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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
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