Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a Multicentre Cohort Study

Overview

Journal Drug Saf

Specialties Pharmacology
Toxicology

Date 2012 May 23

PMID 22612852

Citations 27

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

Antje Neubert

Affiliations

Soon will be listed here.

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.

Citing Articles

Misuse, Abuse and Medication Errors' Adverse Events Associated with Opioids-A Systematic Review.

Gustafsson M, Silva V, Valeiro C, Joaquim J, van Hunsel F, Matos C Pharmaceuticals (Basel). 2024; 17(8).

PMID: 39204114 PMC: 11357286. DOI: 10.3390/ph17081009.

Impact of a computerized physician order entry system on medication safety in pediatrics-The AVOID study.

Wimmer S, Toni I, Botzenhardt S, Trollmann R, Rascher W, Neubert A Pharmacol Res Perspect. 2023; 11(3):e01092.

PMID: 37222491 PMC: 10207936. DOI: 10.1002/prp2.1092.

Adverse Drug Reactions in Children: Comparison of Reports Collected in a Pharmacovigilance Project Versus Spontaneously Collected ADR Reports.

Leitzen S, Dubrall D, Toni I, Stingl J, Christ P, Koberle U Paediatr Drugs. 2022; 25(2):203-215.

PMID: 36369590 PMC: 9931796. DOI: 10.1007/s40272-022-00540-z.

Descriptive analysis of adverse drug reaction reports in children and adolescents from Germany: frequently reported reactions and suspected drugs.

Dubrall D, Leitzen S, Toni I, Stingl J, Schulz M, Schmid M BMC Pharmacol Toxicol. 2021; 22(1):56.

PMID: 34620231 PMC: 8499510. DOI: 10.1186/s40360-021-00520-y.

Analysis of the reporting of adverse drug reactions in children and adolescents in Germany in the time period from 2000 to 2019.

Leitzen S, Dubrall D, Toni I, Stingl J, Schulz M, Schmid M PLoS One. 2021; 16(3):e0247446.

PMID: 33657139 PMC: 7928460. DOI: 10.1371/journal.pone.0247446.

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