President YolaRX Consultants Rutgers The State University of New Jersey Montreal, Canada
Background: Spontaneous reporting practices are known to be influenced by external factors such as media attention. However, the impact of reduced health care access, such as that observed during the COVID-19 lockdown (as of mid-Mar. 2020), or of geopolitical events, such as Brexit on 01 Jan. 2021, remain poorly documented to date.
Objectives: To compare trends in 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 explore safety signal detection following the COVID-19 lockdown.
Methods: Spontaneous reports for the US and the EEA were extracted from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) covering the period from 01 Jan. 2018 to 26 Dec. 2021. Using interrupted autoregressive integrated moving average (ARIMA) models with step (short-term effect) and ramp (long-term effect) intervention functions, time series analyses were conducted according to type of reporter (health care professionals [HCP], consumers) and seriousness of adverse event (AE). Potential delay in signal detection caused by the lockdown was assessed by comparing the reporting odds ratios (ROR) derived for the period until the start of the COVID-19 pandemic and until the date of FDA communication for two signals – hypersensitivity to apremilast and diabetic ketoacidosis to SGLT2 inhibitors in type 1 diabetic patients.
Results: During the first week of lockdown, there was a significant immediate decrease of -746 (95% CI: -1,267; -225) weekly serious reports made by HCPs in the US, and of -1,064 (95% CI: -1,709; -419) in the EEA. Following Brexit, there was a significant immediate decrease in the weekly number of serious reports from the EEA of -1,009 (95% CI: -1,509; -509). For the ROR of disproportionality analysis of SGLT2 inhibitors, this signal was already present at the pandemic.
Conclusions: Both the COVID-19 lockdown and Brexit were followed by an immediate decrease in the weekly spontaneous reports of serious events. Rates did not return to pre-lockdown nor pre-Brexit levels at the end of their study periods. Moreover, safety signal detection may have been delayed by the lockdown. Altogether, these findings provide valuable insight into the importance of monitoring and understanding the effects of external factors on spontaneous reporting practices.
