BILL ANALYSIS Ó
AB 1535
Page 1
Date of Hearing: April 8, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
AB 1535 (Bloom) - As Amended: April 1, 2014
SUBJECT : Pharmacists: naloxone hydrochloride.
SUMMARY : Permits a pharmacist to furnish naloxone
hydrochloride (NH) pursuant to standardized procedures or
protocols developed and approved by the California Board of
Pharmacy (BOP) and the Medical Board of California (MBC).
Specifically, this bill :
1)Permits a pharmacist to furnish NH in accordance with
standardized procedures or protocols developed and approved by
both BOP and MBC, in consultation with the California Society
of Addiction Medicine, the California Pharmacists Association,
and other appropriate entities.
2)Requires BOP 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 education of the person to whom the
drug is furnished regarding the availability of drug
treatment programs; and,
c) Procedures for the notification of the patient's primary
care provider, with patient consent, of any drugs or
devices 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.
3)Prohibits a pharmacist furnishing NH from allowing a person
receiving NH to waive the drug consultation.
AB 1535
Page 2
4)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 of NH, prior to
furnishing NH pursuant to this bill.
5)Authorizes BOP and MBC to ensure compliance with this bill,
and states that each board is specifically charged with
enforcing it with respect to its respective licensees.
6)States that this bill shall not be construed to expand the
authority of a pharmacist to prescribe any drug.
EXISTING LAW :
1)Establishes BOP to administer and enforce the Pharmacy Law.
(Business and Professions Code (BPC) Section 4001).
2)Establishes MBC to administer and enforce the Medical Practice
Act. (BPC 2004)
3)Authorizes pharmacists to furnish emergency contraception drug
therapy, self-administered hormonal contraceptives, nicotine
replacement products, and administer immunizations in
accordance with standardized procedures or protocols, as
specified. (BPC 4052)
4)Authorizes pharmacists to furnish prescription medications not
requiring a diagnosis that are recommended by the federal
Centers for Disease Control and Prevention (CDC) for
individuals traveling outside of the United States. (BPC 4052)
5)Authorizes a pharmacist to provide consultation, training, and
education to patients about drug therapy, disease management,
and disease prevention. (BPC 4052)
6)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) Section 1714.22)
AB 1535
Page 3
7)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. (CC 1714.22)
8)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:
a) The causes of an opiate overdose;
b) Mouth to mouth resuscitation;
c) How to contact appropriate emergency medical services;
and,
d) How to administer NH. (CC 1714.22)
9)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. (CC 1714.22)
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill will allow a pharmacist to
furnish 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, pursuant to standardized procedures
or protocols developed and approved by BOP and MBC. This bill
will enable the wider distribution of a safe,
easy-to-administer and life-saving drug in accordance with
recommendations from the United States Department of Health
and Human Services. This bill is sponsored by the Drug Policy
Alliance.
2)Author's statement . According to the author's office, "Due to
increases in the use and abuse of prescription painkillers in
our state, prescription drug overdose is now the leading cause
AB 1535
Page 4
of accidental death in California - killing more people than
car accidents or gunshots. [NH] is a safe and effective
antidote to opioid overdoses that, when administered by a
family member or another witness, can prevent death or
disability. Currently, [NH] is available only by
prescription, or from programs operating under standing orders
from a physician. This bill would improve access to this
life-saving medication by allowing pharmacists to furnish
naloxone in accordance with standardized procedures developed
an approved by [MBC] and [BOP]."
3)Naloxone hydrochloride . NH is an antidote to opioids. It is
traditionally used in the hospital setting to reverse the
effects of opiates given during surgery, and may be given to
newborns to decrease the effects of opiates received by the
pregnant mother prior to delivery. It is currently available
by prescription only, but is not a scheduled drug.
NH reverses an overdose by blocking the central nervous system
effects of several types of opiate medications such as
morphine, oxycodone, methadone or illegal substances such as
heroin. According to its Food and Drug Administration (FDA)
approved label, NH only causes pharmacologic effects if there
are opioids in someone's body. This means that if NH is
administered to someone who is not overdosing, nothing will
happen. NH is not addictive and has not shown to produce
either physical or psychological dependence.
According to the Opioid Overdose Toolkit from the Substance
Abuse and Mental Health Services Administration (SAMHSA), a
division of the United States Department of Health and Human
Services:
"The safety profile of NH is remarkably high, especially
when used in low doses and titrated to effect. When given
to individuals who are not opioid-intoxicated or
opioid-dependent, NH produces no clinical effects, even at
high doses. Moreover, while rapid opioid withdrawal in
tolerant patients may be unpleasant, it is not
life-threatening.
"NH can be safely be used to manage opioid overdose in
pregnant women."
NH is administered by injection into a large muscle, such as
AB 1535
Page 5
the thighs, buttocks, or shoulder, or through a nasal spray,
and can reverse the effects of an opioid overdose. The
purpose is to restart the patient's breathing, but may not
necessarily cause complete revival. NH is effective for 30-90
minutes, during which time emergency services should be sought
for the patient. When injected into an overdose victim whose
heart is still beating, "it's virtually 100% effective," said
Wilson Compton, deputy director at the National Institute on
Drug Abuse.
According to the National Institute of Health, NH has a shelf
life of approximately two years and should be stored at room
temperature and away from direct light. A typical injectable
or nasal spray NH kit costs $15-$25 per dose.
4)Current California pharmacist furnishing laws . California
pharmacists are currently authorized to furnish the following
medications without a prescription after appropriate training
and pursuant to specified conditions:
a) Emergency contraception drug therapy and
self-administered hormonal contraceptives;
b) Nicotine replacement products;
c) Prescription medications not requiring a diagnosis that
are recommended by CDC for individuals traveling outside of
the United States;
d) Administer immunizations; and,
e) Initiate and administer epinephrine.
5)Community and first responder NH programs . Overdose is common
among persons who use opioids, including heroin and
prescription drug users. A study published in the 2006 Journal
of Substance Abuse Treatment found that of 329 drug users,
64.6% had witnessed a drug overdose and 34.6% had experienced
an unintentional drug overdose.
The Network for Public Health Law says that 17 states, plus
the District of Columbia, have adopted laws expanding access
to NH. Many states limit access to certain first responders,
but a trend towards wider access is emerging. For example,
New York recently developed a pilot program to give a
AB 1535
Page 6
nasal-spritzer form of the drug to police in Suffolk County.
A Feb. 6, 2014 article in the Los Angeles Times reported that
Suffolk County police reversed 172 of the 178 overdoses in
which officers administered NH over the last 18 months.
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 naloxone programs in
communities throughout the United States. These programs
expand naloxone access to drug users and others by providing
comprehensive training on overdose prevention, recognition,
and response (including calling 911 and rescue breathing) in
addition to prescribing and dispensing naloxone. These
programs typically obtain NH via physician-directed standing
orders, which enable NH to be distributed without reference to
an individual patient.
In 2010, HRC surveyed 50 of these programs and reported on
their results in the February 17, 2012 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.
6)Calls for greater access . There are several community-based
efforts underway (discussed further below) to encourage
physicians to prescribe NH concurrently with opioids for
patients who meet criteria for higher overdose risk. However,
data on concurrent prescription rates are limited and not
suggestive of frequent application. 2013 Medi-Cal data
provided by this bill's sponsors indicate that while 62% of
Medi-Cal prescribers prescribe opioids, less than two tenths
of one percent prescribe NH.
Some community-based programs are urging a closer connection
between primary care providers and opioid patients. For
example, Project Lazarus and Operation OpioidSAFE in North
Carolina are community-based, integrated prescription drug
prevention programs that involve multiple tiers of
intervention made up of family, social welfare groups, and
medical professionals. According to those programs' own
published results, they have proven very successful at
reducing deaths among patients that are increased risk of
narcotic abuse. However, the reach of such programs are
AB 1535
Page 7
limited by their funding and geography.
The findings of the 2012 MMWR report suggests that wider
distribution of NH and training in its administration might
prevent numerous deaths from opioid overdoses and save
thousands of dollars in public funds. However, nearly half of
the responding NH programs reported problems obtaining NH due
to cost and supply chain availability. The MMWR report framed
this as a significant public health issue: "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."
7)Role of pharmacists in furnishing NH . According to a March
2014 research letter published in the Journal of the American
Medical Association, the highest-risk and highest-use group of
opioid users is more likely to obtain opioids from a
physician's prescription than from a drug dealer. And these
prescriptions are filled at pharmacies.
The Center for Pharmacy Services (CPS), a community pharmacy
in Pittsburgh, Pennsylvania, collaborated with the Overdose
Prevention Project to develop a model that enlists pharmacists
in overdose prevention. The model uses pharmacists to educate
patients and physicians about opioid safety and the
effectiveness of prophylactic prescription of NH to prevent
fatal overdose.
Beginning in February 2011, patients presenting at CPS with a
prescription for an opioid analgesic were offered counseling
on opioid safety, including potential side effects, how to
take opioid pain relievers safely, possible signs of opioid
over-medication and/or overdose, and safe disposal of unused
prescription medicines. Patients are also provided with opioid
safety educational materials. The patient and/or caregiver
also receives instruction on how to identify and effectively
respond to an overdose and how to administer naloxone.
In the CPS program, a patient who receives the opioid safety
AB 1535
Page 8
education can request a prescription for NH. The pharmacist
facilitates this by fax, sending a simple form to the
prescribing physician requesting they sign an order to
prescribe NH along with the opioids prescribed.
This bill seeks to follow the CPS model by allowing
pharmacists to furnish NH pursuant to a protocol, thereby
streamlining the process by which an individual receives the
drug.
AB 1535 will require BOP and MBC to establish a protocol
(essentially, formalized directions) requiring that furnishing
pharmacists:
a) Educate the patient on 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) Inform the patient about the availability of drug
treatment programs; and,
c) Notify the patient's primary care provider, with patient
consent, of any drugs or devices 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.
8) Arguments in support . The sponsor, Drug Policy
Alliance, writes, "On behalf of the Drug Policy Alliance, a
national advocate for drug policies based on science,
compassion, health and human rights, we are proud to work
in partnership with the California Pharmacy Association and
Assemblymember Bloom to sponsor AB 1535. This bill, if
passed, will permit pharmacists to furnish [NH], the opiate
overdose reversal medicine, upon request to patients and
others who may be present at the scene of an overdose,
pursuant to protocols to be developed by the California
Medical Board and the Board of Pharmacy?.
"Public health experts agree that increasing access to [NH] is
a key strategy in preventing drug overdose deaths. The
AB 1535
Page 9
American Medical Association, the White House Office of
National Drug Control Policy, and the Director of the National
Institutes of Drug Abuse, among others, have called for
expanded access to [NH]?.
Pharmacists are consistently recognized as among the most
highly trusted healthcare professionals. They are trained
experts in 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 [NH] to patients on
long-term or high-dose opioid therapies, their caregivers, and
others who may witness an accidental overdose."
The sponsor, California Pharmacists Association, writes,
"Solving America's drug abuse problem is one of the more
complicated challenges facing us as a society. While there is
no quick fix to solving the problem, increasing access to [NH]
will have an immediate impact on the number of opioid overdose
deaths in California. Just this month, U.S. Attorney General
Eric Holder called for increased distribution of naloxone and
Massachusetts Governor Deval Patrick issued emergency standing
orders that would have the same effect as AB 1535. California
should pass this bill to increase access to this life-saving
medication."
9) Previous 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.
REGISTERED SUPPORT / OPPOSITION :
Support
California Pharmacists Association (sponsor)
Drug Policy Alliance (sponsor)
A New PATH
AB 1535
Page 10
Addiction Research and Treatment
Amity Foundation
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
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
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
Medical Board of California
Motion Picture Association of America
Not One More
Paving the Way Foundation
Phoenix House of Los Angeles
Primary Purpose Sober Living Homes
SHIELDS For Families
Soberspace
Solace
The County Alcohol and Drug Program Administrators Association
of California
The Mary Magdalene Project
Three individuals
Opposition
None on file.
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
AB 1535
Page 11
319-3301