BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 1535|
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THIRD READING
Bill No: AB 1535
Author: Bloom (D), et al.
Amended: 6/24/14 in Senate
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMM. : 9-0, 6/16/14
AYES: Lieu, Wyland, Berryhill, Block, Corbett, Galgiani,
Hernandez, Hill, Torres
SENATE APPROPRIATIONS COMMITTEE : 6-0, 6/30/14
AYES: De León, Walters, Hill, Lara, Padilla, Steinberg
NO VOTE RECORDED: Gaines
ASSEMBLY FLOOR : 73-0, 5/8/14 (Consent) - See last page for vote
SUBJECT : Pharmacists: naloxone hydrochloride
SOURCE : California Pharmacists Association
Drug Policy Alliance
DIGEST : This bill permits a pharmacist to furnish naloxone
hydrochloride (NH) pursuant to standardized procedures and
protocols developed and approved jointly by the Board of
Pharmacy (BOP) and the Medical Board of California (MBC).
ANALYSIS :
Existing law:
1.Establishes BOP to administer and enforce the Pharmacy Law.
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2.Establishes MBC to administer and enforce the Medical Practice
Act.
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.
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.
5.Authorizes a pharmacist to provide consultation, training, and
education to patients about drug therapy, disease management,
and disease prevention.
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.
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.
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.
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.
This bill:
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1.Permits a pharmacist to furnish NH in accordance with
standardized procedures or protocols developed and approved by
BOP and MBC.
2.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.
3.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 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 of NH.
3.Authorizes BOP and MBC to ensure compliance with this bill,
and states that each board is charged with enforcing this bill
with respect to its respective licensees.
4.States that this bill does not expand the authority of a
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pharmacist to prescribe any prescription medication.
5.Authorizes BOP to adopt emergency regulations establishing
standardized procedures or protocols and remain in effect
until the earlier of 180 days following their effective date
or the effective date of regulations adopted, as described
above.
Background
NH, better known as Narcan, is an opioid antidote that can
reverse a drug overdose. 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,
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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 . 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 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."
The Role of Pharmacists in Expanding Access to NH . 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
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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.
Comments
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 of accidental death in
California - killing more people than car accidents or gunshots.
NH is a safe and effective antidote to opioid overdose, 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 improves access to this life-saving
medication by allowing pharmacists to furnish NH in accordance
with standardized procedures developed and approved by the MBC
and BOP.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
According to the Senate Appropriations Committee:
One-time costs less than $75,000 to develop protocols and
adopt regulations by MBC (Contingent Fund of MBC).
One-time costs less than $75,000 to develop protocols and
adopt regulations by BOP (Pharmacy Board Contingent Fund).
Minor anticipated enforcement costs to BOP (Pharmacy Board
Contingent Fund).
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SUPPORT : (Verified 7/1/14)
California Pharmacists Association (co-source)
Drug Policy Alliance (co-source)
A New PATH
Addiction Research and Treatment
Amity Foundation
Bay Area Addiction Recovery Treatment
Behind the Orange Curtain
Broadway Treatment Center
Broken No More
California Association of Alcohol and Drug Program Executives,
Inc.
California Hospital Association
California Mental Health Directors Association
California Narcotic Officers' Association
California Opioid Maintenance Providers
California Pharmacists Association
California Retailers Association
California Society of Addiction Medicine
California United for a Responsible Budget
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
Drug Policy Alliance
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 County HIV Drug & Alcohol Task Force
Mary Magdalene Project
Medical Board of California
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National Federation of Independent Business
Not One More
Paramedics Plus
Paving the Way Foundation
Phoenix House of Los Angeles
Primary Purpose Sober Living Homes
Safer Alternatives thru Networking & Education
San Fernando Recovery Center
SHIELDS For Families
Soberspace
Solace
ARGUMENTS IN SUPPORT : Supporters 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.
ASSEMBLY FLOOR : 73-0, 5/8/14
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Chávez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Grove, Hagman, Harkey, Roger Hernández, Holden, Jones,
Jones-Sawyer, Levine, Linder, Logue, Lowenthal, Maienschein,
Medina, Melendez, Mullin, Muratsuchi, Nazarian, Nestande,
Olsen, Pan, Patterson, Perea, Quirk, Quirk-Silva, Rendon,
Ridley-Thomas, Rodriguez, Salas, Skinner, Stone, Ting, Wagner,
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Waldron, Weber, Wieckowski, Wilk, Williams, Yamada, John A.
Pérez
NO VOTE RECORDED: Eggman, Gorell, Gray, Hall, Mansoor, V.
Manuel Pérez, Vacancy
MW:e 7/1/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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