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药物警戒策略:跨国学习的机会。

Pharmacovigilance strategy: opportunities for cross-national learning.

机构信息

ISOP ISRAEL: The Israeli Chapter of the International Society of Pharmacovigilance and IFC Ltd, Beit Haarava32, Jerusalem, Israel.

出版信息

Isr J Health Policy Res. 2019 Jun 19;8(1):54. doi: 10.1186/s13584-019-0319-3.

Abstract

The Israeli Ministry of Health has set up the foundations of a National Pharmacovigilance System. The next step is to adopt the best of the international ideas, trends and approaches which are shaping the future of pharmacovigilance. Specifically: 1) The risk management approach requires proactively preventing or minimizing risks, starting in early clinical development and extending all along the lifecycle of a pharmaceutical. 2) Drug safety is a multidisciplinary discipline where all stakeholders should be involved. 3) Clinical trials provide an ideal safety profile limited to the restrictive conditions of the trial. Only real-world data, from the post marketing period, will reveal the real risk/benefit balance for the use of a pharmaceutical in regular clinical care. 4) Artificial intelligence is needed to analyze the large amount of data collected through the post-marketing studies, electronic medical records and the internet. Many AI tools have been developed to support better use of pharmaceuticals. 5) Quality-oriented, thorough inspections and audits are critical for achieving patient safety. 6) Patients should be recognized as active players in their treatment who can, and should, have access to safety information through the major agencies' websites.Israel can benefit from several of its key assets to reach a higher level of pharmacovigilance: 1) Israel's four HMOs are organized in a way that allows them to have quick and efficient dialogue with healthcare professionals and with patients. Moreover, a new project named, Big Data in Health, will pool the epidemiologic databases of the HMOs, providing precious information for understanding risk factors, detecting alerts, and developing personalized medicine. 2) Formal risk management activities have long been part of the culture of hospitals and should be applied increasingly to ensuring drug safety.Israel has the organizational, scientific, technological and cultural resources needed to quickly overcome the challenges and go beyond its current state to build a unique pharmacovigilance system which could serve as an example for other countries.

摘要

以色列卫生部已经建立了国家药物警戒系统的基础。下一步是采用国际上最好的理念、趋势和方法,这些方法正在塑造药物警戒的未来。具体而言:1)风险管理方法需要主动预防或最小化风险,从早期临床开发开始,并贯穿药品整个生命周期。2)药物安全是一个多学科领域,所有利益相关者都应该参与其中。3)临床试验提供了一个理想的安全性概况,仅限于试验的限制条件。只有来自上市后期间的真实世界数据,才能揭示在常规临床护理中使用药品的真正风险/效益平衡。4)需要人工智能来分析通过上市后研究、电子病历和互联网收集的大量数据。已经开发了许多人工智能工具来支持更好地使用药品。5)以质量为导向的彻底检查和审计对于实现患者安全至关重要。6)患者应被视为其治疗的积极参与者,他们可以而且应该通过主要机构的网站获得安全信息。以色列可以从其几个关键资产中受益,以达到更高水平的药物警戒:1)以色列的四个 HMO 以允许他们与医疗保健专业人员和患者进行快速有效的对话的方式组织。此外,一个名为“大数据在健康中的应用”的新项目将汇集 HMO 的流行病学数据库,为了解风险因素、检测警报和开发个性化药物提供宝贵信息。2)正式的风险管理活动长期以来一直是医院文化的一部分,应该越来越多地应用于确保药物安全。以色列拥有快速克服挑战并超越当前状态建立独特的药物警戒系统所需的组织、科学、技术和文化资源,该系统可以作为其他国家的榜样。

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本文引用的文献

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Advancing Drug Safety Through Prospective Pharmacovigilance.
Ther Innov Regul Sci. 2018 Jul;52(4):400-402. doi: 10.1177/2168479018766887. Epub 2018 Apr 1.
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3
21st century pharmacovigilance: efforts, roles, and responsibilities.
Lancet Oncol. 2016 Nov;17(11):e486-e492. doi: 10.1016/S1470-2045(16)30312-6.

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