BILL ANALYSIS Ó
SB 669
Page 1
Date of Hearing: July 2, 2013
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Richard S. Gordon, Chair
SB 669 (Huff) - As Amended: May 28, 2013
SENATE VOTE : 38-0
SUBJECT : Emergency medical care: epinephrine auto-injectors.
SUMMARY : Permits a prehospital emergency medical care person,
first responder, or lay rescuer to obtain and use an epinephrine
auto-injector (EA) in emergency situations with certification of
training, as specified. Specifically, this bill :
1)Permits a pharmacy to dispense EAs to a prehospital emergency
medical care person, first responder, or lay rescuer for the
purpose of rendering emergency care, as specified, if both of
the following requirements are met:
a) A physician and surgeon provides a written order, as
follows, that specifies the quantity of EAs to be dispensed
to prehospital emergency medical care person, first
responder, or a lay rescuer:
i) The physician and surgeon has issued the
prescription upon presentation of a current certificate
demonstrating that the person is trained and qualified,
as specified, to administer an EA to another person in an
emergency situation; and,
ii) The prescription specifies that the dispensed EA is
for "EMS [California Emergency Medical Services
Authority] Purposes Only" and that the named recipient is
a "Section 1797.197a Responder;" and a new prescription
is required for any additional EAs; and,
b) The pharmacy labels each EA 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
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"EMS Purposes Only"; and,
iii) The dosage, use, and expiration date.
c) Requires each dispensed prescription to include the
manufacturer's product information sheet for the EA.
2)Requires each person receiving EAs according to this bill to
make and maintain a record for five years reflecting dates of
receipt, use, and destruction of each EA dispensed, the name
of any person to whom epinephrine was administered using an
EA, and the circumstances and manner of destruction of any
EAs.
3)States that the EAs dispensed pursuant to this bill may only
be used for the following purposes and circumstances:
a) The EA is legally obtained by prescription from an
authorized health care provider for the purpose of
rendering emergency care to another person, upon
presentation of current certification demonstrating that
person is trained and qualified to administer an
epinephrine auto-injector as a prehospital emergency
medical care person, first responder, or lay rescuer;
b) The EA is only used on another person, with the
expressed or implied consent of that person, to treat
anaphylaxis;
c) The EA is stored and maintained as directed by the
manufacturer's instructions for that product; and,
d) The person using the EA has successfully completed a
course of training with an authorized training provider, as
specified, and has current certification of training issued
by the provider.
4)Requires authorized training providers to be approved, and the
minimum standards for training and the use and administration
of EAs to be established and approved, by EMS.
5)Permits EMS to designate existing training standards for the
use and administration of EAs by first responders and
prehospital emergency medical care personnel to satisfy the
requirements of this section.
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6)Requires the following to be included in the minimum training
and requirements:
a) Techniques for recognizing circumstances, signs, and
symptoms of anaphylaxis;
b) Standards and procedures for proper storage and
emergency use of EAs;
c) Emergency follow-up 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 EAs;
e) Written material covering the information required under
this bill, including the manufacturer product information
sheets on commonly available models of EAs; and,
f) Completion of a training course in cardiopulmonary
resuscitation (CPR) and the use of an automatic external
defibrillator for infants, children, and adults that
complies with regulations adopted by EMS and the standards
of the American Heart Association or the American Red
Cross, and a current certification for that training.
7)States that certification of training shall be valid for no
more than two years, after which recertification with an
authorized training provider is required.
8)Exempts certain provisions of this bill for a school district
or county office of education, or its personnel, which
provides and utilizes EAs to provide emergency medical aid, as
specified.
9)States that this bill shall not be construed to limit or
restrict the ability of prehospital emergency medical care
personnel, under any other statute or regulation, to
administer epinephrine, including the use of EAs, or to
require additional training or certification beyond what is
already required under the other statute or regulation.
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10)States that any person authorized by this bill who
administers an EA, 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 EA, if that person has complied with the
requirements and standards of this bill.
11)States that the liability exemption 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 EA.
12)States that to encourage the training of authorized persons
in the emergency administration of EAs, 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 this bill, including, but not limited to, EMS; the local
emergency medical system agency; the county department of
health; 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; shall not
be liable for civil damages alleged to result from those
training programs or standards.
13)States that the protection for training groups 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, 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 EA.
14)States that nothing in this bill relieves a manufacturer,
designer, developer, distributor, or supplier of an EA of
liability under any other applicable law.
a) Defines the terms "Anaphylaxis," "EA," "First
responder," "Lay rescuer," and "Prehospital emergency
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medical care person."
15)States that no reimbursement is required by this act pursuant
to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
EXISTING LAW :
1)Requires EMS 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. Existing
law also requires EMS to promulgate regulations regarding
these matters for use by all prehospital emergency medical
care personnel. (Health and Safety Code Section 1797.197)
2)Permits a pharmacy to furnish EAs to a school district or
county office of education if all of the following are met:
a) The EAs are furnished exclusively for use at a school
district site or county office of education; and
b) A physician and surgeon provides a written order that
specifies the quantity of EAs to be furnished. (Business
and Professions Code Section 4119.2(a))
3)Permits a school district or county office of education to
provide emergency EAs to trained personnel, and permits
trained personnel to utilize those EAs to provide emergency
medical aid to persons suffering from an anaphylactic
reaction. (Education Code (EC) Section 49414(a))
4)Permits a school nurse, or if the school does not have a
school nurse, a person who has received training, as
specified, to do the following:
a) Obtain from the school district physician, the medical
director of the local health department, or the local
emergency medical services director a prescription for EAs;
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and,
b) Immediately administer an EA to a person exhibiting
potentially life-threatening symptoms of anaphylaxis at
school or a school activity when a physician is not
immediately available. (EC 49414)
5)Requires the Superintendent of Public Instruction to establish
minimum standards of training for the administration of EAs
that satisfy minimum statutory training requirements, as
specified, and requires that the Superintendent consult with
specified organizations and providers with expertise in
administering EAs and administering medication in a school
environment. (EC 49414(e)(1))
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill authorizes prehospital
emergency medical care personnel, first responders and lay
rescuers to obtain and use an EA in emergency situations after
receiving certification of training. SB 669 is aimed at
expanding the use of EA's by authorizing additional qualified
personnel to use them and granting immunity from civil
liability when used properly. This bill is sponsored by
Conference of California Bar Associations.
2)Author's statement . According to the author's office,
"California law permits school nurses and trained personnel
to obtain and use [EAs] to provide emergency medical aid to
students experiencing anaphylactic shock, where authorized
by local school board or county offices of education, and
permits school nurses and designated personnel to assist a
student in the self-administration of an epinephrine
auto-injector provided a current authorization and release
is on file. These laws are consistent with laws adopted
across the nation reflecting the understanding that the
timely administration of epinephrine is essential to
avoiding serious injury or death in cases of anaphylaxis,
and that epinephrine auto-injectors - which contain
carefully metered doses of this life-saving medication -
are safe to administer by properly trained individuals.
[EAs] are safe, consumer-friendly, in widespread
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distribution, intended to be carried and self-administered
by adults and even children to protect against
life-threatening anaphylactic shock.
"The problem is that the risk of anaphylaxis is not limited
to children, nor is it limited to school or home.
Suffocation and death from an anaphylactic reaction to
substances can occur anywhere, anytime, to anyone, without
warning or adequate time to obtain definitive medical care.
Under current law, it is illegal for first responders to
possess or carry [EAs] to save lives for anyone else
suffering anaphylaxis, be it in the wilderness, or even in
the community where medical care cannot be timely obtained.
Not everyone who has been prescribed an [EA] will have it
at the time of need. Not everyone who has one will be able
to self-administer it in time. Further, not everyone who
suffers a potentially lethal anaphylactic reaction will
have known of their allergic predisposition in advance,
much less have had an [EA] prescribed. Yet, people are
unnecessarily exposed to the real risk of death. People die
from anaphylaxis because what they need---epinephrine---is
not always readily available by someone who can legally
administer it.
"SB 669 addresses this real but unnecessary problem. It
allows those group leaders or first responders who
successfully complete a certified training course, to
obtain and use [EA] to provide life-saving first aid in the
event of anaphylaxis, just as many are already trained and
authorized to do in rendering immediate CPR, administering
a shock from an automatic external defibrillator, applying
tourniquets for unremitting life-threatening hemorrhage,
and effectuating emergency evacuations even in face of
spinal injuries. And, like other Good Samaritan laws, it
provides immunity to properly certified individuals from
civil liability, except in cases of gross negligence."
3)Epinephrine and auto-injectors . According to the National
Institutes of Health, an epinephrine injection is used along
with emergency medical treatment to treat life-threatening
allergic reactions caused by insect bites or stings, foods,
medications, latex, and other causes. Epinephrine works by
relaxing the muscles in the airways and tightening the blood
vessels.
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An auto-injector is usually a type of easy-to-use spring-loaded
syringe, intended for self-administration by the patient or by
untrained personnel.
4)Providers currently authorized to administer EAs . In addition
to certain licensed healthcare professionals, existing law
permits a school nurse or other qualified person designated by
the school district physician, the medical director of the
local health department, or the local emergency medical
services director to administer an EA. This bill would permit
prehospital emergency medical care persons, first responders,
and lay rescuers to obtain and administer EAs with proper
training and certification as well.
5)EA authorization in other states . According to information
provided by the author's office, seven states (Arkansas,
Florida, Maryland, Missouri, North Carolina, North Dakota, and
South Carolina) have certificate programs for lay rescuers,
typically providing for the training and certification of
persons who reasonably expect to have responsibility for
others as a result of occupational or volunteer status, such
as camp counselors, forest rangers, and tour guides. Certified
persons are authorized to obtain EAs and are granted "Good
Samaritan" liability protection.
Six other states also provide some form of immunity for EA
use. Three states provide Good Samaritan immunity for persons
who have received authorized training (Connecticut, New York,
and Oregon), and more three states deem that the
administration of epinephrine by a volunteer rescuer in an
emergency is entitled to Good Samaritan protection (Arizona,
Rhode Island, and Virginia).
6)Arguments in support . The Hospital Corporation of America
writes in support, "Death from anaphylaxis remains a real and
widespread problem. Currently, anaphylaxis leads to 500 -
1,000 deaths per 2.4 million people in the United States.
While mortality rates have decreased, the incidence of
anaphylaxis appear to be increasing from 20 per 100,000 per
year in the 1980s to 50 per 100,000 per year in the 1990s.
Presently there is no effective treatment to prevent
anaphylactic cardiac arrest in the community unless the victim
has an epinephrine auto-injector and is able to
self-administer the injection before losing consciousness.
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Unless specifically used by and for the person who it was
prescribed, an epinephrine auto-injector may not be
administered by a non-physician, even if the auto-injector is
on the scene. Until recent enabling legislation, this was a
problem for school nurses who were unable to assist a child in
anaphylactic shock.
"So while increased protection is available in schools, death
from anaphylaxis outside of schools in community venues is a
real and pervasive problem since those overseeing the welfare
of others, trained first responders and group leaders, are
unable to obtain or administer the auto-epinephrine device."
7)Suggested technical amendments . The following are technical
and clarifying amendments:
Amend HSC 1797.197a (b)(2) to read: "The epinephrine
auto-injector is used on another, with the expressed or
implied consent of that person, for relief of the
conditions described in (a)(1)(A) due to anaphylaxis."
Amend HSC1797.197a (c)(2)(G) should be renumbered to
section (d), and read: "Training certification shall be
valid for nor more than two years, after which...."
8)Prior legislation . AB 559 (Wiggins) Chapter 458, Statutes of
2001, allowed school districts or county offices of education
to provide emergency EAs to trained personnel, and permits
trained personnel to utilize EAs to provide emergency medical
aid to persons suffering from an anaphylactic reaction.
REGISTERED SUPPORT / OPPOSITION :
Support
Conference of California Bar Associations (sponsor)
California Association of Joint Powers Authorities
California Hospital Association
California Medical Association
Civil Justice Association of California
Food Allergy Research and Education
Hospital Corporation of America
Opposition
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None on file.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301