FDA automates event database

Food and Drug Administration officials are increasing their ability to discover bad trends from vaccines or medications, but they still won't be able to do so in real-time.

The FDA plans to rely more on computerized data mining to find trends based on information stored in the agency's Vaccine Adverse Event Reporting System and the Adverse Event Reporting System. In June, FDA tapped Informatica Corp. to build a platform to integrate the two systems and analyze adverse events, such as bad reactions to vaccines or medications, using data from physicians, drug makers, state health agencies, pharmacies and consumers.

But the information is somewhat unreliable and not always timely, said Philip Perucci, project manager for the vaccine event system. Drug makers have 15 days to submit reports of side effects not specified on the labels. Physicians might not report all complaints. And patients often are not aware they can submit an adverse event report, Perucci said.

Until now, the FDA has relied on manual coding and data entry to gather the information, said Sanjay Poonen, Informatica's senior vice president for worldwide marketing. "The software allows that to be a much more automated process," he said.

Better data helps health officials find dangerous trends more quickly, Perucci said.

"If they see something unusual in the data or a large number of reports, they can look at it closer," he said. "There is a tremendous effort for electronic submission of reports. It would get the data into the system much quicker. Data entry is extra expensive and cumbersome."


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