Assessment of off-label prescribing: profile, evidence and evolution.

Objectives: The objectives of the study were to describe the extent and profile of off-label prescriptions, to evaluate the level of evidence supporting these indications, to assess the research activity in these conditions, and to determine to what extent these were authorized as new indications five years after the application.

Methods: A cross-sectional study including all applications conducted in the Hospital Universitario Reina Sofía in Córdoba during 2010.

Analysis:  level of evidence according to the criteria by SIGN-NICE (Scottish Intercollegiate Guidelines Network, National Institute for Health and Care Excellence) and CEBM (Centre for Evidence-based Medicine), registered clinical trials (source: ClinicalTrials.