OBJECTIVES: The impact of COVID-19 on healthcare utilization has been widely reported, however little is known about its impact on patient safety. The objective of this research is to analyze data from the FDA Adverse Event Reporting System (FAERS) to identify trends in medication error reporting.

METHODS: Publicly available FAERS data extract files were utilized. Initial reports submitted between January 1, 2016 and September 30, 2021 were considered eligible for analysis. Duplicate records were excluded to avoid double counting. Medical Dictionary for Regulatory Activities (MedDRA) preferred terms for the standardized MedDRA query (SMQ) relating to medication errors were used to identify cases. The proportion of reports listing a medication error was calculated for each month during the period of observation. Reports were classified as pre-COVID-19 (January 2016 to December 2019) or COVID-19 months (January 2020 to September 2021) based on the date the report was written. Comparisons were made between pre-COVID-19 and COVID-19 time-periods using disproportionality and change-point analysis methods.

RESULTS: 5.6 million eligible reports were analyzed with 13% (728,785) reporting a medication error. Disproportionality analysis identified an increased risk of medication errors (proportional medication error reporting ratio = 1.06, p<0.001) during the COVID months compared to non-COVID months (crude risk = 0.134 vs 0.127, respectively). A change point analysis observed that specific change points occurred during months: April 2018 (increasing trend), November 2018 (decreasing trend) and July 2020 (increasing trend).

CONCLUSION: We identified a small increase in the proportion of FAERS reports listing a medication error during the COVID-19 months. The identified change points warrant further inspection of subgroups to investigate whether factors contributing to increased rates of medication errors can be identified (e.g., source of report and type of medication error).