Background Nowadays in hospitals drugs are more frequently used for purposes other than the ones indicated in the summary of product characteristics.

Purpose To analyse the applications for off-label use of drugs in a third level hospital with the aim of reviewing their approval procedures and setting measures to improve their use.

Material and methods An observational and retrospective study was carried out for the applications for off-label use of drugs received January 2010 to September 2014. A case report form was designed using the following variables: drug, therapeutic use, department, Oxford Centre for Evidence-based Medicine 2011 levels of evidence and type of approval (approval, conditional approval, and non-approval). Drugs requiring a protocol approved by the hospital Pharmacy and Therapeutics Committee were excluded.

Results 128 applications for 59 different therapeutic uses were analysed. A total of 117 (91.4%) were approved, of which 16 were conditionally approved due to the low level of study evidence. Approvals were denied for 11 applications, for 2 of which another treatment was suggested and the physician accepted. Most of the applications were made for rituximab (24 applications,18.7%), for 16 different therapeutic uses, omalizumab (10 applications, 7.8%), bevacizumab and tacrolimus, both of them with 7 application each.

The departments with more applications were Oncology and Haematology (24 applications, 18.7%), Neurology (19 applications, 14.8%), Internal Medicine, Ophthalmology, and the Allergology department, with 10 applications.

For most of the applications, physicians took into account studies with low (case-series studies, follow-up studies and no randomization) levels of evidence 3–4.

Conclusion Due to the high number of applications for different therapeutic uses and the poor level of evidence for them, it is necessary to review the criteria for their approval and to check that these criteria are being observed in order to guarantee the correct and efficient use of the drugs.

References and/or acknowledgements No conflict of interest.