BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Noreen Evans, Chair
2013-2014 Regular Session
AB 635 (Ammiano)
As Amended April 11, 2013
Hearing Date: June 18, 2013
Fiscal: No
Urgency: No
RD
SUBJECT
Drug Overdose Treatment: Liability
DESCRIPTION
Existing law establishes a seven county pilot program, until
January 1, 2016, which provides a qualified immunity to licensed
health care providers who prescribe naloxone (a prescription
drug to counteract an opiate overdose), and to unlicensed
trained persons that administer naloxone in emergency situations
where they believe, in good faith, that the other person is
experiencing a drug overdose.
This bill would expand the pilot program by removing the sunset,
removing the restriction to only seven counties, authorizing
licensed health care providers to also prescribe naloxone to
third parties (family members, friends, or other persons in a
position to assist a person at risk of an opioid-related
overdose), as well as to issue standing orders for the
distribution and/or administration of naloxone. This bill would
also amend the program's limited liability provisions to instead
confer:
qualified immunity from civil liability, criminal prosecution,
or professional review to licensed health care providers who
issue prescriptions or standing orders pursuant to the
program; and
immunity from civil action or criminal prosecution, or
professional review, to any persons who possess or distribute
naloxone pursuant to a prescription or standing order, or
acting with reasonable care in administering naloxone, as
specified.
(more)
AB 635 (Ammiano)
PageB of?
This bill would also require that person who is prescribed
naloxone or possesses it pursuant to a standing order receive
training, as defined.
BACKGROUND
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
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.
AB 635 (Ammiano)
PageC of?
In 2007, in order to facilitate the prescription of naloxone to
trained individuals in California, SB 767 (Ridley-Thomas, Ch.
477, Stats. 2007) established a seven county pilot program
through January 1, 2010, 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, train individuals for how to
recognize and respond to an opiate overdose. AB 2145 (Ammiano,
Ch. 545, Stats. 2010) has since extended the sunset date for the
program to January 1, 2016, extended the deadline for the
reporting requirements to January 1, 2015, and added a new
qualified immunity for unlicensed trained persons who administer
an opioid antidote in emergency situations where they believe,
in good faith, that the other person is experiencing a drug
overdose.
This bill would expand this program statewide, delete the sunset
and the reporting requirements, and, among other things, modify
the limited liability provisions for both licensed health care
professionals who prescribe, dispense or distribute naloxone, as
well as unlicensed persons who act with reasonable care to
administer naloxone to a person is experiencing or is suspected
to be experiencing an overdose.
CHANGES TO EXISTING LAW
Existing law , the California Uniform Controlled Substances Act,
strictly regulates the distribution of controlled substances
within California. (Health & Saf. Code Sec. 11000 et seq.)
Existing law prohibits the prescription, administration, or
dispensing of a controlled substance to an addict, except under
certain circumstances. (Health & Saf. Code Sec. 11156; Bus. &
Prof. Code Sec. 2241.)
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 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 applies to the licensed health care provider even when
the opioid antagonist is administered by and to someone other
AB 635 (Ammiano)
PageD of?
than the person to whom it is prescribed. (Civ. Code Sec.
1714.22(b).)
Existing law permits a person who is not otherwise licensed to
administer an opioid antagonist to administer an opioid
antagonist in an emergency without fee if the person has
received the training information as specified and believes in
good faith that the other person is experiencing a drug
overdose. 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
arising from or related to the unauthorized practice of medicine
or the possession of an opioid antagonist. (Civ. Code Sec.
1714.22(c).)
Existing law requires that each local health jurisdiction that
operates or registers an opioid overdose prevention and
treatment training program, by January 1, 2015, collect, and
report to the Senate and Assembly Judiciary Committees,
specified data on programs within the jurisdiction, including,
among other things: the number of opioid antagonist doses
prescribed, the number of opioid antagonist doses administered,
the number of individuals who received opioid antagonist
injections who were properly revived and the number who were not
revived, as well as the 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(d).)
Existing law limits the application of this law to the Counties
of Alameda, Fresno, Humboldt, Los Angeles, Mendocino, San
Francisco, and Santa Cruz and includes a January 1, 2016 sunset.
(Civ. Code Sec. 1714.22(e)-(f).)
Existing law defines for these purposes "opioid antagonist" and
"opioid overdose prevention and treatment training program."
(Civ. Code Sec. 1714.22(a).)
This bill would remove the restriction to the counties above and
repeal the sunset date.
This bill would authorize a licensed health care provider who is
authorized by law to prescribe an opioid antagonist to, if
acting with reasonable care, prescribe and subsequently dispense
or distribute an opioid antagonist to a person at risk of an
opioid-related overdose or to a family member, friend, or other
AB 635 (Ammiano)
PageE of?
person in a position to assist a person at risk of an
opioid-related overdose.
This bill would permit a licensed health care provider who is
authorized by law to prescribe an opioid antagonist to issue
standing orders 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; and
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 a person experiencing or
reasonably suspected of experiencing an opioid overdose.
This bill would provide that a licensed health care provider who
acts with reasonable care shall not be subject to professional
review, found liable in a civil action, or be subject to
criminal prosecution for issuing a prescription or standing
order pursuant to the bill.
This bill would provide that, notwithstanding any other law, a
person who possesses or distributes an opioid antagonist
pursuant to a prescription or standing order shall not be
subject to professional review, be found liable in a civil
action, or be subject to criminal prosecution for this
possession or distribution.
This bill would provide that, notwithstanding any other law, a
person who acts with reasonable care and administers an opioid
antagonist to a person who is experiencing or is suspected of
experiencing an overdose shall not be subject to professional
review, be liable in a civil action, or be subject to criminal
prosecution for this administration.
This bill would require that a person who is prescribed an
opioid antagonist or possesses it pursuant to a standing order
shall receive the training provided by an opioid overdose
prevention and treatment training program.
COMMENT
1. Stated need for the bill
According to the author:
AB 635 (Ammiano)
PageF of?
Drug overdoses are now the leading cause of injury death in
the United States, surpassing motor vehicle crash deaths.
According to the most recent data released by the Centers for
Disease Control and Prevention [(CDC)], there were 37,000 drug
overdose deaths in the United States in 2009. In 2008, the
most recent year data is available, there were 4,334 drug
poisoning deaths in California. Counties experiencing the
highest numbers of overdose deaths are: Alameda, Fresno, Kern,
Los Angeles, Orange, Riverside, Sacramento, San Bernardino,
San Diego, San Francisco, and Santa Clara Counties.
According to the CDC, in 2009, 28,754 (91 percent) of all
unintentional poisoning deaths were caused by drugs. The
class of drugs known as prescription opioids, which includes
such drugs as methadone, hydrocodone (Vicodin), and oxycodone
(Oxycontin), was most commonly involved, followed by cocaine
and heroin. Drug poisoning is the leading cause of injury
death in California and its effects are felt throughout all
sectors of the state.
When a person overdoses on opioids he/she experiences
depression of the central nervous system and is in danger of
dying because the opioids slow down, and eventually stop, the
person's breathing. Naloxone (also known as Narcan) is
routinely used in hospitals and by paramedics in the field to
revive individuals who are suspected to be overdosing on
opioids.
In California, overdose prevention programs operate in a
handful of cities and counties, but have limited reach in
terms of addressing the overdose issue statewide. Both SB 767
[(Ridley-Thomas, Ch. 477, Stats. 2007)] and AB 2145 [(Ammiano,
Ch. 545, Stats. 2010)] only covered the [c]ounties of 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 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
they are now considered 'best practice' components of high
quality programs that focus on the health of drug users.
AB 635 (Ammiano)
PageG of?
AB 635 safely expands the availability and distribution of
this life-saving drug. [ . . . ]
2. Pilot program reports demonstrate naloxone can be safely
administered by trained lay persons and save a significant
number of lives
To reduce rates of fatal opioid exposure, naloxone, a
nonscheduled prescription drug has been distributed as part of
an emergency kit for opiate abusers in various cities, as
victims of opioid overdoses may be unconscious, incapacitated,
or otherwise unable to inject themselves. As noted in the
Background, since 2007, seven California counties have been
authorized by law to operate a pilot program to allow licensed
health care providers to prescribe, dispense, or distribute
naloxone even where they know that the opioid antagonist will be
administered by and to some other than the person to whom it is
prescribed.
Pursuant to AB 2145, the author has submitted copies of reports
submitted by Los Angeles, San Francisco, Santa Cruz, Humboldt,
and Alameda in 2011 (Fresno and Mendocino have not had funds for
these programs since 2009 and therefore did not have data to
report). Overall, those reports tend to demonstrate that when
used, in most cases, lives were saved. Many of the reports
echoed that where the drug did not work, it's suspected that the
person was already dead when it was administered. The adverse
effects noted in these reports involved anger or vomiting, which
are considered to be within the "normal range" of adverse
outcomes, though the side effects can also include seizures.
More specifically, a summary of the reports provided by the
author demonstrates that in 2011:
In two Alameda County programs, naloxone was prescribed and
distributed to 225 individuals, 65 overdose treatments with
naloxone were reported, and 64 people were successfully
revived. Adverse events, such as anger, vomiting, confusion,
were minor and associated with the rapid withdrawal caused by
naloxone.
In the one Humboldt County program, naloxone was prescribed
and distributed to 13 trained clients in 2011, four overdose
interventions were reported, and all four people were revived.
No adverse events were reported.
Between the three Los Angeles County programs, naloxone was
prescribed and distributed to 199 individuals in 2011, 42
AB 635 (Ammiano)
PageH of?
overdose treatments with naloxone were reported, with 41
people successfully revived. The only adverse event reported
was anger in one case, associated with the rapid withdrawal
caused by naloxone.
In the San Francisco County program, overdose prevention
education and naloxone were provided to 1135 individuals
between January 2010 and December 2011. Additionally, 680
previously-trained individuals returned for refills. During
2010-2011, 185 individuals reported using their naloxone
and/or the skills learned in the training program to revive an
overdosing person, and 182 were successful revived. No
adverse events occurred outside of anger.
In the Santa Cruz County program, training and distribution of
naloxone was provided to 100 individuals and 10 overdose
reversals using naloxone were reported, all of which were
successful and had no adverse outcomes.
Of note, the author and sponsor point out that the Center for
Disease Control and Prevention reports that drug overdoses are
now the leading cause of injury (i.e. accidental) death in the
U.S., surpassing motor vehicle crash deaths, and this bill could
help reduce those deaths. In support of the bill, the
California Opioid Maintenance Providers writes that this bill
would help "address needless overdose deaths that occur when
either a person at risk of overdose or a friend or family member
of such a person does not have access to the medications that
can reverse the symptoms of overdose known as opioid
antagonists. Multiple studies of overdose have shown that death
rarely occurs immediately from a drug related overdose, and most
deaths occur 1 to 3 hours after the initial dose of drugs. Many
overdoses are reversible if the individual gets medical
assistance in time." (Footnote citation omitted.)
Accordingly, this bill seeks to expand the access and
distribution of to this life-saving treatment by removing the
limitation of the current pilot program to those seven counties
and by permitting a licensed health care provider who is
authorized by law to prescribe an opioid antagonist to, if
acting with reasonable care, prescribe and subsequently dispense
or distribute 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. In furtherance of that same goal, this
bill would authorize a licensed health care provider to issue
AB 635 (Ammiano)
PageI of?
standing orders<1> for the distribution and administration of an
opioid antagonist to any of those persons, in order to assist a
person at risk of an opioid-related overdose, or who is
experiencing or is reasonably suspected to be experiencing an
opioid overdose.
3. Limited liability provisions reduce the ability of an
injured party to seek recovery and should therefore operate to
serve important public policy in a measured fashion
The existing pilot program provides a qualified immunity from
civil liability and criminal prosecution to licensed health care
providers who prescribe naloxone even when the opioid antagonist
is administered by and to someone other than the person to whom
it is prescribed, and to persons who administer the opioid
antagonist in an emergency to another person who they believe in
good faith to be experiencing an overdose. In order to
increase the use of naloxone in emergency situations, this bill
not only expands the explicit authorization for licensed health
care providers to issue prescriptions and standing orders for
naloxone, but it also seeks to remove barriers in the
prescription, dispensing of, distribution, or administration of
this drug by providing certain immunities for both licensed
health care professionals and persons possessing, distributing,
or administering the drug.
Specifically, to reduce the hesitation of physicians or other
licensed health care providers in prescribing naloxone, this
bill would provide 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 in accordance with this bill. As acknowledged by the
author, even in doing so, this bill will not prohibit a health
care provider from being sued for negligence.
Additionally, this bill seeks to reduce concerns of third
parties (family members or friends) who fear lawsuits, criminal
---------------------------
<1> Standing orders, which include protocols, generally
prescribe the action to be taken in caring for a patient with a
certain condition, including the dosage and route of
administration for a drug or the schedule for the administration
of a therapeutic procedure. The important characteristic of a
standing order is that all the patients who meet the criteria
for the order receive the same treatment.
AB 635 (Ammiano)
PageJ of?
prosecution or being made subject to professional review for
administering this medication or simply being in possession of
this drug, by providing that notwithstanding any other law: (1)
a person who possesses or distributes an opioid antagonist
pursuant to a prescription or standing order shall not be
subject to professional review, be found liable in a civil
action, or be subject to criminal prosecution for this
possession or distribution; and (2) a person who acts with
reasonable care and administers an opioid antagonist to a person
who is experiencing or is suspected of experiencing an overdose
shall not be subject to professional review, be liable in a
civil action, or be subject to criminal prosecution for this
administration.
As a general rule, California law provides that everyone is
responsible, not only for the result of his or her willful acts,
but also for an injury occasioned to another by his or her want
of ordinary care or skill in the management of his or her
property or person, except so far as the latter has, willfully
or by want of ordinary care, brought the injury upon himself or
herself. (Civ. Code Sec. 1714(a).) Although immunity
provisions are rarely preferable because they, by their nature,
prevent an injured party from seeking a particular type of
recovery, the Legislature has in limited scenarios approved
measured immunity from liability (as opposed to blanket
immunities) to promote other policy goals that could benefit the
public.
a. This bill arguably promotes a policy goal of providing
emergency treatment in a safe and reasonable manner to save
lives .
The California Attorneys for Criminal Justice, in support of
this bill, writes that "many drug-related overdose deaths are
caused by the attempt to avoid penalties. Deterrence policies
that penalize California citizens for accessing medical
services in the event of an emergency drug overdose show
little to no effectiveness at reducing drug use. Furthermore,
the costs of these deaths to the people of California far
outweigh any policy benefit of reduced drug use. AB 635 would
facilitate the ability of licensed professionals to provide
aid to those who are in danger of opioid overdose without fear
of reprisal for themselves or for those receiving that help."
Proponents of this bill also note that:
AB 635 (Ammiano)
PageK of?
The state's longest-running naloxone prescription program
in San Francisco has provided over 3600 take-home naloxone
prescriptions since 2003 through collaboration with the San
Francisco Department of Public Health, using a "standing
order" model with over 900 lives saved. In addition,
prescribers at SFDPH public health clinics are
co-prescribing naloxone with prescription opioids to their
patients. However, many licensed health care practitioners
still fear prescribing take-home opioid antagonists to
their patients because of potential civil and criminal
liability.
As a matter of public policy, given the information submitted
to the Committee, that generally demonstrates that opioid
antagonists such as naloxone can be safely administered by
trained individuals with substantial success and relatively
few and comparatively minor adverse outcomes for individuals
receiving the drug, the expansion of this program arguably
appears justified. To the extent that qualified immunity
provisions may help foster the growth of such programs and
practices, this bill could feasibly help reduce the number of
unnecessary drug overdoses in this state, as noted by many of
the proponents of this bill. As commented by the California
Public Defenders Association, writing in support of the bill:
"[t]his bill recognizes that an individual who is potentially
overdosing on an opioid substance should have the greatest
possible access to an opioid antagonist that may possibly save
that person's life."
Thus, the question necessarily becomes whether the proposed
immunity provisions would appropriately balance the public
policy of saving lives where there is a reasonable method of
providing assistance against the ability for an injured person
to seek recourse for injuries sustained as a result of the
administration of naloxone. (See Comment 3b below for further
discussion).
b. Amendments to ensure the immunity provisions are measured
As noted above, despite the general disfavoring of immunity
provisions for the reasons stated above, where there is a
generally safe, reliable, and easily administrable treatment
that can prevent unnecessary death, as a matter of public
policy, it may be appropriate to confer a limited immunity as
AB 635 (Ammiano)
PageL of?
a way of encouraging the provision of a potentially
life-saving treatment. At the same time, qualified immunity,
as opposed to blanket immunity, is preferable to ensure a
party injured in the provision of this care can seek recourse
in the courts in appropriate circumstances.
Staff notes that this type of qualified immunity is not
without precedent under California law. For example, there is
a comparable California statute under existing law relating to
automatic external defibrillators (AEDs), whereby this state
encourages the provision of emergency care with a reduced risk
of civil liability, in order to avoid preventable deaths. In
the AED context, however, the qualified immunity does not
apply in the case of personal injury or wrongful death which
results from the gross negligence or willful or wanton
misconduct by the person who uses the AED to render emergency
care. (See Civ. Code Sec. 1714.21.)
Earlier this year, this Committee heard and approved a bill,
SB 669 (Huff), which sought to promote a wider use of
epinephrine auto injectors (commonly referred to as epi-pens)
to persons suffering anaphylactic shock due to an allergic
reaction, which can quickly lead to death without treatment.
To do so, that bill would have, among other things, provided
immunity to any trained lay person who administers, in good
faith, and without compensation, epinephrine auto injectors to
another person in emergency situations. As amended in this
Committee, that bill now mirrors the AED statutes to make the
limited liability inapplicable where there was gross
negligence or willful or wanton misconduct by the person
rendering the emergency care.
Arguably, because this bill seeks to encourage the rendering
of emergency care in similar fashion (using naloxone as
opposed to an epinephrine auto-injector or an AED), the scope
of the immunity should also apply in similar fashion as well.
Although the limited liability provisions of this bill have
been drafted differently from the AED statute, the outcome
would arguably be the same in that the licensed care provider
must have acted with reasonable care in prescribing the opioid
antagonist or issuing a standing order for it, and that the
person administering the opioid antagonist must also have
acted reasonably.
That being said, as currently written, the bill is missing two
AB 635 (Ammiano)
PageM of?
of the elements in the qualified immunity provisions of the
AED statute and similar legislation passed out of this
Committee-namely, (1) that the unlicensed person was trained
and acted in compliance with that training, and (2) that the
emergency care was rendered in good faith, and not for
compensation (i.e. ensuring against application to, for
example, an emergency medical technician in the performance of
his or her job). Those elements are currently reflected in
the qualified immunity provision of the existing pilot
program. The following amendments would achieve consistency in
law and also make a clarifying amendment:
Suggested amendment:
On page 4, line 5, strike "Notwithstanding any other law," and
strike lines 7-10 inclusive.
On page 4, line 5, after period insert "Notwithstanding any
other law, a
person not otherwise licensed to administer an opioid
antagonist, but trained as required under subdivision (d), who
acts with reasonable care in administering an opioid
antagonist, in good faith and not for compensation, to a
person who is experiencing or is suspected of experiencing an
overdose shall not be subject to professional review, be
liable in a civil action, or be subject to criminal
prosecution for this administration."
On page 3, line 37 and on page 4, line 3, strike "found"
Support : Berkeley Needle Exchange Emergency Distribution;
California Attorneys for Criminal Justice; California
Association of Alcohol and Drug Program Executives, Inc.
(CAADPE); California Opioid Maintenance Providers; California
Public Defenders Association; Civil Justice Association of
California (CJAC); City and County of San Francisco; Common
Ground, the Westside HIV Community Center; County Alcohol and
Drug Program Administrators Association of California (CADPAAC);
Drug Policy Alliance (DPA); Harm Reduction Therapy Center;
Homeless Health Care Los Angeles; Medical Board of California;
National Coalition Against Prescription Drug Abuse; San
Francisco Drug Users Union; Shasta Community Health Center; one
individual
AB 635 (Ammiano)
PageN of?
Opposition : None Known
HISTORY
Source : California Society of Addiction Medicine; Harm
Reduction Coalition
Related Pending Legislation : SB 669 (Huff) See Comment 3.
Prior Legislation :
AB 2145 (Ammiano, Ch. 545, Stats. 2010) See Background.
AB 767 (Ridley-Thomas, Ch. 477, Stats. 2007) See Background.
Prior Vote :
Assembly Floor (Ayes 77, Noes 0)
Assembly Judiciary Committee (Ayes 8, Noes 0)
**************