Journal Article

Influence of External Factors on Spontaneous Reporting Practices: An Analysis of FAERS Data

Castillon, Genaro, Moride, Yola, Goyer, Camille, Goyette, Victoria Munoz, Castilloux, Anne-Marie

2024

Overview

Aim/Objective: To explore the trends in the number and types of spontaneous reports before and after (i) the COVID-19 lockdown in the United States (US) and the European Economic Area (EEA), (ii) Brexit in the EEA, and to quantitatively assess the impact of the COVID-19 lockdown on safety signal detection. Methods: We analyzed spontaneous reports from the US and EEA, dated 01 Jan. 2018 to 26 Dec. 2021, obtained from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). Time series analyses were performed, based on type of reporter (health care professionals [HCP], consumers) and AE seriousness, using interrupted autoregressive integrated moving average (ARIMA) models with step (short-term effect) and ramp (long-term effect) intervention functions. The study also compared reporting odds ratios (RORs) estimated until the start of the pandemic and up to the date of FDA publication for two signals–(i) hypersensitivity to apremilast (end of Sep. 2020) and (ii) diabetic ketoacidosis linked to SGLT2 inhibitors in type 1 diabetic patients (end of Dec. 2020)–to assess potential delays in signal detection due to the COVID-19 lockdown. Results: Significant and immediate reductions in weekly serious HCP reports of -746 (95% CI: -1,267; -225) in the US, and -1,064 (95% CI: -1,709; -419) in the EEA were present during the first week of lockdown. Similarly analyses showed a significant immediate decrease in weekly serious reports from the EEA of -1,009 (95% CI: - 1,509; -509) following Brexit. Additionally, the ROR for SGLT2 inhibitors was significant at the onset of the pandemic. Conclusion: An immediate decline in the number of weekly spontaneous reports of serious events followed both the COVID-19 lockdown and Brexit. These trends did not revert by the end of their respective study periods. Moreover, the COVID-19 lockdown may have delayed the detection of safety signals. Overall, these findings provide an empirical demonstration of the effects of external factors on spontaneous reporting practices.

• Publisher: Springer Nature B.V
• Subject: Autoregressive models / COVID-19 / Diabetes / Diabetes mellitus / EU membership / Hypersensitivity / Impact analysis / Inhibitors / Ketoacidosis / Pandemics / Pharmacists / Pharmacovigilance / Product safety / Shelter in place / Side effects / Signal detection / Trends