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KMID : 1011320090020020089
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Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 2 p.89 ~ p.96
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Pharmacovigilance System in General Hospitals Applied for the Regional Pharmacovigilance Center in Korea
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Kim Ye-Jee
Lee Joong-Yub
Choi Nam-Kyong
Shin Ju-Young
Seong Jong-Mi
Choi Hyun-Jin
Ahn So-Hyeon
Kim Mi-Sook
Yang Bo-Ram
Lee Jin-Ho
Park Byung-Joo
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Abstract
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Objective: To investigate the pharmacovigilance (PV) system in general hospitals applied for the regional PV center (RPVC) in Korea.
Methods: We identified the structure and function of hospital PV system using application forms for RPVC in 2009. All identifiable information on hospitals was blinded. The structures of PV system were evaluated upon the experience of ADR monitoring board operation and establishment of electronic medical record (EMR) reporting system. The function of PV system included number of ADR reports, causality assessments, academic researches and education from 2006 to 2009. Each of structural and functional aspects of PV system was assessed based on the previous experience of participating in RPVC funded by Korea Food and Drug Administration (KFDA).
Results: We recruited 26 general hospitals for analysis. Majority of hospitals had less than 1,000 beds and 200 specialists. The period of operating ADR monitoring board varied between zero and nine years. At present, most hospitals had built in EMR-based ADR reporting system and exclusive space for ADR monitoring. During the 4 recent years, more than 70% of general hospitals reported less than 500 ADR reports, among which the number of SAEs were less than 50. The number of ADR reported to KFDA was higher in general hospitals with previous experience of participating in RPVC after standardization by number of beds. The research and education activities concerning the spontaneous ADR monitoring was active in only 8 hospitals.
Conclusion: The RPVCs with previous experience of participating in PV program showed higher achievement in ADR monitoring activity even without difference in the structural aspect. Further efforts for development of the standardized guidelines will be needed to help general hospitals for establishing new RPVCs and also activating the existing RPVCs in Korea.
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KEYWORD
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Pharmacovigilance, Regional pharmacovigilance center, Adverse event, Adverse drug reaction report
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