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Classification and definition of misuse, abuse, and related events in clinical trials: ACTTION systematic review and
Shannon M Smith1, Richard C Dart, Nathaniel P Katz
1Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA University of Colorado School of Medicine and Rocky Mountain Poison & Drug Center, Denver Health, Denver, CO, USA Analgesic Solutions, Natick, MA, USA Tufts University, Boston, MA, USA Focus Biocom, Durango, CO, USA Covance Market Access, Gaithersburg, MD, USA Columbia University, New York State Psychiatric Institute, New York, NY, USA Astellas Pharma, Inc., Northbrook, IL, USA Brigham & Women's Hospital, Boston, MA, USA Purdue Pharma LP, Stamford, CT, USA University of Maryland School of Medicine, Baltimore, MD, USA Centers for Disease Control and Prevention, Atlanta, GA, USA Collegium Pharmaceutical, Inc., Canton, MA, USA Department of Neurosurgery, University of Rochester, Rochester, NY, USA National Institute on Drug Abuse, Bethesda, MD, USA University of Pennsylvania, Philadelphia, PA, USA Pfizer Inc., Cary, NC, USA Horizon Pharma, Inc., Deerfield, IL, USA Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, USA Janssen Scientific Affairs, LLC, Raritan, NJ, USA Harvard Medical School, Chestnut Hill, MA, USA Harvard Medical School, Boston, MA, USA Division of Alcohol and Drug Abuse, McLean Hospital, Belmont, MA, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Department of Neurology and Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Abstract:
As the nontherapeutic use of prescription medications escalates, serious associated consequences have also increased. This makes it essential to estimate misuse, abuse, and related events (MAREs) in the development and postmarketing adverse event surveillance and monitoring of prescription drugs accurately. However, classifications and definitions to describe prescription drug MAREs differ depending on the purpose of the classification system, may apply to single events or ongoing patterns of inappropriate use, and are not standardized or systematically employed, thereby complicating the ability to assess MARE occurrence adequately. In a systematic review of existing prescription drug MARE terminology and definitions from consensus efforts, review articles, and major institutions and agencies, MARE terms were often defined inconsistently or idiosyncratically, or had definitions that overlapped with other MARE terms. The Analgesic, Anesthetic, and Addiction Clinical Trials, Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership convened an expert panel to develop mutually exclusive and exhaustive consensus classifications and definitions of MAREs occurring in clinical trials of analgesic medications to increase accuracy and consistency in characterizing their occurrence and prevalence in clinical trials. The proposed ACTTION classifications and definitions are designed as a first step in a system to adjudicate MAREs that occur in analgesic clinical trials and postmarketing adverse event surveillance and monitoring, which can be used in conjunction with other methods of assessing a treatment's abuse potential.
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