Off-label use of drugs in Italy: A prospective, observational and multicentre study

C. Pandolfini, P. Impicciatore, D. Provasi, F. Rocchi, R. Campi, M. Bonati, Maria Grazia Cattaneo, Pieremilio Cornelli, Lorenzo Mirabile, Maria Pia Raffaelli, Walter Sonzogni, Giancarlo Taddei, Laura Tellarini, Nuccia Bagarolo, Luisella Cordiano, Antonella Pedrini, Roberta Rampazzo, Carlo Zorzi, Francesco Chiarelli, Angelika MohnValeria De Donno, Silvia Favetta, Clara Pietraru, Lorena Poggio, Paola Vivani, Giovanna Monina, Ambrogina Primi, Angela Coppini, Pasquale Di Pietro, Rossana Gusmano, Alessandra Mastrangioli, Eleonora Panetta, Francesco Perfumo, Rossella Rossi, Cristina Amato, Giovanni Giaretto, Isabella Marone, Laura Rocatti, Paolo Serravalle, Nicola D'Andrea, Giuseppina Lardo, Federico Marchetti, Maria Cristina Mencoboni, Rosanna Taccardi, Annalisa Ferrarese, Roberta Joppi, Gianfranco Temporin

Research output: Contribution to journalArticlepeer-review


The aims of the study were to measure the paediatric, off-label use of drugs in the Italian hospital setting and to reveal areas for priority intervention by investigating the therapeutic indications most involved. Prescriptions given to all children admitted to nine general paediatric hospital wards from December 1998 to February 1999 were analysed. In total, 4265 prescriptions were given to 1461 children, 10 of which were unlicensed and excluded from further analysis. Sixty percent of prescriptions (range between centres: 44-71%) were off-label and concerned 89% of children receiving medications (80-96%). The main drug classes were antibacterials, antiasthmatics and analgesics, and represented 56% of off-label prescriptions. Paracetamol (385 prescriptions) and beclomethasone (339) were the generic substances most often used off-label. The most common off-label categories were dosage/frequency (50% of prescriptions), indication and lack of paediatric licence (7% each). Fifty-four per cent of all indications that led to off-label prescribing involved only respiratory problems, fever, respiratory tract infections and bronchospasm. Conclusions: Despite prescription profile differences among centres, off-label use was high everywhere. Immediate action for more rational drug use is necessary and requires not only regulatory intervention but also a more evidence-based, therapeutic approach.

Original languageEnglish
Pages (from-to)339-347
Number of pages9
JournalActa Paediatrica, International Journal of Paediatrics
Issue number3
Publication statusPublished - 2002


  • Children
  • Drug labelling
  • Italy
  • Multicentre study
  • Off-label drug use

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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