Korean J Med.  2021 Aug;96(4):341-351. 10.3904/kjm.2021.96.4.341.

A 10-Year Single-Center Experience of Adverse Drug Reaction Monitoring

• Park SB
• Moon M
• Kim HH
• Park GY
• Kang DY
• Lee JY
• Cho YS
• Kang HR
• Cho SH

• KMID: 2519162
• DOI: http://doi.org/10.3904/kjm.2021.96.4.341

Abstract

Background/Aims
Despite proper use of pharmaceuticals, adverse drug reactions (ADRs) can lead to problems related to patient safety. We analyzed the characteristics of ADRs, particularly serious adverse events (SAEs), in a single tertiary medical institution.
Methods
Spontaneous ADR report data collected from 2010 to 2019 in Seoul National University Hospital were assessed. Causality was evaluated according to the World Health Organization-Uppsala Monitoring Centre criteria. Age, sex, onset, severity, seriousness, and system organ class (SOC) of ADRs and SAEs were analyzed.
Results
During the study period, a total of 49,955 individual case safety reports were assessed as possible, probable, or certain. Although the number of gastrointestinal ADR reports was high (25.9%), severe cases were uncommon (2.6%). By contrast, the number of hematologic disorders was low (6.6%) but 39.2% of them were severe. Among ADRs, 10.2% were assessed as SAEs, the proportion of which was high at extreme ages and in males. Body as a whole-general disorders were the most frequently reported SOC for SAEs, followed by skin and appendage disorders. Antineoplastic agents and antibiotics were the most common causative agents of SAEs and ADRs. Anaphylactic reaction was the most frequent SAE (6.5%).
Conclusions
The proportion of SAE differs according to SOC and drug. Attention should be paid to SAEs in children and older adults because the rate of SAEs is significantly higher at extreme ages.

Keyword

약물이상반응 보고 시스템; 약물감시; 약물 관련 부작용; 임상약리; Adverse drug reaction reporting systems; Pharmacovigilance; Drug-related side effects and adverse reactions; Pharmacology, clinical