[A 30-year history of the change in package insert for Japanese pharmaceutical medicines]

Package inserts are very important in the medical field. They are full of useful and fundamental information. We have edited two books, named 'Drugs in Japan - Ethical Drugs' and 'Drugs in Japan - Over-the-Counter Drugs' based on the review of package inserts provided for pharmaceutical medicine for more 30 years. We tried to analyze the change in package insert contents; in particular, information quality and quantity.The quality of the information provided in package inserts has improved year by year, with drastic improvements being seen three times. The information quantity has also increased in proportion to the improvement in quality. We created a graph based on package inserts, Warfarin; Eisai, chronologically. It shows that improvement in information quality is supported by the amount of text in the package insert.