Walden NURS 6521 – Off-Label Drug Use in Pediatrics Advanced Pharmacology Circumstances under which Children Should be Prescribed Drugs for Off-label Use

 More than 50% of drugs approved by the Food and Drug Administration (FDA) do not contain labeling for children. Therefore, pediatricians have to decide the appropriate prescription based on their clinical judgment. There is however specific guidance by various pediatric associations such as the American Academy of Pediatrics (AAP) on circumstances under which physicians can use drugs off-label on children.

These circumstances include absence of safe and licensed therapeutic options for a specific disease, the failure of the existing standard therapy to achieve success in treating the condition and lack of alternative forms of therapy for children. Other circumstances include lack of clinical trials and availability of convincing evidence on their effectiveness and safety of the of label drugs in children (Panther, Knotts, Odom-Maryon, Daratha, Woo & Klein, 2017)