(B-290) The Effectiveness of the Safety Communication for Concurrent Benzodiazepine-Opioid Therapy: A Retrospective Real-World Analysis

Background: Regulatory agencies commonly use safety communication as a tool to minimize patient harm by providing recommendations for certain precautionary measures. For example, the Saudi Food and Drug Authority (SFDA) issued a safety communication concerning the potential risk of respiratory depression related to concomitant use of benzodiazepines and opioids and provided recommendation to avoid such combination unless medically necessary. While such communication may offer important information to minimize harm, their effectiveness needs to be examined. Thus, monitoring trends or changes in practice may provide an important mechanism to reflect on the extent of effectiveness of such regulatory actions.

Objectives: To examine the impact of the safety communications issued by SFDA on the prevalence of concomitant use of opioids and benzodiazepines before and after the safety communication.

Methods: A multicenter retrospective cohort study utilizing data from Real-world Evidence Research Network comprised adult (≥18 years old) users of benzodiazepines and opioids from 2016 throughout 2020. This study employed an interrupted time series analysis using ARIMA model to examine changes in concomitant benzodiazepine and opioid prescriptions before and after the safety communication.

Results: A total of 43,906 concomitant benzodiazepines and opioids prescriptions were identified for 32,035 patients. The prevalence of concomitant prescriptions for benzodiazepines and opioids slightly decreased from 22.5% (22,846 episodes) to 20.4% (21,096 episodes) after the safety communication. The result from the ARIMA model show that the estimated step change was 9.3 in prescriptions (95% CI: -154.5 – 173.2) while the estimated change in slope was -1.7 prescriptions per month (95% CI: -29.4 – 26.1).

Conclusions: In this study, we observed no significant changes in prevalence and trends in concomitant prescriptions of benzodiazepines and opioids. The findings of this study could be used as a benchmark for SFDA to track trends in the application of safety communication over time and to evaluate the performance of various safety communication strategies.