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, 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 begin delete Law, end delete begin insert Law end insert 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 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 begin delete entity pursuant to those provisions. end delete begin insert entity, as provided. end insert 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 State Department of Public Health on incidents related to the administration of epinephrine auto-injectors. The bill would also require the department to issue an annual report summarizing and analyzing the reports submitted to 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 begin delete any employee, agent, or other trained individual 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 end delete 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.

(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 begin delete the possession of 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 defined by paragraph (1) of subdivision (a) of
Section 1714.23 of the Civil Code, or by the person who appears
to be experiencing anaphylaxis, as defined by paragraph (1) of
subdivision (a) of Section 1714.23 of the Civil Code. end delete begin insert use by, or
in connection with, an authorized entity. end insert

(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.

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 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.

begin delete

(2) An authorized health care provider that prescribes or
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 of
the lay rescuer, as defined by paragraph (4) of subdivision (a) of
Section 1797.197a of the Health and Safety Code, who renders
emergency care by administering the epinephrine auto-injector.

(4)

end delete

begin insert (2) end insert  (A) An authorized entity shall not be begin delete liable, end delete begin insert liable end insert 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 begin delete Code, or who,
in good faith, and not for compensation, renders emergency
medical or nonmedical care at the scene of an emergency. end delete begin insert Code. end insert

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

begin delete

(5)

end delete

begin insert (3) end insert  This subdivision does not affect any other immunity or
defense that is available under begin delete 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 compensation, renders emergency medical
or nonmedical care at the scene of an emergency as provided by
section 1799.102 of the Health and Safety Code. end delete begin insert law. end insert

(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 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 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 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). begin delete 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. end delete

(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).

begin delete

(e) An authorized health care provider may prescribe epinephrine
auto-injectors to an authorized entity. 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 authority.

end delete begin insert

(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 certification demonstrating that the person is trained
and qualified to administer an epinephrine auto-injector pursuant
to this section or any other law.

end insert begin insert

(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
qualified to administer an epinephrine auto-injector pursuant to
this section.

end insert

(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
begin delete auto-injector. end delete begin insert auto-injector or used epinephrine auto-injector in
a sharps container. end insert

(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.