Scope of the Report

The charge to the committee was to study current DHHS standards for narcotic addiction treatment and the regulation of methadone treatment programs pursuant to those standards. In this context, the committee sought to evaluate the effects of federal regulations on the provision of methadone treatment services and to explore options for modifying the regulations to encourage optimal clinical practice. It also considered the effects of the regulations on the development of new anti-narcotic medications, albeit briefly, as another IOM committee was convened to address this topic at length. Finally, it assessed the impact of the regulations relative to other factors affecting the provision of treatment services, and examined alternatives to the existing regulations.

In connection with the latter undertaking—examining alternatives to the existing regulations—a key point emerged concerning standards. Although the Secretary of HHS must set standards for narcotic addiction treatment, the sole means of doing so, historically, has been by federal regulations. But the implementation of standards by regulations is not required by law, and other options might be viable. In the course of developing this report, therefore, we examined alternative or complementary ways to implement standards, such as clinical practice guidelines and formal quality assurance systems (discussed on page 12 of this summary).

Although the study was limited to federal regulation of methadone, the report summarizes state rules in five jurisdictions—New York, California, Massachusetts, Illinois, and Florida. Unfortunately, a comprehensive description of the authorities and agencies of the states that govern opiate agonists used for treatment of opiate addiction does not exist. The limits of the charge and available data restricted the committee's evaluation of state regulation.

Balancing the Benefits and Risks of Methadone

Having completed its investigations, the committee urges reassessment of the appropriate balance between the risks of methadone and its benefits so that communities can attain the full potential benefit of this means of treating opiate addiction and its associated problems of crime, disease, and disorder, without increasing the risks of diversion and misuse. Current policy, in the committee's view, puts too much emphasis on protecting society from methadone, and not enough on protecting society from the epidemics of addiction, violence, and infectious diseases that methadone can help reduce.

Why, if methadone is effective, is it regulated so highly and so differently from other drugs? Three factors appear to have determined methadone's



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