ADRIC: Adverse Drug Reactions In Children – a programme of research using mixed methods

Autor: Rosalind L Smyth, Matthew Peak, Mark A Turner, Anthony J Nunn, Paula R Williamson, Bridget Young, Janine Arnott, Jennifer R Bellis, Kim A Bird, Louise E Bracken, Elizabeth J Conroy, Lynne Cresswell, Jennifer C Duncan, Ruairi M Gallagher, Elizabeth Gargon, Hannah Hesselgreaves, Jamie J Kirkham, Helena Mannix, Rebecca MD Smyth, Signe Thiesen, Munir Pirmohamed
Jazyk: angličtina
Rok vydání: 2014
Předmět:
Zdroj: Programme Grants for Applied Research, Vol 2, Iss 3 (2014)
Druh dokumentu: article
ISSN: 2050-4322
2050-4330
DOI: 10.3310/pgfar02030
Popis: Aims: To comprehensively investigate the incidence, nature and risk factors of adverse drug reactions (ADRs) in a hospital-based population of children, with rigorous assessment of causality, severity and avoidability, and to assess the consequent impact on children and families. We aimed to improve the assessment of ADRs by development of new tools to assess causality and avoidability, and to minimise the impact on families by developing better strategies for communication. Review methods: Two prospective observational studies, each over 1 year, were conducted to assess ADRs in children associated with admission to hospital, and those occurring in children who were in hospital for longer than 48 hours. We conducted a comprehensive systematic review of ADRs in children. We used the findings from these studies to develop and validate tools to assess causality and avoidability of ADRs, and conducted interviews with parents and children who had experienced ADRs, using these findings to develop a leaflet for parents to inform a communication strategy about ADRs. Results: The estimated incidence of ADRs detected in children on admission to hospital was 2.9% [95% confidence interval (CI) 2.5% to 3.3%]. Of the reactions, 22.1% (95% CI 17% to 28%) were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44 out of 249 (17.7%) of ADRs, the remainder originating from hospital. A total of 120 out of 249 (48.2%) reactions resulted from treatment for malignancies. Off-label and/or unlicensed (OLUL) medicines were more likely to be implicated in an ADR than authorised medicines [relative risk (RR) 1.67, 95% CI 1.38 to 2.02; p 48 hours, the overall incidence of definite and probable ADRs based on all admissions was 15.9% (95% CI 15.0 to 16.8). Opiate analgesic drugs and drugs used in general anaesthesia (GA) accounted for > 50% of all drugs implicated in ADRs. The odds ratio of an OLUL drug being implicated in an ADR compared with an authorised drug was 2.25 (95% CI 1.95 to 2.59; p
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