BILL ANALYSIS �
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|Hearing Date:May 7, 2012 |Bill No:SB |
| |1329 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 1329Author:Simitian
As Amended:March 29, 2012 Fiscal:No
SUBJECT: Prescription drugs: collection and distribution program.
SUMMARY: Revises and recasts provisions authorizing a county to
establish a drug repository and distribution program, to authorize a
program to be established by an action of the county board of
supervisors, or by the county public health officer, as specified;
expands the types of pharmacies that are eligible to participate in a
program; expands the types of health or care facilities authorized to
donate medication to a program; makes conforming and clarifying
changes.
NOTE : Double-referral to Health Committee, first. This bill was
heard in Senate Health Committee on April 11, 2012 and approved by a 9
to 0 vote.
Existing law, the Health and Safety Code (HSC):
1)Authorizes the establishment of a voluntary drug repository and
distribution program for the purpose of distributing surplus
medications to persons in need of financial assistance to ensure
access to necessary pharmaceutical therapies.
(Health and Safety Code (HSC) � 150200)
2)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. (HSC � 150204)
3)Allows the following entities to donate medication to a program:
(HSC � 150202)
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a) A skilled nursing facility (SNF).
b) A SNF designated as an institution for mental disease (IMD).
c) A drug wholesaler or a drug manufacturer. (HSC � 150203)
4)Limits the types of pharmacies that can dispense medication through
the program to county-owned pharmacies and pharmacies that contract
with the county. (HSC � 150204 (a))
5)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. (HSC � 1050204 (b))
6)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 with the program provisions, except
for noncompliance with the program statute, bad faith or gross
negligence. (HSC �� 150205, 150206)
7)Prohibits the program statute from affecting disciplinary actions
taken by licensing and regulatory agencies. (HSC � 150207)
Existing law, the Business and Professions Code (BPC):
1)Establishes the practice of pharmacy and provides for the licensing
and regulation of pharmacies and pharmacists by the Board of
Pharmacy within the Department of Consumer Affairs.
2)Authorizes a pharmacist to dispense a prescription medication in a
container that meets the requirements of state and federal law and
is correctly labeled. (BPC � 4022)
3)Specifies certain requirements regarding the dispensing and
furnishing of dangerous drugs and devices, and prohibits a person
from furnishing any dangerous drug or device except upon the
prescription of a physician, dentist, podiatrist, optometrist,
veterinarian or naturopathic doctor, as specified. (BPC � 4059)
4)Authorizes a primary care clinic to purchase drugs at wholesale for
the administration and dispensing under the direction of a physician
and surgeon to patients registered at the clinic. (BPC � 4180).
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This bill:
1)Defines the following terms for purposes of the surplus medication
collection and distribution program:
a) "Eligible entities" to mean all of the following:
i. A licensed pharmacy that is county owned or that contracts
with the county.
ii. A licensed pharmacy that is owned and
operated by a licensed primary care clinic.
iii. A licensed primary care clinic that is
licensed to administer and dispense drugs.
b) "Medication" or "medications" to mean, a dangerous drug as
defined in BPC � 4022.
c) "Participating entity" to mean an eligible entity that has
received written or electronic documentation from the county
health department and that operates a repository and distribution
program, as specified.
2)Expands the types of health or care facilities authorized to donate
medication to include the following:
a) A licensed general acute care hospital.
b) A licensed acute psychiatric hospital.
c) A licensed intermediate care facility (ICF).
d) A licensed ICF/developmentally disabled-habilitative facility.
e) A licensed ICF /developmentally disabled-nursing facility.
f) A licensed correctional treatment center.
g) A licensed psychiatric health facility.
h) A licensed chemical dependency recovery hospital.
i) A licensed residential care facility for the elderly (RCFE).
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j) A licensed RCFE for persons with chronic, life-threatening
illness.
aa) An approved mental health rehabilitation center.
3)Revises and recasts the provisions authorizing a county to establish
by ordinance, a repository and distribution program, to instead
authorize the program to be established by an action of the county
board of supervisors, or by the county public health officer, as
delegated by the county board of supervisors.
4)Provides that only an eligible entity may participate in the program.
5)Requires an eligible entity that seeks to participate in the program
to inform the county health department in writing of its intent to
participate. Prohibits an eligible 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.
6)Requires a participating entity 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 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 of Pharmacy
the information in Item # 6) above.
8)Authorizes the county board of supervisors, the county public health
officer, and the Board of Pharmacy to prohibit an eligible or
participating entity from participating in the program if the entity
does not comply with the provisions of the program.
9)Allows medication donated to the program to be transferred to another
participating entity in the program for dispensing to eligible
patients.
10)Provides the health or care facilities authorized by the bill to
donate medication and the eligible entities authorized to dispense
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
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program statute, bad faith or gross negligence.
FISCAL EFFECT: Unknown. This bill has been keyed "non-fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. This bill is sponsored by Supporting Initiatives for
Redistribution of Unused Medication (Sponsor), a non-profit
organization that connects drug donors and pharmacies. According to
the Author, this bill builds on previous legislation, SB 798
(Simitian, Chapter 444, 2005) that authorized counties to set up
drug collection and redistribution programs.
According to the Author, this bill increases the accessibility of
prescription drugs for medically indigent patients by allowing a
greater number of health and community care facilities to donate
surplus medications to be dispensed to those in need, while also
reducing needless pharmaceutical waste. The bill also allows
clinics, which more often serve this community, to participate, and
streamlines the program initiation process for counties, according
to the Author.
The Author states: "One third of California's uninsured forgo
prescription drugs due to cost. The rest face an average retail
price of $71 per prescription. Out of seven million who are
uninsured in California, over half take more than one prescription
a-day. It is estimated that the U.S. generates 250 million pounds
of pharmaceutical waste annually which equates to billions of wasted
dollars; and in California alone, hundreds of millions of dollars in
usable medicine ends up destroyed in incinerators or dumped into our
water supply."
According to the Author, SB 1329 does the following:
" Broadens the prescription drug donor pool to allow other
health and care facilities (e.g. hospitals, long term care
facilities, residential care facilities, psychiatric health
facilities, and correctional treatment centers) to donate drugs
to eligible entities.
" Allows nonprofit, primary care clinics, which are licensed to
dispense prescription drugs by the Board of Pharmacy, to
receive the donated drugs.
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" Allows donated drugs from one pharmacy to be transferred to
another pharmacy.
" Includes an option for the county board of supervisors, or
public health official for the county to take action in
initiating the program.
" Requires that pharmacies and counties be approved by the
county health department and requires them to also notify the
county health department of the source(s) of their donated
medication.
" Allows the county Board of Supervisors, or county public
health official, or the Board of Pharmacy to exclude pharmacies
or clinics from participating.
1. Background. An issue brief from the National Conference of State
Legislatures indicates that 38 states have enacted laws as of 2010,
regarding prescription recycling programs for unused medications.
In California, SB 798 authorized counties to establish a "surplus
prescription drug collection and distribution program" (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 that it has saved approximately $5,000 through the
program as of February 2012.
According to the Author, in these two counties, Program efforts
coordinated by SIRUM (the Sponsor of this measure) are estimated
to have resulted in significant impact and savings since 2009:
" 230,000 pills have been redistributed
" $600,000 of drugs have been donated
" thousands of estimated uninsured patients have been
assisted
" 70 medicine donors are participating
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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.
1.Prior legislation. SB 798 (Simitian, Chapter 444, Statutes of 2005)
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. Arguments in Support. In sponsoring the bill Supporting
Initiatives for Redistribution of Unused Medication (SIRUM)
believes the bill will increase access to necessary, and in many
cases life-sustaining, prescription drugs to medically indigent
Californians while at the same time reduce the environmental impact
of pharmaceutical waste.
Writing in support of the bill, the Santa Clara County Board of
Supervisors states that the county established a program in 2008,
and believes that by expanding the types of health facilities that
can be involved in the program, the bill would increase the
effectiveness of the county's program and assist in establishing
similar programs around the state.
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The California Assisted Living Association (CALA) states that the bill
will allow licensed assisted living communities and other community
care and health care facilities to donate unused medication to
approved local organizations which are authorized to redistribute
the medication to low-income, uninsured Californians.
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% of their prescriptions each month, but that an
increasing number of SNFs (approximately 79 facilities) are taking
advantage of the unique program established by SB 789 in 2005, that
allows these facilities to donate surplus medications for
redistribution to uninsured residents.
Sierra Club California writes in support that this would protect
people and the environment, from pharmaceutical chemicals that have
been linked to phenomena such as "feminized" male fish. Even
though little study has been done to assess health impacts on
humans, pharmaceutical chemicals have been proven to adversely
affect wildlife and the environment, according to the Sierra Club.
The National Federation of Independent Business (NFIB) states that
health facilities currently spend time and money disposing of
perfectly good medications. NFIB argues with proper safeguards,
surplus medications that have not been distributed to the public
and has been maintained by health professionals should be put to
good use.
The American Cancer Society believes the bill will help more cancer
patients and survivors have access to the prescription drugs they
might otherwise have been forced to go without, and states that
more than 300,000 people in this country die from cancer each year
because they do not have access to appropriate care and treatment.
In California, it is estimated that 144,800 people will be
diagnosed with cancer this year, and that 55,415 will die from the
disease.
The California State Association of Counties (CSAC) suggests that the
bill will simplify the way counties may establish a local
prescription drug collection and distribution program by allowing a
program to be authorized by the board of supervisors or by the
county public health officer. CSAC also states the bill would
widen the pool of entities that may participate in a local program
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thereby casting a wider net for eligible pharmaceuticals available
for the program.
Californians Against Waste contends that county repository programs
are a cost-effective and practical way to divert unwanted drugs
from the waste stream.
3.Policy Issue. This bill authorizes the Board of Pharmacy, a county
board of supervisors or a county public health officer to prohibit
an eligible entity or a participating entity from taking part in a
county program. However, the bill does not establish any criteria
for the Board to prohibit a licensee from participating in the
program. Although the Board of Pharmacy has not taken a position on
this bill, the Board's Legislation Committee analysis of the bill
raises this issue pointing out that there is no Board involvement in
the establishment of such a program, nor are there provisions that
require Board approval to participate in such a program.
The Author's office has stated that the provision was included in the
bill following discussions with Board of Pharmacy staff, and was
added to specifically give the Board more authority than it
currently has under the law enacted in 2005. The Author's office
has expressed a willingness to work with the Board to equitably
resolve this concern.
The Author may wish to consider the criteria upon which a county board
of supervisors, a county health officer, or the Board of Pharmacy
may prohibit an eligible entity or a participating entity from
taking part in a county program. As this bill moves forward, the
Author may wish to clarify this provision or remove it from the
bill.
SUPPORT AND OPPOSITION:
Support :
Supporting Initiatives for Redistribution of Unused Medication
(Sponsor)
Aegis of Corte Madera
American Cancer Society
Bethesda Home
California Assisted Living Association
California Assisted Living Association
California Association of Health Facilities (CAHF)
California Medical Association (CMA)
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California State Association of Counties
Californians Against Waste
Children's Recovery Center of Northern California
Community Care on Palm
Golden Age Convalescent Hospital
Golden Empire Convalescent Hospital
Marin Community Clinics
Marlinda Imperial Convalescent Hospital
National Federation of Independent Business
San Francisco Towers
Santa Clara County Board of Supervisors
Sierra Club California
Stonebrook Healthcare Center
Wind Chime of Marin
Opposition :
None received as of May 1, 2012
Consultant:G. V. Ayers