Wu F L, Yang C C, Shen L J, Chen C Y
School of Pharmacy, Department of Family Medicine, National Taiwan University Hospital, Taipei.
J Formos Med Assoc. 1996 Mar;95(3):241-6.
The preliminary results of an interdisciplinary active surveillance adverse drug reaction (ADR) reporting program conducted from April 1992 to December 1993 in the family medicine ward of National Taiwan University Hospital are presented. During this period, every admitted patient was screened for any possible drug-related problems; suspected ADRs were evaluated and documented. The USA Food and Drug Administration's definition of ADR was used, and Naranjo's scale was used to estimate the probability of drug-induced events. A total of 41 ADRs were identified in 38 patients. Among these 41 cases, 18 ADRs occurred during hospitalization, and 23 were the reason for hospitalization. The incidence of ADRs rated as probable or highly probable during hospital stay was 2.0%, or 2.7% if possible reactions were included (based upon 666 hospital admissions to the unit during the study period). The occurrence of admissions due to ADRs rated as highly probable or probable was 2.7%, or 3.5% if possible reactions were included. Twenty-one ADRs (51.2%) were type A reactions and 20 (48.8%) were type B. Thirty-three ADRs (80.5%) were classified as serious or moderate. There was no mortality. Further studies are warranted to determine the incidence of ADRs in different patient populations in Taiwan.
本文呈现了1992年4月至1993年12月在台湾大学医院家庭医学病房开展的一项跨学科主动监测药物不良反应(ADR)报告项目的初步结果。在此期间,对每位入院患者筛查任何可能的药物相关问题;对疑似ADR进行评估并记录。采用美国食品药品监督管理局对ADR的定义,并使用纳兰霍量表来评估药物所致事件的可能性。在38例患者中共识别出41例ADR。在这41例病例中,18例ADR发生在住院期间,23例是住院原因。住院期间评定为很可能或极可能的ADR发生率为2.0%,若包括可能的反应则为2.7%(基于研究期间该科室666例住院病例)。因评定为极可能或很可能的ADR而住院的发生率为2.7%,若包括可能的反应则为3.5%。21例ADR(51.2%)为A型反应,20例(48.8%)为B型反应。33例ADR(80.5%)被分类为严重或中度。无死亡病例。有必要开展进一步研究以确定台湾不同患者群体中ADR的发生率。