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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (3): 320-325.

• 管理与实践 • 上一篇    下一篇

简版疫苗说明书临床需求与内容调查分析

赵晨阳, 黄云虹, 李英丽, 陈艳, 高晨燕*   

  1. 国家药品监督管理局药品审评中心, 北京 100022
  • 收稿日期:2022-10-13 修回日期:2022-11-18 出版日期:2023-03-28 发布日期:2023-03-28

Survey Analysis of Clinical Needs and Contents of Simplified Version of Vaccine Package Inserts

  1. Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • Received:2022-10-13 Revised:2022-11-18 Online:2023-03-28 Published:2023-03-28

摘要: 目的:了解基层人员对简版疫苗说明书的临床需求及对其内容的关注情况。方法: 根据相关资料设计有关简版疫苗说明书的调查问卷,采用抽样调查的方法,对139名疾病预防与控制相关工作人员、基层接种人员、接种者进行问卷调查。结果: 69%的受调查者希望简版疫苗说明书为现行专业版疫苗说明书的简化形式。70%以上的受调查者希望简版疫苗说明书中应呈现的条目为:药品名称、不良反应、作用与用途、注意事项、免疫程序和剂量、禁忌、接种对象、有效期、成分和性状。结论: 简版疫苗说明书存在一定的临床需求,在制定相关政策时应关注使用通俗易懂的语言呈现说明书中的重点内容。
 

关键词: font-size:medium, ">疫苗;说明书;调查

Abstract: Objective:To investigate the clinical needs and contents of simplified version of vaccine package inserts.Methods:The questionnaire about the simplified version of vaccine package inserts was designed based on relevant data, and the method of sampling survey was adopted to conduct questionnaire survey among 139 disease control personnels, grass-roots vaccinators and inoculated persons.Results:69% of respondents wanted the simplified version of the current professional vaccine package inserts.More than 70% of the respondents would like the following items to be included in the simplified version of vaccine package inserts: drug name, adverse reactions, indications and usage,precautions, immunization procedures and dosages, contraindications, object of inoculation, validity date,composition and properties. Conclusion:There are clinical needs for simplified version of vaccine package inserts.It is suggested that the focused contents of vaccine package inserts should be presented in plain language in the simplified version of package inserts.
  

Key words: font-size:medium, ">Vaccine;Package inserts;Survey

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