Regulatory Focus™ > News Articles > Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

Posted 27 June 2014 | By Alexander Gaffney, RAC

Researchers Say FDA Should Take More Active Role in Disseminating Drug Safety Warnings

In addition to approving products and making sure bad ones never make it to market, an indispensable role of healthcare product regulators is warning consumers and healthcare professionals about new risks associated with already-approved healthcare products.

The US Food and Drug Administration (FDA) regularly sends out such warnings, generally known as drug safety communications, and as of 27 June 2014 had already issued 12 warnings in 2014—an average of two per month.

But while the warnings are well-noted in regulatory circles, new research indicates that their effect on the public is more varied on account of the Internet.

The research, published in the New England Journal of Medicine (NEJM), looked at all new drug safety communications for prescription medicines issued by FDA between 1 January 2011 and 31 December 2012.

The researchers, who postulated that most consumers get their medical information through Google and Wikipedia, then evaluated the content of Wikipedia pages, and looked at page views for both Wikipedia and Google search pages.

The good news: FDA's warnings had a positive effect on consumer interest in a drug, leading to an average 82% increase in Google searches during the week after the announcement, and a 175% increase in Wikipedia views on the day of the announcement.

The bad news: Consumers might not have been getting the information FDA would have preferred them to have obtained.

"We found that 41% of Wikipedia pages pertaining to the drugs with new safety warnings were updated within 2 weeks after the warning was issued with information provided in the FDA announcements," the researchers wrote. Pages for drugs that affected more people were more likely to be updated quickly, the researchers found.

However, 23% of all Wikipedia pages were only updated more than two weeks after the announcement, and researchers said that 36% of pages "remained unchanged more than one year later."

In other words, in a place where millions of consumers and healthcare professionals go each year to read brief summaries of healthcare information, it was as if FDA never made a safety warning at all.

The researchers said FDA might do well to consider actively participating in Wikipedia and other "new media" sites, such as it already does with the health website WebMD, to quickly update pages and disseminate timely and accurate information.

"Given the frequency with which patients seek information outside the clinic, and particularly on the Internet, taking advantage of those media appears to be a promising means for the FDA to ensure that patients have ready access to accurate and comprehensive information, including timely updates pertaining to drug-safety issues," the researchers concluded.


NEJM Article: Drug Safety in the Digital Age

Categories: Regulatory News

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