[Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk]. / La prescription hors AMM en gynécologie-obstétrique : du pragmatisme médico-économique au potentiel risque médico-légal.

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.

[Court-ordered treatment: Analysing a complex practise through a literature review]. / Les soins pénalement ordonnés : analyse d'une pratique complexe à travers une revue de la littérature.

INTRODUCTION: In France, there are two main types of court-ordered treatment (COT) as far as mental health is concerned: obligations of treatment and injunctions of treatment. Obligations of treatment date back from 1958 whereas the law implementing injunctions of treatment is fairly recent as it was passed in 1998. Obligations and injunctions of treatment are two different types of COT that differ in terms of proceedings (obligations of treatment require no preliminary forensic psychiatric assessment; as for injunctions of treatment, they require the appointment of a coordinating medical doctor) and that are applied for different offences. However, both are psychiatric commitment procedures connecting the judicial, medical and social fields and their overall numbers have been on the rise. These common psychiatric practices have seldom been assessed and no review of the literature on the subject has ever been published. Better knowledge of such forensic practices is essential to their improvement and even to adjust the legal framework of these measures that are enjoying a boom. The purpose of this literature review is to define the prevalence of COT as well as the sociodemographic, criminal and psychiatric characteristics of those concerned by such measures. MATERIAL AND METHODS: A review of the French medical literature on COT was carried out using Science Direct up to December 2013. The results of seven studies were included and analysed. This was completed with a review of the articles listed in social sciences and law databases (Cairn and Dalloz). RESULTS: It has become increasingly frequent to rely on psychiatric teams to implement COT while at the same time public mental health services have to face a surge in activity with restricted financial means. Obligations of treatment are far more common (about 20,000 court orders a year) than injunctions of treatment (about 4000 measures are currently being enforced). However the latter have showed an increase of 506% over the 2000 decade. Both measures mainly concern men (83-99%) who are rather low on the social scale. In about half of these men, no mental disorder was found, however the prevalence of personality disorders ranged from 22 to 65% while that of psychotic disorders was low. Injunctions of treatment concerned sex offenders (90% of cases) whereas obligations of treatment concern non-sexual abusers (40-70%) rather than sex offenders (20-30%). DISCUSSION: Psychiatric research on COT is still thin on the ground and its methodology does not allow rigorous evaluation though the use of such measures is growing. When confronted with people who have not sought any care or treatment, healthcare professionals are at a loss. In France, training in forensic psychiatry is inadequate and specialised healthcare (particularly for sex offenders) need improving to reach the level of those found in many other European countries. The purpose of psychiatric treatment differs from that of lawmakers whose aim is to prevent recidivism. However, better treatment consistency requires setting up partnerships between justice, health and social services. To improve connections, there are various avenues of work such as, for instance, the creation of coordinating medical doctors for injunctions of treatment in France or European experiments using a multidisciplinary approach to prevent recidivism in sex offenders. The framework of such a partnership remains to be created as it is part and parcel of COT but has not been provided for in the law. Healthcare jurisdictions as defined in the 2009 French National Health Law might provide an appropriate framework for mental health and law professionals to collaborate.

Asymptomatic bacteriuria in pregnancy: a diagnostic and therapeutic approach.

Pregnancy is a predisposing factor for urinary tract infection and pregnant women suffering from this pathology are exposed to dangerous risks which may condition maternal wellbeing and fetal prognosis. The apparently paradoxal finding of a higher incidence of perinatal problems in pregnant women with asymptomatic bacteriuria compared to those with manifest infections may be explained by the fact that the latter are adequately treated, whereas asymptomatic bacteriuria, which is difficult to diagnose, may continue in a subtle form for the entire duration of pregnancy. This emphasises the importance of the early diagnosis of infection using a protocol based on urine tests and urine culture and the adequate treatment of all cases of asymptomatic bacteriuria in order to reduce the incidence of maternal and fetal complications (acute pyelonephritis, increased fetal morbidity and mortality). The choice of the antibiotic to be used must be made on the basis of the urine culture test, the stage of gestation, maternal clinical data and the characteristics of the antibiotic itself (pharmacokinetics, maternal and fetal toxicity). With regard to the treatment protocol, the "single-dose" protocol is currently preferred. After negative urine culture tests, all patients must carry out a complete urine test each month with hormonal and echographic monitoring of the fetoplacental unit.

Asymptomatic bacteriuria in pregnancy: maternal and fetal complications.

From an analysis of the data reported in the literature it is clear that pregnancy is a predisposing factor for urinary tract infection and that pregnant women with this pathology are exposed to dangerous risks which may influence maternal wellbeing and fetal prognosis. Authors do not concur on the specific risks to the mother and fetus, one reason being that the statistics reported to date reveal discrepancies relating to the presence of disorders prior to pregnancy and the environmental, working and socio-hygienic conditions of the populations studied. The apparently paradoxical finding of a higher incidence of perinatal problems in pregnant women with asymptomatic bacteriuria compared to manifest forms can be attributed to the fact that the latter are treated with adequate therapies whereas asymptomatic bacteriuria, which is difficult to diagnose, may persist throughout pregnancy. This underlines the importance of early diagnosis using a protocol which entails the execution of serial urine tests and urine cultures and adequate treatment of all cases of asymptomatic bacteriuria in order to reduce the incidence of urinary tract infections and materno-fetal complications. Non-treated asymptomatic bacteriuria in fact represents a considerable risk factor since it may lead to the onset of acute pyelonephritis in approximately 5% of pregnant women and may increase the risk of fetal mortality.

[Ovarian hyperstimulation syndrome (OHS): borderlines between physiology and pathology]. / Sindrome da iperstimolazione ovarica (SIO): limiti tra fisiologia e patologia.

The use of gonadotropins in therapy has led to the appearance of a complication due to hyperstimulation, referred to as "syndrome due to ovarian hypertension" (SOH). There are three clinical stages of SOH: slight, moderate and severe, caused by a pathogenetic mechanism which is thought to involve the action of prostaglandins and the renin-angiotensin system leading to an alteration in capillary permeability with increased ovarian diameter. SOH can be prevented using a protocol to evaluate clinical conditions during therapy mainly based on hormone assays and echographic monitoring. SOH can be predicted but not prevented, thus making it important to commence immediate treatment for in-patients so as to restore the volume of blood and the blood protein load in the most severe cases.