T-04: Effect of Drug Safety Communications on Adverse Event Reporting in Multiple Sclerosis DMTs using the FAERS Database 2000-2017
Poster Presenter
Hunter Davis
Medical Affairs / Medical Science Liaison Fellow, Genentech
Rutgers University, Ernest Mario School of Pharmacy United States
Objectives
The aim of this study is to analyze the effects FDA Drug Safety Communications (DSCs) in Multiple Sclerosis (MS) therapies have on adverse event reporting trends in the publicly available Federal Adverse Event Reporting System (FAERS) Database.
Method
Therapies chosen were those defined as disease modifying (DMTs) by the National MS Society. Drug Safety Communications from 2000-2017 were identified using FDA Index-to-Drug-Specific Information. Adverse events before and after the communications were collected and analyzed using the FAERS database.
Results
Our preliminary results have identified a total of ¬¬13 multiple sclerosis medications defined as disease modifying therapies by the National MS Society. Of these, 4 DMTs have been the subject of FDA Drug Safety Communications (DSCs) between 2000-2017. A total of 8 DSCs, spanning 3 different MedDRA system organ classes, were analyzed in this study. Related adverse events reported to the FDA before and after these drug safety communications were analyzed. Together, the reports allow us to summarize the affected patient demographics and outcomes for these associated AEs. Additionally, we examine the types of AE reporters as well as trends in volume of AEs around the release of a drug safety communications. In leveraging state Medicaid Utilization data by year, we’re able to contextualize the volume and frequencies of reported AEs for each MS therapy studied. Using the Medical Dictionary for Regulatory Activates (MedDRA) our study determines the most common classes of reactions associated with reported adverse events and drug safety communications as well as the ways in which AE reporting frequency varies following FDA DSCs. Final study results are pending.
Conclusion
The results we present highlight the impact FDA drug safety communications have on adverse event reporting from both voluntary and mandatory reporters. Currently, there is very little published literature around the validity and utility of the new and publicly available FAERS dashboard. In analyzing adverse event reporting trends corresponding to FDA Drug Safety Communications, we provide a benchmark for this relatively new tool to better understand who, when, and what does actually get reported to the FDA in the setting of known safety communications. When Drug Safety Communications do occur, we expect an increase in awareness around the given change. This awareness could either increase AE reporting through familiarity and/or decrease AE reporting through increased patient and provider vigilance. Our study presents data to help better determine how these safety communications affect not only adverse event reporting trends but how and what types of changes affect the reporters of those AEs. Research shows that these types of neurologic patient populations may serve as prognosticators of adverse event reporting trends and the impact of drug safety communications. Although there is a clear relationship between DSCs and the adverse events reported to the FAERS database, more research is needed to determine what value the new, publicly available FAERS dashboard brings to the medical community and how effective DSCs are in disseminating important safety information to providers and patients. Full conclusion pending based on final results.
