FDA Does Bad Job on Recall Communiciation

FDA Does Bad Job on Recall Communiciation

June 6th, 2012 // 1:09 pm @


The FDA has two systems for alerting physicians to product recalls, yet 20 percent of recalls for Class I products – which are the likeliest to cause patient harm – were not communicated through either system between 2004 and 2011, according to an analysis published in the Archives of Internal Medicine. The upshot? Health care providers may not be aware of recalls that threaten patient safety, despite FDA efforts to upgrade its alerts.

“Drug recalls in the United States are common and often involve serious defects that pose health risks to patients. Given the large number of affected units per recall and the widespread distribution of these units, solutions are needed to minimize patient harm when recalls occur,” the researchers write. They note that recalls take place nearly once a month in the US and usually involve thousands of units of products distributed nationwide and beyond. Overall, the most common reason for the recalls were contamination and a wrong dose or release mechanism.

They researchers reached this conclusion after examining 1,734 recall entries in the FDA Enforcement Reports, of which 91, or 5 percent, were Class I recalls. During the same period, the FDA issued 2,912 Recall Alert System announcements, of which 166 were major human drug recalls for 126 unique products. Only 55, or 47 percent, were Class I recalls, but the agency did not a Recall Alert System notice for 36 of those, or 40 percent. Yet half of that group, or 18, were communicated through the Medwatch program, including all five recalls sent due to adverse events. However, 18 of the 91 Class I recalls, or 20 percent, were not communicated through either system (here is the paper).

Two things are not clear. The first is why those 18 recalls were not somehow communicated. The other is whether any patient harm resulted from recalls that were never conveyed to health care providers. We asked the FDA for its reaction to the findings and will update you with any response. Another issue noted by the researchers, by the way, is that Class I recalls that “are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care, such as veterinary drugs.”

[UPDATE: So what might be done? “A simple solution would be to allow subscribers to the Recall Archive altering system to customize the types of alerts they receive. For example, clinicians may be interested in only class 1 alerts, but can’t currently sign up for only those without getting lots of other extraneous notice,” Josh Gagne, one of the authors, who is an instructor in medicine at Harvard Medical School and a pharmacoepidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at the Brigham and Women’s Hospital, writes us in an e-mail.]

There were a couple of limitations to the analysis. One, only 5 percent of Enforcement Report entries for Class I recalls noted adverse events, which the researchers believe may underestimates the frequency with which recalled products may cause harm. Also, they did not evaluate other means by which health care providers may receive information about recalls, such as “Dear Doctor” letters from drugmakers.

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