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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”

       

FDA, Industry Search for Drug Name Solution

http://www.medscape.com/viewarticle/457952?mpid=15477

By Todd Zwillich

WASHINGTON (Reuters Health) Jun 26 - What's in a name? The potential for thousands of prescription drug errors each year, according to the Institute of Medicine. And now the risk has the Food and Drug Administration asking what it can do to avoid potentially confusing and dangerous medication brandnames.

A 1999 Institute of Medicine report on medical errors identified confusing drug names as a primary driver behind hospital and pharmacy mistakes harming patients. At issue are drug names that look similar when written or sound alike when spoken.

"We see them commonly cause and contribute to patient harm," Timothy Lesar, director of pharmacy at Albany Medical Center, said at a workshop on drug names co-sponsored by the FDA and Pharmaceutical Research and Manufacturers of America on Thursday.

Lesar told attendees that at least one-fifth of the more than 32,000 medical errors documented at his hospital since 1987 were related to "nomenclature issues."

    

FDA officials say that they are considering issuing guidance to industry on how to test potential new brandnames for potential safety problems before the drugs reach market.

Experts expressed agreement that safety testing of drug names is neither standardized nor reliable at present.

The FDA retains the right to reject drug names before a product goes to market, so companies routinely test prospective names before submitting them to regulators. Some companies use surveys, others use focus groups, while still others try to simulate real-world use of a drug's name in hospitals and pharmacies in studies of varying size.

"There is no consistent method of name evaluation currently in use," said Susan C. Winckler, vice president of the American Pharmaceutical Association.

Others were critical of drug manufacturers for shortchanging safety considerations by focusing on catchy or otherwise attractive drug names. "There's a perception that safety is not the consideration in product naming," Lesar said.

But manufacturers counter that their internal safety testing can mean little once it reaches regulators at FDA. Some drug industry representatives complained that the agency too lacks a consistent and reliable way to test new drug names.

An informal survey of 22 FDA name reviews showed that proposed brandnames that were prone to generating errors were often less likely to be rejected by the agency than those that were not.

While the survey was not a scientific study, it did confirm that "analysis studies don't really test the name for the risk of a medication error," said Thomas H. Hassal, director of global regulatory policy at Merck & Co.

    

"The bad news from the industry's standpoint is it confirms our sense of unpredictability," he said