Title:Issues Impacting Therapeutic Outcomes in Pediatric Patients: An Overview
Volume: 10
Issue: 3
Author(s): Atin Kalra and Shishu Goindi
Affiliation:
Keywords:
Dosing errors, pediatric dosage forms, therapeutic outcomes.
Abstract: The quest for achieving optimal therapeutic outcomes in pediatric patients has evaded the healthcare professionals
for long and often lack of child specific dosage forms and the associated events that follow with it have been considered
to be major contributor towards suboptimal outcomes. Consequently, there have been sustained efforts over the
years to address this issue with the enactment of legislations like Best Pharmaceutical for Children Act (BPCA), Pediatric
Research Equity Act (PREA) and Pediatric Regulation by European Union (EU) to incentivise the participation of pharmaceutical
industry towards development of child friendly dosage forms. Initiatives taken in past by organisations like
World Health Organisation (WHO) and Drugs for Neglected Diseases Initiative (DNDi) to spur the development of child
friendly dosage forms has helped to address issues pertaining to management of Human Immunodeficiency Virus (HIV)
and malaria in pediatric patients. Present efforts aimed at developing child friendly dosage forms include oro-dispersible
platforms including thin films and mini-tablets. Despite these leaps and advancements in developing better dosage forms
for children, lower therapeutic outcomes in pediatric patients continue to remain an unresolved issue because of detrimental
effects of additional factors such as parents understanding of label instructions and complexities involved in executing
pediatric clinical studies thus requiring a concerted effort from pharmaceutical companies, academic researchers, parents
and healthcare providers to work for better treatment outcomes in children.