Frequency and appropriateness of drug prescribing for unlabeled uses in pediatric patients.

The incidence and appropriateness of drug prescribing for unlabeled indications in a pediatric hospital were examined. During a 19-day period, the medical record of each discharged patient was reviewed to obtain information about the drugs administered during hospitalization. The package insert of each drug was consulted to determine whether the drug had a labeled indication for pediatric use. Using a Delphi group-opinion technique, nine experts in pediatric pharmacology were asked to determine whether or not the use of the drugs with no labeled pediatric indications was supported by the medical literature. A total of 62 (7%) of the 951 drug orders were for unlabeled pediatric indications. A consensus of appropriate use was achieved in 24 (39%) cases, and a consensus of inappropriate use was achieved in 10 (16%) instances. No consensus was reached in 45% of cases. The number of drugs prescribed for unlabeled indications in pediatric patients appears to be small, and sufficient evidence exists in the medical literature to support at least some of those uses.