eHealth Initiative's Drug Safety Collaboration to Partner With FDA on Sentinel Initiative
WASHINGTON, May 22 /PRNewswire-USNewswire/ -- The non-profit eHealth Initiative (eHI) announced today its support of and collaboration with the Food and Drug Administration (FDA) on the Sentinel Initiative, a far-reaching public and private sector program aimed at improving the nation's ability to more quickly and effectively monitor post-market drug performance.
eHI's Connecting Communities for Drug Safety Collaboration (the Collaboration), which will help inform the Sentinel Initiative, is a public-private sector effort conducted in partnership with the FDA. The purpose of the project is to test and evaluate the feasibility and value of using electronic health information--through a distributed model -- to support post-market surveillance and drug safety.
"We are delighted to be partnering with eHI on this important project," said Janet Woodcock, MD, Director, Director, Center for Drug Evaluation and Research, Food and Drug Administration. "The results of the pilots will help us evaluate methods and technical approaches for using electronic data to support post-market surveillance and assess the legal and institutional policy issues involved."
The Collaboration just completed in April 2008 its first iteration of testing and evaluation of using a combination of clinical data from electronic health records and other clinical systems and administrative claims data to detect and evaluate drug safety signals for a set of three "use cases." The use cases tested and evaluated included possible liver side effects related to the use of cholesterol-lowering drugs, bleeding episodes related to warfarin, and a small set of adverse patient events commonly associated with medications, or "designated medical events" or DMEs. This research was conducted in two community-based organizations with advanced stage clinical information systems--Partners Health Care System in Boston, MA and Regenstrief Institute in Indianapolis, IN. The second iteration of testing using these three use cases is now underway in both Boston and Indianapolis. The Collaboration expects to expand the number of pilots over the summer, working with both national and local organizations that have similar interests in using common methods, processes and policies through a decentralized approach for using electronic health information to support drug safety, while effectively protecting patient privacy and confidentiality.
Coordinated and led by the eHealth Initiative Foundation (www.ehealthinitiative.org), a non-profit, multi-stakeholder organization whose mission is to improve the quality, safety and efficiency of health care through information and information technology, with guidance by eHI's multi-stakeholder Leadership Council (http://www.ehealthinitiative.org/about/leadership.mspx) and the Connecting Communities for Drug Safety National Advisory Board (http://www.ehealthinitiative.org/drugsafety/leadership.mspx), the effort involves not only both Partners HealthCare System (http://www.partners.org/) and the Regenstrief Institute (http://www.regenstrief.org/), but also three leading health care organizations-- Eli Lilly and Company (http://www.lilly.com/), Johnson & Johnson (http://www.jnj.com/home.htm), and Pfizer Inc. (http://www.pfizer.com/home/) Along with the FDA, the Agency for Health Care Research and Quality and the Brookings Institution's Engelberg Center for Health Care Reform are working in an advisory capacity on this effort.
Research findings from the "learning laboratories" are now being documented and experiences and methods are being converted into both technical guides and a readiness assessment tool that will be made wi
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