FDA Mini-Sentinel pilot launches

September 9, 2011

The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.

The first step toward a national electronic system that will transform FDA’s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel pilot project.

The Mini-Sentinel pilot project will facilitate the informed development and implementation of the larger fully operational Sentinel System. Through the Mini-Sentinel pilot, FDA will evaluate valid and reliable scientific methods, safety issues using existing electronic healthcare data systems, and the barriers and challenges to building a viable and accurate system of safety surveillance, according to the project’s Website.

The Mini-Sentinel system is designed to accommodate urgent FDA requests for information about medical product exposures and outcomes, and aims to post results relating exposure of a medical product to a health outcome within 30 days of completion of standard checks for accuracy.

FDA cautions that the presence of a drug, device, or biologic as a subject of Mini-Sentinel activity does not mean the agency has concluded there is a risk associated with it. The agency may have identified a potential safety issue, but not a causal relationship between the drug, device, or biologic and the named risk, according to the disclaimer on the project’s Website.

The Mini-Sentinel pilot project database took 2 years to develop, and it focuses on drugs, vaccines, other biologics, and medical devices. With 17 data partners across the United States, the database now includes data on nearly 100 million patients, 2.9 billion prescription drug dispensings, and 2.4 billion unique medical encounters, including 38 million acute inpatient hospital stays.

For more information, visit the Mini-Sentinel Website: http:/mini-sentinel.org/.