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Resume Le bon usage des medicaments peut etre defini simplement comme l’utilisation du bon medicament, a la bonne dose, pendant la duree necessaire, pour un patient donne qui le tolere correctement. Il est impossible, etant donne le nombre de medicaments et le nombre infini des situations cliniques individuelles de ne pas baser la prescription sur une reference. La reference peut etre unique, lorsque la situation clinique est simple et le medicament, a choisir, unique. Dans ce cas une bonne formation initiale et continue sert de reference au choix. L’usage du RCP (Resume des Caracteristiques du Produit) choisi permet d’obtenir une prescription plus precise et plus sure. Dans beaucoup de cas l’usage de telle ou telle strategie therapeutique peut conduire au resultat souhaite. Dans ces cas, des referentiels scientifiques permettent d’aider le prescripteur a choisir la meilleure strategie. Enfin les strategies therapeutiques peuvent avoir une efficacite egale et des couts tres differents. Des referentiels peuvent etre emis pour diminuer le cout d’une prescription donnee. Les difficultes issues de references ou de referentiels sont : 1. Ils ne peuvent pas couvrir l’integralite des situations cliniques. 2. Ils devraient etre evolutifs a mesure que la science progresse et cela est difficile. 3. La multiplicite des emetteurs aboutit a des messages confus parfois contradictoires. 4. Leur pertinence et leur efficacite devraient etre evaluees. 5. Ils peuvent etre inutilisables pour le prescripteur en raison de leur complexite ou de l’eloignement des situations pratiques. Nous proposons un constat et un certain nombre de solutions pour ameliorer la qualite et la pertinence des references ou referentiels : des structures de coordination choisissant les themes et definissant les methodes de redaction, la creation d’un repertoire des referentiels, un cahier des charges de tout referentiel avec exigence de qualite, une formation initiale et continue des soignants destinataires des referentiels. Il est par ailleurs necessaire de mettre en place des mesures d’impact de ces referentiels et de s’imposer une actualisation adaptee periodique. Tout cela devrait permettre une amelioration mesurable de la qualite des soins.

Resume Des lors qu’un nouveau medicament est susceptible d’etre commercialise, la question de l’evaluation du progres therapeutique se pose en deux temps. Tout d’abord quelle est la quantite de progres therapeutique attendu ? Ce premier temps necessite de confronter aux besoins therapeutiques les resultats issus des etudes cliniques sur lesquelles reposent l’autorisation de mise sur le marche, afin d’anticiper le progres therapeutique attendu. Ensuite survient l’evaluation du progres therapeutique effectif. Celui-ci s’inscrit dans le suivi de l’usage du medicament, et sera issu de donnees d’observations en population. Destine a etre confronte au pari et aux incertitudes initiales (en termes de benefice et de risque), ces objectifs et les methodes mises en oeuvre doivent etre determines avant que le medicament ne soit mis a la disposition de la collectivite.

When a candidate drug is likely to become available to prescribers and healthcare policy makers, evaluation of therapeutic progress moves forward in two stages. First, the level of expected therapeutic progress must be established. This first stage requires the determination of therapeutic needs and the comparison of these against the results of the clinical studies that will form the basis of the marketing authorisation of the drug. This determination helps anticipate the therapeutic progress that is attributable to the approved use of the new drug. The second stage of the process, the evaluation of the actual therapeutic progress, involves therapeutic drug monitoring and bases itself on observation. Since such observational data are intended to challenge the initial hypotheses and uncertainties (in terms of benefits and risks), goals and methods must be laid out before the drug becomes available to the general public.

The use of subjective outcome measures for assessing drug efficacy varies according to the disease in question. Subjective outcome measures used to complement an objective outcome measure can clearly claim the status of a main outcome measure. The validation of an instrument follows an appropriate methodology that focuses on two points: the methods used for its construction are set out and its performance is evaluated in a study. In drug evaluation, the importance of the subjective outcome measure should be discussed, depending on the aim and the disease. The methodology of the study obeys the same rules as when an objective outcome measure is used. The issue of the clinical significance of the results should be broached and discussed. Subjective outcome measures deserve to be considered in the evaluation of the drug because they provide a different and complementary perspective on the disease and the patient, both at the time of obtaining the marketing authorization or when reassessing a drug.

L'utilisation de criteres subjectifs d'evaluation de l'efficacite est variable selon les pathologies. Les criteres subjectifs utilises en complement de criteres objectifs peuvent tout a fait pretendre au statut de critere principal d'efficacite. La validation d'un instrument suit une methodologie appropriee portant sur deux points : l'expose des modalites pratiques de sa construction et une etude permettant d'evaluer ses performances. Lors de l'evaluation du medicament, la place du critere subjectif doit etre discutee, en fonction de l'objectif et de la pathologie. La methodologie de l'etude obeit aux memes regles que lorsqu'on utilise un critere objectif. La question de la significativite clinique des resultats doit etre abordee et discutee. Les criteres subjectifs meritent d'etre pris en compte dans l'evaluation du medicament apportant un eclairage different et complementaire sur la maladie et sur le patient, que l'on soit au moment de l'autorisation de mise sur le marche ou en situation de reevaluation.

Proper use of drugs can be defined as the use of the right product, in a correct dosage, during an adequate length of time, for a given patient and provided he has no serious side effects. It is virtually impossible, with such a number of drugs, such a number of clinical situations to prescribe adequately without using references or guidelines. References may lead to a unique choice, when the diagnosis is certain and the drug to be given is unique. With a good initial and continuous medical education, doctors can take easily this type of decision. The Summary of Products Characteristics (SPC) helps them; by sticking to this fundamental reference, prescription might be more precise and safe. In a lot of clinical situations the choice between a large numbers of therapeutic strategies necessitates use of a guideline based on scientific knowledge. Finally, a given therapeutic strategy can be as effective as and considerably less expensive than another. In such cases, payers can drive doctors to the prescription of the less expensive strategy. Some difficulties are common to all references and guidelines: 1. A lot of clinical situations are not covered by guidelines. 2. Guidelines should be updated each time there is a modification of knowledge: it is extremely difficult to do. 3. A great number of guidelines exist, issued by scientific community, health authorities or the payers. Sometime you can find a proposition in a guideline and the reverse in another guideline. It could be confusing. 4. Guidelines should be evaluated rigorously to know if they fulfil their goals. 5. Some of those guidelines simply cannot help doctors. They are too complex or do not take into account practical situations. We have made an inventory of those various guidelines and their weaknesses and we propose some solutions to increase their utility. We propose an analysis of the situation and some solutions to improve the quality and the relevance of the guidelines: to create groups of coordination to choose the aims and the elaboration methods, to initiate a register of guidelines, to list the rules for any new guideline with quality control, to propose a continue medical education for all the health workers. It is necessary to measure the impact of any new recommendation and to do periodical actualisation. The goal of these recommendations is to improve global quality of health.

Epidemiologic data on end-stage renal disease (ESRD) treated with renal dialysis remain sparse and incomplete in France because there is no national registry of dialysis patients. The aim of this study was to determine the characteristics (age, gender, comorbidities, associated handicap) of patients treated with renal dialysis and to compare the dialysis regional practices. We performed a cross-sectional descriptive study from June 2 to June 8, 2003 in all renal dialysis units by enrolling all the patients residing in France with ESRD who were dialysed during that week, irrespective of the treatment they received or where they were being treated. In 2003, the type of dialysis units available and the technique they employ were quite different from one region to another, varying from 41.1 to 70.2% for highly specialized unit, 9.4 to 48.4% for self-care hemodialysis, and 2.9 to 26.5% for peritoneal dialysis.