The impact of regulatory restrictions on pregabalin use in Saudi Arabia: An interrupted time series analysis.

PURPOSE: The Saudi Food and Drug Authority (SFDA) added pregabalin to the list of controlled substances in December 2017 to minimize the risk of its possible abuse and misuse. This study was aimed at assessing the impact of this decision on the overall use of pregabalin in Saudi Arabia and in comparison with drugs prescribed to treat neuropathic pain (i.e., vs. gabapentin, tramadol, duloxetine, and amitriptyline).

METHODS

This was an interrupted time-series analysis of the Saudi quarterly sale data of the study drugs from October/2015 to September/2020. These data were obtained from IQVIA and were converted into use estimates (defined daily dose per 1000 inhabitant-days [DDD/TID]). Segmented regression models were conducted to assess the direct (level) and prolonged (trend) changes in use data after the decision. All analyses were completed using RStudio Version 1.4.1103.

RESULTS

Before the SFDA's decision, there was an increased quarter-to-quarter use of pregabalin (DDD/TID: 0.16; 95% confidence interval [CI] 0.04 to 0.28). Pregabalin overall use dropped sharply by -1.85 DDD/TID (95% CI -2.71 to -0.99) directly after the decision with a prolonged quarter-to-quarter declining effect (DDD/TID: -0.22, CI to -0.37 to -0.05). The decision was associated with a direct increase in the use of gabapentin by 0.62 DDD/TID (95% CI 0.52-0.72) without any impact on the use of other drugs.

CONCLUSIONS

The results of our study showed that the SFDA decision was associated with a decrease in the overall use of pregabalin, which may help minimize the risk of its abuse and misuse.