The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety
Source: U.S. Food and Drug Administration

Imagine a national electronic safety system capable of tracking the performance of a drug or medical product, beginning with the earliest stages of clinical research through its effects on millions of Americans who use it to treat or to recover from an illness or condition.

The U.S. Food and Drug Administration of the 21st century needs such an electronic system to serve as sentinel over the safety of medical products and help FDA fulfill its responsibility to protect the health and well being of the American people. Learning all we can about the risks and benefits of medical products is essential. Accurate and reliable information must be obtained before products are approved and afterwards when they are being used by large and diverse populations.

The FDA works hard to learn all we can about the risks and benefits of medical products, beginning before they are approved and continuing after they reach the market. Nevertheless, uncertainties about the safety of medical products regulated by the FDA will always remain. Once a product goes on the market, additional information about the possible risks of its use can almost always be gained. Postmarket safety monitoring is a critical part of our job, and we analyze this information to help guide the best uses of medical products.

What would an electronic system to monitor product safety look like? It would need to have the capability to draw data from sources like electronic health records and medical claims. It should strengthen the ability of the FDA to query other systems quickly and securely for relevant product safety information, within appropriate privacy guidelines. The system also could support research and epidemiology studies and the Agency’s existing risk identification and analysis processes. It’s possible that such a system could provide a framework for new ways to widely disseminate timely medical product and health-related information.

One of the six key topics identified for action as part of FDA’s Critical Path Initiative is harnessing bioinformatics, and FDA has been working to create a wholly electronic environment for the management of its product information, including safety information. In passing the Food and Drug Administration Amendments Act of 2007, Congress has set the stage for making an electronic safety system a reality.

FDA’s focus on safety and the promise of collaborating with other experts are critical to creating a successful safety system. The Sentinel Initiative’s value to other ongoing medical product performance activities, such as FDA’s Critical Path Initiative, makes it an invaluable asset in helping the FDA make the best possible regulatory decisions with the goal of protecting and promoting public health.

This report provides an overview of the projects already under way and outlines the Agency’s vision and proposed next steps in the creation of a public-private partnership that could design and implement a national strategy for monitoring medical product safety.

See: FDA to develop electronic information system (Government Computer News)

This entry was posted on Thursday, May 29th, 2008 at 9:46 am and is filed under Consumer issues, Government and politics, Health and healthcare, Legal and law enforcement, Prescription drugs, Safety. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.