我院363份药品说明书中有关【药物-食物相互作用】信息的标注情况分析

Analysis of the Warning Remarks for "Drug and Food Interactions" in 363 Package Inserts

目的:了解药品说明书中有关【药物-食物相互作用】(DFI)项目信息的标注情况。方法:参考《化学药品非处方药说明书规范细则》、《化学药品和治疗用生物制品说明书规范细则》等的规定项目,对2010年我院共363份常用药物的药品说明书中有关DFI信息的标注情况进行统计、分析。结果:共涉及化学药269份,中成药94份;其中口服药161份,外用药43份,注射剂159份。调查中仅1份药品说明书明确标注了DFI信息,无任何DFI信息的占调查总数的63.6%,其余只能通过散列于多个项目中的内容获取DFI信息,如【用法用量】、【注意事项】等项目。结论:建议相关部门在药品说明书中增加DFI项目,为临床用药提供更明确的信息,避免食物与药物不良相互作用发生,以提高药物的安全性、有效性。

OBJECTIVE： To investigate the warning remarks for Drug and Food Interactiong （DFI） in package inserts. METHODS： Referring to Regulations for Over-the-counter Drugs Package Inserts of Chemical Drugs and Regulations for Chemical Drugs and Biological Products for Treatment, the warning remarks for DFI were analyzed statistically in 363 package inserts from our hospital in 2010. RESULTS： 269 chemical drugs and 94 Chinese patent medicines were involved, among which there were 161 oral drugs, 43 drugs for external use and 159 injections. Among 363 package inserts, only one package insert was labeled with DFI, and package inserts without any information of DFI accounted for 63.6%. DFI information of others only could be obtained from scattered various items, such as usage and dosage, caution. CONCLUSION： It is suggested to add the item of DFI in package inserts and provide exact information for clinical drug use to avoid adverse drug reactions caused by food and drug interactions, aiming to improve the safety and effectiveness of drugs.