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KMID : 1011320100030030128
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Journal of Pharmacoepidemiology and Risk Management
2010 Volume.3 No. 3 p.128 ~ p.136
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Analysis of Adverse Event Reports Received in KFDA for 2009
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Ha Ji-Hye
Rhou Mi-Kyung
Kim Young-Hoon
Na Han-Sung
Shin Hee-Jung
Park Hyun-Joo
Kim Hae-Deun
Kim Ja-Young
Kim Min-Woo
Han Soon-Young
Kim Seung-Hee
Chung Kyu-Hyuk
Lee Eui-Kyung
Chung Myeon-Woo
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Abstract
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Objective: To describe characteristics and reporting patterns of the spontaneous adverse event reported to Korea Food and Drug Administration (KFDA) in 2009.
Methods: First, active ingredients and adverse events were coded to Anatomical Therapeutic Chemical (ATC) classification code and World Health Organization-Adverse Reaction Terminology (WHO-ART) code, respectively. The number of reports and reporting proportion were analyzed by report sources. Patient characteristics (age, gender) and reporting proportion were also analyzed. The number of reports and reporting rate were obtained by ATC and WHO-ART code.
Results: In 2009, KFDA received 26,827 adverse event report documents and some reports which were lack of suspicious drug or adverse event information could not be entered to KFDA spontaneous reporting database from them. The total number of AE case reports was 25,135 and the total number of adverse event was 36,637. In the age group, ‘unknown’ was the most reported group in 4,129 cases (16.43%) followed by 50’s (50-59 years) and 12,390 cases (49.3%) were reported from female. The most frequent reporting source was hospital in 15,589 cases (58.1%) because of setting 15 regional pharmacovigilance centers in the whole country. Pharmaceutical company was now second place in 11,077 cases (41.3%). Most frequently reported drug class was direct acting antivirals. According to the WHO-ART code, the most frequently reported system-organ class was gastro-intestinal system disorders system for 8,920 events (24.4%) followed by skin and appendages disorders system in 7,995 events (21.8%).
Conclusion:The number of spontaneous adverse drug reaction reporting has reached scores of thousands per year mainly from two sources, regional pharmacovigilance centers (RPVCs, 58.1%) and pharmaceutical companies (41.3%). There are still needs to boost consumers and local pharmacists to report. This could help KFDA in post-authorization safety management with domestic spontaneous reporting data from various sources and with good quality.
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KEYWORD
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Adverse event, Characteristic of adverse event, Pharmacovigilance, Spontaneous adverse event monitoring
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