Estudio de adecuación a la ficha técnica, efectividad, seguridad y coste del rituximab en un hospital de tercer nivel

Abstract

We found that the main cause of the high rate of non-compliance with the package leaflet is patient lack of response to standard treatments, together with clinical practice guides that support the use of rituximab for conditions other than those for which it is indicated. Nevertheless, most of the clinical trials evaluating the efficacy of rituximab for these unauthorized diagnostic profiles have poor methodology, are in phase II, are open studies, have low patient numbers, or in some cases, are not comparative.

Role of the hospital pharmacy and therapeutics committee in detecting and regulating off-label drug use

“…In the study by Conde-García et al [3], the off-label use of the CHOP-Rituximab plan to treat follicular lymphoma (48.1% of plans used in this diagnosis) was supported by the results of high-quality randomised clinical trials [6,7]. As a result, the ''off-label'' use of CHOP-Rituximab during the study period was deemed reasonable.…”

“…Furthermore, as we mentioned above, the evidence supporting the ''off-label'' drug use could be not found or may be of moderate/low-quality [3] (i.e. poor-quality randomised controlled trials and/or several phase II studies).…”

“…This non-approved use is called ''off-label'' drug use [2]. Our work area focuses on cytostatic drugs, and we know that the ''offlabel'' use of these drugs become a common practice in some hospitals [3][4][5]. For example, Conde-García M et al [3] found that Rituximab was used to treat unauthorised diagnoses (18 diagnoses) in 37.1% of patients between 2003 and 2007.…”

“…Our work area focuses on cytostatic drugs, and we know that the ''offlabel'' use of these drugs become a common practice in some hospitals [3][4][5]. For example, Conde-García M et al [3] found that Rituximab was used to treat unauthorised diagnoses (18 diagnoses) in 37.1% of patients between 2003 and 2007. Additionally, Rituximab was used in unauthorised chemotherapy plans (use with other cytostatic drugs) and lines of treatment (order of preference for the treatment alternatives available) in a considerable number of cases.…”