New Study Says Doctors and Patients Rarely Hear About Drug Recalls
07-26-2012
Clinically important pharmaceutical recalls occur nearly once per month in the United States and usually affect thousands of units nationwide or beyond.
But are these recalls being effectively relayed onto health care providers by the U.S. Food and Drug Administration (FDA)?
According to a new study published in the Archives of Internal Medicine, apparently not.
Researchers at Boston’s Brigham & Women’s Hospital found that between 2004 and 2011, FDA failed to send one in every five notifications for the most serious Class I drug recalls through its Recall Alert System or MedWatch database. Health care providers turn to these two systems to learn of important human medical product recalls. So when they are not properly updated, doctors and their patients are likely left in the dark.
In light of these findings, the study recommended a number of varying methods in which FDA could improve upon its communication of drug recall information and subsequently minimize patient harm. For instance, the agency might consider implementing a computerized tracking system to trace the origin of recalled bottles or employ an electronic tagging system to track products through the supply chain.
Regardless of whichever method FDA may turn to in the future, it needs to be comprehensive. Immediacy and clarity are two additional elements that are also vital in an effective recall notification process, especially if the safety of public health is at risk.
What do you think of the Brigham & Women’s Hospital study’s findings? What strategies do you suggest FDA employ to better communicate drug recalls to healthcare providers? We encourage you to share your thoughts below.
Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.
