BILL ANALYSIS �
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|SENATE RULES COMMITTEE | AB 1727|
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THIRD READING
Bill No: AB 1727
Author: Rodriguez (D)
Amended: 6/15/14 in Senate
Vote: 21
SENATE HEALTH COMMITTEE : 9-0, 6/11/14
AYES: Hernandez, Morrell, Beall, De Le�n, DeSaulnier, Evans,
Monning, Nielsen, Wolk
SENATE BUSINESS, PROF. & ECON. DEVELOP. COMM. : 8-0, 6/23/14
AYES: Lieu, Wyland, Berryhill, Corbett, Galgiani, Hernandez,
Hill, Torres
NO VOTE RECORDED: Block
ASSEMBLY FLOOR : 76-0, 5/19/14 - See last page for vote
SUBJECT : Prescription drugs: collection and distribution
program
SOURCE : Author
DIGEST : This bill exempts a prescription drug under a federal
Food and Drug Administration (FDA) Risk Evaluation and
Mitigation Strategies (REMS) from being donated through a
prescription drug donation program (Program).
ANALYSIS : Existing law:
1. Establishes the practice of pharmacy and provides for the
licensing and regulation of pharmacies and pharmacists by the
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Board of Pharmacy (Board).
2. Establishes a licensure category under the authority of the
Board for a "surplus medication collection and distribution
intermediary" (Intermediary).
3. Requires an Intermediary to provide the Board information on
a form as part of its application for licensure, including
the name, address, usual occupation, and professional
qualifications, if any, of the applicant.
4. Requires an Intermediary to keep and maintain for three
years complete records for which the Intermediary facilitated
the donation of medications to, or transfer of medications
between participating entities.
5. Authorizes counties, by ordinance, to establish a Program,
subject to specified requirements, for medically indigent
patients to receive donated prescription drugs free of
charge.
6. Allows the following entities to donate medication to a
program: a hospital; an acute psychiatric hospital; a skilled
nursing facility (SNF); a SNF designated as an institution
for mental disease; an intermediate care facility; a licensed
correctional treatment center; a licensed psychiatric health
facility; a chemical dependency recovery hospital; a
residential care facility for the elderly, an approved mental
health rehabilitation center; a pharmacy whose primary or
sole purpose is limited to SNF; home health care or mail
order; a drug wholesaler; and, a drug manufacturer.
7. Limits the types of pharmacies that can dispense medication
through a Program to county-owned pharmacies and pharmacies
that contract with the county; licensed pharmacies owned and
operated by primary care clinics; and, primary care clinics
licensed to administer and dispense drugs.
8. 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.
9. Prohibits the donation to a Program of the following:
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controlled substance; medication that has been adulterated,
misbranded, or stored under conditions contrary to standards
set by the United States Pharmacopoeia or the product
manufacturer; and, medication that has been in the possession
of a patient or any individual member of the public.
This bill:
1.Prohibits medication that is the subject of FDA REMS from
being donated under the Program if this inventory transfer is
prohibited by that strategy, or if the inventory transfer
requires prior authorization from the manufacturer of the
medication.
2.Requires that medication subject to a FDA REMS that is not
otherwise prohibited from being donated as part of the
strategy to be managed and dispensed according to the
requirements of that strategy.
Background
The issue of rising prescription drug costs, coupled with
concerns about methods for disposal of unused or expired
medication has led to efforts throughout the nation to reuse or
recycle medication from certain, controlled health care settings
and in turn make that medication available to indigent patients.
Estimates of American prescription drug spending have reached as
far as the hundreds of billions of dollars annually. According
to the 2009 California Health Interview Survey conducted by the
University of California Los Angeles, 5.4 million Californians,
or 14.5% of the state's population, were uninsured. Of the
insured in California, 7%, or 2.2 million people, did not have
coverage for prescription drugs.
For many years, a common practice at many health care facilities
has been to dispose of unused pharmaceuticals by flushing them
down the toilet or pouring them down the drain, which in turn
impacts water quality and water supply. According to a report
by the Environmental Protection Agency, Unused Pharmaceuticals
in the Health Care Industry, this practice stems from certain
regulations governing acceptable methods for destroying unused
drugs, as well as factors like size, ease and access of disposal
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and cost. Certain federal regulations constrain how some
medications are destroyed or disposed, including the Controlled
Substances Act (which includes disposal down the drain as an
acceptable destruction option), Resource Conservation and
Recovery Act (which requires certain types of medication and
other hazardous wastes to be transported in approved containers
to permitted hazardous waste disposal facilities by a hazardous
waste transporter, a costly effort for many health facilities)
and the Health Insurance Portability and Accountability Act
(which requires long-term care facilities to destroy all
pharmaceutical labels that contain personal information). The
report states that some facilities are flushing to sewers as a
primary means of disposal because it is easy and accessible, and
in the past, public health agencies and health-related
organizations advised the public to destroy unused medications
this way as well.
California's Efforts to Donate Unused Medication . SB 798
(Simitian, Chapter 444, Statutes of 2005) took effect in 2006,
authorizing California counties to establish a Program for the
distribution of unused, unexpired medication to medically
indigent patients. Under the Program, counties could adopt an
ordinance to establish such a Program, under which SNFs, and
SNFs that are institutions for mental disease, drug wholesalers,
and drug manufacturers could 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.
SB 1329 (Simitian, Chapter 709, Statutes of 2012) made a number
of changes to the way a Program could be authorized and the
entities eligible to donate medications under a Program. The
bill authorized a county public health officer, as delegated by
a county board of supervisors, to implement a Program, in
addition to Program implementation via county ordinance as
authorized in SB 798. SB 1329 also added several categories of
licensed health care facilities that may donate medications.
The bill also allowed both primary care clinic pharmacies and
primary care clinics that have Board licensees, to administer
and dispense medication, provided these Board licensees are in
good standing with the Board. SB 1329 established procedures
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relating to county and Board approval of participating entities,
as well as authority for a county and the Board to prohibit a
certain entity from participating in a Program.
To date, two counties in California (Santa Clara and San Mateo)
have established a Program through ordinance, although the Santa
Clara Program is the only current operational program. As a
result of changes in SB 1329, medication can be donated from a
number of organizations, facilities and entities throughout the
state, but the only recipients of donated medications must be
located within Santa Clara County:
The FDA Amendments Act of 2007 gave the FDA the authority to
require a REMS from manufacturers to ensure that the benefits of
a drug or biological product outweigh its risks. In determining
whether to require a REMS, the FDA is required to consider the
following:
The estimated size of the population likely to use the drug
involved.
The seriousness of the disease or condition that is to be
treated with the drug.
The expected benefit of the drug with respect to such disease
or condition.
The expected or actual duration of treatment with the drug.
The seriousness of any known or potential adverse events that
may be related to the drug and the background incidence of
such events in the population likely to use the drug.
Whether the drug is a new molecular entity.
According to the FDA's Internet Web site, approximately 65 drugs
have a REMS although not all REMS prohibit inventory transfer.
A REMS may be required by the FDA as part of the approval of a
new product, or for an approved product when new safety
information arises. REMS are a safety strategy to manage a known
or potential serious risk associated with a medicine, and to
enable patients to have continued access to such medicines by
managing their safe use. Since medicines are very different
from each other, REMS for each medicine is also different. REMS
can be required for a particular drug, or for an entire drug in
a class.
REMS can require additional information to be provided to
patients (such as an information guide), a communication plan
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to support implementation of the REMS (such as providing
information to health care providers and professional medical
societies about the risks involved in using the drug drug) and a
timetable for determining the effectiveness of the safety
measures in the REMS. A REMS can also include "Elements to
Assure Safe Use," which requires specific actions by health care
providers prior to ordering or dispensing a drug (such as
requiring certification by health care providers or pharmacists
in order to prescribe or dispense the drug), limiting the drug
to only certain settings, requiring patient monitoring when on
the drug, or requiring the patient be enrolled in a registry.
FISCAL EFFECT : Appropriation: No Fiscal Com.: No Local:
No
SUPPORT : (Verified 6/20/14)
BayBio
Biocom
California State Board of Pharmacy
Celgene Corporation
March of Dimes
Pharmaceutical Research and Manufacturers of America
ARGUMENTS IN SUPPORT : Celgene Corporation (Celgene), a
biotech company based in California, writes in support of this
bill to ensure medications with strict FDA restrictions are not
distributed in county surplus drug collection and distribution
programs. Celgene states this bill works to provide safety to
both patients and their families as the federal FDA has imposed
strict restricted distribution programs for specified drugs that
require drug manufacturers to track each prescription from the
doctor, through the pharmacy, to the patient in order to
minimize the risk of fetal exposure. Celgene argues allowing
pharmacies that participate in a repository program to receive
and redistribute these types of drugs undermines the safety
precautions established by its product REMS programs. Celgene
states that other states, including Arizona, Colorado, Montana,
Washington and Wisconsin, have incorporated language similar to
that in AB 1727 in their drug repository programs either through
statute or regulation. Celgene states that, since 2007, all
bills to either create such a program or expand an existing
program have contained this type of protective language.
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The March of Dimes writes in support that this bill would
establish safeguards in the state's program to ensure that
certain prescription drugs with strict FDA restrictions on their
use and distribution, such as those that can cause birth
defects, are not distributed in county surplus drug programs.
One of the medications this would apply to is thalidomide, which
is a highly teratogenic drug with a broad spectrum of
pharmacological activities and causes severe birth defects when
taken during early pregnancy.
ASSEMBLY FLOOR : 76-0, 5/19/14
AYES: Achadjian, Alejo, Allen, Ammiano, Bigelow, Bloom,
Bocanegra, Bonilla, Bonta, Bradford, Brown, Buchanan, Ian
Calderon, Campos, Chau, Ch�vez, Chesbro, Conway, Cooley,
Dababneh, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,
Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gonzalez, Gordon,
Gorell, Gray, Grove, Hagman, Hall, Harkey, Roger Hern�ndez,
Holden, Jones, Jones-Sawyer, Levine, Linder, Logue, Lowenthal,
Maienschein, Medina, Melendez, Mullin, Muratsuchi, Olsen, Pan,
Patterson, Perea, John A. P�rez, V. Manuel P�rez, Quirk,
Quirk-Silva, Rendon, Ridley-Thomas, Rodriguez, Salas, Skinner,
Stone, Ting, Wagner, Waldron, Weber, Wieckowski, Wilk,
Williams, Yamada, Atkins
NO VOTE RECORDED: Mansoor, Nazarian, Nestande, Vacancy
JL:nl 6/25/14 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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