2023 FDA Science Forum
Medication Errors and Risk-Mitigation Strategies for COVID-19 Emergency Use Authorization Drug Products
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Contributing OfficeCenter for Drug Evaluation and Research
Abstract
Background:
The Food and Drug Administration (FDA) has authorized 19 drug products (DP) for Emergency Use Authorization (EUA) in the management of COVID-19. As a part of the EUA, the FDA mandated prescribers or designee to report to the FDA all medication errors (ME) and serious adverse events potentially related to an EUA DP. However, little is known about the overall reporting patterns for MEs, and how this information can be considered for future EUA DPs.
Purpose:
The purpose of this project is to describe ME reporting patterns (including types of MEs, contributing factors, outcomes, and mitigation strategies) associated with EUA DPs. The findings will inform strategies to mitigate MEs related to EUA DP names, labeling, packaging, and design.
Methods:
We searched the FDA Adverse Event Reporting System (FAERS) for US ME reports submitted between February 4th, 2020 and December 31st, 2022 for all EUA DPs authorized for use in the management of COVID-19. The reports were categorized by report type, reporter qualifications (healthcare provider or consumer), DP name and type (injection or tablet), type of ME, contributing factors, reporter recommendations to mitigate the errors, and outcome. Descriptive analyses were performed to identify the ME patterns.
Results:
FAERS contained 3,625 US ME reports associated with the 16 EUA DPs. Fifty-four percent of the cases were associated with oral dosage forms (e.g., Paxlovid) versus injectables. The most frequently reported MEs across all products were incorrect dose, product storage error, incorrect duration of administration, contraindicated product administered (usually related to drug interactions), wrong technique in product usage process, product dispensing error, and product prescribing error. Healthcare providers reported 1,830 of the cases, of which 32% were reported directly to FDA via MedWatch. Approximately 10% of the cases reported a serious outcome, which was more likely related to drug therapy or underlying medical conditions than a ME.
Conclusion:
The analysis characterized MEs for EUA products and identified ME patterns and contributing factors related to EUA DP names, labeling, packaging, and design. Future studies are needed to evaluate the impact of the ME reports to further inform mitigation strategies for EUA DPs.
