BILL ANALYSIS �
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1329
AUTHOR: Simitian
AMENDED: March 29, 2012
HEARING DATE: April 11, 2012
CONSULTANT: Bain
SUBJECT : Prescription drugs: collection and distribution
program.
SUMMARY : 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.
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,
Continued---
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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 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.
aa. A mental health rehabilitation center.
3.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.
4.Allows medication donated to the program to be transferred to
another entity participating in the program for dispensing to
eligible patients.
5.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
SB 1329 | Page 3
documentation from the county health department confirming
that it has received its notice of intent.
6.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.
7.Requires the county board of supervisors or county public
health officer, upon request, to make available to the Board
the information in 6) above.
8.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.
FISCAL EFFECT : This bill is keyed non-fiscal.
COMMENTS :
1.Author's statement. According to the author, for the past six
years the law has allowed for the limited donation and
redistribution of unused prescription drugs without incident
in two counties. SB 1329 will increase the accessibility of
prescription drugs to a greater number of low-income,
uninsured Californians that would otherwise not be able to
afford their medication. Expanding these efforts is especially
important at a time when prescription drug costs continue to
rise. In addition, SB 1329 will divert more usable medication
from the waste stream and help prevent those drugs from
contaminating the water supply.
2.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, 7
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
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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
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.
3.Double referral. This bill is double referred. Should it pass
out of this committee, it will be referred to the Senate
Committee on Business, Professions and Economic Development.
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4.Changes made by this bill. This bill would make a number of
changes to the program that could increase the supply of
donated medication, allow drugs to be transferred among
participating entities, expand the number of entities able to
dispense medication through the program, and make it easier
for counties to establish a program, as described in the
following chart.
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|Issue |Existing Law |SB 1329 |
|----------+-----------------+-----------------------------------|
|Entities |� A SNF |The entities in existing law and |
|that can |� A SNF |the following facilities: |
|donate | designated as |� A general acute care hospital |
|medication| an IMD |� An acute psychiatric hospital. |
| under |� A drug |� An ICF |
|the | wholesaler |� An ICF/DD-habilitative facility |
|program |� A drug |� A licensed ICF /DD-nursing |
| | manufacturer | facility |
| | |� A correctional treatment center |
| | |� A psychiatric health facility |
| | |� A chemical dependency recovery |
| | | hospital |
| | |� An RCFE and a RCFE for persons |
| | | with chronic, life-threatening |
| | | illness |
| | |� A mental health rehabilitation |
| | |center |
|----------+-----------------+-----------------------------------|
|Entities |County-owned |The entities in existing law and |
|that can |pharmacies and |the following entities: |
|dispense |pharmacies that |� A licensed pharmacy that is |
|donated |contract with | owned and operated by a licensed |
|medication|the county | primary care clinic |
| under | |� A licensed primary care clinic |
|the | | that is licensed to administer |
|program | |and dispense drugs |
|----------+-----------------+-----------------------------------|
|Establishm|County ordinance |An action of the county board of |
|ent of | |supervisors or an action of the |
|program | |county public health officer, as |
| | |delegated by the county board of |
| | |supervisors |
|----------+-----------------+-----------------------------------|
SB 1329 | Page 6
|Use of |� Dispense to an |The uses in existing law and the |
|donated | eligible |following use: |
|medication| patient |� Transfer to another |
|s |� Destroy | participating pharmacy or |
| |� Return to a | primary care clinic dispensary |
| | reverse | to be dispensed to eligible |
| | distributor |patients |
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1.Prior legislation. SB 798 (Simitian) authorized the
establishment of a voluntary prescription drug collection and
distribution program for the purpose of distributing surplus
prescription drugs to medically indigent patients free of
charge.
2.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
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
SB 1329 | Page 7
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.
SUPPORT AND OPPOSITION :
Support: Supporting Initiatives to Redistribute Unused Medication
(sponsor)
Alameda County Health Care Services Agency
American Cancer Society
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
Santa Clara County Board of Supervisors
Sierra Club California
Stanford University School of Medicine
Stonebrook Healthcare Center
Sunny View Retirement Community
Villa Siena
One individual
Oppose: None received.
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