Drug Safety System Is Under Way

NOVEMBER 01, 2006

The FDA and Massachusetts Institute of Technology are developing an automated system to identify unanticipated problems with prescription drugs and medical devices. The system would search federal and private health care databases for atypical and emerging patterns that could indicate potential safety concerns.

The agency's current system relies mainly on the manual assessment of reports voluntarily submitted to the FDA. The reports sometimes come months or years after an event has occurred. A more technologically advanced system capable of watching multiple databases would be better at detecting patterns suggestive of emerging problems, noted Scott Gottlieb, MD, the FDA's deputy commissioner for scientific and medical affairs. He added that the system would be built on methods created to identify infectious disease outbreaks, detect bioterrorism attacks, and model the spread of the avian flu.




SHARE THIS SHARE THIS
0
 

In Seniors: Consider CMV Serostatus
When Recommending Flu Vaccine

Older people who have cytomegalovirus seem to have less robust responses to the trivalent influenza vaccine than those who do not have CMV.


 

 

Conference Coverage
News from the year's biggest meetings


Pharmacist Education
Clinical features with downloadable PDFs


 

SIGN UP FOR THE PHARMACY TIMES NEWSLETTER
Personalize the information you receive by selecting targeted content and special offers.