BILL ANALYSIS �
AB 1727
Page 1
CONCURRENCE IN SENATE AMENDMENTS
AB 1727 (Rodriguez)
As Amended June 15, 2014
Majority vote
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|ASSEMBLY: |76-0 |(May 19, 2014) |SENATE: |35-0 |(June 30, |
| | | | | |2014) |
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Original Committee Reference: HEALTH
SUMMARY : Allows donations to a county voluntary drug repository
and distribution program of some prescription drugs under a
federal Food and Drug Administration (FDA) Risk Evaluation and
Mitigation Strategies (REMS). This bill would allow drugs to be
donated if not prohibited by the REMS and if the drug is
dispensed in accordance with the REMS.
The Senate amendments clarify that a drug may not be donated if
this transfer is prohibited by the REMS and if the drug is
dispensed in accordance with the REMS.
FISCAL EFFECT : None
COMMENTS : According to the author, this bill is needed to
strengthen patient protections and ensure patients that 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.
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
AB 1727
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proper safety and management of any medications collected by and
maintained under the authority of 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.
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 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
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to only certain settings, requiring patient monitoring when on
the drug, or requiring the patient be enrolled in a registry.
Celgene Corporation (Celgene) 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 that 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 that other states have enacted
similar controls over products which must adhere to strict FDA
guidelines on distribution.
There is no opposition on file.
Analysis Prepared by : Dharia McGrew / HEALTH / (916) 319-2097
FN: 0004157