Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools?

Meltzer, Ellen C., Hall, Wayne D. and Fins, Joseph J. (2013) Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools?. Pain Medicine, 14 7: 982-987. doi:10.1111/pme.12099


Author Meltzer, Ellen C.
Hall, Wayne D.
Fins, Joseph J.
Title Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools?
Journal name Pain Medicine   Check publisher's open access policy
ISSN 1526-2375
1526-4637
Publication date 2013
Sub-type Article (original research)
DOI 10.1111/pme.12099
Volume 14
Issue 7
Start page 982
End page 987
Total pages 6
Place of publication Hoboken, NJ, United States
Publisher Wiley-Blackwell
Collection year 2014
Language eng
Subject 2728 Clinical Neurology
2703 Anesthesiology and Pain Medicine
Formatted 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.

Conclusion: 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. 
Keyword Clinical Assessment Tool
Diagnosing Prescription Opioid Addiction
Ethics
Federal Regulation
Prescription Opioid Monitoring
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2014 Collection
 
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