我院常用75种注射用抗感染药物药品说明书分析

Analysis on Package Inserts for 75 Kinds of Commonly Used Anti- infective Agents for Injection in Our Hospital

目的:了解我院常用注射用抗感染药物药品说明书标注内容的完整性,为临床合理使用注射用抗感染药物提供参考。方法:根据《药品说明书规范细则(暂行)》和《药品说明书和标签管理规定》,对我院常用注射用抗感染药物药品说明书应包含项目进行调查和统计分析。结果:本次调查共纳入75种注射用抗感染药物药品说明书,药品说明书中规定应有的项目标注率较高,但一些与临床用药密切相关的项目,例如用法用量、儿童用药、药物过量、易过敏药物的皮试等详细标注的比例较低,药动学、药理毒理、不良反应等项目内容详细程度差异较大,尤其是国产药品叙述较为简单。结论:建议生产厂家细化药品过量、特殊人群用药等项目的标注内容,详细说明药物使用方法,使之更具有指导性,确保临床用药安全、有效。

OBJECTIVE:To probe into the integrity of package insert for 75 kinds of commonly used antiinfective agents for injection in our hospital and to provide reference for rational use of antiinfective agents for injection. METHODS:According to Drug Description Specification and Management Regulation for Drug Description and Label,the terms included in package insert for antiinfective agents for injection were analyzed statistically. RESULTS:The package inserts for 75 kinds of antiinfective agents for injection were enrolled. The proportion of integral items were high while that of some terms related to clinic were low such as dosage and usage,medication for children,over dosage and skin test. The descriptions of PK,pharmacology,toxicdogy, ADR,et al. were very simple and different. CONCLUSION:It is suggested that items about over dosage and medication for special population should be detailed as well as usage so that package insert can guide rational use of drugs in the clinic.