32份治疗用生物制品类注射剂说明书标注项的调查与分析  

Survey and Analysis of Label Items in 32 Biological Products Injection for Treatment Instructions

作　　者：胡进平[1] 胡志红[2] 周成莉[2] 李化冰 吴国琴[1] 

机构地区：[1]马鞍山市疾病预防控制中心,安徽马鞍山243000 [2]马鞍山市中心医院,安徽马鞍山243000

出　　处：《中国药房》2016年第19期2722-2725,共4页China Pharmacy

摘　　要：目的:为进一步规范治疗用生物制品类注射剂说明书提供参考。方法:收集马鞍山市疾病预防控制中心和马鞍山市中心医院2015年1-6月在用的32份治疗用生物制品类注射剂说明书,对其标注项信息进行汇总分析。结果与结论:在收集的32份治疗用生物制品类注射剂说明书中,药品名称、主要成分、性状、适应证、规格、用法用量、包装、有效期、执行标准、批准文号、生产企业等项的标注率均达100%;不良反应、禁忌、注意事项、孕妇及哺乳期妇女用药、药物相互作用、药动学、老年用药、贮藏等项标注率虽然也较高,但有些项缺乏具体说明内容;儿童用药、药物过量、毒理、警示语、临床试验等项的标注率较低,分别仅为56.25%、62.50%、59.38%、37.50%、18.75%;部分治疗用生物制品类注射剂说明书的修订不及时、项目内容不完整、书写不规范,临床医师和患者难以通过说明书获取足够的用药安全信息。建议生产企业应尽可能将生物制品类注射剂说明书项目内容标注完整,及时修订与补充说明书中的相关内容,规范与完善说明书。OBJECTIVE：To provide reference for the further standardization of biological products injection for treatment instructions.METHODS：32 biological products injection for treatment instructions collected from Ma＇anshan Center for Disease Control and Prevention and Ma＇anshan Central Hospital during Jan.to Jun.in 2015.The information of marked item was summarized and analyzed.RESULTS CONCLUSIONS：Among 32 biological products injection for treatment instructions,the mark rates of drug names,main ingredients,character,indications,specification,usage and dosage,package,term of validity,operative norm,license number,manufacturing enterprise and other items all reached 100%.Although the mark rates of ADR,contraindication,precaution,drug use of pregnant women and nursing mothers,drug interactions,pharmacokinetics,drug use of the elderly,storage and other items were relatively high,but some items lacked the specific description of the content.The mark rates of drug use of children,drug overdose,toxicology,warnings,clinical trial were 56.25%,62.50%,59.38%,37.50% and 18.75%.Some biological products injection for treatment instructions are not revised timely and not complete in content and non-standard in writing,which can not meet the needs that clinical pharmacists and patients get enough drug safety information from instructions.Manufacturing enterprise is suggested to label the content of package inserts completely,verify and supplement related content,standardize and improve the instructions.

关 键 词：治疗用生物制品 注射剂 说明书 标注项 

分 类 号：R952[医药卫生—药学]