BILL ANALYSIS Ó
SB 669
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Date of Hearing: August 13, 2013
ASSEMBLY COMMITTEE ON JUDICIARY
Bob Wieckowski, Chair
SB 669 (Huff) - As Amended: July 3, 2013
Proposed Consent
SENATE VOTE : 38-0
SUBJECT : Emergency Medical Care: Epinephrine Auto-Injectors
KEY ISSUe : Should prehospital emergency care providers, first
responders and lay rescuers who complete certain training
requirements be permitted to carry and administer epinephrine
auto-injectors to members of the public experiencing
anaphylaxis?
FISCAL EFFECT : As currently in print this bill is keyed fiscal.
SYNOPSIS
This noncontroversial bill would authorize a trained prehospital
emergency medical care person, first responder, or lay rescuer
to obtain and use epinephrine auto-injectors to render emergency
care to another person, pursuant to specified requirements, and
would grant them qualified immunity from liability, as
specified. This bill would also provide qualified immunity to
specified entities that are authorized to train these persons in
the emergency administration of epinephrine auto-injectors for
any civil damages alleged to result from those training
requirements or standards. Additionally, this bill would, among
other things, provide minimal training requirements and require
that the California Emergency Medical Services Authority
establish and approve authorized training providers and minimum
standards for training in the use and administration of
epinephrine auto-injectors. This bill is supported by a host of
groups including the American Academy of Pediatrics, California
Advocates, Inc., California Medical Association and Food Allergy
Research and Education. There is no known opposition and the
measure has had no "no" votes.
SUMMARY : Sponsored by the Conference of California Bar
Associations, this noncontroversial bill aims to expand the
availability of treatment by epinephrine auto-injector to those
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experiencing an anaphylactic reaction. Specifically, this bill ,
among other things:
1)Permits a prehospital emergency medical care person, first
responder, or lay rescuer to use an epinephrine auto-injector
to render emergency care if specified training requirements
are met.
2)Permits a pharmacy to dispense epinephrine auto-injectors to a
prehospital emergency medical care person, first responder, or
lay rescuer for the purpose of rendering emergency care with a
physician's prescription.
3)Specifies that the authorized training providers and minimum
standards for training and the use and administration of
epinephrine auto-injectors shall be established and approved
by the California EMS Authority. Training standards shall
include techniques for recognizing circumstances, signs, and
symptoms of anaphylaxis as well as standards and procedures
for proper storage and emergency use of epinephrine
auto-injectors.
4)Provides that any prehospital emergency medical care person,
first responder, or lay rescuer who administer an epinephrine
auto-injector to another person who appears to be experiencing
anaphylaxis at the scene of an emergency situation, in good
faith and not for compensation, is not liable for any civil
damages resulting from his or her acts or omissions in
administering the epinephrine auto-injector as long as he or
she has complied with the requirements and standards of this
bill, as specified. This bill would not grant immunity from
civil damages to any person whose conduct in rendering
emergency care constitutes gross negligence.
5)Provides qualified immunity to any local agency, governmental
entity, or other organization that sponsors, authorizes,
supports, finances, or supervises the training of those
persons, or develops standards in accordance with this bill.
EXISTING LAW :
1)Requires the Emergency Medical Services (EMS) Authority to
establish training and standards for all prehospital emergency
care personnel, as defined, regarding the characteristics and
method of assessment and treatment of anaphylactic reactions
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and the use of epinephrine. Existing law requires the
authority to promulgate regulations regarding these matters
for use by all prehospital emergency medical care personnel.
(Health and Saf. Code Sec. 1797.197.)
2)Provides that, notwithstanding any other provision of law, a
pharmacy may furnish epinephrine auto-injectors to a school
district or county office of education pursuant to specified
law, if all of the following are met: (1) the epinephrine
auto-injectors are furnished exclusively for use at a school
district site or county office of education; and (2) a
physician and surgeon provides a written order that specifies
the quantity of epinephrine auto-injectors to be furnished.
(Bus. & Prof. Code Sec. 4119.2(a).)
3)Permits a school district or county office of education to
provide emergency epinephrine auto-injectors to trained
personnel, and permits trained personnel to utilize those
epinephrine auto-injectors to provide emergency medical aid to
persons suffering from an anaphylactic reaction. (Ed. Code
Sec. 49414(a).)
4)Permits a school nurse, or if the school does not have a
school nurse, a person who has received training, as
specified, to do the following: (1) Obtain from the school
district physician, the medical director of the local health
department, or the local emergency medical services director a
prescription for epinephrine auto-injectors; and (2)
Immediately administer an epinephrine auto-injector to a
person exhibiting potentially life-threatening symptoms of
anaphylaxis at school or a school activity when a physician is
not immediately available. (Ed. Code Sec. 49414(f).)
5)Requires the Superintendent of Public Instruction to establish
minimum standards of training for the administration of
epinephrine auto-injectors that satisfy the minimum statutory
training requirements, as specified. Existing law requires
that the Superintendent consult with specified organizations
and providers with expertise in administering epinephrine
auto-injectors and administering medication in a school
environment. (Ed. Code Sec. 49414(e)(1).) Existing law also
provides minimum training requirements and standards, as
specified. (Ed. Code Sec. 49414(e)(2).)
COMMENTS : This non-controversial bill would facilitate the
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administration of epinephrine auto-injectors by trained
pre-hospital emergency medical care persons, first responders,
or lay rescuers, in emergency situations that extend beyond
school grounds in order to allow more individuals in the
community to be treated with epinephrine auto-injectors to save
lives. The bill would provide these individuals with a
qualified immunity from civil liability. In order to encourage
training, this bill would also provide qualified immunity to
specified entities who train these individuals in the emergency
administration of epinephrine auto-injectors.
In support, the author states:
SB 669 would create a training program for first responder
and group leader volunteers on the recognition and
emergency care of anaphylactic shock. The proposal calls
for the development of standards for the safe and proper
use of epinephrine auto-injectors (EpiPens). It would make
these auto-injectors available to trained first responders
and group leaders on prescription, and allow them to use it
in an emergency situation on a person suffering from a
potentially fatal anaphylactic reaction. It would provide
Good Samaritan immunity from civil liability if the care is
rendered at the scene of an emergency in good faith,
without gross negligence and not for compensation.
Despite all improvements in the law expanding Good
Samaritan protection fostering trained first responders and
group supervisors to provide emergency care (first aid,
cardiopulmonary resuscitation and automatic external
defibrillation) for someone with a life-threatening
allergic reaction, there is effectively nothing anyone can
do in cases of anaphylaxis to prevent cardio-pulmonary
shutdown unless the victim happens to have an EpiPen and is
able to self-administer epinephrine before losing
consciousness-outside of a medical or school environment.
Unless specifically used by and for the person for whom it
was prescribed, an EpiPen may not be administered by
non-physicians-even if an auto-injector is on the scene.
Until recent passage of enabling legislation, this was even
a problem for school nurses. [ . . . ] Yet, death from
anaphylaxis remains a real and pervasive problem outside of
school, in the wilderness and even in the community, when
group leaders overseeing the welfare of others, and even
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trained first responders at the scene of an emergency,
cannot obtain or administer this miraculous life-saving
device---a device which even little children are trained to
safely use. In the case of anaphylactic shock, death
through suffocation can occur in a matter of minutes.
Definitive medical care cannot always be timely obtained. [
. . . ]
Anaphylaxis is a pervasive lethal threat, both to those
with known allergies and those who suddenly become
sensitized to a substance - such as a simple bee-sting,
ingestion of shellfish, or coming into contact with
peanuts. While an anaphylactic attack cannot always be
prevented, the worrisome consequences of it can be.
In support the sponsor states:
SB 669 would enable California to join a growing group of
states that provide training in the proper use and
administration of epinephrine auto-injectors, and which
make these auto-injectors available by prescription to
individuals who have successfully completed the training.
The purpose of the bill is to increase the chances that if
a person suffers life-threatening allergic reaction, there
will be someone close by with an epinephrine auto-injector
who knows the proper way to use it.
Background : An epinephrine auto-injector is a disposable
medical drug delivery device that delivers a single measured
dose of epinephrine, most frequently for the treatment of acute
allergic reactions to avoid or treat the onset of anaphylaxis.
Anaphylaxis is a severe, whole-body allergic reaction to an
allergen. Anaphylaxis happens quickly after the exposure, is
severe, and involves the whole body. Anaphylaxis is
life-threatening and can occur at any time. Risk factors include
a history of any type of allergic reaction.
Epinephrine auto-injectors can be obtained by prescription only,
and current California law generally does not authorize
non-physicians to administer an epinephrine auto-injector to
another person. In recent years, California law has been
amended to, among other things, permit school districts or
county offices of education to provide emergency epinephrine
auto-injectors to trained personnel, and to permit trained
personnel to utilize the auto-injectors to provide emergency
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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. (AB 559 (Wiggins, Ch.
458, Stats. 2001).)
Need for Legislation : There are benefits to putting more
epinephrine auto-injectors in more trained hands. While ideally
any individuals prone to anaphylaxis would themselves be
carrying an epinephrine auto-injector, research shows that this
is not always the case. Often the individual has only
experienced mild anaphylaxis in the past and their health care
provider did not find it necessary to prescribe an epinephrine
auto-injector. (Simons, Keith J., and F. Estelle R. Simons.
"Epinephrine and its use in anaphylaxis: current issues."
Current opinion in allergy and clinical immunology 10.4 (2010):
354-361.) However, life-threatening anaphylaxis can manifest
itself after only minor attacks in the past. (Simons, 2010.) A
community member carrying and trained to use an epinephrine
auto-injector could be lifesaving in this instance where the
patient had no idea such a serious reaction was possible.
Civil Liability Provisions : Under current law, everyone is
generally appropriately held 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. (Civ. Code Sec. 1714(a).)
However, the Legislature has authorized certain actions to be
immune from civil liability in order to promote good public
policy and actions that benefit the public generally. For
instance, California law already applies qualified immunity to
those who use an AED device in emergency settings as long as
they have undergone certain training and maintenance
requirements. (See Civil Code Sec. 1714. 21.)
In the context of AEDs, lawmakers have granted qualified
immunity for lay operators because AEDs save lives and have been
proven very safe. Studies have shown misuse is nearly
impossible because the device will not operate except in the
case of actual cardiac arrest. (Mitchell, K. Blake, Leo
Gugerty, and Eric Muth. "Effects of brief training on use of
automated external defibrillators by people without medical
expertise." Human Factors: The Journal of the Human Factors and
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Ergonomics Society 50.2 (2008): 301-310.) Additionally, the
device 'walks' the operator through proper use with audio and
visual cues, and manual overrides are impossible (such as to
intentionally shock someone not experiencing cardiac arrest).
Here, epinephrine auto-injectors also clearly save lives and
similarly present only minimal risk of injury through misuse.
Newer designs integrate important safety features such as voice
prompts, and research reveals that the health risks presented by
accidental injection are, as with AEDs, insignificant. For
example, the February 2010 issue of the Journal of Allergy and
Clinical Immunology reports that between 1994 and 2007 over
15,000 unintentional injections were reported to U.S. Poison
Control. Of those, 40% occurred while the operators were trying
to inject themselves or someone else experiencing an allergic
reaction. But only in the case of .2% of those unintentional
injections were the clinical effects considered 'major.'
(Simons, F., et al. "Voluntarily reported unintentional
injections from epinephrine auto-injectors." Journal of Allergy
and Clinical Immunology 125.2 (2010): 419-423.)
ARGUMENTS IN SUPPORT : In support of the bill the California
Hospital Association states:
Existing law authorizes a school district or county office
of education to provide emergency epinephrine
auto-injectors to trained personnel, and authorizes that
trained personnel to utilize the epinephrine auto-injector
to provide emergence medical aid to those suffering from an
anaphylactic reaction. SB 669 would broaden the existing
provisions concerning epinephrine auto-injector in the
school setting? Death from anaphylaxis remains a real and
widespread problem. Currently, anaphylaxis leads to
500-1,000 deaths/per 2.4 million in the United States.
While mortality rates have decreased, the incidence of
anaphylaxis appear to be increasing from 20 per 100,000 per
year in the 1980's to 50 per 100,000 per year in the
1990's. Presently there is no effective treatment to
prevent anaphylactic cardiac arrest in the community unless
the victim has an epinephrine auto-injector and is able to
self- administer the injection before losing consciousness.
Unless specifically used by and for the person who it was
prescribed, an epinephrine auto-injector may not be
administered by a non-physician, even if the auto-injector
is on the scene. Until recent enabling legislation, this
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was a problem for school nurses who were unable to assist a
child in anaphylactic shock.
So while increased protection is available in schools,
death from anaphylaxis outside of schools in community
venues is a real and pervasive problem since those
overseeing the welfare of others, trained first responders
and group leaders, are unable to obtain or administer the
auto-epinephrine devise.
Further, the organization Food Allergy Research & Education
writes:
It has been well documented that the prevalence of food
allergies is on the rise. In 2007, the Centers for Disease
Control and Prevention reported that approximately 3
million children had a food allergy. A 2011 study published
in the medical journal Pediatrics showed that the
prevalence had grown to 5.9 million, or one in every 13
children. That's roughly two per classroom. There are 15
million food allergic Americans?While there is currently no
cure for food allergies, epinephrine is the only medication
that can arrest the symptoms and save the lives of those
experiencing a severe reaction. A study in Pediatrics
showed that 24% of epinephrine use in a school district was
on those without a previous diagnosis of food allergy.
There are many children who may not know they are allergic
and therefore do not have a prescribed epinephrine
auto-injector. Keeping this life-saving mediation on hand
is a matter of first aid. Precious minutes can be lost
waiting for emergency responders.
PRIOR RELATED LEGISLATION : SB 911 (Figueroa, Ch. 163, Stats.
1999), among other things, provides immunity from civil
liability to any person who, in good faith and not for
compensation renders emergency care or treatment by the use of
an automated external defibrillator at the scene of an
emergency, has completed a basic CPR and automated external
defibrillator (AED) use course that complies with regulations
adopted by the Emergency Medical Services (EMS).
AB 559 (Wiggins, Ch. 458, Stats. 2001), authorized school
districts or county offices of education to provide emergency
epinephrine auto-injectors to trained personnel, and to permit
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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.
AB 2041 (Vargas, Ch. 718, Stats. 2002), revises provisions
enacted by SB 911 (above) by deleting the requirement that a
person complete a basic CPR or AED course, and providing
immunity from civil liability to a person or entity that
acquires an AED for emergency use and renders emergency care, if
that person or entity is in compliance with specified
requirements.
AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was
ultimately vetoed.
REGISTERED SUPPORT / OPPOSITION :
Support
American Academy of Pediatrics
Association of Regional Center Agencies
Conference of California Bar Associations (sponsor)
California Advocates, Inc.
California Association of Joint Powers Authorities
California Hospital Association
California Justice Association of California
California Medical Association
Civil Justice Association of America
Food Allergy Research and Education
Hospital Corporation of America
Opposition
None on file
Analysis Prepared by : Drew Liebert and Kelly Bradfield / JUD. /
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