의약품 안전관리를 위한 빅데이터의 활용

Abstract

The development of information technologies has led to the era of big data; such enormous collections of informationon drugs and adverse drug reactions are stored in either a structured, a semistructured, or an unstructured form. Because of the nature of the emerging issue of drug safety, it is common for policy makers and healthcare professionalsto make decisions without sufficient evidence. Big data may be used as an efficient pharmacovigilance tool, whichenables us to recognize adverse drug reactions that may not have been identified in pre-marketing clinical trials, inorder to capture the patterns of drug utilization and adverse events, and to predict the occurrence of adverse drugreactions. National surveillance systems using electronic health databases have been established successfully in the USand Europe. The Korea Institute of Drug Safety and Risk Management (KIDS) plans to establish a big data platform forpharmacovigilance in Korea. The big data may be effectively used for evidence-based regulatory and clinical decisionmaking in the field of drug safety and risk management.