BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 1329|
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UNFINISHED BUSINESS
Bill No: SB 1329
Author: Simitian (D), et al.
Amended: 8/16/12
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 4/11/12
AYES: Hernandez, Harman, Alquist, Anderson, Blakeslee, De
Le�n, DeSaulnier, Rubio, Wolk
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 8-0, 5/7/12
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Vargas, Wyland
NO VOTE RECORDED: Strickland
SENATE FLOOR : 38-0, 5/17/12
AYES: Alquist, Anderson, Berryhill, Blakeslee, Calderon,
Cannella, Corbett, Correa, De Le�n, DeSaulnier, Dutton,
Emmerson, Evans, Fuller, Gaines, Hancock, Harman,
Hernandez, Huff, Kehoe, La Malfa, Leno, Lieu, Liu,
Lowenthal, Negrete McLeod, Padilla, Pavley, Price, Rubio,
Simitian, Steinberg, Vargas, Walters, Wolk, Wright,
Wyland, Yee
NO VOTE RECORDED: Runner, Strickland
ASSEMBLY FLOOR : 78-0, 8/23/12 - See last page for vote
SUBJECT : Prescription drugs: collection and
distribution program
SOURCE : Supporting Initiatives to Redistribute Unused
Medication
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DIGEST : This bill expands the types of entities that can
donate and dispense medication in the prescription drug
depository and distribution program that provides donated
medication to medically indigent patients, includes these
additional entities within the immunity from criminal and
civil liability contained in existing law, and allows
counties to establish a program through an action by the
county board or through an action of the public health
officer of the county, instead of only through county
ordinance under existing law.
Assembly Amendments make clarifying changes in notice
provisions of the bill and allows certain pharmacies to
donate unused medications.
ANALYSIS :
Existing law:
1. Authorizes counties, by ordinance, to establish a
prescription drug repository and distribution program
(program), subject to specified requirements, for
medically indigent patients to receive donated
prescription drugs free of charge.
2. Allows the following entities to donate medication to a
program: a skilled nursing facility (SNF), a SNF
designated as an institution for mental disease (IMD), a
drug wholesaler or a drug manufacturer.
3. Limits the types of pharmacies that can dispense
medication through the program to county-owned
pharmacies and pharmacies that contract with the county.
4. Requires a county that elects to establish a program to
establish procedures for program eligibility for
medically indigent patients, and to ensure proper safety
and management of medications, among other requirements.
5. Exempts prescription drug manufacturers, wholesalers,
participating pharmacies, SNFs, pharmacists and health
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care professionals who accept or dispense prescription
drugs from criminal or civil liability for injury caused
when donating, accepting, or dispensing prescription
drugs in compliance the program provisions, except for
noncompliance with the program statute, bad faith or
gross negligence. Prohibits the program statute from
affecting disciplinary actions taken by licensing and
regulatory agencies.
This bill:
1. Includes a licensed pharmacy that is owned and operated
by a licensed primary care clinic; a licensed primary
care clinic that is licensed to administer and dispense
drugs; and, specified long term care and mail order
pharmacies; in the definition of eligible entities that
are authorized to dispense medication in the program.
Prohibits these additional entities from being on
probation with the Board of Pharmacy (Board).
2. Adds the following categories of facilities to the types
of entities authorized to donate centrally stored
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. A residential care facility for the elderly with
16 or more residents; and,
I. A mental health rehabilitation center.
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3. Requires medication donated by participating entities to
be unexpired medication that would have otherwise been
destroyed by the facility or another appropriate entity;
and, specifies that only medication directly transferred
from the dispensing pharmacy, wholesaler, or
manufacturer, to the participating entity is eligible
for donation.
4. Requires donated medication to be under the supervision
of either licensed health professionals or staff that
have completed training and passed an examination on
topics including medication handling and storage.
5. 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 officer, as directed by the county
board of supervisors. Requires the county to notify the
Board within 30 days after establishing the program.
6. Requires an entity that seeks to participate in the
program to inform the county health department and the
Board 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.
7. 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 on a quarterly basis, and requires a
participating primary care clinic to disclose to the
county health department the physician accountable to
the Board for the clinic's program operations. Requires
the physician to be the clinic's professional director.
8. Directs the county board of supervisors or county public
health officer to make available to the Board, upon
request, the information in 5) above.
9. Allows the county board of supervisors, the county
public health officer, or the Board to prohibit an
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entity from participating in the program if the entity
does not comply with the requirements of the program.
Requires the prohibited entity to be notified in
writing, as specified.
10.Permits medication donated to the program to be
transferred to another entity participating in the
program for dispensing to eligible patients, limits
transfers between participating entities to no more than
once, and requires transferred medication to meet
specified documentation requirements.
11.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.
Background
According to the 2009 California Health Interview Survey
conducted by the University of California Los Angeles, 5.4
million Californians, or 14.5 percent of the state's
population, were uninsured. Of the insured in California,
seven percent or 2.2 million people did not have coverage
for prescription drugs.
SB 798 (Simitian), Chapter 444, Statutes of 2005,
authorizes the establishment of a program. Under the
program, counties can adopt an ordinance to establish such
a program, under which SNFs, SNFs that are IMDs, drug
wholesalers, and drug manufacturers can donate unused
medications to county-owned pharmacies, or pharmacies that
contract with the county for dispensing to medically
indigent patients free of charge. Prior to the enactment
of SB 798, SNFs were required to either destroy the drugs
in the presence of a pharmacist or nurse, or return the
drugs to the issuing pharmacy (if unopened and in a sealed
container) for disposition. To date, two counties (Santa
Clara and San Mateo) have established such a program, and
Santa Clara indicates it has saved approximately $5,000
through the program as of February 2012. According to an
issue brief from the National Conference of State
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Legislatures, 38 states have enacted laws as of 2010
regarding prescription recycling programs for unused
medications.
Counties establishing a program have to meet certain
requirements, including establishing eligibility for
medically indigent patients, developing a formulary of
medications appropriate for the program, ensuring the
privacy of patients donating medication to the program, and
ensuring proper safety and medication management.
Controlled substances (controlled substances are
prescription drugs with the potential for abuse) and
medication in the possession of a patient are not eligible
for donation. Only medication that is donated in unopened,
tamper-evident packaging or modified unit dose containers
that meet specified standards is eligible for donation.
Donated medication cannot have been in the possession of a
patient or any individual member of the public, and
medication donated by a SNF must have been under the
control of the staff of the SNF.
Medication that is dispensed under the program is required
to be in a new and properly labeled container that is
specific to the eligible patient. In addition, medication
donated to the program must be segregated from the
pharmacy's other drug stock by physical means, for
inventory, accounting, and inspection purposes. Pharmacies
must also keep complete records of the acquisition and
disposition of medication donated to and dispensed under
the program. Finally, a participating county-owned or
county-contracted pharmacy must follow the same procedural
drug pedigree requirements for donated drugs as it would
follow for drugs purchased from a wholesaler or directly
from a drug manufacturer.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No
Local: No
SUPPORT : (Verified 5/10/12) (Unable to reverify at time
of writing)
Supporting Initiatives to Redistribute Unused Medication
(source)
Aegis of Corte Madera
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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
Children's Recovery Center of Northern California
Community Care on Palm
County Health Executives Association of California
Crestwood Behavioral Health, Inc.
Golden Age Convalescent Hospital
Golden Empire Nursing and Rehab Center
La Casa Mental Health Rehabilitation Center
La Casa Psychiatric Health Facility
Lincoln Glen Nursing Facility
Marin Community Clinics
Marlinda-Imperial Convalescent Hospital
Masonic Homes of California
National Federation of Independent Business
ResCare Friendship Developmental Services
Royal Oaks Manor - Bradbury Oaks
San Francisco Towers
Santa Clara County Board of Supervisors
Sierra Club California
Stanford University School of Medicine
Stonebrook Healthcare Center
Sunny View Retirement Community
Villa Siena
ARGUMENTS IN SUPPORT : This bill is sponsored by
Supporting Initiatives to Redistribute Unused Medicine
(SIRUM) to increase access to necessary, and in many cases
life-sustaining, prescription drugs for medically indigent
Californians while at the same time reducing the
environmental impact of pharmaceutical waste and producing
savings for state and local governments. This bill builds
upon previous legislation to expand the types of health
facilities that can donate unused medicine, allowing
California to capture the staggering $100 million in usable
medicine from health facilities that ends up destroyed in
incinerators, or worse, dumped into our water supply.
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Additionally, SIRUM states this bill enables non-profit
community clinics to receive and dispense donated medicine,
greatly increasing the number of patients that can access
donated medicine. Finally, only two counties currently
have overcome the bureaucratic hurdles of establishing
redistribution program, and SIRUM states this legislation
will streamline the process for counties by removing
unnecessary burdens. With shrinking budgets for the health
care safety net and rising health care costs for all
Californians, SIRUM argues this bill allows California to
maximize quality patient care by reducing the financial
burden of medicine acquisition and promoting
environmentally sustainable health care practices.
The California Association of Health Facilities (CAHF)
argues this bill would make it easier for counties to
approve programs to allow for the redistribution of unused
medication from health care providers to the uninsured.
CAHF states SNFs are estimated to destroy up to 15 percent
of their prescriptions each month, but that an increasing
number of SNFs (approximately 79 facilities) are taking
advantage of a unique program that allows these facilities
to donate surplus medications for redistribution to
uninsured residents. The Sierra Club writes in support
that this will protect our environment, water supply and
people by reducing the amount of prescription drugs and
pharmaceutical waste that ends up in our drinking water,
lakes and rivers.
ASSEMBLY FLOOR : 78-0, 8/23/12
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall, Bill
Berryhill, Block, Blumenfield, Bonilla, Bradford,
Brownley, Buchanan, Butler, Charles Calderon, Campos,
Carter, Cedillo, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani,
Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Gorell,
Grove, Hagman, Halderman, Hall, Harkey, Hayashi, Hill,
Huber, Hueso, Huffman, Jeffries, Jones, Knight, Lara,
Logue, Bonnie Lowenthal, Ma, Mansoor, Mendoza, Miller,
Mitchell, Monning, Morrell, Nestande, Nielsen, Norby,
Olsen, Pan, Perea, V. Manuel P�rez, Portantino, Silva,
Skinner, Smyth, Solorio, Swanson, Torres, Valadao,
Wagner, Wieckowski, Yamada, John A. P�rez
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NO VOTE RECORDED: Roger Hern�ndez, Williams
CTW:DLW:d 8/25/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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