Overview of the Connecting for Drug Safety Collaboration
The eHealth Initiative Foundation’s Connecting for Drug Safety Collaboration is a public-private sector effort designed to test and evaluate the feasibility and value of using electronic health information to support post-market surveillance and drug safety to inform the Food and Drug Administration’s Sentinel Initiative, which is aimed at improving the nation’s ability to more quickly and effectively monitor postmarketing medication risks in the context of potential medication benefits. With guidance from eHI’s multi-stakeholder Leadership Council and the Connecting for Drug Safety Advisory Board, this collaborative effort involves three leading health care companies — Eli Lilly and Company, Johnson & Johnson, and Pfizer Inc., and two community-based healthcare organizations with advanced stage clinical information systems — Partners HealthCare System and the Regenstrief Institute. The Food and Drug Administration plays a critical advisory role in the Collaboration. The Agency for Healthcare Research and Quality and the Brookings Institution’s Engelberg Center for Health Care Reform also serve in an advisory capacity.
The Collaboration is testing and evaluating safety signals using a combination of clinical data from electronic health records and other clinical systems and administrative claims data for a set of three “use cases”, including 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 which may be associated with medications, or “designated medical events” (DMEs). This research is being conducted within Partners HealthCare System in Boston, MA and Regenstrief Institute in Indianapolis, IN. The first iteration of testing was completed in April 2008. The second iteration of testing using these three use cases is now underway in these two environments and is expected to be completed by the end of August 2008.
Key deliverables of the project include the research findings and lessons learned from three “use cases”; a readiness assessment tool and technical toolkit developed based upon experiences in Boston and Indiana, which are designed to support other health care organizations in conducting post-market surveillance using electronic health information; legal guidance documents and model data use agreements to support responsible use of electronic health information; and tested key messages and communications tools designed to support both consumer and clinician engagement in post-market surveillance and the importantce of the role of electronic health information in supporting these efforts.
Partners HealthCare System’s research and analysis was performed on data for more than four million patients included within the integrated delivery system, including hospitals, community health centers, physician offices, home health institutions, and long-term facilities; as well as transaction systems used to submit claims to payers, and national laboratory systems. The Regenstrief Institute’s research and analysis was performed on data for more than six million patients, from several hospital systems and physician offices, claims transaction systems and claims databases, laboratory systems, and systems providing medication histories.
This critical initiative is intended to contribute to the creation of an active drug safety surveillance system by the Food and Drug Administration through the Sentinel Initiative, which was publicly launched in May 2008, and a key provision of the recent Food and Drug Administration Amendments Act (FDAAA) of 2007 signed into law on September 27, 2007.
