Le facteur VII activé recombinant hors Autorisation de mise sur le marché à l'heure de la tarification à l'activité : enquête de pratique

Abstract

Objectives To evaluate the impact of local recommendations on off label use of recombinant activated factor VII. Type of study Observational, retrospective. Material and methods Recommendations have been diffused by a local working group in 2004, concerning seven groups of indications (traumatology, cardiac, hepatic and various surgeries, obstetrics, neurology and haematology). Conformity to recommendations was studied according to 4 axes: respect of prescribing procedure, indication, posology, and pre ones required with the administration. Results There were thirty-one uses from 2004 to 2006. Thirty patients presented a massive haemorrhage (blood products before administration of recombinant activated factor VII expressed in median [min–max]: red blood cell unit = 15 [0–37], fresh frozen plasma = 11 [0–21]). Gravity score at the admission: SAPSII = 55 ± 22 (average ± SD), 87% patients presented haemorrhagic shock. Prescribing procedure was in conformity with recommendations in 45%, indications were correct in 74%, posology in 55%, and 16% of prescriptions were completely conform. Conclusion With the tariffing to the activity reform, the reimbursement of off label use of expensive molecules will depend on the respect of the evidence-based medicine. According to this study, the observance of local recommendations was insufficient. Rationalizing prescriptions for practice improvement seemed to be difficult and challenging.