BILL ANALYSIS Ó
SB 738
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Date of Hearing: June 30, 2015
ASSEMBLY COMMITTEE ON JUDICIARY
Mark Stone, Chair
SB
738 (Huff) - As Amended May 13, 2015
PROPOSED CONSENT
SENATE VOTE: 36-0
SUBJECT: PUPIL HEALTH: EPINEPHRINE AUTO-INJECTORS: LIABILITY
LIMITATION
KEY ISSUE: SHOULD A PHYSICIAN WHO ISSUES A PRESCRIPTION FOR AN
EPINEPHRINE AUTO-INJECTOR TO A SCHOOL DISTRICT, COUNTY OFFICE OF
EDUCATION, OR CHARTER SCHOOL IN ACCORDANCE WITH THE PROVISIONS
OF EXISTING LAW BE GIVEN QUALIFIED IMMUNITIY FROM CIVIL AND
CRIMINAL LIABILITY FOR NEGLIGENCE, BUT NOT GROSS NEGLIGENCE OR
WANTON OR WILLFULL MISCONDUCT, IN CONNECTION WITH THE ISSUANCE
OF THE PRESCRIPTION?
SYNOPSIS
This non-controversial public health measure provides qualified
immunity to physicians who issue prescriptions for epinephrine
auto-injectors to school districts for emergency use on
individuals afflicted with anaphylactic reaction. An
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epinephrine auto-injector (commonly called an "epi-pen" because
its size and shape is similar to a writing pen) is a disposable
drug delivery system with a spring-activated needle that is
designed for emergency administration of epinephrine. It
provides rapid, convenient first aid for persons suffering a
potentially fatal reaction to anaphylaxis, which can happen when
a person, often in this case a child at school, is stung by a
bee, ingests food such as shellfish or nuts, or maybe even comes
in contact with something as common and generally inoffensive as
latex. Epinephrine is the first line of treatment for someone
who is experiencing anaphylaxis. It can be easily administered
by the use of an epi-pen and has few side-effects or risks of
misuse.
Existing law authorizes public and private schools in California
to voluntarily make emergency epinephrine auto-injectors
available to trained personnel who voluntarily agree to provide
critically-needed emergency medical aid to persons suffering
from anaphylactic reactions. Existing law also requires a school
district, county office of education, or charter school to
ensure that each school employee who volunteers to be trained
and participate in the emergency epinephrine auto-injector
program is provided with defense and indemnification by the
school district, county office of education, or charter school
for any and all civil liability arising from such participation.
Meanwhile, current law provides qualified immunity to all
volunteers who in good faith, and not for compensation, render
emergency medical or nonmedical care at the scene of an
emergency. Existing law does not provide for qualified immunity
or indemnification of physician or surgeons who prescribes
epinephrine auto-injectors to a school nurse, or a school
administrator, even though the law requires a prescription to be
given to school personnel by a school district physician, the
medical director of the local health department, or the local
emergency medical services director. This bill provides
qualified immunity to physicians and surgeons who issue such
standing prescriptions to schools.
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The measure is supported by a broad coalition of medical,
emergency and other groups who state that it will save lives,
especially of children, who are afflicted with anaphylactic
reactions that can cause unnecessary harm and even death without
speedy medical assistance. It recently passed the Assembly
Business and Professions Committee by a vote of 14-0 and has no
known opposition.
SUMMARY: Provides qualified immunity to a physician who issues
a prescription for an epinephrine auto-injector to a school
district, county office of education, or charter school.
Specifically, this bill:
1)Provides that a physician who issues a prescription to a
school district, county office of education, or charter school
for an epinephrine auto-injector shall not be subject to
professional review, be liable in a civil action, or be
subject to criminal prosecution, unless the physician's
issuance of the prescription or order constitutes gross
negligence or willful or malicious conduct.
2)Updates the name of the Stanford Allergy Center, one of the
organizations and providers having expertise in administering
epinephrine auto-injectors and administering medication in a
school environment with whom the Superintendent is required to
consult regarding whether to update training standards for use
of the auto-injectors every five years, to reflect its new
name: the Sean N. Parker Center for Allergy Research.
EXISTING LAW:
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1)Under the Government Tort Claims Act, specifies rules of civil
liability that apply to public entities and public employees
in California. (Gov. Code Section 810 et seq.)
2)Provides that no person who in good faith, and not for
compensation, renders emergency medical or nonmedical care at
the scene of an emergency shall be liable for any civil
damages resulting from any act or omission other than an act
or omission constituting gross negligence or willful or wanton
misconduct. (Health and Safety Code Section 1799.102.)
3)In relevant part, requires a school district or county office
of education to provide emergency epinephrine auto-injectors
to school nurses or trained volunteers, and allows those
individuals to utilize epinephrine auto-injectors to provide
emergency medical aid to persons suffering from an
anaphylactic reaction. (Education Code Section 49414(a).
All further statutory references are to the Education Code,
unless otherwise indicated.)
4)In relevant part, authorizes each public and private
elementary and secondary school in the state to voluntarily
determine, as specified, whether or not to make emergency
epinephrine auto-injectors and trained personnel available at
its school. (Section 49414(c).)
5)Permits each public and private school to designate one or
more volunteers to receive initial and annual refresher
training, based on specified standards, regarding the storage
and emergency use of an epinephrine auto-injector from the
school nurse or other qualified person designated by an
authorizing physician or surgeon. (Section 49414(d).)
6)Requires a school nurse, or if the school does not have a
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school nurse or the school nurse is not onsite or available, a
school administrator, to obtain from the school district
physician, the medical director of the local health
department, or the local emergency medical services director a
prescription for epinephrine auto-injectors. (Section
49414(g).)
7)Requires the Superintendent to review, every five years, or
sooner as deemed necessary by the Superintendent, standards of
training for the administration of epinephrine auto-injectors
by consulting with organizations and providers with expertise
in administering epinephrine auto-injectors and administering
medication in a school environment. (Section 49414(e)(1).)
8)Sets minimum requirements for the training described in #7),
above, requiring certain topics about anaphylaxis and
procedures for rendering emergency treatment to be included in
the training, and for the training to be consistent with
guidelines of the federal Centers for Disease Control and
Prevention. (Section 49414, subdivisions (e)(2) and (e)(3).)
9)Requires a school district, county office of education, or
charter school to ensure that each employee who volunteers
under this section will be provided defense and
indemnification by the school district, county office of
education, or charter school for any and all civil liability,
in accordance with, but not limited to, that provided in
Division 3.6 (commencing with Section 810) of Title 1 of the
Government Code. This information shall be reduced to writing,
provided to the volunteer, and retained in the volunteer's
personnel file. (Sections 49414(j), 49414.7(i).)
10)Defines relevant terms, including "anaphylaxis," "authorizing
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physician and surgeon," "epinephrine auto-injector,"
"qualified supervisor of health," "volunteer," and "trained
personnel." (Section 49414(b).)
11)Identifies the Stanford Allergy Center as one of the
organizations and providers having expertise in administering
epinephrine auto-injectors and administering medication in a
school environment with whom the Superintendent is required to
consult regarding whether to update training standards for
such auto-injectors every five years. (Section 49414(e)(1).)
FISCAL EFFECT: As currently in print this bill is keyed
non-fiscal.
COMMENTS: An epinephrine auto-injector (commonly called an
"epi-pen" because its size and shape is similar to a writing
pen) is a disposable medical drug delivery device that delivers
a single measured dose of epinephrine, most frequently for the
treatment of acute allergic reactions to avoid or treat the
onset of anaphylactic shock. Anaphylactic shock can quickly
cause death if untreated. Epinephrine auto-injectors can be
obtained by prescription only, and California law does not
authorize non-physicians to administer an epinephrine
auto-injector to another person, except in limited
circumstances.
Approximately 6 million children under the age of 18 suffer from
life threatening allergies: one in every 13 children, meaning an
average of one or two in every classroom. Approximately 25
percent of first time allergic reactions that require
epinephrine happen at school. Because neither schools nor the
student have knowledge of the severe allergy, they do not have
the necessary lifesaving medication on hand. Also, children
with known allergies are often sent to school without
epinephrine for reasons including cost, non-understanding of the
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severity of the allergy by parents, or the prohibitive nature of
the school process for bringing medication to campus.
Anaphylaxis is a potentially lethal allergic reaction. It can
happen when a person is stung by a bee, ingests food such as
shellfish or nuts, or maybe even just comes in contact with
something as simple as latex. Reactions can be severe, or even
fatal, without prompt use of epinephrine. Epinephrine is the
first line of treatment for someone who is experiencing
anaphylaxis. It can be easily administered and has very minor
side effects, including paleness, vomiting, and a rapid pulse.
On the other hand, the risk of not using an epi-pen for
anaphylaxis can result in death. (Source: HealthTap,
https://www.healthtap.com/user_questions/20281.)
Legislative Response. In recent years, California law has been
amended to, among other things, permit school districts or
county offices of education to provide emergency epinephrine
auto-injectors to trained personnel, and to permit trained
personnel to utilize the auto-injectors to provide emergency
medical aid to persons suffering from an anaphylactic reaction.
Last year's SB 1266 (Huff, Chap. 321, Stats. 2014) allowed extra
epinephrine injectors to be prescribed as a "standing order" to
public schools so that epinephrine can be on hand in the event
of a severe allergic reaction. SB 1266 also allowed volunteers
to be trained for identifying anaphylaxis and administering the
necessary medication, epinephrine. Finally, it provided defense
and indemnification for those volunteering to administer
epinephrine. (The language for the latter provision was modeled
upon a provision of the Education Code that provides defense and
indemnification to nonmedical school employees who administer
medical assistance to pupils with epilepsy suffering from
seizures. See Section 49414.7(i).) However, SB 1266 did not
provide defense and indemnification, or qualified immunity, to
physicians who issue standing orders for epinephrine
auto-injector prescriptions to schools.
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Qualified Immunity for Good Samaritans. In 2009, the
Legislature amended Section 1799.102 to provide that laypersons
who provide emergency care or assistance, whether medical or
non-medical, shall not be liable for damages caused by their
acts or omissions while rendering emergency care, so long as
their conduct does not constitute "gross negligence" or "willful
or wanton misconduct." (AB 83 (Feuer), Chap. 77, Stats. 2009.)
AB 83 was the Legislature's response to a decision by the
California Supreme Court, Van Horn v. Watson (2008) 45 Cal.4th
322. In the Van Horn case, Lisa Torti pulled her friend and
co-worker, Alexandra Van Horn, from a crashed vehicle in Los
Angeles, fearing the vehicle was about to catch fire or even
explode. Tragically, in doing so, Torti may have worsened Van
Horn's injuries. Van Horn later sued the driver, who in turn
sued Torti for exacerbating Van Horn's injuries. The Court held
that the state's "Good Samaritan" statute, when read as part of
the overall statutory scheme, only provided immunity to persons
with respect to medical care at the scene of an emergency and
did not apply to "non-medical" emergency assistance, such as
pulling a person from a potentially exploding automobile or a
burning building.
AB 83 clarified the general Good Samaritan statute (Section
1799.102), which provides immunity to all rescuers who render
emergency care at the scene of an emergency, so that immunity
applied as long as the care was rendered "in good faith and not
for compensation," regardless of whether the care is found to be
of a medical or non-medical nature. However, AB 83
appropriately clarified that such broad immunity is unavailable
to rescuers who engage in grossly negligent or willful or wanton
misconduct. The limited or "qualified" immunity adopted by AB
83 is a compromise meant to encourage altruistic behavior, but
still protect the public from grossly negligent or deliberately
harmful behavior.
Like AB 83, SB 669 (Huff, Chap. 725, Stats. 2013) sought to
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encourage a trained lay person to render emergency care to a
person in anaphylactic shock by granting the layperson qualified
immunity from liability for use of an epinephrine auto-injector.
Need for the bill. According to the author:
Once SB 1266 took effect, many physicians began raising
questions about issuing the prescription, citing liability
concerns. Unlike normal prescriptions made out to a
specific individual who physicians have a patient
relationship with, a "standing order" for epinephrine will
be made out generically so the school can keep it on hand.
Physicians have stated having liability coverage in the
code (similar to what they have for Automated External
Defibrillator (AED) and opioid antagonists) will help ease
their concern.
In addition to the calls we have received about this issue
from schools, recent data from the California School Nurse
Organization shows that many schools who are trying to
implement SB 1266 (which took effect January 1, 2015)
cannot because they cannot obtain the necessary
prescription.
Trained medical professionals ordinarily are not given the same
protection from liability as laypersons for providing emergency
medical care. However, there are exceptions. For example,
existing law provides a physician who is involved with the
placement of an AED in a commercial building with protection
from civil liability for any civil damages resulting from the
acts or omissions of a person who renders emergency care using
the AED as long as the physician complied with existing law and
did not act with gross negligence, or engage in willful or
wanton misconduct. (See Section 1714.21.) Likewise, AB 635
(Ammiano, Chapter 707, Statutes of 2013), provided similar
protections from civil liability and from professional review
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for licensed health care providers who issue prescriptions or
standing orders for naloxone hydrochloride, an opioid antagonist
used to treat opioid overdose.
Like naloxone hydrochloride, epinephrine is a highly effective
and specialized medication for a specific medical emergency.
Like an AED, it is a highly effective life-saving medical
treatment in an emergency. The Committee is unaware of any
reports of injuries or deaths from the misuse of epinephrine
auto-injectors. In fact, the only reports that seem to be
available regarding misuse involve cases where epinephrine
should have been used, but was not. Therefore, given the minor
risks associated with misuse of epinephrine auto-injectors and
the significant public health benefits of using this effective
and life-saving medication to treat anaphylaxis, qualified
immunity for a physician who issues a standing prescription for
epinephrine auto-injectors to a school seems to be justified.
The physician would still be civilly liable and subject to
professional review, however, in any case in which issuance of
the prescription or order constituted gross negligence or
willful or malicious conduct.
REGISTERED SUPPORT / OPPOSITION:
Support
California Society of Allergy, Asthma and Immunology (sponsor)
Advocacy Council - American College of Allergy, Asthma and
Immunology
American Academy of Allergy, Asthma and Immunology
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American College of Allergy, Asthma and Immunology
Association of Regional Centers Agencies
California Chapter of the American College of Emergency
Physicians
California School Nurses Organization
Civil Justice Association of California
Los Angeles Unified School District
Medical Board of California
Rady Children's Specialists of San Diego
Sanofi
Santa Clara Office of Education
Sutter Medical Foundation
Three individuals
Opposition
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None on file
Analysis Prepared by:Alison Merrilees / JUD. / (916)
319-2334