Methadone-Associated Mortality:
Report of a National Assessment

Acknowledgements

Numerous people contributed to the development of the National Assessment Meeting and this report (see Appendix A). The meeting was conducted by Northrop Grumman Information Technology, Health Solutions & Services, under contract 280-99-0900 with the Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT). Stewart B. Leavitt, PhD, served as researcher/writer and Alan Trachtenberg, MD, MPH, was SAMHSA's medical editor and a meeting facilitator. Johnson, Bassin & Shaw, Inc., provided assistance in the production of this document. Raymond Hylton, Jr., RN, MSN, CSAT, served as the Government project officer.

Disclaimer

The views, opinions and content of this publication are those of the National Assessment participants, authors, and other referenced sources, and do not necessarily reflect the views, opinions, or policies of CSAT, SAMHSA, or any other part of the U.S. Department of Health and Human Services (DHHS).

Public Domain Notice

Material appearing in this document - except quoted passages, tables, graphs, or figures from copyrighted sources - is in the public domain and may be reproduced or copied without permission from SAMHSA or the authors. Citation of the source is appreciated. However, this publication may not be reproduced or distributed for a fee without the specific, written authorization of the Office of Communications, SAMHSA, DHHS.

Electronic Access and Copies of Publication

This publication may be accessed electronically through the following Internet World Wide Web connection: http://www.samhsa.gov. For additional free copies of this document please call SAMHSA's National Clearinghouse for Alcohol and Drug Information at 1-800-729-6686 or 1-800-487-4889 (TDD).

Recommended Citation

Center for Substance Abuse Treatment, Methadone-Associated Mortality: Report of a National Assessment, May 8-9, 2003. CSAT Publication No. 28-03. Rockville, MD: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 2004.

Originating Office

Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, SAMHSA, DHHS, 1 Choke Cherry Road, Rockville, MD 20857.
CSAT Publication No. 28-03
Printed 2004

Preface

Methadone is a medication valued for its effectiveness in reducing the mortality associated with opioid addiction as well as the various medical and behavioral morbidities associated with addictive disorders. It also is an inexpensive and increasingly popular analgesic medication suitable for the treatment of even the most severe acute or chronic pain in well-selected patients.

In 2002 and 2003, articles appeared in prominent newspapers - including the New York Times - describing methadone as "widely abused and dangerous." These alarming reports arose from an apparent increase in deaths among persons using the medication.

The reports were of grave concern to the Substance Abuse and Mental Health Services Administration (SAMHSA), the agency of the Department of Health and Human Services which in 2001 assumed from the Food and Drug Administration (FDA) the responsibility for regulation and oversight of the Nation's opioid treatment programs (OTPs, commonly known as methadone clinics). SAMHSA's Center for Substance Abuse Treatment (CSAT) already was 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 States most directly affected by rising methadone mortality rates. The media reports, coupled with an increase in requests for consultation and assistance from State authorities and practitioners in the field, created added urgency for SAMHSA to evaluate and address the causes of the increase.

To address these issues, SAMHSA convened a multidisciplinary group - including representatives from various Federal and State agencies, researchers, epidemiologists, pathologists, toxicologists, medical examiners, coroners, pain management specialists, addiction medicine experts, and others - to conduct a National Assessment of Methadone-Associated Mortality in May 2003.

The term "methadone-associated mortality" broadly encompasses fatalities in which methadone has been detected during postmortem analysis or is otherwise implicated in a death. Defining methadone's role in such deaths is an unsettled area, complicated by inconsistencies in methods of determining and reporting causes of death, the presence of other central nervous system (CNS) drugs, and the absence of information about the decedent's antemortem physical or mental condition and level of opioid tolerance. Moreover, the source, formulation, and quantity of methadone implicated in an individual's death often are difficult to determine.

Participants in the National Assessment 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. As a result of their deliberations, participants arrived at a number of important conclusions regarding the reports of methadone-associated mortality and formulated recommendations for reducing that mortality.

This document summarizes the data used by the Assessment experts to evaluate the nature and scope of the problem, as well as to present their findings and recommendations. Participants' slides and other presentation materials are available on SAMHSA's web site; a Background Briefing Report prepared for the Assessment also is available on the web site.

These documents provide an excellent source of information and expert analysis of both anecdotal and statistical reports of methadone-associated mortality. The conclusions of the experts assembled for the National Assessment can help inform future policy and assure that appropriate access to this important medication is preserved.

Charles G. Curie, MA, A.C.S.W.,
Administrator, Substance Abuse and Mental Health Services Administration

H. Westley Clark, MD, JD, MPH, CAS, FASAM,
Director, Center for Substance Abuse Treatment,
Substance Abuse and Mental Health Services Administration