Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (9): 555-560.
DOI: 10.19803/j.1672-8629.2019.09.07

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Analysis of Pediatric Use Information in Package Inserts of Antineoplastic Drugs

ZHAO Shuang, SONG Yanqing, WANG Xiangfeng, JINFang, MIAO Qiuli*   

  1. Department of Pharmacy, the First Hospital of Jilin University, Jilin Changchun 130021, China
  • Received:2018-05-30 Revised:2019-10-21 Online:2019-09-20 Published:2019-10-21

Abstract: Objective To investigate the pediatric use information in the package inserts of antineoplastic drugs, so as to provide reference for rational use and standardized management. Methods 141 package inserts of antineoplastic drugs were collected, the dosage and directions for pediatric in the package inserts were organized and analyzed by Excel. Results Among the 141 package inserts, 19(13.47%) were labeled with pediatric dosage, and 47 (33.33%) were labeled with directions for pediatric use. Conclusion In the package inserts of antineoplastic drugs, the information of dosage and directions for pediatric need to be further improved. It is suggested that manufacturers should strengthen the research and track safety issues in pediatric and update the information in the package inserts timely .

Key words: package insert, antineoplastic drug, pediatric, labeling information

CLC Number: