| Summary: | Children need a distinct medicines-use system designed explicitly for them since their continued inclusion in a system of prescription processing developed for adults generates insoluble risk points and workarounds. The American Academy of Pediatrics (AAP), in its policy statement released by the AAP Committee on Drugs in early 2014 about off-label use in children, posits that federal legislation on increased drug testing in children has been effective, as “there have been over 500 pediatric-specific labeling changes.” However, the AAP’s position has not changed materially since the original 2002 policy statement. Indeed, other health professionals, their organizations, or affiliated practice-based research network (PBRNs) mechanisms continue to be excluded from consideration, collaboration, or even honorable mention. It is noteworthy that most of the 500 labeling changes made since 1997 have addressed the scientific validity of indications for medication use in pediatric population without regard to pharmacotherapy formulation or monitoring. Medication use in children continues to be associated with an unacceptably high rate of adverse events, morbidity, and death. Children should no longer be “shoehorned” into the adult medication-use system, which faces challenges in addressing even the adult population’s needs. The time is now to design a multi-phasic, systematic approach to the pharmacotherapy of children. This paper will argue for the establishment of a distinct medication use system for children, a trans-disciplinary system designed thoughtfully and intentionally, not by convention, consensus, or imitation.
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