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 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. 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 4119.3 is added to the Business and
2Professions Code, to read:
(a) Notwithstanding any other law, a pharmacy may
4dispense epinephrine auto-injectors to a prehospital emergency
5medical care person, first responder, or lay rescuer for the purpose
6of rendering emergency care in accordance with Section 1797.197a
7of the Health and Safety Code, if both of the following
8requirements are met:
9(1) A physician and surgeon provides a written order that
10specifies the quantity of epinephrine auto-injectors to be dispensed
11to a person described in subdivision (b) of Section 1797.197a of
12the Health and Safety Code. The physician and surgeon may issue
13the prescription only upon presentation of a current certificate
14demonstrating that the person is trained and qualified under Section
151797.197a of the Health and Safety Code to administer an
16epinephrine auto-injector to another person in an emergency
17situation. The prescription shall specify that the dispensed
18epinephrine auto-injector is for “EMS Purposes Only” and that
19the named recipient is a “Section 1797.197a Responder.” A new
20prescription shall be written for any additional epinephrine
22(2) (A) The pharmacy shall label each epinephrine auto-injector
23dispensed with all of the following:
24(i) The name of the person to whom the prescription was issued.
25(ii) The designations “Section 1797.197a Responder” and “EMS
27(iii) The dosage, use, and expiration date.
P4 1(B) Each dispensed prescription shall include the manufacturer’s
2product information sheet for the epinephrine auto-injector.
3(b) The person described in subdivision (b) of Section 1797.197a
4of the Health and Safety Code receiving epinephrine auto-injectors
5pursuant to this section shall make and maintain a record for five
6years reflecting dates of receipt, use, and destruction of each
7auto-injector dispensed, the name of any person to whom
8epinephrine was administered using an auto-injector, and the
9circumstances and manner of destruction of any auto-injectors.
10(c) The epinephrine auto-injectors dispensed pursuant to this
11section may be used only for the purpose, and under the
12circumstances, described in Section 1797.197a of the Health and
Section 1714.23 is added to the Civil Code, to read:
(a) For purposes of this section, the following
16definitions shall apply:
17(1) “Anaphylaxis” means a potentially life-threatening
18hypersensitivity or allergic reaction to a substance.
19(A) Symptoms of anaphylaxis may include shortness of breath,
20wheezing, difficulty breathing, difficulty talking or swallowing,
21hives, itching, swelling, shock, or asthma.
22(B) Causes of anaphylaxis may include, but are not limited to,
23insect stings or bites, foods, drugs, and other allergens, as well as
24idiopathic or exercise-induced anaphylaxis.
25(2) “Epinephrine auto-injector” means a disposable drug delivery
26system with a spring-activated concealed needle that is designed
27for emergency administration of epinephrine to provide rapid,
28convenient first aid for persons suffering from anaphylaxis.
29(b) Any person described in subdivision (b) of Section
301797.197a of the Health and Safety Code who administers an
31epinephrine auto-injector, in good faith and not for compensation,
32to another person who appears to be experiencing anaphylaxis at
33the scene of an emergency situation is not liable for any civil
34damages resulting from his or her acts or omissions in
35administering the epinephrine auto-injector, if that person has
36complied with the requirements and standards of Section 1797.197a
37of the Health and Safety Code.
38(c) The protection specified in subdivision (b) shall not apply
39in a case of personal injury or wrongful death that results from the
40gross negligence or willful or wanton misconduct of the person
P5 1who renders emergency care treatment by the use of an epinephrine
3(d) (1) In order to encourage training of persons described in
4subdivision (b) of Section 1797.197a of the Health and Safety
5Code in the emergency administration of epinephrine
6auto-injectors, and to encourage that emergency care, a local
7agency, entity of state or local government, or other public or
8private organization that sponsors, authorizes, supports, finances,
9or supervises the training of those persons, or develops standards
10in accordance with Section 1797.197a of the Health and Safety
11Code, including, but not limited to, the California Emergency
12Medical Services (EMS) Authority, the local emergency medical
13system agency, the county department of health, the State
14Department of Public Health, the American Academy of Allergy,
15Asthma & Immunology, the American Academy of Pediatrics, the
16American Heart Association, the American Red Cross, and the
17California Medical Association, shall not be liable for civil
18damages alleged to result from those training programs or
20(2) The protection specified in paragraph (1) shall not apply
21when it is alleged that the personal injury or wrongful death was
22proximately caused by an authorized training provider’s failure to
23meet the minimal statutory training requirements and standards
24established pursuant to subdivision (c) of Section 1797.197a of
25the Health and Safety Code, or it is alleged that the authorized
26training provider otherwise demonstrated gross negligence in the
27training or certification of an individual whose subsequent actions
28caused personal injury or wrongful death in the rendering of
29emergency care treatment by the use of an epinephrine
31(e) Nothing in this section relieves a manufacturer, designer,
32developer, distributor, or supplier of an epinephrine auto-injector
33of liability under any other applicable law.
Section 1797.197a is added to the Health and Safety
35Code, to read:
(a) For purposes of this section, the following
37definitions shall apply:
38(1) “Anaphylaxis” means a potentially life-threatening
39hypersensitivity or allergic reaction to a substance.
P6 1(A) Symptoms of anaphylaxis may include shortness of breath,
2wheezing, difficulty breathing, difficulty talking or swallowing,
3hives, itching, swelling, shock, or asthma.
4(B) Causes of anaphylaxis may include, but are not limited to,
5insect stings or bites, foods, drugs, and other allergens, as well as
6idiopathic or exercise-induced anaphylaxis.
7(2) “Epinephrine auto-injector” means a disposable drug delivery
8system with a spring-activated concealed needle that is designed
9for emergency administration of epinephrine to provide rapid,
10convenient first aid for persons suffering from anaphylaxis.
11(3) “First responder” means a police officer, firefighter, rescue
12worker, or any other person who provides emergency response,
13first aid care, or other medically related assistance either in the
14course of the person’s occupational duties or as a volunteer.
15(4) “Lay rescuer” means any person who has met the training
16standards and other requirements of this section but who is not
17otherwise licensed or certified to use an epinephrine auto-injector
18on another person.
19(5) “Prehospital emergency medical care person” has the same
20meaning as defined in paragraph (2) of subdivision (a) of Section
22(b) A prehospital emergency medical care person, first
23responder, or a lay rescuer may use an epinephrine auto-injector
24to render emergency care to another person if all of the following
25requirements are met:
26(1) The epinephrine auto-injector is legally obtained by
27prescription from an authorized health care provider. An authorized
28health care provider may issue a prescription for an epinephrine
29auto-injector to a person described in this subdivision for the
30purpose of rendering emergency care to another person, upon
31presentation of current certification demonstrating that person is
32trained and qualified pursuant to this section to administer an
33epinephrine auto-injector as a prehospital emergency medical care
34person, first responder, or lay rescuer.
35(2) The epinephrine auto-injector is used on another, with the
36 expressed or implied consent of that person,
begin delete for the indicated described in
begin delete paragraphsend delete
begin delete and (2)end delete of subdivision (a).
39(3) The epinephrine auto-injector is stored and maintained as
40directed by the manufacturer’s instructions for that product.
P7 1(4) The person using the epinephrine auto-injector has
2successfully completed a course of training with an authorized
3training provider, as described in subdivision (c), and has current
4certification of training issued by the provider.
5(c) (1) The authorized training providers shall be approved,
6and the minimum standards for training and the use and
7administration of epinephrine auto-injectors pursuant to this section
8shall be established and approved, by the California Emergency
9Medical Services (EMS) Authority. The authority may designate
10existing training standards for the use and administration of
11epinephrine auto-injectors by first responders and prehospital
12emergency medical care personnel to satisfy the requirements of
14(2) The minimum training and requirements shall include all of
15the following components:
16(A) Techniques for recognizing circumstances, signs, and
17symptoms of anaphylaxis.
18(B) Standards and procedures for proper storage and emergency
19use of epinephrine auto-injectors.
20(C) Emergency followup procedures, including activation of
21the Emergency Medical System, by calling the emergency 911
22telephone number or otherwise alerting and summoning more
23advanced medical personnel and services.
24(D) Compliance with all regulations governing the training,
25indications, use, and precautions concerning epinephrine
27(E) Written material covering the information required under
28this provision, including the manufacturer product information
29sheets on commonly available models of epinephrine auto-injectors.
30(F) Completion of a training course in cardiopulmonary
31resuscitation and the use of an automatic external defibrillator
32(AED) for infants, children, and adults that complies with
33regulations adopted by the EMS Authority and the standards of
34the American Heart Association or the American Red Cross, and
35a current certification for that training.
37 Training certification for no more than two
38years, after which recertification with an authorized training
39provider is required.
P8 1(d) This section shall not apply to a school district or county
2office of education, or its personnel, that provides and utilizes
3epinephrine auto-injectors to provide emergency medical aid
4pursuant to Section 49414 of the Education Code.
5(e) This section shall not be construed to limit or restrict the
6ability of prehospital emergency medical care personnel, under
7any other statute or regulation, to administer epinephrine, including
8the use of epinephrine auto-injectors, or to require additional
9training or certification beyond what is already required under the
10other statute or regulation.
No reimbursement is required by this act pursuant to
12Section 6 of Article XIII B of the California Constitution because
13the only costs that may be incurred by a local agency or school
14district will be incurred because this act creates a new crime or
15infraction, eliminates a crime or infraction, or changes the penalty
16for a crime or infraction, within the meaning of Section 17556 of
17the Government Code, or changes the definition of a crime within
18the meaning of Section 6 of Article XIII B of the California