Comparative Safety Profiles of Sedatives Commonly Used in Clinical Practice: A 10-Year Nationwide Pharmacovigilance Study in Korea

Choi, Yeo Jin; Yang, Seung Won; Kwack, Won Gun; Lee, Tae Hee; Jang, Jun‐Bock; Chung, Eun Kyoung

doi:10.3390/ph14080783

Cited by 5 publications

(9 citation statements)

References 42 publications

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“…Similar to previous studies, our present study suggested an increased risk of drugrelated fatal events in males, elderly patients, and patients concurrently using multiple medications, which was confirmed in the univariate and subsequent multivariate analysis [28][29][30]. While aging and polypharmacy have been extensively reported in previous studies as major risk factors of serious ADRs [28,29], the increased risk of fatal ADRs in males compared to females could not be clearly explained from the physiological standpoint. However, this difference in the risk of drug-induced fatal events between genders might be accounted for by the different attitudes toward health [31,32].…”

Section: Discussionsupporting

confidence: 89%

Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

Jeong

Ryu

et al. 2021

JPM

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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.

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Section: Discussionsupporting

confidence: 89%

Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

Jeong

Ryu

et al. 2021

JPM

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“…Automated nationwide prospective registration of endoscopic procedures and outcomes may be the only reliable solution, as already successfully implemented in some countries (21)(22)(23)(24). This also accounts for the registration of anaesthesiology-related AE (25,26). Mandatory nationwide registration, which is currently not at the seams in Belgium, will also allow reliable analysis of high-volume data and subsequent publication.…”

Section: Discussionmentioning

confidence: 99%

How to track and register adverse events and incidents related to gastrointestinal endoscopy

Casa¹,

Monino²,

Deprez³

et al. 2022

AGEB

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Background and study aims: Gastrointestinal endoscopic procedures have evolved significantly in the last sixty years revolutionising the approach to the diagnostic and therapeutic spheres of medicine. Despite the advantages of using natural orifices to the bowel, adverse events (AE) may occur following endoscopy. Systematic AE registration is an objective in every realm of quality medicine. Despite the obvious advantage as a quality indicator, tracking endoscopy-related AE is not evident. The current study aimed at tracking all AE of all endoscopic procedures during a 3-month period. The three methods used were voluntary reporting by the endoscopist and by the patient in parallel with retrospective data analysis of patients’ electronic medical records to allow capture of all AE and comparison of the three methods. Patients and methods: During a 3-month period endoscopists and patients were requested to report any possible AE. At the end of the period, a systematic review of all patient files was performed to track all AE related to the endoscopic procedure or the endoscopyrelated anaesthesia. In total 2668 endoscopic procedures were reviewed. Results: The total AE rate was 1.95%. Only half (51.9%) of all AE were voluntarily reported by endoscopists, the other half were extracted from the electronic medical record. There were no patient-reported AE. Although the majority (66.7%) of unreported AE were mild, these findings illustrate that voluntary AE reporting is unreliable. However, the retrospective tracking process proved to be difficult and time-consuming. Conclusions: The current study highlighted that systematic registration of all endoscopy-related AE is feasible, but challenging because of multiple hurdles. More practical methods are warranted to obtain reliable and long-term data as part of endoscopy quality measures.

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“…The association of seriousness of drug-induced nephrotoxicity and causative drugs or drug classes was estimated using disproportionality analysis and was expressed in reporting odds ratios (RORs) with corresponding 95% confidence intervals (CIs) and Mantel–Haenszel adjusted p -values. RORs were estimated for specific offending medications or drug classes with at least three SAE reports [ 31 , 32 ]. Univariate analysis was conducted to identify predictors associated with SAEs and certain types of drug-induced nephrotoxicity, and factors included age, causality, sex, and polypharmacy (concurrent administration of at least 5 daily medications).…”

Section: Methodsmentioning

confidence: 99%

A Real-World Data Derived Pharmacovigilance Assessment on Drug-Induced Nephropathy: Implication on Gaps in Patient Care

Kim,

Choi,

Sunwoo

et al. 2023

Healthcare

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This retrospective cross-sectional study aims to investigate the prevalence and seriousness of drug-induced nephrotoxicity and to identify clinical predictors intensifying the seriousness of nephrotoxicity. Adverse drug events (ADEs) reported to the Korean Adverse Event Reporting System Database (KAERS DB) from January 2012 to December 2021 were investigated. The association between the seriousness and the etiologic drug was estimated in reporting odds ratio (ROR) based on disproportionality analysis. Logistic regression was utilized to recognize predictors associated with serious nephrotoxicity. The majority of ADEs were reported in ages 30 to 59, and immunosuppressants were the most etiologic medications. ADEs involving antibiotics, including vancomycin (ROR 0.268; 95% CI 0.129–0.557), were less likely to be serious. More than 93% of cyclosporine-related ADEs were serious nephrotoxicity, whereas tacrolimus was less likely to report serious nephrotoxicity (ROR 0.356; 95% CI 0.187–0.680). The risk of serious nephrotoxicity was decreased with aging (ROR 0.955; 95% CI 0.940–0.972) while increased in women (OR 2.700; 95% CI 1.450–5.008). Polypharmacy was associated with increased risk of interstitial nephritis (OR 1.019; 95% CI 1.001–1.038). However, further studies investigating the impact of clinical practice on ADE incidences as well as clinical prognosis related to nephrotoxicity are obligated.

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Comparative Safety Profiles of Sedatives Commonly Used in Clinical Practice: A 10-Year Nationwide Pharmacovigilance Study in Korea

Cited by 5 publications

References 42 publications

Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

Fatal Events Associated with Adverse Drug Reactions in the Korean National Pharmacovigilance Database

How to track and register adverse events and incidents related to gastrointestinal endoscopy

A Real-World Data Derived Pharmacovigilance Assessment on Drug-Induced Nephropathy: Implication on Gaps in Patient Care

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