The Health, Labour and Welfare Ministry plans to start a project this month to examine the side effects and proper dosage of medicine prescribed for children, using so-called big data - large volume or complex data - and electronic medical records collected from medical institutions across the country.
Information on the effectiveness and safety of medicine for children is insufficient when compared to that of adults. The ministry plans to collect data from 1 million child patients annually from about 60 medical institutions and submit the information to the National Center for Child Health and Development. After data analysis on dosage and other factors, doctors can use the information to safely prescribe medicine to children.
Before the mass production and sale of drugs, clinical trials are usually conducted to check the effects and proper dosage by administering the medicine to patients. In the case of children, however, it is difficult to secure sufficient subjects for clinical trials as the number of children suffering from serious diseases is small compared to adults.
For this reason, medicine is prescribed to children at the discretion of doctors, with many doctors relying on adult cases or overseas data as references. The methods and dosages may be different from that approved in this country. According to experts, the effects and safety of children's medicine have not been sufficiently verified.
The health ministry has positioned the National Center for Child Health and Development as a "children's medicine information centre" and plans to collect data from electronic medical records from about 60 medical institutions, including public hospitals for children and regional clinics across the country, regarding the dosage used, effects and side effects of medicine administered. After getting parents' consent, the ministry plans to compile a database.
"[The database] will also be useful for research on unexpected effects when drugs are combined or on characteristics of children who are prone to develop a specific disease and its prevention," said Naohisa Yahagi, deputy manager at the centre's Division for Data Science and System Strategy.