FDA to require bar codes on many drugs and biologics

Rule may spur centers to add bedside scanning

Pharmacists now can expect thousands of drugs and biological products to have bar codes on their labels by 2006.

The U.S. Food and Drug Administration (FDA) issued the final rule in February that requires linear bar codes to be included on most prescription drugs and on certain over-the-counter drugs that are commonly used in hospitals and ordered by physicians. Each bar code for a drug will have to contain, at a minimum, the drug’s National Drug Code (NDC) number.

"We think it is a great step forward in ensuring patient safety," says Mary Beth Navarra, RN, MBA, director of medication safety for McKesson Corp., a San Francisco, CA-based health care services and information technology company.

"Everyone would liked to have seen lot number and expiration date included, but the reality is that NDC will certainly help prevent medication errors at the bedside by enabling caregivers to scan the bar codes and compare them to the patient profiles."

The rule also requires the use of machine-readable information on container labels of blood and blood components intended for transfusion. These labels contain FDA-approved, machine-readable symbols identifying the collecting facility, the lot number relating to the donor, the product code, and the donor’s blood group and type.

The final rule applies to most drug manufacturers, repackers, relabelers, private label distributors, and blood establishments. New medications covered by the rule will have to include bar codes within 60 days of their approval. Most previously approved medicines and all blood and blood products will have to meet the April 26, 2006, compliance date, which is two years from the rule’s effective date.

The FDA estimates that when the bar code rule is fully implemented, it will help prevent nearly 500,000 adverse events and transfusion errors over 20 years. The economic benefit during that time of reducing health care costs, patient pain and suffering, and lost work time due to adverse events is estimated to be $93 billion.

Rule gives incentive for bedside scanning

The new rule will encourage health care providers to implement point-of-care systems for bedside scanning, Navarra says. Few facilities do it now. Only 1.5% of the hospitals reported that they scanned bar codes at the bedside, according to the results of the 2002 American Society of Health-System Pharmacists national survey of pharmacy practice in hospital settings.

"People believe that one of the barriers to implementing systems for bar code scanning is that not all meds have bar codes on them and that there is no standard," she says. "We hope this will help spur the implementation."

Some of the facilities that implement the technology have reported large reductions in medication errors. For instance, the introduction of a point-of-care bar code scanning system at the University of Wisconsin Hospitals and Clinics in Madison resulted in an 87% reduction in medication administration errors. Of the errors observed in the pre-implementation phase of the study, 44% involved medications given at the wrong time, 21% involved the wrong dose of a medication, 15% resulted from omission of a medication, 15% used the wrong dosage form, and 5% involved use of an incorrect drug.

In addition to reducing medication errors, a point-of-care system for bedside scanning creates a mobile medication administration record for the nurses and pharmacists, Navarra adds.

"Nurses will have real-time information at all times — what is ordered for the patients, what has been given. If they walk into a patient’s room and the patient asks when he or she last received pain medication, they can answer the question without having to hunt down a paper chart," she points out.

In the process of scanning the bar codes and doing safety checks, the health care providers are creating the electronic documentation of the medications being given, too. "It eliminates the need to paper chart or having to go back and initial medications," she says.

Even with the benefits, health care facilities need to do a thorough evaluation before implementing such a system, Navarra notes. "Hospitals need to take a step back, understand their current process, understand the impact that implementing a system like the point-of-care bedside scanning would have on that process, and begin to redesign and prepare for that kind of implementation."

Remember that the rule will not result in every medication being bar coded, she says. "Although the mandate will increase the number of bar codes, there are still going to be either medications that are patient-specific and prepared in the pharmacy, or other medications that will still have to be labeled.

"There is going to be a lot of interaction between nursing and pharmacy on processes and procedures and how they want to handle things," she continues. "It’s a whole new world. You want to automate the process, but you want to take the opportunity to improve it as well."