La prescription hors AMM en gynécologie-obstétrique : du pragmatisme médico-économique au potentiel risque médico-légal

Abstract

The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an “over-cautious” practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession.