Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai
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摘要: 目的 对上海市儿童常用抗肿瘤药物说明书进行梳理，找出问题，寻求对策。 方法 文献回顾和文本分析。 结果 目前说明书中儿童用量标注率仅38.2%，剂量调整依据不统一、不标准，注意事项中，70.6%的说明书使用了“无可靠参考文献”和“有效性安全性尚不明确”等不明确信息，仅29.4%的说明书使用“慎用”、“不推荐”、“禁止”等警示词语。 结论 面对目前药品说明书中儿童用法用量表述不明，超说明书用药在儿童抗肿瘤治疗过程中不可避免。医院方面，应制定超说明书用药流程，伦理委员会应进行超说明书用药审查；政府有关部门应制定相应政策，完善说明书规范，制定超说明书用药相关政策，鼓励制药企业进行儿童用药研究。Abstract: Objective To review the package inserts of children's common antineoplastic agents in Shanghai, identify problems, and seek countermeasures. Methods Reference summarizing and data analysis were used. Results The labeling rate of dosage for children in package inserts was only 38.2%. There were no uniform standards for dosage modification. 70.6% of package inserts used the following ambiguous words to describe children dosage, such as "no reliable reference" or "activity and safety are uncertain". Only a few package inserts used words like "use with caution" or "not recommend" or "contraindicated". Conclusion The off-label use of children's anti-tumor medications is unavoidable due to the limited children dosage information in the package inserts. We recommend that hospital should have a protocol for off-label use which should be examined by the ethics committee. The off-label uses and package insert standardization should be regulated by the related departments in the government. Pharmaceutical manufacturers are encouraged to carry out post market research on children's drug.
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Key words:
- Anti-tumor medications /
- package insert /
- ethical review
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[1] 张伶俐,李幼平,梁毅,等.全球住院儿童超说明书用药的系统评价[J].中国循证医学杂志,2012,12(2):176,187. [2] 张伶俐,李幼平,黄亮,等.四川大学华西第二医院儿科门诊处方超药品说明书用药情况调查[J].中国循证医学杂志,2010,10(10):1120-1124. [3] 国家食品药品监督管理局.药品说明书和标签管理规定.2006-03-15.http://www.sda.gov.cn/ws01/CL0053/24522.html [4] 国家食品药品监督管理局.化学药品和生物制品说明书规范细则. 2006-05-10. http://www.sda.gov.cn/WS01/CL0844/10528.html [5] 国家卫生和计划生育委员会.关于保障儿童用药的若干意见. 2014-05-21. http://www.moh.gov.cn/yaozs/s3581/201405/e51354d631944fa68aac0c4d9585f291.shtml [6] 世界卫生组织儿童基本药物标准清单第2版.http://www.who.int/medicines/publications/essentialmedicines/en/index.html -
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