Danger Lurks when Drug Recalls Go Unnoticed

If you take drugs, especially long-term prescriptions you renew automatically, here’s another reason not to be complacent in the administration of your health care. A report published this month in the Archives of Internal Medicine found significant flaws in how drug recalls are communicated to medical providers and the consumers affected by them.

Recalled drugs are denoted by “class,” which categorizes them according to the degree of danger.

Class III recalls concern products not likely to prompt an adverse health reaction. They might violate FDA labeling or manufacturing regulations, such as a container defect or odd color.

Class II recalls concern products that might prompt a temporary or minor health issue, such as a drug that isn’t as strong as advertised, but isn’t used to treat life-threatening situations.

Class I recalls concern dangerous or defective products that pose a danger of a serious health problem, or even death. They might be contaminated with a toxin, or contain unlabeled allergens. Defective high-risk devices, such as heart valves, also fall into this category.

The new study, as reported on AboutLawsuits.com, found scary flaws in the FDA’s notification system for Class I drug recalls.

“Clinically important drug recalls occur nearly once per month in the United States,” the researchers wrote, “and usually involve thousands of affected units distributed nationwide or beyond. Despite recent efforts by the FDA to address the drug recall burden, health-care providers may be inadequately informed about clinically important recalls that threaten patient safety.”

The FDA is supposed to issue Class I recall notifications through its Recall Alert System and its MedWatch adverse event reporting program. But between 2004 and 2011, the researchers found that 91 of 1,700 drug recalls were unreported Class I recalls.

Of the 91 Class I recalls, the Recall Alert System issued notices for only 55. MedWatch issued notices for 18 of the remaining 36 that were classified as Class I. But 18, or about 1 in 5, were not reported to doctors by any FDA system.

Not only is the lack of information a shocking deficiency of dangerous proportions, but doctors can be confused about which recalls are important and which aren’t-both systems purport to report every drug recall regardless of its intended consumer. Drugs used to treat animals are reported the same way as Class I drugs, and that could be lethal for humans.

“[T] he Class I recalls that are communicated through the Recall Alert System,” the researchers wrote, “become buried in a system that is also used for recalls that have little or no bearing on patient care. It may be difficult for providers who subscribe to and rely on these alerting systems to identify those recalls that are of particular importance.”

The researchers said their analysis was limited because only 5 in 100 reports for Class I recalls noted adverse events, which they thought underestimated the true frequency with which recalled drugs cause harm. They cited as an example heparin, whose recall report in 2008 did not mention adverse events. But the FDA found several, including deaths, associated with contaminated heparin.

They also did not evaluate other means by which health-care professionals might receive drug recall information, such as “Dear Doctor” letters from manufacturers.

But they concluded that a comprehensive new strategy is required to ensure that medical providers are notified efficiently and fully when Class I recalls occur.

In addition to improving communication, they also called for a system to track the distribution of affected products throughout the supply chain, all the way to the consumer. Electronic tagging (radiofrequency identification technology) would enable pharmacies to identify and notify affected individuals as soon as a recall is initiated.

If you take a certain drug or drugs, you should regularly check MedWatch for information. In addition, you can subscribe here to a recall information mailing list distributed by the U.S. Consumer Products Safety Commission.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information