Journal
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
Volume 87, Issue 3, Pages 1541-1546Publisher
WILEY
DOI: 10.1111/bcp.14485
Keywords
adverse drug reactions; clinical pharmacology; neonatology; paediatrics; pharmacovigilance
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Funding
- University of Liverpool
- National Institute for Health Research (NIHR) Alder Hey Clinical Research Facility
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Neonates experience high rates of underreported adverse drug reactions, with current causality assessment tools in need of improvement.
Neonates experience adverse drug reactions (ADRs), but under-reporting of suspected ADRs to national spontaneous reporting schemes in this population is particularly high. A prospective observational study collected suspected neonatal ADRs at a tertiary neonatal unit. Cases were analysed for causality by six assessors using three existing methods. Sixty-three suspected ADR cases were identified in 35/193 neonates (18.1%). The proportion of suspected ADRs where the drug was prescribed off-label was 30/68 (44.1%). When 34 cases were assessed for causality using three methods, global kappa scores of less than 0.3 for each tool suggested only fair inter-rater reliability. Neonatal ADRs can be captured and occur from a variety of drugs affecting many organ systems. The current tools for assessing causality need to be adapted before they can reliably assess neonatal ADRs.
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