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1994 Angarola RT, Joranson DE. California sponsors pain
summit; Maryland fends off new
regulations. APS Bulletin 1994 4(3):11-12.
California Sponsors Pain Summit; Maryland fends off new
regulations.
Robert T. Angarola, Esq., and David E. Joranson, MSSW,
Department Editors
Department editors' note: We report on two significant developments in state policy related
to pain
management that occurred in early 1994. The State of California sponsored an unprecedented
summit on
effective pain management, and in Maryland, health professionals mobilized to testify against
proposed
legislation to increase restrictions on opioid analgesics.
Californians are increasingly concerned about undertreatment of pain and excessive
regulation of
controlled substances-in particular the opioid analgesics. Most recently, a landmark summit
meeting on
pain management was called by Governor Pete Wilson (Trestrail, 1994). There were a number
of
important developments that led to this unique event.
First, the Controlled Substances Prescription Advisory Council, created by the legislature
to study the
triplicate prescription program, was concerned about the programs ineffectiveness in controlling
diversion,
and also about the program's interference with medical practice and pain management. The
council
recommended in 1993 that a less invasive and more efficient electronic prescription monitoring
system be
established (Controlled Substances Prescription Advisory Council, 1993).
Second, the Appropriate Prescribing Task Force of the Medical Board of California (MBC)
recognized
that pain is undertreated in the state in part due to physicians' concern about undergoing
investigation for
overprescribing. The MBC asked the University of Wisconsin (UW) Pain Research Group to
prepare a
positive policy statement on pain management that would clarify the appropriate uses of opioids,
including
in chronic noncancer pain, and strike the right balance with the board's concerns about diversion
and
inappropriate prescribing. The MBC approved the policy statement on May 6, 1994 (Medical
Board of
California, 1994). California's boards of nursing and pharmacy have also drafted statements on
the importance of pain management (Trestrail, 1993).
Third, in 1992 and 1993, the legislature approved several pain-related bills to evaluate
medical school
curricula, to disseminate Agency for Health Care Policy and Research (AHCPR) clinical practice
guidelines, and to establish a task force to address impediments to pain management (State of
California
Department of Consumer Affairs, 1994).
Fourth, healthcare professionals, concerned about the undertreatment of cancer pain,
formed the
Southern California Cancer Pain Initiative in early 1994 and became part of a growing national
movement.
Forum proposed
Meanwhile, there were efforts to lay the groundwork for increased cooperation among state
agencies.
Following a session on improving cooperation between pain and regulatory groups at the Fourth
National
Meeting for State Cancer Pain Initiatives in 1993, APS member Bill Marcus, deputy attorney
general of
the California Department of Justice, drafted a proposal for a forum that would convene the
principal
regulatory agencies to address the pain problem in relation to regulation.
Later that year, the state legislature adopted a proposal to address the regulatory barriers to
pain
management. Governor Wilson vetoed the bill for technical reasons, but recognizing the need to
address
pain management, he directed the State and Consumer Agency to sponsor a meeting on pain. A
planning
committee was convened including Bill Marcus, David Joranson, and representatives of the
Department
of Consumer Affairs, the Medical Board, the California Medical Association, and the Boards of
Pharmacy,
Registered Nursing, and Dental Examiners.
Summit activities
The "Summit on Effective Pain Management: Removing Impediments to Appropriate
Prescribing" was
held on March 18, 1994, in Los Angeles. Approximately 120 representatives of health,
education,
legislative, and regulatory sectors; patients; and the general public convened for 1 day to
examine the
barriers to effective pain management and recommend ways to overcome them. A number of
APS
members participated in the summit: Richard Payne, MD, of the M.D. Anderson Cancer Center
in Houston
and cochair of the AHCPR Cancer Pain Clinical Guideline Panel gave a strong keynote address,
and Betty
Ferrell, PhD RN FAAN, delivered a poignant luncheon presentation on the imperative of pain
management.
The participants reached consensus on a number of recommendations, including the need to
do the
following:
replace, as soon as possible, the triplicate prescription program with an electronic
prescription monitoring program that will not interfere with appropriate prescribing for pain
management;
include questions about pain on the licensing examinations for physicians, nurses, and
pharmacists;
adopt and disseminate positive policy statements by regulatory boards on the appropriate use
of
controlled substances in pain management (the MBC draft policy statement on appropriate
prescribing
received many endorsements from the participants);
revise laws and regulations that interfere in timely availability of opioids to patients in all
care settings
including home care; that contain confusing, undefined terms like "habitual user" or unclear
standards such
as "clearly excessive prescribing" and language that appears to ban prescribing of controlled
substances
to addicts even if they have painful conditions;
establish accountability in the healthcare system for the assessment, management, and
monitoring of
pain;
ensure that healthcare coverage includes pain management services and medications;
accelerate the development of education for the public, patients, and healthcare
professionals; and
inform patients that they have a right to quality pain management.
The State of California has provided an excellent example for other states on how to put
pain management on the policy agenda of a state. This effort required the right combination of preparation,
opportunity,
leadership, and timing. The next step may be the most difficult - the follow-up work, cooperation,
and
monitoring that will be needed to translate these positive recommendations into action on behalf
of people
in pain.
Maryland prescription program
In March 1994, the Maryland legislature considered three bills that would have placed
additional restrictions on the prescribing of opioid analgesics and other controlled substances in the state. One
bill would
have required prescribers to use a colored counterfeit-proof prescription form for schedule II
drugs. The
second would set up a triplicate prescription program for schedule II drugs. The third would
have required
use of a single copy serially numbered government prescription form to prescribe these
substances
(Angarola & Joranson, 1992b). The latter bill also would have required pharmacists to transmit
data on
patients and physicians - either manually or by using an electronic data transfer system - to the
Department
of Health on a monthly basis (Angarola & Joranson, 1992a).
Both the Maryland House and Senate held hearings on these proposals. Representatives
from the
Oncology Nurses Society, the American Cancer Society, the American Society for Clinical
Oncology, and
several members of APS vigorously challenged the adoption of these programs,which would
have reduced
the prescribing of opioids for pain (Angarola & Joranson, 1993a; 1993b). The arguments
presented
included the negative impact on patient care, the cost of operating the programs, and the lack of
evidence
that they in fact reduce drug abuse and diversion.
None of the three bills was enacted into law. This was due in large measure to the effective
and
informed comments presented by the pain treatment community. This stands in stark contrast to
the actions
taken last year in Michigan, where the legislature adopted a single copy prescription program
that will
likely have the same effect on prescribing as triplicate prescriptions (Angarola & Joranson,
1992b;1993b).
Conclusion
In Michigan, there was no testimony from APS members or other healthcare
representatives who had
understanding of the need to use schedule II and other controlled substances in the proper
treatment of pain.
Clearly, however, when informed and concerned professionals take the time and make the effort,
legislators
and regulators can be persuaded. Thus, in California and Maryland - and, as reported in an
earlier column,
in Indiana, which terminated a triplicate prescription program - health professionals are
demonstrating that
they can indeed be effective in preventing and removing barriers to effective pain management
(Angarola
& Joranson, 1994).
Controlled Substances Prescription Advisory Council. (1993, December).
Final report to the
legislature and the attorney general. Sacramento, CA: Author.
Medical Board of California. (1994, May). Prescribing controlled
substances for pain: A
statement by the Medical Board of California. Sacramento,CA: Author.
State of California Department of Consumer Affairs. (1994, July). Summit
on effective pain
management: Removing impediments to appropriate prescribing. Sacramento, CA:
Author.
Trestrail, J. (1993, October). Task force on appropriate prescribing.
Medical Board of
California Action Report, 2.
Trestrail, J. (1994, January). Major summit on appropriate prescribing.
Medical Board of
California Action Report, 4.