Prescription drug labels will soon require bar codes, FDA announces
ASHP sees action as good first step
The American Society of Health-System Pharmacists (ASHP) in Bethesda, MD, has been pushing for a federal mandate requiring scannable bar codes on prescription drug labels for some time. Now the society has gotten its wish.
At the society’s Midyear Clinical Meeting in New Orleans on Dec. 3, 2001, Bobby Jindal, assistant secretary for planning and evaluation with the U.S. Department of Health and Human Services (HHS), announced the Food and Drug Administration’s (FDA) commitment to require bar coding on all prescription drug labels in an effort to help reduce medication errors. The government’s intention of developing a proposed rule was published in the Dec. 3, 2001, Federal Register.
ASHP had written a "strongly worded" letter to HHS Secretary Tommy Thompson in July, saying that the time for the bar coding initiative to come to fruition had arrived, says Gary C. Stein, PhD, director of federal regulatory affairs in ASHP’s government affairs division.
ASHP says there are three primary goals of using bar-coding systems in the inpatient setting:
• Use of such coding would help eliminate medication errors and other preventable adverse drug events by ensuring accurate drug product and patient identification at the point of administration.
• Coding would improve monitoring of drug-use trends within a population of patients so that staff resources can be allocated for optimal patient care.
• Coding would improve overall efficiencies in the medication-use process, including the purchasing, storage, and distribution of drug products.
Even with the push, the announcement came as sort of a surprise, although ASHP knew that FDA had been working on bar coding for a while, Stein says. "The way that it was announced seemed to indicate that it was an actual proposed rule, but it actually was just the unified regulatory agenda."
According to Stein, ASHP thinks the commitment is a good first step. The Federal Register announcement says the proposed rule, which will be open for public comment, will be published around April. FDA sources have since indicated that the publication may be pushed back to summer, Stein says. The society will be ready whenever the proposed rule is released. "We’re certainly going to comment as an organization and then have some of our members comment, as well."
Bar code information undecided
According to the Federal Register, the bar code would contain certain information about the product, such as its National Drug Code number. The agency is considering whether to require other information, such as the drug’s expiration date and lot number, to make it easier to identify expired drugs and recalled drugs that may not be safe and effective for use.
"We’re going to suggest that as much information as possible be put into the bar code so that we can assure that the right patient gets the right dose at the right time," Stein says.
The risks of the proposal
Bar coding will decrease the incidence of medical errors, but implementation will be expensive. FDA’s preliminary estimate puts the cost of the rule between $500 million and $1.4 billion over a 10-year period, although annual costs associated with errors in administering prescription drugs are much higher. The wide range in the cost estimate reflects the agency’s uncertainty as to the costs associated with various pieces of information that might go into a bar code, whether all or some human drug products and biological products will be bar coded, and possible changes in labeling operations.
The changes will be especially costly for drug manufacturers. Jeff Trewhitt, a spokesman for the Pharmaceutical Researchers and Manufacturers of America (PhRMA) in Washington, DC, was guarded in his reaction to the FDA’s statement.
"This could potentially help cut down on errors but the devil is in the details and we need to see the details," he told the Associated Press. "This is going to be technically challenging, potentially time-consuming, and potentially very expensive."
In its statement, FDA admits there is a possible risk that some manufacturers and repackagers, if required to bar code individual unit dose packages, would eliminate that type of packaging and only supply their products in bulk containers to reduce production costs. The individual unit dose packages, however, are more convenient for hospitals.
ASHP says it would be a mistake for drug manufacturers to switch to bulk containers. "It wouldn’t really address the problem of getting the right drug to the right patient," Stein says.
Like PhRMA, ASHP will be closely watching the new bar coding developments. "We think it is a major effort on the part of the FDA to reduce medication errors," Stein says. "If it is done right, it will significantly affect patient care in the right way."
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