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Product recall notification failures may cause patient injury

Drug recalls are intended to protect consumers against dangerous products or items that have known to cause harm. In the U.S., they happen about once a month. New research suggests that consumers may not be properly warned and health care providers may not always be fully aware of drug dangers and recalls.

According to a recent study, researchers found that though the U.S. Food and Drug Administration has systems for communicating recalls, those avenues may not be enough to warn health care providers about drug recall information. A study that was published earlier this month found that the FDA issued official public notices on only half of the recalls deemed most serious.

The FDA expects that while many providers may rely on this communication service, they may not be getting all of the information they need. Researchers analyzed 8 years of data from the FDA’s Enforcement Reports and archives of the reporting systems. Many of the most dangerous drug recalls were not reported, even those that had the greatest likelihood to cause patients serious harm, or death.

Some suspect that important recalls are being lost on less important ones. The FDA did respond saying that there are different methods used to communicate recalls, including email list serves, news release, Twitter and text messaging. Arguably, dissemination of product recall information should not be left up to the FDA alone. Manufacturers should also be responsible about communicating recalls.

Doctors and other healthcare providers should also be sure to check recall lists to protect their patients from harm or injury caused by a dangerous product.

Source: ABC News, “U.S. Has Drug Recall Problem, Study Says,” June 4, 2012.