Amended in Assembly September 3, 2013

Amended in Assembly July 3, 2013

Amended in Senate May 28, 2013

Amended in Senate May 7, 2013

Amended in Senate April 22, 2013

Senate Bill No. 669

Introduced by Senator Huff

(Coauthors: Senators Gaines and Nielsen)

(Coauthors: Assembly Members Dahle and Maienschein)

February 22, 2013

An act to add Section 4119.3 to the Business and Professions Code, to add Section 1714.23 to the Civil Code, and to add Section 1797.197a to the Health and Safety Code, relating to emergency medical care.

LEGISLATIVE COUNSEL’S DIGEST

SB 669, as amended, Huff. Emergency medical care: epinephrine auto-injectors.

(1) Existing law authorizes a school district or county office of education to provide emergency epinephrine auto-injectors to trained personnel, and authorizes that trained personnel to utilize those epinephrine auto-injectors to provide emergency medical aid to persons suffering from an anaphylactic reaction. The Pharmacy Law authorizes a pharmacy to furnish epinephrine auto-injectors to a school district or county office of education if certain conditions are met. A violation of the Pharmacy Law is a crime.

Existing law requires the Emergency Medical Services Authority to establish training and standards for all prehospital emergency medical care personnel regarding the characteristics and method of assessment and treatment of anaphylactic reactions and the use of epinephrine, and to promulgate regulations therefor.

This bill would authorize a prehospital emergency medical care begin delete person, first responder, end delete begin insert person end insert or lay rescuer to use an epinephrine auto-injector to render emergency care to another person, as specified. The bill would require the California Emergency Medical Services (EMS) Authority to approve authorized training providers and to establish and approve minimum standards for training and the use and administration of epinephrine auto-injectors. The bill would specify components to be included in the minimum training and requirements. begin delete Under the bill, these end delete begin insert The bill would authorize the director of the authority to deny, suspend, or revoke any approval or place any approved training provider on probation upon a finding by the director of an imminent threat to public health and safety, as prescribed. The bill would create the Specialized First Aid Training Program Approval Fund, and require the authority to assess a fee, to be deposited into the fund, to cover the reasonable costs incurred by the authority for the ongoing review and approval of training and certification. end insert

begin insert These end insert provisions would 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 care, as specified. begin delete This end delete begin insert The end insert bill would provide that nothing in these provisions shall be construed to limit or restrict the ability of prehospital emergency medical care personnel to administer epinephrine, including the use of epinephrine auto-injectors, or to require additional training or certification, if the administration of epinephrine is part of their scope of practice.

The bill would authorize a pharmacy to dispense epinephrine auto-injectors to a prehospital emergency medical care begin delete person, first responder, end delete begin insert person end insert or lay rescuer for the purpose of rendering emergency care in accordance with these provisions. Because a violation of this requirement would be a crime, the bill would impose a state-mandated local program. begin insert The bill would require epinephrine auto-injectors obtained by prehospital emergency medical care personnel to be used only when functioning outside the course of the person’s occupational duties, or as a volunteer, 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.

This bill would provide that a prehospital emergency medical care begin delete person, first responder, end delete begin insert person end insert or lay rescuer 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 specified certification and training requirements and standards, except as specified. begin delete The bill also would provide immunity to a local agency, entity of state or local government, or other public or private organization that sponsors, authorizes, supports, finances, or supervises the training of those persons, or develops standards, for civil damages alleged to result from those training programs or standards, except as specified. end delete

(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 4119.3 is added to the Business and
Professions Code, to read:

4119.3.  

(a) Notwithstanding any other law, a pharmacy may
dispense epinephrine auto-injectors to a prehospital emergency
medical care begin delete person, first responder, end delete begin insert person end insert or lay rescuer for the
purpose of rendering emergency care in accordance with Section
1797.197a of the Health and Safety Code, if both of the following
requirements are met:

(1) A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be dispensed
to a person described in subdivision (b) of Section 1797.197a of
the Health and Safety Code. The physician and surgeon may issue
the prescription only upon presentation of a current certificate
demonstrating that the person is trained and qualified under Section
1797.197a of the Health and Safety Code to administer an
epinephrine auto-injector to another person in an emergency
situation. The prescription shall specify that the dispensed
epinephrine auto-injector is for begin delete “EMS end delete begin insert “First Aid end insert Purposes Only”
and that the named recipient is a “Section 1797.197a Responder.”
A new prescription shall be written for any additional epinephrine
auto-injectors required.

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

(i) The name of the person to whom the prescription was issued.

(ii) The designations “Section 1797.197a Responder” and begin delete “EMS end delete
begin insert “First Aid end insert Purposes Only.”

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

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

(b) The person described in subdivision (b) of Section 1797.197a
of the Health and Safety Code receiving epinephrine auto-injectors
pursuant to this section shall make and maintain a record for five
years reflecting dates of receipt, use, and destruction of each
auto-injector dispensed, the name of any person to whom
epinephrine was administered using an auto-injector, and the
circumstances and manner of destruction of any auto-injectors.

(c) The epinephrine auto-injectors 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 is added to the Civil Code, 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) 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.

(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.

begin delete

(d) (1) In order to encourage training of persons described in
subdivision (b) of Section 1797.197a of the Health and Safety
Code in the emergency administration of epinephrine
auto-injectors, and to encourage that emergency care, a local
agency, entity of state or local government, or other public or
private organization that sponsors, authorizes, supports, finances,
or supervises the training of those persons, or develops standards
in accordance with Section 1797.197a of the Health and Safety
Code, including, but not limited to, the California Emergency
Medical Services (EMS) Authority, the local emergency medical
system agency, the county department of health, the State
Department of Public Health, the American Academy of Allergy,
Asthma & Immunology, the American Academy of Pediatrics, the
American Heart Association, the American Red Cross, and the
California Medical Association, shall not be liable for civil
damages alleged to result from those training programs or
standards.

(2) The protection specified in paragraph (1) shall not apply
when it is alleged that the personal injury or wrongful death was
proximately caused by an authorized training provider’s failure to
meet the minimal statutory training requirements and standards
established pursuant to subdivision (c) of Section 1797.197a of
the Health and Safety Code, or it is alleged that the authorized
training provider otherwise demonstrated gross negligence in the
training or certification of an individual whose subsequent actions
caused personal injury or wrongful death in the rendering of
emergency care treatment by the use of an epinephrine
auto-injector.

(e)

end delete

begin insert ( end insert begin insert d) end insert  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 is added to the Health and Safety
Code, 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) “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.

begin delete

(3) “First responder” means a police officer, firefighter, rescue
worker, or any other person who provides emergency response,
first aid care, or other medically related assistance either in the
course of the person’s occupational duties or as a volunteer.

end delete begin delete

(4)

end delete

begin insert ( end insert begin insert 3) end insert  “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.

begin delete

(5)

end delete

begin insert ( end insert begin insert 4) end insert  “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 begin delete person, first
responder, or a end delete begin insert person or end insert 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. 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 begin delete pursuant to this section end delete to administer an
epinephrine auto-injector as a prehospital emergency medical care
begin delete person, first responder, end delete begin insert person end insert or lay begin delete rescuer end delete begin insert rescuer, pursuant to
this section or any other statute or regulation end insert .

(2) The epinephrine auto-injector is used on another, with the
expressed or implied consent of that person, to begin delete address the
conditions described in subparagraph (A) of paragraph (1) of
subdivision (a) end delete begin insert treat anaphylaxis end insert .

(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.

begin insert

(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.

end insert begin insert

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

end insert

(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. The authority may designate
existing training standards for the use and administration of
epinephrine auto-injectors by begin delete first responders and end delete 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 begin insert Services end insert System, by calling the emergency
begin delete 911 end delete begin insert 9-1-1 end insert 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 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.

begin insert

(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:

end insert begin insert

(A) Fraud.

end insert begin insert

(B) Incompetence.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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).

end insert begin insert

(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).

end insert begin insert

(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.

end insert begin insert

(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).

end insert begin delete

(d)

end delete

begin insert (e) end insert  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.

begin delete

(e)

end delete

begin insert (f) end insert  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.