BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1266
AUTHOR: Huff
AMENDED: April 21, 2014
HEARING DATE: April 24, 2014
CONSULTANT: Diaz
SUBJECT : Pupil health: epinephrine auto-injectors.
SUMMARY : Requires, rather than authorizes, school districts,
county offices of education, and charter schools to provide
emergency epinephrine auto-injectors to trained personnel, as
specified. Allows trained personnel to use the epinephrine
auto-injectors to aid those who are suffering from an
anaphylactic reaction. Requires public schools to restock, at a
minimum, one adult and one junior epinephrine auto-injector as
soon as reasonably possible when one has been used or before the
expiration date of one that has not been used.
Existing law:
Business and Professions Code
1.Allows pharmacies to furnish epinephrine auto-injectors (EAIs)
to a school district or county office of education if the EAIs
are furnished exclusively for use at a school district site or
county office of education and a physician and surgeon
provides a written order that specifies the quantity of EAIs
to be furnished.
2.Requires records regarding the acquisition and disposition of
EAIs to be maintained by both the school district and county
office of education for three years from the date the records
were created. Makes the school district or county office of
education responsible for monitoring the supply of
auto-injectors and assuring the destruction of expired
auto-injectors.
Education Code
3.Allows a school district or county office of education to
provide emergency EAIs to trained personnel. Allows trained
personnel to utilize those EAIs to provide emergency medical
aid to persons suffering from an anaphylactic reaction.
4.Authorizes public and private elementary and secondary schools
to voluntarily determine whether or not to make emergency EAIs
Continued---
SB 1266 | Page 2
and trained personnel available at its school. Requires
schools, in making a decision, to evaluate the emergency
medical response time to the school and determine whether
initiating emergency medical services (EMS) is an acceptable
alternative to EAIs and trained personnel.
5.Authorizes a public and private elementary and secondary
school to designate one or more school personnel on a
voluntary basis ("designee") to receive initial and annual
refresher training, as specified, regarding the storage and
emergency use of an EAI from the school nurse or other
qualified person designated by the school district physician,
the medical director of the local health department (LHD), or
the local EMS director.
6.Specifies that a school district, county office of education,
and public and private elementary and secondary schools cannot
receive state funds for the purposes of 3) through 5) above.
7.Requires the Superintendent of Public Instruction to establish
minimum standards of training for the administration of EAIs
that satisfy specified requirements. Requires the
Superintendent to consult with specified organizations and
providers with expertise in administering EAIs and
administering medication in a school environment.
8.Authorizes a school nurse or a person who has received
training, as specified, to obtain a prescription for an EAI
from the school district physician, the medical director of
the LHD, or the local EMS director. Authorizes a school nurse
or trained person to immediately administer an EAI to a person
exhibiting potentially life-threatening symptoms of
anaphylaxis at school or a school activity when a physician is
not immediately available.
9.Requires a trained person or school nurse to initiate EMS or
other appropriate medical follow up in accordance with the
training materials, as specified.
10.Requires school districts or county offices of education that
elect to use EAIs for emergency medical aid to create a plan
that: designates the individual who will provide training
pursuant to 5) above; designates from whom the school district
or county office of education will receive the EAI
prescription; documents the individual who will obtain the
prescription and from what pharmacy; and documents where the
SB 1266 | Page
3
medication is stored and how it will be made readily available
in case of an emergency.
This bill:
1.Requires, rather than authorizes, a school district, county
office of education, or charter schools to provide emergency
EAIs to trained personnel.
2.Requires, rather than authorizes, public elementary and
secondary schools to designate one or more school personnel on
a voluntary basis to receive initial and annual refresher
training, as specified, regarding the storage and emergency
use of an EAI from the school nurse or other qualified person
designated by the local educational agency physician, the
medical director of the LHD, or the local EMS director.
3.Requires public schools to designate and have trained at least
one person for the purposes of obtaining a prescription for an
EAI, administering and restocking an EAI, and initiating EMS
or other appropriate medical follow up.
4.Requires, every five years or sooner, as deemed necessary, the
Superintendent to review, rather than establish, minimum
standards of training pursuant to 4) above.
5.Requires, rather than authorizes, a school nurse, school
administrator, or a designee who has received training, as
specified, to obtain a prescription for, at a minimum, one
adult and one junior EAI from the local educational agency
physician, a physician contracting with the local educational
agency, the medical director of the LHD, or the local EMS
director.
6.Requires EAIs to be restocked as soon as reasonably possible
when it has been used or before the expiration date if it has
not been used.
7.Requires a school nurse or designee to report, no later than
30 days after the last day of each school year, any incident
of EAI use to certain entities, as specified. Requires the
specified entities to report incidents on a specified form to
the Department of Education (CDE), and requires CDE to
annually publish the results of the submitted forms on its
Internet Web site.
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8.Requires a school district, county office of education, or
charter school to ensure that each employee who volunteers to
be a designee is provided defense and indemnification by the
school district, county office of education, or charter school
for any and all civil liability. Requires this information to
be reduced to writing, provided to the volunteer, and retained
in the volunteer's personnel file.
9.Allows a public school to accept gifts, grants, and donations
from any source for the support of the public school carrying
out the provisions of this legislation, including acceptance
of EAIs from a manufacturer or wholesaler.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1.Author's statement. According to the author, this bill is in
response to President Barack Obama's signing of H.R. 2094
related to stock epinephrine in schools. According to the bill
sponsor, FARE, as many as 15 million Americans suffer from
life threatening allergies. It is estimated that nearly 6
million of these people are children under the age of 18; that
is one in every 13 children, or 2 in every classroom.
Approximately 25 percent of first time allergic reactions that
require epinephrine happen at school.
Current law requires prescriptions for epinephrine be made to
a specific student for the medication to be stored at schools
so it can be used in case of anaphylactic reactions during
school hours. SB 1266 requires extra epinephrine injectors be
prescribed as a "standing order" so epinephrine can be on hand
in all public schools. By ensuring emergency medication is
available at schools, we can be sure that all students with
allergies are safe at school, even when they don't know they
have any allergy.
Anaphylaxis is a potentially lethal allergic reaction. It can
happen when a person is stung by a bee, ingests food such as
shellfish or nuts, or maybe even just comes in contact with
something as simple as latex. Epinephrine is the first line of
treatment for someone who is experiencing anaphylaxis. It can
be easily administered and has very little side-effect.
Reactions can be so severe, even fatal, without prompt use of
epinephrine.
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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
(such as morphine, x-ray dye, and aspirin) may cause an
anaphylactic-like 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. Risks include a history of any
type of allergic reaction. According to Food Allergy Research
& Education, approximately 25 percent of first-time allergic
reactions that require epinephrine happen at school.
3.What is an EAI? An EAI 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. According to the Food Allergy Research and
Education Web site, epinephrine is a highly effective
medication that can reverse severe symptoms of anaphylaxis but
must be administered promptly to be most effective. The EpiPen
and the EpiPen Jr. (the version for smaller children) are
commonly used EAIs. According to Mylan, which makes the two
products, 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.
According to the CDE Web site, in the existing training
standards for schools, if there is uncertainty about the
diagnosis, but there is reasonable probability that exhibited
symptoms are anaphylaxis, then the episode should be treated
as anaphylaxis and responded to according to the recommended
steps for emergency use of an EAI.
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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 EAIs were
reported to US Poison Control Centers, with 60 percent of
those reported from 2003 to 2007. Those unintentionally
injected had a median age of 14 years, and 85 percent were
injected in their home or another residence. Management of the
individual was documented in only 4,101 of the cases. In these
4,101 cases, 49 percent of the clinical effects were described
as "minor," 20 percent were described as "minimal clinical
effects, not followed," and 15 percent were described as
"moderate." Only 27 cases, or 0.2 percent, were reported as
"major effect," which was described as "significant signs or
symptoms." Seventy-six percent of the unintentional
injections were in a finger or thumb.
5.Triple referral. This bill has been referred to Senate
Education and Senate Judiciary Committees. It passed out of
Senate Education Committee with a vote of 7-0 on April 2,
2014. Should it pass out of this committee, it will be
referred to Senate Judiciary Committee.
6.Prior legislation. SB 669 (Huff), Chapter 725, Statutes of
2013, permitted a prehospital emergency medical care person or
lay rescuer to obtain and use an EAI in emergency situations
with certification of training, as specified.
SB 1069 (Pavley), Chapter 512, Statutes of 2010, in addition
to expanding the scope of practice for physician assistants in
other instances, added physician assistants, in addition to
physician and surgeons, from whom a school pupil must obtain a
written statement in order to carry and self-administer a
prescription EAI.
SB 1912 (Ashburn), Chapter 846, Statutes of 2004, permits
pupils to carry and self-administer inhaled asthma medication
or an EAI at school, as specified.
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 EAIs to trained
personnel, and permit trained personnel to utilize these EAIs
to provide emergency medical aid to persons suffering from an
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anaphylactic reaction at a school or during a school activity.
AB 1791 (Wiggins) of 2000 was an identical measure to AB 559.
This bill was vetoed by Governor Davis who stated that the
shortage of school nurses with the knowledge necessary to
administer medications would assure that the bulk of school
personnel administering epinephrine in emergencies would be
lay personnel. The Governor further stated that lay persons
cannot receive the necessary background in a limited training
program that would provide the essential medical judgment
skills required to administer medication in an emergency
situation.
7.Support. Food Allergy Research & Education (FARE), the sponsor
of this bill, writes in support and cites that eight types of
food account for over 90 percent of allergic reactions. FARE
also states that epinephrine is the only medication that can
arrest the symptoms of a severe allergic reaction and cites a
study in the journal Pediatrics that showed 24 percent of
epinephrine use in a school district was on those without a
previous diagnosis of food allergy.
A coalition of other supports argue that with approximately 25
percent of first-time allergic reactions requiring epinephrine
happening at schools, making epinephrine available is a top
priority. Supporters also cite the signing of H.R. 2094, the
School Access to Emergency Epinephrine Act, in November 2013
as an important first step at elevating the importance of the
issue. The law authorizes the federal Department of Health and
Human Services to give funding preferences to states for
grants if they maintain an emergency supply of EpiPens, permit
trained personnel of the school to administer epinephrine, and
develop a plan for ensuring trained personnel are available to
administer epinephrine during all hours of the school day.
8.Opposition. The California School Employees Association (CSEA)
writes in opposition that the bill should clearly indicate in
all instances where references are made to designees of a
school district administrator that the designee expressly
volunteered. CSEA also writes in opposition based on concerns
that a school district administrator's designee would be
responsible for obtaining an EpiPen prescription and
restocking the medication when it is used or it expires, as
CSEA believes that a high-level medical responsibility is not
appropriate for classified school employees.
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The California Teachers Association (CTA) believes the
reactions to epinephrine could go beyond the scope of training
provided to school personnel, which could create negative
consequences. CTA believes that the health and safety needs of
children are best met through the services of a credentialed
school nurse and that local education agencies will be able to
determine their highest priorities for addressing the health
and safety of students without a one-size-fits-all state
statute.
9.Policy comments.
a. Restocking EAIs. This bill requires EAIs to be
restocked after being used as soon as reasonably possible
and before one reaches its expiration date. However, it
is unclear who is responsible for restocking the
medication or what "as soon as reasonably possible"
means. Committee staff suggests the following amendments
to include the restocking of EAIs in the required
training and in the plan required of those who use EAIs
to help clarify procedures for restocking the medication
and to ensure that the restocking is documented:
Section 49414( e f )(2)(B) Standards and procedures for the
storage , restocking, and emergency use of epinephrine
auto-injectors.
Section 49414( j k )(4) Documentation as to where the
medication is stored , when the medication was restocked,
and how the medication will be made readily available in
case of an emergency.
b. Requiring a volunteer. This bill would require a
public school to designate one or more school personnel
on a voluntary basis to receive training on the storage
and emergency use of an EAI. However, this bill
additionally goes on to require a public school to
designate and train at least one person for the purposes
of obtaining and administering an EAI and initiating
emergency medical services, without mentioning "voluntary
basis." It is unclear how a school can be required to
designate a volunteer, especially if no school personnel
are willing to volunteer. Presumably, the responsibility
would fall on a school nurse or a school administrator.
Committee staff suggests the following amendments to
clarify that the school nurse or school administrator
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would be responsible if there are no volunteers.
Education Code Section 49414:
(d) Each public elementary and secondary school in the
state shall, and each private elementary and secondary
school in the state may , designate one or more school
personnel on a voluntary basis to receive initial and
annual refresher training, based on the standards
developed pursuant to subdivision ( e f ), regarding the
storage and emergency use of an epinephrine auto-injector
from the school nurse or other qualified person
designated by the school district local educational
agency physician, the medical director of the local
health department, or the local emergency medical
services director. However, each public school shall
designate and have trained at least one person for the
purposes listed in subdivisions (f), (g), and (h).
(e) Each public elementary and secondary school,
including a charter school, shall, if there is no school
personnel who volunteers as a designee pursuant to
subdivision (d), require a school nurse or, if the school
does not have a nurse or the school nurse is not onsite
or available, a school administrator to receive initial
and annual refresher training, based on the standards
developed pursuant to subdivision (f), regarding the
storage and emergency use of an epinephrine auto-injector
and for the purposes listed in subdivisions (g), (h), and
(i).
10.Amendments. Committee staff suggests the following
amendments:
Education Code
1) Section 49414(a):
School districts and districts, county offices of
education, and charter schools shall provide emergency
epinephrine auto-injectors to trained personnel, and
trained personnel shall, to the extent feasible, may use
those epinephrine auto-injectors to provide emergency
medical aid to persons suffering , or reasonably believed to
be suffering, from an anaphylactic reaction.
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2) Section 49414( e f )(1):
Every five years, or sooner as deemed necessary by the
Superintendent, the Superintendent shall review minimum
standards of training for the administration of epinephrine
auto-injectors that satisfy the requirements of paragraph
(2). For purposes of this subdivision, the Superintendent
shall consult with organizations and providers with
expertise in administering epinephrine auto-injectors and
administering medication in a school environment,
including, but not limited to, the State Department of
Health Care Services Public Health , the Emergency Medical
Services Authority, the American Academy of Allergy,
Asthma, and Immunology, the California School Nurses
Organization, the California Medical Association, the
American Academy of Pediatrics, Food Allergy Research and
Education, the California Society of Allergy, Asthma and
Immunology, the American College of Allergy, Asthma and
Immunology, and others.
3) Section 49414( f g ):
A school nurse , or or, if the school does not have a school
nurse or the school nurse is not onsite or available, a
school district administrator or his or her voluntary
designee who has received training pursuant to subdivision
(d), shall do the following: obtain from the local
educational agency physician, a physician contracting with
the local educational agency, the medical director of the
local health department, or the local emergency medical
services director a prescription for epinephrine
auto-injectors that, at a minimum, includes one adult , for
elementary schools, one regular epinephrine auto-injector
and one junior epinephrine auto-injector , and for junior
high school and high schools, if there are no students who
require a junior epinephrine auto-injector, one regular
epinephrine auto-injector . The prescription may be filled
by local or mail order pharmacies or epinephrine
auto-injector manufacturers.
4) Section 49414( g h ):
A school nurse, or if the school does not have a nurse or
the school nurse is not onsite or available, a school
administrator or his or her voluntary designee who has
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received training pursuant to subdivision (d) may
administer an epinephrine auto-injector to a person
exhibiting potentially life-threatening symptoms of
anaphylaxis at school or a school activity when a physician
is not immediately available. If the epinephrine
auto-injector is used it shall be restocked as soon as
reasonably possible. Expired epinephrine Epinephrine
auto-injectors shall be restocked before their expiration
date.
5) (h i ) A person who has received training as set forth in
subdivision (d) and (e) or a school nurse shall initiate
emergency medical services or other appropriate medical
follow-up in accordance with the training materials
retained pursuant to paragraph (3) (4) of subdivision ( e f ).
6) Section 49414( i j ):
No later than 30 days after the last day of each school
year, the school nurse or voluntarily designated employee
shall report any incident of epinephrine auto-injector use
to the Superintendent school district, county office of
education, or chartering authority on a form developed by
the Superintendent. In compliance with federal and state
privacy laws, the Superintendent department. The school
district, county office of education, or chartering
authority shall report any incident of epinephrine
auto-injector use to the department on the form developed
by the department. Without violating federal and state
privacy laws, the department shall annually publish the
results of the submitted forms on his or her its Internet
Web site.
7) Section 49414( j k ):
(1) Designation of the school district local educational
agency physician, the medical director of the local
health department, or the local emergency medical
services director that the school district or district,
county office of education, or charter school will
consult for the prescription for epinephrine
auto-injectors pursuant to paragraph (1) of subdivision
( f g ).
(2) Documentation as to which individual, the school
nurse or other voluntarily trained person pursuant to
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subdivision ( f g ), in the school district or district,
county office of education, or charter school will obtain
the prescription from the physician and the medication
from a pharmacist.
(3) Documentation as to which individual, the school
nurse or other trained person pursuant to subdivision (f)
or school administrator , in the school district or
district, county office of education, or charter school
will obtain the prescription from the physician and the
medication from a pharmacist.
1) Section 49414( k l )
2) Section 49414( l m )
Business and Professions Code
3) Section 4119.2:
(a) Notwithstanding any other provision of law, a pharmacy
may furnish epinephrine auto-injectors to a school
district , or county office of education , or charter school
pursuant to Section 49414 of the Education Code if all of
the following are met:
(1) The epinephrine auto-injectors are furnished
exclusively for use at a school district site , or county
office of education , or charter school .
(2) A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be
furnished.
(b) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to
subdivision (a) shall be maintained by both the a school
district , or county office of education , or charter school
for a period of three years from the date the records were
created. The A school district , or county office of
education , or charter school shall be responsible for
monitoring the supply of auto-injectors and assuring the
destruction of expired auto-injectors.
SUPPORT AND OPPOSITION :
Support: Food Allergy Research and Education (sponsor)
Allergy & Asthma Associates of Southern California
Allergy & Asthma Medical Group and Research Center
American Academy of Allergy Asthma and Immunology
Asthma and Allergy Foundation of America
Bay Area Allergy Advisory Board
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Bay Area Food Allergy 5k Walk/Run in Memory of BJ HOM
California Advocates for Food Allergies
California Allergy Support & Anaphylaxis Prevention
California American College of Emergency Physicians
(if amended)
California Society of Allergy, Asthma and Immunology
Food Allergy and Anaphylaxis Connection Team
Food Allergy Support of Sacramento
Kids with Food Allergies
Natalie Giorgi Sunshine Foundation
Nut Free Wok
Red Cross regions of California
San Diego Food Allergy Support Group
SF Bay Area Food Allergy Network
Sanofi
South Orange County Food Allergy Network
San Clemente Food Allergy Support Group
Stanford Food Allergy & Food Sensitivity Center
Community Council
Hundreds of Individuals
Oppose: California School Employees Association (unless
amended)
California Teachers Association
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