BILL ANALYSIS �
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|Hearing Date:June 23, 2014 |Bill No:AB |
| |1727 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Ted W. Lieu, Chair
Bill No: AB 1727Author:Rodriguez
As Amended:June 15, 2014 Fiscal: No
SUBJECT: Prescription drugs: collection and distribution program.
SUMMARY: 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.
NOTE : This bill was referred to the Senate Committee on Health,
first, and was passed out of that Committee by a vote of 9 to 0 on
June 11, 2014.
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 (Board).
2)Establishes a licensure category under the authority of the Board
for a "surplus medication collection and distribution intermediary"
(Intermediary) operating for the purpose of facilitating the
donation of medications to, or transfer of medications between,
participating entities under a county's unused medication repository
and distribution Program. Provides that the Intermediary license
shall be renewed annually. (BPC � 4169.5 (a))
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. Provides that if the applicant is an entity other
than a natural person, the application shall state the information
as to each person beneficially interested in that entity. (BPC �
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4169.5 (b))
4)Exempts an Intermediary licensee from licensure as a wholesaler.
(BPC � 4169.5 (h))
5)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. (BPC � 4169.5 (i))
Existing law, the Health and Safety Code (HSC):
1)Establishes a voluntary drug repository and distribution program
(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 et. seq.)
2)Authorizes a county to establish a Program, by an action of the
county board of supervisors or by an action of the public health
officer of the county, as directed by the county board of
supervisors. Requires the county to notify the Board within 30 days
from the date it establishes a Program. (HSC � 150204)
3) Provides for the following related to medication donated to the
Program: (Id)
a) The medication shall not be a controlled substance.
b) The medication shall not have been adulterated, misbranded, or
stored under conditions contrary to standards set by the United
States Pharmacopoeia (USP) or the product manufacturer.
c) The medication shall not have been in the possession of a
patient or any individual member of the public, and in the case
of medications donated by a health or care facility, shall have
been under the control of a staff member of the health or care
facility who is licensed in California as a health care
professional or has completed, at a minimum, certain training
requirements.
d) Only medication that is donated in unopened, tamper-evident
packaging or modified unit dose containers that meet USP
standards is eligible for donation to the Program, provided lot
numbers and expiration dates are affixed. Medication donated in
opened containers shall not be dispensed by the Program and once
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identified, shall be quarantined immediately and handled and
disposed of in accordance with the Medical Waste Management Act.
e) A pharmacist or physician at a participating entity shall use
his or her professional judgment in determining whether donated
medication meets certain standards before accepting or dispensing
any medication under the Program.
f) A pharmacist or physician shall adhere to standard pharmacy
practices, as required by state and federal law, when dispensing
all medications.
g) Medication that is donated to the Program shall either be
dispensed to an eligible patient, destroyed, returned to a
reverse distributor or licensed waste hauler or transferred to
another participating entity within the county to be dispensed to
eligible patients. Medication that is donated shall not be
transferred by any participating entity more than once, and after
it has been transferred, shall be dispensed to an eligible
patient, destroyed, or returned to a reverse distributor or
licensed waste hauler. Medication transferred pursuant to this
paragraph shall be transferred with documentation that identifies
the drug name, strength, and quantity of the medication, and the
donation facility from where the medication originated shall be
identified on medication packaging or in accompanying
documentation.
h) Medication that is donated to the Program that does not meet
the above requirements shall not be distributed or transferred
under this program and shall be either destroyed or returned to a
reverse distributor.
i) Medication donated to the Program shall be maintained in the
donated packaging units until dispensed to an eligible patient
under this program, who presents a valid prescription. When
dispensed to an eligible patient under the Program, the
medication shall be in a new and properly labeled container,
specific to the eligible patient and ensuring the privacy of the
individuals for whom the medication was initially dispensed.
Expired medication shall not be dispensed.
j) Medication donated to the Program shall be segregated from the
participating entity's other drug stock by physical means, for
purposes including, but not limited to, inventory, accounting,
and inspection.
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aa) A participating entity shall keep complete records of the
acquisition and disposition of medication donated to, and
transferred, dispensed, and destroyed under the Program. These
records shall be kept separate from the participating entity's
other acquisition and disposition records and be readily
retrievable.
bb) Local and county protocols established conform to the Pharmacy
Law regarding packaging, transporting, storing, and dispensing
all medications.
cc) County protocols established for packaging, transporting,
storing, and dispensing medications that require refrigeration,
including, but not limited to, any biological product as defined
in Section 351 of the Public Health Service Act (42 U.S.C. Sec.
262), an intravenously injected drug, or an infused drug, shall
include specific procedures to ensure that these medications are
packaged, transported, stored, and dispensed at appropriate
temperatures and in accordance with USP standards and the
Pharmacy Law.
dd) A participating entity shall 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.
4) Defines "donor organization" as any of the following health and
care facilities that may donate centrally stored unused medications
under the Program: (HSC � 150202)
a) A licensed general acute care hospital.
b) A licensed acute psychiatric hospital.
c) A licensed skilled nursing facility, including a skilled
nursing facility designated as an institution for mental disease.
d) A licensed intermediate care facility.
e) A licensed intermediate care facility/developmentally
disabled-rehabilitative facility.
f) A licensed intermediate care facility/developmentally
disabled-nursing facility.
g) A licensed correctional treatment center.
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h) A licensed psychiatric health facility.
i) A licensed chemical dependency recovery hospital.
j) A licensed residential care facility for the elderly with 16
or more residents.
aa) An approved mental health rehabilitation center.
5)Provides that a prescription drug manufacturer, wholesaler,
governmental entity, participating entity, donor organization,
pharmacist or physician who accepts or dispenses prescription drugs
are not subject to criminal or civil liability for injury caused
when donating, accepting or dispensing prescription drugs under a
Program. Provides that an Intermediary shall not be subject to
criminal or civil liability for injury caused when facilitating the
donation of medications to or transfer of medications under a
Program. (HSC � 150205)
6)Establishes the following related to an Intermediary: (HSC �
150208):
a) Requires an Intermediary to keep and maintain for three years
complete records for which it facilitated the donation of
medications to, or transfer of medications between, participating
entities under the Program.
b) Prohibits an Intermediary from taking possession, custody, or
control of dangerous drugs and devices.
c) Requires an Intermediary to ensure that notification is
provided to participating entities that a package has been
shipped when the Intermediary has knowledge of the shipment and
provided logistical support to facilitate a shipment directly
from a donor organization.
d) Prohibits an Intermediary from selecting or directing a donor
organization to select a specific participating entity to receive
surplus medications.
1)No participating entities shall receive donated medication directly
from the surplus medication collection and distribution
intermediary. (HSC � 150208 (d))
This bill:
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1) Prohibits medication that is the subject of a U.S. Food and Drug
Administration (FDA) managed Risk Evaluation and Mitigation
Strategy pursuant to Section 355-1 of Title 21 of the U.S. code
(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) Provides that medication subject to a FDA REMS that is not
otherwise prohibited from being donated as part of the strategy
shall be managed and dispensed according to the requirements of
that strategy.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by Legislative
Counsel.
COMMENTS:
1. Purpose. The Author is the sponsor of this bill. According to the
Author, this bill seeks to prevent medications that are strictly
regulated by the U.S. FDA from being donated to county Drug
Repository and Distribution Programs. The Author states that "there
are some medications that may have very serious side effects such
as birth defects and vision loss. To ensure the benefits of these
drugs outweigh the risks, the FDA requires doctors, pharmacies and
drug manufactures to follow strict safety guidelines. For certain
drugs, the FDA requires manufacturers to track each prescription
from the doctor, through the pharmacy, to the patient. If these
highly regulated drugs are sent to repository programs, it would
become difficult if not impossible to track each prescription from
the doctor, through the pharmacy, to the patient."
2. 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 percent of the state's population, were uninsured. Of the
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insured in California, 7 percent 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 (EPA), 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
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.
3. 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 "surplus
prescription drug collection and distribution program" (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 skilled nursing
facilities (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
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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 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:
Program efforts in Santa Clara County are coordinated by Supporting
Initiatives to Redistribute Unused Medication (SIRUM) and are
estimated to have resulted in significant impact and savings since
2009:
772,000 units of medicine have been redistributed.
$2 million of medicine have been donated.
Thousands of estimated uninsured patients have been
assisted.
150 medicine donors are participating.
1. FDA Risk Evaluation and Mitigation Study (REMS). The Food and Drug
Administration (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
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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 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 to only certain settings, requiring patient monitoring
when on the drug, or requiring the patient be enrolled in a
registry.
1. Related Legislation This Year. AB 467 (Stone, Chapter 10, Statutes
of 2014) was an urgency measure which established a licensure
category for a surplus medication collection and distribution
Intermediary established for the purpose of facilitating the
donation of medications to, or transfer of medications between,
participating entities under a county's unused medication
repository and distribution program.
2. Prior Related Legislation. SB 1329 (Simitian, Chapter 709,
Statutes of 2012) revised and recasted 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 and expanded the types of entities that are eligible to
participate in a program.
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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.
3. Arguments in Support. According to supporters including Celgene
Corporation and PhRMA , other states have enacted similar controls
as contained in this bill over products which adhere to strict FDA
guidelines on distribution and that the concern for the prevention
of fetal exposure renders these medications unsuitable for
redistribution.
The March of Dimes supports this bill, writing that the mission of
the organization is to prevent birth defects, premature birth and
infant mortality and that the bill will help protect pregnant women
from certain medications that cause birth defects.
SUPPORT AND OPPOSITION:
Support:
Board of Pharmacy
Celgene Corporation
March of Dimes
Pharmaceutical Research and Manufacturers of America (PhRMA)
Neutral:
Supporting Initiatives to Redistribute Unused Medicine (SIRUM)
Opposition:
None on file as of June 18, 2014.
Consultant:Sarah Mason