Le facteur VII active recombinant hors Autorisation de mise sur le marche a l'heure de la tarification a l'activite: enquete de pratique. [Off label use of recombinant activated factor VII: a practice survey]

Détails

ID Serval
serval:BIB_B8F428745E36
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Institution
Titre
Le facteur VII active recombinant hors Autorisation de mise sur le marche a l'heure de la tarification a l'activite: enquete de pratique. [Off label use of recombinant activated factor VII: a practice survey]
Périodique
Annales Françaises d'Anesthésie et de Réanimation
Auteur(s)
Delannoy B., Levrat A., Chamouard V., Aulagner G., Perdrix J.P., Negrier C., Allaouchiche B.
ISSN
1769-6623
Statut éditorial
Publié
Date de publication
09/2007
Peer-reviewed
Oui
Volume
26
Numéro
9
Pages
774-779
Langue
français
Résumé
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.
Mots-clé
Adult Drug Utilization/standards/statistics & numerical data Factor VIIa/*therapeutic use Female *Guideline Adherence Humans Male Middle Aged Recombinant Proteins/therapeutic use Retrospective Studies
Pubmed
Web of science
Création de la notice
14/02/2008 15:03
Dernière modification de la notice
20/08/2019 15:27
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