BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 1329|
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THIRD READING
Bill No: SB 1329
Author: Simitian (D), et al.
Amended: 5/14/12
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
SUBJECT : Prescription drugs: collection and
distribution program
SOURCE : Supporting Initiatives to Redistribute Unused
Medication
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.
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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
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. Expands the types of entities that are authorized to
dispense medication in the program to include two
additional entities: a licensed pharmacy that is owned
and operated by a licensed primary care clinic, and a
licensed primary care clinic that is licensed to
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administer and dispense drugs.
2. Expands the types of facilities authorized to donate
medication to include the following:
A. A general acute care hospital.
B. An acute psychiatric hospital.
C. An intermediate care facility (ICF).
D. An ICF/developmentally disabled (DD)-habilitative
facility.
E. A licensed ICF /DD-nursing facility.
F. A correctional treatment center.
G. A psychiatric health facility.
H. A chemical dependency recovery hospital.
I. A residential care facility for the elderly
(RCFE).
J. A RCFE for persons with chronic, life-threatening
illness.
K. A mental health rehabilitation center.
3. Allows a county to establish a repository and
distribution program, as directed by the county board of
supervisors.
4. Requires the additional facilities authorized by this
bill to dispense and donate medication to receive the
exemption from civil and criminal liability established
under existing law when donating, accepting or
dispensing drugs in the program, except for
noncompliance with the program statute, bad faith or
gross negligence.
5. Allows medication donated to the program to be
transferred to another entity participating in the
program for dispensing to eligible patients.
6. Requires an entity that seeks to participate in the
program to inform the county health department in
writing of its intent to participate. Prohibits an
entity from participating in the program until it has
received written or electronic documentation from the
county health department confirming that it has received
its notice of intent.
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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, 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.
8. Requires the county board of supervisors or county
public health officer, upon request, to make available
to the Board the information in 6) above.
9. Permits the county board of supervisors, the county
public health officer, and the Board to prohibit an
eligible or participating entity from participating in
the program if the entity does not comply with the
provisions of the program.
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)
Supporting Initiatives to Redistribute Unused Medication
(source)
Alameda County Health Care Services Agency
American Cancer Society
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Bethesda Home
California Assisted Living Association
California Association of Health Facilities
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
Marlinda-Imperial Convalescent Hospital
Masonic Homes of California
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.
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
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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.
CTW:do 5/15/12 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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