GOVERNMENT and LAW

FDA plans Rx bar-code mandate to cut drug errors

A Food & Drug Administration official announced at ASHP's recent midyear meeting in New Orleans that the agency plans to develop a rule requiring drug manufacturers to put bar codes on their products as a way to reduce medication errors.

As part of a Health & Human Services effort to cut medical errors, the FDA published a notice in the Federal Register that the agency is proposing to require bar codes on human drugs and biologicals. The bar code would have to include certain information about the product, such as the NDC number. The FDA is considering whether to also require the expiration date and lot number. The agency has not determined whether the bar-coding rule will extend beyond the hospital setting, said an FDA spokeswoman.

The bar-coding price tag for drug manufacturers and repackagers could range anywhere from $500 million to $1.4 billion over a 10-year period, according to the FDA. The wide variance stems from unknowns, such as how much it would cost to require various pieces of information, whether all or just some drugs and biologicals would have to be bar-coded, and possible changes in labeling operations.

The Pharmaceutical Research & Manufacturers of America has adopted a wait-and-see attitude. "We are eagerly awaiting publication of the proposed rule so we can go over it," said spokesman Jeff Trewhitt. "There certainly is the potential, depending on the details of the proposed rule, to reduce the number of medical errors with bar-coding, but the devil is always in the details. We need to see the details, and we need to go over those details very carefully because this is going to be a time-consuming proposition, a technically challenging proposition, and potentially a very expensive proposition."

The FDA announcement was good news to pharmacy leaders who have been advocating bar codes as a way to reduce medication errors. For example, ASHP executive v.p.-CEO Henri Manasse said that he's encouraged the FDA is moving toward bar-coding, which is "an essential step in ensuring that the right patient gets the right medicine every time."

The FDA's bar-code proposal should finally put an end to the chicken-or-the-egg paradox, according to Michael Cohen, president of the Institute for Safe Medication Practices (ISMP). "The drug manufacturers say people aren't using bar-coding systems in hospitals," he said. "Hospitals say that if they had the packaging with bar codes on it, they'd use the system. So now that cycle ends if we can get this accomplished. It will take some time and there are companies that will be technically challenged, but it's going to happen. We are obviously very pleased."

The FDA's bar-code plan is the most significant thing to happen in the past 10 years, said Mark Neuenschwander, an automation technology consultant. "The FDA decision will jump-start all kinds of stuff, and vendors will have better reasons now to follow through with developing and implementing bedside scanning," he added.

At the same time the FDA was talking up bar codes, some health-system suppliers are making their own moves to force adoption of the technology. The supply company of VHA Inc. and the University HealthSystem Consortium (UHC) Novation will require all contracted pharmaceuticals to be bar-coded beginning in 2004.

Drug companies supplying health systems in the Premier Inc. group purchasing organization will have to include consistent product numbers and unit-of-use bar codes as a way to improve patient safety and cut costs. Beginning in 2003, all new and renewed group purchasing contracts will mandate bar codes. Premier has about 150 group contracts worth about $6 billion in pharmacy products annually.

Carol Ukens

Carol Ukens. FDA plans Rx bar-code mandate to cut drug errors.

Drug Topics

2002;2:40.