Magazine article Drug Topics

What's in a Drug Name?

Magazine article Drug Topics

What's in a Drug Name?

Article excerpt

In an effort designed to help prevent medication and medical device errors, the Food & Drug Administration is proposing a multitier plan that will focus on reducing the number of errors caused by unclear and confusing labels and ambiguous or misleading drug names.

At the heart of the FDA's war on errors is a proposal that would require drug manufacturers to get package labeling and new drug names cleared by a panel of pharmacists, physicians, and nurses prior to a new drug approval (NDA).

At a meeting sponsored by the FDA last month in Bethesda, Md., Jerry Phillips, director of the FDA's division of labeling and program support, said, "We believe that our responsibility is not completed when the safety and efficacy of a drug product are determined. It's also our responsibility to help ensure the safe use of drugs by identifying and avoiding brand names that contribute to problems in the prescribing, dispensing, or administration of the product."

Phillips went on to say that the current practice of approving an application or a supplemental indication based upon draft labeling-without the packaging-denies the reviewer the opportunity to comment on print size, prominence, legibility, format, and logo size, all of which may contribute to medication errors.

Some members of the pharmacy community applauded the FDA proposals, calling them long overdue. "It's a step in the right direction," said David Work, executive director of the North Carolina State Board of Pharmacy. Work, who attended the FDA meeting in Bethesda, said that focusing on system-based problems as a way to help prevent errors is essential, but he also pointed out that there must be a focus on the individual practitioners as well. "The public demands accountability."

While high-profile hospital-related deaths due to drug errors receive a lot of publicity, drug misadventures in the retail sector are rising in some states, also. …

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