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NURS 6521N-36 Advanced PharmacologyWeek 11 Off-Label Drug Use in PediatricsCynthia NwokochaAugust 7th, 2017Off-Label Drug Use in PediatricsUntil recently, it was considered unethical or impossible to perform clinical trials of new medicines in children. Consequently, many medicines used for treating children are insufficientlydocumented about dosing, efficacy, and safety (Kimland and Odlind, 2012). The passage of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act has collectively resulted in an improvement in rational prescribing for children, however, off-label drug use remains an important public health issue for infants, children, and adolescents, because an overwhelming number of drugs still have no information in the labeling for use in pediatrics (American Academy of Pediatrics, 2014). Off-label prescribing occurs when a child receives a medication that has not received FDA approval for the child’s age or diagnosis (Bazzano et al, 2009). The purpose of off-label useis to benefit the individual patient. The off-label use of drugs has been extensive in treating the