A multicenter, primary care-based, open-label study to identify behaviors related to prescription opioid misuse, abuse, and diversion in opioid-experienced patients with chronic moderate-to-severe pain

Abstract

ObjectiveTo compare the investigator assessment of patient risk for prescription opioid misuse, abuse, and diversion with patient self-reports of these activities in a population with chronic pain.MethodsAs a secondary objective of an open-label, multicenter, primary care-based clinical study to evaluate the success of converting opioid-experienced patients with chronic pain to morphine sulfate with sequestered naltrexone hydrochloride, risk for misuse, abuse, and diversion was assessed using two nonvalidated questionnaires: one was completed by the investigator and another by the patient (Self-Reported Misuse, Abuse, and Diversion [SR-MAD]). In addition, the validated Current Opioid Misuse Measure (COMM) test and urine drug test were used.ResultsOf the 684 patients assessed by the investigators, 537 returned the self-assessment, SR-MAD. Most patients were assigned by the investigator as low risk for misuse (84.2%), abuse (89.3%), and diversion (94.3%). Of the patients who returned SR-MAD, 60% indicated having taken more opioids than prescribed and 10.9% reported chewing or crushing their opioids in the past. Of the patients who completed COMM, 40.6% were deemed as having aberrant behaviors. COMM results correlated with the risk levels from the investigator assessment. One-third of patients (33.8%) had at least one abnormal urine drug test result.ConclusionMore research is needed to better understand the gap between the investigator assessment of potential risk for misuse, abuse, and diversion and the actual extent of these behaviors among patients with chronic pain.

Factors associated with prescription opioid misuse in a cross-sectional cohort of patients with chronic non-cancer pain

“…This concern has been raised in prior studies using patient report to determine risk of opioid misuse 31. Consequently, future studies should consider objective measures of aberrant substance use (such as cross-referencing prescription drug monitoring programs or urine drug testing), which have been shown in prior studies to be valid indicators of opioid misuse 2,17,31…”

Illicit Substance Use in US Adults With Chronic Low Back Pain

“…1,2 Many concerns have been raised regarding opioid prescribing, including addictive potential, misuse, and accidental overdose. 3,4,5,6 Several studies have shown that a history of illicit drug use is associated with prescription opiate misuse. 7,8,9,10 Little is known about the prevalence of illicit drug use in Americans with chronic low back pain.…”

Measures That Identify Prescription Medication Misuse, Abuse, and Related Events in Clinical Trials: ACTTION Critique and Recommended Considerations

“…Other measures of inappropriate medication use that were briefly considered during the meeting, but that were not well-suited to evaluating and classifying inappropriate medication use events, have been reviewed previously ([28]; see also Table 2 for a summary). Only 2 recently developed approaches (i.e., Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument for prescription opioids [25]; Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS [29]]) that were created specifically to address the gaps in procedures for identifying and adjudicating inappropriate use events occurring in clinical trials were examined in depth. The ALERTT group focused on details presented during the meeting and in articles that have been published since the meeting [25, 29] regarding each tool’s ease of implementation, ability to retrospectively and prospectively identify behaviors suggestive of MAREs, standardization of event adjudication, and ability to gather comprehensive and exhaustive information when behaviors suggestive of inappropriate use events arise in prospective trials.…”

“…Only 2 recently developed approaches (i.e., Self-Reported Misuse, Abuse, and Diversion [SR-MAD] instrument for prescription opioids [25]; Misuse, Abuse, and Diversion Drug Event Reporting System [MADDERS [29]]) that were created specifically to address the gaps in procedures for identifying and adjudicating inappropriate use events occurring in clinical trials were examined in depth. The ALERTT group focused on details presented during the meeting and in articles that have been published since the meeting [25, 29] regarding each tool’s ease of implementation, ability to retrospectively and prospectively identify behaviors suggestive of MAREs, standardization of event adjudication, and ability to gather comprehensive and exhaustive information when behaviors suggestive of inappropriate use events arise in prospective trials. Subsequent to the meeting, a Web of Science search (http://webofknowledge.com; February 20, 2017) for articles citing the standardized MAREs classification and definition system [27] was conducted and did not identify any additional assessment methods.…”

“…Subsequent to the meeting, a Web of Science search (http://webofknowledge.com; February 20, 2017) for articles citing the standardized MAREs classification and definition system [27] was conducted and did not identify any additional assessment methods. In addition, Web of Science searches (February 20, 2017) did not identify any publications citing SR-MAD [25] or MADDERS [29] that provided additional information regarding the use of these tools to capture inappropriate medication use events in a clinical trial. In this article, we briefly describe each tool, followed by examples of how each might be applied, as well as an evaluation of the strengths, limitations, and available data regarding each tool’s measurement properties.…”