[Off label use of recombinant activated factor VII: a practice survey].
OBJECTIVE
To evaluate the impact of local recommendations on off label use of recombinant activated factor VII.


METHODS
Observational, retrospective.


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.


CONCLUSIONS
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.
Delannoy
B
B
Service d'anesthésie-réanimation, hôpital Edouard-Herriot, place d'Arsonval, Lyon cedex 03, France. delannoy.bertrand@caramail.com <delannoy.bertrand@caramail.com>
Levrat
A
A
Chamouard
V
V
Aulagner
G
G
Perdrix
J-P
JP
Négrier
C
C
Allaouchiche
B
B
D000328:Adult; D004363:Drug Utilization / Q000592:standards / Q000706:statistics & numerical data; D015942:Factor VIIa / Q000627:therapeutic use*; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000627:therapeutic use; D012189:Retrospective Studies
D011994:Recombinant Proteins; D015942:Factor VIIa