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KMID : 1011320110040020058
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Journal of Pharmacoepidemiology and Risk Management
2011 Volume.4 No. 2 p.58 ~ p.62
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Spontaneous Adverse Events Report by the Pharmacovigilance Research Network in Korea
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Kim Hye-Kyung
Kim Woo-Sang
Jang Jung-Woo
Sun Woo-Sung
Kim Young-Sik
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Abstract
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Objective: The aim of this study is to describe the aspect of adverse events and associated drugs in spontaneous reporting database of pharmacovigilance research network of the 15 regional pharmacovigilance centers in Korea.
Methods: We used the spontaneously reported data from June 24, 2009 to February 28, 2010 of the 15 regional pharmacovigilance centers. Drugs and adverse events were converted to anatomical therapeutic chemical codes and World Health Organization-Adverse Reaction Terminology (WHO-ART), respectively. Spontaneous adverse events reports were 52,459 cases. These were analyzed by patient’s age, sex, generic name of drugs and system organ class.
Results: Voluntary adverse events reporting showed no difference between age and sex groups. 31% of adverse events were reported among aged 60 and over. Skin was the most frequent organ of adverse events. Most frequently reported adverse events was skin rash (24.0%) and followed by nausea/vomiting (20.9%), dizziness (5.0%), diarrhea (4.8%), abnormal liver function (3.7%) and fever/chill (3.0%). Anti-infective agent was most common drug class cause of adverse events (29%). Most frequently reported drug was oseltamivir because we had concentrated drug-monitoring for oseltamivir during flu epidemic.
Conclusion: Compared to the previous reports, it has improved the accuracy of the data. Despite the improvement of the data quality of reporting, more exact and careful report is necessary.
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KEYWORD
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Spontaneous adverse events, Pharmacovigilance
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