我院35种常用口服药物国产与进口药品说明书对比分析  

Comparison and analysis on domestic and imported instructions of 35 kinds of oral drugs in our hospital

作　　者：王维娜[1] 沈素[1] 

机构地区：[1]首都医科大学附属北京友谊医院西药剂科,北京100050

出　　处：《中国医药导报》2016年第12期189-192,共4页China Medical Herald

摘　　要：目的调查首都医科大学附属北京友谊医院(以下简称"我院")进口和国产药品说明书的编写情况,为促进药品说明书及其监管工作的科学化、合理化和规范化提供参考。方法对我院35种口服药物的进口和国产说明书进行对比分析,提出修改和完善建议。结果 35组说明书存在不同程度的差异,其中16组说明书差别较大,有4个或以上的差异项目。相比于进口药品,国产说明书往往存在完整性、规范性和科学性较差等问题。结论相关部门应加强管理,重视说明书的定期修订和更新;药学人员应大力宣传说明书的重要性;其他医务人员和患者应提高对说明书的重视程度,以促进药品说明书及其监管工作的规范化,确保临床安全合理用药。Objective To investigate the status of preparation of the domestic and imported drug instructions in Beijing Friendship Hospital, Capital Medical University （＂our hospital＂ for short）, so as to provide references for scientific, reasonable and standardized development of the drug instructions and its supervision work. Methods The domestic and imported instructions of 35 kinds of oral drugs in our hospital were compared and analyzed, and some modification and im- provement suggestions were put forward. Results 35 groups of instructions had different degrees of difference. Large dif- ferences were found in 16 groups, with 4 or more different items. Compared with the imported instructions, the domestic instructions were found with poor integrity, normative and scientific. Conclusion Relevant departments should strength- en the instruction management and pay more attention to update and revise the instructions; the pharmacists should publicize the importance of instructions; medical staffs and patients should attach much weight to instructions, so as to promote the normative development of drug instructions and its supervision work, ensure the clinical rational drug use.

关 键 词：说明书 口服药物 国产药品 进口药品 

分 类 号：R969.3[医药卫生—药理学]