Abstract
Adverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019. A nationwide pandemic (such as COVID-19) further challenges the ability of healthcare systems to ensure safe medication use and the pandemic’s effects on safety events remain poorly understood. Here, we investigate drug safety events across demographic groups before and during a pandemic using a dataset of 1,425,371 reports involving 2,821 drugs and 7,761 adverse events. Among 64 adverse events identified by our analyses, we find 54 increased in frequency during the pandemic, despite a 4.4% decrease in the total number of reports. Out of 53 adverse events with a pre-pandemic gender gap, 33 have seen their gap increase with the pandemic onset. We find that the number of adverse events with an increased reporting ratio is higher in adults (by 16.8%) than in older patients. Our findings have implications for safe medication use and preventable healthcare inequality in public health emergencies.
Highlights
Adverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019
We examined 1,425,371 adverse event reports involving 2,821 distinct types of adverse event and spanning 7,761 drugs from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) dataset, collected between January 2013 and September 2020
We developed an approach that identifies clinically meaningful adverse events that satisfy the following criteria: (1) the reporting frequency of an adverse event changed significantly between 2019 and 2020, (2) the change cannot be explained by its trend in previous years (2013 to 2019) and (3) the adverse drug reaction can be attributed to a specific medication
Summary
Adverse patient safety events, unintended injuries resulting from medical therapy, were associated with 110,000 deaths in the United States in 2019. Studies of patient safety during a pandemic are restricted to a very limited set of drugs and adverse reactions and are stifled by the small number of adverse event reports and narrow time ranges[20] Such narrowly focused analyses can be confounded by historical biases in adverse event reporting and by mixing population groups that differ in their relative risks for clinical events. Reporting the frequencies of adverse effects such as anxiety and insomnia were disproportionately increased in women and the elderly, indicating they constitute at-risk patient groups Taken together, these analyses unveil risk-altering adverse events that can inform drug prescription and public health policy, and enable comparison of this pandemic to other health emergencies. This resource can help discover relationships between drugs and safety events, especially in cases of rare events and effects within population subgroups that differ in their risks of specific clinical outcomes and may be disproportionately affected by preventable inequities
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