Abstract
PurposeThe purpose of this study is to uncover previously unrecognised risks of medicines in paediatric pharmacovigilance reports and thereby advance a safer use of medicines in paediatrics.MethodsIndividual case safety reports (ICSRs) with ages less than 18 years were retrieved from VigiBase, the World Health Organization (WHO) global database of ICSRs, in September 2014. The reports were grouped according to the following age spans: 0 to 27 days; 28 days to 23 months; 2 to 11 years; and 12 to 17 years. vigiRank, a data‐driven predictive model for emerging safety signals, was used to prioritise the list of drug events by age groups. The list was manually assessed, and potential signals were identified to undergo in‐depth assessment to determine whether a signal should be communicated.ResultsA total of 472 drug‐event pairs by paediatric age groups were the subject of an initial manual assessment. Twenty‐seven drug events from the two older age groups were classified as potential signals. An in‐depth assessment resulted in eight signals, of which one concerned harm in connection with off‐label use of dextromethorphan and another with accidental overdose of olanzapine by young children, and the remaining signals referred to potentially new causal associations for atomoxetine (two signals), temozolamide, deferasirox, levetiracetam, and desloratadine that could be relevant also for adults.ConclusionsClinically relevant signals were uncovered in VigiBase by using vigiRank applied to paediatric age groups. Further refinement of the methodology is needed to identify signals in reports with ages under 2 years and to capture signals specific to the paediatric population as a risk group.
Highlights
To minimise harm from medication use, healthcare professionals and patients need to know about the risks
The Uppsala Monitoring Centre (UMC)[1] that maintains VigiBase complements these national efforts by conducting periodical open‐ended signal detection screenings of global data
Because this was the first screening of paediatric global data, the test included drug events that represented a wider scope, to allow previously unrecognised safety issues to emerge for drugs, which had been on the market for a long time
Summary
To minimise harm from medication use, healthcare professionals and patients need to know about the risks. Drug toxicity is poorly reported in paediatric clinical trials,[9,10] where clinical trials involve both adults and children.[11] As a consequence, information on dose recommendations, precautions, warnings, and ADR profiles specific to paediatric age groups can be lacking when prescribing and administering medicines to these patients.[12] Children experience a wide range of ADRs, as described from national pharmacovigilance databases,[13] and the reporting pattern differs both from reports for adults and between paediatric age subgroups.[14] In order to increase knowledge for the safer use of medicines in the paediatric population, VigiBase reports were screened to uncover previously unrecognised risks of medicines in this age group
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