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 person, first responder, 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 begin delete establish and end delete approve authorized training providers and begin insert to establish and approve end insert minimum standards for training and the use and administration of epinephrine begin delete auto-injectors, in consultation with representatives from a local emergency medical services agency and a county health department, manufacturers, the State Department of Public Health, and other private organizations end delete begin insert auto-injectors end insert . The bill would specify components to be included in the minimum training and requirements. Under the bill, these 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. This 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 person, first responder, 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.

(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 person, first responder, 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. 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.

(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 person, first responder, 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 “EMS 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 “EMS
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.

(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 begin insert Public end insert Health begin delete Care Services end delete , 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) 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.

(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.

(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, first
responder, or a 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 pursuant to this section to administer an
epinephrine auto-injector as a prehospital emergency medical care
person, first responder, or lay rescuer.

(2) The epinephrine auto-injector is used on another, with the
expressed or implied consent of that person, for the indicated
purpose described in paragraphs (1) and (2) of subdivision (a).

(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.

(c) (1) The authorized training providers begin insert shall be approved, end insert
and begin insert the end insert minimum standards for training and the use and
administration of epinephrine auto-injectors pursuant to this section
shall be established and begin delete approved end delete begin insert approved, end insert by the California
Emergency Medical Services (EMS) Authority begin delete in consultation
with a representative from a local emergency medical services
agency, a representative from a county health department,
manufacturers, 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 end delete .
begin insert The authority may designate existing training standards for the
use and administration of epinephrine auto-injectors by first
responders and prehospital emergency medical care personnel to
satisfy the requirements of this section. end insert

(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 System, by calling the emergency 911
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.

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

(d) 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.

(e)  begin delete Nothing in this end delete begin insert This end insert section shall begin insert not end insert be construed to limit
or restrict the ability of prehospital emergency medical care
personnel begin insert , under any other statute or regulation, end insert to administer
epinephrine, including the use of epinephrine auto-injectors, or to
require additional training or begin delete certification, if the administration of
epinephrine is part of their scope of practice, as determined by
their respective certifying or licensing entity end delete begin insert certification beyond
what is already required under the other statute or regulation end insert .

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.