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药物警戒的历史概述。

An historical overview over Pharmacovigilance.

作者信息

Fornasier Giulia, Francescon Sara, Leone Roberto, Baldo Paolo

机构信息

Pharmacy Unit, Centro di Riferimento Oncologico CRO Aviano, National Cancer Institute - IRCCS, Aviano, Italy.

Pharmacology Unit, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.

出版信息

Int J Clin Pharm. 2018 Aug;40(4):744-747. doi: 10.1007/s11096-018-0657-1. Epub 2018 Jun 15.

Abstract

Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient's safety and the quality of life. In this commentary we report the milestones of pharmacovigilance up to the present day, in order to understand all the steps that have characterized the historical evolution; from the first reports, which were essentially letters or warnings sent by clinicians to publishers of important and famous scientific journals, up to today's modern and ultra-structured electronic registries. The historical phases also help us to understand why pharmacovigilance helped us to achieve such important results for man's health and for pharmacology itself, and to identify the challenges that await Pharmacovigilance in future years.

摘要

药物警戒始于约170年前,尽管当时还未这样命名。它是专业健康领域的结构化活动,具有重要的社会和商业意义,旨在监测药物的风险/效益比,提高患者安全性和生活质量。在这篇评论中,我们报告了截至目前药物警戒的里程碑,以便了解构成历史演变特征的所有步骤;从最初基本上是临床医生发给重要著名科学期刊出版商的信件或警告的报告,到如今现代且高度结构化的电子注册系统。这些历史阶段也有助于我们理解为什么药物警戒能为人类健康和药理学本身取得如此重要的成果,并确定未来几年药物警戒面临的挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c054/6132952/3b04e37cf2c7/11096_2018_657_Fig1_HTML.jpg

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