BILL ANALYSIS Ó
AB 1386
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB
1386 (Low)
As Amended June 28, 2016
Majority vote
--------------------------------------------------------------------
|ASSEMBLY: |78-0 |(January 27, |SENATE: |38-0 |(August 16, |
| | |2016) | | |2016) |
| | | | | | |
| | | | | | |
--------------------------------------------------------------------
Original Committee Reference: B. & P.
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.
Specifically, this bill:
1)Permits a pharmacy to furnish EAIs to an authorized entity for
the purpose of rendering emergency care, as specified, if both
the following conditions are met:
a) The EAIs are furnished exclusively for use by or in
connection with an authorized entity; and,
b) An authorized health care provider provides a
AB 1386
Page 2
prescription that specifies the quantity of EAIs to be
furnished to an authorized entity, as specified, and a new
prescription is written for any additional EAIs required
for use.
2)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.
3)Requires each dispensed prescription to include the
manufacturer's product information sheet for the EAI.
4)States that an EAI dispensed, as specified, may be used only
for the purpose and under the circumstances described in the
Health and Safety Code (HSC) Section 1797.197a.
5)Defines an "EAI" to mean a disposable delivery device designed
for the automatic injection of a premeasured dose of
epinephrine into the human body to treat a life-threating
allergic reaction.
6)Replaces previous definitions of an EAI with 5) above.
7)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.
8)Relieves any authorized entity from liability for any civil
AB 1386
Page 3
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, if the entity has complied with all
applicable requirements of the HSC Section 1797.197a.
9)States that the failure of an authorized entity to possess or
administer an EAI cannot result in civil liability.
10)Specifies that above the provisions does not affect any other
immunity or defense that is available under law.
11)Specifies that an authorizing physician and surgeon is not
subject to professional review, liable in a civil action, or
subject to criminal prosecution for the issuance of a
prescription or order in accordance with HSC Section 1797.197a
unless the prescription or order constitutes gross negligence
or willful or malicious conduct.
12)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.
13)Permits an authorized health care provider to issue a
prescription for an EAI to a prehospital emergency medical
care person or a lay rescuer for the purpose of rendering
emergency care to another person upon presentation of a
current EAI certification card demonstrating that the person
is trained and qualified to administer an EAI, as specified.
14)Permits an authorized health care provider to issue a
prescription for an EAI to an authorized entity if the
authorized entity submits evidence it employs at least one
person, or utilized at least one volunteer or agent, who is
AB 1386
Page 4
trained and has a current EAI certification card demonstrating
that the person is qualified to administer an EAI, as
specified.
15)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 authority a report of each incident that
involves the use of an EAI not more than 30 days after each
use, and requires the authority to annually publish a
report that summarizes and analyzes all reports submitted
to it.
16)Makes other technical and clarifying amendments.
17)Provides that no reimbursement is required by this bill
pursuant to California Constitution Article XIII B Section 6
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.
AB 1386
Page 5
The Senate amendments revise and replace the definition of an
EAI; specify that an authorizing physician and surgeon is not
subject to professional review, be liable in a civil action or
subject to criminal prosecution for the issuance of a
prescription of an EAI, unless the issuance constitutes gross
negligence or willful or malicious conduct; revise the
requirements for an authorized health care provider to issue a
prescription; and make other technical and clarifying changes.
FISCAL EFFECT: According to the Senate Appropriations
Committee, this bill will result in:
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 the bill by the Emergency
Medical Services Authority (General Fund).
2)One-time costs of $130,000 over two years for the adoption of
regulations by the Emergency Medical Services Authority
(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 Emergency Medical Services
Authority (General Fund).
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 United
States (U.S.) has a food allergy, a considerably higher number
AB 1386
Page 6
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 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
AB 1386
Page 7
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
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
AB 1386
Page 8
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
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' Web sites,
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,
AB 1386
Page 9
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
United States and cannot be purchased over-the-counter.
Analysis Prepared by:
Elissa Silva / B. & P. / (916) 319-3301 FN:
0004364