BILL ANALYSIS Ó
AB 635
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 635 (Ammiano)
As Amended August 22, 2013
Majority vote
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|ASSEMBLY: |77-0 |(April 15, |SENATE: |36-0 |(September 6, |
| | |2013) | | |2013) |
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Original Committee Reference: JUD.
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,
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
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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)Requires a person who is prescribed or possesses an opioid
antagonist pursuant to a standing order to receive the
training provided by an opioid overdose prevention and
treatment training program, except that this does not apply to
a person who is prescribed an opioid antagonist directly from
a licensed prescriber.
7)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.
8)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.
The Senate amendments revise the qualified immunity provisions
for administration of an opioid antagonist, to provide that the
immunity applies to a person not otherwise licensed to
administer an opioid antagonist, but who has received the
required training and who acts with reasonable care, in good
faith and not for compensation. In addition, they clarify that
a person who is prescribed an opioid antagonist directly from a
licensed prescriber shall not be required to receive training
from an opioid prevention and treatment training program.
FISCAL EFFECT : None
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 pilot authority, however, is
currently limited to health care providers in only seven
counties and is 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
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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.
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.
This bill would eliminate the pilot status of the naloxone
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 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. In short,
proponents of this bill contend that 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.
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. They also report that county health workers who
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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.
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 or she 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.
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 or her 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
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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
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.
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. At the same time, this bill
requires a person who is prescribed or possesses an opioid
antagonist pursuant to a standing order to receive the training
provided by an opioid overdose prevention and treatment training
program, except that this does not apply to a person who is
prescribed an opioid antagonist directly from a licensed
prescriber. Finally, with respect to the administration of
naloxone, the bill limits civil and criminal liability for a
person not otherwise licensed to administer an opioid
antagonist, but who has received the required training and who
acts with reasonable care in administering an opioid antagonist,
in good faith and not for compensation, to someone who is
experiencing or is suspected of experiencing an overdose.
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
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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.
Analysis Prepared by : Anthony Lew / JUD. / (916) 319-2334
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