST
TREATMENT OF DRUG OVERDOSE, WHICH AUTHORIZES LICENSED HEALTH
CARE PROVIDERS, WORKING IN CONJUNCTION WITH AN OVERDOSE
PREVENTION AND TREATMENT TRAINING PROGRAM, TO PRESCRIBE AND
SUBSEQUENTLY DISPENSE OR DISTRIBUTE AN OPIOID ANTAGONIST
WITHOUT CIVIL OR CRIMINAL LIABILITY, BE EXPANDED STATEWIDE AND
NO LONGER BE SUBJECT TO A SUNSET DATE?
2)SHOULD LIMITED IMMUNITY FROM CIVIL AND CRIMINAL PENALTIES BE
EXTENDED TO LAY PERSONS WHO ADMINISTER AN OPIOID ANTAGONIST IN
AN EMERGENCY TO PREVENT THE POSSIBLE DRUG OVERDOSE OF ANOTHER
PERSON, AS LONG AS THE LAY PERSON HAS RECEIVED SPECIFIED
TRAINING THROUGH A TRAINING PROGRAM APPROVED BY THE LOCAL
HEALTH JURISDICTION?
FISCAL EFFECT : As currently in print this bill is keyed fiscal.
SYNOPSIS
SB 767 (Ridley-Thomas) of 2007 established an overdose
prevention pilot project that granted limited immunity from
civil and criminal penalties to licensed health care providers
who, by the same act, were authorized to prescribe and
distribute opioid antagonists for emergency treatment of drug
overdose. Seven counties were authorized by SB 767 to develop a
so-called "naloxone prescription program" (NPP) and register it
with the state, but to this date only San Francisco and Los
Angeles Counties have done so. In order to increase prevention
of overdose deaths in the state, this bill seeks to broadly
expand parameters of the current pilot project. First, the bill
would expand limited immunity from civil and criminal liability
to lay persons who administer an opioid antagonist in an
emergency, if that lay person has received appropriate training
through a program operated or registered by the local health
jurisdiction. In practice, these persons are most likely to be
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friends or acquaintances of the person using opioid drugs,
present when an overdose begins and thus in the best position to
intervene and administer the opioid antagonist at a point when
it will have its greatest lifesaving effect. This bill would
also expand these provisions statewide, while simultaneously
deleting the 2011 sunset date, thereby extending these
provisions indefinitely. Supporters generally contend that
naloxone prescription programs save lives, and that available
data demonstrate that these programs are actively being used to
produce safe and effective health outcomes. Supporters also
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 will simply avoid employing
naloxone in an emergency even when it is available. This bill
is co-sponsored by Harm Reduction California and the Los Angeles
Overdose Prevention Task Force, and has no known opposition.
SUMMARY : Seeks to expand parameters of the current pilot
program authorizing opioid antagonist (Naloxone) treatment of
drug overdose with limited immunity from liability.
Specifically, this bill :
1)Provides that a person who is not otherwise licensed to
administer an opioid antidote may administer an opioid
antidote in an emergency without fee, if the person believes
in good faith that the other person is experiencing a drug
overdose, and has received specified training through a
training program operated or registered by the local health
jurisdiction. Further provides that the person shall not, as
a result of his or her acts or omissions, be liable for any
violation of any professional licensing statute, or subject to
any criminal prosecution related to the unauthorized practice
of medicine or possession of an opioid antidote.
2)Deletes the provision that currently restricts application of
the Naloxone treatment pilot program to only seven authorized
counties, thereby expanding application of these provisions
statewide.
3)Deletes the sunset date provision that would repeal authority
for the Naloxone treatment pilot program on January 1, 2011,
thereby extending these provisions indefinitely.
4)Deletes the requirement that each local health jurisdiction
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that operates or registers an opioid overdose prevention and
treatment training program must report specified data by
January 1, 2010 to the Senate and Assembly Judiciary
Committees.
5)Requires the Director of Alcohol and Drug Programs to publish
an annual report on drug overdose trends statewide that: (a)
reviews state death rates to ascertain changes in the causes
or rates of fatal and nonfatal drug overdoses for the
preceding period of not less than five years; and (b) provides
information on interventions that would be effective in
reducing the rate of fatal or nonfatal drug overdose.
EXISTING LAW :
1)Provides that a licensed health care provider who is permitted
by law to prescribe an opioid antagonist may, if acting with
reasonable care, prescribe and subsequently dispense or
distribute an opioid antagonist in conjunction with an opioid
overdose prevention and treatment training program, without
being subject to civil liability or criminal prosecution. This
immunity shall apply to the licensed health care provider even
when the opioid antagonist is administered by and to someone
other than the person to whom it is prescribed. (Civil Code
Section 1714.22(b).)
2)Provides that application of these provisions is limited only
to the Counties of Alameda, Fresno, Humboldt, Los Angeles,
Mendocino, San Francisco, and Santa Cruz. (Civil Code Section
1714.22(d).)
3)Provides that the pilot authority for Naloxone treatment with
limited immunity from liability shall remain in effect only
until January 1, 2011, and as of that date is repealed, unless
a later enacted statute, that is enacted on or before January
1, 2011, deletes or extends that date. (Civil Code Section
1714.22(e).)
4)Requires each local health jurisdiction that operates or
registers an opioid overdose prevention and treatment training
program, by January 1, 2010, to collect, and report specified
data to the Senate and Assembly Committees on Judiciary on
such programs within the jurisdiction. (Civil Code Section
1714.22(c).)
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5)Defines "opioid antagonist" to mean naloxone hydrochloride
that is approved by the federal Food and Drug Administration
for the treatment of a drug overdose. (Civil Code Section
1714.22(a)(1).)
6)Defines "opioid overdose prevention and treatment training
program" or "program" to mean any program operated by a local
health jurisdiction or that is registered by a local health
jurisdiction to train individuals to prevent, recognize, and
respond to an opiate overdose, and that provides, at a
minimum, training in all of the following: (a) The causes of
an opiate overdose; (b) Mouth to mouth resuscitation; (c) How
to contact appropriate emergency medical services; and (d) How
to administer an opioid antagonist. (Civil Code Section
1714.22(a)(2).)
7)Provides a qualified immunity from civil claims for persons
rendering cardiopulmonary resuscitation (CPR), in good faith,
after completing a basic CPR course, as specified. (Civil
Code Section 1714.2.)
8)Provides a qualified immunity from civil claims for persons
rendering emergency care or treatment by the use of an
automatic external defibrillator in good faith. (Civil Code
Section 1714.21.)
9)Pursuant to federal law, the Controlled Substances Act,
regulates the manufacture, importation, possession and
distribution of certain controlled substances. Those
substances are classified within five schedules, which are
based upon the potential for abuse, addiction, and medical use
within the United States. (21 U.S.C. 801 et seq.)
10)Pursuant to the California Uniform Controlled Substances Act,
strictly regulates the distribution of controlled substances
within California (Health & Safety Code 11000 et seq.) and
prohibits the prescription, administration, or dispensing of a
controlled substance to an addict, except under certain
circumstances. (Health & Safety Code Section 11156; Bus. &
Prof. Code Section 2241.)
COMMENTS : This bill, co-sponsored by Harm Reduction California
and the Los Angeles Overdose Prevention Task Force, seeks to
expand parameters of the current pilot project that grants
limited immunity from civil and criminal penalties to licensed
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health care providers in seven counties who are authorized to
prescribe and distribute opioid antagonists for emergency
treatment of drug overdose. First, the bill would expand
limited immunity from civil and criminal liability to lay
persons who administer an opioid antagonist in an emergency, if
that lay person has received appropriate training through a
program operated or registered by the local health jurisdiction.
In practice, these persons are most likely to be friends or
acquaintances of the person using opioid drugs, present when an
overdose begins and thus in the best position to intervene and
administer the opioid antagonist at a point when it will have
its greatest lifesaving effect. This bill would also expand the
pilot provisions statewide, while simultaneously deleting the
2011 sunset date, thereby extending these provisions
indefinitely.
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
(or its brand name "Narcan"), and 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. Naloxone is administered by injection
into vein or muscle, with intravenous injection providing for
the fastest action. Once injected, naloxone takes effect after
around two minutes, with effects lasting around 45 minutes,
potentially saving the person's life. A New York Times 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.
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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.
Implementation of Overdose Prevention Programs in California.
According to the Harm Reduction Coalition, overdose prevention
programs that dispense naloxone (often referred to as "naloxone
prescription programs", or NPPs) have been operating legally in
California for ten years, with different levels of support from
city and county public health departments and community-based
organizations. There currently are 18 naloxone prescription
programs operating in twelve counties in CA. Of these twelve
counties, only seven (San Francisco, Los Angeles, Alameda,
Fresno, Humboldt, Mendocino, and Santa Cruz) are authorized to
participate in the specific pilot project created by SB 767
(2007), which this bill seeks to expand. Only San Francisco and
Los Angeles, however, have actually registered their overdose
prevention programs with the state and have reported data to the
Legislature pursuant to SB 767.
According to supporters, these programs do more than just
dispense naloxone. Supporters state that NPPs "provide lay
community members (including drug users, their friends, and
family members) with the training and tools necessary to
intervene effectively when they witness a drug overdose. These
programs also provide overdose prevention, recognition, and
response training, including training in calling 911, rescue
breathing and utilization of take-home prescriptions of
naloxone."
Supporters contend NPPs are safe and effective, justifying
removal of the sunset date for the SB 767 pilot program.
Proponents of this bill contend, very simply, that naloxone
prescription programs save lives, and that available data from
San Francisco and Los Angeles pilot programs demonstrate that
these programs are actively being used to produce safe and
effective health outcomes. These supporters cite numerous
research findings, including the following:
In San Francisco, between January 2008 and December
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2009, 749 individuals were trained and prescribed
naloxone. Of these, 156 (21%) returned for refills
because they reported using naloxone to revive an
overdose victim. These project participants reported a
total of 153 successful overdose reversals-meaning that
in only three cases (or only 2% of the time) a person
experiencing drug overdose received naloxone but was not
revived.
In Los Angeles, during an equivalent period, 273
individuals were trained and prescribed naloxone. These
273 individuals reported responding to a total of 82
overdoses, of which at least 71 (93%) of the overdose
victims were known to have survived.
Additional San Francisco data, reflecting
implementation of their naloxone program predating SB
767, indicate a decline in heroin-related overdose deaths
from over 120 per year in 2000, to under 60 per year in
2005. In addition, since 2003, over 2,000 prescriptions
of naloxone were distributed in total, resulting in a
reported 455 lives saved by laypersons trained through
the San Francisco program (A.P. Hart, City & County of
San Francisco, Annual Report (2006).)
Supporters of this bill also relate that, outside of California,
there are over 100 naloxone prescription programs operating in
17 U.S. states, and they have been shown to be highly effective.
(A complete report summarizing these findings is available on
the Internet at:
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1437163 ).
In general, the supporters of this bill enthusiastically
describe the potential lifesaving effects of making opioid
antagonists available to various individuals who may be in the
presence of an opioid overdose. Those accounts are based upon
existing distribution programs, which have reported few if any
complications and undoubtedly saved numerous lives. The
Committee has not been made aware of any suits or prosecutions
as a result of the current distribution of opioid antagonists.
Supporters contend that high rates of preventable drug overdose
in many counties justify statewide expansion of the pilot
program. Proponents of this bill contend that accidental drug
overdose is a prevalent problem across the state, and that
expansion of the pilot program would help to address unmet needs
in many counties that currently do not enjoy the protections
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provided by the SB 767 pilot project. According to the most
recent report by California Alcohol and Drug Programs, the
counties with the highest number of overdose deaths in 2006 were
Kern, Orange, Riverside, Sacramento, San Bernardino, San Diego,
Santa Clara, Alameda, Fresno, San Francisco, and Los Angeles.
The author notes that only the latter four counties are
authorized as sites for pilot programs in SB 767, and asserts
that there are a number of counties that already have NPPs that
merit protection, as well as many high-need counties yet to
implement programs that would stand to benefit from statewide
expansion proposed by this bill.
Reasons for liability protection for third parties who
administer naloxone. Supporters 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 will simply avoid employing naloxone in
an emergency even when it is available. The author explains:
Opioid overdose is characterized by unconsciousness
caused by failure of the respiratory system.
Therefore, if the person prescribed naloxone is the
one who is at-risk, he will not be able to use it on
himself when actually needed. A companion trained in
naloxone administration must be present to administer
the life-saving drug. Friends, family members, workers
in homeless shelters, residential hotels, and drug
treatment programs are often first responders in an
overdose crisis, but may be fearful to carry a
naloxone prescription because of the lack of 3rd party
protection. A trained, informed Good Samaritan
deserves to keep naloxone in the first aid kit or
medicine cabinet without needless concern.
Supporters report that county health workers who operate or who
desire to operate a NPP report having difficulty finding health
care providers who are comfortable writing prescriptions for a
medication that will, by necessity, be administered by a third
party, without reasonable liability protection. Furthermore,
supporters assert that even so-called "frontline workers" who
have taken overdose prevention trainings, and who often are in
close contact with drug users at sites like homeless shelters
and drug treatment facilities, nevertheless are reluctant to
keep the naloxone close at hand for emergency response, without
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any legal protection for a third party who administrates
naloxone.
REGISTERED SUPPORT / OPPOSITION :
Support
Harm Reduction Coalition (sponsor)
California Public Defenders Association
City and County of San Francisco
Coalition on Homelessness, San Francisco
County Alcohol and Drug Program Administrators Association of
California (CADPAAC)
Desert AIDS Project
Drug Policy Alliance
San Francisco AIDS Foundation
Opposition
None on file
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334