Análisis del uso de fármacos fuera de indicación autorizada en hematología y oncología

Abstract

Background and objective: the use of off-label drugs is the use of medications in conditions other than those included in its prescribing information. The objective of this paper is to analyze the off-label drugs applications   and their results, performed by the Oncology and Hematology services in a second level hospital. Materials and methods: A retrospective observational study of all requests for "off label" drugs received by the Pharmacy Service was carried out. The drugs were classified according to economic impact, a classification according to the type of drug and the reason for the request and according to the degree of evidence. The demographic, diagnostic and treatment data of the patients were analyzed for each request. A follow-up of adverse effects, median progression-free survival and median overall survival is presented. Results: 85 treatment requests were approved. Most of the treatments were high impact, mainly aimed at rare pathologies and last treatment options. 22% of the requests had a high degree of evidence. Progression free survival (PFS) and overall survival (OS) were 6.6 (95% CI 5.2-8) and 9.7 months (95% CI 8.2-11.2). 18.7% of patients had grade 3-4 toxicity when receiving treatment. Conclusions: Despite the heterogeneity of the pathologies, and the low evidence, the results obtained in SLP and SG, together with the low toxicity, force us to continue advancing in the evaluation of this type of treatments.