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KMID : 1011320170090010001
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Journal of Pharmacoepidemiology and Risk Management
2017 Volume.9 No. 1 p.1 ~ p.10
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New Trend of Pharmacovigilance: Transition from Passive to Active Surveillance by Using Distributed Drug Safety Monitoring System
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Kang Min-Gyu
Kang Dong-Yoon
Kang Hye-Ryun
Lee Sue-Hyun
Kim Ju-Han
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Abstract
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Recent advances in the fields of big data and artificial intelligence are rapidly changing many aspects of medicine. In pharmacovigilance, passive surveillance such as spontaneous reporting has crucial roles for many years. However, active surveillances, which attempts to incorporate development of computer technology, is getting more attention recently. U.S FDA created Sentinel Initiatives, which is an active monitoring system of adverse drug reactions. Sentinel is a data-driven active monitoring tools based on a common data model (CDM) optimized to active monitoring of drug safety and collaborate with data partners such as insurance companies, hospitals, and other research networks. U.S FDA is now actively monitoring the safety of many drugs by using these CDM based distributed analysis system called Sentinel Initiatives. Pharmacovigilance in Korea has experienced dramatic developments in quantity, and this is a result of the active encouragement of passive surveillance such as individual case reporting system. Recently, government officials, clinicians, and researchers are also interested in active surveillance systems operated by CDM based distributed approach. In this review, we reviewed the current status of pharmacovigilance in Korea and will introduce the U.S. FDA’s Sentinel initiatives and the main concept of CDM and distributed analysis.
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KEYWORD
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Pharmacovigilance, Adverse Drug Reaction Reporting Systems, Common Data Elements
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