Washington Editor

BETHESDA, Md. - Manufacturers of biologics, drugs and medical devices may find themselves attaching identifying bar codes to products as a way of helping health care workers cut down on medical errors.

The FDA began considering such a policy upon release of the 1999 Institute of Medicine report, "To Err is Human: Building a Safer Health System," that said upward of 100,000 people die every year in U.S. hospitals due to preventable medical errors, oftentimes related to drugs.

The FDA on Friday held an eight-hour meeting to solicit comments on the positive and negative aspects associated with a possible mandatory bar-code policy.

As expected, industry representatives cautiously approached the proposal while professionals working in health care encouraged the agency to implement a policy sooner rather than later.

"There are bar codes all over America - in grocery stores, in retail stores - but we don't have bar codes in the one place they could be the most helpful," Kasey Thompson, a pharmacist and representative of the Bethesda-based American Society of Health Systems Pharmacists, told FDA officials. "If the rule is proposed this fall, it will be another year before anything could be implemented. How long are we going to let the manufacturers hold it up?"

In his view, it's a simple matter. Adding a bar code to packages containing drugs, biologics - and possibly medical devices - could ensure that the right medicines are given to the right patients, at the right dose, at the right time.

Hospitals across the country are in various stages of setting up scanning systems for a number of uses, said John Combes, a senior medical adviser with the American Hospital Association. Already, he said, systems are in place for inventory control purposes as well as for scanning lab specimens and blood products. Those same scanning systems could be used to read bar codes. (The FDA does not regulate the hospital industry and cannot force it to implement a bar-coding system.)

If bar codes were required, most speakers representing heath professionals agreed that they should include the National Drug Code (NDC), the lot number (a code that identifies when and where the product was made) and the expiration date.

But industry representatives, who were not quick to oppose the overall proposal, tiptoed around certain issues, particularly those related to what would go on the bar code.

While Mary Grealy, president of the Healthcare Leadership Council in Washington, said bar codes, including an NDC, could be implemented rather swiftly based on technology readily available, she it would take longer for companies to include a system of lot numbers and expiration dates.

In response, several speakers recommended a "phase-in" process, which could begin with labels including the NDC and down the road end with a complete label including the lot numbers and expiration dates.

But that brings up another problem. Anyone who takes medication knows that real estate on drug packaging is not plentiful.

"Wording on the packaging has to be human-readable and machine-readable. If we add to it, we may end up with unreadable text and that will contribute to medical errors," said Richard Johnson, director of information and policy at Abbott Laboratories, of Abbott Park, Ill., on behalf of the Washington-based Pharmaceutical Research and Manufacturers of America.

Adding bar codes to drug packages may be helpful, but requiring the medical device industry to comply with similar standards would do little to cut down on any errors associated with devices, Tess Cammack, associate vice president for technology and regulatory affairs for the Washington-based Advanced Medical Technology Association, told panel members.

She said the medical device industry is so extensive and diverse that it should be excluded from any rule that applies to biologics and drugs. Furthermore, she said many trade organizations, such as AdvaMed, represent small companies that don't have resources to pay for improvements that would be required to implement such a policy.

Combes said labeling could be useful on medical devices at some point to help track product failures, infections associated with device use and adverse events possibly caused by products. However, he said that there are many products such as bandages, tongue suppressors or crutches that may never need labeling.