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Resume Introduction L’hemorragie massive reste une cause importante de mortalite dans les pays developpes, particulierement en obstetrique, chez le polytraumatise et dans les chirurgies majeures. Le facteur VII active recombinant (rFVIIa) (Novoseven®) a ete developpe pour le traitement substitutif des hemophiles, mais etait actuellement utilise dans d’autres indications de saignement aigu. L’objectif de cette etude etait d’evaluer le respect des criteres d’utilisation hors AMM du rFVIIa selon les groupes definis par l’Afssaps, dans les hopitaux de l’assistance publique a Paris (AP–HP) en 2010. Patients et methodes Nous avons retrospectivement contacte les services d’anesthesie-reanimation des centres ayant une activite en obstetrique, d’accueil de polytraumatises, de chirurgie cardiaque, hepatique et pediatrique pour recuperer tous les dossiers d’utilisation hors AMM du rFVIIa en 2010. La qualite de l’indication et de son utilisation a ete analysee sur la base des recommandations francaises ou europeennes ou selon la litterature existante dans les domaines consideres. Trois categories de prescriptions ont ete etablies : conforme, acceptable et non conforme. Resultats Sur les 59 patients ayant recu du rFVIIa hors AMM en 2010, 49 prescriptions ont pu etre analysees. L’indication et le moment d’administration etaient conformes dans 100 % des prescriptions pour le polytraumatisme et 83 % des prescriptions pour les hemorragies du postpartum. Les criteres biologiques etaient remplis dans deux tiers des prescriptions. La prescription a ete jugee conforme ou acceptable dans 82 % des cas, toutes indications confondues. Conclusion Dans la grande majorite des cas, les prescriptions de rFVIIa, utilise hors AMM a l’AP–HP en 2010, respectaient les recommandations en vigueur.

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.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).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.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.

Mifepristone (Mifegyne 200 mg) is a newly approved drug in France for termination of early pregnancy. Consequently, doctors and pharmacists have to follow strict legal rules of prescription, administration, storage, and dispensing. French requirements are reviewed with particular regard to practical procedures of dispensing.The Government of France has developed strict legislation in terms of the manufacture, storage, dispensing, prescription, and administration of RU-486. The drug has been available in France since 1989 under the trade name Mifegyne (Roussel Laboratories). RU-486 has been classified as a contragestive due to its ability to interrupt an early pregnancy. Physicians who prescribe RU-486 as an abortifacient must receive special training from Roussel. Protocol requires that women who request RU-486 must be provided with information about abortion risks and alternatives, undergo a psychosocial evaluation, and be given a 1-week period for decision making. RU-486 must be taken in the presence of the prescribing physician, and can only be administered to women with an intrauterine pregnancy whose last menstrual period was no more than 49 days earlier. 2 days after RU-486 administration, the patient is given a prostaglandin analog (gemeprost or sulprostone) and monitored for at least 3 hours. 8-12 days after RU-486 administration, the woman must be given a follow-up examination to ensure that the expulsion was complete. RU-486 is available only from pharmacies of hospitals that are authorized to perform pregnancy interruption. The drug must be stored in a locked cabinet, and a double counterfoil book is used to control misuse.