원내 소아 환자에서 보고된 약물 부작용 사례 분석

Abstract

Starting from introducing the adverse drug reaction monitoring system in 1988, KFDA selected several tertiary hospitals including Severance hospital as local pharmacovigilance centers to improve the system. The centers have been expanded to 15 units in 2009 and each center has been collecting, evaluating, and reporting adverse drug reaction cases. The Severance hospital has been also performing the role with ADR monitoring system in OCS. Since the pharmacovigilance research network was launched in July 2009, managing the information has been built up and each center participated in national ADR reporting activation. The centers of the pharmacovigilance research network are monitoring ADR focused about the child, the old, and the drugs that prohibited in more than 5 countries by UN. From among these,children used to be excluded from clinical trial due to ethic and safety reason. As a result, there is no standard of indication or dosage for children and many medicines used to treat children are not licensed for such use (off-label use). Furthermore, children may have different pharmacokinetics and dynamics to adults and therefore have particular vulnerability to ADRs. Moreover,considering many children cannot express their symptoms clearly, medications used for children require careful observation. Thus, we analyzed present condition of reporting and characteristics of ADR in children based on 130 examples (284 cases) of ADR in children less than 12 at Severance hospital from January 2008, to December 2009. Through this research, we would suggest that more safe and reasonable use of medications for children can be caused by intensive ADR monitoring and DUR for children,and tried to find some expected role of pharmacists