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The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals

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

Abstract

Objective

To investigate paediatricians’ perception and awareness of off-label (OL) and unlicensed drug usage in clinical practice.

Methods

We conducted a questionnaire-based, observational study involving 28 departments/speciality units of four tertiary paediatrics Italian hospitals. The questionnaire was sent to a designated paediatrician in each department/speciality unit with the request that they summarise their awareness of OL prescriptions after a group discussion with all paediatricians working in the same department/unit.

Results

A total of 95 drugs were identified. The most common perceived reasons detected for OL use were age and formulation. Corticosteroids, ACE-inhibitors, β-blockers and calcium-antagonists were most frequently indicated as OL for formulation, while ACE-inhibitors, new generation anti-epilepsy drugs, immunosuppressants, ketorolac and propofol as OL for age. Adrenaline, midazolam and ACE-inhibitors were indicated as unlicensed for route of administration. We found a high concordance between the OL drugs identified by physicians and those reported in the “Italian Summary Product Characteristics”.

Conclusions

Italian paediatricians perceived different drugs as unlicensed/OL from those identified by existing prescriptions studies. These perceived drugs may represent a priority in tackling the problem of OL usage in the hospital practice. The review of the Italian Summary Product Characteristics of some of the drugs identified, together with the monitoring of permanent clinical practice and with new clinical research, may be a step forward to reduce OL use in children.

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Authors and Affiliations

  1. Department of Paediatrics, Institute of Child Health, IRCCS Burlo Garofolo and University of Trieste, Via dell’Istria 65/1, 34100, Trieste, Italy

    Federico Marchetti, Jenny Bua & Alessandro Ventura

  2. Department of Paediatrics, University of Brescia, Brescia, Italy

    Luigi D. Notarangelo

  3. Department of Paediatrics, Santobono-Pausilipon Hospital, Naples, Italy

    Salvatore Di Maio

  4. Department of Paediatrics, OIRM S. Anna, Turin, Italy

    Giuseppina Migliore

  5. Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Milan, Italy

    Maurizio Bonati

Authors
  1. Federico Marchetti
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  2. Jenny Bua
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  3. Alessandro Ventura
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  4. Luigi D. Notarangelo
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  5. Salvatore Di Maio
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  6. Giuseppina Migliore
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  7. Maurizio Bonati
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Corresponding author

Correspondence to Federico Marchetti.

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Marchetti, F., Bua, J., Ventura, A. et al. The awareness among paediatricians of off-label prescribing in children: a survey of Italian hospitals. Eur J Clin Pharmacol 63, 81–85 (2007). https://doi.org/10.1007/s00228-006-0223-y

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  • DOI: https://doi.org/10.1007/s00228-006-0223-y

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