eHealth Initiative's Drug Safety Collaboration to Partner With FDA on Sentinel Initiative

eHI's multi-stakeholder "Connecting Communities for Drug Safety Collaboration" conducting drug safety pilots to test and evaluate use of electronic health information to support post-market monitoring efforts

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 widely available to the public to advance safety efforts in the U.S. While commonly accepted principles and policies for assuring the privacy, security and confidentiality of health information are being applied within the research project, the Collaboration is also developing legal guidance documents and model agreements to support responsible handling of electronic information for monitoring post-market performance as drug safety efforts get operationalized. Communications strategies and materials are also being developed by the Collaboration to support effective communication of the importance of using electronic health information for safety and the safeguards that are in place to assure patient privacy. For more information, go to http://www.ehealthinitiative.org/drugsafety/default.mspx.

"eHealth Initiative applauds FDA for moving forward so rapidly on the Sentinel Initiative, which will play an important role in protecting and improving public health. We look forward to contributing to the development of a robust monitoring system, one that relies on the active involvement and expertise of both the public and the private sectors at the national, state and local levels," said eHealth Initiative Chief Executive Officer Janet Marchibroda .

About eHealth Initiative and its Foundation

The eHealth Initiative and its Foundation are independent, non-profit affiliated organizations whose missions are the same: to drive improvements in the quality, safety, and efficiency of healthcare through information and information technology.

eHI engages multiple stakeholders, including clinicians, consumer and patient groups, employers, health plans, health IT suppliers, hospitals and other providers, laboratories, pharmaceutical and medical device manufacturers, pharmacies, public health, public sector agencies, and its growing coalition of more than 200 state, regional and community-based collaboratives, to reach agreement on and drive the adoption of common principles, policies and best practices for improving the quality, safety and effectiveness of healthcare through information and information technology. For more information, go to www.ehealthinitiative.org.

About Partners HealthCare

Partners HealthCare, located in Boston , is an integrated health system founded by Brigham and Women's Hospital and Massachusetts General Hospital. In addition to its two academic medical centers, the Partners HealthCare System also includes community and specialty hospitals, community health centers, a physician network, home health and long-term care services, and other health-related entities. Partners HealthCare is one of the nation's leading biomedical research organizations and a principal teaching affiliate of Harvard Medical School. Partners HealthCare is a non-profit organization.

About Regenstrief Institute

The Regenstrief Institute, Inc., an internationally recognized informatics and healthcare research organization, is dedicated to the improvement of health through research that enhances the quality and cost-effectiveness of healthcare.

About Eli Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind. , Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Johnson & Johnson

Caring for the world, one person at a time ... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Our 119,500 employees at more than 250 Johnson & Johnson companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

About Pfizer Inc

Pfizer Inc, founded in 1849, is dedicated to better health and greater access to healthcare for people and their valued animals. Every day, approximately 90,000 colleagues in more than 150 countries work to discover, develop, manufacture and deliver quality, safe and effective prescription medicines to patients.

SOURCE eHealth Initiative



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