ENSURING DRUG SAFETY IN CHILDREN: ADVANCING A COMPREHENSIVE PEDIATRIC PHARMACOVIGILANCE SYSTEM
Edita ALILI - IDRIZI, Lulzime BALLAZHI, Merita DAUTI, Sihana AHMETI LIKA, Drita HAVZIU
Abstract
Pediatric patients are especially susceptible to adverse drug reactions (ADRs) due to age-related pharmacokinetic variability and the frequent use of off-label medications that often lack adequate safety and efficacy data. Pediatric pharmacovigilance (PV) is essential for detecting, assessing, and preventing drug-related harm in this population. This study aims to explore the key concepts of pediatric pharmacovigilance, identify challenges and drugs most commonly associated with safety concerns in children, and suggest strategic and technological solutions to enhance drug safety monitoring in children. A comprehensive literature review was conducted using databases such as PubMed, ScienceDirect, and official regulatory sources. Key concepts and challenges were analyzed, including developmental pharmacology, limitations of ADR reporting, and the role of digital tools. Major challenges identified include underreporting of ADRs, limited pediatric-specific clinical data, lack formulations suitable for children, and ethical barriers to pediatric trials. Amoxicillin, as one of the most prescribed antibiotics in children, and Ibuprofen, as the most used NSAID, result in being the drugs with the highest frequency of ADR reports. Various strategies such as full implementation of regulatory measures, education and awareness raising on the importance of ADR reporting, data protection, international collaboration with incorporation of mobile applications and artificial intelligence (AI) are powerful opportunities to modernize pediatric pharmacovigilance. The implementation of these strategies will assist the healthcare system in better and timely management of ADRs with the aim of ensuring safe and effective pharmacotherapeutic treatment for the pediatric population.
Pages: 126 - 134