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

Eur J Clin Pharmacol. 2012 May;68(5):801-10. doi: 10.1007/s00228-011-1183-4. Epub 2011 Dec 14.


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.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adolescent Development*
  • Asia / epidemiology
  • Child
  • Child Development*
  • Child, Preschool
  • Cohort Studies
  • Drug-Related Side Effects and Adverse Reactions / epidemiology*
  • Drug-Related Side Effects and Adverse Reactions / physiopathology
  • Drug-Related Side Effects and Adverse Reactions / prevention & control
  • Europe / epidemiology
  • Female
  • Hospitals, General
  • Humans
  • Incidence
  • Infant
  • Infant, Newborn
  • Male
  • Polypharmacy
  • Prospective Studies
  • Risk Factors