(179) Descriptive Analysis of Disproportionate Medication Errors and Associated Patient-Characteristics in The Food and Drug Administration's Adverse Event Reporting System

Publication Number: 510

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

Objectives: To assess MEs, associated patient characteristics and signals of disproportionate reporting (SDRs) on MEs in the Food and Drug Administration’s Adverse Event Reporting System (FAERS).

Methods: FAERS-report data from 2004-2020 was used. ME-related reports were identified by using Preferred Terms (PTs) from the broad Standardised MedDRA Query (SMQ) for MEs. Drug-names have been standardized and mapped to the Anatomical Therapeutic Chemical (ATC) classification system with a forked version of the Adverse Event Open Learning through Universal Standardization (AEOLUS)-system. SDRs were investigated using the reporting odds ratio (ROR). Statistical significance of SDRs was based on a minimum case-count of ≥3 and a lower level 95% confidence interval (CI) of ≥1.

Results: The dataset contained 14,919,552 case reports of which 849,284 (6%) were identified as ME-related, being mostly (57%) submitted by consumers. Yearly ME-reports increased from 157,022 in 2004 up to 1,438,193 in 2020. Reports were characterized by 54% women, 33% men and 13% was unspecified. Median age was 56 years (interquartile range: 35-69 years). In 2 out of 3 cases, 1 unique drug was listed per report. Around 37% of the reports stated a serious health outcome while all other reports did not report an outcome. The most prevalent drug-indications were related to musculoskeletal and connective tissue disorders (11%), psychiatric disorders (10%) and surgical and medical procedures (10%), while 31% of the reports had no indication relating to the drug of interest. The most prevalent ATC-based drug classes were antineoplastic and immunomodulating agents (25%), agents acting on the nervous system (22%) and agents acting on the alimentary tract and metabolism (13%). The most common narrow PT was "incorrect dose administered" (9%) and the most common broad PT was "overdose" (11%). A total of 447 SDRs have been identified of which 408 (91%) represented the narrow SMQ. Adapalene was the most common drug associated with 30,618 MEs and a ROR of 3.22 (95% CI: 3.18-3.26). Ipratropium bromide was associated with 8 MEs and had the strongest ROR of 36 (95% CI: 13-101).

Conclusions: This study offers a first of it’s kind characterization of MEs and the associated patients. Reported MEs are frequent and can lead to serious health risks in individuals. This FAERS data provides insights for future efforts on ME-prevention and additional in-depth analyses.