Abstract
Due to the rapid development of IT in medical field, various kinds of medical and drug information have been digitized. However, with regard to the quality of the drug package insert indispensable for proper use of drugs, systematic surveys on whether the notation is unified have not been conducted so far. This time, we paid attention to pediatric areas and investigated how the information on pediatrics is described in the package insert. As a result, it was found that the proportion of information on dosage regimen for children was only 13.5% in the package insert and 49.2% in frequent medicine for children. In particular, it was found that there were few descriptions for low birth weight infants and newborn babies, which are more detailed childhood classifications. Furthermore, with regard to the method of describing the package insert, it is highly likely that there is ambiguity in the age classification, safety, and the place of entry, which is a barrier to proper use of medicines in pediatric medical field. It is found that it is also necessary to improve the quality of the package insert itself, such as eliminating the fluctuation and ambiguity in the expression of the package insert.
