Incidence of Opioid Overdose Among Patients Using ER/LA Opioid Analgesics Before and After Implementation of the Class-Wide Opioid Risk Evaluation and Mitigation Strategy.

Introduction: The United States (US) Food and Drug Administration (FDA) required a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics on 09 July 2012. Methods: This study compared the incidence of opioid overdose before (July 2010-June 2012) and after (July 2013-September 2016) the initiation of the Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid analgesics. We identified patients with >= 1 ER/LA opioid dispensing in either time period in national data from the HealthCore Integrated Research Database(SM) (HIRD) and in United States (US) Medicaid claims data from four states. We described each population, calculated the incidence rate (IR) of opioid overdose, and assessed crude and propensity score adjusted incidence rate ratios (IRR) comparing the overdose rate after vs before implementation of the REMS. Results: A total of 121,229 commercially insured and 11,488 Medicaid patients were included in the analysis. Rates of overdose were substantially higher in Medicaid patients than in the commercially insured patients (IR 192.0, 95% confidence interval [CI] 162.60-225.18 versus 102.60, 95% CI 93.0-112.93 in the active period). The IRRs for opioid overdose were 1.01 (95% CI 0.87-1.17) in the commercially insured population and 0.70 (95% CI 0.52-0.93) in Medicaid. Conclusion: This leveling off of overdose rates among commercially insured patients and decline among Medicaid patients is encouraging, but it is difficult to disentangle the specific impact of the REMS from many other ongoing initiatives with similar goals.