BILL ANALYSIS Ó
AB 2592
Page 1
Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
AB 2592
(Cooper) - As Amended April 11, 2016
NOTE: This bill is double referred, having previously been heard
by the Assembly Committee on Health and passed on a 18-0 vote.
SUBJECT: Controlled substances: medicine locking closure
packages: grant program.
SUMMARY: Creates within the California Department of Public
Health (CDPH) a pilot program that would award grants to
eligible pharmacies for the purpose of supplying medicine
locking closure packages to patients with prescriptions for
opioids.
EXISTING LAW:
1)Provides for the licensure and regulation of pharmacies by the
California State Board of Pharmacy (Board). (Business and
Professions Code (BPC) Section 4001)
2)Defines "Pharmacist" to mean the holder of an unexpired and
active pharmacist license issued by the board, and who is
entitled to practice pharmacy. (BPC Section 4036)
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3)Defines "Pharmacy" to mean an area, place, or premises
licensed by the board in which the profession of pharmacy is
practiced and where prescriptions are compounded. "Pharmacy"
includes, but is not limited to, any area, place, or premises
described in a license issued by the board wherein controlled
substances, dangerous drugs, or dangerous devices are stored,
possessed, prepared, manufactured, derived, compounded, or
repackages, and from which those substances are furnished sold
or dispensed at retail. (BPC Section 4037(a))
4)Requires the Board to license a surplus medication collection
and distribution intermediary established for the purpose of
facilitating the donation of medications to or transfer of
medications between participating entities under a program
established pursuant to Division 116 of the Health and Safety
Code. (HSC Section 4169.5(a))
5)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, and requires licensed pharmacists to
register for access to CURES 2.0 by July 1, 2016, or upon
issuance of a license, whichever occurs later. (HSC Section
11165.1)
THIS BILL:
6)Makes various findings and declarations regarding the
prescription opioid dependence problem facing California and
the United States.
7)Requires the CDPH to launch a pilot program, to the extent
funding is available, and award grants to participating
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pharmacies in regions where opioid abuse is most prevalent.
8)Requires every medicine locking closure package to be
dispensed with instructions for patient use unless the patient
indicates orally or in writing that instructions are not
needed.
9)Requires participating pharmacies to offer all patients with
opioid prescriptions a medicine locking closure package along
with their medication. The locking closure package shall be
given only with the patient's consent.
10)Defines "medicine locking closure package" to include a
locking closure container, unlocked only with a user-generated
code that only allows the person with the prescription to
access the medicine, which may include an amber prescription
container combined with a resettable alphanumerical code.
11)Prohibits the CDPH from expending General Fund monies on this
program unless those monies are specifically appropriated for
this purpose, and permits the CDPH to seek funds from private
entities, including foundations and nonprofit organizations,
and may apply for federal or other grants, to fund the grant
program.
12)Requires the CDPH to evaluate the effectiveness of the pilot
program to combat prescription drug abuse in targeted areas
and report its findings to the Legislature no later than
December 31, 2019. The report shall be submitted in
compliance with Section 9795 of the Government Code.
13)Repeals the pilot program on January 1, 2020.
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FISCAL EFFECT: Unknown. This bill has been keyed fiscal by the
Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by GateKeepers Innovations,
Inc . According to the author, "[This bill] is a prescription
drug abuse prevention bill. The intent of the bill is to keep
prescription drugs out of the hands of young people.
Prescription drug abuse is arguably the largest healthcare
epidemic in the United States. A study by the Partnership for
Drug-Free Kids, found that one of the key drivers for abusing
prescription pain killers among teens is the availability and
easy access. In the Sacramento area, which includes portions of
my district, 42 overdoses and 10 deaths have been blamed on the
prescription painkiller fentanyl. AB 2592 establishes a pilot
program to measure whether increasing safe storage of opioids
reduces the number of accidental poisonings among young people,
and reduces the overall prescription drug abuse rate among
teens. The Department of Public Health would administer the
voluntary pilot program and award grants to participating
pharmacies in areas with high rates of prescription drug abuse.
Finally, the bill requires a report to the Legislature and
sunsets the program on January 1, 2020."
Background. The Board regulates 140,000 licensees in the
industry. During the Board's last sunset review in March, 2016,
they identified the prescription drug abuse problem as an area
of concern. The Senate Committee on Business, Professions, and
Economic Development, staff 2016 Background Paper stated,
"Federal data for 2014 showed that abuse of prescription pain
killers now ranks second, just behind marijuana, as the nation's
most widespread illegal drug problem. Abuse can stem from the
fact that prescription drugs are legal and potentially more
easily accessible, as they can be found at home in a medicine
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cabinet. Data shows that individuals who misuse prescription
drugs, particularly teens, believe these substances are safer
than illicit drugs because they are prescribed by a health care
professional and thus are safe to take under any circumstances."
CURES 2.0. In recognition of the prescription drug abuse
epidemic, the office of the Attorney General launched the
Controlled Substance Utilization Review and Evaluation System
(CURES). The board utilizes this prescription drug monitoring
program more than any other regulatory board. Pharmacies are
required to report the dispensing of controlled drugs to CURES
by drug name, quantity, prescriber, patient, and pharmacy and
the Board in turn conducts research and monitoring of this data.
Legislation in Other States. Illinois is the first state to
pass legislation to launch a pilot program similar to the
program proposed by this bill. House Bill (HB) 3219 creates a
pilot project requiring that Schedule II controlled substances
containing hydrocodone be dispensed in non-reusable medicine
locking closure packages with instructions for patient use, and
provides that the pilot program only applies to pharmacies that
voluntarily choose to participate. It provides that the
Department of Financial and Professional Regulation shall not
expend more than $150,000 on the pilot program. It exempts
prescriptions reimbursed via the Medicare Part D and Medicaid
programs from the pilot program and prescriptions for
individuals residing in facilities licensed under the Nursing
Home Care Act.
Prior Related Legislation. SB 1329 (Simitian), Chapter 709,
Statutes of 2012, made a number of changes to the way a surplus
prescription drug collection and distribution program could be
authorized and the entities eligible to donate medications under
such a program. The bill authorized a county public health
officer delegated by a county board of supervisors to implement
a program, in addition current law which required a program to
be implemented via a county ordinance. The bill also added
several categories of licensed health care facilities that may
donate medications and allowed both primary care clinic
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pharmacies and primary care clinics that have Board licensees,
to administer and dispense medication, provided these Board
licensees are in good standing with the Board.
SB 809 (De Saulnier), Chapter 400, Statutes of 2013, established
a funding mechanism to update and maintain CURES while also
requiring all prescribing health care practitioners to apply to
access CURES information.
AB 467 (Stone), Chapter 10, Statutes of 2014, established a new
Board licensure category for a surplus medication collection and
distribution intermediary for the purpose of facilitating the
donation of medications to, or transfer of medications between,
participating entities under a county's unused medication
repository and distribution program. The Board now licenses one
intermediary.
ARGUMENTS IN SUPPORT:
GateKeeper Innovation, Inc. writes, "This bill is inspired by
recent legislation passed in Illinois (H.R. 3215). This pilot
program will examine whether the increase in safe storage of
prescription drugs will in fact reduce the number of abuse cases
among children and young adults? Prescription drugs now kill
more people than car accidents. According to the Center for
Disease Control (CDC), 70% of medications are obtained for
illegal use from a friend or relative, and more frequently from
their medicine cabinets."
C.O.R.E. Medical Clinic, Inc. writes, "Many of our current
patients had their first exposure to opioids through a relative
or friend's medicine cabinet. Unfortunately, many individuals
switch to using street heroin due to cost or access issues
related to opioid prescription pills?We believe your pilot
program is a valuable first step in trying to increase safe
storage of prescription medications."
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Capitol Health Network writes, "Our mission is to support and
strengthen the healthcare safety net and to advocate for
vulnerable people in Sacramento and the surrounding region?
"Increasing the safe storage of prescription drugs is a key
prevention measure that will help limit teen and young adult's
access to the nonmedical use of prescription drugs."
POLICY ISSUES:
The definition of "medicine locking closure package" as provided
in this bill may be too prescriptive.
AMENDMENTS:
In order to ensure this bill would allow the pilot program to
accept a variety of medicine locking containers, the author
should amend the bill as follows:
1) Page 2, in line 16, strike shall, and insert:
may,
2) Page 3, in line 22, strike unlocked only with a
user-generated code , strike lines 23-26 inclusive and insert:
accessible only by the designated patient with a passcode, an
alphanumeric code, a key, or by another secure mechanism.
REGISTERED SUPPORT:
AB 2592
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GateKeeper Innovation, Inc. (sponsor)
Capitol Health Network
C.O.R.E. Medical Clinic, Inc.
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Tessa Nevarez / B. & P. / (916) 319-3301,
Vincent Chee / B. & P. / (916) 319-3301