Highlights of FDA hearing on bar coding
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-codingwith its automation of the drug dispensing processresult 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. "Future innovation [in bar-coding technology] might be impeded."
On the question of what kinds of drugs would be subject to bar-coding requirements, William Soller, Ph.D., senior v.p. and director of science and technology at the Consumer Healthcare Products Association, asked that over-the-counter medications be excluded. "Bar-coding to prevent medical errors would not be of value in the 'self-care' setting," he said. "Consumers don't have handheld scanners linked to their medical records. Given that the major use of over-the-counter drugs is by consumers, should bar codes apply where they won't be used and will be very disruptive for distribution? We think not."
Soller added that the idea of putting bar codes on individual medication dosesa notion that was championed by many speakers at the hearingwould be a big burden for OTC drugmakers. "It would mean that we would have to delete the opening instructions on each blister pack," he said.
But putting codes on individual dosage units is preferable to the alternativehaving hospitals buy in bulk from manufacturers and then repackage the drugs themselveswhich introduces more opportunities for error, Thompson said in an interview. "Pharmaceutical companies are experts at packaging. When you take hospitals with patient care demands and ask them to repackage, you're going to have mistakes."
Currently, only about 35% of all prescription drug products come in single-dose units, according to Mary Grealy, president of the Washington-based Healthcare Leadership Council. But drugmakers say that single-dose packaging is more expensive and that demand for it has dropped as hospitals buy more drugs in bulk to save money.
Panelists also discussed what information should be included in the bar code. Many bar codes currently in use include only the National Drug Code number. While most speakers agreed that the NDC number, lot number, and expiration date would be the ideal data elements, people were divided on whether a regulation should be enacted now or whether the FDA should wait until more bar codes contain all three pieces of data.
Joyce Frieden. Drugmakers, hospitals give FDA earful about bar-coding pros, cons.