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Frequency and appropriateness of drug prescribing for unlabeled uses in pediatric patients
Insights
Prescribing drugs for unlabeled pediatric indications is uncommon. While some uses lack consensus, medical literature supports many off-label pediatric drug uses.
Area of Science:
- Pediatric Pharmacology
- Drug Utilization Research
Background:
- Unlabeled drug indications in pediatric patients present challenges for safe and effective medication use.
- Assessing the appropriateness of off-label prescribing is crucial for pediatric patient safety.
Purpose of the Study:
- To determine the incidence and appropriateness of drug prescribing for unlabeled indications in a pediatric hospital.
- To evaluate the medical literature's support for these unlabeled pediatric drug uses.
Main Methods:
- A 19-day review of medical records for all discharged patients.
- Consultation of drug package inserts for labeled pediatric indications.
- Delphi group-opinion technique with nine pediatric pharmacology experts to assess literature support for unlabeled uses.
Main Results:
- 62 (7%) of 951 drug orders were for unlabeled pediatric indications.
- Consensus on appropriate use was reached in 24 (39%) cases; inappropriate use in 10 (16%).
- No consensus was reached in 45% of cases, indicating areas for further research.
Conclusions:
- The number of drugs prescribed for unlabeled pediatric indications is relatively small.
- Existing medical literature provides evidence to support many of these off-label pediatric drug uses.
- Further research is needed to establish consensus for cases lacking clear evidence.
Abstract:
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.