Problems and countermeasures of the package inserts for children's anti-tumor medications in Shanghai

Key words: 
• Anti-tumor medications /
• package insert /
• ethical review

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.