Amended in Senate May 7, 2013

Amended in Senate April 22, 2013

Senate BillNo. 669


Introduced by Senator Huff

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(Coauthors: Senators Gaines and Nielsen)

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(Coauthors: Assembly Members Dahle and Maienschein)

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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 establishbegin delete orend deletebegin insert andend insert approve authorized training providers and minimum standards for training and the use and administration of epinephrine 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. 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-injectorbegin insert, in good faith and not for compensation,end insert to another person who appears to be experiencing anaphylaxis at the scene of an emergency situationbegin delete, in good faith and not for compensation,end delete 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 standardsbegin insert, except as specifiedend insert. 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 standardsbegin insert, except as specifiedend insert.

(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
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
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.

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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-injectorbegin insert, in good faith and not for compensation,end insert
32 to another person who appears to be experiencing anaphylaxis at
33the scene of an emergency situationbegin delete, in good faith and not for
34compensation,end delete
is not liable for any civil damages resulting from
35his or her acts or omissions in administering the epinephrine
36auto-injector, if that person has complied with the requirements
37and standards of Section 1797.197a of the Health and Safety Code.

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38(c) This section does not grant immunity from civil damages to
39any person whose conduct in rendering emergency care constitutes
40 gross negligence.

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P5    1(c) The protection specified in subdivision (b) shall not apply
2in a case of personal injury or wrongful death that results from
3the gross negligence or willful or wanton misconduct of the person
4who renders emergency care treatment by the use of an epinephrine
5auto-injector.

end insert

6(d) begin insert(1)end insertbegin insertend insert In order to encourage training of persons described in
7subdivision (b) of Section 1797.197a of the Health and Safety
8Code in the emergency administration of epinephrine
9auto-injectors, and to encourage that emergency care, a local
10agency, entity of state or local government, or other public or
11private organization that sponsors, authorizes, supports, finances,
12or supervises the training of those persons, or develops standards
13in accordance with Section 1797.197a of the Health and Safety
14Code, including, but not limited to, the California Emergency
15Medical Services (EMS) Authority, the local emergency medical
16system agency, the county department of health, the State
17Department of Health Care Services, the American Academy of
18Allergy, Asthma & Immunology, the American Academy of
19Pediatrics, the American Heart Association, the American Red
20Cross, and the California Medical Association, shall not be liable
21for civil damages alleged to result from those training programs
22or standards.

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23(2) The protection specified in paragraph (1) shall not apply
24when it is alleged that the personal injury or wrongful death was
25proximately caused by an authorized training provider’s failure
26to meet the minimal statutory training requirements and standards
27established pursuant to subdivision (c) of Section 1797.197a of
28the Health and Safety Code, or it is alleged that the authorized
29training provider otherwise demonstrated gross negligence in the
30training or certification of an individual whose subsequent actions
31caused personal injury or wrongful death in the rendering of
32emergency care treatment by the use of an epinephrine
33auto-injector.

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34(e) Nothing in this section relieves a manufacturer, designer,
35developer, distributor, or supplier of an epinephrine auto-injector
36of liability under any other applicable law.

37

SEC. 3.  

Section 1797.197a is added to the Health and Safety
38Code
, to read:

39

1797.197a.  

(a) For purposes of this section, the following
40definitions shall apply:

P6    1(1) “Anaphylaxis” means a potentially life-threatening
2hypersensitivity or allergic reaction to a substance.

3(A) Symptoms of anaphylaxis may include shortness of breath,
4wheezing, difficulty breathing, difficulty talking or swallowing,
5hives, itching, swelling, shock, or asthma.

6(B) Causes of anaphylaxis may include, but are not limited to,
7insect stings or bites, foods, drugs, and other allergens, as well as
8idiopathic or exercise-induced anaphylaxis.

9(2) “Epinephrine auto-injector” means a disposable drug delivery
10system with a spring-activated concealed needle that is designed
11for emergency administration of epinephrine to provide rapid,
12convenient first aid for persons suffering from anaphylaxis.

13(3) “First responder” means a police officer, firefighter, rescue
14worker, or any other person who provides emergency response,
15first aid care, or other medically related assistance either in the
16course of the person’s occupational duties or as a volunteer.

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17(4) “Lay rescuer” means any person not otherwise licensed or
18certified to use an epinephrine auto-injector on another who has
19met the training standards and other requirements of this section.

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20(4) “Lay rescuer” means any person who has met the training
21standards and other requirements of this section but who is not
22otherwise licensed or certified to use an epinephrine auto-injector
23on another person.

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24(5) “Prehospital emergency medical care person” has the same
25meaning as defined in paragraph (2) of subdivision (a) of Section
261797.189.

27(b) A prehospital emergency medical care person, first
28responder, or a lay rescuer may use an epinephrine auto-injector
29to render emergency care to another person if all of the following
30requirements are met:

31(1) The epinephrine auto-injector is legally obtained by
32prescription from an authorized health care provider. An authorized
33health care provider may issue a prescription for an epinephrine
34auto-injector to a person described in this subdivision for the
35purpose of rendering emergency care to another person, upon
36presentation of current certification demonstrating that person is
37trained and qualified pursuant to this section to administer an
38epinephrine auto-injector as a prehospital emergency medical care
39person, first responder, or lay rescuer.

P7    1(2) The epinephrine auto-injector is used on another, with the
2 expressed or implied consent of that person, for the indicated
3purpose described in paragraphs (1) and (2) of subdivision (a).

4(3) The epinephrine auto-injector is stored and maintained as
5directed by the manufacturer’s instructions for that product.

6(4) The person using the epinephrine auto-injector has
7successfully completed a course of training with an authorized
8training provider, as described in subdivision (c), and has current
9certification of training issued by the provider.

10(c) (1) The authorized training providers and minimum
11standards for training and the use and administration of epinephrine
12auto-injectors pursuant to this section shall be established and
13approved by the California Emergency Medical Services (EMS)
14Authority in consultation with a representative from a local
15emergency medical services agency, a representative from a county
16health department, manufacturers, the State Department of Public
17Health, the American Academy of Allergy, Asthma &
18 Immunology, the American Academy of Pediatrics, the American
19Heart Association, the American Red Cross, and the California
20Medical Association.

21(2) The minimum training and requirements shall include all of
22the following components:

23(A) Techniques for recognizing circumstances, signs, and
24symptoms of anaphylaxis.

25(B) Standards and procedures for proper storage and emergency
26use of epinephrine auto-injectors.

27(C) Emergency followup procedures, including activation of
28the Emergency Medical System, by calling the emergency 911
29telephone number or otherwise alerting and summoning more
30advanced medical personnel and services.

31(D) Compliance with all regulations governing the training,
32indications, use, and precautions concerning epinephrine
33auto-injectors.

34(E) Written material covering the information required under
35this provision, including the manufacturer product information
36sheets on commonly available models of epinephrine auto-injectors.

37(F) Completion of a training course in cardiopulmonary
38resuscitation and the use of an automatic external defibrillator
39(AED) for infants, children, and adults that complies with
40regulations adopted by the EMS Authority and the standards of
P8    1the American Heart Association or the American Red Cross, and
2a current certification for that training.

3(G) Training certification for no more than two years, after
4which recertification with an authorized training provider is
5required.

6(d) This section shall not apply to a school district or county
7office of education, or its personnel, that provides and utilizes
8epinephrine auto-injectors to provide emergency medical aid
9pursuant to Section 49414 of the Education Code.

10(e) Nothing in this section shall be construed to limit or restrict
11the ability of prehospital emergency medical care personnel to
12administer epinephrine, including the use of epinephrine
13auto-injectors, or to require additional training or certification, if
14the administration of epinephrine is part of their scope of practice,
15as determined by their respective certifying or licensing entity.

16

SEC. 4.  

No reimbursement is required by this act pursuant to
17Section 6 of Article XIII B of the California Constitution because
18the only costs that may be incurred by a local agency or school
19district will be incurred because this act creates a new crime or
20infraction, eliminates a crime or infraction, or changes the penalty
21for a crime or infraction, within the meaning of Section 17556 of
22the Government Code, or changes the definition of a crime within
23the meaning of Section 6 of Article XIII B of the California
24Constitution.



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