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KMID : 1011320160080010001
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Journal of Pharmacoepidemiology and Risk Management
2016 Volume.8 No. 1 p.1 ~ p.7
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Current Operating Status in the Foreign Regional Pharmacovigilance Centers
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Kim Su-Jin
Kim In-Hye
Kim Hyun-Jung
Jung Soo-Youn
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Abstract
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Spontaneous reporting of adverse drug reactions (ADRs) is the basis of pharmacovigilance (PV). Many countries operate monitoring centers for collecting and evaluating ADR reports, espacially regional PV centers (RPVCs). Most of RPVCs collect ADR reports, do causality assessment between suspected drugs and events, and then report safety information to national PV centers (NPVCs) or national regulatory authorities (NRAs). Also they offer consultations to patients and operate education and training programme for healthcare professionals to expand the PV activities. The number of RPVCs has been gradually increased globally. There are 31 RPVCs in France, 5 in United Kingdom, over 400 in China, 150 in India, and 27 in Korea in 2014. In this paper we examined current operation characteristics in the foreign RPVCs as well as their PV activities. Then, we proposed the direction for further development of operating PRVCs in Korea.
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KEYWORD
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Adverse drug reactions (ADRs), Pharmacovigilance (PV), Regional pharmacovigilance center (RPVC), National PV centers (NPVCs), National regulatory authorities (NRAs)
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