title: [Off-label use of oncology drugs: national survey results].
abstract: OBJECTIVE
  identify by means of a survey the off-label treatments more often used in the oncohaematology area, as well as to know the established procedures and criteria used to authorise those treatments.
  
  
  METHODS
  a four-section survey was designed: 1) demographic data and hospital activity, 2) Off-label treatments protocol, 3) Approval criteria and 4) Off-label oncology treatments conducted during the last year.
  
  
  RESULTS
  in 42.1% of the hospitals it's needed an authorisation before dispensing in more tan 80% of the treatments. The most influential factor in the approval-dispensation system is the available evidence. The consent of the hospital management with previous Pharmacy department's report was the most common authorisation procedure. 55.3% of the hospitals settled specific patient criteria to help the decision-making altogether with the available safety and efficacy data of the drug for the requested indication. In most centers a lower level of evidence is accepted if there are no therapeutic alternatives as well as in tumors of low prevalence. Most of the centers have not clearly established a criterion of effectiveness to consider a benefit as clinically relevant, nor the cost-effectiveness threshold for approving a FFT.
  
  
  CONCLUSIONS
  there is a great variability in the off-label treatments use and also in the criteria used for its approval.
authors.affiliation: Servicio de Farmacia Hospital General Universitario Gregorio Marañón, Madrid.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: Eva
authors.initials: E
authors.lastname: González-Haba Peña
authors.affiliation: Servicio de Farmacia Hospital Miguel Servet, Zaragoza.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: María José
authors.initials: MJ
authors.lastname: Agustín Ferrández
authors.affiliation: Servicio de Farmacia Hospital Universitari Arnau de Vilanova, Lleida.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: Irene
authors.initials: I
authors.lastname: Mangues Bafalluy
authors.affiliation: Servicio de Farmacia Hospital General Universitario Gregorio Marañón, Madrid.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: Nicolás
authors.initials: N
authors.lastname: Alfredo López
authors.affiliation: Servicio de Farmacia Complejo Hospitalario Mancha Centro. Alcázar de San Juan, Ciudad Real.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: María Dolores
authors.initials: MD
authors.lastname: Fraga Fuentes
authors.affiliation: Servicio de Farmacia Hospital Universitario de Valme, Sevilla.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: Roberto
authors.initials: R
authors.lastname: Marín Gil
authors.affiliation: Servicio de Farmacia Hospital Universitario Puerta del Mar, Cádiz.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: María José
authors.initials: MJ
authors.lastname: Martínez Bautista
authors.affiliation: Servicio de Farmacia Institut Català d'Oncologia, Barcelona. España.. eva.gonzalezhaba@salud.madrid.org.
authors.forename: Ana
authors.initials: A
authors.lastname: Clopés Estela
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017277:Drug Approval; D019538:Health Care Surveys; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D056687:Off-Label Use / Q000592:standards / Q000706:statistics & numerical data*; D010607:Pharmacy Service, Hospital; D013030:Spain / Q000453:epidemiology
chemical_list: D000970:Antineoplastic Agents