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KMID : 1011320080010010020
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Journal of Pharmacoepidemiology and Risk Management
2008 Volume.1 No. 1 p.20 ~ p.24
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Spontaneous Adverse Drug Reaction Reporting Program in Korea
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Park Jung-Won
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Abstract
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Spontaneous adverse drug reaction (ADR) reporting program is the component of postmarket surveillance and may contribute to prevent the occurrence of the ADR. In 1988, spontaneous ADR reporting program has been introduced in Korea, but little progress was done till 2006 when the Korean regional pharmacovigilance (PV) program started. 6 regional PV centers were established at the leading general hospitals and the centers organized the regional PV programs with the private clinics or pharmacy. In 2007, Korean Association of Regional PharmacoVigilance Center (KARP) was found based on the 9 centers which consisted of 731 private clinics or pharmacy, and the association reported to KFDA 1,512 cases in 2007 only. The association collected the ADR cases from doctors, pharmacists, nurses and patients using Fax or homepage (www.medalert.co.kr) and adapted WHO-Uppsala monitoring center criteria for evaluation of causal-relationship. There are some points to be supplemented in the Korean spontaneous ADR reporting programs. Low reporting rate is the main problem of spontaneous ADR reporting. Education for the significance of spontaneous reporting is urgent. The ADR reporting pipelines are not yet unified. ADR cases are now collected by both KFDA and KARP centers, but the KFDA has little capacity to evaluate the ADR causal relationship, and the credence for government has been markedly impaired by the recent public health issues. KARP may be the solution for the problems and contribute to the successful settlement of postmarket surveillance program in Korea.
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KEYWORD
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Spontaneous adverse drug reaction reporting, Regional pharmacovigilance center
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