Bar Codes Could Bar Medication Errors

An FDA proposal to require scanned codes on drug products may cut down on medical mistakes

FRIDAY, Dec. 7, 2001 (HealthDayNews) -- A new Food and Drug Administration proposal would bring supermarket technology into hospitals in an effort to make them safer for patients.

The proposal, announced this week by U.S. Department of Health and Human Services Assistant Secretary Bobby Jindal, would require human drug products and biological products destined for hospitals to carry a bar code. That way, hospitals would be able to use scanners to make sure the right medicine is going to the right patient at the right time. The proposal is intended to help reduce the number of deaths that occur each year as a result of medication errors.

According to a 1999 report issued by the Institute of Medicine, between 44,000 and 98,000 Americans may die each year because of medical mistakes made by healthcare professionals. Most of the deaths appear to be the result of medication errors.

"Medication errors are extremely significant in terms of overall medical errors," says Gary Stein, director of federal regulatory affairs for the American Society of Health-System Pharmacists (ASHP).

The same report concluded that the number of deaths attributable to medication error may have more than doubled in the decade between 1983 and 1993. The direct costs of drug-related mortality and morbidity were estimated at between $76.6 billion and $177.4 billion, with indirect costs of between $138 billion and $182 billion.

Many healthcare and consumer groups have praised the proposed move.

"We're encouraged to see that the FDA is taking steps to ensure that patient safety in terms of medication is going to be improved through the use of bar coding on prescription labels," says Stein.

Although careful not to criticize the proposal, pharmaceutical manufacturers have been more circumspect in their assessments.

"The only thing we can say is that there is certainly some potential for reducing human errors. But the devil is always in the details, and we want to see the details," says Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America (PHRMA). "Now we have to go through the formal rule process, which is fairly elaborate. You have to come up with language, wording. It's a potentially expensive, time-consuming process."

The FDA estimates that the cost of implementing the proposal will be between $500 million and $1.4 billion over a 10-year time frame, depending on how much information is included in the bar code. Manufacturers will no doubt end up bearing the brunt of the impact of this bill, say experts.

And coding drugs and patients is not as simple as process as it might seem on the surface.

Prescription medicines are sent to hospitals as individually wrapped tablets, says Art Poremba, manager of ambulatory pharmacy services at the University of Michigan Health System in Ann Arbor.

If the new requirement goes into effect, each of those tablets would need to be bar coded by the manufacturer to include information on the medication's properties and expiration dates. Each patient would also have to be tagged with a bar code (probably on a wristband), which would include, among other things, information on allergies. Hospitals would be obligated to buy the necessary bar scanner and computer equipment.

"When you put the whole thing together, you have a much-improved system," says Poremba. "When it's time to administer the drug, the nurse would scan the drug and the patient, and a computer would indicate 'right drug, right dose, right time' or 'wrong patient, [etc.]'"

The University of Michigan already uses an internal bar coding system to dispense drugs. This system reduces errors in issuing the drugs, but not in giving them to patients.

What To Do

Here's more information about what the HHS is doing, and you might want to see the extensive look the FDA took at the subject.

For more on medical errors, see this extensive Agency for Healthcare Research and Quality site and its prevention tip sheet.

SOURCES: Interviews with Jeff Trewhitt, spokesman, Pharmaceutical Research and Manufacturers of America, Washington, D.C.; Art Poremba, M.S., manager, ambulatory pharmacy services, University of Michigan Health System, Ann Arbor; Gary Stein, Ph.D., director, federal regulatory affairs, American Society of Health-System Pharmacists (ASHP), Bethesda, Md.; Bill Pierce, U.S. Department of Health and Human Services; Dec. 3, 2001, Federal Register
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