title: Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools?
abstract: BACKGROUND
  Clinicians who prescribe chronic opioid therapy are concerned about identifying patients who are at-risk for misusing, abusing, or diverting (i.e. selling) their pain medications. Experts have specifically recommended using clinical assessment tools as part of a comprehensive plan for mitigating opioid-related risks. These tools are typically short, standardized questionnaires that screen for the presence or absence of putatively aberrant medication-related behaviors thought to be predictive of addiction. Interestingly, these tools remain wholly unregulated by the Food and Drug Administration (FDA) or other authorities.
  
  
  OBJECTIVE
  This paper reviews how these instruments are used and the normative assumptions informing their use, fully appreciating that these screening tools do not have the power to diagnose illness or an addiction disorder.
  
  
  CONCLUSIONS
  We conclude that these clinical assessment tools should be regulated because, as we will argue, any screening tool that can assess patients for the potential for opioid-related aberrant behaviors are powerful instruments that merit additional scrutiny and oversight--perhaps by the FDA and other regulatory agencies.
authors.affiliation: Division of Medical Ethics, Weill Cornell Medical College, New York, New York 10021, USA. elc9076@med.cornell.edu
authors.forename: Ellen C
authors.initials: EC
authors.lastname: Meltzer
authors.forename: Wayne D
authors.initials: WD
authors.lastname: Hall
authors.forename: Joseph J
authors.initials: JJ
authors.lastname: Fins
mesh_terms: D000701:Analgesics, Opioid; D006801:Humans; D009293:Opioid-Related Disorders / Q000517:prevention & control; D064226:Prescription Drug Diversion / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D063487:Prescription Drug Misuse / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data*; D019966:Substance-Related Disorders / Q000175:diagnosis*; D011795:Surveys and Questionnaires; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000701:Analgesics, Opioid
keywords: Clinical Assessment Tool; Diagnosing Prescription Opioid Addiction; Ethics; Federal Regulation; Prescription Opioid Monitoring