摘要
美国对于部分非处方药规定:在申请上市,或者说明书内容需更正修改时,必须递交关于目标人群对这些非处方药说明书理解力的测试结果。同时,美国对参与非处方药测试的人群则规定必须涉及社会各个层面,从而保证测试结果的可信度。测试方法以调查问卷为主,通过开放式或闭合式问卷,了解被测试人群对测试药品说明书的理解程度和正确运用说明书合理用药情况,以及利用说明书指导消费者合理用药情况等。因此,非处方药说明书理解力测试在美国为指导消费者合理用药和说明书的改进优化做出了重要贡献。参照美国对非处方药管理,我国在药品说明书的管理上则监管缺位,所以美国对非处方药监管的经验对于我国药品监管工作具有较大的借鉴意义。
According to U.S FDA regulations,before the approval of some new drug product for the nonprescription market or proposing some substantive labeling changes,a label comprehension studies that are designed to evaluate consumer＇s comprehension of proposed nonprescription drug product label were requested.Label comprehension studies should assess whether normal literate and low literate individuals can understand a drug product label,which ensures the validity of the studies.The questionnaires are often designed with open-ended or close-ended questions.The goal of a label comprehension study should be to test consumer＇s comprehension of the content and by reading the label,whether they can use the drug product correctly.Such a kind of comprehension studies makes a great contribution to promoting rational use of nonprescription drugs and making better modification of drug product label,which would be a good reference for China＇s drug supervision.
出处
《医学与社会》
2011年第8期46-49,共4页
Medicine and Society
关键词
非处方药
说明书
Nonprescription drugs
Product label
