Children require a dedicated medication utilization system tailored specifically to their needs. This necessity arises because their integration into an adult-oriented prescription processing system creates problematic risk factors and necessitates unconventional solutions. In its 2014 policy statement regarding off-label medication use in children, the American Academy of Pediatrics (AAP) asserted that federal legislation aimed at enhancing drug testing in children has yielded positive results, with "over 500 pediatric-specific labeling changes" being implemented. However, the AAP's stance has remained largely unchanged since its initial 2002 policy statement. Furthermore, it is noteworthy that various other healthcare professionals, their associations, or affiliated practice-based research network (PBRNs) mechanisms have continued to be disregarded, excluded from cooperation, or even neglected in acknowledgments. It is important to highlight that the majority of the 500 labeling modifications made since 1997 have primarily focused on the scientific validity of indications for medication use in the pediatric population, without addressing issues related to medication formulation or monitoring. Consequently, medication usage among children remains associated with an unacceptably high incidence of adverse events, morbidity, and even fatalities.
