BILL ANALYSIS
AB 2018
Page 1
Date of Hearing: April 25, 2000
Chief Counsel: Bruce E. Chan
ASSEMBLY COMMITTEE ON PUBLIC SAFETY
Carl Washington, Chair
AB 2018 (Thomson) - As Amended: April 5, 2000
SUMMARY : Repeals the requirement that Schedule II controlled
substances be written on an official prescription form (known as
the "triplicate form") issued by the Department of Justice
(DOJ), and repeals the sunset date of the electronic
prescription tracking pilot project (CURES), thereby making the
program permanent. Specifically, this bill :
1)Repeals provisions of existing law relating to the triplicate
prescription requirement for Schedule II controlled
substances.
2)Includes Schedule II controlled substances within existing
provisions of law governing the prescribing of controlled
substances listed in Schedules III, IV and V, except for
provisions permitting the oral and electronic transmission of
prescriptions for controlled substances.
3)Permits an order for a Schedule II substance to be dispensed
on an oral or electronic transmission order where failure to
issue a prescription may result in loss of life or intense
suffering, subject to specified requirements. Repeals the
provision of existing law that requires the prescriber to
provide a triplicate prescription by the seventh day,
following the initial transmission of the order, permitting
instead a written prescription.
4)Repeals the provision of existing law requiring the prescriber
to preserve for three years the book containing copies of
issued prescriptions.
5)Repeals the July 1, 2003 sunset date of the CURES project, and
repeals references to "pilot project," thereby making this
program permanent. Repeals a requirement that DOJ, in
consultation with the Board of Pharmacy (Board), submit an
annual report on the CURES pilot project.
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EXISTING LAW :
1)Prohibits any person from furnishing any dangerous drug or
device except upon the prescription of a physician, dentist,
podiatrist, optometrist or veterinarian. (Health and Safety
Code (HSC) Section 11150.)
2)Establishes the California Uniform Controlled Substances Act,
which lists controlled substances in five schedules, with
Schedule I containing substances with the highest restrictions
(generally illegal) and Schedule V with the least restrictive.
Schedule II substances are generally the most dangerous
substances that can still be legally prescribed, such as
morphine, Methadone, Demerol, and Percodan. (HSC Section
11055.)
3)Requires each prescription for a controlled substance
classified in Schedule II to be wholly written in ink or
indelible pencil in the handwriting of the prescriber upon an
official prescription form, in triplicate, issued by DOJ.
Requires the original and duplicate of the prescription to be
delivered to the pharmacist filling the prescription.
Requires the duplicate to be retained by the pharmacist, and
the original to be transmitted to DOJ at the end of the month
in which the prescription was filled. (HSC Section 11164.)
4)Requires triplicate prescription blanks to be issued by DOJ in
serially numbered groups of not more than 100 forms each, and
to be furnished to any practitioner authorized to write a
prescription for Schedule II controlled substances. Requires
the prescription blanks to bear the preprinted name, address,
and category of professional licensure of the practitioner to
whom they are issued, and the federal registry number for
controlled substances. Permits DOJ to charge a fee for the
prescription blanks sufficient to reimburse the department for
the actual costs associated with the preparation, processing,
and filing of the forms. Provides that any unauthorized
person possessing a triplicate prescription blank is guilty of
a misdemeanor. (HSC Section 11161.)
5)Exempts orders for controlled substances from the prescription
procedure, including the triplicate form for Schedule II
substances, when used by a patient in a hospital, as long as
specified information is recorded in the patient's medical
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record. (HSC Section 11159.)
6)Exempts Schedule II prescriptions from the triplicate
procedure when prescribed for use by a patient who has a
terminal illness, defined in part as an illness that will, in
the judgment of the physician, bring about the death of the
patient within a period of one year. These prescriptions must
meet certain requirements, including a requirement that they
be wholly written in the handwriting of the prescriber. (HSC
Section 11159.2.)
7)Requires the prescriber to maintain a prescription book
containing copies of issued prescriptions for three years.
(HSC Section 11168.)
8)Provides for criminal penalties for issuing false
prescriptions, furnishing controlled substances for other than
legitimate purposes, and counterfeiting official prescription
forms. (HSC Section 11153 et seq.)
9)Establishes the CURES Pilot Project within DOJ for the
electronic monitoring of the prescribing and dispensing of
Schedule II controlled substance in order to assist law
enforcement and regulatory agencies in their efforts to
control the diversion and resultant abuse of Schedule II
controlled substances. The CURES Pilot Project was
established on July 1, 1997, and is required to be
administered concurrently with the existing triplicate
prescription process to examine the comparative efficiencies
between the two systems. (HSC Section 11165.)
FISCAL EFFECT : Unknown
COMMENTS :
1)Author's Statement : According to the author, "AB 2018 would
repeal the requirement that a Schedule II controlled substance
prescription be written on a triplicate prescription, and
would make permanent the electronic monitoring of those same
drugs through the CURES system. California is one of only 8
states that require a government-issued prescription for
Schedule II drugs. The triplicate is widely viewed by the
medical and patient community as a barrier to pain management.
For patients, pain management is all too frequently reported
to be poor. Studies indicate that cancer-related pain could
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be well controlled in 80% to 90% of affected patients, but
recent findings indicate that more than 40% of cancer patients
receive inadequate pain relief. Many patients with chronic,
intractable pain are not treated effectively or appropriately.
Some physicians simply refuse to use triplicates. Researches
have found that multiple-copy prescription programs result in
prescribers substituting drugs that do not require a
triplicate for those that do, which means patients may not be
getting the pain relief they need. AB 2018 does not end
monitoring of Schedule II drugs - it simply eliminates the
government-issued prescription required and makes electronic
monitoring permanent. The 1994 California Pain Summit
included a recommendation for legislators to consider:
'Replace the requirement for a special, state-issued
prescription form (triplicate system) with electronic
monitoring of controlled substances prescription that can
foster better, more effective pain management and better
diversion detection.' AB 2018 implements that
recommendation."
The author cites a study published in 1993 in the Annals of
Internal Medicine that showed physicians practicing in states
requiring multiple-copy prescriptions were more likely to cite
physician reluctance to prescribe opioids and concern about
excessive drug regulation as barriers to cancer pain
management when compared to physicians in other states.
According to the author, only 40,333 of the 74,518
California-licensed physicians with Schedule II privileges had
triplicates issued to them.
2)Pharmaceutical Drug Diversion: The Need To Monitor Schedule
II Controlled Substances : DOJ's report to the Legislature
regarding the CURES program described the four principal
methods of illegal diversion of drugs: (a) illegal sales or
dispensing by health care professionals; (b) inappropriate or
careless prescribing by the physician or dispensing by the
pharmacist; (c)"doctor shopping" by individuals who visit
several unwitting physicians to illegally obtain a
prescription drug; and, (d) prescription forgery, stolen
prescriptions, theft of drugs from a pharmacy or physician's
office. According to information from a recent conference
sponsored by the State Board of Pharmacy:
a)15 of the 20 most commonly abused drugs are prescription
drugs.
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b)33% of illicit drug sales involve prescription drugs.
c)Over 3.5 billion dosage units of prescription drugs are
diverted to illicit sales each year.
d)Diverted prescription drugs are the fastest growing segment
of the illicit drug market in the United States.
e)In 1996, over 30% of all drug abuse deaths and 25% of all
drug-related emergency room admissions involved lawfully
manufactured controlled substances.
3)Triplicate Prescriptions: All prescription drugs in
California are monitored and regulated in a schedule system
similar to federal law. 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
DOJ. Since the mid-1940's, California has administered the
existing system for the monitoring of Schedule II controlled
substances through the use of DOJ-issued, serialized
triplicate prescription forms. Existing law requires the
pharmacist to forward the original of the prescription form to
the DOJ each month. The prescriptions are sorted, coded, and
prepared for entry into an automated system. Although filled
prescriptions are reviewed, DOJ does not have the resources to
input all the data collected. Thus, the vast majority of
information is not available to DOJ for enforcement, research,
or drug utilization review.
4)Electronic Prescription Monitoring: The History Of CURES: The
Controlled Substances Prescription Advisory Council,
established in 1992 by Senate Concurrent Resolution 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 the
current system. The Council submitted a report to the
Attorney General and the Legislature in December 1993. In the
final report submitted to the Legislature and Attorney
General, the Controlled Substances Prescription Advisory
Council recommended that DOJ implement a technologically
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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.
AB 3042 (Takasugi), Chapter 738, Statutes of 1996, established
the CURES project. AB 3042 was sponsored by the Attorney
General who described the need for the legislation: "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?By
integrating existing systems, virtually 100% of the data could
be captured at the point of sale, and the information made
accessible to law enforcement."
As originally enacted, the CURES project was intended "to assist
law enforcement and regulatory agencies in their efforts to
control the diversion and resultant abuse of Schedule II
controlled substances." (Penal Code Section 11165.) In 1999,
the statutory language regarding the purposes of CURES was
amended to include, "and for statistical analysis, education,
and research."
5)The CURES Report: AB 3042 required a report prepared by DOJ
to be submitted to the Legislature in January 1999. According
to this report, CURES has been implemented in a timely
and cost-effective manner. At the time of the report,
automated collection of Schedule II prescription data from the
state's 5,000 pharmacies had been in place for almost one
year, and the data analysis and on-line communications linkage
to the state agencies had also been established in its initial
phase. According to the report, in 1995, the triplicate
program reached its peak production level by manually entering
data from 256,303 triplicate prescription forms into the
computer system. Since 1995, productivity has steadily
declined, and in 1998 only 39,945 triplicate prescription
forms, representing 1.7% of the total, were manually entered
into the system. The report states that CURES has solved the
data entry backlog problem experience by the triplicate
program. Through CURES, DOJ and
medical-related licensing boards have ready access to
up-to-date information on Schedule II drug prescriptions. In
the first seven months that CURES was operational, a total of
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892,985 Schedule II prescriptions were transmitted by
pharmacies into the CURES system. The report made several
recommendations, including making CURES permanent, and
reclassifying, as appropriate, current triplicate prescription
program staff to classifications more suitable to the
investigative and analytical duties they will perform for
CURES.
6)Existing Law Provides For An Exemption For Terminally Ill: In
1999, AB 2693 (Migden), Chapter 789, Statutes of 1998,
exempted Schedule II prescriptions from the triplicate
procedure when prescribed for use by a patient who has a
terminal illness. Terminal illness is defined in part as an
illness that will, in the judgment of the physician, bring
about the death of the patient within a period of one year.
These prescriptions must meet certain requirements, including
a requirement that they be wholly written in the handwriting
of prescribers.
7)Arguments In Support: Numerous organizations and individuals
are in support of this bill. The arguments in support may be
summarized as follows:
a)CURES is superior to the existing triplicate system at
detecting abuse and diversion: The sponsor of this bill,
the Board of Pharmacy, states that because the triplicate
program relies upon manual data entry and storage, fewer
than 2% of all triplicate prescriptions are being entered
into DOJ's computer system. CURES works instead by having
pharmacies make electronic copies of all Schedule II
prescriptions dispensed each month. The electronic data
from all pharmacies is then compiled into a statewide
database. The CURES program has clearly established that
electronic monitoring is a superior alternative to
collecting the more than 2 million paper prescriptions
written each year. The Board argues that the CURES system
makes identifying patterns of abuse and diversion of
prescription drugs into illicit markets much easier because
all data is readily available for analysis. The triplicate
prescription process has out-lived its utility as
demonstrated by the small percentage of forms actually
being entered into the database.
b)Restricting the availability of controlled substances
interferes with the adequate and compassionate treatment of
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patients: The American Cancer Society (ACS) states in
support that research indicates less than half of cancer
patients get adequate relief of their pain even though the
means to relieve almost all cancer pain currently exists.
ACS states that it has found there is a dichotomy between
the effort to restrict the availability of controlled
substances and the need to adequately
and compassionately treat patients experiencing pain, and
ACS has long supported CURES as a way to address both
concerns.
c)Triplicate prescription forms stigmatize pain reduction
strategies and result in physician underuse of appropriate
medication: Americans for Death with Dignity (ADD) states
that physician's fears about law enforcement are not idle
fears given the lack of understanding about the use of
opioid drugs as acceptable medical practice by both medical
boards and physicians in this country. ADD points to
studies in the early 1990's which revealed appalling
statistics of medical board members and physicians who
thought that prescribing narcotics to relieve pain was an
illegal act and/or not acceptable treatment, which it is
neither. ADD argues that it is time to eliminate the
stigma of triplicate prescriptions for the medical use of
narcotics for terminally ill and dying patients. The
Congress of California Seniors states in support that some
in the medical profession have been hesitant to adequately
prescribe medication for severe pain because some have been
prosecuted for over-prescribing in cases of terminal
patients, and this bill will begin to resolve such
restrictions. The California Medical Association states
that survey data indicates that 54% of physicians modify
their pain prescriptions based on concerns of regulatory
oversight, and physicians have continually expressed
concerns over restrictive regulations, feeling threatened,
and fearing harassment and/or prosecution by enforcement
authorities.
d)Triplicate prescription forms are an unnecessary
administrative burden that do not measurably reduce the
diversion of controlled substances justifying interference
in the doctor-patient relationship: The California Academy
of Family Physicians states that triplicate prescriptions
are an administrative "hassle" for prescribers, can also
interfere with the patient-physician relationship, and
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often results in inadequate relief for patients in pain.
The California Nurses Association states that every day,
nurses see the barriers that triplicate prescriptions cause
when doctors choose to under-prescribe non-narcotic
analgesics to treat serious pain because they do not want
to apply to DOJ for triplicate prescription forms. The
California Association of Health Plans argues that
interference in the physician-patient relationship does not
become defensible simply because it may, in some broad and
non-specific manner, relate to a law enforcement objective,
and believes this principle should be accorded the
strongest possible consideration when the care of very
seriously ill people is involved.
e)Small amounts of Schedule II drugs are diverted to
non-medical use: ADD states "tiny amounts of Schedule II
drugs are diverted to non-medical use?1.4% of Schedule II
drugs were illegally used in 1996. There were no Schedule
II drugs in the top 20 drugs of abuse in the same year.
Lastly, according to the DOJ data, only 1.7% of the 39,945
triplicate prescription forms were manually entered into an
automated system to check for potential illegal use."
8)Arguments In Opposition: The arguments in support may be
summarized as follows:
a)Illegal use of Schedule II controlled substances is a
significant public safety problem: The DOJ states that law
enforcement estimates that abuse of prescription drugs
accounts for nearly 50% of all drug-related injuries and
deaths in the country. The illegal trade in California of
prescription medication may be as much as $1 billion
annually. Illegal diversion, intentional misuse and over
prescribing of benzodiazepines accounted for 20% of drug
diversion arrests in California from 1988-1990. The federal
Drug Enforcement Administration (DEA) estimates the
nationwide cost of prescription drug diversion to be in
excess of $25 billion annually.
b)States without serialized forms have higher rates of
prescription forgery: The California Police Chiefs and
Peace Officers Association assert that states that do not
have a program of serialized prescriptions are prone to
high incidences of forgery of prescriptions. For instance,
New York reported a 12% forgery rate prior to the
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implementation of its state-serialized program, while
implementation of the program reduced the forgery rate down
to 0.0006%. Surveys performed by DOJ report that Oklahoma,
Nevada, North Carolina and Mississippi, which do not have
serialized prescription programs, have reported high
incidences of forgeries and counterfeited prescription
pads.
c)Electronic monitoring unaccompanied by serialized forms is
inadequate to safeguard against forgery and counterfeiting
of prescriptions: The DOJ states that CURES alone is
insufficient to monitor illegal diversion. The current
forms provide strong evidence in the prosecution of
diversion cases, since each serialized prescription is
assigned to a specific, individual practitioner. Moreover,
the original document is required as evidence in a
prosecution because computer printouts are not admissible
and present substantial issues regarding authentication and
reliability of the record. A serialized prescription
requirement also provides control over the distribution of
forms to valid DEA registrants and is crucial for
validating the data in CURES.
d)Serialized forms are not a deterrent to pain management:
increasing amounts of lawful prescriptions for Schedule II
controlled substances: While proponents of the elimination
of California's serialized prescription requirement allege
that it is a deterrent to appropriate pain management,
federal data indicates that California practitioners have
prescribed ever-increasing amounts of Schedule II drugs
from 1980 to 1997, in parallel with United States trends.
If anything, serialized forms provide a higher degree of
protection to practitioners because distribution is limited
to valid DEA registrants with Schedule II privileges.
e)Serialized forms provide for self-monitoring before
prescribing: CURES provides monitoring after the fact:
According to DOJ, the total number of pharmacies in
California is larger than any other state. According to
DEA, California has 5,652 - 10% of the nation's 61,109
pharmacies. Second to California is New York with 4,211.
In light of the fact that 26% of all nationally
DEA-registered practitioners in states with prescription
monitoring programs are located in California, it is
premature for California to move to a purely electronic
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monitoring system because current technology cannot ensure
the security of such a system.
REGISTERED SUPPORT / OPPOSITION :
Support
California State Board of Pharmacy - Sponsor
Adventist Health Home Care Services
Alliance of Catholic Health Care
American Academy of Pain Management
American Academy of Pain Medicine
American Academy of Pediatrics
American Cancer Society
American Pain Foundation
Americans for Death with Dignity
Assisted Home Hospice
Betty Ford Center
California Academy of Family Physicians
California Academy of Ophthalmology
California Arthritis Foundation Council
California Association of Health Facilities
California Association of Health Plans
California Association of Health Services at Home
California Association of Public Hospitals and Health Systems
California Church IMPACT
California Grocers Association
California Hospice and Palliative Care Association
California Hospital Medical Center
California Medical Association
California Nurses Association
California Pharmacists Association
California Psychiatric Association
California Retailers Association
California Society of Anesthesiologists, Inc.
Catholic Healthcare West Bay Area Region
Catholic Healthcare West North State Region
Congress of California Seniors
Death With Dignity National Center
The Elizabeth Hospice
Gray Panthers of Sacramento
Hoffmann Hospice
Hope Hospice, Inc.
Hospice of Amador
Hospice by the Bay
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Hospice Care of California
Hospice of the Central Coast
Hospice of Marin
Hospice of Napa Valley
Hospice of Palliative Care of Contra Costa
Hospice of Petaluma
Hospice of San Joaquin
Hospice Services of Lake County
Hospice of Tulare County, Inc.
Hospice of the Valley
Hospice of the Valleys
Kaiser Permanente Medical Care Program
Madrone Hospice
Mercy Hospital and Health Services, Merced
Mission Hospice, Inc. of San Mateo County
Mission Hospital Regional Medical Center
North Bay Hospice and Bereavement
Older Women's League of California
Pharmaceutical Research & Manufacturers of America
Sacramento-El Dorado Medical Society
Saint Agnes Medical Center
San Diego Hospice
Southern California Cancer Pain Initiative
St. Joseph Health System - Humboldt County
St. Joseph Health System, Southern California Region
St. Joseph's Medical Center
Sutter Hospice/Roseville
TMJ Society of California
Torrance Memorial Home Health & Hospice
United Food & Commerical Workers
Visiting Nurse Association and Hospice
VITAS Healthcare Corporation
VNA and Hospice of Northern California
VNA Care Hospice in the Home
Yolo County Medical Society
ZG International Health Care Division Individuals
1 Private Citizen
Opposition
California Attorney General
California Narcotic Officers Association
California Peace Officers' Association
California Police Chiefs Association
California State Sheriffs' Association
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San Bernardino County Sheriff
Analysis Prepared by : Bruce Chan / PUB. S. / (916) 319-3744