Adverse drug reactions in neonates and infants: A population-tailored approach is needed
British Journal of Clinical Pharmacology , Volume 80 - Issue 4 p. 788- 795
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.
|adverse drug reaction, developmental pharmacology, infant, newborn, pharmacovigilance|
|British Journal of Clinical Pharmacology|
|This work was funded by the European Commission 7th Framework Programme; grant id fp7/223614 - Evaluation of antibiotics (ciprofloxacin and fluconazole) for the treatment of infections in preterm and term neonates (TINN), This work was funded by the European Commission 7th Framework Programme; grant id fp7/260908 - Treat Infections in NeoNates 2 - Evaluation of an infective agent (azithromycin) for the treatment of infections in preterm and term neonates (TINN2), This work was funded by the European Commission 7th Framework Programme; grant id fp7/261060 - Global Research in Paediatrics (GRIP)|
|Organisation||Erasmus MC: University Medical Center Rotterdam|
Allegaert, K.M, & van den Anker, J.N. (2015). Adverse drug reactions in neonates and infants: A population-tailored approach is needed. British Journal of Clinical Pharmacology, 80(4), 788–795. doi:10.1111/bcp.12430