Magazine article Drug Topics

Drugmakers, Hospitals Give FDA Earful on Bar-Coding Pros, Cons

Magazine article Drug Topics

Drugmakers, Hospitals Give FDA Earful on Bar-Coding Pros, Cons

Article excerpt

The pharmacy student attending the Food & Drug Administration hearing on bar-coding of drugs and medical devices in Bethesda, Md., last month had only one question: Will bar-coding-- with its automation of the drug dispensing process-result in fewer jobs for pharmacists?

Several members of the panel who were testifying smiled at her query. "I'm fairly confident that this will not eliminate the need for pharmacists," said Kasey Thompson, Pharm.D., director of the Center on Patient Safety at ASHP. "This is just another layer of protection for patients. But these systems are complex, and I think you have a long career ahead of you."

In fact, bar-coding pharmaceuticals could actually mean that hospital pharmacists will get involved in more patient management decisions, noted John Combes, M.D., senior medical adviser at the American Hospital Association. "The more we can free pharmacists up from checking and counterchecking and get them involved in the care team, the better off our patients are," he said.

For many of the other 400 audience members at the crowded hearing, the question was not whether bar-coding would cost them their livelihoods but rather whether the FDA was going to require it, and how soon. In its hearing announcement in the Federal Register, the agency noted that some of the approximately 770,000 adverse drug events occurring in U.S. hospitals each year might be avoided through the use of bar codes. "For example, if a health professional could use a bar-code scanner to compare the bar code on a human drug product to a specific patient's drug regimen, the health professional would be able to verify that the right patient is receiving the right drug, at the right dose, and at the right time," the notice said.

Many speakers at the hearing applauded this line of reasoning.

"Time is slipping by, and this action is long overdue," Thompson said. "The FDA is well aware of the overwhelming support for this important step for patient safety."

But others urged FDA officials, which included deputy commissioner Lester Crawford, D.V.M., not to move ahead too quickly. "The benefits of the rule outweigh the risks, but sometimes when the FDA issues a rule, everything stops," said Joseph Cranston, Ph.D., director of science research and technology at the American Medical Association. …

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