|
?:abstract
|
-
Purpose The COVID-19 pandemic was widely reported to present a stress to medical systems globally and disrupted the lives of patients and health care practitioners. Since spontaneous reporting heavily relies on both health care professionals and patients, an understandable question is whether the stress of the pandemic diminished spontaneous reporting. Herein we assess the hypothesis that the COVD-19 pandemic negatively impacted spontaneous reporting of adverse drug events. Methods We analyzed 119 weeks of spontaneous report counts from the Pfizer Safety database (January 1, 2018 to April 12, 2020). We fitted autoregressive integrated moving average models to aggregated and disaggregated time series and charted the model residuals on Individual value-moving range and exponentially weighted moving average charts to identify statistically unexpected changes associated with the pandemic. Results Overall reporting of serious adverse events showed no unexpected decline, Total global reporting declined, driven by health care professional reporting (both serious and non-serious), starting after week 8, 2020, exceeding model expectations by week 15, 2020, suggesting the pandemic as an assignable cause. However, reporting remained within longer term historic ranges. The Japan time series was the one individual country time series showing a significant decline, and unusual periodicity related to national holidays. A few countries, notably Taiwan, showed statistically unexpected reporting increases associated with the pandemic commencing as early as week 3, 2020. Literature reporting of adverse drug events was stable. Ancillary findings included prevalent year-end/beginning reporting minima, more with health professional than consumer reports. Implications In a large and diverse pharmaceutical company database we did detect a significant global decline in total reporting, driven by healthcare professionals, not consumers, and non-serious reports, consistent with the pandemic as an assignable cause, but the reporting remained within long term ranges. suggesting a relative durability. Importantly, our analyses found no unexpected decline in overall serious reporting. Future avenues for research include assessing whether these effects impaired signal detection, performing the same analysis on large public spontaneous reporting system data to assess generalizability of our findings, and follow-up analysis to assess if impacts on spontaneous reporting abate.
|
![[This page as RDF]](https://research.tib.eu/covid-19/static/rdf-icon.gif){kind=icon}