BILL ANALYSIS Ó
SB 1438
Page 1
Date of Hearing: June 17, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
SB 1438 (Pavley) - As Amended: June 11, 2014
SENATE VOTE : 31-0
SUBJECT : Controlled substances: opioid antagonists.
SUMMARY : Adds peace officers to those allowed to administer an
opioid antagonist to a person at risk of an opioid-related
overdose. Requires the Emergency Medical Services Authority
(EMSA) to develop and adopt training and standards for all
prehospital emergency care personnel regarding the use and
administration of naloxone hydrochloride (naloxone) and other
opioid antagonists and to include the administration of naloxone
in the training and scope of practice for emergency medical
technician I (EMT-I) certification. Requires the Attorney
General (AG) to authorize hospitals and trauma centers to share
data on controlled substance overdose trends with local law
enforcement agencies and local emergency medical services
agencies (LEMSAs). Specifically, this bill :
1)Adds peace officers to those allowed to administer an opioid
antagonist to a person at risk of an opioid-related overdose,
when issued by standing order or prescribed by a licensed
health care provider who is authorized by law to prescribe an
opioid antagonist, without being subject to professional
review, liable in a civil action, or subject to criminal
prosecution for that act.
2)Requires EMSA to develop, and after approval by the Commission
on Emergency Medical Services (EMS), adopt training and
standards for all prehospital emergency care personnel
regarding the use and administration of naloxone and other
opioid antagonists.
3)Requires EMSA to develop, and after approval by the EMS
Commission, to adopt regulations, on or before July 1, 2015,
that include administration of naloxone in EMT-I certification
training substantially similar to the training currently
required for EMT-II certification. Requires these regulations
to authorize and EMT-I to receive EMT-II training in the
administration of naloxone hydrochloride without having to
complete the entire EMT-II certification course. Expands the
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scope of duties for EMT-I to include the administration of
naloxone to a person at risk of an opioid-related overdose.
4)Allows EMSA to adopt existing training and standards for
prehospital emergency care personnel regarding the statewide
use and administration of naloxone or another opioid
antagonist to satisfy the requirements in 2) above.
5)Allows the director of a LEMSA to use pertinent training
completed by prehospital emergency care personnel to satisfy
the requirements established by EMSA in 2) above.
6)Requires the AG, in order to encourage research on misuse and
abuse of controlled substances, to authorize hospitals and
trauma centers to share data on controlled substance overdose
trends with local law enforcement agencies and LEMSAs.
7)Limits the shared data in 5) above to be limited to the number
of overdoses and the substances suspected as the primary cause
of the overdoses and requires that these data be shared with
complete patient confidentiality.
EXISTING LAW :
1)Defines "opioid antagonist" as naloxone that is approved by
the federal Food and Drug Administration (FDA) for the
treatment of an opioid overdose.
2)Allows a licensed health care provider who is authorized to
prescribe naloxone to prescribe and dispense or distribute the
medication to a person at risk of an overdose or to a family
member, friend, or other person in a position to assist the
person at risk of overdose. Allows a licensed health care
provider to issue standing orders for these purposes.
3)Requires a person who is prescribed or possesses naloxone
pursuant to a standing order to receive training by an
overdose prevention and treatment training program, as
specified. Specifies that a person who is prescribed naloxone
directly from a licensed prescriber, and not through a
standing order, is not subject to the training requirement.
4)Exempts a health care provider who acts with reasonable care
in issuing a prescription for naloxone and any person who
possesses, distributes, or administers naloxone, with
reasonable care, from professional review, civil action, or
criminal prosecution.
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5)Requires EMSA to establish training and standards for all
prehospital emergency care personnel, as defined, regarding
the characteristics and method of assessment and treatment of
anaphylactic reactions and the use of epinephrine. Requires
EMSA to promulgate regulations for use by all prehospital
emergency care personnel.
6)Requires the AG to encourage research on the misuse and abuse
of controlled substances. Allows the AG to develop new and
improved approaches, techniques, systems, equipment, and
devices to strengthen enforcement of the Controlled Substances
Act, and to enter into contracts entities, as specified, to
conduct demonstrations or special projects that bear directly
on the misuse and abuse of controlled substances.
FISCAL EFFECT : According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, California and
the nation are in the midst of a drug abuse crisis.
Prescription opioid and heroin abuse have precipitated a
public health epidemic marked by a spike in fatal overdoses.
While naloxone, an opiate antidote that reverses opiate
overdoses, has been used by paramedics and advanced EMTs to
save lives for the last few decades, current law is unclear
about the ability of other first emergency responders, such as
law enforcement, to use this medication.
Recently, California has taken several steps to prevent overdose
fatalities. Legislation enacted last year expanded the use of
naloxone for health care providers, family, friends, and other
persons who may assist overdose victims, but the law has been
interpreted to lack specific clarity about law enforcement's
ability to carry and administer the drug.
While paramedics and emergency medical technicians are often the
first to respond to a medical emergency, some localities
report that peace officers are increasingly the first to
encounter an overdose victim. A recent internal survey within
the San Diego Sheriff's Department found that sheriff's
deputies responded to over 200 overdose-related emergency
calls in the first nine months of 2013. In over 50% of those
cases, the sheriff's deputy was the first emergency responder
on the scene. Last month, in recognition of the nationwide
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surge in opiate overdoses, U.S. Attorney General Eric Holder
echoed the plea made by the director of the White House Office
of National Drug Control Policy to train and equip law
enforcement officers with naloxone.
2)BACKGROUND .
a) Deaths related to opioid overdose. The abuse of opioids
- a group of drugs that includes heroin and prescription
painkillers - is having a devastating impact on public
health and safety in communities across the Nation. In
2010, there were over 19,000 drug poisoning deaths
nationally and approximately 4,300 drug poisoning deaths in
California. Counties experiencing the highest numbers of
overdose deaths were: Alameda, Fresno, Kern, Los Angeles,
Orange, Riverside, Sacramento, San Bernardino, San Diego,
San Francisco, and Santa Clara. More Americans are using
and dying from prescription painkillers than from heroin.
According to the Centers for Disease Control and Prevention
(CDC), there has been a 20% increase in overdose deaths
involving prescription painkillers since 2006. In 2009,
28,754 (91%) of all unintentional poisoning deaths were
caused most commonly by prescription opioids, which include
such drugs as methadone, hydrocodone (Vicodin), and
oxycodone (Oxycontin), followed by cocaine and heroin.
b) Naloxone. According to the FDA, naloxone, which is not
a controlled substance, rapidly reverses the effects of
opioid overdose and is the standard treatment for overdose,
which is characterized by decreased breathing or heart rate
or loss of consciousness. When administered quickly and
effectively, naloxone immediately restores breathing to a
victim in the throes of an opioid overdose. The National
Institute on Drug Abuse's Internet website states that, as
of March 2014, 17 states have passed laws that allow for
wider prescribing of naloxone to those who can help prevent
overdoses, such as family and friends of drug addicts and a
wide array of emergency personnel, like police and
firefighters. Some overdose prevention programs use
syringes fitted with atomizers to enable the medication to
be sprayed into the nose.
In April 2014, the FDA announced the approval of a new
hand-held auto-injector to reverse opioid overdose. The
medication is injected into the muscle or under the skin.
The new device provides verbal instruction, similar to an
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automated defibrillator. The FDA granted a fast-track
designation, which is designed to facilitate development
and to expedite the review of drugs to treat serious
conditions and fill unmet medical need, according to the
FDA's Internet website.
c) Law enforcement and naloxone distribution and
administration. Every overdose is preventable. The Obama
Administration is encouraging first responders to carry the
overdose-reversal drug naloxone. Because police are often
the first on the scene of an overdose, the Obama
Administration strongly encourages local law enforcement
agencies to train and equip their personnel with this
lifesaving drug. Used in concert with "Good Samaritan"
laws, which grant immunity from criminal prosecution to
those seeking medical help for someone experiencing an
overdose, it can and will save lives.
Law enforcement agencies in other states have been
successfully carrying and administering naloxone. The
police officers in Quincy, a suburb of Boston,
Massachusetts, have been carrying a nasal form of naloxone,
known commonly by its trade name, Narcan, since October
2010. Quincy officers have administered the drug 221 times
and reversed 211 overdoses. In New York City in 2012,
there were 190 painkiller deaths citywide, with 37 of them
on Staten Island. In response, 180 Staten Island police
officers were trained in December 2013, to administer the
spray as part of a pilot program to fight the high rate of
painkiller abuse.
A 2012 CDC report on programs known to distribute naloxone
documented the reversal of more than 10,000 heroin
overdoses. The programs provided opioid overdose education
and naloxone to drug users and to those who might be
present during a drug overdose in order to help reduce
overdose deaths. However, of the 48 programs that
responded, nearly half reported problems in obtaining
naloxone related to cost and a shortage of supply.
According to the Drug Policy Alliance's Internet website,
naloxone has been safely and effectively used for more than
40 years in ambulances and emergency rooms across the
country. Naloxone has no potential for abuse and side
effects are rare. The Drug Policy Alliance also cites
ongoing research showing that expanding access to naloxone
does not promote increased drug use or risk-taking behavior
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that results in unintended overdoses.
3)SUPPORT . The Drug Policy Alliance writes that this bill is an
urgently needed measure to allow first responders to
administer opiate overdose reversal medication, naloxone, to a
person at risk of a fatal overdose. Naloxone has been
extensively researched and widely used by a number of health
care entities for decades and several states have already
expanded usage to peace officers with no reports of negative
outcomes for patient safety. The Drug Policy Alliance
believes this bill is part of a comprehensive strategy to
combat the epidemic of opiate overdoses in California.
The San Diego Sheriff's Department writes in support of
providing naloxone to and the training of deputies and
officers in the administration of the opioid antagonist in
order to help efforts in San Diego County to stem the tide of
overdose-related deaths in their community. The San Diego
Sheriff's Department recently conducted an internal survey and
found that their deputies responded to over 200
overdose-related emergency calls in the first nine months of
2013, and in over half of those cases the deputy was the first
emergency responder on the scene.
4)DOUBLE REFERRAL . This bill is double referred. Upon passage
in this Committee, this bill will be referred to the Assembly
Committee on Judiciary.
5)PREVIOUS LEGISLATION .
a) AB 635 (Ammiano), Chapter 707, Statutes of 2013, expands
the program in AB 2145 (Ammiano), Chapter 545, Statutes of
2010, statewide; deletes the sunset date and the reporting
requirements; and, modifies the limited liability
provisions for both licensed health care professionals who
prescribe, dispense, or distribute naloxone and unlicensed
persons who act with reasonable care to administer naloxone
to a person who is experiencing or is suspected to be
experiencing an overdose.
b) AB 2145 (Ammiano) extends the sunset date of the
seven-county pilot program established under SB 767
(Ridley-Thomas), Chapter 477, Statutes of 2007, to January
1, 2016; extends to January 1, 2015, the deadline for the
requirement of local health jurisdictions operating an
overdose prevention program to report, as specified, to the
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Senate and Assembly Committees on Judiciary; and adds
immunity for unlicensed trained people who administer an
opioid antidote in emergency situations during which they
believe that a person is experiencing a drug overdose.
c) SB 767 (Ridley-Thomas) establishes a seven-county pilot
program until January 1, 2010, in which licensed health
care providers were given immunity from civil liability or
criminal prosecution when they prescribed naloxone to a
person in connection with an opioid overdose prevention and
training program on how to recognize and respond to an
opiate overdose. Requires local health jurisdictions
operating an overdose prevention program to report, as
specified, to the Senate and Assembly Committees on
Judiciary by January 1, 2010.
d) SB 1695 (Escutia), Chapter 678, Statutes of 2002,
authorizes counties to establish training and certification
programs to permit an EMT-I to administer naloxone by means
other than intravenous injection if he/she has completed
training and passed a test. Requires EMSA to develop
guidelines relating to the county certification programs.
e) SB 1134 (Escutia) of 2001 contained, among other things,
the provisions in SB 1695 above. SB 1134 was vetoed by
Governor Davis who cited cost reasons related to provisions
in the bill that required grants for drug overdose
prevention programs.
f) SB 851 (Oller) of 2001 would have required EMSA to
develop and implement procedures and protocols to permit
EMT-I's in Sierra County to obtain training and
certification to safely administer emergency medical
procedures, including naloxone, that are outside of their
scope of practice. SB 851 died in the Senate Health and
Human Services Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California Professional Firefighters (sponsor)
California Chapter of the American College of Emergency
Physicians
California Opioid Maintenance Providers
California Pharmacists Association
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California State Sheriff's Association
Drug Policy Alliance
Emergency Medical Services Administrators Association of
California
San Diego County Sheriff's Department
Opposition
None on file.
Analysis Prepared by : Patty Rodgers / HEALTH / (916) 319-2097