Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children

Wang Xin; Sun Yanyan

doi:10.13407/j.cnki.jpp.1672-108X.2023.08.005

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Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children

更新时间：2023-08-23

- Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children
- Vol. 29, Issue 8, Pages: 16-19(2023)
- 作者机构：
  
  天津市儿童医院,天津,300134
- 作者简介：
- 基金信息：
- DOI：10.13407/j.cnki.jpp.1672-108X.2023.08.005
  CLC：
- Published：2023，
  
  Published Online：10 August 2023，
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Wang Xin, Sun Yanyan. Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children. [J]. 29(8):16-19(2023)
DOI：

Wang Xin, Sun Yanyan. Investigation on Information of Over-The-Counter Drug Instructions of Chinese Patent Medicines for Children. [J]. 29(8):16-19(2023) DOI： 10.13407/j.cnki.jpp.1672-108X.2023.08.005.

摘要

目的:分析儿童中成药非处方药(OTC)说明书信息情况

以提高儿童合理用药水平

促进中成药说明书规范化。方法:收集 186 种儿童用中成药 OTC 的 1 441 份流通药品说明书

对儿童不良反应、用药禁忌、注意事项、药物相互作用等进行调查分析

并与国家药品监督管理局(NMPA)发布的范本说明书进行比较

重点关注缺项、不明确和差异内容。结果:1 441 份说明书中

不良反应、用药禁忌、注意事项、药物相互作用的缺项和不明确内容总占比分别为 94. 1%、85. 9%、16. 6%、95. 0%。 86 种流通药品说明书与范本说明书存在差异

差异率为 47. 0%。结论:目前儿童中成药 OTC 说明书内容不完善

缺项、表述不明确与范本比较存在差异的现象较严重

相关部门应督促申报企业对不规范药品说明书进一步修订完善

为临床合理用药提供可靠的法定依据。

Abstract

Objective: To analyze the information of over-the-counter drug (OTC) instructions of Chinese patent medicines in children

so as to improve the level of rational drug use in children and promote the standardization of drug instructions of Chinese patent medicines. Methods: Totally 1

441 instructions of 186 kinds of OTC Chinese patent medicines for children were collected

and adverse drug reactions

drug contraindications

precautions and drug interactions in children were investigated and analyzed. The sample instructions issued by the National Medical Products Administration (NMPA) was compared with OTC instructions of Chinese patent medicines

focusing on the missing items

unclear and different contents. Results: Of the 1

441 instructions

the total proportion of adverse drug reactions

drug contraindications

precautions

missing items and unclear contents of drug interactions were 94. 1%

85. 9%

16. 6% and 95. 0%

respectively. There were differences between the instructions of 86 kinds of circulating drugs and the sample instruction

the difference rate was 47. 0%. Conclusion: At present

the content of OTC instructions of Chinese patent medicines for children is not complete

and the phenomenon of missing items and unclear expression is serious. Relevant departments should urge the declaration of enterprises to further improve the specification of non-standard drug instructions

so as to provide reliable legal basis for the clinical rational drug use.

关键词

儿童中成药非处方药药品说明书

Keywords

childrenChinese patent medicinesover-the-counter drugrug instructions

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