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

2021 ◽  
Vol 12 (1) ◽  
pp. 5
Author(s):  
Hyeong-Geun Jo ◽  
Kyeoul Jeong ◽  
Ji-Young Ryu ◽  
Soyun Park ◽  
Yun-Seok Choi ◽  
...  
Keyword(s):  
Contrast Media ◽  
Adverse Drug Reactions ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
World Health ◽  
Reporting Odds Ratio ◽  
Global Public Health ◽  
Drug Reactions ◽  
Cross Sectional ◽  
Relative Paucity

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.

scholarly journals Real-world data-based adverse drug reactions detection from the Korea Adverse Event Reporting System databases with electronic health records-based detection algorithm

2021 ◽  
Vol 27 (3) ◽  
pp. 146045822110330
Author(s):  
Hyunah Shin ◽  
Jaehun Cha ◽  
Youngho Lee ◽  
Jong-Yeup Kim ◽  
Suehyun Lee
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
World Health ◽  
Drug Reactions ◽  
Event Reporting ◽  
Medical Databases ◽  
Electronic Health

Pharmacovigilance involves monitoring of drugs and their adverse drug reactions (ADRs) and is essential for their safety post-marketing. Because of the different types and structures of medical databases, several previous surveillance studies have analyzed only one database. In the present study, we extracted potential drug–ADR pairs from electronic health record (EHR) data using the MetaNurse algorithm and analyzed them using the Korean Adverse Event Reporting System (KAERS) database for systematic validation. The Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Adverse Reactions Terminology (WHO-ART) were mapped for signal detection. We used the Side Effect Resource (SIDER) database to select 2663 drug-ADR pairs to investigate unknown drug-induced ADRs. The reporting odds ratio (ROR) value was calculated for the drug-exposed and non-exposed groups of drug–ADR pairs, and 19 potential pairs showed significant signals. Appropriate terminology systems and criteria are needed to handle diverse medical databases.

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

2021 ◽  
Vol 14 (8) ◽  
pp. 783
Author(s):  
Yeo-Jin Choi ◽  
Seung-Won Yang ◽  
Won-Gun Kwack ◽  
Jun-Kyu Lee ◽  
Tae-Hee Lee ◽  
...  
Keyword(s):  
Heart Rate ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
World Health ◽  
Gastrointestinal Disorders ◽  
Reporting Odds Ratio ◽  
Cross Sectional ◽  
Factors Associated ◽  
Concurrent Use ◽  
Health Organization

This study aims to compare the prevalence and seriousness of adverse events (AEs) among sedatives used in critically ill patients or patients undergoing invasive procedures and to identify factors associated with serious AEs. Retrospective cross-sectional analysis of sedative-related AEs voluntarily reported to the Korea Adverse Event Reporting System from 2008 to 2017 was performed. All AEs were grouped using preferred terms and System Organ Classes per the World Health Organization—Adverse Reaction Terminology. Logistic regression was performed to identify factors associated with serious events. Among 95,188 AEs, including 3132 (3.3%) serious events, the most common etiologic sedative was fentanyl (58.8%), followed by pethidine (25.9%). Gastrointestinal disorders (54.2%) were the most frequent AEs. The most common serious AE was heart rate/rhythm disorders (33.1%). Serious AEs were significantly associated with male sex; pediatrics; etiologic sedative with etomidate at the highest risk, followed by dexmedetomidine, ketamine, and propofol; polypharmacy; combined sedative use; and concurrent use of corticosteroids, aspirin, neuromuscular blockers, and antihistamines (reporting odds ratio > 1, p < 0.001 for all). Sedative-induced AEs are most frequently reported with fentanyl, primarily manifesting as gastrointestinal disorders. Etomidate is associated with the highest risk of serious AEs, with the most common serious events being heart rate/rhythm disorders.

scholarly journals Completeness of adverse drug reactions reports of the Saudi adverse event reporting system

2015 ◽  
Vol 36 (7) ◽  
pp. 821-828 ◽  
Author(s):  
Thamir Alshammari, ◽  
Wa’ad Al-Kathiri ◽  
Hervé Le Louet ◽  
Hisham Aljadhey
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Event Reporting

Assessing Adverse Drug Reactions Reported for New Respiratory Medications in the FDA Adverse Event Reporting System Database

2021 ◽  
pp. respcare.08809
Author(s):  
Hyunwoo Kim ◽  
Colin M Pfeiffer ◽  
Matthew P Gray ◽  
Britney A Stottlemyer ◽  
Richard D Boyce ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Drug Reactions ◽  
Reporting System ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Drug Reactions ◽  
Event Reporting ◽  
System Database

scholarly journals A study on drug induced cutaneous adverse drug reactions at a tertiary care hospital, Mysore, India

2019 ◽  
Vol 8 (4) ◽  
pp. 777
Author(s):  
Kishore M. S. ◽  
Shashikala S. Konnur
Keyword(s):  
Adverse Drug Reactions ◽  
Adverse Reactions ◽  
Tertiary Care ◽  
World Health ◽  
Uppsala Monitoring Centre ◽  
Care Hospital ◽  
Drug Reactions ◽  
Drug Induced ◽  
Cross Sectional ◽  
Physician Visits

Background: Drugs, however safe and efficacious, are associated with risk of adverse reactions. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality. ADRs was rated as the fifth leading cause of death among all diseases. Consequences of ADRs range from diminished quality of life, increased physician visits, hospitalizations, and even death. The objectives of the study were to obtain information about drug induced cutaneous adverse reactions and to establish the causal relationship.Methods: Observational cross sectional study, a total of 76 patients were recruited for the study,conducted in dermatology outpatient department of K R Hospital Mysore Medical College And Research Institute Mysore for 3 months. The drug reactions were recorded in ADR form of Central Drugs Standard Control Organisation (CDSCO). Causality was assessed using Naranjo algorithm and World Health Organization- Uppsala monitoring centre (WHO-UMC) criteria.Results: 76 patients with CADRs were included in the study during the 3 months study period. Most common age group with CADRs was 20-30 years; with 55.73% of females 20.26% male and the most common suspected drug group causing CADRs was antimicrobial 35.46%. And most common lesion is maculopapular rashes. According to Naranjos scale 67.30% of CADRs were probably caused by drugs.Conclusions: variety of drugs causes CADRs. Awareness among clinicians is required for active reporting of CADRs. Patients need to be educated for the cautious use of drugs causing ADRs to prevent the same.

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