Pharmacovigilance and Safety of Psychotropic Medications in Youth - Volume II

Despite remarkable advancements in child and adolescent psychiatry, including improved diagnostic tools, therapeutic interventions, and early prevention strategies, significant gaps remain in our understanding of the safety, tolerability and long-term effects of psychotropic medications in young populations.Children and adolescents differ substantially from adults in pharmacokinetics, pharmacodynamics, and neurodevelopmental processes, which may alter drug efficacy and risk profiles, since they are not just little adults but a different special population. However, many psychotropic medications prescribed in this age group are used off-label, with limited clinical trial data supporting their safety and tolerability. This underscores the urgent need for robust pediatric pharmacovigilance systems capable of detecting, assessing, and preventing adverse drug reactions (ADRs) and long-term side effects.The goal of this Research Topic is to strengthen the evidence base for safe and effective psychopharmacological treatment in pediatric psychiatry. We seek to promote a comprehensive understanding of how pharmacovigilance data can enhance clinical decision-making, inform treatment guidelines, and protect young patients from preventable harm. The topic also aims to highlight and address ethical considerations, the challenges of data-sharing, and the crucial role of caregivers, clinicians, and regulators in upholding drug safety monitoring throughout childhood and adolescence.Although we accept submissions from all areas of pediatric pharmacovigilance, we especially welcome contributions on the following sub-themes:• Descriptions of the frequency, type, and severity of adverse drug reactions in children and adolescents treated with psychotropic medications• Off-label psychotropic prescribing patterns and associated safety outcomes• Pharmacogenomic or developmental factors influencing drug metabolism and response in pediatric populations• Effectiveness of pharmacovigilance reporting systems in pediatric psychiatry• Analyses of ethical and regulatory challenges in collecting and reporting pediatric adverse events• Evaluations of caregiver and clinician awareness of medication safety and risk communication• Long-term neurodevelopmental or metabolic outcomes of early psychotropic exposure• Methods for improving real-world data collection, patient registries, and digital pharmacovigilance toolsWe encourage contributions that foster interdisciplinary collaboration among psychiatrists, pediatricians, and pharmacologists to advance safe, evidence-based, and developmentally sensitive psychopharmacological care for children and adolescents. Topic editors: Renato de Filippis, André Luiz Schuh Teixeira, Alex Vicente Spadini Source: https://www.frontiersin.org/research-topics/85963/pharmacovigilance-and-safety-of-psychotropic-medications-in-youth---volume-ii