Amended in Senate April 22, 2013

Senate BillNo. 669


Introduced by Senator Huff

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 emergencybegin insert medicalend insert 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 withbegin delete theend deletebegin insert representatives from aend insert local emergency medicalbegin delete system agency, theend deletebegin insert services agency and aend insert county health department,begin delete the manufacturerend deletebegin insert manufacturersend insert, the State Department ofbegin insert Publicend insert Healthbegin delete Care Servicesend delete, and other private organizations. The bill would specify components to be included in the minimum training and requirements.begin delete The billend deletebegin insert Under the bill, these provisionsend insert wouldbegin delete provide that these minimum standardsend deletebegin insert notend insert apply to a school district or county office ofbegin delete education for the emergency administration ofend deletebegin insert education, or its personnel, that provides and utilizesend insert epinephrinebegin delete auto-injectors, but would permit the adoption of more stringent standardsend deletebegin insert auto-injectors to provide emergency medical care, as specifiedend insert.begin insert 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.end insert

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 emergencybegin insert medicalend insert 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:

P3    1

SECTION 1.  

Section 4119.3 is added to the Business and
2Professions Code
, to read:

3

4119.3.  

(a) Notwithstanding any other law, a pharmacy may
4dispense epinephrine auto-injectors to a prehospital emergency
5begin insert medical end insert 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 1797.197abegin insert of
12the Health and Safety Codeend insert
. 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
21auto-injectors required.

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
26Purposes Only.”

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
13Safety Code.

14

SEC. 2.  

Section 1714.23 is added to the Civil Code, to read:

15

1714.23.  

(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 to another person who appears to be
32experiencing anaphylaxis at the scene of an emergency situation,
33in good faith and not for compensation, 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) This section does not grant immunity from civil damages to
39any person whose conduct in rendering emergency care constitutes
40 gross negligence.

P5    1(d) In order to encourage training of persons described in
2subdivision (b) of Section 1797.197a of the Health and Safety
3Code in the emergency administration of epinephrine
4auto-injectors, and to encourage that emergency care, a local
5agency, entity of state or local government, or other public or
6private organization that sponsors, authorizes, supports, finances,
7or supervises the training of those persons, or develops standards
8in accordance with Section 1797.197a of the Health and Safety
9Code, including, but not limited to, the California Emergency
10Medical Services (EMS) Authority, the local emergency medical
11system agency, the county department of health, the State
12Department of Health Care Services, the American Academy of
13Allergy, Asthma & Immunology, the American Academy of
14Pediatrics, the American Heart Association, the American Red
15Cross, and the California Medical Association, shall not be liable
16for civil damages alleged to result from those training programs
17or standards.

18(e) Nothing in this section relieves a manufacturer, designer,
19developer, distributor, or supplier of an epinephrine auto-injector
20of liability under any other applicable law.

21

SEC. 3.  

Section 1797.197a is added to the Health and Safety
22Code
, to read:

23

1797.197a.  

(a) For purposes of this section, the following
24definitions shall apply:

25(1) “Anaphylaxis” means a potentially life-threatening
26hypersensitivity or allergic reaction to a substance.

27(A) Symptoms of anaphylaxis may include shortness of breath,
28wheezing, difficulty breathing, difficulty talking or swallowing,
29hives, itching, swelling, shock, or asthma.

30(B) Causes of anaphylaxis may include, but are not limited to,
31insect stings or bites, foods, drugs, and other allergens, as well as
32idiopathic or exercise-induced anaphylaxis.

33(2) “Epinephrine auto-injector” means a disposable drug delivery
34system with a spring-activated concealed needle that is designed
35for emergency administration of epinephrine to provide rapid,
36convenient first aid for persons suffering from anaphylaxis.

37(3) “First responder” means a police officer, firefighter, rescue
38worker, or any other person who provides emergency response,
39first aid care, or other medically related assistance either in the
40course of the person’s occupational duties or as a volunteer.

P6    1(4) “Lay rescuer” means any person not otherwise licensed or
2certified to use an epinephrine auto-injector on another who has
3met the training standards and other requirements of this section.

4(5) “Prehospital emergency medical care person” has the same
5meaning as defined in paragraph (2) of subdivision (a) of Section
61797.189.

7(b) A prehospital emergency medical care person, first
8responder, or a lay rescuer may use an epinephrine auto-injector
9to render emergency care to another person if all of the following
10requirements are met:

11(1) The epinephrine auto-injector is legally obtained by
12prescription from an authorized health care provider. An authorized
13health care provider may issue a prescription for an epinephrine
14auto-injector to a person described in this subdivision for the
15purpose of rendering emergency care to another person, upon
16presentation of current certification demonstrating that person is
17trained and qualified pursuant to this section to administer an
18epinephrine auto-injector as a prehospital emergency medical care
19person, first responder, or lay rescuer.

20(2) The epinephrine auto-injector is used on another, with the
21 expressed or implied consent of that person, for the indicated
22purpose described in paragraphs (1) and (2) of subdivision (a).

23(3) The epinephrine auto-injector is stored and maintained as
24directed by the manufacturer’s instructions for that product.

25(4) The person using thebegin insert epinephrineend insert auto-injector has
26successfully completed a course of training with an authorized
27training provider, as described in subdivision (c), and has current
28certification of training issued by the provider.

29(c) (1) The authorized training providers and minimum
30standards for training and the use and administration of epinephrine
31auto-injectors pursuant to this section shall be established and
32approved by the California Emergency Medical Services (EMS)
33Authority in consultation withbegin delete theend deletebegin insert a representative from aend insert local
34emergency medicalbegin delete systemend deletebegin insert services end insert agency,begin delete theend deletebegin insert a representative
35from aend insert
county health department, manufacturers, the State
36Department ofbegin delete Health Care Services,end deletebegin insert Public Health,end insert the American
37Academy of Allergy, Asthma & Immunology, the American
38Academy of Pediatrics, the American Heart Association, the
39American Red Cross, and the California Medical Association.

P7    1(2) The minimum training and requirements shall include all of
2the following components:

3(A) Techniques for recognizing circumstances, signs, and
4symptoms of anaphylaxis.

5(B) Standards and procedures for proper storage and emergency
6use of epinephrine auto-injectors.

7(C) Emergency followup procedures, including activation of
8the Emergency Medical System, by calling the emergency 911
9telephone number or otherwise alerting and summoning more
10advanced medical personnel and services.

11(D) Compliance with all regulations governing the training,
12indications, use, and precautions concerning epinephrine
13auto-injectors.

14(E) Written material covering the information required under
15this provision, including the manufacturer product information
16sheets on commonly available models of epinephrine auto-injectors.

17(F) Completion of a training course in cardiopulmonary
18resuscitation and the use of an automatic external defibrillator
19(AED) for infants, children, and adults that complies with
20regulations adopted by the EMS Authority and the standards of
21the American Heart Association or the American Red Cross, and
22a current certification for that training.

23(G) Training certification for no more than two years, after
24which recertification with an authorized training provider is
25required.

begin delete

26(3) The minimum standards established and approved pursuant
27to this subdivision apply to a school district or county office of
28education, which may adopt more stringent standards for training
29and the use and emergency administration of epinephrine
30auto-injectors pursuant to Section 49414 of the Education Code.

end delete
begin insert

31(d) This section shall not apply to a school district or county
32office of education, or its personnel, that provides and utilizes
33epinephrine auto-injectors to provide emergency medical aid
34pursuant to Section 49414 of the Education Code.

end insert
begin insert

35(e) Nothing in this section shall be construed to limit or restrict
36the ability of prehospital emergency medical care personnel to
37administer epinephrine, including the use of epinephrine
38auto-injectors, or to require additional training or certification,
39if the administration of epinephrine is part of their scope of
P8    1practice, as determined by their respective certifying or licensing
2entity.

end insert
3

SEC. 4.  

No reimbursement is required by this act pursuant to
4Section 6 of Article XIII B of the California Constitution because
5the only costs that may be incurred by a local agency or school
6district will be incurred because this act creates a new crime or
7infraction, eliminates a crime or infraction, or changes the penalty
8for a crime or infraction, within the meaning of Section 17556 of
9the Government Code, or changes the definition of a crime within
10the meaning of Section 6 of Article XIII B of the California
11Constitution.



O

    98