원내 약물부작용 보고 유형별 분석

Abstract

Pharmacovigiliance is the study of the safety of marketed drugs under the practical conditions of clinical use in large communities. The events of cold medicines containing PPA(Phenylpropanolamine) in 2004 are causing great concern in medical circles and KFDA(Korean Food and Drug Administration) reorganized various systems in this regard. In 2006, with the Korean regional pharmacovigilance(PV) program started in 3 regions, and in 2009,pharmacovigilance research network(PVnet) was established and Korean regional PV centers were enlarged in 15 areas. Each center promoted the invigorating of Pharmacovigiliance. By this effort, Internal adverse drug reaction(ADR) cases reported in KFDA increased rapidly from 148cases in 2002 to 26,827 cases in 2009. In spite of increasing trend, Institutional conditions in Korea are inadequate compared with developed country because of lack of social perception, medical team and nation actively participate in reporting ADR. Severance regional pharmacovigilance center was designated PV center and started OCS(Order Communication System) spontaneous ADR reporting program. But the problems with lack of enthusiastic education and promoting, worry about extended business hours and fear of accepting liability, etc affect limitation factors of spontaneous ADR reporting. So to expand ADR reporting, clinical data repository(CDR) auto detecting in 2006 and active surveillance in 2009 were imposed. The purpose of this study is to describe the methods to ADR reporting through the Severance Regional Pharmacovigilance center. Through this study, more effective ADR monitoring system presented, ultimately ADR reporting rates will has been rised so this study will contribute to active pharmacovigilance.