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Challenges in the assessment of adverse drug reactions in children and neonates

Bracken, Louisea,b; Nunn, Anthonya,b; Peak, Matthewa,c; Turner, Marka,b,d

doi: 10.1097/FAD.0000000000000030
Invited Review Article

Summary Adverse drug reactions (ADRs) are common in children and it is often difficult to distinguish ADRs from other underlying conditions. Children range from preterm neonates to adolescents with changing patterns of disease, pharmacokinetics and pharmacodynamics. The continuous development during childhood presents a challenge to developing, prescribing and administering age-appropriate medicines. Paediatric ADRs can be difficult to characterize. There is a lack of agreed definitions, which are needed so that data on ADRs can be consistently reported and reliably interpreted. Many of the adult tools to assess causality and avoidability are difficult to apply in paediatrics. Paediatric ADRs are under-reported in spontaneous reporting systems, and there is little research. Steps addressing the challenges include the Liverpool causality and avoidability assessment tools, improved definitions and more paediatric drug research following the introduction of Paediatric Regulation in 2007, requirement for risk assessment and after marketing surveillance. Advances in assessing susceptibility through pharmacogenomics offer hope of avoiding ADRs.

aPaediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's NHS Foundation Trust

bDepartment of Women's & Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool

cSchool of Pharmacy and Biomedical Sciences, University of Central Lancashire, Preston, Lancashire

dLiverpool Women's NHS Foundation Trust, Liverpool, United Kingdom

Correspondence to Louise Bracken, Paediatric Medicines Research Unit, Institute in the Park, Alder Hey Children's Health Park, Liverpool, United Kingdom. E-mail: louise.bracken@alderhey.nhs.uk

Editor: R E Ferner, MSc, MD, FRCP, Director of the West Midlands Centre for Adverse Drug Reaction Reporting and Consultant Physician at City Hospital, Birmingham, UK. Assistant Editor: Mr C Anton, MA, MEng. Editorial Board: Australia: Dr M Kennedy, Professor G M Shenfield, Denmark: Professor J S Schou; England: Dr J K Aronson, Dr A Hitchings; India: Professor N Gogtay; Netherlands: Professor C J van Boxtel, Dr B H Ch Stricker; New Zealand: Dr T Maling; Scotland: Dr D N Bateman; Sweden Dr S Hägg; Wales: Professor P A Routledge.

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