의약품 안전관리 선진화를 위한 한국의약품안전관리원의 역할

Abstract

Pharmacovigilance is defined as the science and activities relating to the detection, assessment,understanding and prevention of adverse effects or any other drug-related problem. The Korea Institute of Drug Safety and Risk Management (KIDS) was established in April 2012. The main missions of the KIDS are to collect, analyze, evaluate, and manage adverse drug reaction (ADR) data, develop drug utilization review (DUR) criteria, distribute medication guidelines for health professionals, perform retrospective DUR, and perform causality assessment on ADRs, or signals derived from spontaneous reporting or other sources. The KIDS aims to provide evidence to enhance national health quality through a better drug safety and risk management system in Korea. The purpose of this paper is to suggest possible approaches and the KIDS’s role in strengthening the pharmacovigilance system in Korea.