Measures That Identify Prescription Medication Misuse,Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations |
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| Authors: | 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 Robert H. Dworkin |
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| Affiliation: | 1. Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, New York;771. Department of Anesthesiology, Neurology, and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, New York;2. The Degge Group, Fairfax, Virginia;3. Departments of Pharmacology and Health Sciences, Georgetown University School of Medicine, Washington, DC;4. School of Public Health, University of Michigan School of Public Health, Ann Arbor, Michigan;5. Analgesic Solutions, Natick, Massachusetts;6. Departments of Anesthesiology and Public Health and Community Medicine, Tufts University, Boston, Massachusetts;7. Pfizer Inc, Cary, North Carolina;11. INC Research, Raleigh, North Carolina;12. Boehringer Ingelheim, Ridgefield, Connecticut;8. GW Pharmaceuticals, plc, London, United Kingdom;9. LORA Group, LLC, Royal Oak, and School of Pharmacy, University of Maryland, Baltimore, Maryland;10. Department of Psychiatry, Columbia University, New York State Psychiatric Institute, New York, New York;71. Division of Clinical Pharmacology and Toxicology, University of Colorado School of Medicine and Rocky Mountain Poison & Drug Center, Denver Health, Denver, Colorado;112. Department of Pharmacology and Toxicology, Brody School of Medicine, East Carolina University, Greenville, North Carolina;123. Purdue Pharma LP, Stamford, Connecticut;84. Department of Psychiatry, University of Maryland School of Medicine, Baltimore, Maryland;95. Collegium Pharmaceutical, Inc, Canton, Massachusetts;106. BAM Consultants, Guilford, Connecticut;77. Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut;1111. National Institute on Drug Abuse, Bethesda, Maryland;88. Horizon Pharma, Inc, Deerfield, Illinois;99. Departments of Anesthesiology and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania;1010. Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington |
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| Abstract: | ![]()
Accurate 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.PerspectiveIdentifying a medication's abuse potential requires assessing inappropriate medication use events in clinical trials on the basis of a standardized event classification system. The strengths and limitations of the 2 published methods designed to evaluate inappropriate medication use events are reviewed, with recommended considerations for further development and current implementation. |
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| Keywords: | Medication abuse medication misuse abuse potential |
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