[Events and adverse reactions in biovigilance: Descriptive analysis of French national data following a four-year practical experience].
Biovigilance is defined as the surveillance of therapeutic use in man of organs, tissues and cells. Four years after the implementation of the French biovigilance system, a first analysis of data collected has been performed by Afssaps. Quantitatively, with the exception of 2004, the first year of implementation, the average number of annual notifications reaches 166. Taking into account the total number of human applications, it has to be noted that events and adverse reactions notified and involving tissues are rather low compared to those involving organs and cells. From a qualitative point of view, this analysis allows to identify different categories of events and adverse reactions with the corresponding number of notifications for each of them. This descriptive analysis should constitute for the French National Commission of Biovigilance the starting point of a reflection aiming at improving both exhaustiveness and quality of notifications in order to facilitate further analysis of data collected. This improvement should aim first at identifying more precisely the categories of events and adverse reactions to be notified or not in biovigilance. It should also allow updating the notification form. Before completion of his first three-year mandate, the National Commission of Biovigilance should be able to set up all the necessary tools of the biovigilance network and to make them available and understandable by all the stakeholders.
Cellule de biovigilance, département de l'évaluation des produits biologiques, Agence française de sécurité sanitaire des produits de santé (Afssaps), 143-147, boulevard Anatole-France, 93285 Saint-Denis cedex, France. karine.martiniere@afssaps.sante.fr
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Martinière
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Lucas
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Zorzi
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D001364:Awareness; D017690:Cell Transplantation / Q000009:adverse effects*; D018563:Disease Notification / Q000706:statistics & numerical data*; D005602:France; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012308:Risk Management / Q000592:standards / Q000706:statistics & numerical data; D014180:Transplantation / Q000009:adverse effects*