PRIORITIES AMONG OFF-LABEL PRESCRIPTIONS: PAEDIATRICIANS’ PERSPECTIVE

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.