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Eur J Clin Pharmacol DOI 10.1007/s00228-011-1183-4

PHARMACOEPIDEMIOLOGY AND PRESCRIPTION

Risk factors associated with adverse drug reactions in hospitalised children: international multicentre study Asia N. Rashed & Ian C. K. Wong & Noel Cranswick & Stephen Tomlin & Wolfgang Rascher & Antje Neubert

Received: 29 July 2011 / Accepted: 22 November 2011 # Springer-Verlag 2011

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 A. N. Rashed : I. C. K. Wong : A. Neubert Centre for Paediatric Pharmacy Research, The School of Pharmacy, University of London, 29-39 Brunswick Square, London WC1N 1AX, UK

high-risk and low-risk drug groups. Analgesics, antiepileptics, 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 (n0145), Germany (n0372), Hong Kong (n0 138), Malaysia (n0291), UK (n 0307)]. 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; p2 to≤11, >11 to ≤18 years), gender, number of low-risk drugs per patient (in groups: 1–4, 5–10, >10 drugs), number of high-risk drugs per patient (in groups: 1, 2–3, >3 drugs), diagnosed with ‘diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism’ (D50–D89), ‘diseases of the nervous system’ (G00–G99), ‘certain conditions originated in the perinatal period’ (P00–P96), ‘endocrine, nutritional and metabolic diseases’ (E00–E90), ‘certain infectious and parasitic diseases’ (A00–B99). The final model was adjusted by country. Gender and younger age (0 to ≤2 years and >2 to ≤11 years) were included in the full model despite their non-significance in the univariable analysis because previous studies had identified sex and gender as risk factors for ADR incidence [3, 24]. In all statistical tests p values 3 ICD 10 code A00–B99 (yes/no) D50–D89 (yes/no) G00–G99 (yes/no) P00–P96 (yes/no) E00–E90 (yes/no)

Univariable OR (95% CI)

p-value

Full modelb OR (95% CI)

p-value

1.1 (0.79–1.6) 1.00 (reference) 1.7 (1.0–2.8) 0.96 (0.70–1.3)

0.498

0.351

0.031 0.776

1.2 (0.80–1.9) 1.00 (reference) 2.1 (1.1–3.8) 0.94 (0.65–1.4)

1.00 (reference) 1.4 (0.91–2.2)

0.129

1.00 (reference) 2.3 (1.4–4.0)

0.002

4.8 (2.8–8.2) 18.4 (7.6–44.5)