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药物警戒:全球药物安全监测的万能钥匙。

Pharmacovigilance: a worldwide master key for drug safety monitoring.

作者信息

Jeetu G, Anusha G

机构信息

Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal, Karnataka, India.

出版信息

J Young Pharm. 2010 Jul;2(3):315-20. doi: 10.4103/0975-1483.66802.

Abstract

Pharmacovigilance is like a sunshade to describe the processes for monitoring and evaluating ADRs and it is a key component of effective drug regulation systems, clinical practice and public health programmes. The number of Adverse Drug Reactions (ADRs) reported resulted in an increase in the volume of data handled, and to understand the pharmacovigilance, a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. The current global network of pharmacovigilance centers, coordinated by the Uppsala Monitoring Centre, would be strengthened by an independent system of review. This would consider litigious and important drug safety issues that have the potential to affect public health adversely beyond national boundaries. Recently, pharmacovigilance has been confined, mainly to detect adverse drug events that were previously either unknown or poorly understood. Pharmacovigilance is an important and integral part of clinical research and these days it is growing in many countries. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs. In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors.

摘要

药物警戒就像一把遮阳伞,用于描述监测和评估药品不良反应的过程,它是有效药物监管系统、临床实践和公共卫生项目的关键组成部分。报告的药品不良反应数量导致了所处理数据量的增加,为了理解药物警戒,需要高水平的专业知识来快速检测药物风险,并为产品抵御不当撤市。由乌普萨拉监测中心协调的当前全球药物警戒中心网络,将通过一个独立的审查系统得到加强。这将考虑到可能对跨国界公共卫生产生不利影响的诉讼性和重要药物安全问题。最近,药物警戒主要局限于发现以前未知或了解不足的药品不良事件。药物警戒是临床研究的重要组成部分,如今在许多国家都在不断发展。如今,许多药物警戒中心在全球范围内致力于药物安全监测,然而,在千年之交,药物警戒在药物更好的安全性和监测方面面临重大挑战。在这篇综述中,我们将讨论药物安全、全球药物警戒中心及其作用、药物警戒的益处和挑战以及其在医疗保健领域的未来考量。

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