BILL ANALYSIS Ó
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|Hearing Date:June 16, 2014 |Bill No:AB |
| |1535 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: AB 1535Author:Bloom
As Amended:April 1, 2014 Fiscal: Yes
SUBJECT: Pharmacists: Naloxone Hydrochloride.
SUMMARY: Permits a pharmacist to furnish naloxone hydrochloride (NH)
without a prescription pursuant to standardized procedures and
protocols developed and approved jointly by the California Board of
Pharmacy (Board) and the Medical Board of California (MBC).
Existing law:
1)Establishes the Pharmacy Law which provides for the licensure and
regulation of pharmacies, pharmacists and wholesalers of dangerous
drugs or devices by the Board of Pharmacy (Board) within the
Department of Consumer Affairs (DCA).
2)Licenses and regulates physicians and surgeons under the Medical
Practice Act (Act) by the Medical Board of California (MBC).
3)Permits pharmacists to perform the following procedures under
physician protocols in licensed health care facilities: (BPC
§4052.1)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to a
prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
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authorization or order by the patient's prescriber.
1)Permits pharmacists in a number of specified settings to do the
following: (BPC § 4052.2)
a) Order and perform routine drug therapy-related patient
assessment procedures.
b) Order drug therapy-related laboratory tests.
c) Administer drugs and biologicals by injection pursuant to a
prescriber's order.
d) Initiate or adjust a patient's drug regimen pursuant to
authorization or order by the patient's treating prescriber.
Prohibits the substitution or selection of a different drug
unless authorized by protocol and requires prescriber
notification of initiated drug regimens to be transmitted within
24 hours.
e) Specifies that a patient's treating prescriber may prohibit
pharmacists from making any changes or adjustments to patients'
drug regimens.
f) Requires the governing policies, procedures and protocols to
be developed by specified health professionals and established
minimum requirements for those policies, procedures and
protocols.
g) Requires pharmacists performing procedures authorized by this
section to have successfully completed clinical residency
training or demonstrated clinical experience in direct patient
care delivery.
5) Authorizes an advanced practice pharmacist (APP) recognized by the
Board to do all of the following: (BPC § 4052.6)
a) Perform patient assessments.
b) Order and interpret drug-therapy related tests, ensuring that
the ordering of those tests is done in coordination with the
patient's primary care provider or diagnosing prescriber, as
appropriate, including promptly transmitting written notification
to the patient's diagnosing prescriber or entering the
appropriate information in a patient record system shared with
the prescriber, when available and as permitted by that
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prescriber.
c) Refer patients to other health care providers.
d) Participate in the evaluation or management of diseases and
health conditions in collaboration with other health care
providers.
e) Initiate, adjust or discontinue drug therapy pursuant to the
authority established in current law for pharmacists to perform
certain procedures in a licensed health care facility.
1) Provides that an APP who adjusts or discontinues drug therapy shall
promptly transmit written notification to the patient's diagnosing
prescriber or enter the appropriate information into a patient
record system shared with the prescriber. Provides that an APP who
initiates drug therapy shall promptly transmit written notification
or enter the appropriate information into a patient record system
shared with the patient's primary care provider or diagnosing
provider. (Id.)
2) Requires an APP to register with the DEA prior to initiating or
adjusting a controlled substance. (Id.)
8)Authorizes a licensed health care provider to prescribe and dispense
NH 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. (Civil Code (CC) § 1714.22)
9)Authorizes a licensed health care provider to issue standing orders
for the administration of NH to a person at risk of an
opioid-related overdose, a family member, friend, or other person in
a position to assist a person experiencing or reasonably suspected
of experiencing an overdose. (Id.)
10)Requires a person who is prescribed or possesses NH pursuant to a
standing order to receive training provided by an opioid overdose
prevention and treatment training program operated by a local health
jurisdiction or that is registered by a local health jurisdiction
that provides, at a minimum, training in (Id.):
a) The causes of an opiate overdose.
b) Mouth to mouth resuscitation.
c) How to contact appropriate emergency medical services.
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d) How to administer NH.
11)Does not require a person who is prescribed NH directly from a
licensed prescriber to receive training from an opioid prevention
and treatment training program. (Id.)
This bill:
1) Permits a pharmacist to furnish NH in accordance with standardized
procedures or protocols developed and approved by the Board and
MBC.
2) Permits a pharmacist to furnish NH in accordance with standardized
procedures or protocols developed and approved by both the Board
and MBC, in consultation with the California Society of Addiction
Medicine, the California Pharmacists Association, and other
appropriate entities.
3) Requires the Board and MBC to include in the standardized
procedures or protocols:
a) Procedures to ensure education of the person to whom the drug
is furnished, including, but not limited to opioid overdose
prevention, recognition, and response, safe administration of NH,
potential side effects or adverse events, and the imperative to
seek emergency medical care for the patient.
b) Procedures to ensure the education of the person to whom the
drug is furnished regarding the availability of the drug
treatment programs.
c) Procedures for the notification of the patient's primary care
provider with patient consent of any drugs or devises furnished
to the patient, or entry of appropriate information in a patient
record system shared with the primary care provider, as permitted
by that primary care provider, and with patient consent.
1) Prohibits a pharmacist furnishing NH from allowing a person
receiving NH to waive the drug consultation.
2) Requires a pharmacist to complete a training program on the use of
opioid antagonists that consists of at least one hour of approved
continuing education on the use NH.
3) Authorizes Board and MBC to ensure compliance with this bill, and
states that each board is charged with enforcing this bill with
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respect to its respective licensees.
4) States that this bill does not expand the authority of a pharmacist
to prescribe any prescription medication.
FISCAL EFFECT: This measure is keyed "fiscal" by Legislative Counsel.
According to the Assembly Appropriations Committee analysis dated
April 30, 2014, this bill will result in minor one-time costs, under
$100,000, to the MBC and to the Board to jointly develop standardized
procedures and protocols and related training and educational content.
The analysis also stated that the bill will result in minor and
absorbable ongoing costs to both boards for enforcement.
COMMENTS:
1.Purpose. This bill is sponsored by the Drug Policy Alliance and the
California Pharmacists Association . According to the Author, "Drug
overdose deaths by prescription pain pills and heroin have reached
the point of becoming a public health crisis in California. We
urgently need an environmental, public health intervention right now
to reduce these deaths. This bill, which authorizes the Medical
Board of California and the Board of Pharmacy to develop a statewide
protocol for pharmacists to furnish naloxone, will widen access to
this successful and safe live-saving drug. Naloxone reverses an
opioid overdose, and should be widely available in order to combat
the drug overdose crisis. Pharmacists are highly trained
professionals who are readily accessible to the public in many
communities, and allowing them to do this is of enormous importance
to families across California and to public health as a whole."
2.Prescription Drug Deaths. A 2013 Centers for Disease Control (CDC)
analysis found that drug overdose deaths increased for the 11th
consecutive year in 2010 and prescription drugs, particularly opioid
analgesics, are the top drugs leading the list of those responsible
for fatalities. According to CDC, 38,329 people died from a drug
overdose in 2010, up from 37,004 deaths in 2009, and 16,849 deaths
in 1999. CDC found that nearly 60 percent of the overdose deaths in
2010, involved pharmaceutical drugs, with opioids associated with
approximately 75 percent of these deaths. Nearly three out of four
prescription drug overdoses are caused by opioid pain relievers.
3.Naloxone Hydrochloride. Naloxone Hydrochloride (NH), better known
as Narcan, is an opioid antidote that can reverse a drug overdose.
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NH reverses depression of the central nervous system and respiratory
systems that have shut down during an overdose. NH is commonly used
when a person excessively uses morphine, oxycodone, methadone, or
illegal substances such as heroin. NH is meant to sustain breathing
for 30-90 minutes, during which time emergency medical services
should be sought for the patient. The drug is non-narcotic, does
not produce intoxication, and has no potential for addiction or
abuse. NH also only causes pharmacological effects if there are
opioids in someone's body. If NH is administered to someone who is
not overdosing, no adverse effects will happen.
NH is typically administered intramuscularly, which causes the drug
to act within one minute and last up to 45 minutes. The emergency
treatment works like the well-known EpiPen, an epinephrine
auto-injector for serious allergic reactions, as it is injected into
the muscle and does not require training, making it more
user-friendly. NH may also be administered via intravenously,
subcutaneous (under the skin), or intranasally. A typical
injectable or nasal spray NH kit costs $15-$25 per dose.
California is one of a number of states that have recently enacted
legislation to address the public health concern of prescription
drug overdose. 17 states and the District of Columbia, have enacted
laws expanding access to NH. Most notably, programs that have
required police officers to carry NH have been proven successful at
curbing overdose deaths. According to a report by CNN, "The police
department in Quincy, Massachusetts was the first in the nation to
require its officers to carry naloxone and has successfully reversed
211 overdoses with a success rate of over 95%." New York recently
implemented a similar idea in Suffolk County, where 563 lives were
saved last year alone.
Community based programs have existed since 1996 to get NH into the
hands of those able to help. The national advocacy organization
Harm Reduction Coalition (HRC) reports that there are currently over
200 take-home NH programs in communities throughout the United
States that help to increase access to NH and training education on
overdose.
In 2010, HRC surveyed 50 of these programs and reported the results
in the February 17, 2012 issue of Morbidity and Mortality Weekly
Report (MMWR), a publication of the CDC. The survey found that
since these programs first began, 53,032 persons were trained on the
use of NH and the programs received reports of 10,171 overdose
reversals. Other community based projects like Project Lazarus and
Operation OpioidSAFE in North Carolina are working to increase the
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accessibility of NH. Education is provided by these programs about
opioid safety and the administration of NH however these programs
are limited in their funding and geographic reach.
Despite evidence that shows widening distribution of NH helps
decrease drug overdose deaths, its implementation faces some
difficulties. MMWR reports that "nearly half (43.7%) of the
responding opioid overdose programs reported problems obtaining
naloxone related to cost and the supply chain. Price increases of
some formulations of naloxone appear to restrict current program
activities and the possibility of new programs. Economic pressures
on state and local budgets could decrease funding of opioid overdose
prevention activities. To address the substantial increases in
opioid-related drug overdose deaths, public health agencies could
consider comprehensive measures that include teaching laypersons how
to respond to overdoses and administer naloxone to those in need."
4.The Role of Pharmacists in Expanding Access to Naloxone. The Center
for Pharmacy Services (CPS), a community pharmacy in Pittsburg,
Pennsylvania recently collaborated with the Overdose Prevention
Project to enlist pharmacists in overdose prevention. This project
used pharmacists to educate patients and physicians about opioid
safety and the effectiveness of NH to prevent fatal overdose. After
training, patients that showed up at CPS with a NH prescription were
offered counseling on opioid safety, taught how to take opioid pain
relievers safely, and demonstrated how to safely dispose of unused
prescription medicines. The caregiver and patient were additionally
taught how to identify an overdose and how to administrate NH. This
program is unique in that any person that goes through the CPS
program and receives the opioid safety education can request a
prescription for naloxone. The pharmacist facilitates this by fax,
sending a simple form to the prescribing physician requesting they
sign an order to prescribe naloxone along with the opioids
prescribed.
This bill mirrors this approach to expand the distribution of NH.
5.Related Legislation This Year. SB 500 (Lieu) requires MBC to update
prescriber standards for controlled substances once every five years
and adds the American Cancer Society, specialists in pharmacology
and specialists in addiction medicine, to the entities MBC may
consult with in developing the standards. ( Status: The bill is
currently pending in the Assembly Business, Professions, and
Consumer Protection.)
SB 1438 (Pavley) requires the Emergency Medical Services Authority
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(EMSA) to develop and adopt training and standards, and promulgate
regulations, for all prehospital emergency care personnel, regarding
the use and administration of naloxone hydrochloride and other
opioid antagonists. This bill also permits, at the discretion of
the medical director of the local EMS agency, that pertinent
training completed by pre-hospital emergency care personnel may be
used to satisfy part of the training requirements regarding the use
and administration of naloxone hydrochloride and other opioid
antagonists by pre-hospital emergency care personnel. Both types of
training satisfy specified requirements allowing for immunity from
criminal and civil liability for administering an opioid antagonist.
Lastly, this bill would permit the Attorney General to authorize
hospitals and trauma centers to share information with local law
enforcement and medical service agencies about controlled
substances. SB 1438 would limit the data that may be provided by
hospitals and trauma centers to the number of overdoses and the
substances suspected as the primary cause of the overdoses.
( Status: This bill is currently pending in the Assembly).
6.Prior Related Legislation. AB 635 (Ammiano, Chapter 707, Statutes
of 2013) expanded an existing pilot program which provides qualified
immunity to licensed health care providers who prescribe NH by
removing the program's sunset date, expanding the program's reach
from seven to all counties, authorizing licensed health care
providers to prescribe NH to third parties (family members, friends,
or other persons in a position to assist a person at risk of an
opioid-related overdose), as well as to issue standing orders for
the distribution and/or administration of NH.
AB 831 (Bloom) of 2013 would have established, within the California
Health and Human Services Agency, a temporary working group to
develop a plan to reduce the rate of fatal drug overdoses in the
state. The bill would have also required the temporary working group
to make recommendations to the Chair of the Senate Committee on
Health and the Chair of Assembly Committee on Health on or before
January 1, 2015. ( Status: This bill was held under submission in the
Assembly Committee on Appropriations.)
AB 2145 (Ammiano, Chapter 545, Statutes of 2010) authorized a person
who is not otherwise licensed to administer an opioid antagonist in
an emergency without fee if the person has received specified
training information and believes in good faith that the other
person is experiencing a drug overdose. The bill prohibited a
person, as a result of his or her acts or omissions, from being
liable for any violation of any professional licensing statute, or
subject to any criminal prosecution arising from or related to the
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unauthorized practice of medicine or the possession of an opioid
antagonist.
AB 767 (Ridley-Thomas, Chapter 477, Statutes of 2007) authorized,
until January 1, 2011, a licensed health care provider, who is
already permitted to prescribe an opioid antagonist and if acting
with reasonable care, to prescribe and subsequently dispense or
distribute an opioid antagonist in conjunction with an opioid
overdose prevention and treatment training program without being
subject to civil liability or criminal prosecution. The bill also
required a local health jurisdiction that operates or registers an
opioid overdose prevention and treatment training program to collect
prescribed data and report it to the Senate and Assembly Committees
on Judiciary by January 1, 2010. The bill only applied to certain
counties.
7.Arguments in Support. Supporters of this measure write that "public
health experts agree that increasing access to naloxone is a key
strategy in preventing drug overdose deaths." They note that in
California, naloxone is currently available only by prescription and
from a very small number of programs operating under standing orders
from a physician and the next logical step in combating the epidemic
of overdose in California is to allow community pharmacies to
provide naloxone and counseling to at-risk patients. Supporters
also cite the recognition that pharmacists are "among the most
highly trusted healthcare professionals" who are trained experts at
working with "patients at risk of the harms associated with
prescription medications. Pharmacists interact with patients and
their family members more often than many physicians. They are well
positioned to provide overdose prevention information and naloxone
to patients on long-term or high-dose opioid therapies, their
caregivers and others who may witness an accidental overdose."
Supporters believe this bill is a simple, low-to-no-cost solution
that would move California in the right direction toward reducing
accidental overdose fatalities.
SUPPORT AND OPPOSITION:
Support:
California Pharmacists Association (Sponsor)
Drug Policy Alliance (Sponsor)
A New PATH
Addiction Research and Treatment
Amity Foundation
Bay Area Addiction Recovery Treatment (BAART)
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Behind the Orange Curtain
Broadway Treatment Center
Broken No More
California Hospital Association
California Mental Health Directors Association
California Narcotic Officers' Association
California Opioid Maintenance Providers
California Retailers Association
California Society of Addiction Medicine
Center for Living and Learning
County Alcohol and Drug Program Administrators Association of
California
CRI-HELP, Inc.
Drug and Alcohol Addiction Awareness and Prevention Program
Families ACT!
Fred Brown Recovery Services
Gateways Hospital and Mental Health Center
Grief Recovery After a Substance Passing
Health Officers Association of California
Health Right 360
Hillview Mental Health Center
Homeless Health Care Los Angeles
Hope of the Valley Rescue Mission
In Depth
Legal Services for Prisoners with Children
Los Angeles Centers for Alcohol and Drug Abuse
Los Angeles Community Action Network
Los Angeles HIV Drug and Alcohol Task Force
Mary Magdalene Project
Medical Board of California
National Federation of Independent Business
Not One More
Paramedics Plus
Paving the Way Foundation
Phoenix House of Los Angeles
Primary Purpose Sober Living Homes
San Fernando Recovery Center
SANE (Safer Alternatives Through Networking and Education)
SHIELDS For Families
Soberspace
Solace
Opposition:
None on file as of June 11, 2014.
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Consultant: Mark Mendoza