Characteristics of medication errors among respiratory drugs within the Food and Drug Administration’s Adverse Event Reporting System

Abstract

<b>Background:</b> Use of respiratory drugs, especially inhalators, is prone to medication errors (MEs) which lead or might lead to patient harm. Limited studies have been conducted on the frequency of MEs using spontaneous reporting systems. <b>Aim:</b> Investigate signals of disproportionate reporting (SDRs) on MEs among respiratory drugs (MERs) in Food and Drug Administration’s Adverse Event Reporting System (FAERS). <b>Methods:</b> FAERS-report data from 2004-2020 was used. All MERs were selected having&nbsp;Anatomical Therapeutic Chemical (ATC)-code 9R039. SDRs were investigated using the reporting odds ratio (ROR). <b>Results:</b> 39,163 MER-reports were identified giving a total of 46,431 respiratory drug-ME combinations. Around 87% of MERs were submitted by consumers. Most health outcomes for MERs were missing (85%) or resulted in hospitalization (6%) and other serious events (9%). Top-3 frequent SDRs are described in Table 1. Demographics of individuals with MERs are described in Table 2. Table 1 Table 2 <b>Conclusion:</b> MERs are frequent among commonly used respiratory drugs in practice and the majority relate to incorrect use of the device. Insight in FAERS reports is a first and import step in the prevention of MERs.