News | November 28, 2007

eHealth Initiative Foundation Launches Research to Improve Drug Safety

November 29, 2007 - The nonprofit eHealth Initiative Foundation (eHI) announced today the formation of an innovative research program designed to improve drug safety for patients.

The eHI Connecting Communities for Drug Safety Collaboration is a public-private sector effort designed to test new approaches and develop replicable tools for assessing both the risks and the benefits of new drug treatments through the use of health information technology. Results of the collaborative effort will be placed in the public domain to accelerate the timeliness and effectiveness of drug safety efforts. Using a set of three “use cases” the project will test and evaluate the value and utility of blinded, anonymized, electronic clinical health information to detect and evaluate drug safety signals. Using clinical information - while protecting patients' privacy - promises to accelerate the timeliness, accuracy, and effectiveness of methods currently used to monitor drug safety and facilitate healthcare system response.

The collaboration is coordinated and led by the eHealth Initiative, a nonprofit, multi-stakeholder organization whose mission is to improve the quality, safety and efficiency of healthcare through information and information technology. With guidance from eHI’s multi-stakeholder Leadership Council, the collaboration involves three leading healthcare companies - Pfizer Inc., Johnson & Johnson, and Eli Lilly and Company and two community-based healthcare organizations with advanced stage clinical information systems - Partners HealthCare System and the Regenstrief Institute.

Over a 12-month period, participants will evaluate safety signals using a combination of clinical and administrative data for three “use cases,” including the use of cholesterol-lowering drugs and laboratory results related to liver failure, warfarin-related bleeding episodes, and a small set of adverse patient events commonly associated with medications, or designated medical events through research conducted in two clinical environments in Indianapolis, IN, and Boston, MA. Insights gleaned will be documented and converted into technical guides and tools that will be made widely available to the public to stimulate advancement of drug safety efforts in the field.

This initiative is intended to contribute to the creation of an active drug safety surveillance system in the U.S., which is a key provision of the recent FDA Amendments Act (FDAAA) of 2007 signed into law two months ago. The FDA will work with the collaboration in an advisory capacity.

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