BILL ANALYSIS �
AB 1727
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Date of Hearing: May 6, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1727 (Rodriguez) - As Introduced: February 14, 2014
SUBJECT : Prescription drugs: collection and distribution
program.
SUMMARY : Prohibits the redistribution of a prescription drug
that can only be dispensed to a patient who is registered with
the drug's manufacturer in accordance with federal Food and Drug
Administration (FDA) requirements.
EXISTING LAW :
1)Authorizes counties to establish a voluntary drug repository and
distribution program (program), subject to specified
requirements, for the purpose of distributing surplus
medications to financially needy persons to ensure access to
necessary pharmaceutical therapies.
2)Allows specified health care facilities to donate medication to
the program; limits the entities that may dispense medication
through the program to pharmacies owned by or contracting with
the county.
3)Requires an entity that seeks to participate in the program to
inform the county health department 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.
4)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.
5)Directs the county board of supervisors or county public health
officer to make available to the Board, upon request, the
information receiving from the participating entity.
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6)Allows the county board of supervisors, the county public health
officer, and the Board to prohibit an entity from
participating in the program if the entity does not comply
with the requirements of the program.
7)Permits medication donated to the program to be transferred to
another entity participating in the program for dispensing to
eligible patients.
8)Exempts specified facilities allowed 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.
9)Existing federal law authorizes the FDA to require Risk
Evaluation and Mitigation Strategies (REMS) from
pharmaceutical manufacturers.
FISCAL EFFECT : None
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, this bill is
needed to strengthen patient protections and ensure patents
who are using drugs with serious side effects have access to
the required monitoring procedures. The author notes existing
law governing county surplus drug collection and distribution
programs does not prohibit medications which are mandated by
the FDA to have a REMS from being donated to and dispensed
from drug repository programs. REMS programs imposed by the
FDA require pharmaceutical manufactures to track prescriptions
from the doctor, through the pharmacy, and to the patient in
order to minimize serious side effects. The author argues
allowing pharmacies that participate in a repository program
to receive and re-distribute these types of drugs undermines
the safety precautions established by REMS programs.
2)BACKGROUND . Counties that adopt an ordinance to establish a
voluntary drug repository and distribution program in
California must also establish eligibility for medically
indigent patients who may participate in the program free of
charge; develop a formulary of appropriate medications for the
program; provide for the proper safety and management of any
medications collected by and maintained under the authority of
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a participating licensed pharmacy; and, protect the privacy of
individuals for whom the medication was originally prescribed.
Controlled substances, i.e. prescription drugs with the
potential for abuse, and medication in the possession of a
patient or any individual member of the public are not
eligible for donation.
Drugs that are dispensed under the program are required to be
in a new and properly labeled container that is specific to
the eligible patient. In addition, donated drugs are required
to be physically separated from the participating pharmacy's
other drug stock for purposes of inventory, accounting, and
inspections. Pharmacies must also keep complete records of
the acquisition and disposition of medication donated to and
dispensed under the program. Lastly, a participating pharmacy
is required to follow the same procedural drug pedigree
instructions for donated drugs as it would follow for drugs
purchased from a wholesaler or directly from a manufacturer.
Only Santa Clara County has established a voluntary drug
repository and distribution program.
3)FDA AND REMS . The Food and Drug Administration Amendments Act
of 2007 gave FDA the authority to require a REMS from
manufacturers to ensure that the benefits of a drug or
biological product outweigh its risks. Many different drugs
are on this list, including some that are quite commonly
prescribed.
The elements of the REMS can vary dramatically. For Androgel,
a commonly prescribed drug used in testosterone replacement
therapy, the very brief REMS requires dispensing a consumer
information packet with each prescription. There is no
registration of the patients. For thalidomide, a drug that
once resulted in the death or mutation of 10,000 children
worldwide, the requirements are much different. The FDA
approved a 179-page REMS with very strict controls, including
limiting prescription and dispensing rights only to authorized
prescribers and pharmacies, keeping a registry of all patients
prescribed thalidomide, providing extensive patient education
about the risks associated with the drug, and providing
periodic pregnancy tests for women who take the drug. The
program includes physician-patient agreements governing use of
contraceptives and contingencies if the patient needs to be
tested for pregnancy. The FDA approved the use of the drug
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because it has therapeutic value for a number of very serious
illnesses and conditions, including many cancers.
4)SUPPORT . Celgene Corporation supports this bill because it
will help provide safety to both patients and their families
and comply with the strict controlled distribution guidelines
for various drugs that require the manufacturers to track each
prescription from the doctor, through the pharmacy, to the
patient to minimize the risk of fetal exposure. Celgene notes
these risk management programs are an integral part of the FDA
approval and are designed to minimize the risk of fetal
exposure. Celgene argues allowing pharmacies to participate
in a repository program to receive and redistribute these
types of drugs undermines the safety precautions established
by the FDA program. The Pharmaceutical Research and
Manufacturers of America (PhARMA) support this bill because it
will protect consumers. According to PhARMA, concerns about
possible fetal exposure renders these medications unsuitable
for redistribution. They note other states have enacted
similar controls over products which must adhere to strict FDA
guidelines on distribution.
5)PREVIOUS LEGISLATION .
a) SB 1329 (Simitian), Chapter 709, Statutes of 2012,
expands the types of entities that can donate and dispense
medication.
b) SB 798 (Simitian), Chapter 444, Statutes of 2006,
establishes a voluntary, county-option drug repository and
distribution program to distribute surplus medications to
persons in need of financial assistance to ensure access to
necessary pharmaceutical therapies.
REGISTERED SUPPORT / OPPOSITION :
Support
Celgene Corporation
Pharmaceutical Research and Manufacturers of America
Opposition
None on file.
AB 1727
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Analysis Prepared by : Roger Dunstan / HEALTH / (916) 319-2097