• Shannon M Smith, Judith K Jones, Nathaniel P Katz, Carl L Roland, Beatrice Setnik, Jeremiah J Trudeau, Stephen Wright, Laurie B Burke, Sandra D Comer, Richard C Dart, Raymond Dionne, J David Haddox, Jerome H Jaffe, Ernest A Kopecky, Bridget A Martell, Ivan D Montoya, Marsha Stanton, Ajay D Wasan, Dennis C Turk, and Robert H Dworkin.
• Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York. Electronic address: shannon1_smith@urmc.rochester.edu.
• J Pain. 2017 Nov 1; 18 (11): 1287-1294.

AbstractAccurate assessment of inappropriate medication use events (ie, misuse, abuse, and related events) occurring in clinical trials is an important component in evaluating a medication's abuse potential. A meeting was convened to review all instruments measuring such events in clinical trials according to previously published standardized terminology and definitions. Only 2 approaches have been reported that are specifically designed to identify and classify misuse, abuse, and related events occurring in clinical trials, rather than to measure an individual's risk of using a medication inappropriately: the Self-Reported Misuse, Abuse, and Diversion (SR-MAD) instrument and the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS). The conceptual basis, strengths, and limitations of these methods are discussed. To our knowledge, MADDERS is the only system available to comprehensively evaluate inappropriate medication use events prospectively to determine the underlying intent. MADDERS can also be applied retrospectively to completed trial data. SR-MAD can be used prospectively; additional development may be required to standardize its implementation and fully appraise the intent of inappropriate use events. Additional research is needed to further demonstrate the validity and utility of MADDERS as well as SR-MAD.Copyright © 2017 American Pain Society. Published by Elsevier Inc. All rights reserved.

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