title: Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).
abstract: Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials.
  
  
  
  The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials.
  
  
  
  The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS.
  
  
  
  MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity.
  
  
  
  Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651).
authors.affiliation: Department of Neurology, Massachusetts General Hospital & Harvard Medical School, Boston, Massachusetts.|Analgesic Solutions, Natick, Massachusetts.
authors.forename: Roi
authors.initials: R
authors.lastname: Treister
authors.affiliation: Boehringer Ingelheim, Ridgefield, Connecticut.
authors.forename: Jeremiah J
authors.initials: JJ
authors.lastname: Trudeau
authors.affiliation: Analgesic Solutions, Natick, Massachusetts.
authors.forename: Richard
authors.initials: R
authors.lastname: Van Inwegen
authors.affiliation: The Degge Group, Fairfax, Virginia.|Georgetown University School of Medicine, Washington, District of Columbia.|University of Michigan School of Public Health, Ann Arbor, Michigan.
authors.forename: Judith K
authors.initials: JK
authors.lastname: Jones
authors.affiliation: Analgesic Solutions, Natick, Massachusetts.|Tufts University, Boston, Massachusetts.
authors.forename: Nathaniel P
authors.initials: NP
authors.lastname: Katz
mesh_terms: D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000494:pharmacology*; D002648:Child; D017326:Clinical Trials, Phase III as Topic / Q000379:methods / Q000592:standards; D004346:Drug Information Services / Q000458:organization & administration; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D057970:Inappropriate Prescribing / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D000067490:Prescription Drug Overuse / Q000517:prevention & control; D012308:Risk Management / Q000379:methods; D019966:Substance-Related Disorders / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D014481:United States
chemical_list: D000700:Analgesics