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

Abstract

Dear Sir, We have read the article published by Duran-Garcia et al. [1] and would like to congratulate the authors on their work. Moreover, based on our own experience, we would also like to highlight the importance of the role of the Pharmacy and Therapeutics Committee in detecting and regulating the ‘‘off-label’’ drug use in hospitals. Prescription-indication studies can be used to detect if medication is being used in ways other than those authorised by the drug regulatory agencies. 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 [3–5]. For example, Conde-Garcia 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. On the other hand, Vargas-Rivas et al. [4] found that Trastuzumab was used in patients (36.4% of cases) who did not have HER2-Overexpressing (HER2-Overexpressing is one of the requirements established by regulatory agencies for using this drug). When situations like these are detected, it is important to assess whether use of the medication is pertinent or suitable. To assess it, first it is necessary to search for scientific evidence supporting the use of drugs in these unauthorised conditions (‘‘off-label’’ use). If evidence is not found or may be of moderate/lowquality, new studies should be designed to evaluate the effectiveness of the ‘‘off-label’’ drug use, and, ideally, to evaluate the cost-effectiveness ratio of treatment. In the study by Conde-Garcia 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. Moreover, this chemotherapy plan was later approved and authorised by the national drug regulatory agency. In other words, ‘‘offlabel’’ drug use could be sometimes the correct treatment approach and can have positive effects on patient health, even before this use is approved by regulatory boards. On these occasions, the work carried out by the hospital Pharmacy and Therapeutics Committee becomes particularly important, as one of its main objectives is to assess the suitability of the ‘‘off-label’’ drug use [1]. If high-quality scientific evidence supporting the ‘‘off-label’’ drug use is found, the committee can decide to authorise this use in the corresponding hospitals, accepting the entailed advantages and drawbacks. 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 situation should be the starting point for well-designed studies, which could generate evidence for the benefit/risk ratio of treatments, and help us to decide whether the ‘‘offlabel’’ use of a certain drug could be suitable. In these studies, it is important to include a specialist physician in the research team. With this fact, we want to ensure that clinical outcomes are correctly assessed and interpreted, J. E. Vargas-Rivas (&) D. Sabater-Hernandez M. A. Calleja-Hernandez M. J. Faus F. Martinez-Martinez Pharm. D. Pharmaceutical Care Research Group, Grupo de Investigacion en Atencion Farmaceutica, University of Granada, Campus Universitario de Cartuja S/N, 18071 Granada, Spain e-mail: jevargasrivas@gmail.com