BILL ANALYSIS Ó
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Date of Hearing: May 5, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 1069
(Gordon) - As Amended March 26, 2015
SUBJECT: Prescription drugs: collection and distribution
program.
SUMMARY: Modifies the handling and repackaging requirements for
donated pharmaceuticals at voluntary, county-operated
prescription drug collection and distribution programs.
EXISTING LAW:
1)Establishes a voluntary, county-operated prescription drug
collection and distribution program (Program) to distribute
surplus medications to persons in need of financial assistance
to ensure access to necessary pharmaceutical therapies.
2)Requires a county to establish written procedures for its
Program including, at a minimum, the following:
a) Establishing eligibility for medically indigent patients
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who may participate in the Program;
b) Ensuring that patients eligible for the program are not
charged for any medications provided under the Program;
c) Developing a formulary of medications appropriate for
the Program;
d) Ensuring proper safety and management of any medications
collected by and maintained under the authority of a
participating entity; and,
e) Ensuring the privacy of individuals for whom the
medication was originally prescribed.
3)Establishes a licensure and regulatory framework for a
"surplus medication collection and distribution intermediary"
(SMCDI) to facilitate the donation of surplus medications in
California.
4)Specifies that only medication that is donated in unopened,
tamper-evident packaging or modified unit dose containers that
meet specified standards is eligible for donation to the
program, provided that lot numbers and expiration dates are
affixed; and, prohibits medication donated in opened
containers from being dispensed by the program.
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5)Establishes the California Board of Pharmacy (BOP) to regulate
the practice of pharmacy and enforce the pharmacy law.
Authorizes the BOP to adopt rules and regulations pertaining
to establishments wherein any drug or device is compounded,
prepared, furnished, or dispensed.
6)Requires, under federal law, all prescription drugs for human
use be labeled with specific information including, but not
limited to, the recommended or usual dosage, the active
ingredients, and an identifying lot or control number from
which it is possible to determine the complete manufacturing
history of the package of the drug.
FISCAL EFFECT: None.
COMMENTS:
1)PURPOSE OF THIS BILL. The author states that this bill is
necessary to improve current and future Programs by making
four necessary operational changes which would allow for the
packaging of medications in advance, address the handling of
recalls, allow for transfers to non-adjacent counties, and
define tamper-evident packaging in state law. When the
Program was initially enacted, it was one of the first in the
country and had few examples to draw from. The Program has
been operational for almost five years and has provided enough
medications to fill over 30,000 prescriptions. According to
the author, it has become evident that improvements are needed
to help streamline the program's operations, encourage
additional counties to participate, and help more low-income
Californians get the medicine that they need to stay healthy.
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2)BACKGROUND. The Program was created by SB 798 (Simitian),
Chapter 444, Statutes of 2005, and SB 1329 (Simitian), Chapter
709, Statutes of 2012, which authorizes counties to establish
a system to facilitate the collection and distribution of
surplus unused medications to medically indigent persons. To
date, two counties in California (Santa Clara and San Mateo)
have established a Program through local ordinance, although
the Santa Clara Program is the only current operational
program.
Supporting Initiatives to Redistribute Unused Medicine (SIRUM),
the sponsor of this bill, is a tax-exempt nonprofit
organization that connects safety-net clinics with unexpired,
unopened donated drugs from suppliers, pharmacies, and health
facilities. SIRUM works with Santa Clara County through their
Program. SIRUM has reported that over 150 participating
health facilities currently donate eligible medication. An
October 2013 California Healthline report stated that, to
date, SIRUM had administered the redistribution of 444,380
units of medicine worth about $1.5 million wholesale.
3)Similar Programs in Other States. According to the National
Conference of State Legislatures, as of January 2015, at least
38 states and Guam have enacted laws and programs which are
similar to the Program a county may establish under current
California law. While many other state programs exist at the
state level or as part of a statewide effort, California is
unique in that a Program is established at the county level.
Virtually all laws across states include some restrictions
designed to assure purity, safety and freshness of the
products. Unless otherwise noted, all programs require:
a) Donated drugs must not be expired and must have a
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verified future expiration date;
b) Controlled substances defined by the DEA must be
excluded;
c) A state-licensed pharmacist or pharmacy must be part of
the verification and distribution process; and,
d) Each patient receiving a drug must have a valid
prescription form.
4)SUPPORT. SIRUM, sponsor of this bill, states that this bill
will increase access to necessary, and in many cases
life-sustaining, prescription drugs to medically indigent
Californians while at the same time reducing the environmental
impact of pharmaceutical waste. SIRUM states that with
shrinking budgets for the healthcare safety net and rising
healthcare costs for all Californians, enacting this bill
would allow California to maximize quality patient care by
reducing the financial burden of pharmaceutical acquisitions
and promote environmentally sustainable healthcare practices.
The Santa Clara County Board of Supervisors states that
improving this program would encourage more counties to
consider implementation of a drug collection and distribution
program.
5)OPPOSITION. The BOP opposes this bill because it would create
conflicts between state and federal law. Regulation of drug
distribution is complex, with a myriad of state and federal
laws designed to ensure the safety and efficacy of
prescription drugs. BOP states that they understand the
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author's intent to address the needs of indigent patients to
secure access to medications; however, this bill in its
current form eliminates existing patient protections
established in state and federal law and, if improperly done,
could harm patients.
6)PREVIOUS LEGISLATION.
a) AB 467 (Stone), Chapter 10, Statutes of 2014,
establishes a license and regulatory framework for an SMCDI
to facilitate the donation of surplus medications in
California.
b) SB 1329 expands the types of entities that can donate
and dispense medication in the Program that provides
donated medication to medically indigent patients, 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.
c) SB 798 establishes a voluntary drug collection and
distribution program to allow surplus medications to be
shared with persons in need of financial assistance.
7)POLICY COMMENTS:
a) Repackaging is not appropriate for all drugs. While the
language of this bill intends to make the process of
repackaging faster for pharmacists and waiting patients, it
fails to address concerns that some classes of drugs should
not be repackaged. Due to their chemical structure, some
drugs may degrade when exposed to light or oxygen, and
potentially lose efficacy each time they are repackaged.
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Moving forward, the author may wish to work with BOP to
clarify certain drug classes which should have limited
handling and repackaging.
b) There is only one county currently participating.
Current law limits transfers of donated drugs to adjacent
counties. This bill would remove that limitation, allowing
transfer to any other county-operated pharmacy in the
state. Since there is currently only one county operating
a drug collection and redistribution pharmacy, the
Committee may wish to consider whether this change is
premature.
8)SUGGESTED AMENDMENTS.
a) Tamper-evident packaging definition is problematic. The
definition created in this bill would be in conflict with
federal law. That provision of this bill should be
stricken.
b) Lot numbers are required under federal law. Provisions
of this bill that would allow participating entities to
hold and redistribute medications without lot numbers may
be in conflict with federal law. Lot numbers are
necessary, in case of recalls, to be able to track the
entire manufacturing history and chain of custody of a
medicine. Provisions of the bill removing the requirements
for lot numbers should be stricken.
c) The number of times medicine is repackaged should be
limited. Current law requires pharmacies to repackage
donated drugs before distributing to new patients. The
sponsors state that repackaging while the patient waits is
unduly time consuming. However, there are concerns that
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the repackaging provisions of this bill are too vague. The
author should amend the bill to limit the number of times
medication can be repackaged.
REGISTERED SUPPORT / OPPOSITION:
Support
Supporting Initiatives to Redistribute Unused Medicine (sponsor)
California Association of Health Facilities
California Chronic Care Coalition (in concept)
Santa Clara County Board of Supervisors
Opposition
California State Board of Pharmacy (unless amended)
Analysis Prepared by:Dharia McGrew / HEALTH / (916) 319-2097
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