child’s diagnosis or age. Providers should be concerned when prescribing “off-label” drugs because of the inadequate information on drug efficacy, safety, and appropriate use in children. “Off-label” drug prescribing not only occurs in the above-mentioned way but also when providers prescribe drugs that are indicated for one use but prescribed for another use (such as prescribing clonidine for hot flashes). Another is example is that of prescribing a beta blocker for CHF (that has not been FDA approved for CHF, but rather a cardiac condition). Also, the FDA functions to regulate drug manufacturers, but is not authorized to regulate practice of clinicians. Circumstances that Warrant Off-Label Prescribing in Children “Off-label” prescribing in pediatrics is warranted when appropriate, adequate evidence-based studies have been conducted on the specifics of the prescribed drug. Passages of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act have precipitated improvements in judicious prescribing for children, including greater than 500 changes in drug labeling; however, there are still many drugs that do not have adequate or even any information for use in pediatric patients.
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- Summer '15
- Pharmacology, pediatric patient, Label Drug Use