J Korean Med Assoc.  2012 Sep;55(9):861-868. 10.5124/jkma.2012.55.9.861.

The role of the KIDS for enhancing drug safety and risk management in Korea

• Chung SY
• Jung SY
• Shin JY
• Park BJ

• KMID: 1787249
• DOI: http://doi.org/10.5124/jkma.2012.55.9.861

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.

Keyword

Pharmacovigilance; Pharamcoepidemiology; Drug utilization review; Risk management

MeSH Terms

Drug Toxicity
Drug Utilization Review
Health Occupations
Humans
Korea
Missions and Missionaries
Pharmacovigilance
Retrospective Studies
Risk Management

Figure

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  Figure 1 Organization and work process of Korea Institute of Drug Safety and Risk Management (KIDS). ADR, adverse drug reaction; RPVC, regional pharmacovigilance center; HCP, healthcare professional; ICSR, individual case safety reports; DUR, drug utilization review; KFDA, Korea Food and Drug Administration.

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  Figure 2 Spontaneous adverse event reports in Korea. AE, adverse event; KDFA, Korea Food and Drug Administration; PV, pharmacovigilance.

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  Figure 3 National adverse drug reaction monitoring system. RPVC, regional pharmacovigilance center; HCP, Healthcare Professionals, WHO-UMC, World Health Organization-Uppsala Monitoring Center; AsPEN, Asian Pharmaco-Epidemiology Network; KFDA, Korea Food and Drug Administration; KIDS, Korea Institute of Drug Safety and Risk Management; ADR, Adverse Drug Reaction; HIRA, Health Insurance Review and Assessment Service; NSO, National Statistical Office; EMR, Electronic Medical Record; NECA, National Evidence-based Healthcare Collaborating Agency.

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