中药注射剂说明书中的警示缺陷  

Failure to warn in package insert of traditional Chinese medicine injection

作　　者：张建平[1] 

机构地区：[1]浙江医药高等专科学校,浙江宁波315100

出　　处：《中国医院药学杂志》2014年第8期664-667,共4页Chinese Journal of Hospital Pharmacy

基　　金：浙江省哲学社会科学规划课题"缺陷药品侵权的救济问题研究"(编号:11XKGJ10)

摘　　要：目的:分析中药注射剂说明书中的警示缺陷。方法:采用比较研究方法、文献研究方法。结果:中药注射剂说明书中的警示缺陷多表现为无效警示、不足警示及过时警示。结论:企业应对警示对象负责,说明书经过核准并不能排除警示缺陷的存在。药品警示并不能替代更为安全的药品设计。OBJECTIVE To analyze failure to warning in package insert of traditional Chinese medicine injection（TCMI）. METHODS Literature research method and comparative study method were adopted. RESULTS The warning defects on the package insert of traditional Chinese medicine injection consisted of invalid warning, inadequate and overdue warnings. CON- CLUSION Enterprises should be responsible for the warning objects. Package insert approved did not rule out the existence of warning defects Warning in package insert could not replace a safer drug design.

关 键 词：警示缺陷 药品说明书 中药注射剂 产品责任 药品不良反应 

分 类 号：R95[医药卫生—药学]