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KMID : 1138720150410020019
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Korean Public Health Research
2015 Volume.41 No. 2 p.19 ~ p.28
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Recent Advance in Pharmacovigilance Activities of World Health Organization and U.S. Food and Drug Administration
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Seong Jong-Mi
Park Byung-Joo
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Abstract
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Objective: Pharmacovigilance(PV) aims to improve patient safety and welfare by reducing the risks of medicines, through the detection, assessment, understanding and prevention of adverse effects and other drug related problems. This study aimed to introduce recent advance in PV activities of World Health Organization (WHO) and U.S. Food and Drug Administration (FDA).
Methods: Information on recent PV activities of WHO and U.S. FDA were collected and reviewed through lectures and educational materials by WHO-Uppsala Monitoring Centre (UMC)’s staffs and U.S. FDA’s staffs in the 16th international training course of WHO-UMC.
Results: PV has seen rapid growth over the past decade and will continue to develop in response to the special needs. To support country for developing the stronger national systems of PV and adverse drug reaction (ADR) reporting, WHO has developed PV indicators that provide the standard of PV system. PV in principle involves the identification and evaluation of ADR signals. WHO-UMC has an intensified interest in the application of more advanced analysis methods to signal detection in PV. U.S. FDA build the process of postmarketing evaluation of new data on new molecular entities for the early release of safety information and post the summary information on the results of evaluation.
Conclusion: To advance PV system in Korea, it will be good to benchmark these recent activities of WHO and U.S. FDA
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KEYWORD
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pharmacovigilance, signal detection, postmarketing safety evaluation, risk communication
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