Bar codes may help avoid the most common errors

The road has been paved for using bar codes on all medications to reduce errors, with the Food and Drug Administration (FDA) announcing recently that is proposing a rule requiring bar codes on all medication packages, a mandate that some say would significantly improve patient safety in the nation’s hospitals. But don’t think the bar codes will be an immediate fix for medication errors. Implementing the system will take time.

The proposed rule, announced by Secretary of Health and Human Services Tommy Thompson, would require bar codes to include the National Drug Code (NDC), a system that contains the drug name, dosage form, and strength. But the proposed regulation stops short of mandating the inclusion of the medication’s lot number and expiration date in the bar code, citing the cost as well as the need for more evidence of its value.

Pfizer Inc., a major medication manufacturer, also announced that it will print bar codes on individually packaged pills used in hospitals, the most comprehensive move yet by a the pharmaceutical industry to address medication errors. Over the next year, Pfizer expects to have bar coding and text on all 30 medicines it sells in blister packs for hospital use that identifies the medicine, the dosage, lot number and expiration date.

ASHP applauds moves

The moves by the FDA and Pfizer were welcomed by the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD. Henri R. Manasse Jr., PhD, ScD, ASHP, executive vice president and chief executive officer, says it is clear that bar codes can improve patient safety. He hopes the FDA will go further to require that all manufacturers include the lot number and expiration date in addition to what the FDA has proposed.

"Requiring bar codes that include the NDC is an important first step, and we applaud the FDA for this proposal," he says. "But including the lot number and expiration date is a critical element to protect patients from medications that may have been recalled or are past their expiration date. We will continue to work with the FDA and other organizations to clearly demonstrate the value of including this vital information."

Manasse says there is substantial public support for these requirements. In its 1999 report, "To Err is Human: Building a Safer Health Care System," the Institute of Medicine noted that bar coding "is an effective remedy" for medication errors when used to ensure the right dose is administered to the right patient. The ASHP’s Kasey Thompson, PharmD, director of the ASHP Center on Patient Safety, told the FDA at a hearing recently that medication bar codes are long overdue.

"Bar coding technology is entrenched throughout America in all types of venues — grocery stores, department stores, libraries. It is something that everyone expects, and it is found everywhere, except where it can do the greatest good — saving lives," she said. At that time, ASHP also called for bar codes to be placed on both the inner and outer wrap of all drug packages, including single-unit doses.

"Bar codes can be the last line of defense against making a dangerous medication error," Thompson added. "This technology can help hospitals ensure that the right medication is given to the right patient at the right time."

The bar codes could have a major impact in hospital emergency departments (EDs). The United States Pharmacopeia (USP) recently identified leading medication errors in EDs and offered tips for preventing medication errors in this critical setting. USP created recommendations after analyzing medication error data from its national databases containing more than 360,000 medication error reports since its inception in 1998. In 2001, hospitals reported more than 2,000 ED-related medication errors.

The combination of interruptions, intense pressure, and a fast-paced environment can lead to medication errors and fewer error interceptions in the ED than in other settings, the USP reports. In the ED, USP found that 23% of errors were intercepted before reaching patients as opposed to 39% intercepted in other areas of the hospital.