BILL ANALYSIS Ó
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2015 - 2016 Regular
Bill No: AB 1069 Hearing Date: July 6,
2015
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|Author: |Gordon |
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|Version: |July 1, 2015 Amended |
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|Urgency: |No |Fiscal: |No |
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|Consultant|Sarah Mason |
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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) Provides for the practice of pharmacy and licensing and
regulation of pharmacies and pharmacists in the Pharmacy Law
by the Board of Pharmacy (Board) and within the Department of
Consumer Affairs (DCA).
2) Exempts from the definition of manufacturer in Pharmacy Law a
pharmacy that, at a patient's request, repackages a drug
previously dispensed to the patient or to the patient's
agent, pursuant to a prescription. (Business and Professions
Code (BPC) § 4033 (a) (3))
3) Defines "repackager" as a person or entity that is registered
with the federal FDA as a repackager and operates an
establishment that packages finished drugs from bulk or that
repackages dangerous drugs into different containers,
excluding shipping containers. (BPC § 4044)
4) Establishes a licensure category under the authority of the
Board for a "surplus medication collection and distribution
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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
(Program). (BPC § 4169.5)
5) Defines "donor organization" as any of the following health
and care facilities that may donate centrally stored unused
medications under the Program:
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.
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. (Id.)
6)Prohibits an Intermediary from taking possession, custody, or
control of dangerous drugs and devices. (Id.)
7)Requires an Intermediary to ensure that notification is
provided to participating entities that a package has been
shipped, when the surplus medication collection and
distribution intermediary has knowledge of the shipment and
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provided logistical support to facilitate a shipment directly
from a donor organization. (Id.)
8)Establishes the Sherman Food, Drug, and Cosmetic Law (Sherman
Law), administered by the State Department of Public Health,
which regulates the packaging, labeling, and advertising of
drugs and devices. (Health and Safety Code (HSC) §§ 109875 et
seq.)
9)Defines "manufacture" with the Sherman Law as the preparation,
compounding, propagation, processing, or fabrication of any
food, drug, device, or cosmetic. The term "manufacture"
includes repackaging or otherwise changing the container,
wrapper, or labeling of any food, drug, device, or cosmetic in
furtherance of the distribution of the food, drug, device, or
cosmetic. The term "manufacture" does not include repackaging
from a bulk container by a retailer at the time of sale to its
ultimate consumer. (HSC § 109970)
10)Establishes a voluntary Program for the purpose of
distributing surplus medications to persons in need of
financial assistance to ensure access to necessary
pharmaceutical therapies. (HSC § 150200-150207)
11)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)
12) 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
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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 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.
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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.
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.
1)Establishes the United States Food and Drug Administration
(FDA) to protect the public health by assuring the safety,
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effectiveness, quality, and security of human and veterinary
drugs, vaccines and other biological products, and medical
devices through the Food, Drug, and Cosmetic Act (FDCA). (21
United States Code (USC) 301 et seq.)
14)Establishes the Drug Supply Chain Security Act (Act), as part
of the Drug Quality and Security Act (DQSA), which outlines
steps to build an electronic, interoperable system to
identify and trace certain prescription drugs as they are
distributed in the United States. (21 USC 351 et seq.)
This bill:
1) Authorizes a participating entity to transfer eligible
medication that has been donated to a Program to a
participating entity in another county that has adopted a
Program.
2) Authorizes a pharmacy to transfer up to fifteen percent of
its donated medications annually.
3) Authorizes donated medication to be repackaged up to two
times but does not require that donated medication must be
repackaged two times. Requires the following safeguards to
be met when donated medication is repackaged:
a) Medication shall be repackaged into a container than
holds an individual prescription for a supply of up to 90
days or less.
b) Repackaged medication shall be labeled with all
applicable lot numbers.
c) Repackaged medication shall be labeled with the earliest
expiration date.
d) Repackaged medication shall be identifiable as donated
medication.
e) Repackaged medication shall be labeled with the number
of times that medication has been repackaged.
4) Makes technical changes.
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FISCAL
EFFECT: Unknown. This bill is not keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1. Purpose. This measure is sponsored by Supporting Initiatives
to Redistribute Unused Medicine (SIRUM). According to the
Author, "because of the voluntary drug repository and
distribution program's operational requirements, Santa Clara
County is currently the only county with an active program.
When the program was initially enacted, it was one of the
first in the country and had few examples to draw from. Now
that the voluntary drug repository and distribution program
has been operational for almost 5 years and has provided
enough medications to fill over 30,000 prescriptions, 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."
According to the Author, this bill makes two operational
changes that would improve the voluntary drug repository and
distribution program, specifically allowing for transfers of
eligible donated medication from one county to another,
regardless of whether the counties are adjacent as well as
allowing for medication to be "repackaged" in advance.
The Author notes that under existing law, transfers between
participating counties are only allowed when the counties are
adjacent. Currently, only Santa Clara County operates a drug
repository and distribution program, however, the Author
states that in the future as counties establish the program,
they would be limited to transfers if the counties are not
adjacent. According to the Author, this restriction is
unnecessary and can be viewed as a disincentive for counties
looking to establish the program. The Author states that this
bill removes the barrier by enabling transfers between
participating counties that have established the program
regardless of whether or not the counties are adjacent.
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According to the Author, under the current law, participating
entities must repackage medications in a new container prior
to dispensing to a patient, but cannot do this in advance.
The Author states that repackaging donated medicine is very
time-consuming because most medicine comes in unit-dose
packaging, which means each pill needs to be individually
popped out and placed in a new container. The Author is
concerned that this currently must be done while the patient
waits and that allowing participating entities to repackage
the medications in advance alleviates the time pressure on
the pharmacist and prevents the patient from a needlessly
long wait. The Author states that this bill would also
prohibit donated medication from being repackaged more than
two times so that prescription drugs which require limited
handling are not needlessly repackaged.
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.
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
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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 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.
In 2013, AB 467 (Stone, Chapter 10, Statutes of 2014)
established a licensure category in the Pharmacy Law for a
surplus medication collection and distribution Intermediary
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like SIRUM. The license requires an Intermediary to apply to
the Board, provide certain information, pay a fee and
maintain three years of complete records for which it
facilitated the donation of medications to, or transfer of
medications between, participating entities under the
Program. AB 467 also expressly exempted an Intermediary
licensee from licensure as a wholesaler. To date, there is
no licensed intermediary in the state.
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 SIRUM.
4. Similar Programs in Other States. According to the National
Conference of State Legislatures (NCSL), at least 38 states
and Guam have enacted similar laws and programs which are
similar to the Program a county may establish under current
California law. While not all authorized programs are
operational, California is unique in that a Program is
established at the county level, while many other state
programs exist at the state level or as part of a statewide
effort.
The majority of laws throughout the nation authorizing the
creation of a Program have the following characteristics:
Authorize the return of prescription drugs in
single use or sealed packaging from state programs,
nursing homes and other medical facilities.
Provisions in place for the financial terms of the
donations or regulating sales.
Restrictions are in place aimed at assuring
purity, safety and freshness of the products.
According to NCSL, all Programs provide that:
Donated drugs must not be expired and must have a
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verified future expiration date.
Controlled substances defined by the DEA must be
excluded.
A state-licensed pharmacist or pharmacy must be
part of the verification and distribution process.
Each patient receiving a drug must have a valid
prescription form.
Examples of similar programs to California's:
Connecticut (HB 6002, 2000) allows long-term care
facilities to donate prescription drug products to
vendor pharmacies or the state Department of Social
Services for drug repackaging and reimbursement. The
drugs are then donated to eligible patients. The drugs
must be sealed in individually packaged units, returned
to the vendor pharmacy within the recommended shelf,
inspected by a licensed pharmacist, and cannot be a
controlled substance.
Ohio (HB 221, 2003) allows any person, drug
manufacturer, or healthcare facility to donate
prescription drugs to any pharmacy, hospital, or
nonprofit clinic that has elected to participate in the
program and meets certain eligibility requirements
established in rules adopted by their Pharmacy Board.
The drugs can then be donated to individuals with a
prescription. The drugs must be in their original
sealed tamper-evident unit dose packaging.
Arkansas (HB 1031, 2005) allows a nearby nursing
facility to donate drugs to charitable clinic
pharmacies. The drugs are then donated to qualified
indigent patients who are not eligible for Medicaid and
cannot afford private health insurance. The charitable
pharmacy can only accept drugs in their original sealed
and tamper-evidence packaging, and it cannot accept
controlled substances.
Iowa (HF 724, 2005) allows any person to donate
prescription drugs and supplies to participating medical
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facilities or pharmacies. The drugs are donated to
individuals or other eligible facilities or pharmacies
for use. The drugs must be inspected and in their
original sealed and tamper evidence packaging. The
program is operated by the Iowa Prescription Drug
Corporation, a non-profit organization that contracts
with the State Department of Public Health.
Oklahoma (SB 1640, 2006) which inspired SB 798,
allows pharmaceutical manufacturers and certain medical
and skilled care facilities to donate unused
prescription drugs to state, county, and city pharmacies
and charitable clinics for the purpose of distributing
the medications. The drugs are then donated to Oklahoma
residents who are medically indigent. Controlled
substances are not accepted.
Guam established medicine banks in 2004 which
distribute donated drugs to indigent individuals.
Colorado , Florida , Kentucky , Minnesota , and Nebraska have
also enacted programs but only for cancer drugs.
Michigan , New Mexico , Alabama and I ndiana programs allow
donations between correctional facilities.
New Hampshire only allows manufacturer's samples to be
donated.
New York allows donations back to the specific pharmacy that
initially distributed it.
North Carolina , Oregon , South Carolina , and West Virginia
have state medication repurposing policies but do not allow
repositories.
1. Drug Supply Regulation. The Food, Drug and Cosmetic Act
(FDCA) was passed by Congress to ensure public confidence in
our drug distribution system and to require that drugs are
both safe and effective. The FDCA requires FDA to regulate
drug manufacturers and to approve drugs for sale but also
requires state governments to regulate the drug distribution
system by licensing and regulating drug wholesalers. In the
simplest situation, a manufacturer sells drugs directly to
one of the major wholesalers who then sell the drugs to a
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hospital or pharmacy. However, this simple distribution
pattern is not the only distribution route taken through the
supply chain. Typically, there is more than one wholesaler
who receives the drugs before they reach the pharmacy. These
transactions include transfers between separate facilities
owned by major wholesalers and transfers between the major
wholesalers and the large drug store chains that have their
own wholesale facilities in the company distribution system.
Common carriers may transport the drugs between licensed
entities and in some cases will store, select and then ship
products to pharmacies at the direction of manufacturers.
The distribution system is further complicated by the
practice of "repackaging." Unlike European countries and
Canada, most drugs in the United States are not packaged in a
"unit of use" size by the drug manufacturers. Instead, many
drugs are sold by the manufacturers in large bulk containers
and then are repackaged by additional companies into smaller
containers for resale to the pharmacy. And the distribution
system is complicated yet again by the existence of a
"secondary" wholesale market. "Secondary" wholesalers are
smaller companies (often regional down to small family owned
companies) that focus their business on selling drugs to
other wholesalers and serving smaller niche clients that are
not routinely served by the major wholesalers (individual
practitioners, small clinics, rural locations, etc.).
Drugs routinely move between both primary and secondary
wholesalers and from pharmacies to secondary wholesalers as
well. These intermediate steps pose the greatest
opportunities for compromising the integrity of the drug
distribution system. The primary threat to system integrity
is the introduction of counterfeit products. Counterfeit
drugs are most likely to be introduced into a distribution
system that involves multiple wholesalers because drugs are
largely untraceable unless they are only handled by a major
wholesaler who purchases directly from the manufacturer.
Without being able to trace a drug back, there is no
assurance to the consumer that the drug has been stored and
handled appropriately to preserve its potency and safety.
In response to a growing threat to the pharmaceutical supply
chain from counterfeit, misbranded, adulterated or diverted
drugs, California enacted SB 1307 (Figueroa, Chapter 857,
Statutes of 2004) which made comprehensive changes to the
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drug distribution system to protect the integrity of the
pharmaceutical supply chain. That legislation enacted the
nation's strongest pharmaceutical consumer protection measure
and included provisions pertaining to the licensure and
qualifications of wholesalers, restrictions on furnishing and
the requirement, beginning January 1, 2007, of an electronic
pedigree (e-pedigree) to accompany and validate drug
distributions for the purpose of tracking each prescription
drug at the saleable unit (item) level through the
distribution system. Subsequent Board sponsored legislation,
SB 1476 (Figueroa, Chapter 658, Statutes of 2006) delayed the
implementation date for the e-pedigree component to January
1, 2009 and granted the Board the authority to extend the
deadline an additional two years to allow the industry
additional time to implement technologies necessary for
electronic pedigrees. In 2008, the Board sponsored SB 1307
(Ridley-Thomas, Chapter 713, Statutes of 2008), which amended
the law to resolve implementation issues, specifically
staggering and extending the implementation dates for
e-pedigree compliance, establishing grandfathering of
existing stock in the supply chain, allowing the Board to
establish criteria for inference, and preempting California's
requirements in the event federal legislation is enacted in
this area. Per SB 1307, California's e-pedigree requirements
for prescription drugs would have taken effect on a staggered
basis from January 1, 2015 through July 1, 2017:
50 percent of a manufacturer's products by 2015 would have
had to have an
e-pedigree; the remaining 50 percent of the manufacturer's
products would have had to have an e-pedigree by 2016;
wholesalers and repackagers would have had to accept and
forward products with the e-pedigree by July 1, 2016 and;
pharmacy and pharmacy warehouses would have had to accept and
pass e-pedigrees by
July 1, 2017.
In 2013, Congress passed and President Obama signed H.R.
3034, the DQSA. Among other provisions, the bill created a
national set of standards to track pharmaceuticals through
the distribution chain, aimed at curbing illegal importation
and patient harm caused by counterfeit drugs and devices.
The new law contained two parts - the Compounding Quality Act
and the Drug Supply Chain Security Act. The Compounding
Quality Act created a voluntary compliance regime where
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compounding pharmacies that voluntarily register as
"outsourcing facilities" will be subject to oversight by the
FDA in much of the same way that traditional pharmaceutical
manufacturers are monitored. The Drug Supply Chain Security
Act built upon California's e-pedigree efforts to create a
national electronic track and trace system for prescription
drugs. The Act replaced the patchwork system adopted by
individual states and created a unified national program. In
doing this, the Act explicitly preempted any state's
requirements for tracing products through the distribution
system that are inconsistent with, more stringent than, or in
addition to any of the requirements under the Act,
effectively preempting California's e-pedigree law.
2. Prior Related Legislation. AB 467 (Stone, Chapter 10,
Statutes of 2014) 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.
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.
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. Writing in support of the bill, SIRUM
and the California Assisted Living Association (CALA) state
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
environment impact of pharmaceutical waste. According to the
groups, AB 1069 will bring the program more in line with
other states, enable additional counties to participate, and
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help more Californians get the medicine that they need to
stay healthy.
The California Association of Health Facilities (CAHF)
states, "With shrinking budgets for the healthcare safety net
and rising healthcare costs for all Californians, enacting AB
1069 allows California to maximize quality patient care by
reducing the financial burden of medicine acquisition and
promoting environmentally sustainable healthcare practices."
The California Chronic Care Coalition (CCCC) states that
supports the concepts of this bill in part due to the
documented success of Santa Clara County, currently the only
county to have developed a voluntary drug repository and
distribution program in our state. CCCC hopes that as a
consequence of the changes in this bill, other counties
throughout the state will be encouraged to seriously consider
adopting this worthy program of merit.
4. Arguments in Opposition. The Board of Pharmacy has an oppose
unless amended position on this bill. According to the
Board, the proposed amendments would remove a pharmacist from
the several aspects of the redistribution program, allow a
participating entity to transfer drugs like a distributor
without appropriate licensure and control and allow for the
unlawful repackaging of and co-mingling of previously
dispensed medications, including donated medications from
various sources. According to the Board, this is all to the
detriment of the patient. The Board states that the bill
will eliminate existing patient protections established in
state and federal law that are afforded to all Californians.
The Board states that the elimination of important patient
safety safeguards for a specific population of Californians -
- indigent patients-- is both inappropriate and contrary to
the Board's consumer protection mandate.
5. Policy Issues:
a) Is the Intention for Participating Entities to Repackage
Medication? The goal of provisions in this bill related to
repackaging are to decrease wait times for patients while
easing pharmacist workload when dispensing donated
medications. However, use of the term "repackage" may not
be appropriate given the federal requirements outlined
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above for repackaging and given the constraints outlined in
federal and state law for repackaging, which in a pharmacy
setting, is only allowable for patient specific
prescriptions. While certain facilities are authorized
under federal law to perform anticipatory compounding
before a patient actually needs the drug, the allowance is
only for a limited amount, based on a patient's prescribing
history. U.S. Pharmacopeia guidance for those engaging in
repackaging specifies that the functions are beyond the
practice of a regular pharmacist. While it does not appear
to be the Author's intention to expand the authority of
pharmacists participating in a Program beyond that of
colleagues dispensing medication outside of a Program, the
current language in this bill conflicts with current
federal requirements outlining who can repackage.
b) Is the Intention for non-pharmacist personnel to perform
the duties outlined in this bill for purposes of a Program?
A participating entity under the Program includes
facilities other than pharmacies, like primary care
clinics, that may employ a pharmacist to perform
inspections and provide some oversight of the facilities'
drug supply, but are not required to be present and on the
premises at all times. It may not be the Author's
intention to allow individuals other than pharmacists to
perform the activities outlined in the bill.
SUPPORT AND OPPOSITION:
Support:
Supporting Initiatives to Redistribute Unused Medicine (Sponsor)
California Assisted Living Association
California Association of Health Facilities
California Chronic Care Coalition
Opposition:
Board of Pharmacy
-- END --
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