Background The extended use of rituximab for off-label indications accentuates the need for creating standardised protocols to speed up both the administrative processes and the supply to the patient.

Purpose To analyse rituximab’s off-label indications as well as the treatment schedule used to evaluate the degree of compliance with the Royal Decree which regulates the use of medicines under special circumstances.

Material and methods An observational retrospective study was carried out in 2015, in which all patients treated with rituximab, both exclusively or in combination with other drugs, were included. For data collection, the oncologic treatment management tool, Onconfarm, and the electronic clinic history programme, Selene, were used: age, gender, diagnosis, treatment schedule received, off-label indication or not, and, if affirmative, whether it was processed and authorised by the medical board at the hospital.

Results 74 patients were included, 38 women and 36 men, with an average age of 69 years (20–90). A total of 103 treatments were applied, the following being the most frequent: follicular lymphoma (23%), giant cell lymphoma (13.5%) and chronic lymphocytic leukaemia (CLL) (12%). The most used treatment schedules were: R-CHOP (22%), rituximab every 2 months (13.5%) and rituximab quarterly (12.5). Of all treatments applied, 48 (47%) did not comply with the indications in the technical data sheet. The most frequent indications were: membranous glomerular nephropathy (14.5%), CLL as maintenance treatment (12.5%) and Mantle cell lymphoma and Waldenström’s macroglobulinaemia (10.5%). Of all the off-label treatments, 58% were processed following the procedures related to the use of medicines under special circumstances and authorised to be applied, while the remaining 42% were applied without being administratively processed.

Conclusion Prescribing Rituximab for off-label indications is very frequent in hospitals. These situations should be registered under some therapeutic protocols, mandatory for physicians, and in which regulation by the Pharmaceutical and Therapeutical Commission should be actively engaged and involved.

References and/or acknowledgements

1. García-Sabina A, Rabunal Rey R, Martínez-Pacheco R. Review of use of drugs for conditions not included in product characteristics. Farmhosp (Internet). 2016 (mentioned 10 Oct 2016); 2011;35:264–77. Available at http://www.sefh.es/fh/118_121v35n05pdf009.pdf

2. European Assessment Report, de la European Medicines Agency. Procedure No. EMEA/H/C/165/II/0060. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000165/WC500025821.pdf, mentioned 10 Oct 2016

References and/or acknowledgementsNo conflict of interest