Details
The U.S. Food and Drug Administration (FDA) initiated this methods development study to test a new Sentinel System analytic tool to perform Interrupted Time Series (ITS) analyses for assessing the impact of FDA regulatory actions on drug utilization. The newly developed analytic tool and the impact of FDA's February 2010 and June 2010 Drug Safety Communications (DSCs) concerning the safety of using long-acting beta-2 agonists (LABA) alone without the use of long-term asthma controller medications in adult asthma patients were assessed. Findings from this test case demonstrated the successful development of the ITS tool. Study results showed that the initiation of LABA alone declined among asthma patients aged 18-45 years before the FDA DSC in June 2010 (-0.10% per quarter; 95% CI: -0.11% to -0.09%), and the downward trend continued after the FDA DSC. These findings were consistent with FDA’s previous LABA studies published in 2016 and 2017.
The reusable analytic tool can be applied to real-world databases formatted to the Sentinel Common Data Model for assessing the impact of FDA regulatory actions on drug utilization.