SB 669, as introduced, 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 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 establish or approve authorized training providers and 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 bill would specify components to be included in the minimum training and requirements. The bill would provide that these minimum standards apply to a school district or county office of education for the emergency administration of epinephrine auto-injectors, but would permit the adoption of more stringent standards.
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 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. 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.
(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
5care person, first responder, or lay rescuer for the purpose of
6rendering 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. The
12physician and surgeon may issue the prescription only upon
13presentation of a current certificate demonstrating that the person
14is trained and qualified under Section 1797.197a of the Health and
15Safety Code to administer an epinephrine auto-injector to another
16person in an emergency situation. The prescription shall specify
17that the dispensed epinephrine auto-injector is for “EMS Purposes
18Only” and that the named recipient is a “Section 1797.197a
19Responder.” A new prescription shall be written for any additional
20epinephrine auto-injectors required.
21(2) (A) The pharmacy shall label each epinephrine auto-injector
22dispensed with all of the following:
23(i) The name of the person to whom the prescription was issued.
24(ii) The designations “Section 1797.197a Responder” and “EMS
26(iii) The dosage, use, and expiration date.
27(B) Each dispensed prescription shall include the manufacturer's
28 product information sheet for the epinephrine auto-injector.
29(b) The person described in subdivision (b) of Section 1797.197a
30of the Health and Safety Code receiving epinephrine auto-injectors
31pursuant to this section shall make and maintain a record for five
32years reflecting dates of receipt, use, and destruction of each
33auto-injector dispensed, the name of any person to whom
34epinephrine was administered using an auto-injector, and the
35circumstances and manner of destruction of any auto-injectors.
36(c) The epinephrine auto-injectors dispensed pursuant to this
37section may be used only for the purpose, and under the
P4 1circumstances, 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
5definitions shall apply:
6(1) “Anaphylaxis” means a potentially life-threatening
7hypersensitivity or allergic reaction to a substance.
8(A) Symptoms of anaphylaxis may include shortness of breath,
9wheezing, difficulty breathing, difficulty talking or swallowing,
10hives, itching, swelling, shock, or asthma.
11(B) Causes of anaphylaxis may include, but are not limited to,
12insect stings or bites, foods, drugs, and other allergens, as well as
13idiopathic or exercise-induced anaphylaxis.
auto-injector” means a disposable drug delivery
15system with a spring-activated concealed needle that is designed
16for emergency administration of epinephrine to provide rapid,
17convenient first aid for persons suffering from anaphylaxis.
18(b) Any person described in subdivision (b) of Section
191797.197a of the Health and Safety Code who administers an
20epinephrine auto-injector to another person who appears to be
21experiencing anaphylaxis at the scene of an emergency situation,
22in good faith and not for compensation, is not liable for any civil
23damages resulting from his or her acts or omissions in
24administering the epinephrine auto-injector, if that person has
25complied with the requirements and standards of Section 1797.197a
26of the Health and Safety Code.
27(c) This section does not grant immunity from civil damages to
28any person whose conduct in rendering emergency care constitutes
29 gross negligence.
30(d) In order to encourage training of persons described in
31subdivision (b) of Section 1797.197a of the Health and Safety
32Code in the emergency administration of epinephrine
33auto-injectors, and to encourage that emergency care, a local
34agency, entity of state or local government, or other public or
35private organization that sponsors, authorizes, supports, finances,
36or supervises the training of those persons, or develops standards
37in accordance with Section 1797.197a of the Health and Safety
38Code, including, but not limited to, the California Emergency
39Medical Services (EMS) Authority, the local Emergency Medical
40System Agency, the county Department of Health, the State
P5 1Department of Health Care Services, the American Academy of
2Allergy, Asthma & Immunology, the American Academy of
3Pediatrics, the American Heart Association, the American Red
4Cross, and the California Medical Association, shall not be liable
5for civil damages alleged to result from those training programs
7(e) Nothing in this section relieves a manufacturer, designer,
8developer, distributor, or supplier of an epinephrine auto-injector
9of liability under any other applicable law.
Section 1797.197a is added to the Health and Safety
11Code, to read:
(a) For purposes of this section, the following
13definitions shall apply:
14(1) “Anaphylaxis” means a potentially life-threatening
15hypersensitivity or allergic reaction to a substance.
16(A) Symptoms of anaphylaxis may include shortness of breath,
17wheezing, difficulty breathing, difficulty talking or swallowing,
18hives, itching, swelling, shock, or asthma.
19(B) Causes of anaphylaxis may include, but are not limited to,
20insect stings or bites, foods, drugs, and other allergens, as well as
21idiopathic or exercise-induced anaphylaxis.
22(2) “Epinephrine auto-injector” means a
disposable drug delivery
23system with a spring-activated concealed needle that is designed
24for emergency administration of epinephrine to provide rapid,
25convenient first aid for persons suffering from anaphylaxis.
26(3) “First responder” means a police officer, firefighter, rescue
27worker, or any other person who provides emergency response,
28first aid care, or other medically related assistance either in the
29course of the person’s occupational duties or as a volunteer.
30(4) “Lay rescuer” means any person not otherwise licensed or
31certified to use an epinephrine auto-injector on another who has
32met the training standards and other requirements of this section.
33(5) “Prehospital emergency medical care person” has the same
34meaning as defined in paragraph (2) of subdivision (a) of Section
36(b) A prehospital emergency medical care person, first
37responder, or a lay rescuer may use an epinephrine auto-injector
38to render emergency care to another person if all of the following
39requirements are met:
P6 1(1) The epinephrine auto-injector is legally obtained by
2prescription from an authorized health care provider. An authorized
3health care provider may issue a prescription for an epinephrine
4auto-injector to a person described in this subdivision for the
5purpose of rendering emergency care to another person, upon
6presentation of current certification demonstrating that person is
7trained and qualified pursuant to this section to administer an
8epinephrine auto-injector as a prehospital emergency medical care
9person, first responder, or lay rescuer.
10(2) The epinephrine auto-injector is used on another, with the
11 expressed or implied consent of that person, for the indicated
12purpose described in paragraphs (1) and (2) of subdivision (a).
13(3) The epinephrine auto-injector is stored and maintained as
14directed by the manufacturer’s instructions for that product.
15(4) The person using the auto-injector has successfully
16completed a course of training with an authorized training provider,
17as described in subdivision (c), and has current certification of
18training issued by the provider.
19(c) (1) The authorized training providers and minimum
20standards for training and the use and administration of epinephrine
21auto-injectors pursuant to this section shall be established and
22approved by the California Emergency Medical Services (EMS)
23Authority in consultation with the local emergency medical system
24agency, the county health department, manufacturers, the State
25Department of Health Care Services, the American Academy of
26Allergy, Asthma & Immunology, the American Academy of
27Pediatrics, the American Heart Association, the American Red
28Cross, and the California Medical Association.
29(2) The minimum training and requirements shall include all of
30the following components:
31(A) Techniques for recognizing circumstances, signs, and
32symptoms of anaphylaxis.
33(B) Standards and procedures for proper storage and emergency
34use of epinephrine auto-injectors.
35(C) Emergency follow-up procedures, including activation of
36the Emergency Medical System, by calling the emergency 911
37telephone number or otherwise alerting and summoning more
38advanced medical personnel and services.
P7 1(D) Compliance with all regulations governing the training,
2indications, use, and precautions concerning epinephrine
4(E) Written material covering the information required under
5this provision, including the manufacturer product information
6sheets on commonly available models of epinephrine auto-injectors.
7(F) Completion of a training course in cardiopulmonary
8resuscitation and the use of an automatic external defibrillator
9(AED) for infants, children, and adults that complies with
10regulations adopted by the EMS Authority and the standards of
11the American Heart Association or the American Red Cross, and
12a current certification for that training.
13(G) Training certification for no more than two years, after
14which recertification with an authorized training provider is
16(3) The minimum standards established and approved pursuant
17to this subdivision apply to a school district or county office of
18education, which may adopt more stringent standards for training
19and the use and emergency administration of epinephrine
20auto-injectors pursuant to Section 49414 of the Education Code.
No reimbursement is required by this act pursuant to
22Section 6 of Article XIII B of the California Constitution because
23the only costs that may be incurred by a local agency or school
24district will be incurred because this act creates a new crime or
25infraction, eliminates a crime or infraction, or changes the penalty
26for a crime or infraction, within the meaning of Section 17556 of
27the Government Code, or changes the definition of a crime within
28the meaning of Section 6 of Article XIII B of the California