BILL NUMBER: AB 1386 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY JANUARY 4, 2016
AMENDED IN ASSEMBLY APRIL 16, 2015
AMENDED IN ASSEMBLY MARCH 26, 2015
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, 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 also requires the
California Emergency Medical Services (EMS)
Authority to establish or approve
authorized training providers and the minimum standards
for training and the use and administration of epinephrine
auto-injectors, in consultation with the local emergency medical
system agency, the county health department, the manufacturer, the
State Department of Health Care Services, and other private
organizations. The auto-injectors. The existing
Pharmacy Law 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.
This bill would authorize 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 pursuant to those
provisions. Because a violation of these provisions would be a crime,
the bill would impose a state-mandated local program. The bill would
also 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 State Department of Public Health on
incidents related to the administration of epinephrine
auto-injectors, and for auto-injectors. The bill would
also require the department to issue an annual report
summarizing and analyzing the reports submitted to it.
the department pursuant to the bill's provisions.
(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 employees, agents, or other trained
individuals of an authorized entity 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. The bill would
also provide that an authorized entity located in this state shall
not be liable, in this state, for any injuries or related damages
that result from the provision or administration of an epinephrine
auto-injector by its employees or agents outside of this state if the
entity or its employee or agent would not have been liable for those
injuries or related damages had the provision or administration
occurred within this state.
The
(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 at 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.
(b)
(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.
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 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.
(b) (1) Any person described in subdivision (b) of Section
1797.197a of the Health and Safety Code or employees, agents, or
other trained individuals of an authorized entity, as defined by
paragraph (2) of subdivision (a) 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) An authorized health care provider that prescribes or
dispenses an epinephrine auto-injector or a pharmacist
that dispenses an epinephrine auto-injector to a person
described in subdivision (b) of Section 1797.197a of the Health and
Safety Code or an authorized entity is not liable for any civil
damages resulting from any act or omission related to the provision
of an epinephrine auto-injector.
(3) A person that conducts the training described in subdivision
(c) of Section 1797.197a of the Health and Safety Code is not liable
for any civil damages resulting from any act or omission related to
the acquisition, possession, administration, or provision of an
epinephrine auto-injector.
(4) An authorized entity located in this state shall not be
liable, in this state, for any injuries or related damages that
result from the provision or administration of an epinephrine
auto-injector by its employees or agents outside of this state if the
entity or its employee or agent would not have been liable for those
injuries or related damages had the provision or administration
occurred within this state.
(5) An authorized entity that possesses and makes available
epinephrine auto-injectors, including third parties that facilitate
the availability of epinephrine auto-injectors to an authorized
entity, is not liable for any injuries or related damages that result
from any act or omission taken pursuant to this section.
(5)
(6) This subdivision does not eliminate, limit, or
reduce any other immunity or defense that may otherwise be available
under state 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.
SEC. 3. 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 entity or organization in
connection with, or at which, allergens capable of causing
anaphylaxis may be present, including, but not limited to, recreation
camps, colleges and universities, day care facilities, youth
sport sports leagues, amusement parks,
restaurants, places of employment, and sports arenas.
(3) "Epinephrine auto-injector" means a disposable drug delivery
system with a spring-activated concealed needle that is designed for
emergency administration of epinephrine to provide rapid, convenient
first aid for persons suffering from anaphylaxis.
(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, lay rescuer, or
employees, agents, or other trained individuals of an authorized
entity 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). An authorized health care provider may
issue a prescription for an epinephrine auto-injector to a person
described in this subdivision 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
epinephrine auto-injector as a prehospital emergency medical care
person or lay rescuer, pursuant to this section or any other statute
or regulation.
(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 California Emergency
Medical Services (EMS) Authority. 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 EMS Authority
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 of the authority 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) An authorized health care provider may prescribe epinephrine
auto-injectors to an authorized entity or to an employee or agent of
which that an authorized entity who
holds a current valid certification
demonstrating that the person is trained and qualified to administer
an epinephrine auto-injector as a lay rescuer. Epinephrine
auto-injectors acquired by an authorized entity shall be stored in a
location readily accessible in an emergency and in accordance with
the epinephrine auto-injectors instructions for use and any
additional requirements that may be established by the EMS
Authority. authority.
(f) An authorized entity that possesses and makes available
epinephrine auto-injectors shall submit 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.
(2) Submit to the State
Department of Public Health, on a form developed by the State
Department of Public Health, a report of each incident on the
authorized entity's premises that involves the administration of an
epinephrine auto-injector. The State Department of Public Health
shall annually publish a report that summarizes and analyzes 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.
SEC. 4. 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.