| Popis: |
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. |
