J Korean Med Assoc JKMA Journal of the Korean Medical Association 1975-8456 2093-5951 Korean Medical Association 10.5124/jkma.2012.55.9.861 Focused Issue of This Month Drug Safety and Risk Management The role of the KIDS for enhancing drug safety and risk management in Korea Chung Soo Youn MD 1 Jung Sun-Young PhD 1 Shin Ju-Young PhD 1 Park Byung-Joo MD 1 2 Korea Institute of Drug Safety and Risk Management, Seoul, Korea. Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, Korea. Corresponding author: Byung-Joo Park, bjpark@drugsafe.or.kr 09 2012 20 09 2012 55 9 861 868 19 08 2012 31 08 2012 Copyright © 2012 Korean Medical Association 2012

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

 Pharmacovigilance Pharamcoepidemiology Drug utilization review Risk management Park BJ Prospectus of the Korean Society for Pharmacoepidemiology and Risk Management J Pharmacoepidemiol Risk Manag 2008 1 5 7 Korea Food and Drug Administration Pharmacovigilance Research Network Standard operation procedures for pharmacovigilance research network regional pharmacovigilance centers 2011 Seoul Pharmacovigilance Research Network Choi NK Park BJ Adverse drug reaction surveillance system in Korea J Prev Med Public Health 2007 40 278 284 Jang BW Pharmaceutical affairs law and administration 2012 Seoul SinilBooks 520 Uppsala Monitoring Center Active ICSRS in the WHO global ICSR database per million inhabitants and year [Internet] 2012 cited 2012 Aug 27 Uppsala Uppsala Monitoring Center Available from: http://who-umc.org/graphics/26930.gif Uppsala Monitoring Center Guidelines for setting up and running a pharmacovigilance centre [Internet] 2000 cited 2012 Aug 27 Uppsala Uppsala Monitoring Center Available from: http://www.who-umc.org/DynPage.aspx?id=105828&mn1=7347&mn2=7259&mn3=7297&mn4=7496 Evans SJ Waller PC Davis S Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports Pharmacoepidemiol Drug Saf 2001 10 483 486 Rothman KJ Lanes S Sacks ST The reporting odds ratio and its advantages over the proportional reporting ratio Pharmacoepidemiol Drug Saf 2004 13 519 523 Bate A Lindquist M Edwards IR Olsson S Orre R Lansner A De Freitas RM A Bayesian neural network method for adverse drug reaction signal generation Eur J Clin Pharmacol 1998 54 315 321 Seong JM Choi NK Ahn SH Park BJ Development of signal detection program for adverse drug reaction J Pharmacoepidemiol Risk Manag 2011 4 15 21 Council for International Organizations of Medical Sciences Working Group VIII Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII 2010 Geneva Council for International Organizations of Medical Sciences Stahl M Lindquist M Edwards IR Brown EG Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database Pharmacoepidemiol Drug Saf 2004 13 355 363 Center for Drug Evaluation and Research (US) Center for Biologics Evaluation and Research (US) Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment 2005 Rockville US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Waller PC Tilson HH Stephens MD Talbot JC Waller P Managing drug safety issues with marketed products Stephens' detection of new adverse drug reactions 2004 5th ed Hoboken John Wiley & Sons 345 374 Loke YK Price D Herxheimer A Cochrane Adverse Effects Methods Group Systematic reviews of adverse effects: framework for a structured approach BMC Med Res Methodol 2007 7 32 Hall GC Sauer B Bourke A Brown JS Reynolds MW Casale RL Guidelines for good database selection and use in pharmacoepidemiology research Pharmacoepidemiol Drug Saf 2012 21 1 10 Choi NK Hahn S Park BJ Increase in mortality rate following coprescription of cisapride and contraindicated drugs Ann Pharmacother 2007 41 667 673 Park BJ Drug utilization review J Pharmacoepidemiol Risk Manag 2008 1 13 19 Choi NK Park BJ Strategy for establishing an effective Korean drug utilization review system J Korean Med Assoc 2010 53 1130 1138

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.

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

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.