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Drug Safety
Published in: Drug Safety 6/2012

01-06-2012 | Original Research Article

Adverse Drug Reactions in Children — International Surveillance and Evaluation (ADVISE)

A Multicentre Cohort Study

Authors: Asia N. Rashed, Ian C. K. Wong, Noel Cranswick, Barbara Hefele, Stephen Tomlin, John Jackman, Kenneth Lee, Kam-Lun E. Hon, Jeffrey Ong, Maisoon Ghaleb, Siew Siang Chua, Tea Ming Hui, Wolfgang Rascher, Dr Antje Neubert

Published in: Drug Safety | Issue 6/2012

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Abstract

Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied.
Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries.
Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia, Germany, Hong Kong, Malaysia and the UK. Children aged 0–18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs.
Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and the UK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0–7). Patients received a total of 5367 drugs (median 3; IQR 2–5) and median length of hospital stay was 4 days (IQR 3–7). A total of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95% CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed in Malaysia and the UK. 65.3%(n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.
Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children.
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Metadata
Title
Adverse Drug Reactions in Children — International Surveillance and Evaluation (ADVISE)
A Multicentre Cohort Study
Authors
Asia N. Rashed
Ian C. K. Wong
Noel Cranswick
Barbara Hefele
Stephen Tomlin
John Jackman
Kenneth Lee
Kam-Lun E. Hon
Jeffrey Ong
Maisoon Ghaleb
Siew Siang Chua
Tea Ming Hui
Wolfgang Rascher
Dr Antje Neubert
Publication date
01-06-2012
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 6/2012
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/11597920-000000000-00000

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