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KMID : 1011320130060010037
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Journal of Pharmacoepidemiology and Risk Management
2013 Volume.6 No. 1 p.37 ~ p.42
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Analysis of Safety Letters and Alerts in Korea Food & Drug Administration, 2001-2011
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Kim Mi-Sook
Shin Ju-Young
Kim Ji-Young
Jin Xue-Mei
Lee Jin-Ho
Park Byung-Joo
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Abstract
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Objective: To describe the characteristics and patterns of safety letters and alerts issued by the Korea Food and Drug Administration (KFDA) from 2001 to 2011.
Methods: This study was conducted to analyze the data based on the safety letters and alerts issued from KFDA between January 2001 and December 2011. The frequency and proportion of safety letters and alerts were described along the year. Evidence of safety letters were categorized according to the source countries including the Korea, US, Europe, Japan, France and others, and their frequency and proportion were also described along the year.
Results: One hundred and fifty one safety letters were issued during 11 years. The number of issued safety letters increased steadily along the year, and increased sharply since 2008. Most frequent safety information sources were from US FDA (53.6%), followed by EMA (8.6%), and it expanded to from the diverse countries such as France, Japan and Canada recently. Among the evidence source of safety letters from Korea, the most frequent source was the reports of adverse drug reaction (33.3%), followed by off-label use (20.0%), and media reports (13.3%).
Conclusion: Safety letters and alerts have been increased recently reflecting the increasing awareness of the importance of risk communication and the growing of the drug market. Scientific evidences generated from Korean should be encouraged and also the effective system would be established for risk communication.
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KEYWORD
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Safety alert, Risk communication, Korea food & drug administration, Drug safety information
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