Department of Clinical Pharmacology and Epidemiology, Centro Studi SIFO, Consorzio Mario Negri Sud, Via Nazionale 8/a, 66030, S. Maria Imbaro, Italy.
Eur J Clin Pharmacol. 2012 Jan;68(1):11-9. doi: 10.1007/s00228-011-1096-2. Epub 2011 Jul 20.
The present work has the main objective of summarizing the history of pharmacovigilance and the associated methods and legislation and of showing how it could/should be reformulated in terms of a transition from a drug-centered to a patient/population-centered approach. The recurrent emergencies associated with new drug molecules raise many questions about the efficacy and efficiency of methodological tools as well as the role of regulatory systems. Drugs cannot be considered as an independent variable: the evaluation of all their effects must take into account the real contexts in which they are used and which affect not only their efficacy but also their tolerability and safety. Specific emphasis is given to recent and promising developments focused on the participation of patients and populations as key actors in producing knowledge that could technically integrate what has been produced so far and allow the evolution of surveillance from a role of controlling severe adverse reactions attributable to individual molecules to one of promoting a comprehensive assessment of the benefit/risk profile of drugs as they are utilized in society.
本研究的主要目的是总结药物警戒学的历史以及相关的方法和法规，并展示如何从以药物为中心的方法向以患者/人群为中心的方法进行转变。与新药物分子相关的反复出现的紧急情况引发了许多关于方法学工具的有效性和效率以及监管系统作用的问题。药物不能被视为一个独立的变量：对其所有作用的评估必须考虑到它们实际使用的环境，这些环境不仅会影响其疗效，还会影响其耐受性和安全性。特别强调了最近和有前途的发展，这些发展侧重于让患者和人群作为产生知识的关键角色参与其中，这些知识可以在技术上整合迄今为止所产生的知识，并允许监测从控制归因于单个分子的严重不良反应的角色演变为促进对药物的获益/风险特征进行全面评估，因为它们在社会中得到了应用。
