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出自识林

2014-12-30 FDA Voice

2014年12月30日 FDA Voice
FDA药品审评与研究中心主任 Janet Woodcock博士
千里之行，始于足下。2008年FDA推出“哨兵行动”并由此开始了使用重要科学技术—“主动监测”，挑战开发全面医疗产品安全监管项目的漫长旅程。“主动监测”补充了FDA不良事件报告系统（FAERS）。FAERS已经开发完善并使用了同样重要的技术—“被动监测”。今天，我想介绍我们在前进的道路上取得的进展。

FDA“迷你哨兵”计划—2009年启动，历时5年的成功试点项目—现在正按计划过渡到全面“哨兵”系统。我想和大家分享“迷你哨兵”试点项目的成功，以及在新的“哨兵系统”下FDA迈向全面“主动监测”旅程的一些愿景。

首先，快速讨论一下“主动监测”的重要性：多年来，FDA FAERS计划已成为我们评估医疗产品安全性的主要工具。该系统依赖于患者、医务人员和产品生产商向我们报告FDA监管产品的潜在安全问题。

FAERS是非常宝贵的财富，我们并不是寻找它的替代品。但是，哨兵系统为我们提供了激动人心的可能性：不是等待安全性信息以报告的形式递交给我们，而是我们主动走出去获得这些信息。大大增加了我们的安全监控能力。这就是主动监测。

过去5年中，“迷你哨兵”试点项目已经为超过1.78亿全国患者建立对电子医疗数据的安全访问，使研究人员可以评估大量有价值的安全信息。在保护患者个人身份的同时，我们可以从“迷你哨兵”获得有价值的信息帮助我们更好地理解潜在安全问题，并与大家分享安全用药信息。我们已经使用“迷你哨兵”研究了许多安全问题，帮助FDA加强安全监测能力，为药品和疫苗的决策过程提供宝贵意见。

我们现在正在开发一个国家范围的快速应答电子主动监测系统—“哨兵系统”，用于监测FDA监管的药品和其它医疗产品的安全性。

那么这一旅程将带我们去向何方？

• FDA将以“迷你哨兵”试点的成功为基础。在”迷你哨兵“下进行的各种安全评估将继续开展，我们还将寻求”哨兵系统“影响力和能力的扩展；
• ”迷你哨兵“已经给我我们一个重要的开动，但必须继续发展和完善现有的科学方法来评估通过哨兵系统获得的数据；
• 我们看到”哨兵“作为一个潜在的有价值的国家资源为FDA以外的其他安全研究者使用。展望未来，我们的希望是，与科学团体合作，创建国家数据基础设施，允许其他使用者（例如，其它政府机构、学术界或企业界的研究者）获得”哨兵“基础设施用于多种用途（例如，医疗产品研究、质量改进）；
• 这种机会不仅将直接服务于公众健康，还有利于项目维持，因为只有如此，利益攸关方才会有动力为项目的维护和成长提供支持（资金和其它方面）。

从一开始，“哨兵行动”的目标就是庞大的并且是开创性的。我们知道这将历经数年的时间，但“迷你哨兵”的顺利完成标志着取得了重要进展。我们期待在过渡到全面哨兵项目的同时，继续并扩大主动监测能力。

编译：识林-椒 2014-12-30
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Another important step in FDA's journey towards enhanced safety through full-scale “active surveillance”
Posted on December 30, 2014 by FDA Voice
By: Janet Woodcock, M.D.

They say the longest journey begins with a single step. In 2008, FDA launched the Sentinel Initiative and thus began a long journey toward the challenging goal of developing a full-scale medical product safety monitoring program using an important scientific technique called “active surveillance,” which complements our FDA Adverse Event Reporting System (FAERS). FAERS is already well developed and uses the equally important technique of “passive surveillance.” Today, I'd like to recognize our progress along the way.

After a successful five-year pilot program, which began in 2009, FDA's Mini-Sentinel program is now transitioning, as planned, to the full-scale Sentinel System. I'd like to share with you the success of our Mini-Sentinel pilot program and some of FDA's visions for our new leg of the journey toward full-scale “active surveillance” under the new Sentinel System.

First, a quick discussion of the importance of “active surveillance”: Over many years, FDA's program that we now call FAERS has been our main tool for assessing the safety of medical products. This system relies on patients, medical professionals, and product manufacturers to report to us potential safety issues of the products FDA regulates.

FAERS is an invaluable asset, and we're not seeking to replace it. However, the Sentinel System offers us the exciting possibility of not waiting for safety information to come to us in the form of reports, but rather it enables us to go out and get that information, adding greatly to our safety monitoring capability. This is active surveillance.

Over the past five years, the Mini-Sentinel pilot program has established secure access to the electronic healthcare data of more than 178 million patients across the country, enabling researchers to evaluate a great deal of valuable safety information. While protecting the identity of individual patients we can get valuable information from Mini-Sentinel that helps us better understand potential safety issues, and share with you information on how to use medicines safely. We have used Mini-Sentinel to explore many safety issues, helping FDA enhance our safety surveillance capabilities, and giving us valuable input in decision-making on drugs and vaccines.

We’re now well on our way to developing a nationwide rapid-response electronic active surveillance system, Sentinel System, for monitoring the safety of FDA-regulated drugs and other medical products.

So where does our journey take us from here?

• FDA will build on the successes of the Mini-Sentinel Pilot. We have a variety of safety assessments ongoing under Mini-Sentinel that will continue and we will seek to expand our reach and capabilities with the Sentinel System;
• Mini-Sentinel gave us an important start, but it is essential to continue to develop and refine existing scientific methods to evaluate the data we access through the Sentinel System;
• We see Sentinel as a potentially valuable national resource for other safety researchers, besides those at FDA. Looking even further ahead, our hope is that, working with other scientific groups, we will be able to create a National Data Infrastructure that would enable other users (e.g., other governmental agencies, researchers from academia or industry) to access the Sentinel infrastructure for multiple purposes (e.g., medical product research, quality improvement);
• Not only will such access directly serve the public health, it will also help sustain these programs because stakeholders will have an incentive to provide support (financial and otherwise) for its maintenance and growth.

From the outset, the goals of the Sentinel Initiative have been large and of ground-breaking scale. We knew it would be years in the making, but Mini-Sentinel’s successful completion marks important progress. We look forward to continuing and expanding our active surveillance capabilities as we now transition to the full-scale Sentinel program.