ABSTRACT
PURPOSE: The COVID-19 pandemic has been widely reported to present stress to medical systems globally and to disrupt the lives of patients and health care practitioners (HCPs). Given that spontaneous reporting heavily relies on both HCPs and patients, an understandable question is whether the stress of the pandemic has diminished spontaneous reporting. Herein, the hypothesis that the COVID-19 pandemic has negatively affected the spontaneous reporting of adverse drug events was assessed. METHODS: Spontaneous-report counts from 119 weeks (January 1, 2018, to April 12, 2020) were identified using Pfizer's safety database and were analyzed. Autoregressive integrated moving-average models were fitted to aggregated and disaggregated time series (TSs). Model residuals were charted on individual-value and moving-range charts and exponentially weighted moving-average charts for the identification of statistically unexpected changes associated with the pandemic. FINDINGS: Overall, the reporting of serious adverse events showed no unexpected decline. Total global reporting declined, driven by HCP reporting (of both serious and nonserious events), starting after week 8 of 2020 and exceeding model expectations by week 15 of 2020, suggesting the pandemic as an assignable cause. However, reporting remained within longer-term historical ranges. The TS from Japan was the only national TS that showed a significant decline, and an unusual periodicity related to national holidays. A few countries, notably Taiwan, showed unexpected statistical increases in reporting associated with the pandemic, commencing as early as week 3 of 2020. In the literature, the reporting of adverse drug events was stable. Ancillary findings included prevalent year-end/beginning reporting minima, with more reports from HCPs than from consumers. IMPLICATIONS: Using data from a large-scale and diverse safety database from a pharmaceutical company, a significant global decline in total reporting was detected, driven by HCPs, not consumers, and reports of nonserious events, consistent with the pandemic as an assignable cause, but the reporting remained within long-term ranges, suggesting relative durability. Importantly, the analyses found no unexpected decline in overall reporting of serious events. Future avenues of research include the use of data from large-scale, publicly available spontaneous reporting systems for assessing the generalizability of the present findings and whether they correlate with impaired signal detection, as well as a follow-up analysis of whether the effects on spontaneous reporting abate after the pandemic.