title: Adverse drug reactions in neonates and infants: a population-tailored approach is needed.
abstract: Drug therapy is a powerful tool to improve outcome, but there is an urgent need to improve pharmacotherapy in neonates through tailored prevention and management of adverse drug reactions (ADRs). At present, infants commonly receive off-label drugs, at dosages extrapolated from those in children or adults. Besides the lack of labelling, inappropriate formulations, (poly)pharmacy, immature organ function and multiple illnesses further raise the risk for ADRs in neonates and infants. Pharmacovigilance to improve the prevention and management of ADRs needs to be tailored to neonates and infants. We illustrate this using prevention strategies for drug prescription and administration errors (e.g. formulation, bedside manipulation, access), detection through laboratory signalling or clinical outlier data (e.g. reference laboratory values, overall high morbidity), assessment through algorithm scoring (e.g. Naranjo or population specific), as well as understanding of the developmental toxicology (e.g. covariates, developmental pharmacology) to avoid re-occurrence and for development of guidelines. Such tailored strategies need collaborative initiatives to combine the knowledge and expertise of different disciplines, but hold promise to become a very effective tool to improve pharmacotherapy and reduce ADRs in infants.
authors.affiliation: Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium.|Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
authors.forename: Karel
authors.initials: K
authors.lastname: Allegaert
authors.affiliation: Division of Pediatric Clinical Pharmacology, Children's National Medical Center, Washington, DC, USA.|Departments of Pediatrics, Pharmacology and Physiology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.|Intensive Care, Erasmus MC, Sophia Children's Hospital, Rotterdam, The Netherlands.|Department of Paediatric Pharmacology, University Children's Hospital, Basel, Switzerland.
authors.forename: Johannes N
authors.initials: JN
authors.lastname: van den Anker
mesh_terms: D000465:Algorithms; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D060735:Pharmacovigilance; D012307:Risk Factors
keywords: adverse drug reaction; developmental pharmacology; infant; newborn; pharmacovigilance