ABSTRACT
OBJECTIVE: To investigate and analyze the problems in information for children existing in package inserts of medications commonly used in pediatrics in 15 hospitals and try to establish a template and provide reference for standardizing package inserts of medications in China. METHODS: The method of text analysis and literature survey were used. Information for children in the package inserts were collected, analyzed and evaluated according to Guidance for Industry and Review Staff; Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (Draft) issued by U.S. FDA and other references. RESULTS: In 660 package inserts of 338 medications, 8.0%, 56.9%, 16.4%, 11.7% and 45.8% contained the information on children's indications, dosages and administrations, adverse drug reactions, contraindications and precautions, respectively, while only 2.3% had information of pediatric clinical trials or children's pharmacokinetic data CONCLUSION: The current information for Children in package inserts are insufficient and lack of standards, so further management should be strengthened to improve the situation.