BILL ANALYSIS
SENATE COMMITTEE ON CRIMINAL PROCEDURE
Senator Milton Marks, Chair A
1995-96 Regular Session B
3
0
AB 3042 (Takasugi) 4
As amended March 28, 1996 2
Hearing date: June 11, 1996
Health and Safety Code
BM:js
Controlled Substance Utilization Review and
Evaluation System (CURES) - Prescribing of
Controlled Substances
HISTORY
Source: Attorney General, Daniel. E. Lungren
Prior Legislation: SCR 74 (Presley); Chapt.116, Stats. 1992
Support: County of Los Angeles Sheriffos Department,;
California Society of Health-System Pharmacists
Opposition: None Known
Assembly Floor Vote: Ayes 76 - Noes 0
KEY ISSUE
Should the department of justice be authorized to establish the controlled
substance utilization review and evaluation system (CURES) for the electronic
MONITORING of the prescribing and dispensing of schedule ii controlled
substances by all practitioners authorized to prescribe or dispense these
controlled substances?
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PURPOSE
Existing law states that no person other than a physician,
dentist, podiatrist or veterinarian, or under certain
conditions a pharmacist, registered nurse, or physicianos
assistant shall write a prescription. (Health and Safety
Code Section 11150)
Existing law states that, except as provided, no controlled
substance shall be dispensed without a prescription. (Health
and Safety Code Section 11158)
Existing law provides that prescription blanks shall be
issued by the Department of Justice in serially numbered
groups of not more than 100 forms each in triplicate, and
shall be furnished to any practitioner authorized to write a
prescription for controlled substances classified in Schedule
II. (Health and Safety Code Section 11161)
Existing law states that the Department of Justice may charge
a fee for the prescription blanks, not to exceed the actual
costs of printing and distribution. The prescription blanks
shall not be transferable. (Health and Safety Code Section
11161)
Existing law states that the Department of Justice shall not,
during any 30-day period, issue more than 100 triplicate
prescription blanks to any authorized practitioner, until
written justification has been received and approved by the
Department of Justice. Any person possessing a triplicate
prescription blank otherwise than as provided in this section
is guilty of a misdemeanor. (Health and Safety Code Section
11161)
This bill would authorize the Department of Justice to
establish the Controlled Substance Utilization Review and
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Evaluation System (CURES) for the electronic monitoring of
the prescribing and dispensing of Schedule II controlled
substances by all practitioners authorized to prescribe or
dispense these controlled substances. This bill would also
provide that the Department of Justice may charge a fee for
the prescription blanks that is sufficient to reimburse the
department for the actual costs associated with the
preparation, processing, and filing of specified forms.
The purpose of this bill is to establish the Controlled
Substance Utilization Review and Evaluation System (CURES),
an electronic monitoring system for the prescribing and
dispensing of Schedule II controlled substances, and to
authorize the Department of Justice to charge a fee for
prescription blanks.
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COMMENTS
1. Stated Need.
According to the author,
California law requires triplicate prescription
forms for all Schedule II drugs. The Department of
Justice receives approximately 1.6 million
triplicate prescription forms annually, but is only
able to enter 12 percent (190,000) of them into the
existing database. The information captured on the
current system is not complete and therefore not
useful in identifying and investigating those
suspected of abusing the prescribing and dispensing
process. Almost 100 percent of all Schedule II
prescriptions are already entered into automated
databases by pharmacies for their own business
reasons (i.e., billing to Medi-Cal). By
integrating existing systems, virtually 100 percent
of the data could be captured at the point of sale,
and the information made accessible to law
enforcement. The technology is readily available
and is already used by other states with success.
2. Background.
The Controlled Substances Prescription Advisory Council,
established in 1992 by a Senate Concurrent Resolution (SCR
74), was created to evaluate, among other things, the
multiple-copy prescription programs and electronic data
tracking systems used in other states and the benefits of
modernizing our stateos current system. The Council
submitted a report to the Attorney General and the
Legislature in December of 1993.
In the final report submitted to the Legislature and Attorney
General, the Controlled Substances Prescription Advisory
Council recommended that the Department of Justice implement
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a technologically sophisticated data monitoring system to
collect as much data as is needed and provide easy access to
the data collected for educational, law enforcement,
regulatory, and research purposes. The Council concluded
that the technology was now available to provide this type of
monitoring system at a cost not dramatically different from
current costs.
3. The Existing Triplicate Prescription Program.
All prescription drugs in California are monitored and
regulated in a oscheduleo system similar to that used in the
Federal United States Code. Represented by Roman Numerals I,
II, III, IV, and V, the schedules identify the legality and
abuse potential of individual drugs. Schedule II controlled
substances are the strongest, highest abuse potential drugs
available by prescription yet have substantial medical value.
Existing law requires that any person prescribing a Schedule
II controlled substance issue the prescription on a
triplicate prescription form provided by the California
Department of Justice (DOJ), Bureau of Narcotic Enforcement
(BNE).
Since the mid-1940os, California has administered the
existing system for the monitoring of Schedule II controlled
substances through the use of BNE issued, serialized
triplicate prescription forms. Existing law requires the
pharmacist to forward the original (top sheet) of the paper
triplicate prescription form to the California DOJ each
month. Approximately, 1.6 million triplicate prescriptions
are sent to DOJ annually. The prescriptions are sorted,
coded, and prepared for entry into the Automated Triplicate
Prescription System (ATPS).
DOJ began entering filled prescription forms into an
automated system based on a hierarchy of criteria developed
by DOJ in 1987. Although all filled prescriptions are
reviewed by hand, the department does not have the resources
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to input all the data collected. In 1994, only 12% of the
total number of triplicate prescriptions were entered into
the system. The remainder of the prescription forms are
banded and stored. For those few prescriptions entered into
ATPS as many as 90 days elapse between the time the drug is
dispensed by the pharmacy to when it is hand-entered into the
system. Therefore 88% of the triplicate prescription
information is not available to DOJ for enforcement,
research, or drug utilization review.
4. The Controlled Substance Utilization Review and
Evaluation System (CURES).
CURES would work in tandem with existing computerized
pharmacy systems, permitting 100 percent of the Schedule II
prescription data to be collected at the time the
prescription is dispensed. This would provide complete and
timely data to allow law enforcement agencies and
professional licensing boards to effectively identify
prescribers, dispensing pharmacies and patients who are
suspected of diversion activities.
CURES would be capable of providing data to appropriate
state, local, and federal persons, or public agencies for
disciplinary, civil, or criminal purposes and to other
agencies or entities, as determined by the Department of
Justice, for the purpose of educating practitioners and
others in lieu of disciplinary, civil, or criminal actions.
CURES would also be capable of providing data to public or
private entities, as approved by the department, for
educational, peer review, statistical, and research purposes,
provided that the confidentiality of patients and patient
information, including any information that would identify
the patient, is not compromised.
Under this bill, CURES will be implemented by the Department
of Justice on a trial basis and the existing triplicate
prescription process will still be used until CURES is
completely established and proven to be effective and
efficient.
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5. Other States Using the System.
The technology used to implement CURES is readily available
and currently in use by other states, including Oklahoma,
Massachusetts, Indiana, and Hawaii, who employ fully
automated prescription systems. Nevada is about to release a
request for proposals to implement an automated system to
track Schedule II-V drugs (1.2 million prescriptions), where
the data will be sent via disk or through an 800 line to the
contracted vendor. A recent report issued in Colorado
recommends a similar tracking program for all scheduled drugs
in that state and Texas anticipates introducing legislation
next year.
6. Diversion of Drugs.
The Drug Enforcement Administration estimates that the
diversion of legal drugs for illicit purposes is a $25
billion nationwide industry. Prescription drugs are a
constant factor in emergency room admissions, addictions, and
deaths.
According to the Board of Pharmacy, prescription drugs
constitute the largest growing source of street drugs in the
United States. Prescription drugs such as morphine, Demerol,
Dilaudid, codeine, Ritalin and diazepam are mostly abused
because of their psychological or physical effects.
Prescription drugs account for one-third of all illegally
sold drugs. According to the Board of Pharmacy, 3.5 billion
diverted prescription drugs end up on the street each year.
7. Funding.
No funding is sought from the General Fund to establish or
maintain CURES.
Under Health and Safety Code Section 11161, the Department of
Justice may charge a fee for the prescription blanks used in
the triplicate prescription process.
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This bill will provide that funding to support CURES will
come from fees collected for the current triplicate
prescription process. The Department of Justice is also
seeking federal funds to implement the CURES system.
8. The Board of Pharmacy and Proposed Amendments.
The Board of Pharmacy (BOP) is responsible for the
enforcement of federal and state laws pertaining to the
acquiring, storing, distributing, and dispensing of dangerous
drugs (including controlled substances) and devices as they
relate to pharmacies, pharmacists, drug wholesalers, clinics,
non-resident pharmacies, medical device retailers and
out-of-state distributors. To meet its enforcement
responsibilities associated with drug diversion, fraud and
abuse, the Board has the authority to investigate licensees
suspected of unlawful conduct and to audit the inventory of
controlled substances to detect illegal drug diversion.
Disciplinary penalties include probation, licensed revocation
and suspension.
According to the Board of Pharmacy, the Board uses the
current Department of Justiceos Automated Triplicate
Prescription System rarely because of its limited value since
the reports are incomplete and not available in a timely or
convenient manner.
The Board of Pharmacy financed the research and study by the
Controlled Substances Prescription Advisory Council in 1993
that concluded and recommended to the Department of Justice
that a technologically sophisticated data monitoring system,
like CURES, needed to be implemented.
The Board of Pharmacy has proposed an amendment to AB 3042 to
reflect a joint effort between the Department of Justice and
the Board of Pharmacy for implementation and operation of
CURES. The Board of Pharmacy is willing to set aside from
its contingent funds up to $350,000 annually for three years,
if federal funding is not forthcoming to ensure
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implementation of the CURES project. This amendment would
make the implementation and operation of CURES, part of an
interagency agreement between the Board of Pharmacy and the
Department of Justice.
The author and sponsors have not accepted these amendments.
SHOULD THIS BILL BE AMENDED TO ALLOW THE BOARD OF PHARMACY TO
APPROPRIATE $350,000 ANNUALLY FOR THREE YEARS FROM ITS FUNDS
TO HELP THE DEPARTMENT OF JUSTICE IMPLEMENT AND OPERATE
CURES?
SHOULD THE IMPLEMENTATION AND OPERATION OF CURES BE A JOINT
EFFORT BETWEEN THE DEPARTMENT OF JUSTICE AND THE BOARD OF
PHARMACY?
In addition to their proposal to help implement CURES, the
Board of Pharmacy would like to see CURES eventually
outsourced to the private sector. The Board of Pharmacy is
confident there is a vendor capable of implementing CURES
more cost-effectively and competitively than the government
can. The Board is willing to share the risk with the private
sector to implement CURES and is seeking a partnership with
the Department of Justice. According to the Board of
Pharmacy, several chain community pharmacies and a large
health maintenance organization have expressed a willingness
to participate in implementing and operating CURES.
9. Arguments in Support.
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According to the County of Los Angeles Sheriffos Department,
oCurrently, the Department of Justice is responsible for
distributing preprinted triplicate prescription forms to
eligible physicians and dentists upon request for dispensing
Schedule II controlled substances. The tracking system for
the Schedule II prescriptions is severely backlogged and
outdated. In turn, illegal sales, prescription forgeries,
and careless dispensing of prescriptions by medical
practitioners goes unnoticed. AB 3042 would automate and
monitor over a million triplicate forms annually enabling the
Department of Justice to readily identify diversion of
Schedule II drugs by physicians and pharmacists.o
According to the California Society of Health-System
Pharmacists, oIt has been reported that only ten percent of
prescriptions for Schedule II controlled substances are
actually reviewed and tracked by the Department of Justice.
This bill would authorize the Department of Justice to
establish an electronic method of monitoring prescriptions
for Schedule II controlled substances. AB 3042 will result
in better pain management for patients by removing some of
the clerical burden now carried by health care providers
prescribing and dispensing Schedule II controlled
substances.o
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