Assessment of risk of prescription opioid abuse and aberrant behaviors in the primary care setting

Abstract

This multicenter open-label trial in chronic-pain patients evaluated the effectiveness of once-daily morphine sulfate extended-release (AVINZA®) and the potential for prescription opioid abuse and misuse (POAM) for up to 4-months in primary care settings. Patients were opioid-tolerant and -naïve adults with pain scores ≥4/11-pt scale or unacceptable opioid side-effects (opioid-tolerant only). Primary care investigators (PCIs, N=268) determined doses of AVINZA® in adherence with prescribing information and used 7 assessment tools, including treatment-agreement, SOAPP-R®, and urine drug tests (UDTs), to provide initial and ongoing assessment of POAM risk, risk-stratification, and appropriate interventions. Post-study surveys were conducted at 3- and 6-months to determine clinical utility and subsequent use of assessment tools. Here we report results related to POAM risk. The safety population (N=1487) was primarily female (57%), opioid-tolerant (79%), aged 40-69 years (71%), with chronic pain history >1 year (92%). In total, 561 (38%) patients completed the study through 4-months. Five percent (5%) of patients were withdrawn due to high risk-level. At baseline, 14% and 10% of patients had positive UDTs for marijuana and cocaine, respectively; 54% had SOAPP-R® scores of 10-21 (moderate risk). At baseline, overall risk-level assignment was consistent with SOAPP-R® scores for most patients (54%); however, 45% and 1% of patients had an underestimated and overestimated risk-level, respectively, relative to their SOAPP-R® score. At study-end, the risk-level remained the same for most patients (77%), decreased for 15% and increased for 8% relative to baseline. At 3- and 6-months post-study, 94% and 92% of PCIs continued to use at least 1 of the assessment-tools, respectively. Results suggest that the majority of chronic-pain patients in primary care settings are at moderate risk for POAM. A combination of clinical tools and risk-stratification may have utility in assessing and monitoring the risk of POAM in these settings. (Supported by King Pharmaceuticals®, Inc.) This multicenter open-label trial in chronic-pain patients evaluated the effectiveness of once-daily morphine sulfate extended-release (AVINZA®) and the potential for prescription opioid abuse and misuse (POAM) for up to 4-months in primary care settings. Patients were opioid-tolerant and -naïve adults with pain scores ≥4/11-pt scale or unacceptable opioid side-effects (opioid-tolerant only). Primary care investigators (PCIs, N=268) determined doses of AVINZA® in adherence with prescribing information and used 7 assessment tools, including treatment-agreement, SOAPP-R®, and urine drug tests (UDTs), to provide initial and ongoing assessment of POAM risk, risk-stratification, and appropriate interventions. Post-study surveys were conducted at 3- and 6-months to determine clinical utility and subsequent use of assessment tools. Here we report results related to POAM risk. The safety population (N=1487) was primarily female (57%), opioid-tolerant (79%), aged 40-69 years (71%), with chronic pain history >1 year (92%). In total, 561 (38%) patients completed the study through 4-months. Five percent (5%) of patients were withdrawn due to high risk-level. At baseline, 14% and 10% of patients had positive UDTs for marijuana and cocaine, respectively; 54% had SOAPP-R® scores of 10-21 (moderate risk). At baseline, overall risk-level assignment was consistent with SOAPP-R® scores for most patients (54%); however, 45% and 1% of patients had an underestimated and overestimated risk-level, respectively, relative to their SOAPP-R® score. At study-end, the risk-level remained the same for most patients (77%), decreased for 15% and increased for 8% relative to baseline. At 3- and 6-months post-study, 94% and 92% of PCIs continued to use at least 1 of the assessment-tools, respectively. Results suggest that the majority of chronic-pain patients in primary care settings are at moderate risk for POAM. A combination of clinical tools and risk-stratification may have utility in assessing and monitoring the risk of POAM in these settings. (Supported by King Pharmaceuticals®, Inc.)