TY - JOUR KW - Analgesics, Opioid KW - Clinical Assessment Tool KW - Diagnosing Prescription Opioid Addiction KW - ethics KW - Federal Regulation KW - Humans KW - Opioid-Related Disorders/prevention & control KW - Prescription Drug Diversion/ethics/legislation & jurisprudence/statistics & numerical data KW - Prescription Drug Misuse/legislation & jurisprudence/statistics & numerical data KW - Prescription Opioid Monitoring KW - Substance-Related Disorders/diagnosis KW - Surveys and Questionnaires KW - United States KW - United States Food and Drug Administration AU - E. C. Meltzer AU - W. D. Hall AU - J. J. Fins A1 - AB - 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. BT - Pain medicine (Malden, Mass.) C5 - Opioids & Substance Use CP - 7 CY - England DO - 10.1111/pme.12099 IS - 7 JF - Pain medicine (Malden, Mass.) N2 - 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. PP - England PY - 2013 SN - 1526-4637; 1526-2375 SP - 982 EP - 987 EP - T1 - Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools? T2 - Pain medicine (Malden, Mass.) TI - Error and bias in the evaluation of prescription opioid misuse: should the FDA regulate clinical assessment tools? U1 - Opioids & Substance Use U2 - 23594383 U3 - 10.1111/pme.12099 VL - 14 VO - 1526-4637; 1526-2375 Y1 - 2013 ER -