Survey of Current State of Off-label Drug Usage in Pediatrics and Pediatric Dosages

At present, the number of drugs approved for use in children is much less than that approved for adults, and the lack of drug information for pediatric pharmacotherapy is a problem. In this regard, both the quantity and quality of information in drug package inserts concerning use in children are often inadequate.In the present study, we retrospectively surveyed the approval status of drugs for pediatric use and dosing information for children using the database of Shinshu University Hospital. We did searches by patients' hospital numbers, dates of birth, drugs administered, date and route of administration, dosage and number of doses, etc. Also, the actual doses administered to patients were compared with the appropriate doses calculated for each patient and the applicability of formulae for calculating pediatric dosages in off-label use was examined. Approximately 60 % of prescription drugs were administered under off-label use. The dosage deviation ranges by Young' s age rule were statistically significant (p<0.0001), while by Augsberger's age rule (II) and von Hamack's rule deviation ranges were not significant. From our survey, we concluded that many drugs are used under off-label use and for a great many of them pediatric dosage information is lacking. In off-label use, it is convenient to use von Harnack' s rule for working out prescription dosages and for prescription auditing under such use.