Methadone-Associated Mortality:
Report of a National Assessment

Part 1. Purpose of the National Assessment

Methadone has a long, successful history as a potent analgesic and a highly effective medication for reducing the morbidity and mortality associated with opioid addiction (Joseph and Woods, 1994; Joseph, et al., 2000). However, recent reports of methadone-associated deaths have stirred public concern. Diversion, abuse, and deaths associated with many opioid medications, including methadone, have been the subject of front-page news. Articles appearing in prominent newspapers, including the New York Times, have described methadone as a "killer drug" that is "widely abused and dangerous" (Belluck, 2003a, 2003b, 2003c; Associated Press, 2002; Washington Times, 2003).

While these articles focused on the dangerous consequences of opioid medications when misused, the articles often did not balance that negative perspective with positive information about how the drugs provide vital relief to persons suffering from serious pain and, in the case of methadone, opioid addiction. The articles tended to perpetuate long-standing myths and misconceptions about opioid-based medications. Such misinformation has the potential to discourage the appropriate use of these medications even though, properly administered, they have demonstrated efficacy and safety in millions of patients worldwide.

The news reports were and remain of grave concern to the Substance Abuse and Mental Health Services Administration (SAMHSA), within the U.S. Department of Health and Human Services. In 2001, SAMHSA assumed responsibility from the Food and Drug Administration (FDA) for the regulation and oversight of the Nation's opioid treatment programs (OTPs, commonly referred to as "methadone clinics"). SAMHSA's Center for Substance Abuse Treatment (CSAT) already had been working with the Centers for Disease Control and Prevention (CDC), the Drug Enforcement Administration (DEA), the National Institute on Drug Abuse (NIDA), and the FDA, as well as with some of the affected States, to assess the issue of opioid overdose deaths. However, the media reports, combined with increasing requests for consultation and assistance from State authorities and practitioners in the field, added urgency to SAMHSA's efforts to address the causes of methadone-associated mortality in a focused and expeditious manner.

Thus, on May 8-9, 2003, SAMHSA's CSAT convened a multidisciplinary group of more than 70 experts - including representatives of various Federal and State agencies, researchers, epidemiologists, pathologists, toxicologists, medical examiners, coroners, pain management specialists, addiction medicine experts, and others (see Appendix 1 for a complete list of participants) - to conduct a National Assessment of Methadone-Associated Mortality.

The experts who participated in the National Assessment sought to determine whether opioid treatment programs (OTPs) that use methadone in the treatment of opioid addiction and the revised Federal regulations governing the manner in which OTPs administer methadone could be contributing to methadone-associated mortality.

Participants presented and carefully reviewed the available data on methadone formulation, distribution, patterns of prescribing and dispensing, as well as the relevant data on drug toxicology and drug-associated morbidity and mortality. Based on their assessments, participants arrived at a number of important conclusions regarding the reports of methadone-associated mortality and formulated recommendations for reducing that mortality.