Pharmacovigilance system and the future challenges in India-A Perspective

Pharmacovigilance system and the future challenges in India-A Perspective
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印度药物警戒体系及未来挑战-透视

DOI:
10.31838/ijprt/08.02.03
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发表时间:
2019
期刊:
International Journal of Pharmacy Research & Technology
影响因子:
--
通讯作者:
Radha Sharma
Radha Sharma
中科院分区:
--
文献类型:
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作者:
Sandhya Jain;Vikas Jain;Radha Sharma

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PVPI是收集、监测、研究、评估和评价来自医疗保健提供者和患者的关于药物、生物制品、血液制品、草药、疫苗、医疗器械、传统和补充药物的不良反应的信息的科学,旨在识别与产品相关的危害的新信息,并防止对患者造成伤害。本文简要概述了印度药物警戒的现状和未来挑战。对在印度实施适当药物警戒的重要性进行了分析,印度首次启动药物警戒活动的尝试可追溯到1986年,当时提出了一个正式的药物不良反应(ADR)监测系统,该系统由12个区域中心组成,每个中心的人口为5000万。然而,这一制度并没有形成。1997年,印度加入了设在瑞典乌普萨拉的世界卫生组织药品不良反应监测计划。’乌普萨拉监测中心(UMC)维护着一个来自世界各地的疑似药物不良反应报告的国际数据库,以支持关于服药患者治疗方案的获益和风险的良好决策
PVPI is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, blood products, herbals, vaccines, medical device, traditional and complementary medicines with a view to identifying new information about hazards associated with products and preventing harm to patients. This article provides a brief overview about the current situation and the future challenges of pharmacovigilance in India. The importance of implementing proper pharmacovigilance in the Indian scenario has been analysed the first recognised attempt to start pharmacovigilance activities in India dates back to 1986, when a formal Adverse Drug Reaction (ADR) monitoring system with 12 regional centres for a population of 50 million each, was proposed. However, the system did not come into existence. In 1997, India joined the World Health Organization’s ADR Monitoring Programme based in Uppsala, Sweden. The Uppsala Monitoring Centre (UMC) maintains an international database of suspected adverse drug reaction reports from all over the world to support good decision-making regarding the benefits and risks of treatment options for patients taking medicines