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1994 Angarola RT, Joranson DE. Recent developments in pain
management and regulation.
APS Bulletin 1994:4(1):9-11.
Recent Developments in
Pain Management and Regulation
Robert T. Angarola, Esq.; David E. Joranson, MSSW
In the October/November 1993 issue of APS Bulletin, this department reported
on a bill the Michigan
legislature was considering to replace the existing triplicate prescription program with an
electronic data transfer (EDT)
system and a government-issued, single-copy, serialized prescription form (Angarola &
Joranson, 1993b). Starting
January 1, 1995, house bill 4117 would require pharmacists to transmit information on schedule
II controlled
substances, including many strong opioids, to the state's Department of Commerce either
electronically or by mail.
In its evaluation of the triplicate program, the Michigan Department of Commerce, which also
administers the program
and the Controlled Substance Advisory Commission, reported that it had noted a "decrease in the
number of
prescriptions and units prescribed for the three most diverted Schedule II drugs (Percodan ,
Demerol and
Dilaudid)" but admitted that "requests to access [the triplicate prescription] data by law
enforcement personnel had
been minimal" (Michigan Department of Commerce, Bureau of Occupational and Professional
Regulation, Office of
Health Services, & Michigan Controlled Substances Advisory Commission, 1993, p. v). The
report stated that Blue
Cross/Blue Shield oxycodone prescriptions decreased by 49%, meperidine prescriptions by 35%,
and hydromorphone
prescriptions by 22% since implementation of the triplicate requirement (pp. 9-10). Dosage unit
volume did not
decrease as much. Michigan dropped from the 11th state in morphine consumption to 40th
during that time (p. 32).
The report provided no information on the effect of the program on patient care.
At the urging of state and federal law enforcement and regulatory officials and the
Michigan Pharmacy Association, the Michigan House and Senate passed the EDT and single-copy government
prescription legislation, which
will take effect in 1995. A report on the effectiveness of government prescription form programs
in reducing drug
diversion is due in September 1997.
It is likely that the single-copy prescription form will have the same chilling effect on the
prescription of opioid
analgesics that the triplicate prescription program had (Angarola & Joranson, 1992). A few pain
specialists attempted
to modify the Michigan legislation at the last minute but did not have adequate time to affect the
outcome. It is
possible that the law could be modified in 1994 before it becomes effective. The APS Analgesic
Regulatory Issues
Committee discussed this situation at the APS annual meeting held in November in Orlando, FL;
the editors will report
the outcome of this discussion in an upcoming issue of APS Bulletin.
Indiana triplicate prescription program sunsets
On July 1, 1993, Indiana became the first state to abolish a triplicate prescription program
and not replace it with
an electronic or paper-based prescription tracking system. The triplicate requirement originally
went into effect in
1989. As with Michigan, there was a "sunset" provision in the authorizing legislation that
required the legislature to
reapprove the program this year. The Indiana legislature apparently did not consider it to be a
cost-effective means
of reducing drug diversion and abuse and was concerned about possible negative effects the
program had on
appropriate prescribing and patient care.
Hawaii is reported to be phasing out its duplicate prescription system in favor of an EDT
program. California,
Illinois, and New York are considering similar modifications to their multiple-copy prescription
programs. Legislators
and regulators in each of these states would welcome comments from the pain research and pain
treatment
communities on their perspectives on the impact of these programs.
The Alabama experiment
The Alabama State Board of Medical Examiners hosted a pain management educational
program for state medical
regulators August 20-21, 1993. The University of Wisconsin Pain Research Group (PRG)
sponsored the seminar,
"Pain Management in a Regulated Environment," in cooperation with the American Pain Society
Analgesic Regulatory
Issues Committee.
The program was designed as a response to the PRG's national survey of state medical
board members. The results
of that survey indicated that many medical board members lack knowledge about pain
management and that some
would investigate extended prescribing of opioids for chronic cancer and noncancer pain, even
though this is a
legitimate medical practice (Joranson, Cleeland, Weissman, & Gilson, 1992). These findings
supported previous
observations and studies that physicians who prescribe opioids for chronic pain may alter their
prescribing to avoid
what they perceive as a risk of regulatory sanction (Angarola & Joranson, 1993a; Hill, 1989,
1993; Portenoy, 1990;
Turk & Brody, 1992; Weissman, Joranson, & Hopwood, 1991).
The PRG presented the survey results to medical and drug regulators at several national
conferences and offered
to provide an educational demonstration program for a state medical board. The Alabama board
accepted the offer
and dedicated its annual retreat to a program on pain management.
The purpose of the seminar was to inform state medical regulators about the appropriate
pharmacologic
management of pain in an effort to harmonize the regulation of medical practice and controlled
substances prescribing
with contemporary pain management principles and practices. The objectives were to improve
medical board
members' knowledge and understanding in the following areas:
the common reasons for the undertreatment of pain;
the basic principles of pain management, in particular the pharmacologic management
of chronic cancer
and noncancer pain;
the meaning of physical dependence, tolerance, and addiction, as well as the
similarities and differences
between patients who need better pain relief and persons who seek illicit drugs;
the policy relationship between pain management and the regulation of controlled
substances;
recent national efforts to improve pain management; and
the efforts of state medical boards to clarify their policies related to prescribing opioids
for pain.
The participants included approximately 30 physician members of the Alabama State Board
of Medical Examiners
and the Alabama Licensure Commission, as well as board attorneys and investigators and
observers from the Alabama
Medical Society and the Federation of State Medical Boards of the United States. Each
participant received a syllabus
that contained selected articles on pain management and regulatory policy.
The faculty assembled by the PRG included David E. Joranson, MSSW, June L. Dahl,
PhD, J. David Haddox, MD,
and Albert M. Brady, MD. Brady is a co-chair of the APS Analgesic Regulatory Issues
Committee.
The participants evaluated the program and indicated strong agreement that it had achieved
the educational
objectives. Furthermore, the PRG administered a survey instrument immediately before and
after the seminar. The
preliminary results showed significant positive changes in knowledge and attitudes. The survey
will be administered
again in 6 months. Finally, the PRG will monitor any policy developments concerning the
prescribing of opioids for
pain in Alabama.
The Alabama experiment is one example of how the pain management community can
work with regulatory
authorities toward the common goals of ensuring proper medical practice and preventing drug
abuse and diversion.
Already, the Alabama Medical Society is planning statewide educational seminars on pain
management for
practitioners that will include the Board of Medical Examiners. Will other state and federal
regulatory agencies be
able to use Alabama as a model to promote a positive regulatory environment for pain
management?
Pain physician keeps DEA registration
The administrator of the Drug Enforcement Administration (DEA) has recently decided
that a physician who
prescribed opioids for pain for extended periods to patients with noncancerous conditions and a
history of drug abuse
should not lose his federal controlled substances registration. (See 58FR 37507-35708, July 12,
1993.)
The DEA had investigated an Ohio physician who treated patients injured during employment
and who was a
consultant for other practitioners on spinal injury cases. The majority of his patients suffered
from chronic low back
pain or other injuries that resulted in chronic pain syndrome.
The DEA began its investigation upon receipt of a complaint from the county sheriff that
the physician was
prescribing controlled substances to known drug abusers and traffickers. Based on the
investigation, the DEA's Office
of Diversion Control proposed to deny the physician's application for DEA registration, which a
practitioner needs
to prescribe controlled substances.
During the administrative law hearing on this matter, the DEA placed into evidence several
patient charts that
indicated that the physician had prescribed a variety of controlled substances to his patients over
extended periods of
time. In one case, the patient chart read, "Drug addiction to Vicodin." In another, the physician
noted that the patient
was using more medication than he should have. It was clear from the evidence that at least one
of his patients had
a serious substance abuse problem.
The DEA's administrative law judge (ALJ) determined, however, that the medications the
physician prescribed
(including controlled substances such as Valium (R) and other muscle relaxants, and analgesics such
as Vicodin (R) and
Tylenol with Codeine #3 and #4 (R)) may be legitimately used in the treatment of chronic pain
syndrome. Furthermore,
the ALJ found that the DEA had not met its burden of proving that the controlled substances had
been prescribed for
illegitimate purposes. In fact, the ALJ concluded that "the physician had issued controlled
substances prescriptions
to these patients for legitimate medical purposes, such as the relief of pain, muscle spasms and
anxiety." The
administrator of the DEA concurred with the ALJ and granted this practitioner a DEA
registration.
Several key points emerge from this case. First, the local police initiated the case based on
the misperception that
it is not legitimate medical practice -- and is, therefore, unlawful -- to prescribe controlled substances
to addicts. The DEA
investigators and the Office of Diversion Control investigated and prosecuted the case,
presumably accepting the
premise that this prescribing practice was not for a legitimate medical purpose. Finally, the DEA
administrator (who
makes the final decision on registration applications for the agency) determined that this
physician's prescribing of
controlled substances for pain, muscle spasms, and anxiety was legitimate medical practice and,
therefore, lawful.
Consequently, the DEA has officially recognized that a physician's use of controlled
substances to treat medical
conditions such as pain is a legitimate medical practice, even for patients who may be drug
abusers. (It remains illegal
under federal law for a practitioner to prescribe controlled substances solely to maintain
addiction unless specifically
authorized to do so as part of a narcotic treatment program.) Although the pain field itself has not
reached a consensus
on when opioids should be used for chronic nonmalignant pain, it is reassuring that the principal
federal drug law
enforcement agency in the United States recognizes the legitimacy of using opioid analgesics to
treat pain in these
patient populations, leaving the clinical issues to be resolved within the scientific and medical
communities.
Hill, C.S. (1989, November). The negative effect of regulatory agencies on adequate pain
control. Primary Care
and Cancer, 47-53.
Hill, C.S. (1993). The negative influence of licensing and disciplinary boards and drug
enforcement agencies on
pain treatment with opioid analgesics. Journal of Pharmaceutical Care in Pain & Symptom
Control, l(l),
43-62.
Michigan Department of Commerce, Bureau of Occupational and Professional Regulation,
Office of Health Services,
& Michigan Controlled Substances Advisory Commission. (1993). Michigan triplicate
prescription program
evaluation report. Lansing, MI: Author.
Portenoy, R.K. (1990). Chronic opioid therapy in nonmalignant pain. Journal of Pain
and Symptom
Management, 5(l) (Suppl.), S46-S62.
Turk, D.C., & Brody, M.C. (1992). What position do APS's physician members take on chronic
opioid therapy?
APS Bulletin, 2(2), 1-5.
