BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 669
AUTHOR: Huff
INTRODUCED: February 22, 2013
HEARING DATE: April 17, 2013
CONSULTANT: Marchand
SUBJECT : Emergency medical care: epinephrine auto-injectors.
SUMMARY : Permits a prehospital emergency medical care person,
first responder, or a lay rescuer to use an epinephrine
auto-injector to render emergency care to another person if
certain requirements are met, including obtaining specified
training and certification. Permits a health care provider to
issue a prescription, and permits a pharmacy to dispense, an
epinephrine auto-injector to a person who presents current
certification as meeting the requirements of this bill. Provides
immunity from civil liability to a person who administers an
epinephrine auto-injector in conformance with this bill.
Existing law:
1.Permits a school district or county office of education to
provide emergency epinephrine auto-injectors to trained
personnel, and permits trained personnel to utilize these
epinephrine auto-injectors to provide emergency medical aid to
persons suffering from an anaphylactic reaction.
2.Permits each elementary and secondary school to designate one
or more school personnel on a voluntary basis to receive
initial and annual refresher training, based on standards
developed by the Superintendent of Public Instruction in
consultation with organizations with expertise, including the
Emergency Medical Services Authority and others.
3.Permits a school nurse, or if the school does not have a nurse
then the person who has received the training, to 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.
4.Permits a school nurse, or if the school does not have a nurse
then the person who has received the training, to immediately
administer an epinephrine auto-injector to a person exhibiting
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potentially life-threatening symptoms of anaphylaxis at school
or a school activity when a physician is not immediately
available.
5.Provides civil liability immunity, with certain restrictions,
to persons who complete a basic cardiopulmonary resuscitation
course and who, in good faith, renders emergency
cardiopulmonary resuscitation at the scene of an emergency.
6.Provides civil liability immunity 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. Specifies that the protections in
this bill do not apply in the 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 by the use of an automated external
defibrillator.
7.Provides civil liability immunity, as part of a pilot project
in seven counties, to a person who administers an opioid
antagonist, who is not otherwise licensed to do so, in an
emergency without fee if the person has received specified
training. Sunsets this provision on January 1, 2016.
8.Establishes the Emergency Medical Services Authority (EMSA)
within the California Health and Human Services Agency, and
requires EMSA, among other things, to develop planning and
implementation guidelines for emergency medical services
systems which address specified components, including manpower
and training, communications, transportation, system
organization and management, data collection and evaluation,
and disaster response.
9.Defines pre-hospital emergency medical personnel as any of the
following: authorized registered nurse or mobile intensive
care nurse, emergency medical technician (EMT)-I EMT-II,
EMT-paramedic, lifeguard, firefighter, or peace officer, as
defined, or a physician who provides pre-hospital emergency
medical care or rescue services.
This bill:
1.Permits a pre-hospital emergency medical care person, first
responder, or a lay rescuer to use an epinephrine
auto-injector to render emergency care to another person if
all of the following requirements are met:
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a. The epinephrine auto-injector is legally obtained by
prescription from an authorized health care provider;
b. The epinephrine auto-injector is used on another person,
with the expressed or implied consent of that person, for
the treatment of anaphylaxis, as defined;
c. The epinephrine auto-injector is stored and maintained
as directed by the manufacturer's instructions; and,
d. The person using the epinephrine auto-injector has
successfully completed a course of training with an
authorized training provider, as described in this bill,
and has current certification of training issued by the
provider.
2.Permits a pharmacy, notwithstanding any other provision of
law, to dispense epinephrine auto-injectors to a pre-hospital
emergency care person, first responder, or lay rescuer for the
purpose of rendering emergency care if both of the following
requirements are met:
a. A physician provides a written order that specifies the
quantity of epinephrine auto-injectors to be dispensed to a
person who has a current training certification, as
specified, and the prescription specifies that the
auto-injector is for "EMS Purposes Only" and that the named
recipient is a "Section 1797.197a Responder;"
b. The pharmacy includes the manufacturer's product
information sheet for the epinephrine auto-injector and
labels each epinephrine auto-injector with the following
information: the name of the person to whom the
prescription is issued; the designations "Section 1797.197a
Responder" and "EMS Purposes Only"; and, the dosage, use
and expiration date.
3.Requires a person who is certified, pursuant to the provisions
of this bill, as being able to use an epinephrine
auto-injector to render emergency care to another person, to
make and maintain a record for five years reflecting the dates
of receipt, use, and destruction of each auto-injector
dispensed, the name of any person to whom epinephrine was
administered, and the circumstances and manner of destruction
of any auto-injectors.
4.Limits the use of epinephrine auto-injectors dispensed
pursuant to this bill to only the purpose, and under the
circumstances, described in this bill.
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5.Permits an authorized health care provider to issue a
prescription for an epinephrine auto-injector to a person who
presents current certification demonstrating that person is
trained and qualified, under the provisions of this bill, to
administer an epinephrine auto-injector.
6.Requires the authorized training providers, the minimum
standards for training, and the use and administration of
epinephrine auto-injectors under this bill to be established
and approved by EMSA in consultation with the local emergency
medical system agency, the county health department,
manufacturers, the Department of Health Care Services, the
American Academy of Allergy, Asthma and Immunology, the
American Academy of Pediatrics, the American Heart
Association, the American Red Cross, and the California
Medical Association.
7.Requires the minimum training and requirements to include all
of the following components:
a. Techniques for recognizing circumstances,
signs, and symptoms of anaphylaxis;
b. Standards and procedures for proper storage and
emergency use of epinephrine auto-injectors;
c. Emergency follow-up procedures, including calling the
emergency 911 telephone number or otherwise alerting and
summoning more advanced medical personnel and services;
d. Compliance with all regulations governing the training,
indications, use, and precautions concerning epinephrine
auto-injectors;
e. Written material covering the required information,
including the manufacturer product information sheets on
commonly available models of epinephrine auto-injectors;
f. Completion of a training course in cardiopulmonary
resuscitation and the use of an automatic external
defibrillator for infants, children, and adults that
complies with regulations adopted by the Emergency Medical
Services Authority and the standards of the American Heart
Association or the American Red Cross, and a current
certification for that training; and
g. Training certification for no more than two years, after
which recertification with an authorized training provider
is required.
8.Requires the minimum standards established and approved under
this bill to apply to a school district or county office of
education, and permits a school district or county office of
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education to adopt more stringent standards for training and
the use of epinephrine auto-injectors under specified
provisions of the Education Code pertaining to the use of
epinephrine in school settings.
9.Provides immunity from civil liability to any person who is
certified under this bill who administers 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, as long as that person has
complied with the requirements and standards of this bill.
Specifies that this provision does not grant civil immunity to
any person whose conduct in rendering emergency care
constitutes gross negligence.
10.Provides immunity from civil liability to any local agency,
entity of state or local government, or other public or
private organization that sponsors, authorizes, supports,
finances or supervises the training of persons to use
epinephrine auto-injectors under the provisions of this bill,
in order to encourage training.
11.Specifies that nothing in this bill relieves a manufacturer,
designer, developer, distributor, or supplier of an
epinephrine auto-injector of liability under any other
applicable law.
12.Defines various terms for purposes of this bill, including:
a. "Anaphylaxis" as a potentially life-threatening
hypersensitivity or allergic reaction to a substance, with
causes including insect stings or bites, foods, drugs, and
other allergens;
b. "Epinephrine auto-injector" as a disposable drug
delivery system with a spring-activated concealed needle
that is designed for emergency administration of
epinephrine to provide rapid, convenient first aid for
persons suffering from anaphylaxis;
c. "First responder" as a police officer, firefighter,
rescue worker, or any other person who provides emergency
response, first aid care, or other medically related
assistance either in the course of the person's
occupational duties or as a volunteer; and
d. "Lay rescuer as a person not otherwise licensed or
certified to use an epinephrine auto-injector on another
person who has met the training standards and other
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requirements of this bill.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. California recently joined other states
in finally allowing school nurses to obtain and use
epinephrine auto-injectors on students suffocating from
anaphylactic shock who were not prescribed an epinephrine
auto-injector by their physician. While the use of epinephrine
auto-injectors to combat a potentially lethal anaphylactic
reaction mostly focuses on protecting kids in school, and even
training non-nurses or medical professionals---such as
teachers, coaches, group leaders - in how to use it, the same
analysis should apply to protecting children when they are not
in a school environment. Both adults and children need
life-saving intervention when they are not on school grounds.
This is why we see states slowly moving to what is being
proposed by SB 669. We must allow first responders who receive
training to obtain and use these epinephrine auto-injectors -
just as they are authorized to do life-saving CPR or
administer an automatic external defibrillator, or apply
tourniquets.
2.What is anaphylaxis? According to the National Institutes of
Health, anaphylaxis is a severe, whole-body allergic reaction
to a chemical that has become an allergen. After being exposed
to a substance such as bee sting venom, the person's immune
system becomes sensitized to it. When the person is exposed to
that allergen again, an allergic reaction may occur.
Anaphylaxis happens quickly after the exposure, is severe, and
involves the whole body. Tissues in different parts of the
body release histamine and other substances. This causes the
airways to tighten and leads to other symptoms. Some drugs
(morphine, x-ray dye, aspirin, and others) may cause an
anaphylactic-like reaction (anaphylactoid reaction) when
people are first exposed to them. These reactions are not the
same as the immune system response that occurs with "true"
anaphylaxis. However, the symptoms, risk for complications,
and treatment are the same for both types of reactions.
Anaphylaxis can occur in response to any allergen. Anaphylaxis
is life-threatening and can occur at any time. Risks include a
history of any type of allergic reaction.
3.What is an epinephrine auto-injector? An epinephrine
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auto-injector is a medical device used to deliver a measured
dose of epinephrine (also known as adrenaline) using
autoinjector technology, most frequently for the treatment of
acute allergic reactions to avoid or treat the onset of
anaphylaxis. The EpiPen (and the version for smaller
children, the EpiPen Jr.) are commonly used epinephrine
auto-injectors. According to Mylan, which makes the EpiPen and
EpiPen Jr., the EpiPen contains 0.3mg of epinephrine and is
intended for those who weigh 66 pounds or more, while the
EpiPen Jr. contains 0.15mg, and is intended for patients
weighing between 33 to 66 pounds. Mylan's product information
states that it is not known if EpiPen and EpiPen Jr. are safe
and effective in children who weigh less than 33 pounds. The
devices are intended to be injected into the middle of the
outer thigh, and patients are directed not to inject the
device into a vein, buttock, fingers, toes, hands or feet.
4.Study on unintentional injections. An article published in
the February 2010 issue of the Journal of Allergy and Clinical
Immunology, Voluntarily reported unintentional injections from
epinephrine auto-injectors, found that from 1994 to 2007, a
total of 15,190 unintentional injections from epinephrine
auto-injectors were reported to US Poison Control Centers,
with 60% of those reported from 2003 to 2007. Those
unintentionally injected had a median age of 14 years, and 85%
were injected in a home or other residence. Management of the
individual was documented in only 4101 of the cases. In these
4101 cases, 49% of the clinical effects were described as
"minor," 20% were described as "minimal clinical effects, not
followed," and 15% were described as "moderate." Only 27 cases
(0.2%) were reported as "major effect," which was described as
"significant signs or symptoms." Most of the unintentional
injections (76%) were in a finger or thumb.
5.Double referral. This bill is double referred. Should it pass
out of this committee, it will be referred to the Senate
Judiciary Committee.
6.Prior legislation. AB 559 (Wiggins), Chapter 458, Statutes of
2001, established provisions of law that permit a school
district or county office of education to provide emergency
epinephrine auto-injectors to trained personnel, and permit
trained personnel to utilize these epinephrine auto-injectors
to provide emergency medical aid to persons suffering from an
anaphylactic reaction at a school or during a school activity.
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7.Support. This bill is sponsored by the Conference of
California Bar Associations (CCBA), representing more than 25
metropolitan, regional and specialty bar associations. CCBA
states that like almost all states, California has responded
to the dangers of anaphylaxis in our schools by enacting
legislation to permit school districts or county offices of
education to provide emergency epinephrine auto-injectors to
trained personnel, and to permit those personnel to utilize
these auto-injectors to provide emergency medical aid to
students suffering from an anaphylactic reaction. CCBA states
that this bill would enable California to join a growing group
of states that provide training in the proper use of
epinephrine auto-injectors and which makes these
auto-injectors available by prescription to individuals who
have successfully completed the training. The purpose of this
bill is to increase the chances that if a person suffers a
life-threatening allergic reaction, there will be someone
close by with an epinephrine auto-injector. Additionally, if
the person already has their own epinephrine auto-injector but
is unable to use it, this bill will increase the odds there
will be someone close by who can assist in the proper
administration.
This bill is supported by the California Hospital Association
(CHA), which states that 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
appears to be increasing from 20 per 100,000 per year in the
1980s to 50 per 100,000 in the 1990s. CHA states that 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.
8.Oppose unless amended. The California School Employees
Association, AFL-CIO (CSEA) is opposed to this bill unless it
is amended to ensure that the provisions of this bill do not
in any way impact current epinephrine auto-injector laws
governing school districts and county offices of education and
their employees. CSEA is requesting that the provision in
this bill applying the minimum standards created by this bill
to school districts and county offices of education be deleted
from the bill (p. 7, lines 16-20). Additionally, CSEA is
requesting that a new provision be added which states the
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following "(d) This section shall not apply to school
districts and county offices of education and their personnel
in epinephrine auto-injector programs established pursuant to
Section 49914 of the Education Code."
The Consumer Attorneys of California (CAC) have also written a
letter of concern, stating that this bill provides broad
immunities to persons who use an epinephrine auto-injector to
render emergency care to another person. CAC states that
while it recognizes the benefit to have appropriately trained
personnel deliver life-saving injections, it would like to
work with the author and sponsor to narrow the bill if or as
it proceeds to the Senate Judiciary Committee.
9.Prehospital emergency personnel may already have this ability.
This bill permits not only lay rescuers, but also prehospital
emergency medical care personnel and first responders to
administer an epinephrine auto-injector, but only if the
person is trained and certified under the provisions of this
bill. This bill requires EMSA to establish and approve the
training standards. However, some prehospital emergency
personnel already have it within their scope of practice to
administer epinephrine, and this bill could be interpreted to
require these personnel to get additional training and
certification before they are permitted to continue utilizing
this part of their training. According to EMSA, epinephrine
auto-injectors are a local optional scope of practice item for
EMT-Is (meaning it would have to be approved by the local
emergency medical services agency), while EMT-II/Advanced EMTs
and EMT-Paramedics have the administration of epinephrine for
allergic reaction in their basic scopes of practice. When it
is part of their scope of practice, EMSA states that the EMTs
employer would stock the epinephrine auto-injectors.
The author may wish to consider amending this bill to ensure
that any professional who is already licensed to administer
epinephrine auto-injectors under their current scope of
practice may continue to do so without obtaining the
additional training and certification required by this bill.
10.Technical amendments. On page 6, lines 23 through 25, this
bill requires EMSA to consult with "the local emergency
medical system agency, the county health department," and the
Department of Health Care Services. Given that there are
multiple county health departments and multiple local
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emergency medical services agencies, this bill should either
delete these references, or specify that EMSA consult with a
"representative from a local emergency medical services
agency" and "a representative from a county health
department." Additionally, the bill should refer to the
Department of Public Health, rather than the Department of
Health Care Services, which primarily governs the state's
Medi-Cal program.
SUPPORT AND OPPOSITION :
Support: Conference of California Bar Associations (sponsor)
California Hospital Association
Oppose: None received
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