The research, led by FMUP and published in the journal Frontiers in Pharmacology, aims to improve the monitoring of medication safety in pediatric populations. Renato Ferreira da Silva, lead author of the study, emphasizes that "children are not miniature adults" and that how they respond to medications varies significantly with age and development.
Many medications used in children were initially studied in adults, with limited safety data for the pediatric population. The research group suggests using structured questionnaires, which can be answered by the children themselves or their caregivers, to better characterize the frequency, severity, and impact of symptoms on daily activities.
These instruments, called PROM (Patient-Reported Outcome Measures), would complement traditional pharmacovigilance systems, which are largely passive and rely on spontaneous reporting. Structured data collection can improve data quality and identify relevant symptoms in higher-risk treatments.
Renato Ferreira da Silva acknowledges practical limitations, such as consultation time, but believes that progress will involve better links between care settings, clinical records, and pharmacovigilance units. The application will be targeted at contexts where monitoring adverse reactions is particularly relevant.
The work involves collaboration from researchers at FMUP, the Pharmacovigilance Unit of Porto, the RISE-Health Research Unit, the Faculty of Pharmacy of the University of Coimbra, and the Faculty of Medicine of the University of Lisbon.




