Program

PO3-12-34

Identification of available tools for the assessment of causality and severity in paediatric population

[Speaker] Donato Bonifazi:1
[Co-author] Kejla Musaraj:1, Adelaida Tushe:1, Cristina Manfredi:1, Mariagrazia Felisi:1
1:Consorzio per Valutazioni Biologiche e Farmacologiche, Italy

Background: As it is illustrated in the 2007 European Medicines Agency (EMA) 'Guideline on conduct of pharmacovigilance for medicines used by the paediatric population', it is not possible to compare the paediatric population with the adult one because physiological growth changes may influence the pharmacologic aspects of medicines used in children in terms of efficacy, safety and dosing regimens. Consequently, safety data in children cannot necessarily be extrapolated from data in adults. So the ability to assess the safety profile in children is particularly limited and the evaluation and detection of Adverse Drug Reactions (ADRs) in this population require specific expertise. The aim of our study is to identify the already available tools for the assessment of severity and causality of Adverse Events (AEs) and ADRs in the paediatric population.
Methods: We conducted a systematic review of published paediatric studies from 1966 to 2017 using the MEDLINE database. Keywords included 'paediatric, 'adverse events', 'causality tool' and 'severity tool'.
Results: A total of 718 paediatric studies have been reviewed and only 151 reported the causality assessment tool used. The most used tools are: Naranjo (25.16 percent), WHO-UMC (5.16 percent), others (25.16 percent (Karch&Lasagna, Liverpool's tool, Barkley's etc.)). About severity assessment tool no scales were mentioned. Further research using two keywords 'Adverse drug event' and 'Severity' showed that the most available tool used for determining the severity are 'Hartwig and Seigel' and 'Karch and Lasagna'.
Conclusions: Our bibliographic research highlighted the lack of use of tools for the assessment of AEs' and ADRs' causality in paediatric studies. Only few studies employed specific tools that however are algorithms developed for adults and need adaptation to the paediatric population and possibly also stratification to each of its subsets.
As for the severity assessment, no relevant results have been reached because no tool has been used or identified.
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