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 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 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 twelve-month period, Collaboration participants will test and 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 (DMEs)" through research conducted in two clinical environments in Indianapolis, IN, and Boston, MA. Insights gleaned from these two "learning laboratories" 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 Food and Drug Administration Amendments Act (FDAAA) of 2007 signed into law just two months ago. The Food and Drug Administration will work with the Collaboration in an advisory capacity. "We are very excited about this effort," said Janet Woodcock, MD, Deputy Commissioner and Chief Medical Officer, Food and Drug Administration. "This is a wonderful example of how public and private organizations can work together to benefit the public health."
The Collaboration expects its learnings to contribute to and build off of those of the Reagan-Udall Foundation, a new private and independent non-profit organization established by Congress under the FDAAA. The mission of the Foundation is to identify and help to address the unmet scientific needs in the development, manufacture, and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation.
Mark McClellan, MD, PhD, Director of the Engelberg Center for Health Care Reform at the Brookings Institution and Chair of the Reagan-Udall Foundation's Board, applauded the effort, in saying that "collaborative partnerships like these will provide critical insights to identify and advance new, innovative approaches to improving the quality and safety of medical products."
"We're very pleased to partner with eHealth Initiative and the other organizations in this effort," said Gretchen Dieck, Senior Vice President, Safety and Risk Management, Pfizer, Inc. "Our hope is that it will advance the quality of information we use to understand patients' experiences with our medicines. We owe it to patients, doctors and caregivers to deliver the most accurate, timely and useful information we have about the benefits and risks of our drugs."
Tim Garnett, MD, Vice President, Global Patient Safety, Eli Lilly and Company noted, "Early detection of safety signals is a vital part of our continued efforts to provide safe and effective medicines to patients. We are proud to partner with eHealth Initiative as part of our ongoing efforts to identify safety signals quickly and accurately and to communicate risk and benefit data. Innovations such as this, involving both academia and the pharmaceutical industry, take advantage of our complementary expertise and will be an important part of future efforts to ensure the safety of the medicines we develop."
As part of the project, eHI will adopt and apply commonly accepted principles and policies for assuring the privacy, confidentiality and security of health care information. eHI will also conduct research and develop legal guidance documents and model agreements to facilitate responsible handling of information for drug safety purposes by others in the field that are exploring use of health information for safety-related purposes. Educational strategies and materials will be developed to support effective communication of the importance of using electronic clinical information for safety, and the safeguards that are in place to assure patient privacy.
"Detecting adverse drug or device events is yet another example of how standardized, longitudinal data can be leveraged to improve the safety of patient care," said J. Marc Overhage, MD, PhD, Director of the Regenstrief Institute. John Glaser, PhD, Vice President and Chief Information Officer of Partners HealthCare noted, "New, innovative approaches are needed to increase the timeliness and effectiveness with which we can identify drug safety issues. This collaboration gives us an opportunity to assess the feasibility of using clinical data for these issues, and develop methodologies that can be replicated by others."
eHealth Initiative Chief Executive Officer Janet Marchibroda said, "We're delighted to be launching this new, multi-stakeholder collaboration. Leaders at the national, state and local levels will gain practical insights from this work, and it is our hope that the lessons learned and tools that emerge from the project will stimulate the development of new approaches that will not only improve the timeliness and effectiveness of assessing the risks of new drug treatments, but also the benefits."
A multi-stakeholder National Advisory Board made up of academic experts, clinicians, consumers, hospitals, pharmacists, privacy experts, state and local leaders, and the federal government will provide direct guidance to the effort and also oversee the development of the technical, legal, and communications-related tools, which will be made widely available to accelerate the creation of an active drug safety surveillance system in the U.S. through the use of health IT and health information exchange.
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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 Johnson & Johnson
Johnson & Johnson is the world's most comprehensive and broadly based manufacturer of healthcare products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. The more than 250 Johnson & Johnson operating companies employ approximately 120,000 men and women in 57 countries and sell products throughout the world. For further information, visit www.jnj.com.
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 â through medicines and information â for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
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. For further information, visit www.pfizer.com.