의약품 안전관리 선진화를 위한 한국의약품안전관리원의 역할 = The role of the KIDS for enhancing drug safety and risk management in Korea

다국어 초록 (Multilingual 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.

참고문헌 (Reference)

1 최남경, "한국형 DUR의 효과적 추진전략" 대한의사협회 53 (53): 1130-1138, 2010

2 최남경, "우리나라 약물유해반응 감시체계" 대한예방의학회 40 (40): 278-284, 2007

3 Evans SJ, "Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports" 10 : 483-486, 2001

4 Rothman KJ, "The reporting odds ratio and its advantages over the proportional reporting ratio" 13 : 519-523, 2004

5 Loke YK, "Systematic reviews of adverse effects: framework for a structured approach" 7 : 32-, 2007

6 Korea Food and Drug Administration, "Standard operation procedures for pharmacovigilance research network regional pharmacovigilance centers" Pharmacovigilance Research Network 2011

7 Park BJ, "Prospectus of the Korean Society for Pharmacoepidemiology and Risk Management" 1 : 5-7, 2008

8 Council for International Organizations of Medical Sciences Working Group VIII, "Practical aspects of signal detection in pharmacovigilance: report of CIOMS Working Group VIII" Council for International Organizations of Medical Sciences 2010

9 Jang BW, "Pharmaceutical affairs law and administration" SinilBooks 520-, 2012

10 Waller PC, "Managing drug safety issues with marketed products, In Stephens’ detection of new adverse drug reactions. 5th ed" John Wiley & Sons 345-374, 2004

11 Stahl M, "Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database" 13 : 355-363, 2004

12 최남경, "Increase in mortality rate following coprescription of cisapride and contraindicated drugs" HARVEY WHITNEY BOOKS CO 41 : 667-673, 200704

13 Uppsala Monitoring Center, "Guidelines for setting up and running a pharmacovigilance centre" Uppsala Monitoring Center

14 Hall GC, "Guidelines for good database selection and use in pharmacoepidemiology research" 21 : 1-10, 2012

15 Center for Drug Evaluation and Research (US), "Guidance for industry: good pharmacovigilance practices and pharmacoepidemiologic assessment" US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2005

16 Park BJ, "Drug utilization review" 1 : 13-19, 2008

17 Seong JM, "Development of signal detection program for adverse drug reaction" 4 : 15-21, 2011

18 Uppsala Monitoring Center, "Active ICSRS in the WHO global ICSR database per million inhabitants and year" Uppsala Monitoring Center

19 Bate A, "A Bayesian neural network method for adverse drug reaction signal generation" 54 : 315-321, 1998