Roberts, Eve K, Hawcutt, Daniel B 
ORCID: 0000-0002-8120-6507 and Turner, Mark A ORCID: 0000-0002-5299-8656
(2021)
Prospective identification and causality evaluation of suspected adverse drug reactions in neonates.
BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 87 (3).
pp. 1541-1546.
|
Text
ADRIN BJCP paper version 10 ER 090120 Submission Two - my rough copy v3 (1).pdf - Author Accepted Manuscript Download (252kB) | Preview |
Abstract
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | adverse drug reactions, clinical pharmacology, neonatology, paediatrics, pharmacovigilance |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 13 Aug 2020 14:04 |
| Last Modified: | 18 Jan 2023 23:38 |
| DOI: | 10.1111/bcp.14485 |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3095792 |
Dimensions
Dimensions
