BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Hannah-Beth Jackson, Chair
2015-2016 Regular Session
AB 1748 (Mayes)
Version: June 17, 2016
Hearing Date: June 28, 2016
Fiscal: Yes
Urgency: No
RD
SUBJECT
Pupils: pupil health: opioid antagonist
DESCRIPTION
This bill would authorize specified educational agencies to
provide an emergency opioid antagonist to school nurses or
trained personnel and would authorize a school nurse or trained
personnel (volunteers) to administer an opioid antagonist to a
person suffering from an opioid overdose, as specified.
This bill would, for these purposes, provide trained volunteers
with immunity from civil liability, except where there has been
gross negligence or willful or wanton misconduct of the person
rendering the emergency care, and would require that volunteers
be provided defense and indemnification by the school district,
county office of education, or charter school for any and all
civil liability, in accordance with, but not limited to, that
provided in Division 3.6 (commencing with Section 810) of Title
1 of the Government Code, as specified. This bill would also
ensure that an authorizing physician and surgeon shall not be
subject to professional review, be liable in a civil action, or
be subject to criminal prosecution for the issuance of a
prescription or order pursuant to this section, unless the
physician and surgeon's issuance of the prescription or order
constitutes gross negligence or willful or malicious conduct.
BACKGROUND
Opioid overdoses are characterized by central nervous system and
respiratory depression, leading to coma and death. While there
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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.
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) extended the sunset date for the program
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to January 1, 2016, extended the deadline for the reporting
requirements, 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.
Subsequently, in 2013 AB 635 (Ammiano, Ch. 707, Stats. 2013)
expanded this program statewide, deleted the sunset and the
reporting requirements, and, among other things, modified 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 who is experiencing or is
suspected to be experiencing an overdose.
This bill would now expand the use of opioid antagonists into
schools, similar to how the Legislature has previously done in
the context of automatic external defibrillators and epinephrine
auto-injectors. To help encourage and facilitate this emergency
care, the bill would provide qualified immunities to both
trained volunteers and physicians writing prescriptions for use
by schools, as specified.
This bill was heard in the Senate Education Committee on June
15, 2016, and passed out on a vote of 9-0.
CHANGES TO EXISTING LAW
Existing law requires school districts, county offices of
education, and charter schools to provide emergency epinephrine
auto-injectors to school nurses or trained personnel who have
volunteered, as specified, and provides that school nurses or
trained personnel may use epinephrine auto-injectors to provide
emergency medical aid to persons suffering, or reasonably
believed to be suffering, from an anaphylactic reaction.
Existing law provides for the defense and indemnification of any
employees who volunteer under this law, from any and all civil
liability, in accordance with, but not limited to, the
Government Tort Claims Act, as specified. (Ed. Code Sec.
49414(a), (j).)
Existing law provides that an authorizing physician and surgeon
shall not be subject to professional review, be liable in a
civil action, or be subject to criminal prosecution for the
issuance of a prescription or order, for the above purposes,
unless the physician and surgeon's issuance of the prescription
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or order constitutes gross negligence or willful or malicious
conduct. (Ed. Code Sec. 49414(g)(4).)
Existing law authorizes a pharmacy, notwithstanding any other
provision of law, to furnish epinephrine auto-injectors to a
school district, county office of education, or charter school
pursuant to specified law, if:
the auto-injectors are furnished exclusively for use at a
school district site or county office of education; and
a physician and surgeon provides a written order that
specifies the quantity of auto-injectors to be furnished.
(Bus. & Prof. Code Sec. 4119.2(a).)
Existing law requires a school district, county office of
education, or charter school to keep certain records of
epinephrine auto-injectors furnished pursuant to the law, above,
and makes the entities responsible for monitoring the supply of
auto-injectors and ensuring the destruction of expired
auto-injectors. (Bus. & Prof. Code Sec. 4119.2(b).)
Existing law provides that any prehospital emergency medical
care person or lay rescuer who administers an epinephrine
auto-injector, in good faith and not for compensation, to
another person who appears to be experiencing anaphylaxis at the
scene of an emergency situation is not liable for any civil
damages resulting from his or her acts or omissions in
administering the epinephrine auto-injector, if that person has
complied with the requirements and standards of the Health and
Safety Code, as speciifed. This protection from civil liability
does not apply in a case of personal injury or wrongful death
that results from the gross negligence or willful or wanton
misconduct of the person who renders emergency care treatment by
the use of an epinephrine auto-injector. (Civ. Code Sec.
1714.23(b), (c).)
Existing law provides that a person or entity that acquires an
automatic external defibrillator (AED) for emergency use is not
liable for any civil damages resulting from any acts or
omissions when the AED is used to render emergency care,
provided that the person or entity has complied with certain
notice, maintenance, and other reasonable care requirements
under the Health and Safety Code, as specified. (Civ. Code Sec.
1714.21(d)(1).) These requirements include that the person or
entity must:
comply with all regulations governing the placement of an AED;
notify an agent of the local EMS agency of the existence,
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location, and type of AED acquired;
ensure that the AED is maintained and tested according to the
operation and maintenance guidelines set forth by the
manufacturer;
ensure that the AED is tested at least biannually and after
each use;
ensure that an inspection is made of all AEDs on the premises
at least every 90 days for potential issues related to
operability of the device, as specified; and
ensure, when an AED is placed in a building, that at least
once a year a demonstration is made to at least one person
associated with the building so that the person can be walked
through how to use an AED properly in an emergency, and that
instructions are posted next to the AED, as specified, on how
to use the AED. (Health & Saf. Code Sec. 1797.196(b).)
Existing law provides that the qualified immunities described
above do not apply in the case of personal injury or wrongful
death which results from the gross negligence or willful or
wanton misconduct of the person who uses the AED to render
emergency care. (Civ. Code Sec. 1714.21(f).)
Existing law provides that a licensed health care provider who
acts with reasonable care and issues a prescription for, or an
order for the administration of, an opioid antagonist to a
person experiencing or suspected of experiencing an opioid
overdose is not subject to professional review, liable in a
civil action, or subject to criminal prosecution for issuing the
prescription or order. Existing law also provides that a person
who is not otherwise licensed to administer an opioid
antagonist, but who meets certain other conditions, is not
subject to professional review, liable in a civil action, or
subject to criminal prosecution for administering an opioid
antagonist. (Civ. Code Sec. 1714.22(e), (f).) For these
purposes, existing law defines "opioid antagonist" to mean
naloxone hydrochloride that is approved by the federal Food and
Drug Administration for the treatment of an opioid overdose.
(Civ. Code Sec. 1714.22(a)(1).)
This bill would authorize school districts, county offices of
education, and charter schools to provide emergency naloxone
hydrochloride or another opioid antagonist, as defined, to
school nurses or trained personnel and would authorize a school
nurse or trained volunteers to administer naloxone hydrochloride
or another opioid antagonist to provide emergency medical aid to
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a person suffering, or reasonably believed to be suffering, from
an opioid overdose, as specified.
This bill authorizes each public and private elementary and
secondary school to voluntarily determine whether or not to make
emergency naloxone hydrochloride or another opioid antagonist
and trained personnel available at its school, as specified.
This bill would authorize these schools to designate one or more
volunteers to receive initial and annual refresher training,
based on specified standards, from the school nurse or other
qualified person designated by an authorizing physician and
surgeon. Those minimum standards, to be established by the
Superintendent, as specified, must include, among other things:
techniques for recognizing symptoms of an opioid overdose;
standards and procedures for the storage, restocking, and
emergency use of naloxone hydrochloride or another opioid
antagonist; and
basic emergency follow-up procedures, including but not limited
to, a requirement for the school or charter school
administrator, or if the administrator is not available,
another school staff member to call 911 and to contact the
student's parent or guardian.
This bill would generally require a qualified supervisor of
health at a school district, county office of education, or
charter school electing to utilize naloxone hydrochloride or
another opioid antagonist for emergency aid, to obtain from an
authorizing physician and surgeon a prescription for each school
for naloxone hydrochloride or another opioid antagonist. The
qualified supervisor of health at a school district, county
office of education, or charter school shall be responsible for
stocking the naloxone hydrochloride or another opioid antagonist
and restocking it if it is used. A qualified supervisor of
health may include, but is not limited to, a school nurse.
This bill would authorize a school nurse or, if the school does
not have a school nurse or the school nurse is not onsite or
available, a volunteer to administer naloxone hydrochloride or
another opioid antagonist to a person exhibiting potentially
life-threatening symptoms of an opioid overdose at school or a
school activity when a physician is not immediately available.
Volunteers may administer naloxone hydrochloride or another
opioid antagonist only by nasal spray or by auto-injector.
Furthermore, a volunteer shall be allowed to administer naloxone
hydrochloride or another opioid antagonist in whatever form
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(nasal spray or auto-injector) that the volunteer is most
comfortable with. An "auto-injector" means a disposable
delivery device designed for the automatic injection of a
premeasured dose of an opioid antagonist into the human body and
approved by the federal Food and Drug Administration for
layperson use.
This bill would require that a school district, county office of
education, or charter school electing to utilize naloxone
hydrochloride or another opioid antagonist for emergency aid
ensure that each employee who volunteers is provided defense and
indemnification by the school for any and all civil liability in
accordance with, but not limited to, that provided in Division
3.6 (commencing with Section 810) of Title 1 of the Government
Code. This bill would require this information to be reduced to
writing, provided to the volunteer, and retained in the
volunteer's personnel file.
This bill would provide that a person who has been trained and
who administers naloxone hydrochloride or another opioid
antagonist, in good faith and not for compensation, shall not be
subject to professional review, be liable in a civil action, or
be subject to criminal prosecution for acts or omissions in
administering the naloxone hydrochloride and another opioid
antagonist. This bill would specify that any public employee who
volunteers to administer naloxone hydrochloride or another
opioid antagonist is not providing emergency medical care "for
compensation," notwithstanding the fact that the person is a
paid public employee.
This bill would provide that an authorizing physician and
surgeon shall not be subject to professional review, be liable
in a civil action, or be subject to criminal prosecution for the
issuance of a prescription or order, unless the physician and
surgeon's issuance of the prescription or order constitutes
gross negligence or willful or malicious conduct.
This bill would provide that notwithstanding any other law, a
pharmacy may furnish naloxone hydrochloride or another opioid
antagonist to a school district, county office of education, or
charter school pursuant to Section 49414.3 of the Education
Code, as added by this bill, if all of the following are met:
the naloxone hydrochloride or another opioid antagonist is
furnished exclusively for use at a school district schoolsite,
county office of education schoolsite, or charter school; and
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a physician and surgeon provides a written order that
specifies the quantity of naloxone hydrochloride or another
opioid antagonist to be furnished.
This bill would require the school district, county office of
education, or charter school to maintain records regarding the
acquisition and disposition of naloxone hydrochloride or another
opioid antagonist furnished pursuant to the above for a period
of three years from the date the records were created. This bill
would further require the school district, county office of
education, or charter school shall be responsible for monitoring
the supply of naloxone hydrochloride or another opioid
antagonist and ensuring the destruction of expired naloxone
hydrochloride or another opioid antagonist.
This bill would authorize an employee who volunteers for these
purposes to rescind his or her offer to administer emergency
naloxone hydrochloride or another opioid antagonist at any time,
including after the receipt of training.
This bill would prohibit a benefit from being granted to or
withheld from any individual based on his or her offer to
volunteer and would prohibit retaliation against any individual
for rescinding the offer to volunteer, including after receiving
training.
This bill would define "opioid antagonist" as naloxone
hydrochloride or another drug approved by the federal Food and
Drug Administration that, when administered, negates or
neutralizes in whole or in part the pharmacological effects of
an opioid in the body, and has been approved for the treatment
of an opioid overdose.
This bill would define "volunteer" or "trained personnel" as an
employee who has volunteered to administer naloxone
hydrochloride or another opioid antagonist to a person if the
person is suffering, or reasonably believed to be suffering,
from an opioid overdose, has been assigned by a school, and has
received specified training.
COMMENT
1. Stated need for the bill
The author cites information from the Centers for Disease
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Control and Prevention reporting that there were over 4,500
deaths caused by drug overdoses in California in 2014-nearly 50
[percent] higher than the 3,074 traffic fatalities that occurred
in the state for that same time period. The author also
provides the Committee with information supporting that Naloxone
is a medication that can block the effects of opioid overdoses,
noting that in November 2015, the Food and Drug Administration
(FDA) approved an easy-to-use variant, administered by nasal
spray. (FDA News Release, FDA moves quickly to approve
easy-to-use nasal spray to treat opioid overdose (Nov. 18, 2015)
[as of Jun. 19, 2016].) Further information provided
by the author supports that Naloxone has few side effects on
individuals not using opioids. When administered to an
individual who has been using opioids, the side effects are
typically opioid withdrawal symptoms, since the medication
blocks the effects of the opioids. These withdrawal symptoms are
not life-threatening. (Drugs.com Naloxone Side Effects
[as of
Jun. 19, 2016].)
As such, as stated by the author:
This bill provides clear statutory authority for schools to
stock, and for trained employees to administer, opioid
antagonists like naloxone. Importantly, the bill directs [the
California Department of Education] to produce training
standards, authorizes pharmacists to issue prescriptions to
schools, includes employee protection provisions, and provides
certain liability benefits to individuals acting under the
section. The bill exempts from liability:
An authorizing physician or surgeon who provides a
prescription for an opioid antagonist to a school.
A person trained to administer an opioid antagonist, as
specified, and who administers an opioid antagonist to an
individual the person believes, in good faith and not for
compensation, to be experiencing an overdose.
Additionally, the bill requires that school districts that
choose to stock an opioid antagonist provide authorized
employees with defense and indemnification from civil
liability.
2. Long history of Good Samaritan laws encouraging life-saving
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treatment by way of granting trained volunteers qualified
immunity from any resulting liability
In 1999, the Legislature passed and the Governor signed SB 911
(Figueroa, Ch. 163, Stats. 1999) which created a qualified
immunity from civil liability for trained persons who use
automatic external defibrillators (AEDs<1>) in good faith and
without compensation when rendering emergency care or treatment
at the scene of an emergency. SB 911 also provided qualified
immunity from liability for building owners who installed AEDs
as long as they ensured that expected AED users completed a
training course. AB 2041 (Vargas, Ch. 718, Stats. 2002)
expanded this immunity by repealing the training requirements
for good faith users and also relaxing the requirement that
building owners must ensure that expected users complete
training as a condition of immunity. AB 2041 was enacted with a
five-year sunset which was extended another five years to
January 1, 2013, by AB 2083 (Vargas, Ch. 85, Stats. 2006). Most
recently, SB 1436 (Lowenthal, Ch. 71, Stats. 2012) was enacted
to delete the sunset, thereby extending the operation of those
provisions indefinitely.
Additionally, in 2005, AB 254 (Nakanishi, Ch. 111, Stats. 2005)
amended the above provisions to specify that, if an AED is
placed in a public or private K-12 school, the school principal
must annually provide school administrators and staff with a
brochure describing the proper use of an AED, post similar
information next to the AED, and designate trained employees to
be available to respond to an emergency that may involve the use
of an AED during normal operating hours. In 2014, AB 2217
(Melendez, Ch. 812, Stats. 2012) was enacted to state the intent
of the Legislature to encourage all public schools to acquire
and maintain at least one AED and allow schools to solicit and
receive nonstate funds for that purpose. That bill also
provided a qualified immunity for a school district and its
employees who use, attempt to use, or do not use an AED to
render emergency care or treatment.
Separately, over the years, California law has been amended to
---------------------------
<1> An AED is a medical device which is used to administer an
electric shock through the chest wall to the heart after someone
suffers cardiac arrest. Built-in computers assess the patient's
heart rhythm, determine whether the person is in cardiac arrest,
and signal whether to administer the shock. Audible cues guide
the user through the process.
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permit school districts or county offices of education to
provide emergency epinephrine auto-injectors (commonly known as
"epi pens") to trained personnel, and to permit trained
personnel to utilize the auto-injectors to provide emergency
medical aid to persons suffering from an anaphylactic reaction,
as it is not uncommon for children to come into contact with
specific allergens (such as bee stings) or accidentally ingest
foods they are allergic to at school. (See AB 559 (Wiggins, Ch.
458, Stats. 2001); see also SB 1266 (Huff, Ch. 321, Stats.
2014), which was subsequently enacted to require, as opposed to
simply authorize, school districts, county offices of education,
and charter schools to provide emergency epinephrine
auto-injectors to voluntary, trained personnel who, consistent
with existing law, may use the auto-injectors to provide
emergency medical aid to persons suffering from an anaphylactic
reaction.)
More recently, in 2013, California law was expanded to also
permit certain Good Samaritans (specifically, prehospital
emergency medical care persons or lay rescuers), to obtain and
administer epinephrine auto-injectors to provide emergency
medical aid to persons suffering from anaphylactic shock. (SB
669 (Huff, Ch. 725, Stats. 2013).) In doing so, the legislation
granted such individuals, acting in good faith and not for
compensation, immunity for any civil damages resulting from any
acts or omissions in administering the auto-injector to a person
who appears to be experiencing anaphylaxis at the scene of an
emergency, as long as the person did not act with gross
negligence or willful or wanton misconduct and otherwise
complies with certain requirements and standards, including
training requirements.
Additionally, just this last year, SB 738 (Huff, Ch. 132, Stats.
2015) was brought to address an issue of concern for doctors who
are needed to write these prescriptions so that schools may
obtain and stock epinephrine auto-injectors as required by these
bills. The proponents of SB 738 reported that schools were
having difficulty obtaining epinephrine auto-injectors because
doctors were declining to write those prescriptions out of fear
of both professional disciplinary action and both civil and
criminal liability from any resulting acts or omissions in
relation to the administration of the prescribed auto-injector
in an emergency. While such Good Samaritan laws encouraging
life-saving emergency treatment have largely stopped short
(intentionally so) of providing immunity to individuals for
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negligent acts or omissions in the performance of their
professional duties, it has also become clear that doctors, in
their ordinary practice of medicine, do not and cannot prescribe
medication to third persons. Accordingly, SB 738 was enacted to
grant any physician or surgeon issuing a prescription or order
for these purposes immunity from any potential civil or criminal
liability or from professional disciplinary action, unless the
physician and surgeon's issuance constitutes gross negligence or
willful or malicious conduct.
Lastly, of particular relevance to this bill was AB 635
(Ammiano, Ch. 707, Stats. 2013), which, building on many of the
above bills, provided qualified immunities to encourage the
prescription and administration of opioid antagonists to save
lives of individuals who have overdosed. (See Background.)
3. Qualified immunities under this bill follow models used for
AEDs and epi-pens
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
limited immunity from liability (as opposed to blanket
immunities) to promote other policy goals that could benefit the
public. Along these lines, this Legislature has on multiple
occasions enacted legislation that encourages the use of life
saving medications or medical interventions (such as automatic
external defibrillators (AEDs), epinephrine auto-injectors
(epi-pens), and opioid antagonists) in order to avoid
preventable deaths by limiting the liability of "Good
Samaritans," as long as certain minimal requirements are met.
In doing so, however, the Legislature has consistently ensured
that 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
renders the care. (See Civ. Code Sec. 1714.21.)
With respect to epi-pens, specifically, as noted in Comment 2
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above, California law already encourages the use of this
life-saving medication to avoid preventable deaths in both
schools and in the general public. In this vein, the Civil Code
provides certain Good Samaritans-namely, prehospital emergency
care persons and lay persons, as defined-acting in good faith
and not for compensation, qualified immunity from civil damages
for any of their acts or omissions in administering the epi-pen
to a person who appears to be suffering from anaphylaxis at the
scene of emergency, if the person complies with certain
requirements and standards, including training requirements. As
mentioned above, this immunity is, however, qualified (i.e.,
limited), insofar as it does not apply to protect the person
from civil damages in any personal injury or wrongful death case
involving gross negligence or willful or wanton misconduct in
rendering emergency care treatment by use of the auto-injector.
Separately, recognizing that public employees (in particular,
school nurses) already enjoy liability protections under the
Government Tort Claims Act, existing law requires that schools
provide defense and indemnification to employees who volunteer
for training to administer epi-pens in emergency situations from
any and all civil liability, in accordance with, but not limited
to, that Act. (See Ed. Code Sec 49414.)
Recognizing that employees may hesitate to volunteer to be
trained to administer opioid antagonists in emergencies to
individuals suffering from overdose out of fear of personal
liability, this bill would, modeled upon those existing
statutes, now add similar protection from civil liability for
trained school employee volunteers who administer naloxone
hydrochloride or another opioid antagonist, in good faith and
not for compensation, to a person who appears to be experiencing
an opioid overdose shall not be subject to professional review,
be liable in a civil action, or be subject to criminal
prosecution for his or her acts or omissions in administering
the naloxone hydrochloride or another opioid antagonist. At the
same time, however, like the previous qualified immunities
provided in the context of epi-pens and AEDs, this protection
from liability would not apply in a case of gross negligence or
willful and wanton misconduct of the person who renders
emergency care treatment by the use of naloxone hydrochloride or
another opioid antagonist. At the same time, the bill, similar
to SB 1266 (Huff, Ch. 321, Stats. 2014), which required schools
to maintain epi-pens for use by trained volunteers and required
indemnification of volunteers for those purposes, this bill
would require that a school district, county office of
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education, or charter school electing to utilize naloxone
hydrochloride or another opioid antagonist for emergency aid
shall ensure that each employee who volunteers under this
section will be provided defense and indemnification by the
school district, county office of education, or charter school
for any and all civil liability, as specified. This information
would also have to be reduced to writing, provided to the
volunteer, and retained in the volunteer's personnel file.
Staff notes, however, that in the context of epi-pens and
schools, school employees who otherwise volunteer for this
training are not currently provided any specific qualified
immunity under the Education Code, recognizing that public
employees are generally protected under the Government Tort
Claims Act. Arguably, it might have sufficed for this bill to
follow the Education Code and SB 1266 model for school
volunteers, which provides for defense and indemnification of
school employees, and not the Civil Code model that provides
qualified immunity to lay persons and pre-hospital emergency
personnel. That being said, to the extent that the concern is
that these employees are volunteering outside of the scope of
their ordinary duties, this bill provides for a measured,
qualified immunity that is consistent with existing law in
comparable situations.
4. Recent need to add qualified physician immunities to help
effectuate these laws
This bill seeks to provide immunity for doctors who write a
prescription for opioid antagonists to a qualified supervisor of
health (e.g. a school nurse) at a school district, county office
of education, or charter school for purposes of rendering
emergency care to another person who appears to be suffering
from an overdose.
With respect to the doctors who are relied upon to write the
prescription or orders for the medication or medical device,
similar liability protection has been provided in both the AED
and opioid antagonist context. Most recently, it was also
applied in the epi-pen context, but only insofar as the
prescription was for a school. As discussed in Comment 2,
above, just last year, SB 738 (Huff, Ch. 132, Stats. 2015) added
a similar provision in law for physicians and surgeons who issue
prescriptions or orders for epi-pens to schools, in furtherance
of existing California law that requires schools to provide
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emergency epinephrine auto-injectors to trained personnel who
may use the auto-injectors to provide emergency medical aid to
persons suffering from anaphylactic reaction. That provision
was based, in part, upon those provisions already in place with
respect to AEDs and naloxone.
For example, existing law provides physicians who are involved
with the placement of an AED protection against any civil
liability for any civil damages resulting from any acts or
omissions of a person who renders emergency care using that AED,
if that physician, person, or entity has complied with existing
law requirements. That law also provides that any limited
liability protection does not apply in the case of personal
injury or wrongful death which results from the gross negligence
or willful or wanton misconduct of the person who renders
emergency care or treatment by the use of an AED. (See Civ. Code
Sec. 1714.21.) Separately, in 2013, AB 635 (Ammiano, Ch. 707,
Stats. 2013) was enacted to 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 for 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, as specified. (See Civ. Code Sec.
1714.22.)
Similar to those bills, this bill ensures that an authorizing
physician and surgeon shall not be subject to professional
review, be liable in a civil action, or be subject to criminal
prosecution for the issuance of a prescription or order pursuant
to this section, unless the physician and surgeon's issuance of
the prescription or order constitutes gross negligence or
willful or malicious conduct.
5. Nasal sprays versus auto-injectors
As noted in Comment 1, the FDA recently approved nasal spray
forms of naloxone. In its press release, the FDA explained
that:
Until this approval, naloxone was only approved in injectable
forms, most commonly delivered by syringe or auto-injector.
Many first responders and primary caregivers, however, feel a
nasal spray formulation of naloxone is easier to deliver, and
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eliminates the risk of a contaminated needle stick. As a
result, there has been widespread use of unapproved naloxone
kits that combine an injectable formulation of naloxone with
an atomizer that can deliver naloxone nasally. Now, people
have access to an FDA-approved product for which the drug and
its delivery device have met the FDA's high standards for
safety, efficacy and quality.
This bill, as recently amended, allows for the trained
volunteers to choose either version of the medication that they
are comfortable administering in an emergency. For purposes of
limited liability, both of these are FDA-approved methods of
administering this life-saving medication to an individual who
is, or appears to be, suffering from an opioid overdose, and the
Committee is unaware of any information suggesting that such
medication could cause harm to someone who is not suffering from
an overdose.
6. Opposition
The California Teachers Association writes in opposition that
they have a long-standing organizational policy stating that
"'CTA believes the health and safety of children are best met
through the services of a credentialed school nurse' and
'certificated instructional staff shall not be required to
perform these services.' Given the flexibility to [local
education agencies] under the Local Control Funding Formula,
there is absolutely no reason for education employees, other
than trained school nurses, to be recruited to administer
medications. In many school settings, probationary and
temporary educators, along with classified employees are 'asked'
to be a trained volunteer. Their failure to agree to volunteer
impacts their contract status. While we are extremely
sympathetic to every occurrence during the school day resulting
in medical intervention, there is no language in the measure
prohibiting school administrators from unduly influencing and/or
pressuring non-medically trained school employees to volunteer
to be trained to respond to this type of medical emergency." In
response, the author writes:
Unfortunately, every school does not have a nurse present at
every time. Even if every school in California did have a
full-time school nurse, it would still be necessary to allow
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trained volunteer employees to administer emergency
medication. For instance, a need might arise when the nurse
cannot be quickly located. Even a few moments' delay can mean
the difference between full recovery and death.
Allowing schools to recruit volunteers to administer certain
medications in emergency situations is not new. SB 1266 (Huff,
2014) passed the Legislature without a single No vote, and AB
1748 closely mirrors its language.
Regarding naloxone specifically, public health experts
strongly support expanded access to the medication, including
providing it to laypersons. A 2009 article in the American
Journal of Public Health, written by researchers at the
American Medical Association, Tufts University, and Yale
University, concluded that "lay persons are consistently
successful in safely administering naloxone and reversing
opioid overdose." Additionally, the article found:
Naloxone is an eminently safe and nonabusable substance
that has 1 pharmacological function: to reverse the effects
of opioids on the brain and respiratory system in order to
prevent the ultimate adverse event, death?Current
medico-legal biases and regulations have nonetheless unduly
restricted the availability of naloxone for those who need
it most.
Support : American Nurses Association/California; California
Pharmacists Association;
California School Nurses Organization; California Society of
Addiction Medicine;
Drug Policy Alliance
Opposition : California Teachers Association
HISTORY
Source : Author
Related Pending Legislation :
AB 1719 (Rodriguez, 2016) would provide for various immunities
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relating to the instruction of students in compression-only CPR
or use of an AED. AB 1719 bill is also set to be heard by this
Committee.
AB 1386 (Low, 2016) would permit "authorized entities," as
defined to include both private and government entities, to
obtain epinephrine auto-injectors for the use of any one of
their employees, volunteers, or agents, who is a lay rescuer, as
specified, to render emergency care to another person, and would
provide various immunities for these purposes. AB 1386 was
recently approved by this Committee.
Prior Legislation : See Comment 2
Prior Vote :
Senate Education Committee (Ayes 9, Noes 0)
Assembly Floor (Ayes 74, Noes 3)
Assembly Appropriations Committee (Ayes 20, Noes 0)
Assembly Judiciary Committee (Ayes 9, Noes 1)
Assembly Education Committee (Ayes 7, Noes 0)
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