摘要
目的:评价中国医院药物警戒系统(China Hospital Pharmacovigilance System,CHPS)对医院药品不良反应(adverse drug reactions,ADRs)上报的影响。方法:选取2019年1月—12月(安装CHPS前,56例)、2020年1月—12月(安装过渡期,70例)和2021年1月—12月(安装CHPS后,161例)福建省福州儿童医院上报的ADRs作为研究资料,比较安装CHPS前后医院上报ADRs的数量和质量。结果:安装CHPS后医院的ADR上报数较安装CHPS前明显增加(161例vs 56例),增幅达187.50%,其中新的或严重ADRs的上报数亦是明显增加(25例vs9例);安装CHPS后医院所上报ADR的报告质量总分亦较安装CHPS前显著提高(85.88±8.572 vs 68.73±12.075,P<0.05);安装CHPS后上报的ADR中超说明书用药的例数较安装CHPS前有所增加(5例vs 20例),但其占比经比较无统计学意义(8.93 vs 12.42%,P>0.05)。结论:安装CHPS有效减少了医院ADRs的漏报、少报情况,并且有效提升了ADRs的报告质量。
Objective:To evaluate the impact of China Hospital Pharmacovigilance System(CHPS)on reporting adverse drug reactions(ADRs)in hospitals.Methods:ADRs reported by Fuzhou Children's Hospital of Fujian Province from January to December 2019(56 cases before installing CHPS),January to December 2020(70 cases during the installation transition period),and January to December 2021(161 cases after installing CHPS)were selected as the research data to compare the quantity and quality of ADR reports of the hospital before and after installing CHPS.Results:After installing CHPS,the number of ADRs reported by the hospital significantly increased compared to that before installing CHPS(161 cases vs 56 cases),with an increase of 187.50%.Among them,the number of new or severe ADRs reported also increased significantly(25 cases vs 9 cases).The total quality score of ADR reports of the hospital after installing CHPS also significantly improved compared to that before installing CHPS(85.88±8.572 vs 68.73±12.075,P<0.05).The number of ADR cases reported after installing CHPS increased compared with that before installing CHPS(5 cases vs 20 cases),but the proportion was not statistically significant(8.93%vs 12.42%,P>0.05).Conclusion:Due to installation of the CHPS,the missed reporting and underreporting of hospital ADRs are effectively reduced,and the reporting quality of ADRs is effectively improved.
作者
陈榕
翁烽
张惠玲
黄允玲
蔡华晶
CHEN Rong;WENG Feng;ZHANG Hui-ling;HUANG Yun-ling;CAI Hua-jing(Department of Pharmacy,Fuzhou Children's Hospital of Fujian Province,Fuzhou 350001,China)
出处
《抗感染药学》
2023年第9期914-917,共4页
Anti-infection Pharmacy
关键词
中国医院药物警戒系统
药品不良反应
报告质量
规范性
完整性
China Hospital Pharmacovigilance System
adverse drug reactions
reporting quality
standardization
integrity
作者简介
陈榕(1991-),女,药师【电子邮箱】617065906@qq.com。
