Antibiotic stewardship programmes: legal framework and structure and process indicator in Southwestern French hospitals, 2005-2008.

French hospitals are required to implement antibiotic stewardship programmes (ABS) to improve antibiotic use. We analysed the legal framework on ABS and assessed its impact on hospitals' ABS development in Southwestern France. For each official text, required measures, date of issue, means of control and incentives were analysed. Annual retrospective surveys were conducted in 84 hospitals from 2005 to 2008 to monitor implementation of ABS components: organisation, resources and actions. Evolution of individual measures and of a structure and process indicator (SPI) reflecting ABS was described for each hospital. From 2002, official texts issued by health authorities set out requirements on ABS, based on previous professional guidelines. Incentives and means of control were reinforced in 2006 and in 2007 with mandatory reporting of SPI for public disclosure. ABS implementation improved during the course of the study period. In 2008, at least 98% of hospitals had implemented formularies, antibiotic committees, surgical prophylaxis guidelines, and monitored antibiotic use; antibiotic advisors were appointed in 85% of hospitals. Little progress was made regarding time dedicated by pharmacists to antibiotic management and restrictive dispensation using stop-orders. Computerised tools, continuing education and audits remained under-used. SPI values were higher in private hospitals and rehabilitation centres than in others. Official texts and the SPI public disclosure increased professionals' and hospital managers' commitment to develop ABS, resulting in improvements. However, some actions still need to be reinforced. It appears crucial to monitor practical implementation to better approach ABS effectiveness and to adapt requirements.

[The French system of evaluation of dependence: establishment in a legal system]. / Le système français d'évaluation de la pharmacodépendance et de l'abus: consécration juridique.

The French system of evaluation of dependence has been defined in the French Public Health Code by decree 99-249 of 31 March 1999. It was created by health authorities 10 years earlier and concerns dependence and abuse, which were previously just submitted to control under the designation of non-conforming use and misuse. The consultative function of the narcotics and psychotropics commission has been reinforced and its mission extended to include evaluation. Cooperation with different actors has been organized. This is based on the complexity of the methods of evaluation and the impact of decisions concerning control and/or information. The same principles organize the cooperation of this system at the European and international levels.

[Drug prescriptions outside the marketing product license and its responsibilities]. / Prescription de médicaments hors AMM et responsabilités.

In France, drugs are commercialized after obtaining marketing approval. There are some situations however in which clinicians are authorized to prescribe drugs outside the limits set by the approval document. Clinicians must comply with certain number of regulations. Compliance with prescription modalities, particularly precautions concerning prescription writing or the patient's informed consent, is mandatory. Although patients cannot be reimbursed for drugs prescribed outside the approval limitations, they may nevertheless benefit from special dispositions: temporary approval for use and experimentation within the framework of the Huriet law. We analyze here the question of liability in case of drug prescriptions outside approval limitations, discussing the issues of civil and penal law and patient reimbursement.

[Plurality of provideurs of information on drugs]. / La pluralité des émetteurs de l'information sur le médicament.

The life cycle of pharmaceuticals is accompanied by information flows, from the first steps of biomedical research through the end stage i.e., the consumption by the users. The information flows are provided by a great number of people and organizations. They equally raise a great number of problems related to relevance, accuracy, safety, laws, ethics and the like. The article presents some of these problems in France. Undoubtedly they are common to nearly all countries.

[Study of the composition of aqueous humor in normal subjects by means of automatic analytical technics]. / Nouvelle contribution à l'étude des composants de l'humeur aqueuse chez le sujet normal par utilisation des techniques d'analyses automatiques

Five new constituents in the aqueous humour were measured as part of a study on the constitution of the aqueous in normal subjects; urea, glucose, phosphorus, calcium and the carbonates and bicarbonates representing the alkaline reserve. Each of these constituents were measured by an automatic method using the Technicon auto-analyser, a similar sample of aqueous humour serving in some cases for simultaneous measurement of several constituents. The principles of the reaction, the Manifold used and the results obtained are reported for each of these. The latter were studied more particularly as a function of age on the one part and also a function of the serum levels of the same constituent. This simultaneous study establishes a relationship between the aqueous humor and the plasma which is compared with preceding reports in the literature and with results obtained more often in animals. Several important physiological and physiopathological considerations arise from these findings.