摘要
目的:规范管理药品标签与说明书,确保患者用药的安全合理。方法:按照《药品说明书和标签管理规定》及其配套文件逐项调查某医院447种常用药品标签和说明书。结果 :药品标签和说明书存在缺项,项目内容未按规定标示,字体不规范、印字脱落,未按规定要求排版,标签内容与说明书不一致等5类主要问题。结论:药品标签和说明书相关法规文件的执行有待加强,药品生产企业需进一步严格规范药品标签和说明书的撰写并不断完善,药监部门要将其作为药品法制管理的重要内容加以规范,医疗机构、经营企业发现问题要加强与药监部门及生产企业的沟通。
Objective ：To standardize the administration of labels and package inserts of drugs and make sure that patients use drug safely and reasonably. Methods ：According to the Regulations for the Management of Labels and Package Inserts of Drugs and its supporting documents,447 kinds of commonly used drug labels and package inserts were investigated. Results ：Problems were found in drug labels and package inserts such as missing items in both drug labels and package inserts,item contents not meeting with the requirements,nonstandard fonts,printing off,composing type not meeting with the requirements and the inconformity of label contents to package inserts.Conclusion ： The relevant regulations for drug labels and package inserts should be followed more strictly.Pharmaceutical enterprises should further standardize the compiling of drug labels and package inserts and make improvement. Drug administrative departments should attach the importance to the standardization of legal management of drugs. Medical institution and business enterprises should intensify communication with drug supervision departments and pharmaceutical producing enterprises if finding problems.
出处
《中国执业药师》
CAS
2015年第3期12-16,共5页
China Licensed Pharmacist
关键词
标签
说明书
规范
Label
Package Insert
Standardization
