BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1386|
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THIRD READING
Bill No: AB 1386
Author: Low (D)
Amended: 6/28/16 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 7-0, 6/8/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Hall, Wolk
SENATE JUDICIARY COMMITTEE: 7-0, 6/21/16
AYES: Jackson, Moorlach, Anderson, Hertzberg, Leno, Monning,
Wieckowski
SENATE APPROPRIATIONS COMMITTEE: 7-0, 8/11/16
AYES: Lara, Bates, Beall, Hill, McGuire, Mendoza, Nielsen
ASSEMBLY FLOOR: 78-0, 1/27/16 (Consent) - See last page for
vote
SUBJECT: Emergency medical care: epinephrine auto-injectors
SOURCE: Allergy and Asthma Network
Mylan
DIGEST: This bill 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-injectors.
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ANALYSIS:
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) 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.
3) 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.
4) 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.
5) 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
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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.
6) 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.
This bill:
1) Permits a health care provider to issue a prescription for
an epinephrine auto-injector to an authorized entity, as
defined 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) Revises the definition of "epinephrine auto-injector" to
eliminate the reference to a spring-activated needle, and
instead defines this term as a "disposable delivery device
designed for automatic injection of a premeasured dose of
epinephrine into the human body to prevent or treat a
life-threatening allergic reaction."
3) 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.
4) Requires an authorized entity that possesses and makes
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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.
5) 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.
6) 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:
a) The epinephrine auto-injectors are furnished
exclusively for use by, or in connection with, an
authorized entity; and,
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b) An authorized health care provider provides a
prescription that specifies the quantity of epinephrine
auto-injectors to be furnished. Requires a new
prescription to be written for any additional epinephrine
auto-injectors required for use.
7) 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.
8) 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.
9) 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.
10)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.
11)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,
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as defined. Prohibits the failure of an authorized entity to
possess or administer an epinephrine auto-injector from
resulting in civil liability.
12)Provides an authorizing physician with immunity from civil
liability, criminal prosecution, and professional review, for
the issuance of a prescription for epinephrine auto-injectors
pursuant to this bill unless the physician's issues of the
prescription constitutes gross negligence or willful or
malicious conduct.
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 bill expands access and allows 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 stock epinephrine
auto-injectors and be better prepared in the event of an
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emergency. It does not require any entity to stock
epinephrine auto-injectors, but simply allows 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.
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FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: Yes
According to the Senate Appropriations Committee:
1)One-time costs of $50,000 for the development of information
technology systems to track information relating to the
issuance of certificates and collection of data on usage of
epinephrine auto-injectors under this bill by the EMSA
(General Fund).
2)One-time costs of $130,000 over two years for the adoption of
regulations by the EMSA (General Fund).
3)Ongoing costs of $90,000 per year to review training programs,
issue certificates to participating individuals, and report
data on the program by the EMSA (General Fund).
SUPPORT: (Verified 8/13/16)
Allergy and Asthma Network (co-source)
Mylan (co-source)
American Latex Allergy Association
American Red Cross
California Chapter of the American College of Emergency
Physicians
California Retailers Association
California Society of Allergy, Asthma and Immunology
Food Allergy Research and Education
SF Bay Area Food Allergy Network
Two individuals
OPPOSITION: (Verified 8/13/16)
None received
ARGUMENTS IN SUPPORT: This bill is co-sponsored by Mylan and
the Allergy and Asthma Network. Mylan, which is a manufacturer
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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 builds 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.
ASSEMBLY FLOOR: 78-0, 1/27/16
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Campos, Chang,
Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle,
Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden,
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Page 10
Irwin, Jones, Jones-Sawyer, Kim, Lackey, Levine, Linder,
Lopez, Low, Maienschein, Mayes, McCarty, Medina, Melendez,
Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson,
Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago,
Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber,
Wilk, Williams, Wood, Atkins
NO VOTE RECORDED: Mathis
Prepared by:Vince Marchand / HEALTH / (916) 651-4111
8/15/16 20:10:03
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