A survey of the use of off-label and unlicensed drugs in a Dutch children's hospital

Background. The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an app ropriate formulation. We have studied the extent of use of drugs that are n ot licensed for use in children (unlicensed) and drugs that are used outsid e 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 pres criptions in a pediatric ward and 3 intensive care units. We classified the prescribed drugs in 3 main categories-licensed, unlicensed, and off-label- and determined the nature of their unlicensed and off-label use. Results. Two thousand one hundred thirty-nine courses of drugs were adminis tered to 237 patients in 442 patient-days. Of 2139 prescriptions, 725 (34%) were licensed, 1024 (48%) were unlicensed, and 390 (18%) were off-label. I n 392 (90%) of 435 patient-days, children received 1 or more courses of an unlicensed or off-label drug prescription in hospital. Conclusion. With regard to the availability of drugs of proven quality and adequate license for pediatric patients in hospital, dramatic shortcomings exist. As a result, drug legislation originally designed to protect patient s and prescribing physicians against unsafe drug use and unjustified claims has turned into an insurmountable threshold to make proper drugs available for a vulnerable minority of patients.