BILL ANALYSIS
AB 2018
Page 1
Date of Hearing: April 11, 2000
ASSEMBLY COMMITTEE ON HEALTH
Martin Gallegos, Chair
AB 2018 (Thomson) - As Amended: April 5, 2000
SUBJECT : Controlled substances: Schedule II: triplicate
prescription.
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 Controlled Substance
Utilization Review and Evaluation System (CURES) pilot project,
thereby making this program permanent. Specifically, this bill :
1)Repeals provisions of law relating to the triplicate
prescription requirement for Schedule II controlled substances
(as specified in existing law below).
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, including
requiring the prescriber to provide a written prescription by
the seventh day following the initial transmission of the
order.
4)Repeals the July 1, 2003 sunset date of the CURES project, and
repeals references to "pilot project," thereby making this
program permanent.
5)Repeals a requirement that DOJ, in consultation with the Board
of Pharmacy (board), submit an annual report on the CURES
pilot project.
EXISTING LAW :
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1)Prohibits any person from furnishing any dangerous drug or
device except upon the prescription of a physician, dentist,
podiatrist, optometrist or veterinarian.
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 the least restrictive.
Schedule II substances are generally the most dangerous
substances that can still be legally prescribed, such as
morphine, Demerol, and Percodan.
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.
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.
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
record.
6)Exempts Schedule II prescriptions from the triplicate
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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.
7)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.
FISCAL EFFECT : Unknown
COMMENTS :
1)PURPOSE OF THIS BILL . According to the author, triplicate
prescriptions are an administrative hassle for prescribers and
can result in inadequate relief for patients in pain. The
author states that for patients, pain management is frequently
reported to be poor, and the author argues that triplicates
interfere with the patient-physician relationship. 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. The author states
that researchers have found that multiple copy prescription
programs result in prescribers substituting drugs that do not
require a triplicate for those that do. The author further
asserts that many physicians do not have the full range of
tools necessary to treat patients with severe pain because
they do not have triplicate forms. According to the author,
only 40,333 of the 74,518 California-licensed physicians with
Schedule II privileges had triplicates issued to them.
Finally, the author points to the Institute of Medicine's 1997
book Approaching Death: Improving Care at the End of Life,
which recommends the "reform of prescription laws?that impede
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effective use of opioids to releive pain and suffering." The
author also cites a recommendation from the 1994 California
Pain Summit that California "replace the requirement for a
special, state-issued prescription form (triplicate system)
with electronic monitoring of controlled substances
prescriptions that can foster better, more effective pain
management and better diversion detection."
2)CURES REPORT . AB 3042 (Takasugi), Chapter 738, Statutes of
1996, established the CURES Pilot Project, which was to begin
July 1, 1997. As required by AB 3042, a report prepared by
DOJ, in consultation with the board, was submitted to the
Legislature in January of 1999 regarding the implementation of
CURES. 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 percent 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
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.
3)BOARD OF PHARMACY . This bill is sponsored by the Board of
Pharmacy. According to the board, under the triplicate
program, once the original is mailed by the pharmacy to DOJ,
these prescriptions must be entered manually into a computer
system and/or filed in boxes for manual searches. This
labor-intensive system resulted in fewer than 2 percent of all
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triplicate prescriptions being entered into DOJ's computer
system in recent years. The board states that CURES, instead,
works by having pharmacies make electronic copies of all
Schedule II prescriptions dispensed each month. The
electronic data from all California pharmacies is then
compiled into a statewide database that is provided to DOJ.
The board states that it is sponsoring this legislation
because the CURES program has clearly established that
electronic monitoring is a superior alternative to collecting
the more than 2 million paper prescriptions that are 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 board states that with
CURES, the triplicate prescription process has out-lived its
utility.
4)SUPPORT . Numerous organizations are in support of this bill.
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. 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 1990s 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
foolish restrictions. The California Medical Association
states that survey data indicates that 54 percent of
physicians modify their pain prescriptions based on concerns
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of regulatory oversight, and physicians have continually
expressed concerns over restrictive regulations, feeling
threatened, and fearing harassment and/or prosecution by
enforcement authorities. The California Academy of Family
Physicians states that triplicate prescriptions are an
administrative hassle for prescribers and can also interfere
with the patient-physician relationship, and 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.
5)OPPOSITION . This bill is opposed by the California Peace
Officers' Association (CPOA) and the California Police Chiefs
Association (CPCA). CPOA and CPCA state that California's
triplicate system enables law enforcement to monitor the
distribution of Schedule II controlled substances statewide
through the issuance of serialized triplicate prescription
forms and the receipt and review of cashed triplicates, and
allows them to respond to specific law enforcement or
regulatory inquiry and to forward investigative leads to
prevent diversion of prescription drugs into the illegal
market, all without interfering with lawful prescribing
practices. CPOA and CPCA state that the diversion of
controlled substances from legitimate sources into illicit
street drug traffic is a significant problem in California,
with DOJ estimating that illegal trade in controlled
substances is approximately a $1 billion a year industry.
Serialized prescription forms are a useful tool in eliminating
forgery and counterfeiting, and CPOA and CPCA point out in
contrast that states that do not have such a program are prone
to high incidences of forgery of prescriptions. For instance,
CPOA and CPCA state that New York reported a 12 percent
forgery rate prior to the implementation of its
state-serialized program, while implementation of the program
slashed the forgery rate down to .0006 percent. CPOA and CPCA
state that surveys done by DOJ report that Oklahoma, Nevada,
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North Carolina and Mississippi, which do not have a serialized
prescription program, have reported high incidences of
forgeries and counterfeited prescription pads. CPOA and CPCA
state that perhaps there will be a time when CURES will have
sufficient safeguards to operate as a "stand-alone" monitoring
strategy, but until CURES has technology to ensure security,
or to be able to capture signatures, fingerprints or retinal
scans, abandonment of the serialized triplicate system is
premature.
This bill is also opposed by the California State Sheriffs'
Association, which states that the current triplicate system
has no impact on the consumer and what little negative impact
it may have on doctors and pharmacists is mitigated by the
public safety benefits of the system in protecting against
illegal diversion of prescription drugs to the criminal
market.
6)DOUBLE REFERRAL . Should this bill pass out of this Committee,
it will be referred to the Assembly Public Safety Committee.
REGISTERED SUPPORT / OPPOSITION :
Support
California 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 Cancer Society
Americans for Death with Dignity
California Academy of Family Physicians
California Academy of Ophthalmology
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 Hospice and Palliative Care Association
California Medical Association
California Nurses Association
California Psychiatric Association
California Society of Anesthesiologists, Inc.
Catholic Healthcare West Bay Area Region
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Catholic Healthcare West North State Region
Congress of California Seniors
Death with Dignity National Center
Hoffman Hospice
Hope Hospice, Inc.
Hospice and Palliative Care of Contra Costa
Hospice by the Bay
Hospice Care of California
Hospice Caring Project
Hospice of Marin
Hospice of San Joaquin
Hospice of the Valley
Hospice of the Valleys
Hospice Services of Tulare County, Inc.
Kaiser Permanente
Madrone Hospice
Mercy Hospital and Health Services, Merced
Mission Hospital Regional Medical Center
NorthBay Hospice and Bereavement
Odyssey HealthCare, Inc.
Older Women's League of California
Sacramento-El Dorado Medical Society
San Diego Hospice
Southern California Cancer Pain Initiative
St. Joseph Health System - Humboldt County
St. Joseph's Medical Center
The Elizabeth Hospice
The TMJ Society of California
Torrance Memorial Home Health & Hospice
Visiting Nurse Association and Hospice
Yolo County Medical Society
Z G International Health Care Division
Opposition
California Peace Officers' Association
California Police Chiefs Association
California State Sheriffs' Association
Analysis Prepared by : Vincent D. Marchand / HEALTH / (916)
319-2097