Martinière K, Lucas S, Zorzi P
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.
Transfus Clin Biol. 2008 Sep;15(4):179-89. doi: 10.1016/j.tracli.2008.04.008. Epub 2008 Jun 5.
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.
生物警戒被定义为对人体器官、组织和细胞治疗用途的监测。法国生物警戒系统实施四年后，法国药品安全局（Afssaps）对收集到的数据进行了首次分析。从数量上看，除了实施的第一年即2004年外，年度通报的平均数量达到166起。考虑到人体应用的总数，必须指出的是，与涉及器官和细胞的情况相比，通报的涉及组织的事件和不良反应相当少。从质量角度来看，该分析能够识别不同类别的事件和不良反应，并为每一类列出相应的通报数量。这种描述性分析应为法国生物警戒国家委员会提供思考的起点，旨在提高通报的详尽性和质量，以便于对收集到的数据进行进一步分析。这种改进首先应旨在更精确地确定生物警戒中应通报或不应通报的事件和不良反应类别。它还应允许更新通报表格。在其首个三年任期结束前，生物警戒国家委员会应能够建立生物警戒网络的所有必要工具，并使其可供所有利益相关者使用和理解。
