BILL ANALYSIS Ó
SENATE JUDICIARY COMMITTEE
Senator Hannah-Beth Jackson, Chair
2015-2016 Regular Session
SB 1229 (Jackson and Stone)
Version: March 28, 2016
Hearing Date: April 12, 2016
Fiscal: No
Urgency: No
RD
SUBJECT
Pharmacies: secure drug take-back bins
DESCRIPTION
This bill would provide specified collectors that are authorized
under federal law to engage in drug take-back collection with
limited protection from civil and criminal liability (or
"qualified immunity") for maintaining secure drug take-back
bins.
Specifically, a collector would not be liable in a civil action,
or be subject to criminal prosecution, for maintaining a secure
drug take-back bin on its premises if the collector, in good
faith and not for compensation, takes specified steps to ensure
the health and safety of consumers and employees and the proper
disposal of the home-generated pharmaceutical waste contained in
the secure drug take-back bin. This qualified immunity would not
apply in the case of personal injury or wrongful death which
results from the collector's gross negligence or willful or
wanton misconduct in maintaining a secure drug take-back bin.
BACKGROUND
Prior to 2010, as a matter of federal law, individuals who
wanted to dispose of unused, unwanted, or expired pharmaceutical
controlled substances only had limited disposal options because
the federal Controlled Substances Act (21 U.S.C. Sec. 801 et
seq.) only permitted individuals to either destroy those
substances themselves (such as by flushing or discarding),
surrender them to law enforcement, or otherwise seek assistance
from the federal Drug Enforcement Administration (DEA).
According to the DEA, these restrictions resulted in the
accumulation of pharmaceutical controlled substances in
household medicine cabinets that were available for abuse,
misuse, diversion, and accidental ingestion. (DEA, Final Rule,
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Disposal of Controlled Substances (Sept. 9, 2014)
p. 53520 [as of Apr. 3, 2016].) In 2010, the federal
Secure and Responsible Drug Disposal Act of 2010 (Disposal Act)
was enacted, amending the Controlled Substances Act to authorize
specified individuals, called "ultimate users," to deliver their
pharmaceutical controlled substances to another person for the
purpose of disposal in accordance with regulations promulgated
by the U.S. Attorney General.
Accordingly, in September of 2014, the DEA issued its final rule
implementing the Disposal Act and governing the secure disposal
of controlled substances by registrants and ultimate users.
Those regulations have expanded the options available to collect
controlled substances from ultimate users for the purpose of
disposal, including take-back events, mail-back programs, and
collection receptacle locations and, among other things, allow
authorized manufacturers, distributors, reverse distributors,
narcotic treatment programs, hospitals/clinics with an on-site
pharmacy, and retail pharmacies to voluntarily administer
mail-back programs and maintain collection receptacles (what
this bill refers to as "secure drug take-back bins"). (See id.)
While the changes to federal law are rather recent, there has
already been a significant push to increase the use and
availability of secure drug take-back programs both across the
nation and in this state. (See Comment 2 for more.) For
example, one major retailer, Walgreens, announced earlier this
year that it has begun to install safe medication disposal
kiosks in more than 500 drugstores in 39 states and Washington,
D.C. to make the disposal of medications - including opioids and
other controlled substances - easier and more convenient while
also helping to reduce the misuse of medications and the rise in
overdose deaths. (Walgreens Press Release, Walgreens Leads
Fight Against Prescription Drug Abuse with New Programs to Help
Curb Misuse of Medications and the Rise in Overdose Deaths (Feb.
9, 2016)
(as of Apr. 3, 2016).)
Additionally, at least one state has already sought to
incentivize pharmacies to engage in similar activities.
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Specifically, the state of Virginia recently enacted a law that
provides that no person that participates in a drug disposal
program shall be liable for any theft, robbery, or other
criminal act related to participation in the pharmacy drug
disposal program or for any acts of simple negligence in the
collection, storage, or destruction of prescription drugs
collected through such pharmacy drug disposal program, provided
that the pharmacy practice site is acting in good faith and in
accordance with applicable state and federal law and
regulations. (See Virginia's HB 629,
[as of Apr. 3, 2016]).
This bill would now state the intent of the California
Legislature to: (1) encourage the good faith participation of
federally-authorized entities to maintain secure drug take-back
bins on their premises for the convenience and public health and
safety of prescription drug consumers and the proper disposal in
the waste stream of the pharmaceutical waste contained in the
bins; and (2) limit the civil and criminal liability of
participating entities that meet certain minimum standards
enumerated in the bill and take reasonable care to ensure the
health and safety of consumers and employees when maintaining
secure drug take-back bins on their premises. This bill's
qualified immunity would not apply in cases of gross negligence
or willful or wanton misconduct that causes the personal injury
or wrongful death of another person.
CHANGES TO EXISTING LAW
Existing 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).)
Existing law provides that a person or entity that acquires an
automatic external defibrillator (AED) for emergency use is not
liable for any civil damages resulting from any acts or
omissions when the AED is used to render emergency care,
provided that the person or entity has complied with certain
notice, maintenance, and other reasonable care requirements
under the Health and Safety Code, as specified. (Civ. Code Sec.
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1714.21(d)(1).) These requirements include that the person or
entity must:
comply with all regulations governing the placement of an AED;
notify an agent of the local EMS agency of the existence,
location, and type of AED acquired;
ensure that the AED is maintained and tested according to the
operation and maintenance guidelines set forth by the
manufacturer;
ensure that the AED is tested at least biannually and after
each use;
ensure that an inspection is made of all AEDs on the premises
at least every 90 days for potential issues related to
operability of the device, as specified; and
ensure, when an AED is placed in a building, that at least
once a year a demonstration is made to at least one person
associated with the building so that the person can be walked
through how to use an AED properly in an emergency, and that
instructions are posted next to the AED, as specified, on how
to use the AED. (Health & Saf. Code Sec. 1797.196(b).)
Existing law provides that the qualified immunities described
above do 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 uses the AED to render
emergency care. (Civ. Code Sec. 1714.21(f).)
Existing law provides that a licensed health care provider who
acts with reasonable care and issues a prescription for, or an
order for the administration of, an opioid antagonist to a
person experiencing or suspected of experiencing an opioid
overdose is not subject to professional review, liable in a
civil action, or subject to criminal prosecution for issuing the
prescription or order. Existing law also provides that a person
who is not otherwise licensed to administer an opioid
antagonist, but who meets certain other conditions, is not
subject to professional review, liable in a civil action, or
subject to criminal prosecution for administering an opioid
antagonist. (Civ. Code Sec. 1714.22(e), (f).)
Existing law provides that any prehospital emergency medical
care person or lay rescuer, as specified, 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
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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 requirements of the
Health and Safety Code. (Civ. Code Sec. 1714.23(b).) Existing
law provides that this protection 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(c).)
Existing law provides that an authorizing physician and surgeon
shall not be subject to professional review, be liable in a
civil action, or be subject to criminal prosecution for the
issuance of a prescription or order to a qualified supervisor of
health or administrator at a school district, county office of
education, or charter school for epinephrine auto-injectors, as
specified, 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).)
This bill would now provide that any collector, as defined, that
maintains a secure drug take-back bin, in good faith and not for
compensation, shall not be liable in a civil action, or be
subject to criminal prosecution, for maintaining a secure drug
take-back bin on its premises if the collector takes specified
steps to ensure the health and safety of consumers and employees
and the proper disposal in the waste stream of the
home-generated pharmaceutical waste contained in a secure drug
take-back bin. This immunity would not apply in a case of
personal injury or wrongful death which results from the
collector's gross negligence or willful or wanton misconduct in
maintaining a secure drug take-back bin.
This bill provides that a collector must do all of the following
in order to be subject to the qualified civil or criminal
immunity protections, above:
comply with all applicable state and federal laws and
regulations relating to the collection of home-generated
pharmaceutical waste for disposal in secure drug take-back
bins, including, but not limited to, the federal Secure and
Responsible Drug Disposal Act of 2010;
notify local law enforcement and any local environmental
health department as to the existence and location of any
secure drug take-back bin on the collector's premises and the
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status of the collector's registration as a collector with the
federal Drug Enforcement Administration (DEA);
ensure that the secure drug take-back bin is placed in a
location that is regularly monitored by employees of the
registered collector;
ensure that conspicuous signage is posted on the secure drug
take-back bin that clearly notifies customers as to what
controlled and non-controlled substances are and are not
acceptable for deposit into the bin, as well as the hours
during which collection is allowed;
ensure that public access to the secure drug take-back bin is
limited to hours wherein employees of the registered collector
are present and able to monitor the operation of the secure
drug take-back bin;
regularly inspect the area surrounding the secure drug
take-back bin for potential tampering or diversion and
maintain certain records and logs, as specified;
notify local law enforcement authorities of any suspected or
known tampering, theft, or significant loss of controlled
substances within one business day of discovery, unless the
collector maintains daily business hours, in which case the
notification must be within one calendar day; and
notify local law enforcement as to any decision to discontinue
its voluntary collection of controlled substances, as
specified.
This bill provides that nothing in the above shall be construed
to require entities that may qualify as a collector to acquire,
maintain, or make available to the public a secure drug
take-back bin on its premise.
This bill defines various terms for these purposes.
Specifically, among other things:
"Collector" includes only those entities authorized by and
registered with the DEA to receive a controlled substance for
the purpose of destruction, if the entity is in good standing
with any applicable licensing authority.
"Compensation" means reimbursement or funds received from a
customer to compensate for the cost incurred in obtaining,
installing, or maintaining a secure drug take-back bin.
Compensation does not include reimbursement or funds received
from any other person or entity, other than a customer, to
compensate for the costs incurred in obtaining, installing, or
maintaining a secure drug take-back bin.
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"Home-generated pharmaceutical waste" means a pharmaceutical
that is no longer wanted or needed by the consumer and
includes any delivery system, such as pills, liquids, and
inhalers.
"Secure drug take-back bin" means a collection receptacle as
described in Section 1317.75 of Title 21 of the Code of
Federal Regulations.
This bill would include various findings and statements of
legislative intent.
COMMENT
1. Stated need for the bill
According to the author:
Home-generated pharmaceutical waste (i.e., prescription or
over-the-counter human or veterinary drugs that are "left
over" from treatment or have expired), has become an
increasing problem nationwide and in California. With the rise
of prescription drug abuse, these excess drugs-often stored in
medicine cabinets or under sinks for years-have found their
way into recreational use by teens or are otherwise misused by
seniors or others. People taking un-prescribed or expired
drugs are creating a growing public health and safety risk.
Without a safe means of disposal, many people with excess
drugs are turning to throwing them in the trash or flushing
them in a toilet. This creates serious problems with soil and
water quality, especially since our water treatment plants are
not capable of removing pharmaceuticals from wastewater.
Law enforcement and pioneering pharmacies concerned with
public safety and environmental health have been hosting drug
take-back programs and bins voluntarily. These early efforts
are laudable, but the scope of these drug take-back options
has remained relatively small in relation to the demand for
convenient and safe disposal. Many pharmacies have raised
concerns regarding potential liability as the reason behind
their reluctance to host a drug take-back bin. [ . . . ]
In order to help protect the public from prescription drug
abuse and to protect water quality from home-generated
pharmaceutical waste, SB 1229 would encourage [other]
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pharmacies to host secure drug take-back bins by:
1. Establishing a duty of care for the proper oversight of
secure drug take-back bins.
2. Providing limited civil and criminal liability immunity
for pharmacies hosting drug take-back bins if they meet
that duty of care.
Clean Water Action writes in support of the bill:
By establishing a duty [of] care for pharmacies that host
take-back bins with limited civil and criminal liability
immunity to that pharmacy, SB 1229 ensures both the safety of
the program and the ability of pharmacies to provide this
important service to their communities.
Pharmaceuticals provide a wealth of benefits to public health.
However, the reality is that both prescription and over the
counter drugs are often not used completely and become out of
date or unwanted. Advanced wastewater treatment is not
financially accessible to most California communities, and
even where it exists, it is not adequate to remove all of the
complex chemicals in medications. Consequently, when drugs
are flushed down the toilet or thrown in the trash (where they
end up in groundwater or effluent that is later put through
the wastewater system), they enter our waterways and drinking
water supplies. The effects on wildlife are well documented,
including reproductive harm, negative behavioral changes, and
endocrine disruption.
While improper disposal has sobering environmental impacts,
Clean Water Action's members also recognize that without
convenient options, medications are often stockpiled in the
home, posing a growing threat to youth and the elderly who may
mistakenly misuse them. For this reason, pharmacies that
choose to host bins provide an important public service.
Again, SB 1229 ensures that such bins meet minimum standards
while providing these responsible retailers the assurance that
they too are protected from unreasonable liability. This is a
win-win for the public and for pharmacies.
2. This bill seeks to set a statewide policy encouraging
voluntary participation in secure drug take-back collections
irrespective of mandatory local programs
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This bill seeks to encourage the safe disposal of left-over or
expired prescription or over-the-counter human or veterinary
drugs ("home generated pharmaceutical waste") by way of
collection in secure drug take-back bins. According to the U.S.
Food and Drug Administration (FDA), "[m]edicines play an
important role in treating many conditions and diseases and when
they are no longer needed it is important to dispose of them
properly to help reduce harm from accidental exposure or
intentional misuse." The FDA advises consumers and caregivers
to remove expired, unwanted, or unused medicines from their home
as quickly as possible to help reduce the chance that others may
accidentally take or intentionally misuse the medicine, noting
also that:
Medicine take-back programs are a good way to safely dispose
of most types of unneeded medicines. The U.S. Drug Enforcement
Administration (DEA) periodically hosts National Prescription
Drug Take-Back events where collection sites are set up in
communities nationwide for safe disposal of prescription
drugs. Local law enforcement agencies may also sponsor
medicine take-back programs in your community. Likewise,
consumers can contact their local waste management authorities
to learn about medication disposal options and guidelines for
their area.
Another option for consumers and long-term care facilities,
like nursing homes, to dispose of unneeded medicines is to
transfer unused medicines to collectors registered with the
DEA. DEA-authorized collectors safely and securely collect
and dispose of pharmaceuticals containing controlled
substances and other medicines. In your community, authorized
collection sites may be retail pharmacies, hospital or clinic
pharmacies, and law enforcement locations. Some authorized
collection sites may also offer mail-back programs or
collection receptacles, sometimes called "drop-boxes," to
assist consumers in safely disposing of their unused
medicines.
(FDA, Disposal of Unused Medicines: What You Should Know [last
updated Dec. 9, 2015]
[as of Mar. 29, 2016].)
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As noted in the Background, the federal government has only
recently begun to encourage the use of drug take-back programs
by way of mail back programs, collection receptacles, or take
back events. At the same time, however, a handful of California
counties have adopted ordinances to require drug take-back
programs in their counties. Indeed, Alameda County's 2012
ordinance appears to have been the first in the nation to
require pharmaceutical companies to fund the collection and
disposal of unused medications from the public. Other
California counties that have since followed suit include the
City and County of San Francisco, and the counties of San Mateo,
Marin, Santa Clara, and Santa Cruz. (See e.g. SF Environment,
Safe Drug Disposal Stewardship Ordinance
[as of Apr. 3, 2016]; County of San Mateo
Health System, Safe Medicine Disposal Ordinance
[as of Apr. 3, 2016].) According to
the author of this bill, Los Angeles and Santa Barbara Counties
are also currently considering adopting such ordinances.
This bill now seeks to take a different approach from that
sought by various local entities, whereby, as a matter of state
law, California would encourage entities authorized by the DEA
to act as collectors (including retail pharmacies, narcotic
treatment programs, distributors, wholesalers, reverse
distributors, and hospitals/clinics with onsite pharmacies) to
register with the DEA and voluntarily maintain secure drug
take-back bins on their premises. To incentivize this voluntary
activity, this bill seeks to provide a qualified immunity to
participants who meet certain basic standards, discussed further
below. Notably, this bill would have no bearing on those local
ordinances; rather, it would merely provide immunity to any
qualifying collector who meets the minimum standards of this
bill in maintaining a secure drug-take back bin.
3. This bill provides limited liability protection to
collectors that maintain secure drug take-back bins in order
to promote an important public policy in a measured fashion
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
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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
qualified 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 (naloxone)) in order to avoid
preventable deaths by limiting the liability of "Good
Samaritans," as long as certain minimal requirements are met.
Notably, none of these immunities 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 Secs. 1714.21, 1714.22 and 1714.23; in the
context of opioid antagonists, the law specifically mandates
reasonable care to have been taken in order for the qualified
immunity to apply.)
Here, the author seeks to incentivize voluntary activity on
behalf of certain entities, including pharmacies, to maintain
secure drug take-back collection bins on their premises by way
of providing these "collectors" reasonable assurance that they
will not be subject to civil or criminal liability for simple
negligence in maintaining such a bin on their premises. At the
same time, by creating a qualified immunity as opposed to
blanket immunity, the bill appears to recognize the importance
of balancing the public policy of promoting the safe and secure
collection and disposal of pharmaceutical waste against the
ability for an injured person to seek recourse for injuries
sustained.
As a preliminary matter, this bill limits the entities that can
qualify for the bill's immunity protections. "Collectors,"
under federal regulations, can include registered manufacturers,
distributors, reverse distributors, narcotic treatment programs,
hospital/clinics with an on-site pharmacy, or retail pharmacies
authorized by and registered with the DEA to receive a
controlled substance for the purpose of destruction. However,
because many of these entities would also have to be licensed by
the state as a matter of California law regardless of any
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participation in these drug take-back activities, this bill also
requires that a collector be in good standing with any
applicable licensing authority to qualify for the immunity
protections of the bill.
Further, under this bill, a qualifying collector would then only
be granted immunity from civil and criminal liability for
maintaining a secure drug take-back bin, if it acts in good
faith and not for compensation, and takes specified steps to
ensure the health and safety of consumers and employees and the
proper disposal in the waste stream of the home-generated
pharmaceutical waste contained in the secure drug take-back bin.
These steps effectively operate to establish minimal standards
of reasonable care for immunity purposes. For example, the
collector must, at minimum:
comply with all applicable state and federal laws and
regulations relating to the collection of home-generated
pharmaceutical waste for disposal in secure drug take-back
bins;
ensure that the secure drug take-back bin is placed in a
location that is regularly monitored by employees of the
registered collector;
ensure that public access to the secure drug take-back bin is
limited to hours wherein employees of the registered collector
are present and able to monitor the operation of the secure
drug take-back bin; and
notify local law enforcement authorities of any suspected or
known tampering, theft, or significant loss of controlled
substances, within specified time periods.
Even still, the bill further ensures that any immunity
protection would not apply in any case of personal injury or
wrongful death that involves gross negligence or willful or
wanton misconduct.
As a matter of public policy, given the reasonable limitations
placed on the bill's immunity protections, above, this bill
arguably takes a measured approach in incentivizing a safe and
secure method of collecting and properly destroying
home-generated pharmaceutical waste. In doing so, the bill
would be similar to protections already in place with respect to
AEDs, epi-pens, and naloxone.
4. Record logs serve to protect both the public health and
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safety and to assist the collector seeking to claim immunity
pursuant to this bill
As discussed above, to claim any immunity under this bill, a
collector would have to comply with certain minimum
requirements. While many of these requirements help ensure that
basic reasonable care is taken by any collector seeking immunity
protection for voluntarily maintaining a secure drug take-back
bin on its premises, others also would assist the collector who
attempts to claim these immunity protections in court. For
example, this bill requires that a collector regularly inspect
the area surrounding the secure drug take-back bin for potential
tampering or diversion in furtherance of public health and
safety, and requires that record logs of those inspections be
maintained and retained for four years, reflecting the date and
time of the inspection, and the initials of the employee
inspecting the area. In the event that a collector is sued and
seeks to claim immunity pursuant to this bill, such logs could
help the collector prove it has complied with the bill's minimum
requirements and thus is subject to its immunity protections.
5. Technical and clarifying author amendments
The author provides the following amendments to: (1) ensure that
the good faith standard applies the bill's minimum standards,
(2) to reduce the minimum number of years that record logs and
mandated reports must be maintained to two years, and (3) to
make technical corrections.
Author's Amendments
On page 2, line 12; page 3, line 33; page 4, line 39; and page
5, line 29, strike "Agency" and insert "Administration"
On page 4, lines 22-23, strike "bin, in good faith and not for
compensation," and insert "bin"
On page 4, line 25, strike "collector" and insert "collector,
in good faith and not for compensation,"
On page 4, line 33, insert comma after "but not limited to"
On page 5, lines 15 and 19, strike "four" and insert "two"
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Support : Californians Against Waste; City of Palo Alto; City of
Torrance; Clean Water Action; County Health Executives
Association of California; League of Cities; Los Angeles County
Solid Waste Management Committee/Integrated Waste Management
Task Force; Medication Education and Disposal Safety Coalition;
Napa Sanitation District; San Luis Obispo County Integrated
Waste Management Authority; Santa Clara County Board of
Supervisors; Solid Waste Association of North America
Opposition : None Known
HISTORY
Source : California Product Stewardship Council
Related Pending Legislation : None Known
Prior Legislation :
SB 738 (Huff, Ch. 132, Stats. 2015) provided that an authorizing
physician and surgeon shall not be subject to professional
review, be liable in a civil action, or be subject to criminal
prosecution for the issuance of a prescription or order to a
qualified supervisor of health or administrator at a school
district, county office of education, or charter school for
epi-pens pursuant to specified law, unless the physician and
surgeon's issuance constitutes gross negligence or willful or
malicious conduct.
SB 669 (Huff, Ch. 725, Stats. 2013), among other things,
authorized a trained pre-hospital emergency medical care person,
first responder, or lay rescuer to obtain and use epi-pens to
render emergency care to another person, pursuant to specified
requirements, and granted them qualified immunity from civil
liability, as specified.
AB 635 (Ammiano, Ch. 707, Stats. 2013) provided that a licensed
health care provider who acts with reasonable care and issues a
prescription for, or an order for the administration of, an
opioid antagonist to a person experiencing or suspected of
experiencing an opioid overdose is not subject to professional
review, liable in a civil action, or subject to criminal
prosecution for issuing the prescription or order. The bill also
provided that a person who is not otherwise licensed to
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administer an opioid antagonist, but who meets other specified
conditions, is not subject to professional review, liable in a
civil action, or subject to criminal prosecution for
administering an opioid antagonist.
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