Background The off-label drugs use in paediatrics is high and there are few studies undertaken on off-label drug use in Spain.

Purpose To analyse off-label drugs use in paediatrics services, to analyse which clinical units requested more often off-label drugs and which were the causes that led to the consideration of off-label treatment.

Material and methods Descriptive observational study from October 2009 to September 2014. We included all individual requests of off-label drugs received in the Pharmacy Department by the different paediatrics clinical units. Individualised assessment reports were developed with an analysis of efficacy, safety, convenience and cost, which were referred to hospital medical administration to make the decision to authorise or deny its use.

Results A total of 141 requests were analysed, of which 95.1% (134) were finally authorised and 4.9% (7) were denied. The most petitioned drugs were Levosimendan with 14.9% (14 requests in cardiac surgery using extracorporeal circulation and 7 in diastolic dysfunction), Adalimumab with 8.5% (6 requests for juvenile idiopathic arthritis, 3 in ulcerative colitis and 3 for Crohn’s disease), Palivizumab with 6.4% (6 requests for prophylaxis of Human respiratory syncytial virus (RSV) in immunocompromised patients and 3 in treatment of RSV) and Pegfilgrastim with 4.9% (7 requests for neutropenia after chemotherapy in paediatric patients).

According to cause which led to the consideration of off-label, in 58.2% (82) was due to an unauthorised indication. Furthermore, the reason for off-label in 41.8% (59) due to unauthorised indication for patient age.

The most petitioned paediatrics clinical units were oncology with 46.1% (65), rheumatology with 12.1% (17), cardiology with 9.9% (14) and paediatric Intensive Care Unit with 8.5% (12).

Conclusion There is a variety of off-label drugs used in paediatric clinical units. Off-label drugs were requested mostly in the field of oncology and rheumatology. There were a high number of requests for drugs approved in adults but not in paediatric indications.

References and/or acknowledgements No conflict of interest.