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Error and Bias in the Evaluation of Prescription Opioid Misuse: Should the FDA Regulate Clinical Assessment Tools?


  • All work performed at Weill Cornell Medical College and University of Queensland.
  • Disclosures: No funding sources were provided and no conflicts of interest exist.

Reprint requests to: Ellen C. Meltzer, MD, FACP, Division of Medical Ethics, NewYork-Presbyterian Weill Cornell Medical Center, 435 East 70th Street, Suite 4J, New York, NY 10021, USA. Tel: 212-746-5377; Fax: 212-746-8738; E-mail:



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.


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.


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.