REIN : un outil au service de la vigilance et de la pharmaco-épidémiologie

Abstract

On the occasion of the 20th anniversary of the REIN (French Renal Epidemiology and Information Network), a summary work on the contributions of the national French ESKD register was carried out. On the issue of its role in vigilance, the following key messages were retained. The vigilance system consists, among other things, of collecting information that is useful for the surveillance of health products that are drugs for pharmacovigilance, and medical devices for materiovigilance. This includes the reporting of adverse events by health professionals and manufacturers as well as the use of any information concerning the risk of adverse events. Vigilance enables improving and optimising product and patient safety by reducing the risks of adverse events and better understanding the risks and benefits. Using data from the REIN registry, cross-referenced with other external sources, it is possible to conduct post-marketing studies of these products. These studies generate hypotheses, are low-cost and are yet to be confirmed by randomised studies. Following the presentation of a study suggesting an unfavourable role of citrate dialysates on mortality, and thanks to the mobilisation of all the operators of the network, the REIN registry was able to conduct a study in a few months that made it possible to conclude that the use of citric acid in dialysates does not present a risk of excess mortality for the patients. With this example, the REIN registry has shown its adaptability and utility as a vigilance tool.