ABSTRACT
With Law no. 96 and subsequent updates, in Italy the use of authorized medicinal products is allowed outside of the summary of product characteristics indications under the direct responsibility of the prescriber and in patients who cannot be treated satisfactorily with authorized standard treatments. Considering that to date no guidelines on request and authorization procedures for off-label use have been established at a national, or at least regional level, an anonymous survey was conceived to outline the current framework on this topic. The survey was structured with 10 multiple choice answers and checkboxes, and one comments section. The link to access the questionnaire was firstly sent by email to select Italian physicians and clinical research coordinator to test the tool. Corrections were made in line with observations and suggestions and it was then shared with a wider audience through the Italian Group of data Manager’s mailing list. The total number of completed surveys collected was 34. The off-label use requests are performed in most cases by the prescribing physicians alone (59%, n = 20) or with the help of a study coordinator (41%, n = 14). Moreover, most sites (64.5%, n = 22) have a multidisciplinary commission evaluating the off-label use requests, and in almost half (41%, n = 14) the health director is responsible for the final authorization. The latter is granted in less than a week in 38.2% (n = 13). 79.5% of respondents (n = 27) confirmed the evaluation can be expedited in urgent cases. Despite a common approach in the majority of cases, there is still a notable variability in the request and authorization processes for off-label use among prescribing sites so there is an urgent need for an update in legislation on this topic to standardize the process.

IMPACT STATEMENT
There is an urgent need for an update in legislation about off label use to standardize the process of request and authorization.