FDA tracks the bad stuff

Although the reporting system is voluntary, 'the most important thing you can do is collect whatever adverse reports you can,' Dr. Ken Falci says.

Susan Whitney-Wilkerson

The Food and Drug Administration's ban on ephedra products took effect last week, but only after the deaths of 155 people in the United States had been tied to the substance's use'deaths that the FDA had discovered by using an application to track adverse drug effects online.

The agency built its case against ephedra over several years, receiving more than a thousand reports about adverse reactions such as strokes, heart attacks and deaths. FDA collected much of this information online through its MedWatch Web site, at www.fda.gov/medwatch.
Now, FDA is setting its sights on a new MedWatch tool to improve the collection of data about harmful products.

FDA wants to speed the process of alerting the public about questionable substances, getting manufacturers to make their goods safe and removing harmful products from the market, said Dr. Ken Falci, director of FDA's Office of Scientific Analysis and Support.

The Center for Food Safety and Applied Nutrition Adverse Event Reporting System, known as CAERS, ultimately may save lives, he said. It requires more data than FDA's older online systems and stores it in a searchable database from which it can be routed to medical personnel for review.

'Never before have we been able to have such rapid dissemination of information to medical and clinical personnel,' Falci said.

CAERS collects data about cosmetics, food and supplements such as artificial sweeteners, which FDA's Center for Food Safety and Applied Nutrition regulates. MedWatch previously channeled limited amounts of data from reports to stovepipe systems that were difficult to search, Falci said.

FDA developed CAERS to replace a patchwork of internal legacy systems that compiled reports for the food safety center by category'food supplement, cosmetic or food product'but were unable to communicate with one another.

CAERS, which taps an Oracle8i database, integrates the information. FDA hired Booz Allen Hamilton Inc. of McLean, Va., to develop the system.

Consumers, hospital personnel and manufacturers can report problems with products via the MedWatch site. They also can call and mail in reports to FDA field officers who then log the data into the database.

The new system still has some limitations. Reporting about cosmetics, food and supplements is voluntary, so CAERS doesn't collect as much data as systems that track pharmaceuticals and medical devices, Falci said. CAERS generally receives five to seven reports daily.

To expand its knowledge, FDA plans this year to study food, supplements and cosmetics reports collected at local poison control centers and hospital emergency rooms to determine if the agency should mine that data for CAERS, he said.

Mandatory reporting systems are more effective.

'Only 1 or 2 percent of adverse events get reported into a voluntary system,' Falci said. 'Unfortunately, there's no standardized reporting, so the level of information and type varies. Nevertheless, the most important thing you can do is collect whatever adverse reports you can.'
The reports become evidence on which FDA can base its decisions, as in the ephedra case. By the time the FDA announced in December that it would ban the sale of the supplement, MedWatch had logged 1,173 ephedra incidents.

Scanning reports

When patient medical records and coroner reports arrive through the mail, FDA workers electronically scan and transmit the documents to medical personnel investigating the product's effects. CAERS uses document management software for converting the data to Adobe Portable Document Format.

'We can more quickly begin to think about changing policy and addressing potential consumer advisories depending on what the data shows,' Falci said. Previously, the review process was totally paper-based.

The expanded data fields comply with E2B, an electronic standard for medical terminology and presenting information in reports, such as patient identifier, date of birth, weight, problems related to a product, relevant tests and laboratory data.

'There are a lot of ways of searching databases if you can get this data standardized and well recorded,' Falci said.

FDA officials expect CAERS will help the government combat bioterrorism by identifying when an unusual number of problems occur. FDA can query CAERS for a particular symptom or ingredient that might be associated with a bioterror agent, for instance.

All FDA users who receive personally identifiable and sensitive information from CAERS'about 30 now'are given passwords. They have access only to certain data screens based on the needs of their jobs.

Falci eventually wants to launch a Web site to make public useful information that CAERS extracts from reports.

The agency already does that when people call and ask for information, but 'instead of waiting around for thousands of people to ask questions, we could release the information online,' he said.

About the Author

Mary Mosquera is a reporter for Federal Computer Week.

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