Descriptive analysis on disproportionate medication errors and associated patient characteristics in the Food and Drug Administration's Adverse Event Reporting System

Victor Pera*, Frauke Van Vaerenbergh, Jan Kors, Erik van Mulligen, Rowan Parry, M (Marcel) de Wilde, Lies Lahousse, Johan van der Lei, Peter Rijnbeek, Katia Verhamme

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

3 Downloads (Pure)

Abstract

Background
Medication errors (MEs) are a major public health concern which can cause harm and financial burden within the healthcare system. Characterizing MEs is crucial to develop strategies to mitigate MEs in the future.

Objectives
To characterize ME-associated reports, and investigate signals of disproportionate reporting (SDRs) on MEs in the Food and Drug Administration's Adverse Event Reporting System (FAERS).

Methods
FAERS data from 2004 to 2020 was used. ME reports were identified with the narrow Standardised Medical Dictionary for Regulatory Activities® (MedDRA®) Query (SMQ) for MEs. Drug names were converted to the Anatomical Therapeutic Chemical (ATC) classification. SDRs were investigated using the reporting odds ratio (ROR).

Results
In total 488 470 ME reports were identified, mostly (59%) submitted by consumers and mainly (55%) associated with females. Median age at time of ME was 57 years (interquartile range: 37–70 years). Approximately 1 out of 3 reports stated a serious health outcome. The most prevalent reported drug class was “antineoplastic and immunomodulating agents” (25%). The most common ME type was “incorrect dose administered” (9%). Of the 1659 SDRs obtained, adalimumab was the most common drug associated with MEs, noting a ROR of 1.22 (95% confidence interval: 1.21–1.24).

Conclusion
This study offers a first of its kind characterization of MEs as reported to FAERS. Reported MEs are frequent and may be associated with serious health outcomes. This FAERS data provides insights on ME prevention and offers possibilities for additional in-depth analyses.
Original languageEnglish
Article numbere5743
JournalPharmacoepidemiology and Drug Safety
Volume33
Issue number1
Early online date29 Dec 2023
DOIs
Publication statusPublished - Jan 2024

Bibliographical note

Publisher Copyright:
© 2023 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

Fingerprint

Dive into the research topics of 'Descriptive analysis on disproportionate medication errors and associated patient characteristics in the Food and Drug Administration's Adverse Event Reporting System'. Together they form a unique fingerprint.

Cite this