Off-label antibiotic use in children in three European countries

Alessandro Porta, Susanna Esposito, Esse Menson, Nikos Spyridis, Maria Tsolia, Mike Sharland, Nicola Principi

Research output: Contribution to journalArticlepeer-review


Objective: Antibiotics are the drugs most frequently prescribed for children, and most of them lack patent protection. The aim of this study was to evaluate off-label antibiotic use in three European countries. Methods: Data relating to all patients admitted to the neonatal intensive care units (NICUs) and paediatric wards of the participating centres were collected by the same investigator over a 2-week survey period between February and May 2009. The data included age, date of birth, weight, relevant medical history and diagnosis, together with details of all of the antibiotics prescribed (compound, route of administration, dose, and indication for use). Results: The study involved 616 children (110 admitted to NICUs: 62 in the UK, 38 in Italy and 10 in Greece; 506 admitted to general paediatric wards: 265 in the UK, 94 in Italy and 147 in Greece). A total of 1244 antibiotic prescriptions were issued (290 in NICUs and 954 in paediatric wards). The results showed that off-label antibiotic use is very common among European paediatric patients, with generally only slight, but sometimes significant differences between countries. However, this use relates almost exclusively to doses and indications, and rarely to age. The only antibiotics found to be used off-label in an age-related manner in paediatric clinical practice are meropenem for neonates and quinolones or linezolid for older children, which represent priorities for future studies. Conclusion: European-wide educational programmes are urgently needed to meet the objectives of improving paediatricians' working knowledge of the recommendations surrounding licensed antibiotics-use in children, and of reducing uncontrolled patterns of prescribing.

Original languageEnglish
Pages (from-to)919-927
Number of pages9
JournalEuropean Journal of Clinical Pharmacology
Issue number9
Publication statusPublished - Sep 2010


  • Antibiotic use
  • Antibiotics
  • Antimicrobial prescribing
  • Antimicrobials
  • Children
  • Off-label drugs

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology


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