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Off-label antibiotic use in children in three European countries

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

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.

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Acknowledgements

We would like to thank all of our colleagues who contributed to the data collection: Fabio Mosca, Lorenza Pugni, Maria Cristina Pietrogrande, Rosa Maria Dellepiane, Edoardo Calderini and Maurizio Torricelli at the Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy; Dimitris Kafetzis, George Kourakis, George Petousis and Alexandros Passalidis at P. and A. Kyriakou Children’s Hospital, University of Athens, Athens, Greece.

The authors have no conflict of interest to declare. This study was supported in part by a grant from the Pediatric Unit 1, Fondazione IRCCS Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milan, Italy.

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Authors and Affiliations

  1. Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS “Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena”, Via Commenda 9, 20122, Milan, Italy

    Alessandro Porta, Susanna Esposito & Nicola Principi

  2. Evelina Children’s Hospital, London, UK

    Esse Menson

  3. P. and A. Kyriakou Children’s Hospital, University of Athens, Athens, Greece

    Nikos Spyridis & Maria Tsolia

  4. St. George’s Hospital, London, UK

    Mike Sharland

Authors
  1. Alessandro Porta
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  2. Susanna Esposito
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  3. Esse Menson
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  4. Nikos Spyridis
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  5. Maria Tsolia
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  6. Mike Sharland
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  7. Nicola Principi
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Corresponding author

Correspondence to Nicola Principi.

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Porta, A., Esposito, S., Menson, E. et al. Off-label antibiotic use in children in three European countries. Eur J Clin Pharmacol 66, 919–927 (2010). https://doi.org/10.1007/s00228-010-0842-1

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  • DOI: https://doi.org/10.1007/s00228-010-0842-1

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