Amended in Senate June 13, 2016

Amended in Senate May 31, 2016

Amended in Assembly January 13, 2016

Amended in Assembly January 5, 2016

Amended in Assembly January 4, 2016

Amended in Assembly April 16, 2015

Amended in Assembly March 26, 2015

California Legislature—2015–16 Regular Session

Assembly Bill No. 1386

Introduced by Assembly Member Low

February 27, 2015

An act to add Section 4119.4 to the Business and Professions Code, to amend Section 1714.23 of the Civil Code, begin insert to amend Section 49414 of the Education Code, end insert and to amend Section 1797.197a of the Health and Safety Code, relating to emergency medical care.

LEGISLATIVE COUNSEL’S DIGEST

AB 1386, as amended, Low. Emergency medical care: epinephrine auto-injectors.

(1) Existing law authorizes a prehospital emergency medical care person, first responder, or lay rescuer to use an epinephrine auto-injector to render emergency care to another person, as specified. Existing law requires the Emergency Medical Services Authority to approve authorized training providers and the minimum standards for training and the use and administration of epinephrine auto-injectors. The existing Pharmacy Law also authorizes a pharmacy to dispense epinephrine auto-injectors to a prehospital emergency medical care person, first responder, or lay rescuer for the purpose of rendering emergency care in accordance with these provisions. A violation of the Pharmacy Law is a crime. begin insert Existing law requires school districts, county offices of education, and charter schools to provide emergency epinephrine auto-injectors, as defined, to school nurses and trained personnel who have volunteered to use epinephrine auto-injectors under emergency circumstances, as specified, and authorizes school nurses and trained personnel to use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. end insert

This bill would permit an “authorized entity,” as defined, to use an epinephrine auto-injector to render emergency care to another person in accordance with these provisions. The bill would also authorize a pharmacy to furnish epinephrine auto-injectors to an authorized entity, as provided. Because a violation of these provisions would be a crime, the bill would impose a state-mandated local program. The bill would require an authorized entity to create and maintain a specified operations plan relating to its use of epinephrine auto-injectors, and would require those entities to submit a report to the Emergency Medical Services Authority of each incident that involves the administration of an epinephrine auto-injector, not more than 30 days after each use. The bill would also require the authority to publish an annual report summarizing the reports submitted to the authority pursuant to the bill’s provisions. begin insert The bill would define the term “epinephrine auto-injector” for purposes of these provisions and other related provisions that authorize the use of epinephrine auto-injectors, as specified. end insert

(2)  Under existing law, everyone is generally responsible, not only for the result of his or her willful acts, but also for an injury occasioned to another by his or her want of ordinary care or skill in the management of his or her property or person, except so far as the latter has, willfully or by want of ordinary care, brought the injury upon himself or herself. Existing law also provides that a prehospital emergency care person, first responder, or lay rescuer who administers an epinephrine auto-injector to another person who appears to be experiencing anaphylaxis at the scene of an emergency situation, in good faith and not for compensation, is not liable for any civil damages resulting from his or her acts or omissions in administering the epinephrine auto-injector, if that person has complied with specified certification and training requirements and standards.

This bill would provide that an authorized entity is not liable for any civil damages resulting from any act or omission connected to the administration of an epinephrine auto-injector, as specified. begin insert The bill would also exempt an authorizing physician and surgeon from certain sanctions for the issuance of an epinephrine auto-injector under those provisions, except as specified. end insert

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes.

The people of the State of California do enact as follows:

SECTION 1.  

Section 4119.4 is added to the Business and
Professions Code, to read:

4119.4.  

(a) Notwithstanding any other law, a pharmacy may
furnish epinephrine auto-injectors to an authorized entity, as
defined by Section 1797.197a of the Health and Safety Code, if
both of the following requirements are met:

(1) The epinephrine auto-injectors are furnished exclusively for
use by, or in connection with, an authorized entity.

(2) An authorized health care provider provides a prescription
that specifies the quantity of epinephrine auto-injectors to be
furnished.

(b) The pharmacy shall label each epinephrine auto-injector
dispensed with all of the following:

(1) The name of the person or entity to whom the prescription
was issued.

(2) The designations “Section 1797.197a Responder” and “First
Aid Purposes Only.”

(3) The dosage, use, and expiration date.

(c) Each dispensed prescription shall include the manufacturer’s
product information sheet for the epinephrine auto-injector.

(d) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to subdivision (a)
shall be maintained by the authorized entity for a period of three
years from the date the records were created. The authorized entity
shall be responsible for monitoring the supply of epinephrine
auto-injectors and ensuring the destruction of expired epinephrine
auto-injectors.

(e) The epinephrine auto-injector dispensed pursuant to this
section may be used only for the purpose, and under the
circumstances, described in Section 1797.197a of the Health and
Safety Code.

begin insert

(f) For purposes of this section, “epinephrine auto-injector”
means a disposable delivery device designed for the automatic
injection of a premeasured dose of epinephrine into the human
body to prevent or treat a life-threatening allergic reaction.

end insert

SEC. 2.  

Section 1714.23 of the Civil Code is amended to read:

1714.23.  

(a) For purposes of this section, the following
definitions shall apply:

(1) “Anaphylaxis” means a potentially life-threatening
hypersensitivity or allergic reaction to a substance.

(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to,
insect stings or bites, foods, drugs, and other allergens, as well as
idiopathic or exercise-induced anaphylaxis.

(2) “Epinephrine auto-injector” means a disposable begin delete 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. end delete begin insert end insert begin insert delivery
device designed for the automatic injection of a premeasured dose
of epinephrine into the human body to prevent or treat a
life-threatening allergic reaction. end insert

(b) (1) Any person described in subdivision (b) of Section
1797.197a of the Health and Safety Code 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 or her acts or omissions in
administering the epinephrine auto-injector, if that person has
complied with the requirements and standards of Section 1797.197a
of the Health and Safety Code.

(2) (A) An authorized entity shall not be liable 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 epinephrine
auto-injector by any one of its employees, volunteers, or agents
who is a lay rescuer, as defined by paragraph (4) of subdivision
(a) of Section 1797.197a of the Health and Safety Code.

(B) The failure of an authorized entity to possess or administer
an epinephrine auto-injector shall not result in civil liability.

(3) This subdivision does not affect any other immunity or
defense that is available under law.

(c) The protection specified in subdivision (b) shall not apply
in a case of personal injury or wrongful death that results from the
gross negligence or willful or wanton misconduct of the person
who renders emergency care treatment by the use of an epinephrine
auto-injector.

(d) Nothing in this section relieves a manufacturer, designer,
developer, distributor, or supplier of an epinephrine auto-injector
of liability under any other applicable law.

begin insert

(e) 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 pursuant
to this section, unless the physician and surgeon’s issuance of the
prescription or order constitutes gross negligence or willful or
malicious conduct.

end insert

begin insert

begin insert SEC. 3. end insert   

end insert

begin insert Section 49414 of the end insert begin insert Education Code end insert begin insert is amended to
read: end insert

49414.  

(a) School districts, county offices of education, and
charter schools shall provide emergency epinephrine auto-injectors
to school nurses or trained personnel who have volunteered
pursuant to subdivision (d), and school nurses or trained personnel
may use epinephrine auto-injectors to provide emergency medical
aid to persons suffering, or reasonably believed to be suffering,
from an anaphylactic reaction.

(b) For purposes of this section, the following terms have the
following meanings:

(1) “Anaphylaxis” means a potentially life-threatening
hypersensitivity to a substance.

(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to,
an insect sting, food allergy, drug reaction, and exercise.

(2) “Authorizing physician and surgeon” may include, but is
not limited to, a physician and surgeon employed by, or contracting
with, a local educational agency, a medical director of the local
health department, or a local emergency medical services director.

(3) “Epinephrine auto-injector” means a disposable begin delete drug delivery
system with a spring-activated needle that is designed for
emergency administration of epinephrine to provide rapid,
convenient first aid for persons suffering a potentially fatal reaction
to anaphylaxis. end delete begin insert end insert begin insert delivery device designed for the automatic injection
of a premeasured dose of epinephrine into the human body to
prevent or treat a life-threatening allergic reaction. end insert

(4) “Qualified supervisor of health” may include, but is not
limited to, a school nurse.

(5) “Volunteer” or “trained personnel” means an employee who
has volunteered to administer epinephrine auto-injectors to a person
if the person is suffering, or reasonably believed to be suffering,
from anaphylaxis, has been designated by a school, and has
received training pursuant to subdivision (d).

(c) Each private elementary and secondary school in the state
may voluntarily determine whether or not to make emergency
epinephrine auto-injectors and trained personnel available at its
school. In making this determination, a school shall evaluate the
emergency medical response time to the school and determine
whether initiating emergency medical services is an acceptable
alternative to epinephrine auto-injectors and trained personnel. A
private elementary or secondary school choosing to exercise the
authority provided under this subdivision shall not receive state
funds specifically for purposes of this subdivision.

(d) Each public and private elementary and secondary school
in the state may designate one or more volunteers to receive initial
and annual refresher training, based on the standards developed
pursuant to subdivision (e), regarding the storage and emergency
use of an epinephrine auto-injector from the school nurse or other
qualified person designated by an authorizing physician and
surgeon.

(e) (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 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, the Sean N. Parker Center for Allergy Research, and
others.

(2) Training established pursuant to this subdivision shall include
all of the following:

(A) Techniques for recognizing symptoms of anaphylaxis.

(B) Standards and procedures for the storage, restocking, and
emergency use of epinephrine auto-injectors.

(C) Emergency followup procedures, including calling the
emergency 911 telephone number and contacting, if possible, the
pupil’s parent and physician.

(D) Recommendations on the necessity of instruction and
certification in cardiopulmonary resuscitation.

(E) Instruction on how to determine whether to use an adult
epinephrine auto-injector or a junior epinephrine auto-injector,
which shall include consideration of a pupil’s grade level or age
as a guideline of equivalency for the appropriate pupil weight
determination.

(F) Written materials covering the information required under
this subdivision.

(3) Training established pursuant to this subdivision shall be
consistent with the most recent Voluntary Guidelines for Managing
Food Allergies In Schools and Early Care and Education Programs
published by the federal Centers for Disease Control and
Prevention and the most recent guidelines for medication
administration issued by the department.

(4) A school shall retain for reference the written materials
prepared under subparagraph (F) of paragraph (2).

(f) A school district, county office of education, or charter school
shall distribute a notice at least once per school year to all staff
that contains the following information:

(1) A description of the volunteer request stating that the request
is for volunteers to be trained to administer an epinephrine
auto-injector to a person if the person is suffering, or reasonably
believed to be suffering, from anaphylaxis, as specified in
subdivision (b).

(2) A description of the training that the volunteer will receive
pursuant to subdivision (d).

(g) (1) A qualified supervisor of health at a school district,
county office of education, or charter school shall obtain from an
authorizing physician and surgeon a prescription for each school
for epinephrine auto-injectors that, at a minimum, includes, for
elementary schools, one regular epinephrine auto-injector and one
junior epinephrine auto-injector, and for junior high schools, middle
schools, and high schools, if there are no pupils who require a
junior epinephrine auto-injector, one regular epinephrine
auto-injector. A qualified supervisor of health at a school district,
county office of education, or charter school shall be responsible
for stocking the epinephrine auto-injector and restocking it if it is
used.

(2) If a school district, county office of education, or charter
school does not have a qualified supervisor of health, an
administrator at the school district, county office of education, or
charter school shall carry out the duties specified in paragraph (1).

(3) A prescription pursuant to this subdivision may be filled by
local or mail order pharmacies or epinephrine auto-injector
manufacturers.

(4) An authorizing physician and surgeon shall not be subject
to professional review, be liable in a civil action, or be subject to
criminal prosecution for the issuance of a prescription or order
pursuant to this section, unless the physician and surgeon’s issuance
of the prescription or order constitutes gross negligence or willful
or malicious conduct.

(h) A school nurse or, if the school does not have a school nurse
or the school nurse is not onsite or available, a volunteer 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, but no later than two weeks after it is used.
Epinephrine auto-injectors shall be restocked before their expiration
date.

(i) A volunteer shall initiate emergency medical services or
other appropriate medical followup in accordance with the training
materials retained pursuant to paragraph (4) of subdivision (e).

(j) A school district, county office of education, or charter school
shall ensure that each employee who volunteers under this section
will be provided defense and indemnification by the school district,
county office of education, or charter school for any and all civil
liability, in accordance with, but not limited to, that provided in
Division 3.6 (commencing with Section 810) of Title 1 of the
Government Code. This information shall be reduced to writing,
provided to the volunteer, and retained in the volunteer’s personnel
file.

(k) A state agency, the department, or a public school may
accept gifts, grants, and donations from any source for the support
of the public school carrying out the provisions of this section,
including, but not limited to, the acceptance of epinephrine
auto-injectors from a manufacturer or wholesaler.

begin delete SEC. 3. end delete

begin insert SEC. 4. end insert   

Section 1797.197a of the Health and Safety Code is
amended to read:

1797.197a.  

(a) For purposes of this section, the following
definitions shall apply:

(1) “Anaphylaxis” means a potentially life-threatening
hypersensitivity or allergic reaction to a substance.

(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.

(B) Causes of anaphylaxis may include, but are not limited to,
insect stings or bites, foods, drugs, and other allergens, as well as
idiopathic or exercise-induced anaphylaxis.

(2) “Authorized entity” means 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 described in subdivision (c).

(3) “Epinephrine auto-injector” means a disposable begin delete 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. end delete begin insert end insert begin insert delivery
device designed for the automatic injection of a premeasured dose
of epinephrine into the human body to prevent or treat a
life-threatening allergic reaction. end insert

(4) “Lay rescuer” means any person who has met the training
standards and other requirements of this section but who is not
otherwise licensed or certified to use an epinephrine auto-injector
on another person.

(5) “Prehospital emergency medical care person” has the same
meaning as defined in paragraph (2) of subdivision (a) of Section
1797.189.

(b) A prehospital emergency medical care person or lay rescuer
may use an epinephrine auto-injector to render emergency care to
another person if all of the following requirements are met:

(1) The epinephrine auto-injector is legally obtained by
prescription from an authorized health care provider or from an
authorized entity that acquired the epinephrine auto-injector
pursuant to subdivision (e).

(2) The epinephrine auto-injector is used on another, with the
expressed or implied consent of that person, to treat anaphylaxis.

(3) The epinephrine auto-injector is stored and maintained as
directed by the manufacturer’s instructions for that product.

(4) The person using the epinephrine auto-injector has
successfully completed a course of training with an authorized
training provider, as described in subdivision (c), and has current
certification of training issued by the provider.

(5) The epinephrine auto-injectors obtained by prehospital
emergency medical care personnel pursuant to Section 4119.3 of
the Business and Professions Code shall be used only when
functioning outside the course of the person’s occupational duties,
or as a volunteer, pursuant to this section.

(6) The Emergency Medical Services System is activated as
soon as practicable when an epinephrine auto-injector is used.

(c) (1) The authorized training providers shall be approved,
and the minimum standards for training and the use and
administration of epinephrine auto-injectors pursuant to this section
shall be established and approved, by the authority. The authority
may designate existing training standards for the use and
administration of epinephrine auto-injectors by prehospital
emergency medical care personnel to satisfy the requirements of
this section.

(2) The minimum training and requirements shall include all of
the following components:

(A) Techniques for recognizing circumstances, signs, and
symptoms of anaphylaxis.

(B) Standards and procedures for proper storage and emergency
use of epinephrine auto-injectors.

(C) Emergency followup procedures, including activation of
the Emergency Medical Services System, by calling the emergency
9-1-1 telephone number or otherwise alerting and summoning
more advanced medical personnel and services.

(D) Compliance with all regulations governing the training,
indications, use, and precautions concerning epinephrine
auto-injectors.

(E) Written material covering the information required under
this provision, including the manufacturer product information
sheets on commonly available models of epinephrine auto-injectors.

(F) Completion of a training course in cardiopulmonary
resuscitation and the use of an automatic external defibrillator
(AED) for infants, children, and adults that complies with
regulations adopted by the authority and the standards of the
American Heart Association or the American Red Cross, and a
current certification for that training.

(3) Training certification shall be valid for no more than two
years, after which recertification with an authorized training
provider is required.

(4) The director may, in accordance with regulations adopted
by the authority, deny, suspend, or revoke any approval issued
under this subdivision or may place any approved training provider
on probation upon a finding by the director of an imminent threat
to public health and safety, as evidenced by any of the following:

(A) Fraud.

(B) Incompetence.

(C) The commission of any fraudulent, dishonest, or corrupt
act that is substantially related to the qualifications, functions, or
duties of training program directors or instructors.

(D) Conviction of any crime that is substantially related to the
qualifications, functions, or duties of training program directors
or instructors. The record of conviction or a certified copy of the
record shall be conclusive evidence of the conviction.

(E) Violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of, or conspiring to violate,
any provision of this section or the regulations promulgated by the
authority pertaining to the review and approval of training
programs in anaphylaxis and the use and administration of
epinephrine auto-injectors, as described in this subdivision.

(d) (1) The authority shall assess a fee pursuant to regulation
sufficient to cover the reasonable costs incurred by the authority
for the ongoing review and approval of training and certification
under subdivision (c).

(2) The fees shall be deposited in the Specialized First Aid
Training Program Approval Fund, which is hereby created in the
State Treasury. All moneys deposited in the fund shall be made
available, upon appropriation, to the authority for purposes
described in paragraph (1).

(3) The authority may transfer unused portions of the Specialized
First Aid Training Program Approval Fund to the Surplus Money
Investment Fund. Funds transferred to the Surplus Money
Investment Fund shall be placed in a separate trust account, and
shall be available for transfer to the Specialized First Aid Training
Program Approval Fund, together with the interest earned, when
requested by the authority.

(4) The authority shall maintain a reserve balance in the
Specialized First Aid Training Program Approval Fund of 5 percent
of annual revenues. Any increase in the fees deposited in the
Specialized First Aid Training Program Approval Fund shall be
effective upon determination by the authority that additional
moneys are required to fund expenditures pursuant to subdivision
(c).

(e) (1) An authorized health care provider may issue a
prescription for an epinephrine auto-injector 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 epinephrine auto-injector certification card issued by the
authority demonstrating that the person is trained and qualified to
administer an epinephrine auto-injector pursuant to this section or
any other law.

(2) An authorized health care provider may issue a prescription
for an epinephrine auto-injector to an authorized entity 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 the
authority demonstrating that the person is qualified to administer
an epinephrine auto-injector pursuant to this section.

(f) An authorized entity that possesses and makes available
epinephrine auto-injectors shall do both of the following:

(1) Create and maintain on its premises an operations plan that
includes all of the following:

(A) The name and contact number for the authorized 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 training program required by this section 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.

(E) The process to replace the expired epinephrine auto-injector,
including the proper disposal of the expired epinephrine
auto-injector or used epinephrine auto-injector in a sharps
container.

(2) Submit to the authority, in a manner identified by the
authority, a report of each incident that involves the use of an
epinephrine auto-injector, not more than 30 days after each use.
The authority shall annually publish a report that summarizes all
reports submitted to it under this subdivision.

(g) This section shall not apply to a school district or county
office of education, or its personnel, that provides and utilizes
epinephrine auto-injectors to provide emergency medical aid
pursuant to Section 49414 of the Education Code.

(h) This section shall not be construed to limit or restrict the
ability of prehospital emergency medical care personnel, under
any other statute or regulation, to administer epinephrine, including
the use of epinephrine auto-injectors, or to require additional
training or certification beyond what is already required under the
other statute or regulation.

begin delete SEC. 4. end delete

begin insert SEC. 5. end insert   

No reimbursement is required by this act pursuant to
Section 6 of Article XIII B 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, within the meaning of Section 17556 of
the Government Code, or changes the definition of a crime within
the meaning of Section 6 of Article XIII B of the California
Constitution.