BILL ANALYSIS Ó
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|Hearing Date:April 25, 2011 |Bill No:SB |
| |431 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 431Author:Emmerson
As Amended:April 11, 2011 Fiscal: Yes
SUBJECT: Pharmacies: regulation.
SUMMARY: Expands existing reporting requirements to the Board of
Pharmacy (Board) when a pharmacy discovers that an employee has been
stealing drugs. Prohibits a pharmacist whose California license has
been revoked from dispensing medication to Californians via mail.
Requires a pharmacy to use a licensed hazardous waste hauler to
dispose of previously dispensed prescription drugs.
Existing law, The Pharmacy Law:
1)Provides for the licensure and regulation of pharmacies, pharmacists
and wholesalers of dangerous drugs or devices by the Board within
the Department of Consumer Affairs (DCA).
2)Defines the following terms:
a) "Authorized officers of the law" as inspectors of the Board,
inspectors of the Food and Drug Branch of the State Department of
Public Health (DPH), and investigators of DCA's Division of
Investigation (DOI) or peace officers engaged in official
investigations. (Business and Professions Code (BPC) § 4017)
b) "Designated representative" as an individual to whom a license
has been granted to provide sufficient and qualified supervision
in a wholesaler or veterinary food-animal drug retailer.
Specifies that the designated representative shall protect the
public health and safety in the handling, storage, and shipment
of dangerous drugs and dangerous devices. "Designated
representative-in-charge" means a designated representative or a
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pharmacist proposed by a wholesaler or veterinary food-animal
drug retailer and approved by the Board as the supervisor or
manager responsible for ensuring compliance with all state and
federal laws. (BPC § 4022.5)
c) "Pharmacist-in-charge" as a pharmacist proposed by a pharmacy
and approved by the Board as the supervisor or manager
responsible for ensuring the pharmacy's compliance with all state
and federal laws and regulations pertaining to the practice of
pharmacy. (BPC § 4036.5)
d) "Reverse distributor" as every person who acts as an agent for
pharmacies, drug wholesalers, manufacturers, and other entities
by receiving, inventorying, and managing the disposition of
outdated or nonsalable dangerous drugs. (BPC § 4040.5)
3)Requires pharmacies to keep records of manufacture, sale,
acquisition or disposition of dangerous drugs or dangerous devices
for three years, and requires these records to be available for
inspection by authorized officers of the law. Requires that an
inventory be kept by every manufacturer, wholesaler, pharmacy,
veterinary food-animal drug retailer, physician, dentist,
podiatrist, veterinarian, laboratory, clinic, hospital, institution,
or establishment holding a currently valid and unrevoked
certificate, license, permit, registration who maintains a stock of
dangerous drugs or devices. Makes the owner, officer, partner and
pharmacist-in-charge or designated representative-in-charge
responsible for maintaining records and keeping inventory.
Clarifies that the pharmacist-in-charge or designated
representative-in-charge are not criminally responsible for the acts
of an owner, officer, partner or employee if the
pharmacist-in-charge or designated representative-in-charge had no
knowledge of the acts. (BPC § 4081)
4)Requires pharmacies to have procedures in place to take action when
a licensed individual employed by or with the pharmacy is
chemically, mentally, or physically impaired to the extent it
affects his or her ability to practice the profession or occupation
he or she is licensed to practice, or when a licensed individual has
engaged in the theft, diversion, or self-use of dangerous drugs.
Requires pharmacies to have written policies and procedures for
addressing chemical, mental, or physical impairment, as well as
theft, diversion, or self-use of dangerous drugs, among licensed
individuals employed by or with the pharmacy. States that anyone
making a report has immunity from any civil or criminal liability
that might otherwise arise from making of the report. Requires
pharmacies to report the following to the Board within 30 days:
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a) Any admission by a licensed individual of chemical,
mental, or physical impairment affecting his or her ability to
practice.
a) Any admission by a licensed individual of theft,
diversion, or self-use of dangerous drugs.
b) Any video or documentary evidence demonstrating chemical,
mental, or physical impairment of a licensed individual to the
extent it affects his or her ability to practice.
c) Any video or documentary evidence demonstrating theft,
diversion, or self-use of dangerous drugs by a licensed
individual.
d) Any termination based on chemical, mental, or physical
impairment of a licensed individual to the extent it affects
his or her ability to practice.
e) Any termination of a licensed individual based on theft,
diversion, or self-use of dangerous drugs. (BPC § 4104)
1)Requires all records or other documentation of the acquisition and
disposition of dangerous drugs and dangerous devices by any entity
licensed by the Board to be retained on the licensed premises in
readily retrievable form. (BPC § 4105)
2)Specifies that a nonresident pharmacy is any pharmacy located
outside of California that ships, mails or delivers controlled
substances, dangerous drugs, or dangerous devices into California
and establishes certain licensing, disclosure and record keeping
requirements for these entities. (BPC § 4112)
This bill:
1)Clarifies that any record pertaining to the return of dangerous
drugs to a wholesaler, or provided to a reverse distributor, must
document the quantity or weight of the drugs returned, the date the
drugs were returned and the name of the reverse distributor or
wholesaler to whom the drugs were provided. Specifies that a
reverse distributor must not accept the return of dangerous drugs
that have been dispensed to a patient and later returned by a
patient or patient's agent.
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2)Clarifies that any record pertaining to the return of dangerous
drugs to a hazardous waste hauler must list the volume in weight or
measurement of the pharmaceutical waste returned, the date the waste
was returned and the name of the hazardous waste hauler to whom
waste was provided. Specifies that a pharmacy may furnish dangerous
drugs to a hazardous waste hauler for the sole purpose of waste
disposal of pharmaceutical waste returned to the pharmacy by a
patient or patient's agent. Specifies that only a hazardous waste
hauler can pick up or handle dangerous drugs returned by a patient
or patient's agent to a pharmacy.
3)Requires that, in addition to reporting certain information and
evidence about licensees related to chemical, mental, or physical
impairment to the extent it affects his or her ability to practice
and theft, diversion or self-use of dangerous drugs to the Board
within 30 days, a pharmacy must also provide the information and
evidence to the Board within 30 days.
4)In the event of information or evidence pertaining to chemical,
mental or physical impairment of a licensee (to the extent it
affects his or her ability to practice) or theft, diversion or
self-use of dangerous drugs, requires a pharmacy to conduct an audit
to determine the quantity and type of dangerous drugs stolen,
diverted, or used by a licensed individual employed by or with the
pharmacy and submit a copy of the audit to the Board within 30 days.
5)Requires the owner, corporate officer, or manager of an entity
licensed by the Board, when requested by an authorized officer of
the law or by an authorized representative of the Board, to provide
the requested records within 72 hours of the time the request was
made. Specifies that the entity may request an extension in writing
for up to 14 days, subject to Board approval.
6)Clarifies that a nonresident pharmacy shall not permit a pharmacist
whose license has been revoked by the Board to manufacture,
compound, furnish, sell, dispense, or initiate the prescription of a
dangerous drug or dangerous device, or to provide any
pharmacy-related service, to a person residing in California.
FISCAL EFFECT: Unknown. Legislative Counsel has keyed this bill
"fiscal."
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COMMENTS:
1. Purpose. This bill is sponsored by the Board of Pharmacy (Board).
According to the Author, SB 431 will increase consumer protection
as well as better ensure the proper disposal of prescription drugs.
Without a safe and effective method for disposal, prescription
drugs may be left in medicine cabinets where they pose a threat of
potential drug misuse or abuse. The Author asserts that this bill
will also make certain that when drugs are received by a pharmacy
that it has established a take-back program, they are properly
disposed of, and not re-introduced into the pharmaceutical supply.
The Author believes that this bill also contains consumer
protection measures that provide the Board with information it
needs to quickly discipline errant licensees by requiring
additional reporting on drug loss. Additionally, the Author notes
that ensuring that an individual whose pharmacist license has been
revoked in California is not able to dispense medication to
Californians via mail supports the Board's public protection
efforts.
2. Prescription Drug Disposal. There are growing concerns about the
impact of drugs and pharmaceutical waste based on improper
disposal, which in turn leads to contamination of water systems and
improper access by potential abusers. The U.S. Geological Survey
conducted a study in 2002, sampling 139 streams across 30 states
and found that 80 percent had measurable concentrations of
prescription and nonprescription drugs, steroids, and reproductive
hormones. Exposure, even to low levels of pharmaceuticals, has
been shown to have negative effects on fish and other aquatic
species and may have negative effects on human health. Proper
disposal is believed to decrease the threat of these substances to
the environment and waterways.
According to recent studies, and data collected by the federal
government, prescription drug abuse is the fastest-growing drug
problem in the U.S. As prescription drugs are legal, they are
easily accessible, often from a home medicine cabinet. Studies
show that some individuals who misuse prescription drugs,
particularly teens, believe these substances are safer than illicit
drugs because they are prescribed by a health care professional and
sold behind the counter. Proper disposal is believed to decrease
the availability of expired and unused prescription drugs to
abusers.
The guidelines for proper disposal of prescription drugs can be
confusing, lack uniformity throughout the state and nation, and are
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cumbersome to the consumer. For example, the federal Food and Drug
Administration highlights certain very harmful drugs that should be
flushed down a toilet, but the organization also recommends a
lengthy process for proper disposal of the majority of
prescriptions drugs, including mixing whole tablets or capsules
with an unpalatable substance such as kitty litter or used coffee
grounds then placing that mixture in a sealed container before
throwing it in household trash. The Board's recommended process
for disposal is similarly extensive and requires even additional
steps.
Take-back programs for medication disposal have risen in popularity
due to problems surrounding safe, accessible, easy disposal
options. These programs are seen as a good way to remove expired,
unwanted, or unused medicines from the home and reduce the chance
that others may accidentally take the medicine or it ends up being
flushed. In California, though, current law views these drugs as
medical waste in terms of how they can be handled and disposed of.
There are rigorous management and tracking requirements for medical
waste including requiring the use of hazardous or medical waste
haulers and strict manifesting requirements.
While this bill does not expand take-back programs or authorization
for these programs, it clarifies that drugs previously dispensed to
patients, which are taken back by a pharmacy, must be disposed of
by hazardous waste haulers licensed by the Department of Public
Health (DPH), while drugs which have not been dispensed to patients
can be returned and handled by reverse distributors licensed by the
Board.
3. Board's EffortsTo Strengthen Enforcement. The Board's Enforcement
Committee oversees all enforcement activities which the Board
believes are essential for it to meet its consumer protection
mandate. The enforcement program uses a combination of education,
communication, and enforcement actions to achieve compliance with
federal and state pharmacy laws. The Board conducts routine
inspections of licensees, provides educational materials to
licensees, provides regular communication to licensees, and cites
and fines for violations of the Pharmacy Law.
Health boards throughout DCA have struggled to meet enforcement goals
and streamline what have become extremely lengthy disciplinary
processes. Complaints against a licensee often take a circuitous
route through several clogged bureaucracies; from the health care
boards for initial assessment to the Division of Investigation of
the DCA for investigation, to the AG's office for filing of an
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accusation and prosecution, to the State Office of Administrative
Hearings (OAH) for disciplinary hearings and back to the licensing
board for a final decision. Compounding this process are recent
mandatory furloughs, a state hiring freeze which limits boards'
ability to hire staff, despite demonstrated need and proper
approval, and loans from special fund agencies like DCA boards to
the state's General Fund.
In response to press criticism and review by the Legislature of public
health and safety impacted by enforcement delays, then-Governor
Schwarzenegger established a goal for all investigation cases to be
closed between 12 to 18 months in 2009, and the DCA designed a new
enforcement model for all boards to comply with this timeline. As
compared to other boards, the Board is relatively timely in
processing investigations, but given a significant growth in the
number of licensees that the board regulates, there is a related
growth in investigations, the number of complaints received and
initial application investigations. During conversations about the
DCA-wide changes to enhance enforcement, the Board identified
internal improvements that could be made as well as statutory
efforts necessary to strengthen its enforcement program and provide
quicker resolutions.
Specifically, the Board believes the provisions in this bill, as
outlined below, will allow for better enforcement, quicker outcomes
in disciplinary cases and an enhanced ability to fulfill its
regulatory mission. They are as follows:
Specify the time period by which records must be provided
to the Board when requested by an inspector or authorized
representative.
Requires that a pharmacy provide the board, within 14
days, evidence of licensee's theft or impairment. Requires a
pharmacy to conduct an audit to determine the scope of a drug
loss and to provide the Board with a copy of the audit
results.
Require that a nonresident pharmacy cannot allow a
pharmacist, whose license has been revoked in California, from
providing pharmacist related services to Californians.
1. Related Legislation. SB 1111 (Negrete McLeod) of 2010, enacted the
Consumer Health Protection Enforcement Act that included various
provisions affecting the investigation and enforcement of
disciplinary actions against licensees of DCA healing arts boards.
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The bill failed passage in this Committee. SB 544 (Price) was
introduced this year and was recently amended to provide similar
provisions to SB 1111, to reform the health board's enforcement
programs.
SB 966 (Simitian, Chapter 542, Statutes of 2007) requires the
California Integrated Waste Management Board to develop, in
consultation with appropriate state, local, and federal agencies,
model programs for the collection and proper disposal of
pharmaceutical drug waste.
2. Concerns Raised. The California Pharmacists Association (CPhA)
expresses its concerns about the bill as it is currently written.
CPhA argues that the bill's requirement on pharmacies to conduct an
audit of their entire stock to determine the quantity and type of
dangerous drugs stolen, diverted or used, is "onerous and serves no
public purpose." It explains that since a dangerous drug is, by
definition, any type of prescription drug, this requirement can be
triggered by the diversion of drugs such as antihistamines. It
suggests that instead, the audit requirement be imposed only when
(a) controlled substances or other drugs that create a public
safety concern are at issue and (b) the audit is requested by the
Board.
Another concern expressed by the CPhA is that this bill would
require pharmacies to provide the Board with requested records
within 72 hours of the time the request was made. Although the
bill allows a pharmacy to request up to a 14 day extension, the
request is subject to Board approval without any limitations on the
board. This would mean that a pharmacy may not be informed until
the last moment that its extension request has been denied. The
CPhA suggests that this provision be amended to provide that the
extension is automatic unless the Board denies the request within a
specified timeframe, such as 24 hours. It argues that this
amendment would also allow the Board to obtain information more
quickly if necessary and that where there is a public danger, the
Board has other remedies such as shutting down a pharmacy.
SUPPORT AND OPPOSITION:
Support: Board of Pharmacy (Sponsor)
Concerns: California Pharmacists Association (CPhA)
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Consultant:Sarah Mason