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

  • Jaime E. Vargas-RivasEmail author
  • Daniel Sabater-Hernández
  • Miguel A. Calleja-Hernández
  • María J. Faus
  • Fernando Martínez-Martínez
Letter to the Editor

Dear Sir,

We have read the article published by Durán-García 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 “off-label” 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...


Trastuzumab Scientific Evidence Follicular Lymphoma Hospital Pharmacy Pharmacy Service 
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  1. 1.
    Durán-García E, Santos-Ramos B, Puigventos-Latorre F, Ortega A. Literature review on the structure and operation of Pharmacy and Therapeutics Committees. Int J Clin Pharm. 2011;33(3):475–83.PubMedCrossRefGoogle Scholar
  2. 2.
    Radley DC, Finkelstein SN, Stafford RS. Off-label prescribing among office-based physicians. Arch Intern Med. 2006;166:1021–6.PubMedCrossRefGoogle Scholar
  3. 3.
    Conde-García M, Fernández-Feijoo M, Calleja-Hernández MA. Estudio de adecuación a la ficha técnica, efectividad, seguridad y coste del rituximab en un hospital de tercer nivel. Farm Hosp. 2009;33:305–11.PubMedCrossRefGoogle Scholar
  4. 4.
    Vargas-Rivas JE, Montes-Casas MM, Cancela-Diez B, Martínez-Martínez F, Sabater-Hernández D, Calleja-Hernández MA. Estudio de adecuación a la ficha técnica de las prescripciones de Trastuzumab en un hospital de tercer nivel. Farm Hosp. 2011 (forthcoming).Google Scholar
  5. 5.
    Vargas J, García B, Conde M, Jiménez A, Hernández J, Fernández MA. Compliance with prescription information sheet of trastuzumab prescriptions in a tertiary level Spanish hospital [Abstract]. Pharm World Sci. 2008;30:672–3.Google Scholar
  6. 6.
    Hiddemann W, Kneba M, Dreyling M, Schmitz N, Lengfelder E, Schmits R, et al. Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood. 2005;106:3725–32.PubMedCrossRefGoogle Scholar
  7. 7.
    Ferguson JSJ, Summerhayes M, Masters S, Schey S, Smith IE. New treatments for advanced cancer: an approach to prioritization. Br J Cancer. 2000;83:1268–73.PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media B.V. 2011

Authors and Affiliations

  • Jaime E. Vargas-Rivas
    • 1
    Email author
  • Daniel Sabater-Hernández
    • 1
  • Miguel A. Calleja-Hernández
    • 1
  • María J. Faus
    • 1
  • Fernando Martínez-Martínez
    • 1
  1. 1.Pharm. D. Pharmaceutical Care Research Group, Grupo de Investigación en Atención FarmacéuticaUniversity of GranadaGranadaSpain

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