[Off-label use of recombinant factor VII (rFVIIa) in teaching hospitals in Paris in 2010]

Abstract

Introduction: Recombinant activated factor VII (rFVIIa) (Novoseven(®)) was initially developed as a substitutive treatment in haemophiliacs but has then been used in situations of major haemorrhage in non-haemophiliacs (off-label use). The goal of the present study was to assess the practice patterns when rFVIIa is used in off-label indications in major teaching hospitals of Paris in 2010.

Methods: We retrospectively identified files of patients in whom rFVIIa had been used. Physicians in charge of these patients (or the most proxy physician available) were contacted and files analysed with one of the authors. Quality of rFVIIa used in these off-label situations was determined based on either French or European guidelines or the available literature when no guidelines could be found. Three categories were defined for indication, dosage, timing, associated biological factors and overall use: adequate, acceptable (mainly adequate but lacking some characteristics of an "ideal" prescription) and inadequate (lacking most of the necessary characteristics of an "ideal" prescription).

Results: Among 59 patients who had an off-label prescription of rFVIIa, 49 prescriptions could be analysed. Indication for use and timing of administration were adequate in 100% of multiple trauma cases and 83% of obstetrical cases. Biological criteria associated with an improved efficacy were found in two thirds of prescriptions analysed. Overall, prescriptions were adequate or acceptable in 82% of cases.

Conclusion: In the vast majority of patients who received rFVIIa for off-label indications in teaching hospitals of the Paris area in 2010, prescriptions were in line with recommendations.

Keywords: Cardiac surgery; Chirurgie cardiaque; Costly drugs; Esophageal varices; Evaluation of practice patterns; Facteur VII activé recombinant; Haemorrhage; Haemostasis; Hémorragie; Hémostase; Multiple trauma; Médicaments coûteux; Obstetrics; Obstétrique; Polytraumatisme; Recombinant activated factor VII; Varices œsophagiennes; Évaluation des pratiques professionnelles.