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Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study

  • Pharmacoepidemiology and Prescription
  • Published:
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Abstract

Background

Understanding the epidemiology and risk factors of adverse drug reactions (ADRs) is important in order to develop appropriate prevention strategies. This study aimed to identify risk factors associated with ADRs in hospitalised children and recommend strategies to minimise ADRs.

Methods

A prospective multicentre cohort study was conducted on paediatric general medical wards in five European and non-European hospitals. ADRs were identified by intensive chart review. Multivariable logistic regression was used to investigate risk factors associated with ADRs. For the risk factor analysis, prescribed drugs were divided into high-risk and low-risk drug groups. Analgesics, anti-epileptics, antibacterials and antimycotics for systemic use, corticosteroids for systemic use and immunosuppressant agents were considered as high-risk groups whereas the remaining drug classes were defined as low-risk drug groups.

Results

A total of 1,253 paediatric patients were identified [Australia (n = 145), Germany (n = 372), Hong Kong (n = 138), Malaysia (n = 291), UK (n = 307)]. A total of 328 ADRs were observed in 16.7% of patients (186/1,115). Use of five or more low-risk drugs per patient or  three or more high-risk drugs was a strong predictor for ADRs (OR 4.7, 95% CI 2.4–9.3; OR 6.5, 95% CI 2.7–16.0 respectively; p < 0.001). Older children were more likely to experience ADRs; gender was not significantly associated.

Conclusion

To reduce the risk of ADRs in children, clinicians and pharmacists should aim to minimise polypharmacy and be aware of higher ADR risks associated with some drug groups.

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Acknowledgements

Asia Rashed was funded by the Yamani Cultural and Charitable Foundation, London, United Kingdom. In addition, authors wish to thank Professor Stephen Evans for his statistical advice Dr Lynda Wilton for reviewing the manuscript and Ben Cross for developing the database.

Contributors

I.C.K.W. and A.N. created the idea of the study. I.C.K.W. revised methodology and supervised the study. A.N. was the chief investigator of the study and supervised the analysis and data collection. A.N.R. was responsible for the management and analysis of the data from all sites, data collection and assessment in the UK and entering the data into the database. N.C., W.R., S.T. were responsible for study implementation, data collection and assessment at their sites. A.N.R. produced the first draft of the manuscript and all authors approved the final draft. I.C.K.W. is guarantor for the study.

Conflicts of interest

All authors declared that they have no financial interests that may be relevant to the submitted work.

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Authors and Affiliations

  1. Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, 29-39 Brunswick Square, London, WC1N 1AX, UK

    Asia N. Rashed, Ian C. K. Wong & Antje Neubert

  2. Department of Pharmacology & Pharmacy, Li Ka Shing Faculty of Medicine, University of Hong Kong, Pokfulam, Hong Kong

    Ian C. K. Wong

  3. Pharmacology Research Unit, Royal Children’s Hospital, Flemington Road, Parkville, VIC, 3052, Australia

    Noel Cranswick

  4. Evelina Children’s Hospital, Guy’s & St. Thomas’ NHS Foundation Trust, London, SE1 7EH, UK

    Stephen Tomlin

  5. Department of Children and Adolescents Medicine, Friedrich-Alexander-University Erlangen/Nuremberg, Loschgestr. 15, 91054, Erlangen, Germany

    Wolfgang Rascher & Antje Neubert

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  1. Asia N. Rashed
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  2. Ian C. K. Wong
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Corresponding author

Correspondence to Antje Neubert.

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Rashed, A.N., Wong, I.C.K., Cranswick, N. et al. Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study. Eur J Clin Pharmacol 68, 801–810 (2012). https://doi.org/10.1007/s00228-011-1183-4

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  • DOI: https://doi.org/10.1007/s00228-011-1183-4

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