BILL ANALYSIS
SENATE JUDICIARY COMMITTEE
Senator Ellen M. Corbett, Chair
2009-2010 Regular Session
AB 2145 (Ammiano)
As Amended May 28, 2010
Hearing Date: June 22, 2010
Fiscal: No
Urgency: No
BCP
SUBJECT
Drug Overdose Treatment: Liability
DESCRIPTION
Existing law establishes a seven county pilot program that
provides licensed health care providers with a qualified
immunity from civil liability or criminal prosecution when they
prescribed naloxone (a prescription drug to counteract an opiate
overdose). That pilot program sunsets on January 1, 2011.
This bill seeks to expand that program by removing the sunset,
removing the restriction to only those seven counties, and by
adding a new qualified immunity for unlicensed trained persons
that administer an opioid antidote in emergency situations where
they believe, in good faith, that the other person is
experiencing a drug overdose.
BACKGROUND
According to the Centers for Disease Control, drug overdoses are
the second leading cause of unintentional injury death in the
United States. Those overdoses arguably include numerous
preventable deaths from opioid overdose where the victim did not
receive prompt medical treatment.
Opioid overdoses are characterized by central nervous system and
respiratory depression, leading to coma and death. While there
are various opioid antagonists, the most popular appears to be
naloxone, which has the ability to counteract depression of the
central nervous and respiratory system caused by an opioid
overdose. Naloxone is administered by either injection into
(more)
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vein or muscle or via a nasal atomizer. Once administered,
naloxone takes effect after around a minute, with effects
lasting around 45 minutes, potentially saving the person's life.
The New York Times August 21, 2005 article entitled 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.
. . .
According to a study published in the journal Drug and
Alcohol Dependence, 57 percent of 1,184 hard drug users
interviewed had witnessed at least one overdose. Medical
help was sought in only two-thirds of the instances, and
this was usually only after efforts to revive the victim by
hitting him or rubbing him with ice had failed . . . More
than half of the drug users in the study cited fear of
arrest as the main reason for delaying or failing to seek
help.
In order to facilitate the prescription of naloxone to trained
individuals, SB 767 (Ridley-Thomas, Chapter 477, Statutes of
2007) established a seven county pilot program that provided
licensed health care providers with a qualified immunity from
civil liability or criminal prosecution when they prescribed
naloxone. That immunity only applies where the health care
provider dispensed that drug in connection with an opioid
overdose prevention and training program - those programs,
either registered or run by a local health jurisdiction, trained
individuals for how to recognize and respond to an opiate
overdose. The pilot program sunsets on January 1, 2011, and the
seven participating counties were required to report specified
information to the Senate and Assembly Committees on Judiciary
by January 1, 2010.
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This bill would expand that program by removing the sunset,
removing the restriction to only those seven counties, and by
adding a new qualified immunity for unlicensed trained persons
that administer an opioid antidote in emergency situations where
they believe, in good faith, that the other person is
experiencing a drug overdose.
CHANGES TO EXISTING LAW
Existing law 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 that antagonist in conjunction with an opioid
overdose prevention and treatment training program, without
being subject to civil liability or criminal prosecution. (Civ.
Code Sec. 1714.22(b).)
Existing law applies the above immunity to a licensed health
care provider even when the opioid antagonist is administered by
and to someone other than the person to whom it is prescribed.
(Civ. Code Sec. 1714.22(b).)
Existing law requires each local health jurisdiction that
operates or registers an opioid overdose prevention and
treatment training program to, by January 1, 2010, collect, and
report to the Senate and Assembly Committees on Judiciary, all
of the following data on programs within the jurisdiction:
Number of training programs operating in the local
health jurisdiction;
Number of individuals who have received a prescription
for, and training to administer, an opioid antagonist;
Number of opioid antagonist doses prescribed;
Number of opioid antagonist doses administered;
Number of individuals who received opioid antagonist
injections who were properly revived;
Number of individuals who received opioid antagonist
injections who were not revived; and
Number of adverse events associated with an opioid
antagonist dose that was distributed as part of an opioid
overdose prevention and treatment training program. (Civ.
Code Sec. 1714.22(c).)
Existing law limits the application of the above provisions to
the Counties of Alameda, Fresno, Humboldt, Los Angeles,
Mendocino, San Francisco, and Santa Cruz, and sunsets the above
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provisions on January 1, 2011. (Civ. Code Sec. 1714.22(d),(e).)
Existing law defines "opioid overdose prevention and treatment
training program" as 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: (1) the causes of an opiate
overdose; (2) mouth to mouth resuscitation; (3) how to contact
appropriate emergency medical services; and (4) how to
administer an opioid antagonist. (Civ. Code Sec. 1714.22(a)(2).)
This bill would additionally provide that a person who is not
otherwise licensed to administer an opioid antidote may
administer an opioid antidote in an emergency, without a fee, if
the person has been trained by an opioid overdose prevention and
treatment training program and believes in good faith that the
other person is experiencing a drug overdose. That person would
not, as a result of their acts or omissions, be liable for any
violation of any professional licensing statute, or be subject
to any criminal prosecution arising from or related to the
unauthorized practice of medicine or the possession of an opioid
antidote.
This bill would remove the sunset date of January 1, 2011,
remove the report requirement, and remove the restriction to the
above seven counties.
COMMENT
1. Stated need for the bill
According to the author:
In 2008, the Overdose Treatment Liability Act . . .
established a three-year pilot project. Scheduled to sunset
on January 1, 2011, the act granted limited immunity from
civil and criminal penalties to licensed health care
providers in seven counties - Alameda, Fresno, Humboldt, Los
Angeles, Mendocino, San Francisco, and Santa Cruz. These
counties were designated as pilot counties because they had
existing overdose prevention programs in place already,
through their local syringe access and disposal programs.
The Harm Reduction Coalition is working with health
advocates in Kern, Lake, Sacramento, San Diego, Santa Clara,
and Sonoma counties who are either already doing independent
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Naloxone distribution as part of an overdose prevention
program or would like to start.
2. New immunity, application statewide
When approved by this committee, SB 767 (Ridley-Thomas, 2007)
reflected a compromise that sought to add a qualified immunity
for licensed health care providers who dispense naloxone in
connection with specified opioid overdose prevention and
treatment training programs. The intent of that provision was
to address concerns that physicians were not prescribing
naloxone due to liability concerns. Those concerns included
that the prescribing physician understood that although the drug
is prescribed to a particular individual, in reality, that
individual would rely upon those surrounding him/her to inject
the drug in the case of an overdose. As a result, the immunity
provision specifically includes the situation where the naloxone
is administered by someone other than the person to whom it is
prescribed.
This bill would make three changes to the pilot program enacted
by SB 767: (1) add a new qualified immunity (from liability for
violations of professional licensing statutes or criminal
prosecution) for trained third parties who administer the drug
in good faith in an emergency; (2) remove the restriction to
seven counties, thus applying the program statewide; and (3)
remove the sunset and associated reports. (See Comment 4 for
the discussion regarding sunset and reports.) Absent the
enactment of a bill during this Legislative session to extend
the original sunset, the current pilot project will sunset on
January 1, 2011.
a. Additional qualified immunity for third parties
In addition to the existing qualified immunity for those who
prescribe naloxone, this bill would enact a new qualified
immunity for third parties who administer naloxone in an
emergency, without a fee, provided that the person has both
received training and believes, in good faith, that the other
person is experiencing a drug overdose. That immunity would
remove liability for any violation of a professional licensing
statute and prevent a criminal prosecution arising from, or
related to, the unauthorized practice of medicine or the
possession of naloxone. Although a similar immunity was
stricken from SB 767 in this Committee, that stricken immunity
differed in two key aspects: (1) it applied to untrained
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bystanders; and (2) it provided a blanket immunity from civil
liability or criminal prosecution. This Committee's analysis
for SB 767 expressed the following concerns about that
immunity provision:
. . . [T]he language of the bill only requires the
antagonist to be "obtained through a licensed health care
provider . . ." and does not specifically state that the
person administering the drug must have obtained the
antagonist themselves from the opioid prevention and
treatment training program. Thus, a casual observer, or
fellow untrained drug user could be acting as the good
samaritan and potentially qualify for the immunities
provided by this bill.
At the time of the injection, the antagonist may have
been carried by the drug user for many months, become
contaminated, stored improperly, expired, or otherwise
compromised. Provided that the person injecting the drug
acts with reasonable care, this bill would provide
immunity from civil liability for any damages caused as a
result. That immunity includes damages from a resultant
infection, assault or battery, or even death caused by
improper administration. Although supporters emphasize
that the antagonist is innocuous if there are no opioids
in the body, the antagonist must still be injected,
potentially opening the body to infection or causing
serious blood loss due to the puncturing of an artery.
Some may argue that injecting an individual under
circumstances that would lead to those injuries would not
constitute reasonable care, but if the individual
injecting the antagonist is untrained, and acting in good
faith, it may be difficult to prove a lack of
reasonableness as to that person.
Despite those prior concerns, the third-party immunity
proposed by this bill differs in several significant ways that
act to partially address the previous concerns about the
stricken provision of SB 767.
First, the proposed immunity only applies to individuals who
have been trained - casual observers or untrained drug users
would not be covered. Second, the civil immunity provision is
narrowed to only cover liability for violations of a
professional licensing statute. Lastly, the provision
providing immunity from criminal prosecution is limited to
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circumstances "arising from or related to the unauthorized
practice of medicine or the possession of an opioid antidote."
Although the limitation on criminal prosecution could still
prevent charges for assault, battery, and other crimes arising
out the administration of naloxone, the requirement that the
person actually be trained and act in good faith would appear
to preclude a successful criminal prosecution in most of those
cases.
Supporters assert that the proposed immunity is intended to
allow for the distribution of naloxone to trained individuals
working in environments where the employee may encounter an
overdosing individual. For example, volunteers at a shelter
with a high number of opiate addicts may desire to have
naloxone on-site so as to provide emergency response to any
individual who shows signs of an overdose. If trained
pursuant to a qualifying program, those volunteers could
qualify for immunity from any professional licensing statute
or from criminal prosecution relating to the unauthorized
practice of medicine or possession of naloxone (a prescription
drug for which they may not have a prescription). Unlike the
third party immunity stricken from SB 767, this provision
would not confer a blanket civil immunity on those third party
administrators.
Provided that new immunity is subject to a sunset and report,
the addition of that immunity would appear to permit the
proponents of this measure to extend their naloxone
distribution program (arguably saving an unknown number of
lives), while providing the Legislature with the opportunity
to reexamine the immunity (and any unintended consequences)
after several years of use.
b. Removing restriction to seven specific counties
As part of the compromise amendments accepted in this
Committee in 2007, SB 767's application was narrowed to only
seven counties (Alameda, Fresno, Humboldt, Los Angeles,
Mendocino, San Francisco, and Santa Cruz). That limitation
permitted the proposed immunity to be tested out by counties
that, at the time, appeared interested in implementing the
pilot. Each of those counties was required to submit a report
containing specified information about their program to this
Committee.
In addition to adding the immunity described in Comment 2(a),
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the bill would expand the pilot statewide by removing the
language limiting the bill to those seven counties. Given
that only two of those seven counties actually participated in
the pilot project, and that no additional counties have
submitted a request to participate in the pilot, the Committee
should consider amending the bill to re-insert the limitation
to seven counties.
SHOULD THE BILL BE LIMITED TO THE ORIGINAL SEVEN COUNTIES?
3. Reported information
SB 767 required each local health jurisdiction that operates an
opioid overdose prevention and training program to report to the
Senate and Assembly Committees on Judiciary regarding the: (1)
number of training programs operating in the local health
Jurisdiction; (2) number of individuals who have received a
prescription for, and training to administer, an opioid
antagonist; (3) number of opioid antagonist doses prescribed;
(4) Number of opioid antagonist doses administered; (5) number
of individuals who received opioid antagonist injections who
were properly revived; (6) number of individuals who received
opioid antagonist injections who were not revived; and (7)
Number of adverse events associated with an opioid antagonist
dose that was distributed as part of an opioid overdose
prevention and treatment training program, including a
description of the adverse events.
Although seven counties were authorized to participate in the
pilot project, the Committee only received reports from programs
in Los Angeles and San Francisco counties. The Harm Reduction
Coalition notes that "[a]lthough there are opioid overdose
prevention projects that are privately funded in at least 5
other California counties, since the bill did not specify with
whom or how to register such programs, we believe there is only
reporting data from these two counties." Consistent with that
observation, SB 767's immunity and reporting requirements only
applied to an "opioid overdose prevention and treatment training
program" that is either operated or registered by a local health
jurisdiction. Street Outreach Supporters, in support, further
notes that although Santa Cruz was named in SB 767, the "only
organization that was in a position to set up such a program,
the Santa Cruz AIDS Project (SCAP), turned down several
proposals, quoting liability concerns."
Regarding how the program worked in Los Angeles County, Homeless
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Health Care Los Angeles (HHCLA) and Common Ground The Westside
HIV Community Center's combined report stated:
The results of the pilot overdose prevention programs are
promising. In the approximately three years since the
implementation of the first overdose prevention program in
Los Angeles, HHCLA and Common Ground have trained 273
clients and 57 agency staff or service providers to
appropriately recognize and respond to opioid overdoses.
The 272 clients reported responding to a total of 82
overdoses during that same period, and reported that at
least 71/82 (93%) of those overdose victims were known to
have survived.
Among those overdoses that were not successfully reversed,
all were reported in the first two years of the program. .
. . In most of the reported unsuccessful reversals, it
appears that the overdose victims were already dead at the
time that the responder attempted to assist. Few adverse
events were reported; those that were reported (e.g.,
vomiting, anger at experiencing withdrawal symptoms upon
revival) are within the scope of expected effects of an
opioid overdose and naloxone administration, did not cause
lasting morbidity, and were trivial in nature compared to
death as a likely alternate outcome. The small trial
program has demonstrated that naloxone can be successfully
distributed to injection drug users and their peers in Los
Angeles with minimal unintended consequences and
considerable evidence that the naloxone is being used to
save lives.
The program appeared to have similar success in San Francisco
where the Drug Overdose Prevention and Education (DOPE) Project
reported that a total of 749 individuals were trained and
prescribed naloxone (a total of 1,498 individual doses were
prescribed). The DOPE Project reports that "[a] total of 193
individual doses of naloxone were administered during the 156
overdose reversal events reported by trained participants. More
than one dose of naloxone was administered in 51 (33%) of
overdose reversal events." Of those 156 events, DOPE Project
participants reported a total of 153 successful reversals - only
three instances were unsuccessful. The DOPE Project further
reported that:
No adverse events were reported outside the normal range of
symptoms that a person will experience upon receiving an
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opioid antagonist. Twenty-two people reported that the
overdose victim vomited upon waking, which is included in
the normal range of effects of precipitated opioid
withdrawal. Three participants reported that the overdose
victim was angry after being revived due to experiencing
opioid withdrawal symptoms. Other negative consequences of
the overdose revival included police and EMS harassment,
being evicted from the SRO room and arrest - none of which
are attributed to receiving naloxone.
4. Removal of sunset and report
This bill would further strike the existing sunset date and its
associated reporting requirement. Considering that the original
program was only implemented three years ago, and considering
the risk of potentially serious consequences for the qualified
immunities contained within the bill, the Committee should
consider amending the bill to include a five-year sunset, and a
report from any local health jurisdiction in the seven counties
that implement a program pursuant to its provisions.
From a policy standpoint, that extended sunset and report will
allow the pilot program to proceed while providing the
Legislature an additional opportunity to both evaluate its
effectiveness and address any issues that arise during over the
next five years.
SHOULD THE BILL INCLUDE A FIVE YEAR SUNSET AND REQUIRE A REPORT
TO BE SUBMITTED BY EACH LOCAL HEALTH JURISDICTION WHICH
PARTICIPATES IN THE PROGRAM?
5. Technical amendments
The following amendments are suggested to replace references to
"opioid antidote" with "opioid antagonist" in order to conform
the provisions added by AB 2145 to the existing language added
by SB 767.
Suggested technical amendments:
1) On page 3, line 9, strike out "antidote" and insert:
antagonist
2) On page 3, line 17, strike out "antidote" and insert:
antagonist
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Support : AIDS Community Research Consortium; Desert AIDS
Project; California Association of Alcohol and Drug Program
Executives; California Medical Association; California Public
Defenders Association; City and County of San Francisco;
Coalition on Homelessness, San Francisco; County Alcohol and
Drug Administrators of California; Drug Policy Alliance; Health
Officers Association of California (HOAC); Homeless Health Care
Los Angeles; Street Outreach Supporters; Los Angeles County
Board of Supervisors; San Francisco AIDS Foundation
Opposition : None Known
HISTORY
Source : Harm Reduction Coalition
Related Pending Legislation : None Known
Prior Legislation : See Background.
Prior Vote :
Assembly Judiciary Committee (Ayes 9, Noes 0)
Assembly Appropriations Committee (Ayes 17, Noes 0)
Assembly Floor (Ayes 74, Noes 1)
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