Background. The treatment of pediatric patients with drugs in hospitals is being impeded by
a shortage in the availability of licensed drugs in an appropriate formulation. We have
studied the extent of use of drugs that are not licensed for use in children (unlicensed) and
drugs that are used outside the terms of the product license (off-label). We conducted this
study in a Dutch academic children's hospital. Methods. In a prospective study of 5 weeks'
duration, we reviewed drug prescriptions in a pediatric ward and 3 intensive care units. We …

A total of 2,139 courses of drugs given to 237 children in 442 days were examined. Three
categories of drugs were defined and prescribed:(i) licensed,(ii) unlicensed, and (iii) off-
label.'Unlicensed'describes drugs administered to children without a license to do so.'Off-
label'denotes drugs which are used outside the terms of the product license.Each
participating unit was studied for differing days each week for five weeks. Children were
between 0 days and 17 years and were admitted with a range of medical problems. Of the …