Resumen

GONZALEZ-HABA PENA, Eva  y  SEFH. GRUPO GEDEFO (Grupo de Farmacia Oncológica et al. Off-label use of oncology drugs: national survey results. Farm Hosp. [online]. 2015, vol.39, n.5, pp.275-287. ISSN 2171-8695.  https://dx.doi.org/10.7399/fh.2015.39.5.8979.

Purpose: 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.

Palabras clave : Off-label use; Antineoplastic drugs; Non-approved indications; Drugs in especial situations.

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