BILL ANALYSIS Ó
AB 2592
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Date of Hearing: April 5, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
AB 2592
(Cooper) - As Amended March 18, 2016
SUBJECT: Controlled substances: medicine locking closure
packages: grant program.
SUMMARY: Establishes the Opioid Abuse Prevention Pilot Program
(Pilot Program) within the Department of Public Health (DPH) to
award grants to combat opioid abuse. Specifically, this bill:
1)Requires DPH to establish the Pilot Program to the extent
funding is available, to award grants to participating
pharmacies to combat opioid abuse and improve the safe
prescribing of opioids. Provides that these grants will target
areas where the prevalence of prescription drug abuse is high
as determined by data that has been collected by DPH and the
California HealthCare Foundation.
2)Requires pharmacies awarded grants to offer all patients who
are prescribed an opioid with a medicine locking closure
package. Specifies that pharmacies must obtain oral or
written consent and provide the patient with instructions
before providing the patient with a medicine locking closure
package, as specified.
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3)Prohibits DPH from expending General Fund monies, unless
specifically appropriated for the Pilot Program. Allows DPH
to seek funds from private entities, as specified.
4)Defines medicine locking closure package as a locking closure
mechanism that can only be unlocked by a user-generated,
resettable alphanumerical code in combination with an amber
prescription container that only allows the patient to access
the medicine container.
5)Requires DPH to evaluate the Pilot Program's effectiveness to
combat prescription drug abuse in targeted areas and report
its findings to the Legislature no later than December 31,
2021, as specified.
6)Sunsets the provisions of this bill until January 1, 2022,
unless that date is deleted or extended.
EXISTING LAW:
1)Establishes the Poison Prevention Packaging Act of 1970 which
among other provisions specifies various requirements for the
packaging of numerous materials, including any drug that is
intended for human use that is in a dosage form intended for
oral administration and that is required to be dispensed only
by or upon an oral or written prescription of a practitioner
licensed by law to administer such drug.
2)Classifies controlled substances into five designated
schedules, with the most restrictive limitations generally
placed on controlled substances classified in Schedule I, and
the least restrictive limitations generally placed on
controlled substances classified in Schedule V.
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3)Prohibits the delivery of Schedule II, III, or IV controlled
substances to a pharmacy unless a receipt for the merchandise
is signed by a pharmacist or authorized receiving personnel.
FISCAL EFFECT: This bill has not yet been analyzed by a fiscal
committee.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the sponsor, GateKeeper
Innovations (GateKeeper), California has taken steps to
address the prescription drug abuse epidemic by providing
substance abuse disorder services and creating a statewide
drug monitoring program called the Controlled Substance
Utilization Review and Evaluation System (CURES). The state
has also funded many county programs through the Community
Prevention Initiative under Department of Health Care
Services. The sponsor argues that there is one prevention
initiative that has gone widely unaddressed, specifically, the
safe storage of prescription medications. GateKeeper explains
that this bill would establish the Pilot Program to examine
whether increasing the safe storage of prescription drugs
would reduce the number of drug abuse cases amongst teens and
young adults. According to sponsor, the Centers for Disease
Control and Prevention (CDC) reports that 70% of schedule
medications are obtained for illegal use from a friend or
relative, and more frequently from their medicine cabinets.
Yet, the CDC has also reported that fewer than 3% of
households lock up their schedule prescription medications.
2)BACKGROUND.
a) Federal hearings. The House Committee on Oversight and
Government Reform recently convened a hearing to discuss
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ways to improve the federal response to the heroin and
opioid abuse problem as the House considers path forward on
bipartisan legislation. This hearing follows Senate
passage of a bill earlier this month, the Comprehensive
Addiction and Recovery Act (S. 524) (CARA), which would
authorize the administration to offer grants to states to
expand their treatment offerings and increase access to
naloxone, an overdose prevention drug. CARA would also
give the U.S. Department of Justice additional tools to
combat drug trafficking.
Additionally, the CDC issued new prescribing guidelines for
opioids, which may help doctors and patients better
understand the risks associated with prescription
painkiller use. In addition to the CDC guidelines, the
Obama Administration requested more than $1 billion in new
mandatory funding in next year's budget to address opioid
drug abuse. The Food and Drug Administration (FDA)
announced changes to the safety warnings that are required
on the labels of prescription painkillers - the labels must
now include a boxed warning about risks of misuse,
addiction, overdose, and death. FDA also revealed new
steps to scrutinize applications for opioids.
b) CURES 2.0. CURES 2.0 is a database of Schedule II, III,
and IV controlled substance prescriptions dispensed in
California serving the public health, regulatory oversight
agencies, and law enforcement. California law requires all
California licensed prescribers authorized to prescribe
scheduled drugs to register for access to CURES 2.0 by July
1, 2016 or upon issuance of a Drug Enforcement
Administration Controlled Substance Registration
Certificate, whichever occurs later. California licensed
pharmacists must register for access to CURES 2.0 by July
1, 2016, or upon issuance of a Board of Pharmacy Pharmacist
License, whichever occurs later. California Health &
Safety Code Section 11165(d) requires dispensing
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pharmacies, clinics, or other dispensers of Schedule II
through IV controlled substances to provide specified
dispensing information to the California Department of
Justice (DOJ) on a weekly basis in a format approved and
accepted by the DOJ.
c) Prescription Opioid Misuse and Overdose Prevention
Workgroup. In response to the national epidemic of
prescription medication misuse and overdose, DPH and its
state partners convened a Prescription Opioid Misuse and
Overdose Prevention Workgroup in Spring 2014. This
workgroup is exploring opportunities to improve
collaboration and expand joint efforts among state
departments working to address this epidemic. It has
identified two priorities: expansion and strengthening of
prevention strategies and improvement of monitoring and
surveillance.
d) Medicine Locking Closure. This bill defines a medicine
locking closure package as a locking closure mechanism that
can only be unlocked by a user-generated resettable
alphanumerical code in combination with an amber
prescription container that only allows the patient to
access the medicine container. An example of this locking
mechanism is "Safer Lock" manufactured by GateKeeper, the
sponsor of this bill. According to GateKeeper's Website,
"Safer Lock is a patented 4-digit combination locking cap
designed to prevent misuse or abuse of in-home medications
and other substances that should be kept out of curious
hands." A single unit of Safer Lock retails for $17.99.
Since Safer Lock is patented, it is not clear if there are
other manufacturers in the market for this type of medicine
locking closure.
e) Similar laws in other states. Effective 2016, Illinois
will implement numerical locking devices similar to those
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used on gym lockers. Under the one-year program,
participating pharmacies will place the locks on bottles of
painkillers that contain hydrocodone, which is also known
as Vicodin or Norco. In 2010, Massachusetts added
Safeguards to the Prescription Monitoring Program and
furthering Substance Abuse Education and Prevention and
required all pharmacies in Massachusetts that dispense
schedule II, III, IV, or V prescription drugs to make lock
boxes available for sale at each location.
3)SUPPORT. GateKeeper, the sponsor of this bill, contends that
this bill will examine whether the increase in safe storage of
prescription drugs will reduce the number of abuse cases among
children and young adults. Specifically, this bill would
require DPH to implement a pilot project that would
incentivize pharmacies to dispense opioid prescriptions in a
non-reusable medicine locking closure package. Per the
sponsor, pharmacies can voluntarily choose to participate and
patients can choose to opt-out. Furthermore, the vendor for
the locking closure packages would be selected by DPH or
pharmacy through a competitive bidding process. DPH would
then evaluate the effectiveness of the Pilot Program to
determine whether safer storage contributed to a decrease in
prescription drug abuse.
REGISTERED SUPPORT / OPPOSITION:
Support
GateKeeper Innovations, Inc. (sponsor)
Opposition
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None on file.
Analysis Prepared by:Kristene Mapile / HEALTH / (916) 319-2097