GSK, London, UK; London School of Hygiene and Tropical Medicine, University of London, London, UK; New York University, New York, NY, USA.
GSK, Wavre, Belgium.
Trends Pharmacol Sci. 2021 Dec;42(12):1051-1063. doi: 10.1016/j.tips.2021.09.007. Epub 2021 Oct 9.
The systematic safety surveillance of real-world use of medicinal products and related activities (pharmacovigilance) started in earnest as a scientific field only in the 1960s. While developments have occurred over the past 50 years, adding to its complexity and sophistication, the extent to which some of these advances have positively impacted the capability for ensuring patient safety is questionable. We review how the conduct of safety surveillance has changed, highlight recent scientific advances, and argue how they need to be harnessed to enhance pharmacovigilance in the future. Specifically, we describe five changes that we believe should and will need to happen globally in the coming years: (i) better, more diverse data used for safety; (ii) the switch from manual activities to automation; (iii) removal of limited value, extraneous transactional activities and replacement with sharpened focus on scientific efforts to improve patient safety; (iv) patient-involved and focussed safety; and (v) personalised safety.
药品真实世界使用的系统性安全监测及相关活动（药物警戒）作为一门科学领域，直到 20 世纪 60 年代才真正起步。虽然在过去的 50 年里取得了发展，使其变得更加复杂和先进，但其中一些进展在多大程度上积极影响了确保患者安全的能力仍值得怀疑。我们回顾了安全性监测工作的变化，强调了最近的科学进展，并就如何利用这些进展来增强未来的药物警戒提出了看法。具体来说，我们描述了我们认为在未来几年全球范围内应该而且需要发生的五个变化：（i）更好、更多样化的数据用于安全性；（ii）从手动活动到自动化的转变；（iii）消除无价值的、多余的事务性活动，将重点转移到提高患者安全性的科学努力上；（iv）患者参与和关注安全性；以及（v）个性化安全性。
