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KMID : 1011320120050020087
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Journal of Pharmacoepidemiology and Risk Management
2012 Volume.5 No. 2 p.87 ~ p.91
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Standardization of the Criteria for Serious Adverse Event/Adverse Drug Reaction in Spontaneous Reporting: Korea Food and Drug Administration Pharmacovigilance Research Network Regional Pharmacovigilance Centers
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Shin Hee-Young
Hong Chein-Soo
Park Byung-Joo
Kim Sang-Heon
Kim Cheol-Woo
Kim Tae-Bum
Park Young-Min
Park Hye-Kyung
Sohn Seong-Wook
Lee Byung-Jae
Lee Jae-Hyun
Koh Young-Il
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Abstract
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Objective: There have been no consistent criteria for serious adverse event (AE)/adverse drug reaction (ADR) in spontaneous reporting from Regional Pharmacovigilance Centers (RPVCs) in Korea. This study aimed to develop the standardization of the criteria for serious AE/ADR.
Methods: A task force team (TFT) was organized to make a draft for the standardized criteria for serious AE/ADR among the researchers of RPVCs. First, the current situations of serious AE/ADR reporting were reviewed, and then the first version of the standardized criteria for serious AE/ADR was prepared. After having feedbacks and discussions, the TFT made the revision. The revised standardization was reviewed again and finalized through the consensus of researchers.
Results: The questionnaire on the current criteria for serious AE/ADR in RPVCs revealed that each center had different detailed criteria or it did not have specific criteria. The standardized criteria for serious AE/ADR were proposed and modified through feedbacks and discussions. The criteria including detailed information on six conditions were finalized.
Conclusion: The standardization of the criteria for serious AE/ADR will help RPVCs report in a consistent way and improve the quality of spontaneous reporting data.
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KEYWORD
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Pharmacovigilance, Regional pharmacovigilance center, Serious adverse event, Adverse drug reaction, Standardization
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