Drug safety surveillance, or “Pharmacovigilance” (PV), has received significant public attention due to unfortunate, unexpected adverse events associated with drug therapies (e.g. Vioxx and cardiovascular adverse events). Numerous PV efforts have arisen from government, industry, and non-profit organizations; however, a robust PV solution has yet to be proven and a significant unmet need remains.
The growth in electronic medical records, and the ability to de-identify clinical data for quality and safety research purposes may offer an exciting new approach to detecting and preventing unintended adverse events from drug therapies. Academic Medical Centers with robust information systems infrastructure, rich clinical data, and informatics expertise are in a unique situation to provide a valuable PV solution. Partners HealthCare has these three assets and has been active in PV for a number of years, investing heavily in research and development. Partners has also been involved with leading national PV efforts such as the eHealth Initiative - Connecting for Drug Safety Collaboration and the Observational Medical Outcomes Partnership (funded and managed through the Foundation for the National Institutes of Health).
Partners’ research focuses on developing the ability to detect, explore, validate, and prospectively monitor adverse events associated with drug therapies. Key patient quality and safety programs may be realized from the transformative insights resulting from these efforts. Even modest success from these efforts would result in local benefit for Partners patients and tremendous societal benefit.
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