Off-label use of oncology drugs: national survey results

• Main Authors: Eva González-Haba Peña (Author), María José Agustín Ferrández (Author), Irene Mangues Bafalluy (Author), Nicolás Alfredo López (Author), María Dolores Fraga Fuentes (Author), Roberto Marín Gil (Author), María José Martínez Bautista (Author), Ana Clopés Estela (Author)
• Format: Book
• Published: Elsevier, 2015-09-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.
• Notes: 10.7399/fh.2015.39.5.8979; 1130-6343; 2171-8695
• Keywords: Off-label use; ; Antineoplastic drugs; ; Non-approved indications; Drugs in especial situations.; Pharmacy and materia medica; RS1-441; Therapeutics. Pharmacology; RM1-950
• Source: Farmacia Hospitalaria, Vol 39, Iss 5, Pp 275-287 (2015)

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.