1Istituto per l'Infanzia “Burlo Garofolo”, Trieste (coordinamento);
2Ospedale dei Bambini, Brescia;
3AO Santobono - Pausilipon, Napoli;
4AO OIRM S. Anna, Torino;
5Laboratorio per la Salute Materno-Infantile, Istituto Mario Negri, Milano
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Key words: Off-label drugs, Children, Hospital-based survey
Two thirds of the drugs prescribed for children are off-label. However, off-label is not synonymous with incorrect, since it often represents the most rational, evidence-based therapy. Existing data on the use of off-label in children are based on prescriptions registers. The aim of our study was to investigate the paediatricians’ perspective on off-label use in their everyday hospital practice. Four Paediatrics Italian Hospitals were involved in the study. Questionnaires covered eight different department/speciality units. Our findings showed that the most common reasons detected for off-label use were formulation and age. Corticosteroids, antihypertensive drugs and midazolam were most frequently indicated as off-label for formulation, while ciprofloxacin, new generation anti-epilepsy drugs (lamotrigine, oxcarbazepine) and immunosuppressant (mycophenolate, rituximab) for age. The drugs identified as off-label differed according to department, although some recurred (i.e. ACE inhibitors, ketorolac). Our survey might be of help for planning appropriate interventions to tackle the problem of off-label use in paediatrics.
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