BILL ANALYSIS �
AB 635
Page 1
Date of Hearing: April 2, 2013
ASSEMBLY COMMITTEE ON JUDICIARY
Bob Wieckowski, Chair
AB 635 (Ammiano) - As Introduced: February 20, 2013
SUBJECT : DRUG OVERDOSE TREATMENT: LIABILITY
KEY ISSUES :
1)SHOULD THE EXISTING PILOT PROGRAM FOR OPIOID ANTAGONIST
TREATMENT OF DRUG OVERDOSE, WHICH PROVIDES CONDITIONAL
AUTHORITY TO LICENSED HEALTH CARE PROVIDERS TO PRESCRIBE AND
DISTRIBUTE AN OPIOID ANTAGONIST WITHOUT CIVIL OR CRIMINAL
LIABILITY, BE EXPANDED STATEWIDE AND NO LONGER BE SUBJECT TO A
SUNSET DATE?
2)SHOULD SPECIFIED IMMUNITY FROM CIVIL AND CRIMINAL PENALTIES BE
EXTENDED TO A PERSON WHO ACTS WITH REASONABLE CARE AND
ADMINISTERS AN OPIOID ANTAGONIST IN AN EMERGENCY TO PREVENT
THE POSSIBLE DRUG OVERDOSE OF ANOTHER PERSON?
FISCAL EFFECT : As currently in print this bill is keyed
non-fiscal.
SYNOPSIS
Current law authorizes licensed health care providers to
prescribe and distribute opioid antagonists for emergency
treatment of drug overdose, if done in conjunction with a local
overdose prevention program, without being subject to civil
liability or criminal prosecution. This authority, however, is
currently limited to health care providers in only seven
counties and is set to expire in 2016, pursuant to a pilot
program established by SB 767 of 2007. This bill, co-sponsored
by Harm Reduction Coalition and the California Society of
Addiction Medicine, seeks to expand this authority statewide and
remove the 2016 sunset date. These proponents contend that
recent SB 767 pilot project data demonstrate that naloxone
prescription is safe and effective in preventing fatal overdoses
without producing significant adverse events, thus justifying
removal of the sunset date and pilot program status.
Among other things, this bill would allow health care providers
to independently prescribe or issue standing orders for the
AB 635
Page 2
distribution or administration of naloxone, as specified,
without requiring such acts to be in conjunction with a local
prevention program. This bill provides that a licensed health
care provider who acts with reasonable care shall not be subject
to professional review, be found liable in a civil action, or be
subject to criminal prosecution for issuing a prescription or
standing order if he or she complies with the standards set
forth by this bill. In addition, this bill limits liability for
any person who possesses or distributes naloxone if it was done
pursuant to a prescription or standing order, and limits
liability for a person who administers naloxone if the person
acts with reasonable care and only administers the drug to
someone who is experiencing or is suspected of experiencing an
opioid overdose. The bill is also supported by the Civil
Justice Association, defense attorneys, and public defenders,
and has no known opposition.
SUMMARY : Revises provisions from the current pilot program
authorizing prescription of opioid antagonists for treatment of
drug overdose and limiting civil and criminal liability, expands
these provisions statewide, and removes the 2016 sunset date.
Specifically, this bill :
1)Permits a licensed health care provider who is authorized by
law to prescribe an opioid antagonist, if acting with
reasonable care, to prescribe and subsequently dispense or
distribute an opioid antagonist to a person at risk of an
opioid-related overdose or a family member, friend, or other
person in a position to assist a person at risk of an
opioid-related overdose.
2)Permits the 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, or to a family member,
friend, or other person in a position to assist a person at
risk of an opioid-related overdose.
3)Permits the licensed health care provider to issue a standing
order for the administration 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.
4)Provides that a licensed health care provider who acts with
reasonable care shall not be subject to professional review,
AB 635
Page 3
be found liable in a civil action, or be subject to criminal
prosecution for issuing a prescription or standing order.
5)Provides that any person who possesses or distributes an
opioid antagonist pursuant to a prescription or standing
order, or any person who acts with reasonable care in
administering an opioid antagonist to a person experiencing an
overdose, shall not be subject to professional review, be
found liable in a civil action, or be subject to criminal
prosecution for that act.
6)Deletes provisions restricting the scope of these provisions
to seven pilot counties and establishing a 2016 sunset date,
extending these provisions indefinitely and expanding
authority for the program statewide.
7)Deletes the requirement that each local health jurisdiction
that operates or registers an opioid overdose prevention and
treatment training program must report specified data by
January 1, 2015 to the Senate and Assembly Judiciary
Committees.
EXISTING LAW :
1)Defines "opioid overdose prevention and treatment training
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). Unless otherwise stated, all further
references are to that code.)
2)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.
Further provides that 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
AB 635
Page 4
whom it is prescribed. (Section 1714.22(b).)
3)Provides that a person who is not otherwise licensed to
administer an opioid antagonist may administer it in an
emergency without fee if the person has received specified
training information and believes in good faith that the other
person is experiencing a drug overdose, and shall not as a
result of doing so be subject to civil liability for a
violation of any professional licensing statute, or subject to
any criminal prosecution arising from or related to the
unauthorized practice of medicine or the possession of an
opioid antagonist. (Section 1714.22(c).)
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. (Section 1714.22(d).)
5)Restricts application of these provisions only to the Counties
of Alameda, Fresno, Humboldt, Los Angeles, Mendocino, San
Francisco, and Santa Cruz. (Section 1714.22(e).)
6)Provides that the pilot authority for opioid antagonist
treatment with limited immunity from liability shall remain in
effect only until January 1, 2016, and as of that date is
repealed, unless a later enacted statute, that is enacted on
or before January 1, 2016, deletes or extends that date.
(Section 1714.22(f).)
7)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 : Current law authorizes licensed health care providers
to prescribe and distribute opioid antagonists for emergency
treatment of drug overdose, if done in conjunction with an
overdose prevention and treatment training program ("overdose
prevention program"), without being subject to civil liability
or criminal prosecution. This authority, however, is currently
limited to health care providers in only seven counties and is
AB 635
Page 5
set to expire in 2016. This bill, co-sponsored by Harm
Reduction Coalition and the California Society of Addiction
Medicine, seeks to expand this authority statewide and remove
the 2016 sunset date. Among other things, this bill would allow
health care providers to independently prescribe or issue
standing orders for the distribution or administration of
naloxone, as specified, but not necessarily in conjunction with
a local overdose prevention program.
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. Naloxone is administered by injection
into a 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.
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
AB 635
Page 6
treated. The drug has no effect on those who haven't taken
opioids.
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. SB 767 designated the counties of Alameda, Fresno,
Humboldt, Los Angeles, Mendocino, San Francisco, and Santa Cruz
as pilot counties because they already had existing overdose
prevention programs in place through their local syringe access
and disposal programs. In 2010, AB 2145 (Ammiano) extended the
sunset to 2016 and extended liability protection to third party
administrators of naloxone.
The Harm Reduction Coalition, a co-sponsor of the bill, reports
that it is working with health advocates in Stanislaus, San
Joaquin, Sacramento, Sonoma, San Diego, Kern, Santa Clara,
Ventura and Orange counties who are either already doing
independent naloxone distribution as part of an overdose
prevention program, or would like to start, as naloxone
distribution is now considered 'best practice' components of
high quality overdose treatment programs. Supporters believe
that the current pilot program, limited as it is to only seven
counties, should be expanded statewide to better address
widespread problems of prescription drug overdose.
This bill would eliminate the SB 767 pilot project and its
associated reporting requirements, extending these provisions
statewide with no sunset date. According to the author and
sponsor, additional data reported by participating pilot
counties since AB 2145 was enacted in 2010 demonstrates that the
project has achieved a high rate of success in preventing
overdose, coupled with the near total lack of any adverse events
associated with administration of naloxone. These reported
figures include the following:
San Francisco: For the 2-year period between January
2010 and December 2011, a total of 1135 individuals
AB 635
Page 7
received overdose prevention education and were
prescribed a total of 2,270 individual doses of naloxone
(2 doses per prescription). A total of 251 individual
doses of naloxone were administered during the 185
overdose events reported by trained individuals. Of
these events, 182 (98%) resulted in a successful overdose
reversal, and in only three cases was the person
experiencing drug overdose not revived after receiving
naloxone. No adverse events were reported outside the
normal range of symptoms associated with receiving
naloxone.
Los Angeles: In 2011, a total of 199 individuals
received overdose prevention education and were
prescribed naloxone. A total of 42 overdose events were
reported by trained individuals. Of these events, 41
(98%) resulted in a successful overdose reversal, and in
only one case was the person not revived after receiving
naloxone. No adverse events were reported outside the
normal range of symptoms associated with receiving
naloxone.
Alameda County: In 2011, a total of 226 individuals
received overdose prevention education and were prescribed
naloxone under the auspices of three separately
administrated programs. A total of 65 overdose events were
reported by trained individuals. Of these events, 64 (98%)
resulted in a successful overdose reversal, and in only one
case was the person not revived after receiving naloxone.
No adverse events were reported outside the normal range of
symptoms associated with receiving naloxone.
Humboldt: In 2011, 13 individuals were trained and
prescribed naloxone through the local program. A total of
four overdose interventions were reported, and all four
resulted in successful revival of the individual receiving
naloxone. No adverse events were reported in those cases.
Santa Cruz: In 2011, 100 individuals were trained and
prescribed naloxone through the local program. A total of
10 overdose interventions were reported, and all 10
resulted in successful revival of the individual receiving
naloxone. No adverse events were reported in those cases.
Programs in Fresno and Mendocino at one time had engaged
AB 635
Page 8
in authorized distribution of naloxone under SB 767, but
neither program has had sufficient funding to continue
dating back to at least 2010, thus no data was reported.
In short, proponents of this bill contend that SB 767 pilot
project data demonstrate that naloxone prescription is safe and
effective in saving lives without producing significant adverse
events, thus justifying removal of the sunset date and pilot
program status.
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 wise 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.
Supporters report that county health workers who operate or who
desire to operate a naloxone prescription program report are
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 any legal protection for a third
party who administrates naloxone.
In order to facilitate statewide application, this bill revises
the authority of health care providers to prescribe naloxone.
For the reasons mentioned above, it is necessary to ensure that
naloxone may be distributed not only to a person at risk of an
overdose, but to others who are in the best position to
intervene and administer naloxone in time to possibly prevent
death. Because naloxone is a prescription medication, a person
must be prescribed the drug in order to obtain it. This bill
permits a licensed health care provider to prescribe and
subsequently dispense or distribute an opioid antagonist to (1)
a person at risk of an opioid-related overdose; or (2) a family
member, friend, or other person in a position to assist a person
at risk of an opioid-related overdose.
AB 635
Page 9
Under existing law, a licensed health care provider may
prescribe naloxone "in conjunction with an opioid overdose
prevention and treatment training program." This bill would
strike that requirement and instead permit the health care
provider to prescribe the drug as long as he acts with
reasonable care and is authorized by law to prescribe an opioid
antagonist. In order for naloxone to be available to
potentially save lives outside the seven pilot counties, the
author recognizes that its prescription cannot be limited to
only those doctors working in conjunction with overdose
prevention programs-particularly when such programs do not exist
in many counties in the state, often because of lack of
financial resources.
The author notes that naloxone is: (1) non-addictive and
regulated at the same level as prescription ibuprofen; (2) has
no effect on a person if opioids are absent in their system; and
(3) can be safely administered by minimally trained laypeople,
as has been demonstrated by data reported through the SB 767
pilot project. In addition, physicians who prescribe
medications already have a professional duty to explain those
medications to their patients and families, including
indications, use, risks and benefits. For these reasons, the
author contends that naloxone prescriptions need not be limited
to only doctors operating in conjunction with a local overdose
prevention program.
Standing orders for naloxone distribution or administration.
This bill also authorizes licensed health care providers to
issue a standing order for the distribution or the
administration of the opioid antagonist to the person at risk,
or his family member, friend or other person in assistance.
Unlike a prescription, which facilitates direct access of the
drug to the person for whose use it is intended, a standing
order is a type of physician's order that allows other health
care workers to exercise the order when certain predetermined
conditions are met.
Under this bill, an authorized physician may issue one of two
kinds of standing orders. The first authorizes naloxone to be
distributed to a person at risk for overdose, or a family
member, friend, or other person in a position to assist in the
case of an overdose. Distribution in this context is a
preventive measure to increase the chance that naloxone will be
available should an overdose event occur. The second type of
AB 635
Page 10
standing order under this bill authorizes naloxone to be
administered (i.e. injected) to help save the life of a person
experiencing or reasonably suspected of experiencing an opioid
overdose.
Limitations on liability. With respect to liability for issuing
a prescription or standing order, this bill provides that a
licensed health care provider who acts with reasonable care
shall not be subject to professional review, be found liable in
a civil action, or be subject to criminal prosecution for
issuing a prescription or standing order if he or she complies
with the standards set forth by this bill. With respect to
liability for possession of naloxone, this bill reasonably
limits liability for any person who possesses or distributes
naloxone if it was done pursuant to a prescription or standing
order. Finally, with respect to the administration of naloxone,
the bill limits civil and criminal liability only if the person
administers the drug to someone who is experiencing or is
suspected of experiencing an overdose, and who acts with
reasonable care.
By limiting liability for naloxone prescription and use strictly
pursuant to a prescription or standing order issued by a
licensed health care professional, this bill seeks to encourage
and enable more health care providers to prescribe naloxone,
where appropriate, to certain patients at risk of opioid
overdose-particularly important in light of evidence of a
substantial epidemic of prescription drug overdoses. In
addition, the author contends, this bill will remove an obstacle
to the creation and expansion of more overdose prevention
programs in California.
REGISTERED SUPPORT / OPPOSITION :
Support
Harm Reduction Coalition (co-sponsor)
California Society of Addiction Medicine (co-sponsor)
California Attorneys for Criminal Justice
California Opioid Maintenance Providers
California Public Defenders Association
Civil Justice Association of California (CJAC)
Opposition
AB 635
Page 11
None on file
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334