BILL ANALYSIS �
SB 1329
Page 1
Date of Hearing: June 19, 2012
ASSEMBLY COMMITTEE ON HEALTH
William W. Monning, Chair
SB 1329 (Simitian) - As Amended: May 14, 2012
SENATE VOTE : 38-0
SUBJECT : Prescription drugs: collection and distribution
program.
SUMMARY : Revises existing law authorizing a voluntary,
county-option drug repository and distribution program (program)
to distribute surplus unused medications to medically indigent
persons to expand the categories of facilities that can dispense
and donate medications in the program; include these additional
entities in the immunities from civil and criminal liability
granted to entities participating in the program; and, modify
the method by which a county may establish the program.
Specifically, this bill :
1)Includes a licensed pharmacy that is owned and operated by a
licensed primary care clinic, and a licensed primary care
clinic that is licensed to administer and dispense drugs, in
the definition of eligible entities that are authorized to
dispense medication in the program.
2)Adds the following categories of facilities to the types of
entities authorized to donate medication under the program:
a) A general acute care hospital;
b) An acute psychiatric hospital;
c) An intermediate care facility (ICF).
d) ICF/developmentally disabled facilities, as specified;
e) A correctional treatment center;
f) A psychiatric health facility;
g) A chemical dependency recovery hospital;
h) Residential care facilities for the elderly (RCFEs), as
specified; and,
i) A mental health rehabilitation center.
3)Deletes existing law authorizing a county to establish the
program by local ordinance and, instead, allows a county to
establish the program through an action by the county board of
supervisors or through an action of the county public health
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officer, as directed by the county board of supervisors.
4)Requires an entity that seeks to participate in the program to
inform the county health department in writing of its intent
and prohibits an entity from participating in the program
until it has received written or electronic documentation from
the county health department confirming that its notice of
intent has been received.
5)Requires an entity participating in the program to disclose to
the county health department the name and location of the
source of all donated medication it receives, and requires a
participating primary care clinic to disclose to the county
health department the physician accountable to the Board of
Pharmacy (Board) for the clinic's program operations.
6)Directs the county board of supervisors or county public
health officer to make available to the Board, upon request,
the information in 5) above.
7)Allows the county board of supervisors, the county public
health officer, and the Board to prohibit an entity from
participating in the program if the entity does not comply
with the requirements of the program.
8)Permits medication donated to the program to be transferred to
another entity participating in the program for dispensing to
eligible patients.
9)Exempts the additional facilities authorized by this bill to
dispense and donate medication from existing civil and
criminal liability when donating, accepting or dispensing
drugs in the program, except in cases of noncompliance with
existing law governing the program, bad faith, or gross
negligence.
EXISTING LAW :
1)Authorizes counties, by local ordinance, to establish a
voluntary drug repository and distribution program, subject to
specified requirements, for the purpose of distributing
surplus medications to financially needy persons to ensure
access to necessary pharmaceutical therapies.
2)Limits the entities that may donate medication to the program
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to a skilled nursing facility (SNF), as specified, and a drug
wholesaler or drug manufacturer; and limits the entities that
may dispense medication through the program to pharmacies
owned by or contracting with the county.
3)Requires a county that chooses to establish a program to
provide procedures for program eligibility for medically
indigent patients, and to ensure proper safety and management
of medications, among other requirements.
4)Specifies that only medication that is donated in unopened,
tamper-evident packaging or modified unit dose containers that
meet specified standards is eligible for donation to the
program, provided that lot numbers and expiration dates are
affixed; prohibits medication donated in opened containers
from being dispensed by the program.
5)Requires donated medication that does not meet the
requirements of the program to be destroyed or returned to a
"reverse distributor," defined as every person who acts as an
agent for pharmacies, drug wholesalers, manufacturers, and
other entities by receiving, inventorying, and managing the
disposition of outdated or nonsalable dangerous drugs.
6)Prohibits prescription drug manufacturers, wholesalers,
participating pharmacies, SNFs, pharmacists, and health care
professionals who accept or dispense prescription drugs from
being subject to criminal or civil liability for injury caused
when donating, accepting, or dispensing prescription drugs in
compliance the program provisions, except in cases of
noncompliance with existing law governing the program, bad
faith, or gross negligence.
7)Provides that nothing in existing law governing the program
shall affect disciplinary actions taken by licensing and
regulatory agencies.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
intended to enhance efforts to implement prior legislation, SB
798 (Simitian), Chapter 444, Statutes of 2005, which allows
counties to set up drug collection and redistribution
programs. The author notes that, under SB 798, only SNFs,
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drug wholesalers, and drug manufacturers are allowed to donate
unused medications and only county-owned or county-contracted
pharmacies are authorized to receive and dispense the donated
drugs. The author contends that this bill is needed to allow
health and care facilities, other than SNFs, that also
accumulate unused and unexpired drugs that would otherwise be
destroyed, to participate as drug donors in the program.
Additionally, the author states that this bill will enable
clinics, which often serve the medically indigent, to receive
and dispense the donated drugs and will remove a bureaucratic
hurdle for many counties by eliminating the requirement for a
program to be initiated by a county ordinance and instead
allow it to be established through an action by the county
board of supervisors or the county public health officer.
2)BACKGROUND . Counties that adopt an ordinance to establish a
program in California must also establish eligibility for
medically indigent patients who may participate in the program
free of charge; develop a formulary of appropriate medications
for the program; provide for the proper safety and management
of any medications collected by and maintained under the
authority of a participating licensed pharmacy; and, protect
the privacy of individuals for whom the medication was
originally prescribed. Controlled substances, i.e.
prescription drugs with the potential for abuse, and
medication in the possession of a patient or any individual
member of the public are not eligible for donation.
Medication donated by a SNF is required to have been under the
control of the staff of the SNF. Prior to the enactment of SB
798, SNFs either destroyed the medication in the presence of a
pharmacist or nurse, or returned it, if unopened and in a
sealed container, to the issuing pharmacy for disposition.
Drugs that are dispensed under the program are required to be in
a new and properly labeled container that is specific to the
eligible patient. In addition, donated drugs are required to
be physically separated from the participating pharmacy's
other drug stock for purposes of inventory, accounting, and
inspections. Pharmacies must also keep complete records of
the acquisition and disposition of medication donated to and
dispensed under the program. Lastly, a participating pharmacy
is required to follow the same procedural drug pedigree
instructions for donated drugs as it would follow for drugs
purchased from a wholesaler or directly from a manufacturer.
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According to information from the sponsor of this bill,
Supporting Initiatives for Redistribution of Unused Medication
(SIRUM), a non-profit group that links drug donors and
pharmacies, two counties, Santa Clara and San Mateo, have
established such a program so far and have not experienced any
problems. SIRUM indicates that, in 2010 and 2011, 230,000
pills were redistributed, $600,000 worth of drugs was donated,
thousands of uninsured patients were assisted, and 70 donor
entities participated. Santa Clara also reports that, as of
February 2012, it has saved an estimated $5,000 through the
program. SIRUM acts as an information intermediary for these
programs in that it provides the tracking mechanism to
determine where a donated pharmaceutical has been at all
times. According to SIRUM, an evaluation of Santa Clara
County's program will be taking place within the next three
years once seed funding is identified. SIRUM notes that
Sonoma and Riverside counties have also expressed interest in
initiating a program.
3)OTHER STATES . The National Conference of State Legislatures
(NCSL) reports that, as of 2010, 38 states have enacted laws
regarding prescription drug recycling, repository, or
redistribution programs. According to NCSL, all state
programs have substantial restrictions on who can donate, who
can dispense, and what types of prescription products may be
donated. NCSL indicates that all states require unexpired
drugs only; prohibit the donation of pills in opened or partly
used bottles; exclude or prohibit controlled substances;
require a state-licensed pharmacist or pharmacy to be part of
the verification and distribution process; mandate the donated
drugs to be delivered to a specific type of medical or
pharmacy facility; and, require the patient receiving the
donated drug to have a valid prescription in his or her own
name. NSCL states that it is still too early to know the
overall impact that these programs will have on offsetting the
costs of care for the medically indigent in emergency rooms
and clinics. NCSL identifies lack of awareness about the
programs and added work for repository sites accepting
donations as the main obstacles that have prevented widespread
implementation.
4)SUPPORT . Supporters, representing counties, potential donor
entities, patient advocates, and environmental groups, state
that this bill will increase the accessibility of prescription
drugs to a greater number of low-income, uninsured
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Californians while reducing the environmental impact of
pharmaceutical waste. Supporters agree that implementing more
prescription recycling programs for unused medications
throughout the state is especially important at a time when
prescription drug costs continue to rise as budgets for the
health care safety net are shrinking. The California State
Association of Counties and the County Health Executives
Association of California note in support that this bill
simplifies the process for counties to authorize a program,
broadens the pool of entities that may participate, and
enables participating pharmacies to transfer donated medicine
between facilities, thereby allowing more eligible
pharmaceuticals to be shared and utilized. The California
Association of Health Facilities and the California Assisted
Living Association point out that allowing more health and
community care facilities, such as ICFs and RCFEs, to make
donations of medication is an extremely satisfying and easy
way for providers to assist members of their communities who
are truly in need and increases the opportunity for
pharmaceutical redistribution programs to be replicated in
other areas of the state. The Congress of California Seniors
states in support that this bill contains proper safeguards to
ensure that surplus medication that has not been distributed
to the public and has been maintained by health professionals
is put to good use. Californians Against Waste adds that
county repository programs are a cost-effective and practical
way to divert the dumping of unwanted drugs into the waste
stream.
5)SUPPORT IF AMENDED . The Board has taken a support if amended
position on this bill and requests clarifying amendments to
ensure that this bill does not inadvertently create drug
diversion opportunities. According to the Board, previously
dispensed drugs donated to county programs are not subject to
the normal controls built into the distribution requirements
for prescription medication so preventing opportunities where
these drugs, some of which are very costly to purchase, could
be illegally resold back into the supply chain is a Board
goal.
6)AUTHOR'S AMENDMENTS . In order to address concerns raised by
the Board, the author has agreed to accept amendments to
ensure participating pharmacies are not on probation with the
Board; to require the county to advise the Board within 30
days after establishing a program and eligible entities to
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provide written notification to the county and the Board of
their intent to participate; to modify the provision allowing
the county or the Board to exclude an entity from
participating in the program to require a written prohibition
notice; and, to clarify that the physician accountable to the
Board for the participating clinic's program operations must
be the professional director of the clinic. These amendments
reflect agreement between the author and the Board regarding
the Board's suggested amendments.
The Board has requested additional amendments that the author
has not addressed that would clarify the participation of
pharmacies owned and operated by non-profit primary care
clinics; require the patient's consent to donate medication;
exclude RCFEs; require medication to be under the control of
California-licensed health care staff; and, restrict transfers
between participating pharmacies to within the county. The
negotiations between the author and the Board on these
outstanding issues are ongoing.
REGISTERED SUPPORT / OPPOSITION :
Support
Supporting Initiatives for Redistribution of Unused Medication
(Sponsor)
Aegis of Corte Madera
Alameda County Health Care Services Agency
American Cancer Society
Bethesda Home
California Assisted Living Association
California Association of Health Facilities
California Medical Association
California State Association of Counties
Californians Against Waste
Canyon Manor Residential Treatment Center
Children's Recovery Center of Northern California
Community Care on Palm
Community Health Partnership
Congress of California Seniors
County Health Executives Association of California
Crestwood Behavioral Health, Inc.
Golden Age Convalescent Hospital
Golden Empire Convalescent Hospital
La Casa Mental Health Rehabilitation Center
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Lincoln Glen Nursing Facility
Marin Community Clinics
Marlinda Imperial Convalescent Hospital
Masonic Homes of California
National Federation of Independent Business
Royal Oaks Manor - Bradbury Oaks
San Francisco Towers
San Mateo County Board of Supervisors
Santa Clara County Board of Supervisors
Sierra Club California
Sonoma County Board of Supervisors
Stanford University School of Medicine
Stonebrook Healthcare Center
Sunny View Manor
Villa Siena
WindChime of Marin
One individual
Opposition
None on file.
Analysis Prepared by : Cassie Royce / HEALTH / (916) 319-2097