BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Hannah-Beth Jackson, Chair
2015-2016 Regular Session
AB 1386 (Low)
Version: June 13, 2016
Hearing Date: June 21, 2016
Fiscal: Yes
Urgency: No
RD
SUBJECT
Emergency medical care: epinephrine auto-injectors
DESCRIPTION
This bill would allow "authorized entities," as defined to
include both private and government entities, to obtain
epinephrine auto-injectors for the use of any one of their
employees, volunteers, or agents, who is a lay rescuer, as
specified, to render emergency care to another person. This bill
would further ensure, however, that the failure of an authorized
entity to possess or administer an epinephrine auto-injector
shall not result in civil liability. Additionally, this bill
would apply an existing qualified immunity for physicians and
surgeons who write prescriptions for epinephrine auto-injectors
for use in schools to physicians and surgeons who write
prescriptions to prehospital medical care persons, laypersons,
or for use of qualifying employees, volunteers, or agents of
authorized entities. Lastly, this bill would also authorize
pharmacies to furnish prescriptions to authorized entities for
these purposes, as specified, and would otherwise revise
existing requirements and standards under the Health and Safety
Code relating to the administration of epinephrine
auto-injectors by Good Samaritans in emergencies.
BACKGROUND
An epinephrine auto-injector 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.
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Anaphylactic shock can quickly result in 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.
Over the years, California law has been amended to 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, as it is not uncommon for children to come into
contact with specific allergens (such as bee stings) or
accidentally ingest foods they are allergic to at school. (See
AB 559 (Wiggins, Ch. 458, Stats. 2001); see also SB 1266 (Huff,
Ch. 321, Stats. 2014), which was subsequently enacted to
require, as opposed to simply authorize, school districts,
county offices of education, and charter schools to provide
emergency epinephrine auto-injectors to voluntary, trained
personnel who, consistent with existing law, may use the
auto-injectors to provide emergency medical aid to persons
suffering from an anaphylactic reaction.)
More recently, in 2013, California law was expanded to also
permit certain Good Samaritans (specifically, prehospital
emergency medical care persons or lay rescuers), to obtain and
administer epinephrine auto-injectors to provide emergency
medical aid to persons suffering from anaphylactic shock. (SB
669 (Huff, Ch. 725, Stats. 2013).) In doing so, the legislation
granted such individuals, acting in good faith and not for
compensation, immunity for any civil damages resulting from any
acts or omissions in administering the auto-injector to a person
who appears to be experiencing anaphylaxis at the scene of an
emergency, as long as the person did not act with gross
negligence or willful or wanton misconduct and otherwise
complies with certain requirements and standards, including
training requirements.
Of import to this bill, just this last year, SB 738 (Huff, Ch.
132, Stats. 2015) was brought to address an issue of concern for
doctors who are needed to write these prescriptions so that
schools may obtain and stock epinephrine auto-injectors as
required by these bills. The proponents of SB 738 reported that
schools were having difficulty obtaining epinephrine
auto-injectors because doctors were declining to write those
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prescriptions out of fear of both professional disciplinary
action and both civil and criminal liability from any resulting
acts or omissions in relation to the administration of the
prescribed auto-injector in an emergency. While these types of
Good Samaritan laws have largely stopped short (intentionally
so) of providing immunity to individuals for negligent acts or
omissions in the performance of their professional duties, it
has also become clear that doctors, in their ordinary practice
of medicine, do not and cannot prescribe medication to third
persons. Accordingly, SB 738 was enacted to grant any physician
or surgeon issuing a prescription or order for these purposes
immunity from any potential civil or criminal liability or from
professional disciplinary action, unless the physician and
surgeon's issuance constitutes gross negligence or willful or
malicious conduct.
This bill would now add authorization for other "authorized
entities" to obtain epinephrine auto-injectors so that any
employees, volunteers, or agents of the entity who otherwise
meet the existing definition of "lay rescuer" could render
emergency care to a person who appears to be suffering from
anaphylaxis in accordance with existing law for lay rescuers.
This bill would extend the existing qualified immunity for
physicians and surgeons to physicians and surgeons who write
prescriptions to prehospital medical care persons, laypersons,
or for use of qualifying employees, volunteers, or agents of
authorized entities, in accordance with specified law.
CHANGES TO EXISTING LAW
1.Existing law requires school districts, county offices of
education, and charter schools to provide emergency
epinephrine auto-injectors to school nurses or trained
personnel who have volunteered, as specified, and provides
that school nurses or trained personnel may use epinephrine
auto-injectors to provide emergency medical aid to persons
suffering, or reasonably believed to be suffering, from an
anaphylactic reaction. (Ed. Code Sec. 49414(a).) Existing
law provides for the defense and indemnification of any
employees who volunteer under this law, from any and all civil
liability, in accordance with, but not limited to, the
Government Tort Claims Act, as specified. (Ed. Code Sec.
49414(j).)
Existing law provides that an authorizing physician and
surgeon shall not be subject to professional review, be liable
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in a civil action, or be subject to criminal prosecution for
the issuance of a prescription or order, for the above
purposes, unless the physician and surgeon's issuance of the
prescription or order constitutes gross negligence or willful
or malicious conduct. (Ed. Code Sec. 49414(g)(4).)
Existing law provides that any prehospital emergency medical
care person or lay rescuer who administers an epinephrine
auto-injector, 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 epinephrine auto-injector, if that person
has complied with the requirements and standards of Section
1797.197a of Health and Safety Code, below. This protection
from civil liability does 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 epinephrine
auto-injector. (Civ. Code Sec. 1714.23(b), (c).)
This bill would add to the Civil Code that an authorized
entity shall not 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
connected to the administration of an epinephrine
auto-injector by any one of its employees, volunteers, or
agents, who is a lay rescuer as defined under existing law.
This bill would further provide that the failure of an
authorized entity to possess or administer an epinephrine
auto-injector shall not result in civil liability.
This bill would provide the proposed qualified immunity for
authorized entities, and the existing qualified immunity for
prehospital emergency medical care person or lay rescuers,
shall not affect any other immunity or defense available under
law.
This bill would add that an authorizing physician and surgeon
is not subject to professional review, liable in a civil
action, or subject to criminal prosecution for the issuance of
a prescription or order pursuant to this section, unless the
issuance of the prescription or order constitutes gross
negligence or willful or malicious conduct.
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2.Existing law , Section 1797.197a of the Health and Safety Code,
requires the Emergency Medical Services authority (EMSA) to
establish and approve the authorized training providers and
minimum standards for training and the use and administration
of epinephrine auto-injectors, as specified. The minimum
training and requirements must include, among other things:
techniques for recognizing circumstances, signs, and
symptoms of anaphylaxis;
standards and procedures for proper storage and
emergency use of epinephrine auto-injectors; and
specified emergency follow up procedures (e.g., calling
9-1-1). (Health & Saf. Code Sec. 1797.197a(c).)
Existing law authorizes a prehospital emergency medical care
person or lay rescuer to use an epinephrine auto-injector to
render emergency care to another person if specified
requirements are met. The requirements include, among other
things, that:
the auto-injector is legally obtained by prescription
from an authorized health care provider, as specified;
the auto-injector is used on another, with the express
or implied consent of that person, for the purpose of
treating anaphylaxis;
the person using the auto-injector has successfully
completed a training course, as specified and has current
certification of training issued by the training provider;
and
the auto-injectors obtained by prehospital emergency
medical care personnel from a pharmacy, as authorized by
law, are used only when functioning outside the course of
the person's occupational duties, or as a volunteer.
(Health & Saf. Code Sec. 1797.197a(b).)
Existing law permits an authorized health care provider to
issue a prescription for an epinephrine auto-injector to a
prehospital emergency medical care person or lay rescuer 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 specified. (Health & Saf. Code Sec.
1797.197a(b)(1).)
This bill would, instead, authorize a prehospital medical care
person or lay rescuer to use an epinephrine auto-injector to
render emergency care to another person if, among other
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things, the epinephrine auto-injector is legally obtained by
prescription from an authorized health care provider or from
an authorized entity that acquired the epinephrine
auto-injector, as specified, below.
This bill would permit an authorized health care provider to
issue a prescription for an epinephrine auto-injector to a
prehospital emergency medical care person or a lay rescuer for
the purpose of rendering emergency care to another person upon
presentation of a current epinephrine auto-injector
certification card issued by the EMSA demonstrating that the
person is trained and qualified to administer an epinephrine
auto-injector, as specified.
This bill would similarly permit an authorized health care
provider to issue a prescription for an epinephrine
auto-injector to an authorized entity if the authorized entity
submits evidence it employs at least one person, or utilizes
at least one volunteer or agent, who is trained and has a
current epinephrine auto-injector certification card issued by
the EMSA demonstrating that the person is qualified to
administer an epinephrine auto-injector, as specified.
This bill would require a participating authorized entity to:
create and maintain on its premises an operations plan
that includes, among other things:
o the names of the designated employees or agents who
have completed the required training program, and who are
authorized to administer the auto-injector; and
o how and when the auto-injector will be inspected for
an expiration date; and
submit to the EMSA, as specified, a report of each
incident that involves the use of an epinephrine
auto-injector, not more than 30 days after each use. The
EMSA must, in turn, annually publish a report that
summarizes all such reports.
This bill would define "authorized entity" to mean any
for-profit, nonprofit, or government entity or organization
that employs at least one person or utilizes at least one
volunteer or agent that has voluntarily completed a training
course, as required.
1.Existing law authorizes a pharmacy, notwithstanding any other
provision of law, to furnish epinephrine auto-injectors to a
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school district, county office of education, or charter school
pursuant to specified law, if:
the auto-injectors are furnished exclusively for use at
a school district site or county office of education; and
a physician and surgeon provides a written order that
specifies the quantity of auto-injectors to be furnished.
(Bus. & Prof. Code Sec. 4119.2(a).)
Existing law requires a school district, county office of
education, or charter school to keep certain records of
epinephrine auto-injectors furnished pursuant to the law,
above, and makes the entities responsible for monitoring the
supply of auto-injectors and ensuring the destruction of
expired auto-injectors. (Bus. & Prof. Code Sec. 4119.2(b).)
Existing law authorizes a pharmacy, notwithstanding any other
law, to dispense epinephrine auto-injectors to a prehospital
emergency medical care person or lay rescuer for the purpose
of rendering emergency care, in accordance with Section
1797.197a, above, if:
A physician and surgeon provides a written order that
specifies the quantity of auto-injectors to be dispensed by
a prehospital emergency medical care person or lay rescuer,
as specified. The prescription may be issued only upon
presentation of a current certificate demonstrating that
the person is trained and qualified, as specified, to
administer an auto-injector to another person in an
emergency. The prescription must state certain information
and a new prescription is required for any additional
auto-injectors.
The pharmacy must label each auto-injector dispensed
with certain information, including the designations
"Section 1797.197a Responder" and "First Aid Purposes
Only." (Bus. & Prof. Code Sec. 4119.3(a).)
Existing law requires a prehospital emergency medical care
person or lay person receiving epinephrine auto-injectors
pursuant to the above to make and maintain certain records, as
specified, including as to the circumstances and manner of
destruction of any auto-injectors. (Bus. & Prof. Code Sec.
4119.3(b).)
Existing law specifies that the epinephrine auto-injectors
dispensed to prehospital emergency medical care persons or lay
rescuers pursuant to the above, may be used only for the
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purpose, and under the circumstances, described in Section
1797.197a of the Health and Safety Code. (Bus. & Prof. Code
Sec. 4119.3(c).)
This bill would authorize a pharmacy, notwithstanding any
other law, to furnish epinephrine auto-injectors to an
"authorized entity" if:
the auto-injectors are furnished exclusively for use by,
or in connection with, an authorized entity; and
an authorized health care provider provides a
prescription that specifies the quantity of auto-injectors
to be furnished. The pharmacy must label each
auto-injector dispensed with certain information, such as:
the name of the person or entity to whom the prescription
was issued, and the designations "Section 1797.197a
Responder" and "First Aid Purposes Only."
This bill would require that the authorized entity maintain
certain records of epinephrine auto-injectors furnished to
them in accordance with the above, and would provide that the
authorized entity shall be responsible for monitoring the
supply and the destruction of expired epinephrine
auto-injectors.
This bill would specify that the epinephrine auto-injector
dispensed to authorized entities pursuant to the above, may be
used only for the purpose, and under the circumstances,
described in Section 1797.197a of the Health and Safety Code.
1.Existing law provides that an "epinephrine auto-injector"
means a disposable drug delivery system with a
spring-activated concealed needle that is designed for
emergency administration of epinephrine to provide rapid,
convenient first aid for persons suffering from anaphylaxis.
(Civ. Code Sec. 1714.23(a)(2); Health & Saf. Code Sec.
1797.197a(a)(1)(2), Educ. Code Sec. 49414(b)(3).)
This bill would, instead, define "epinephrine auto-injector"
to mean a disposable delivery device designed for the
automatic injection of a premeasured dose of epinephrine into
the human body to prevent or treat a life-threatening allergic
reaction.
This bill would make other technical and non-substantive
changes.
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COMMENT
1. Stated need for the bill
According to the author:
Allergies to food, insect stings and other substances that can
cause anaphylaxis are increasing. There are approximately
90,000 emergency room visits and an estimated 1,500 deaths a
year from anaphylaxis in the United States. This legislation
would allow for greater access of epinephrine auto-injectors
at locations where individuals could come into contact with
allergens known to cause anaphylaxis in those with allergies.
While existing law allows individuals who have been trained in
recognition of symptoms of allergic reactions and anaphylaxis
to administer epinephrine auto-injectors to others in an
emergency and provides liability protection for these
individuals, current law does not allow the business, group or
entity that the individual is employed by or associated with
to obtain a prescription for an epinephrine auto-injector or
to have liability protection if the epinephrine auto-injector
is used on the entities premises.
2. Q ualified immunity for authorized entities
As a general rule, California law provides that everyone is
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. (Civ. Code Sec. 1714(a).) Although immunity
provisions are rarely preferable because they, by their nature,
prevent an injured party from seeking a particular type of
recovery, the Legislature has in limited scenarios approved
limited immunity from liability (as opposed to blanket
immunities) to promote other policy goals that could benefit the
public. Along these lines, this Legislature has on multiple
occasions, enacted legislation that encourages the use of life
saving medications or medical interventions (such as automatic
external defibrillators (AEDs), epinephrine auto-injectors
(epi-pens), and opioid antagonists) in order to avoid
preventable deaths by limiting the liability of "Good
Samaritans," as long as certain minimal requirements are met.
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In most of those scenarios, however, the qualified immunity does
not apply in the case of personal injury or wrongful death which
results from the gross negligence or willful or wanton
misconduct by the person who renders the care. (See Civ. Code
Sec. 1714.21.)
With respect to epi-pens, specifically, as noted in the
Background, California law already encourages the use of this
life-saving medication to avoid preventable deaths in both
schools and in the general public. Recognizing that public
employees (in particular, school nurses) already enjoy liability
protections under the Government Tort Claims Act, existing law
requires that schools provide defense and indemnification to
employees who volunteer for training to administer epi-pens in
emergency situations from any and all civil liability, in
accordance with, but not limited to, that Act. (See Ed. Code
Sec 49414.) Separately, the Civil Code provides certain Good
Samaritans-namely, prehospital emergency care persons and lay
persons, as defined-acting in good faith and not for
compensation, qualified immunity from civil damages for any of
their acts or omissions in administering the epi-pen to a person
who appears to be suffering from anaphylaxis at the scene of
emergency, if the person complies with certain requirements and
standards, including training requirements. As mentioned above,
this immunity is, however, qualified (i.e., limited), insofar as
it does not apply to protect the person from civil damages in
any personal injury or wrongful death case involving gross
negligence or willful or wanton misconduct in rendering
emergency care treatment by use of the auto-injector.
This bill would now add similar protection from civil liability
for authorized entities that choose to obtain epinephrine for
use by their employees, volunteers, or agents, who otherwise
meet the existing definition of "lay rescuer" to render
emergency care to a person who appears to be suffering from
anaphylaxis in accordance with existing law requirements for lay
rescuers. In other words, these individuals would otherwise
have to be trained and comply with any other standards of
requirements that would apply to other lay rescuers in order to
be subject to the existing qualified immunity when administering
an epi-pen to render emergency medical care to a person who
appears to be suffering from anaphylaxis. Notably, for these
purposes, authorized entities include not only nonprofit or for
profit private entities or organizations, but also government
entities or organizations. Presumably, government entities are
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already significantly protected from liability under the
Government Tort Claims Act. To the extent that this bill
creates any new liability protections, however, for nonprofit
and for profit entities that obtain epi-pens for such emergency
use, or even for government entities, that immunity is also
qualified and would not apply where there has been gross
negligence or willful or wanton misconduct in connection with
the administration of the epi-pen.
In support, sponsor Mylan cites that nearly 6 million or 8
percent of children in the U.S. have food
allergies-approximately 1 in 13. Food allergens account for 30
percent of fatal cases of anaphylaxis, of which there are
approximately 1,500, annually. Mylan writes that "California
has made great strides to address this issue, but more can be
done to ensure that the state is better prepared in the event
that children or adults experience an anaphylactic reaction for
the first time or in a public location. Schools were a very
important first step in addressing anaphylaxis. This
legislation will build upon California's current school access
law and expand access to this critical medication. This
legislation would expand access to allow colleges and
universities, churches, summer camps, sports arenas,
restaurants, recreational parks and other places where children
and adults could come into contact with potentially
life-threatening allergens to stock epinephrine auto-injectors
and allow trained personnel to administer them in emergencies."
Staff notes, in the years since passing legislation encouraging
the stocking and application of epi-pens for emergency use by
both schools and trained individuals, the Committee has not
received direct reports or anecdotes of any harm that has
resulted from the availability and application of the medication
by school volunteers, lay rescuers, or prehospital emergency
care persons.
3. Suggested amendments to further clarify and narrow the
qualified immunity
As discussed above, this bill ensures that an authorized entity
is not rendered immune from any acts or omissions of its
employees, volunteers, or agents that constitute gross
negligence or willful or wanton misconduct connected to the
administration of the auto-injector. Staff notes, however, that
the bill's qualified immunity for authorized entities should
also be made contingent upon meeting the statutory requirements
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imposed on these authorized entities under the Health and Safety
Code. Specifically, this bill would revise Section 1797.197a of
the Health and Safety Code to require an authorized entity that
possesses and makes available epinephrine auto-injectors to
create and maintain, on its premises, a specified operations
plan that includes, for example: where and how the auto-injector
will be stored; the names of the designated employees or agents
who have completed the required training program under existing
law, and who are authorized to administer the injector; and how
and when the auto-injector will be inspected for an expiration
date. Furthermore, under that section, the entity would also
have to submit a report of each incident that involves the use
of an epinephrine auto-injector to the state Emergency Medical
Services authority. And, notably, this particular statute
(again, as to be amended by the bill) recognizes that the entity
must submit evidence that it employs at least one person, or
utilizes at least one volunteer or agent, who is trained and has
a current epinephrine auto-injector certification card issued by
the authority demonstrating that the person is qualified to
administer an epinephrine auto-injector, as specified, in order
to receive a prescription from a physician.
Accordingly, the author has agreed to the following amendment to
ensure that the entity has complied with its duties under the
Health and Safety Code as a threshold matter, in order to enjoy
any immunity for any negligent acts or omissions of its
qualifying employees, volunteers, or agents in connection to
their administration of the auto-injector:
Suggested amendment:
On page 5, line 7, add to the end of the sentence: ", if the
entity has complied with all applicable requirements of
Section 1797.197a of the Health and Safety Code."
Additionally, because the proposed civil immunity for authorized
entities would expressly disallow application of that immunity
where there has been gross negligence or willful or wanton
misconduct on part of the entity's employee, volunteer or agent
in the administration of an epinephrine auto-injector, to avoid
confusion the author has also agreed to the following technical
amendment to limit the application of the current exception for
gross negligence or willful or wanton misconduct to the
provision providing immunity for prehospital emergency care
persons and lay persons.
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Technical amendment :
On page 5, line 12, amend subdivision (c) of Section 1714.23
of the Civil Code to read: "The protection specified in
paragraph (1) of subdivision (b) 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 epinephrine
auto-injector."
4. Qualified immunity for physicians
As recently amended by the author, in part due to opposition
concerns, this bill seeks to provide immunity for doctors who
write a prescription for epinephrine auto-injectors to an
authorized entity, or to a lay person or prehospital emergency
medical care person, for purposes of rendering emergency care to
another person who appears to be suffering from anaphylaxis.
With respect to the doctors who are relied upon to write the
prescription or orders for the medication or medical device,
similar liability protection has been provided in both the AED
and opioid antagonist context. Most recently, it was also
applied in the epi-pen context, but only insofar as the
prescription was for a school. As discussed in the Background,
just last year, SB 738 (Huff, Ch. 132, Stats. 2015) added a
similar provision in law for physicians and surgeons who issue
prescriptions or orders for epi-pens to schools, in furtherance
of existing California law that requires schools to provide
emergency epinephrine auto-injectors to trained personnel who
may use the auto-injectors to provide emergency medical aid to
persons suffering from anaphylactic reaction. That provision
was based, in part, upon those provisions already in place with
respect to AEDs and naloxone.
For example, existing law provides physicians who are involved
with the placement of an AED protection against any civil
liability for any civil damages resulting from any acts or
omissions of a person who renders emergency care using that AED,
if that physician, person, or entity has complied with existing
law requirements. That law also provides that any limited
liability protection does not apply in the case of personal
injury or wrongful death which results from the gross negligence
or willful or wanton misconduct of the person who renders
emergency care or treatment by the use of an AED. (See Civ. Code
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Sec. 1714.21.) Separately, in 2013, AB 635 (Ammiano, Ch. 707,
Stats. 2013) was enacted to provide that a licensed health care
provider who acts with reasonable care shall not be subject to
professional review, found liable in a civil action, or be
subject to criminal prosecution for issuing a prescription or
standing order for an opioid antagonist to a person at risk of
an opioid-related overdose or to a family member, friend, or
other person in a position to assist a person at risk of an
opioid-related overdose, as specified. (See Civ. Code Sec.
1714.22.)
This bill, modeled upon last year's SB 738, would expand the
existing physicians' immunity in the epi-pen context to ensure
that an authorizing physician and surgeon will also not be
subject to professional review, liable in a civil action, or
subject to criminal prosecution for the issuance of a
prescription or order to a prehospital emergency medical care
person, lay person, or authorized entity, as specified, unless
the issuance constitutes gross negligence or willful or
malicious conduct. In doing so, the bill would not only be
consistent with SB 738, but it would arguably further the
original intent of SB 669 (Huff, Ch. 725, Stats. 2013) to ensure
that trained personnel and Good Samaritans, acting in good faith
and not for compensation, have epi-pens available for the
emergency treatment of individuals suffering from anaphylactic
shock, in order to avoid preventable deaths.
Additionally, the author has agreed to the following amendment
to further ensure that the physician and surgeon has prescribed
the epi-pen in accordance with the Health and Safety Code,
which, under this bill, would authorize providers to issue a
prescription to a prehospital emergency medical care person, lay
rescuer, or authorized entity, upon the presentation of a
specified certification card demonstrating that the person or
the entity's employee, agent, or volunteer is trained and
qualified to administer an epinephrine auto-injector in
accordance with specified law. (Emphasis added.)
Suggested amendment
On page 5, line 23, strike "pursuant to this section" and
insert "and in accordance with Section 1797.197a of the Health
and Safety Code"
5. Other clarifying amendments
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This bill permits pharmacies to furnish epinephrine
auto-injectors to authorized entities for the purpose of
rendering emergency care in accordance with specified Health and
Safety Code standards, as long as: (1) a physician and surgeon
provides a prescription that specifies the quantity of
epinephrine auto-injectors to be furnished; and (2) the
epinephrine auto-injectors are furnished exclusively for use by,
or in connection with, an authorized entity. Staff notes,
however, that in a parallel statute authorizing a pharmacy to
dispense an epinephrine auto-injector to lay rescuers and
prehospital emergency medical persons, existing law additionally
specifies that the physician and surgeon may issue the
underlying prescription only upon presentation of a current
certificate demonstrating that the person is trained and
qualified under Section 1797.197a of the Health and Safety Code
to administer an epinephrine auto-injector to another person in
an emergency situation. (See Bus. & Prof. Code Sec. 4119.3.) By
way of another example, under existing law, the epi-pen must not
only specify that the dispensed epinephrine auto-injector is for
"First Aid Purposes Only" and that the named recipient is a
"Section 1797.197a Responder"(which this bill would similarly
require), but also, a new prescription must be written for any
additional epinephrine auto-injectors required (which this bill
does not expressly require). The following amendments will add
further consistency between the existing provisions governing
pharmacies that dispense epi-pens to a prehospital medical care
person or lay person and the bill's correlating provision for
authorized entities.
Suggested amendments:
On page 3, lines 10-11, after "the quantity of epinephrine
auto-injectors to be furnished" insert "to an authorized
entity described in subdivision (a) of Section 1797.197a of
the Health and Safety Code. A new prescription shall be
written for any additional epinephrine auto-injectors
required."
On page 3, lines 3-6, amend proposed Section 4119.4 of the
Business and Professions Code to read: "Notwithstanding any
other law, a pharmacy may furnish epinephrine auto-injectors
to an authorized entity , as defined by Section 1979.197a of
the Health and Safety Code, for the purpose of rendering
emergency care in accordance with Section 1797.197a of the
AB 1386 (Low)
Page 16 of ?
Health and Safety Code , if both of the following are met:"
6. Removal of opposition
Staff notes that the organizations previously registered in
opposition to this bill have since removed their opposition
based on the June 13, 2016, version of the bill, which added a
qualified immunity for physicians. Those groups, the Allergy &
Asthma Network, California Society of Allergy, Asthma and
Immunology, and Food Allergy Research & Education, are now in
support of the bill.
Support : Allergy & Asthma Network; Allergy Station @ SacENT;
American Latex Allergy Association; American Red Cross;
California Society of Allergy, Asthma and Immunology; California
Chapter of the American College of Emergency Physicians;
California Retailers Association; Food Allergy Research &
Education; SF Bay Area Food Allergy Network; two individuals
Opposition : None Known
HISTORY
Source : Mylan
Related Pending Legislation :
AB 1748 (Mayes, 2016) would, among other things, authorize
school nurses or, if the school does not have a school nurse, a
person who has received training regarding opioid antagonists,
as specified, to immediately administer the medication under
certain circumstances. The bill would provide for various
immunities, as specified.
AB 1719 (Rodriguez, 2016) would provide for various immunities
relating to the instruction of students in compression-only CPR
or use of an AED.
Prior Legislation :
SB 738 (Huff, Ch. 132, Stats. 2015) See Background.
SB 1266 (Huff, Ch. 321, Stats. 2014) See Background.
SB 669 (Huff, Ch. 725, Stats. 2013) See Background.
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SB 635 (Ammiano, Ch. 707, Stats. 2013) See Comment 2.
SB 161 (Huff, Ch. 560, Stats. 2011) authorized a school
district, county office of education, or charter school to
participate in a program to provide nonmedical school employees
with voluntary emergency medical training to provide, in the
absence of an onsite credentialed school nurse or other licensed
nurse, emergency medical assistance to pupils with epilepsy
suffering from seizures, in accordance with specified
guidelines. SB 161 provided volunteers with defense and
indemnification by the school district, county office of
education, or charter school, for any and all civil liability,
as specified.
AB 559 (Wiggins, Ch. 458, Stats. 2001) See Background.
AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was
ultimately vetoed.
Prior Vote :
Senate Health Committee (Ayes 7, Noes 0)
Assembly Floor (Ayes 78, Noes 0)
Assembly Appropriations Committee (Ayes 17, Noes 0)
Assembly Judiciary Committee (Ayes 9, Noes 0)
Assembly Business and Professions Committee (Ayes 14, Noes 0)
Assembly Rules Committee (Ayes 10, Noes 0)
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