Abstract
Adverse drug reactions (ADRs) pose a global public health threat, substantially contributing to death. Due to the relative paucity of clinical evidence regarding fatal ADRs, this study was performed to characterize the epidemiology of fatal ADRs in Korea. This was a retrospective, cross-sectional analysis of ADR cases reported to the Korea Adverse Event Reporting System from 2010 to 2019. All ADRs were coded using the World Health Organization-Adverse Reaction Terminology system and classified as either fatal or non-fatal events. Logistic regression was performed to identify factors associated with fatal events. Among 289,756 ADR records, 629 fatal events (0.2%) occurred. The most common causative agent of fatal ADRs was antibacterials (20.3%), followed by antimycobacterials (5.4%), analgesics (4.0%), and contrast media (1.9%). Among antimicrobials, vancomycin was most frequently implicated without significantly increasing the risk of fatal events. The risk for fatal ADRs was significantly increased with male sex; advanced age; polypharmacy; piperacillin/β-lactamase inhibitor; cefotetan; ceftriaxone; combination antimycobacterial therapy consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol; morphine; and iopromide (reporting odds ratio > 1, p < 0.05 for all). Although fatal ADRs are uncommon (<1%) in Korea, they are primarily caused by commonly used medications including antibiotics, analgesics, and contrast media.
Highlights
Adverse drug reactions (ADRs) pose a substantial global burden in healthcare and medicine, endangering patient safety
A total of 289,756 adverse drug events (ADEs) records reported to the Korea Adverse Event Reporting System (KAERS) from January 2010 to December 2019 were included in this study
While non-fatal ADRs were more likely to occur in females [n = 164,621 (56.9%)], fatal events were predominantly reported in males [n = 361 (57.4%)]
Summary
Adverse drug reactions (ADRs) pose a substantial global burden in healthcare and medicine, endangering patient safety. According to the Global Burden of Disease Study, ADRs commonly occur with the reported prevalence and incidence of 2,673,100 and 34,975,000 in 2017, respectively [1]. According to the Food and Drug Administration (FDA), the number of serious adverse event reports has been consistently increasing every year, leading to a 2.6-fold increase in the total serious adverse event reports from 2006 to 2014 [3]. Previous studies suggested adverse drug events (ADEs) as one of the most common causes of hospitalization, accounting for approximately. The number of fatal ADE cases reported to the FDA has been continuously increasing with a 2.7-fold increase over the period of 2006 to 2014 [3], accounting for the fourth to sixth leading cause of death [6]
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