BILL ANALYSIS Ó
AB 1386
Page 1
Date of Hearing: January 12, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 1386
Low - As Amended January 5, 2016
NOTE: This bill is double referred, and if passed by this
Committee, it will be referred to the Assembly Committee on
Judiciary.
SUBJECT: Emergency medical care: epinephrine auto-injectors.
SUMMARY: Permits a pharmacy to furnish epinephrine
auto-injectors (EAIs) to an authorized entity, as specified, if
the EAIs are furnished exclusively for use at or in connection
with an authorized entity, as specified; an authorized health
care provider provides a prescription; and, the records are
maintained by the authorized entity for three years. Requires
the authorized entity to create and maintain an operations plan
related to its use of EAIs; makes other technical and clarifying
amendments; and, contains specified immunity provisions.
EXISTING LAW:
1)Authorizes a pharmacy to furnish an EAI to a school district,
county office of education, or charter school, as specified,
if the EAIs are furnished for use at a school site and a
physician and surgeon provide a written order that specifies
the quantity of EAIs to be furnished. Business and Professions
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Code (BPC) Section 4119.2(a)
2)Requires the records regarding acquisition and disposition of
EAIs be maintained by the school district, county office of
education, or charter school for a period of three years, and
requires those entities to be responsible for monitoring the
supply of EAIs and ensuring the destruction of expired EAIs.
(BPC 4119.2(b))
3)Authorizes a pharmacy to dispense EAIs to a prehospital
emergency medical care person or lay rescuer for the purpose
of rendering emergency medical care, as specified, if
conditions are met, including that a physician or surgeon
provides a written order that specifies the number of EAIs to
be dispensed; the individual receiving the prescription has
obtained the certificate of training, as specified; the
prescription label specifies that the prescription is for
"First Aid Purposes Only;" and a new prescription is required
for any additional EAIs. (BPC Section 4119.3)
4)Requires a pharmacy to label each EAI with the name of the
person to whom the prescription was issued, the designations,
"Section 1797.197a Responder" and "First Aid Purposes Only,"
the dosage use and expiration date, and requires dispensed
prescriptions to include the manufacturer's product
information sheet. (BPC Section 4119.3)
5)Requires school districts, county offices of education, and
charter schools to provide emergency EAIs to school nurses or
trained personnel who have volunteered, as specified, and
authorizes school nurses or trained personnel to use EAIs to
provide emergency medical aid to persons suffering, or
reasonably believed to be suffering from an anaphylactic
reaction. Education Code (EDC) Section 49414(a))
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6)Permits each private elementary and secondary school in the
state to voluntarily determine whether or not to make EAIs and
trained personnel available at its school, as specified. (EDC
Section 49414(c))
7)Authorizes a prehospital emergency medical care person or lay
rescuer to use an EAI to render emergency care to another
person if all of the following requirements are met:
a) The EAI is legally obtained by prescription from an
authorized health care provider. An authorized health care
provider may issue a prescription for an EAI to a person,
as specified, for the purpose of rendering emergency care
to another person, upon presentation of current
certification demonstrating that person is trained and
qualified to administer an EAI as a prehospital emergency
medical care person or lay rescuer;
b) The EAI is used on another, with the expressed or
implied consent of that person, to treat anaphylaxis;
c) The EAI is stored and maintained as directed by the
manufacturer's instructions for that product;
d) The person using the EAI has successfully completed a
course of training with an authorized training provider,
and has current certification of training issued by the
provider;
e) The EAI obtained by prehospital emergency medical care
personnel, as specified, shall be used only when
functioning outside the course of the person's occupational
duties, or as a volunteer, pursuant to this section; and,
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f) The emergency medical services system is activated as
soon as practicable when an EAI is used. (Health and Safety
Code (HSC) Section 1797.197a)
THIS BILL:
8)Permits a pharmacy to furnish EAIs to an authorized entity, as
specified, if both the following conditions are met:
a) The EAIs are furnished exclusively for use at or in
connection with an authorized entity; and for use by its
employees, volunteers, and agents, first responder, or by a
family member or caregiver of the person who appears to be
experiencing anaphylaxis, as specified, or by the person
who appears to be experiencing anaphylaxis, and,
b) An authorized health care provider provides a
prescription that specifies the quantity of EAIs to be
furnished.
9)Requires a pharmacy to label each EAI dispensed with all of
the following information:
a) The name of the person or entity to whom the
prescription was issued;
b) The designations "Section 1797.197a Responder" and
"First Aid Purposes Only"; and,
c) The dosage, use, and expiration date.
10)Requires each dispensed prescription to include the
manufacturer's product information sheet for the EAI.
11)States that an EAI dispensed, as specified, may be used only
for the purpose and under the circumstances described in
Section 1797.197a of the HSC.
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12)Requires records regarding the acquisition and disposition of
EAIs 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 EAIs and ensuring the destruction of
expired EAIs.
13)States that an authorized health care provider that
prescribes or dispenses an EAI to a person authorized to use
an EAI to render emergency care, as specified, or to an
authorized entity is not liable for any civil damages
resulting from any act or omission related to the provision of
an EAI.
14)Relieves a person who conducts the training as specified in
HSC Section 1797.197a, from liability for any civil damages
resulting from any act or omission of the lay rescuer, as
specified, who renders emergency care by administering the
EAI.
15)Relieves any authorized entity from liability for any civil
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 EAI by any
one of its employees, volunteers, or agents who is a lay
rescuer, as specified, or who in good faith, and not for
compensation, renders emergency medical or nonmedical care at
the scene of an emergency.
16)States that the failure of an authorized entity to possess or
administer an EAI cannot result in civil liability.
17)Specifies that above the provisions does not affect any other
immunity or defense that is available under law, including,
but not limited to, the immunity from liability for any civil
damages resulting from any act or omission other than an act
or omission constituting gross negligence or willful or wanton
misconduct of a person who in good faith, and not for
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compensation, renders emergency medical or nonmedical care at
the scene of an emergency as provided by HSC Section 1799.102.
18)Defines an "authorized entity" 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 as specified.
19)Permits an authorized health care provider to prescribe EAIs
to an authorized entity.
20)Requires that an EAI, which is acquired by an authorized
entity, be stored in a location readily accessible in an
emergency and in accordance with the EAI instructions for use
and any additional requirements that may be established by the
Authority.
21)Requires an authorized entity that possesses and makes
available EAIs to do both of the following:
a) Create and maintain on its premises an operation plan
that includes all of the following:
i) The name and contact number for the authorized
health care provider who prescribed the EAI;
ii)Where and how the EAI will be stored;
iii)The names of the of the designated employees or agents
who have completed the training program as required and
who are authorized to administer the EAI;
iv)How and when the EAI will be inspected for an expiration
date; and,
v) The process to replace the expired EAI, including
the proper disposal of an expired EAI.
b) Submit to the Department of Public Health (DPH) on a
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form developed by the DPH, a report of each incident on the
authorized entity's premises that involves the
administration of an EAI, and requires the DPH to annually
publish a report that summarizes and analyzes all reports
submitted to it.
13)Provides that no reimbursement is required by this bill
pursuant to Section 6 of Article XIIB of the California
Constitution because the only costs that may be incurred by a
local agency or school district will be incurred because this
act creates a new crime or infraction, eliminates a crime or
infraction, or changes the penalty for a crime or infraction.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by Mylan . 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 estimated only
a few [years] ago. [Additionally] children and adults are
allergic to insect stings and other factors that can result in
anaphylaxis. Unfortunately, over the past several years, there
have been several high profile anaphylaxis-related tragedies
around the country in schools and outside of schools. Deaths
in Illinois in 2011, Georgia and Virginia in 2012, California,
Texas and New York (in 2013) resulted in significant attention
to the issue and much discussion on how to best address it?
This issue is serious and 47 states, including California, now
have laws to allow or mandate schools to stock [EAIs]. At
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least 54,000 schools across the U.S. are stocking [EAIs]. But
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[s] and
other entities to stock [EAIs] and allow for trained
employees, agents and others to use those [EAIs] in an
emergency.
This legislation would expand access and allow day care
[facilities], 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 [EAIs] and be
better prepared in the event of an emergency. It would not
require any entity to stock [EAIs], but would simply allow
it."
Background. An EAI is used for the emergency treatment of
severe allergic reactions (including anaphylaxis) to insect
bites or stings, medicines, foods, or other substances. It is
also used to treat anaphylaxis caused by unknown substances or
triggered by exercise. To help increase access to EAIs in the
event of an anaphylactic emergency, this bill will allow a
pharmacy to furnish EAIs to authorized entities such as
recreation camps, colleges and universities, day care
facilities, youth sports leagues and other businesses to be used
by trained persons in the event of a potential anaphylactic
emergency. In order for the entity to acquire the EAIs, they
would need to obtain a prescription from an authorized health
care provider who would be responsible for determining the
appropriate number of EAIs to be dispensed. The representative
of the authorized entity would need to meet the appropriate
training requirements as approved by the Emergency Medical
Services Authority (EMS).
The author notes, that while existing law allows individuals who
have been trained in recognition of symptoms of allergic
reactions and anaphylaxis to administer EAIs to others in an
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emergency situation, and provides liability protection for these
individuals, current law does not allow a business, group, or
other entity that the individual is employed by or associated
with to obtain a prescription for an EAI or to have liability
protection if the EAI is used on the entity's premises.
This bill would allow businesses, organizations, and other
entities to obtain a prescription and to stock EAIs for use in
an emergency if the business, organization or entity has
employees, agents or others who are trained in recognition of
anaphylaxis and the administration of EAIs. It would also
provide liability protection to the business, organization, or
entity that obtained the EAI and allow it to be used by a
trained employee, agent, or other individual under certain
circumstances. This bill does not mandate that an "authorized
entity" participate in this voluntary program.
This bill seeks to create greater access to EAIs at locations
where individuals could come into contact with allergens known
to cause anaphylaxis in those persons with allergies.
Current Use of EAIs in California. SB 669 (Huff) Chapter 725,
Statutes of 2013, authorized an off duty prehospital emergency
medical care person or lay rescuer to use an EAI to render
emergency care to another person. That bill required the EMS to
establish and approve minimum standards for training in the use
and administration of EAIs. In addition, EMS was required to
approve the authorized training providers and determine the
components to be included in the minimum training and
requirements. In order to implement the training program
required by SB 669, the EMS convened a work group of EMS
stakeholders and subject matter experts to assist the EMS in the
development of the training standards and the initial drafting
of regulations to outline the training and certification process
and requirements for a lay rescuer or off duty EMS personnel to
obtain an EAI. The EMS concluded the regulatory process in
October of 2015. Beginning January 1, 2016, the EMS can begin
the process of reviewing and approving the required training
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programs to obtain the appropriate lay rescuer certification.
Other States. According to the author, in 2013 and 2014,
Oregon, Florida, and Rhode Island passed legislation similar to
what is included in this bill; in total there are 17 states that
offer similar provisions for stockpiling EAIs outside of a
school setting.
In 2013, President Obama signed into law the School Access to
Emergency Epinephrine Act. The Act amends the Public Health
Service Act, with respect to asthma-related grants for child
health services, to give an additional preference to a state
that allows self-administration of asthma and anaphylaxis
medication
( https://www.congress.gov/bill/113th-congress/senate-bill/1503/al
l-info ). The Act requires elementary and secondary schools in
such a state to: 1) permit trained personnel to administer
epinephrine to a student reasonably believed to be having a
reaction; 2) maintain a supply of epinephrine in a secure
location that is easily accessible to trained personnel for such
treatment; and, 3) have in place a plan for having on the school
premises during operating hours one or more designated personnel
trained in administration of epinephrine.
EAIs. According to one of the EAI's manufacturers' websites,
there are two different doses of epinephrine available based on
the weight of the individual. According to information provided
by the American College of Allergy, Asthma and Immunology,
common side effects of epinephrine may include anxiety,
restlessness, dizziness, and shakiness. In addition, it was
noted that after use of an EAI, it is recommended that an
individual immediately visit a physician or an emergency room
for medical treatment.
While EAIs appear to be commonly recommended as a method to
treat specified anaphylactic conditions, EAIs are only available
via a prescription from a licensed health care provider in the
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United States and cannot be purchased over-the-counter.
Previous Related Legislation. SB 738 (Huff), Chapter 132,
Statutes of 2015, provides that an authorizing physician and
surgeon will not be subject to professional review, liable in a
civil action or be the subject of criminal prosecution for
issuing a prescription or order, as specified, for an EAI,
unless the physician or surgeon's issuance constitutes gross
negligence or willful or malicious conduct.
SB 1266 (Huff), Chapter 321, Statutes of 2014, requires school
districts, county offices of education (COE), and charter
schools to provide emergency EAIs to school nurses or trained
personnel who have volunteered, and authorizes school nurses or
trained personnel to use EAIs 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, permits a
prehospital emergency medical care person, first responder, or
lay rescuer to obtain and use an EAI in emergency situations
with certification of training, as specified.
AB 559 (Wiggins), Chapter 458, Statutes of 2001, allowed school
districts or COEs to provide emergency EAIs to trained
personnel, and permits trained personnel to utilize EAIs to
provide emergency medical aid to persons suffering from an
anaphylactic reaction.
ARGUMENTS IN SUPPORT: Mylan writes in support, "[This bill]
would expand access and allow day care [facilities], colleges
and universities, summer and day camps, 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 obtain a prescription for and stock [EAIs], and
allow trained personnel to administer them in emergencies.
Oregon, Florida and Rhode Island passed legislation similar to
[this bill] in 2013 and 2014. Eight states (Arkansas, Georgia,
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Kentucky, Indiana, Iowa, Oklahoma, West Virginia and Utah) have
passed legislation this year and at least 27 states are
considering similar legislation."
ARGUMENTS IN OPPOSITION:
None on file.
POLICY ISSUES FOR CONSIDERATION:
SB 669 established a voluntary procedure for a lay rescuer to
meet training and certification requirements in order to obtain
a prescription for an EAI. This bill would expand the current
program by authorizing a business or other entity to stockpile
EAIs if that business or entity has a trained person who holds
the valid certification. In an effort to maintain the voluntary
nature of the current program, the author may wish to specify
that an authorized entity cannot require its employees or agents
to obtain the voluntary training and certification as a
condition of employment.
Additionally, this bill will authorize a pharmacy to furnish
EAIs to authorized entities that have designated volunteers
including employees, agents or other trained individuals who
have met the appropriate training requirements to render
emergency care to another person. Although this bill requires
the authorized entity to allow only those individuals who hold
the appropriate training to be able to use an EAI in the event
of an anaphylactic emergency, it is unclear what the appropriate
procedure would be when a person is experiencing an anaphylactic
reaction at a business or other location and the trained
volunteer is not available. The author may wish to consider
clarifying the process or procedure for use and access to the
EAIs when the trained lay rescuer, which holds the EMS
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certification, is not available.
AMENDMENTS:
The author has requested the following amendments to address
technical issues raised by this committee, and other issues
raised by the Assembly Committee on Judiciary.
On page, 3, in line 7, after "for" insert use at or in
connection with an authorized entity. and strike lines 8-15.
On page 4, Strike lines 38-40.
On page 5, strike lines 1-12.
On page 5, in line 24, after "code" strike "or who, in good
faith, and not for" and strike lines 25-26.
On page 5, in line 37, after "under" insert state and after
"law" strike "including but not limited to, the immunity" and
strike lines 38-40.
On page 6, strike lines 1-3.
On page 7, in line 12 after "(e)" strike "An authorized health
care provider" and strike lines 13-19.
On page 9, in line 31 after "(c)." insert (e)( 1) An authorized
health care provider may issue a prescription for an epinephrine
auto-injector to a prehospital emergency medical person or a lay
rescuer for the purpose of rendering emergency care to another
person upon presentation of a current certification
demonstrating that the person is trained and qualified to
administer an epinephrine author-injector, pursuant to this
section or any other statute or regulation.
(2) An authorized health care provider may issue a prescription
for an epinephrine auto-injector to an authorized entity, as
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defined in paragraph (2) of subdivision (a), if the authorized
entity submits evidence it employs at least one person, or
utilizes at least one volunteer or agent, that is trained and
qualified to administer an epinephrine author-injector, pursuant
to this section.
On page 9, strike lines 32-40.
On page 10, in line 15, after "auto-injector" insert or used
epinephrine auto-injector in a sharps container.
REGISTERED SUPPORT:
Mylan (sponsor)
American Latex Allergy Association
American Red Cross
Sanofi
SF Bay Area Food Allergy Network
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Elissa Silva / B. & P. / (916) 319-3301
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