ABSTRACT
Objectives: To compare the results of two open-label primary care–based studies that examined investigator assessment of patient risk for prescription opioid misuse, abuse, and diversion relative to patient self-reports and urine drug tests (UDTs).
Methods: Risk assessment data from two open-label, multicenter, primary care–based US studies in patients with chronic pain were compared.
Results: In one study (n = 1487), 54.4% of patients were at moderate, 24.8% at high, and 20.8% at low risk based on patients’ self-reports at baseline on the Screener and Opioid Assessment for Patients with Pain®-Revised questionnaire. Investigators assigned 1.3% of patients as high risk despite 5.0% self-reporting prior illicit drug use and 15.3% with positive UDT(s) for an illicit drug at baseline. In the second study (n = 684), few patients were considered by investigators to be at high risk for misuse (1.6%), abuse (1.8%), or diversion (1.0%). However, 10.4% of patients reported prior illicit drug use; 23.4% had at least one abnormal baseline UDT; 60% of 537 patients reported on the Self-Reported Misuse, Abuse, and Diversion questionnaire they took more opioids than prescribed; and 10.9% reported chewing/crushing opioids in the past. Of patients completing the Current Opioid Misuse Measure, 40.6% were classified as having aberrant behaviors.
Conclusion: A comparison of risk assessment across two studies indicates a tendency for investigators to assess patients as lower risk for opioid-related aberrant behaviors despite a significant proportion self-reporting aberrant behavior and/or presenting with illicit UDTs. These consistent findings underline the importance of appropriate implementation of objective measures and self-reporting tools when evaluating risk in patients.
Clinical trial registration: www.clinicaltrials.gov identifiers: NCT00640042 and NCT01179191
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Declaration of interest
The two studies were sponsored by King Pharmaceuticals, Inc., which was acquired by Pfizer in March 2011. Medical writing support was provided by Vardit Dror, PhD, and Diane Hoffman, PhD, of Engage Scientific Solutions and was funded by Pfizer. CL Roland and GC Pixton are employees of and hold stock and stock options in Pfizer; they were employees of King Pharmaceuticals, Inc. at the time the studies were conducted. B Setnik and KW Sommerville were employees of Pfizer and held stock options when the manuscript was initiated; they were employees of King Pharmaceuticals, Inc. at the time the studies were conducted. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.