BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 1386
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|AUTHOR: |Low |
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|VERSION: |May 31, 2016 |
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|HEARING DATE: |June 8, 2016 | | |
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|CONSULTANT: |Vince Marchand |
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SUBJECT : Emergency medical care: epinephrine auto-injectors
SUMMARY : Permits a health care provider to issue a prescription for,
and a pharmacy to dispense, an epinephrine auto-injector to an
authorized entity, which is defined as any entity or
organization that employs at least one person that has completed
an approved training course on the emergency use of epinephrine
auto-injector.
Existing law:
1)Defines "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.
2)Defines "lay rescuer" as any person who has met the training
standards and other requirements of existing law relating to
the emergency use of epinephrine auto-injectors but who is not
otherwise licensed or certified to use an epinephrine
auto-injector on another person.
3)Requires the Emergency Medical Services Authority (EMSA) to
establish minimum standards for training and the use of
epinephrine auto-injectors, and to approve authorized training
providers. Requires the training requirements to include
techniques for recognizing the signs and symptoms of
anaphylaxis, as well as completion of a training course in
cardiopulmonary resuscitation and the use of an automatic
external defibrillator, and specifies that the training
certification is only valid for two years, after which
recertification is required.
AB 1386 (Low) Page 2 of ?
4)Permits a pre-hospital emergency medical care person, or lay
rescuer to use an epinephrine auto-injector to render
emergency care to another person, if certain requirements are
met, including that the epinephrine auto-injector is legally
obtained by prescription, and that the person using the
epinephrine auto-injector has a current certification of
training issued by an authorized training provider.
5)Permits a pharmacy to dispense epinephrine auto-injectors to a
pre-hospital emergency medical care person, first responder,
or lay rescuer for the purpose of rendering emergency care in
accordance with specified requirements.
6)Requires epinephrine auto-injectors obtained by pre-hospital
emergency medical care personnel to be used only when
functioning outside the course of the person's occupational
duties, or as a volunteer, as specified.
7)Provides that a pre-hospital emergency medical care person,
first responder, 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/her acts or omissions in
administering the epinephrine auto-injector, if that person
has complied with specified certification and training
requirements and standards, except as specified.
8)Permits a school district or county office of education to
provide 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.
9)Establishes 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.
This bill:
1)Permits a health care provider to issue a prescription for an
epinephrine auto-injector to an authorized entity, as defined
AB 1386 (Low) Page 3 of ?
by this bill, if the authorized entity submits evidence it
employs at least one person, or utilizes at least one
volunteer or agent, who is trained and has a current
epinephrine auto-injector certification card issued by EMSA.
2)Defines an "authorized entity," for purposes of this bill, as
any for-profit, nonprofit, or government entity or
organization that employs at least one person or utilizes at
least one volunteer or agent that has voluntarily completed a
training course approved by EMSA for the emergency use of
epinephrine auto-injectors, as specified in existing law.
3)Requires an authorized entity that possesses and makes
available epinephrine auto-injectors to create and maintain on
its premises an operations plan that includes all of the
following:
a) The name and contact number for the health
care provider who prescribed the epinephrine
auto-injector;
b) Where and how the epinephrine auto-injector
will be stored;
c) The names of the designated employees or
agents who have completed the required training
program and who are authorized to administer the
epinephrine auto-injector;
d) How and when the epinephrine auto-injector
will be inspected for an expiration date; and,
e) The process to replace the expired epinephrine
auto-injector, including the proper disposal of the
expired or used epinephrine auto-injector in a sharps
container.
4)Requires an authorized entity that possesses and makes
available epinephrine auto-injectors to submit to EMSA a
report of each incident involving the use of an epinephrine
auto-injector, within 30 days after each use. Requires EMSA to
annually publish a report that summarizes all reports
submitted to it under this bill.
5)Permits a pharmacy to furnish epinephrine auto-injectors to an
authorized entity, as defined by this bill, if both of the
following requirements are met:
AB 1386 (Low) Page 4 of ?
a) The epinephrine auto-injectors are furnished
exclusively for use by, or in connection with, an
authorized entity; and,
b) An authorized health care provider provides a
prescription that specifies the quantity of
epinephrine auto-injectors to be furnished.
6)Requires the pharmacy to label each epinephrine auto-injector
dispensed pursuant to the provisions of this bill with all of
the following; the name of the person or entity to whom the
prescription was issued; the designations "Section 1797.197a
Responder" and "First Aid Purposes Only;" and the dosage, use,
and expiration date.
7)Requires each epinephrine auto-injector prescription dispensed
pursuant to the provisions of this bill to include the
manufacturer's product information sheet for the epinephrine
auto-injector.
8)Requires records regarding the acquisition and disposition of
epinephrine auto-injectors to be maintained by the authorized
entity for a period of three years from the date the records
were created, and requires the authorized entity to be
responsible for monitoring the supply of epinephrine
auto-injectors and ensuring the destruction of expired
epinephrine auto-injectors.
9)Permits an epinephrine auto-injector dispensed pursuant to the
provisions of this bill to be used only for the purpose, and
under the circumstances, specified under existing law for
emergency use of epinephrine auto-injectors.
10)Provides authorized entities, as defined by this bill, with
immunity from civil liability for damages resulting from any
act or omission, other than an act or omission constituting
gross negligence or willful or wanton misconduct connected to
the administration of an epinephrine auto-injector by any one
of its employees, volunteers, or agents who is a lay rescuer,
as defined. Prohibits the failure of an authorized entity to
possess or administer an epinephrine auto-injector from
resulting in civil liability.
FISCAL
EFFECT : According to the Assembly Appropriations Committee,
AB 1386 (Low) Page 5 of ?
minor one-time GF costs to CDPH to develop a form, and ongoing
GF costs not likely to exceed $50,000 annually to compile
reports and publish a summary.
PRIOR
VOTES :
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|Assembly Floor: |78 - 0 |
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|Assembly Appropriations Committee: |17 - 0 |
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|Assembly Judiciary Committee: | 9 - 0 |
|Assembly Business and Professions |14 - 0 |
|Committee: | |
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|Assembly Rules Committee: |10 - 0 |
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COMMENTS :
1)Author's statement. According to the author, food allergies,
which can sometimes lead to a life-threatening allergic
reaction, or anaphylaxis, are a large and growing public
health problem. Today, an estimated one out of 13 children and
one out of 20 adults in the U.S. has a food allergy, a
considerably higher number than estimates only a few years
ago. Additional children and adults who are allergic to
insect stings and other factors can result in anaphylaxis.
Anaphylaxis to food allergies results in approximately 90,000
emergency department visits each year in the U.S. Anaphylaxis
results in approximately 1,500 deaths annually. This issue is
serious and 47 states, including California, now have laws to
allow or mandate schools to stock epinephrine auto-injectors.
Schools are not the only place where children can come into
contact with allergens capable of causing anaphylaxis. Greater
access is needed to allow businesses, organization and other
entities to stock epinephrine auto-injectors and allow for
trained employees, agents and others to use those
auto-injectors in an emergency. This legislation would expand
access and allow day care, colleges and universities, summer
and day camps, restaurants, sports arenas, sports leagues,
scout troops, before and after school programs, recreational
parks and other places where children and adults could come
into contact with potentially life-threatening allergens to
AB 1386 (Low) Page 6 of ?
stock epinephrine auto-injectors and be better prepared in the
event of an emergency. It would not require any entity to
stock epinephrine auto-injectors, but would simply allow it.
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
auto-injector is a medical device used to deliver a measured
dose of epinephrine (also known as adrenaline) using
auto-injector 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
AB 1386 (Low) Page 7 of ?
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. SB 738 (Huff, Chapter 132, Statutes of
2015), provided qualified immunity to a physician who issues a
prescription for an epinephrine auto-injector to a school
district, county office of education, or charter school.
SB 1266 (Huff, Chapter 321, Statutes of 2014), required 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.
Authorized school nurses or trained personnel to use the
epinephrine auto-injectors to provide emergency medical aid to
persons suffering, or reasonably believed to be suffering,
from an anaphylactic reaction.
SB 669 (Huff, Chapter 725, Statutes of 2013), permitted 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.
Permitted 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. Provided immunity from civil
liability to persons who administer an epinephrine
auto-injector in conformance with this bill.
AB 559 (Wiggins, Chapter 458, Statutes of 2001), established
AB 1386 (Low) Page 8 of ?
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.
7)Support. This bill is co-sponsored by Mylan and the Allergy
and Asthma Network. Mylan, which is a manufacturer of generic
and specialty medications, including epinephrine
auto-injectors, states in support that while California has
made great strides to address anaphylaxis-related tragedies,
more can be done to ensure the state is better prepared. Mylan
states that this bill would build upon California's current
school access law and expand access to this critical
medication. The Allergy and Asthma Network (Network) states in
support that venues that wish to stock epinephrine will ensure
staff is trained to identify and respond to life-threatening
anaphylactic reactions. According to the Network, the data
shows that death from anaphylaxis occurs more often when the
individual is away from home and there is either a delay
before epinephrine is administered or it is not given at all.
The American Red Cross also support this bill, stating that
this bill strives to protect the millions of Californians who
are at risk for anaphylactic shock, and will also protect the
businesses that obtain a prescription for epinephrine with
liability protection. The California Retailers Association
states in support that this bill sets sufficient training
requirements for employees and volunteers and establishes a
detailed tracking process for when epinephrine auto-injectors
are used. The California Chapter of the American College of
Emergency Physicians states that this bill will save lives by
increasing the availability of epinephrine auto-injectors and
the training for their use by lay persons. The American Latex
Allergy Association states that one in 13 children and one in
20 adults has a food allergy, additionally, others have insect
and other non-food allergies that trigger anaphylactic shock,
and that epinephrine auto-injectors are crucial for treating
anaphylaxis. The SF Bay Area Food Allergy Network states that
while legislation providing epinephrine auto-injectors in
schools was a great step forward, there is no such measure
available to day care centers and preschools, and this bill
will give them the ability to be better prepared to respond in
an allergic emergency.
AB 1386 (Low) Page 9 of ?
8)Oppose unless amended. Food Allergy Research and Education
(FARE), states that it is opposed to this bill unless amended
to add back important indemnification language recently
removed from the bill. FARE states that it strongly supports
the intent of the bill as epinephrine is the only medication
that can stop the symptoms of a severe, life-threatening
allergic reaction. However, FARE states that the bill should
be amended to include liability protection for physicians
writing standing orders to public entities. Without explicit
liability protection, FARE states that physicians are
reluctant to write these standing orders, and public venues
may not be able to acquire epinephrine. FARE points out that
in 2014, the legislature passed SB 1266 (Huff ) to require
schools to stock epinephrine. SB 1266 did not provide
indemnification for health care providers, and FARE states as
a result, it was difficult, if not impossible, for schools to
obtain the epinephrine auto-injectors. FARE states that it
wasn't until the following year that SB 738 (Huff) passed,
providing indemnification for physicians writing the standing
orders. According to FARE, across the country language such as
that from SB 738 has passed, allowing physicians to assist
thousands of schools by writing standing orders that allow
trained, authorized personnel to safely administer epinephrine
in emergency situations. The Allergy and Asthma Network, a
former co-sponsor of this bill, is now also opposed unless
amended, for similar reasons to FARE. Finally, the California
Society of Allergy, Asthma and Immunology (CSAAI) opposes this
bill unless amended to include liability protection for
physicians writing epinephrine prescriptions, and also to
include "education and training standards." In addition, CSAAI
states that epinephrine devises do have a "use by date" and
should be checked regularly for efficacy purposes.
SUPPORT AND OPPOSITION :
Support: Mylan (co-sponsor)
American Latex Allergy Association
American Red Cross
California Chapter of the American College of
Emergency Physicians
California Retailers Association
SF Bay Area Food Allergy Network
Two individuals
Oppose: Food Allergy Research and Education (unless amended)
Allergy and Asthma Network (unless amended)
AB 1386 (Low) Page 10 of ?
California Society of Allergy, Asthma and Immunology
(unless amended)
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