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| Health > Health News > Reuters |
|
FDA, Industry Search for Drug Name Solution |
| June 26, 2003 02:41:32 PM PST, Reuters |
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What's in a name? The potential for thousands of prescription drug
errors each year, according to the Institute of Medicine (news
-
web sites).
And now the risk has the Food and Drug Administration (news - web sites) (FDA) asking what it can do to avoid potentially confusing and dangerous medication brand names. 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 to others when they are written out or sound like other drugs when spoken. Experts have recorded thousands of such errors, ranging from confusion between cancer drugs Taxol and Taxotere to mix-ups between differently acting forms of insulin called Humalog and Humulin-L. "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 the Pharmaceutical Researchers and Manufacturers of America. Lesar told the conference audience that at least one-fifth of more than 32,000 medical errors documented at his hospital since 1987 are related to "nomenclature issues." FDA officials say they are considering issuing guidance to industry on how to test potential new brand names for potential safety problems before the drugs reach market. While most manufacturers go through great pains to test drug names for marketability, experts expressed agreement that safety testing is neither standardized nor reliable. 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, and 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 Pharmaceuticals Association. Others were critical of drug manufacturers for shortchanging safety considerations when choosing 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 also lacks a consistent and reliable way to test new drug names for confusing appearance or pronunciation. An informal survey of 22 FDA name reviews showed that proposed brand names that were prone to generating errors were often less likely to be rejected by the agency than those that were not so prone. 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. "The bad news from the industry's standpoint is it confirms our sense of unpredictability," he said. |
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