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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:

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).

References

Angarola, R.T., & Joranson, D.E. (1992a). Legislating proper pain management. APS Bulletin, 2(l), 13-15.

Angarola, R.T., & Joranson, D.E. (1992b). Single-copy serialized prescriptions: Old regulation in new clothing? APS Bulletin, 2(4), 14-15.

Angarola, R.T., & Joranson, D.E. (1993a). More federal drug control initiatives: Are they warranted? Will they consider the patient? APS Bulletin, 3(2), 1-2, 8-9.

Angarola, R.T., & Joranson, D.E. (1993b). Wins and losses in pain control. APS Bulletin, 3(4),8-9.

Angarola, R.T., & Joranson, D.E. (1994). Recent developments in pain management and regulation. APS Bulletin, 4(l), 9-11.

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.