NURS 6521N-36 Advanced Pharmacology
Week 11 Off-Label Drug Use in Pediatrics
Cynthia Nwokocha
August 7
th
, 2017
Off-Label Drug Use in Pediatrics
Until recently, it was considered unethical or impossible to perform clinical trials of new
medicines in children. Consequently, many medicines used for treating children are insufficiently
documented 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 use
is to benefit the individual patient. The off-label use of drugs has been extensive in treating the
