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Article Navigation >  Journal of Pharmaceutical Practice and Service  > 2017  >  35(1): 78-81

WANG Yanqiong, FAN Hui, REN Yijiong. Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 78-81. doi: 10.3969/j.issn.1006-0111.2017.01.020
Citation: WANG Yanqiong, FAN Hui, REN Yijiong. Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 78-81. doi: 10.3969/j.issn.1006-0111.2017.01.020
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Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai

doi: 10.3969/j.issn.1006-0111.2017.01.020
  • 1.

    Children's Medical Center, School of Medicine, Jiaotong University, Department of Pharmacy

  • 2.

    Children's Medical Center, School of Medicine, Jiaotong University, Child Health Advocacy Institute, Shanghai 200127, China

  • Received Date: 2016-04-05
  • Rev Recd Date: 2016-10-20
  • 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.
  • [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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Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai

doi: 10.3969/j.issn.1006-0111.2017.01.020
  • 1. Children's Medical Center, School of Medicine, Jiaotong University, Department of Pharmacy
  • 2. Children's Medical Center, School of Medicine, Jiaotong University, Child Health Advocacy Institute, Shanghai 200127, China
  • Received Date: 2016-04-05
  • Rev Recd Date: 2016-10-20

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.

WANG Yanqiong, FAN Hui, REN Yijiong. Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 78-81. doi: 10.3969/j.issn.1006-0111.2017.01.020
Citation: WANG Yanqiong, FAN Hui, REN Yijiong. Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai[J]. Journal of Pharmaceutical Practice and Service, 2017, 35(1): 78-81. doi: 10.3969/j.issn.1006-0111.2017.01.020
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