Overview of the Connecting for Drug Safety Collaboration

The eHealth Initiative Foundation’s Connecting for Drug Safety Collaboration was 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. 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.; two community-based healthcare organizations with advanced stage clinical information systems — Partners HealthCare System and the Regenstrief Institute; and the Department of Defense. The Food and Drug Administration played 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.

Key deliverables from the project included:

Readiness assessment tool and technical toolkit developed based upon experiences in Boston and Indiana;
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.
Research findings and lessons learned from three “use cases”;
- Department of Defense Final Report
- Regenstrief Institute Final Report
- Partners Healthcare System Final Report

The Collaboration tested and evaluated 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).

The research was conducted within Partners HealthCare System in Boston, MA, the Regenstrief Institute in Indianapolis, IN, and the Department of Defense. 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. Department of Defense research and analysis was performed on data sets for 12 million patients. Robust policies for privacy and information sharing are being applied.

This critical initiative contributed 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.

The Partnership for Connecting Communities for Better Health Program would not have been possible without the support of many, many organizations. Eli Lilly & Company, Johnson & Johnson, and Pfizer Inc. have provided support to the Foundation's work related to drug safety. Intercomponentware, Inc. or "ICW" and Booz Allen provided general support for the eHealth Initiative Foundation's Partnership for Connectng Communities for Better Health Program. In addition, several organizations provided support for many elements of eHI's strategic initiatives and the Partnership's work.