Medical Device Link.

Originally Published PMPN February 2002

REGULATORY FOCUS

An agency proposal aims at reducing medication errors by requiring bar codes.

In an effort to reduce medication errors, FDA intends to propose that all human drug and biological products should be bar coded, according to a document recently published in the Federal Register.

In a December 3, 2001, submission [66 FR:61173–61174] outlining its regulatory agenda, the agency said the bar code requirement is one step it intends to take to curtail medication errors, citing the 1999 Institute of Medicine report "To Err Is Human: Building a Safer Health System," which estimated that 44,000–98,000 people in the United States die each year from medical errors, many of them medication errors.

The agency estimates that it will cost between $500 million and $1.4 billion over a 10-year period to implement a universal bar code mandate. This wide price range stems from the agency's "uncertainty as to the costs associated with the various pieces of information that might go into a bar code, whether all or some human drug products and biological products are coded, and possible changes in labeling operations." The less information required on the bar code, the smaller the cost would be to drug manufacturers and labelers—but the bar code would also then be less useful in helping to reduce medication errors.

A notice of proposed rule making is slated for publication in April 2002, according to the document.

Most organizations and associations that the agency has sought input from recommend that the bar code contain the product's National Drug Code (NDC) number, a lot number, and an expiration date. In the December 3 document, the agency says it will mandate the NDC number and is considering whether to require the expiration date and lot number, which help in identifying recalled and expired drugs.

The agency favors a mandate over a voluntary program. The latter, it stated, "would be akin to a 'no action' alternative as many products are not bar coded or not coded in a manner that would help health professionals."

In addition, the agency said, a voluntary system might lead to the adoption and proliferation of incompatible bar coding formats, which would make it difficult for hospitals and healthcare professionals to buy appropriate bar code scanners and computer equipment.

FDA said there is a risk that if drug manufacturers and repackagers were required to bar code individual unit-dose packages, some might decide to eliminate those packages and replace them with bulk containers. The agency acknowledged that unit-dose packages are convenient for hospitals, health professionals, and patients, but they are more costly to produce, and a bar coding requirement could increase the costs further. Therefore, some firms might reduce the number of packages that would be subject to a bar coding requirement, and unit-dose packages might be targeted in that reduction.

However, the agency said, the costs of adding a bar code are far less than the costs of medication errors. It cited a 1995 article estimating that preventable drug-related mortality and morbidity produced $76.6 billion in direct costs annually, much of it from drug-related hospital admissions. Adding indirect costs placed the total cost between $138 billion and $182 billion. Another article the agency cited, published in 2001, claimed that direct costs exceeded $177.4 billion, with $121.5 billion due to hospital admissions. By enabling health professionals to verify that the patient is receiving the right dose of the right drug at the right time, bar codes could reduce those costs in the long run, FDA said, though it noted that it had not yet determined the extent to which medication errors in particular would be reduced.

Because the requirement would aid in the enforcement of sections 501 and 502 of the Federal Food, Drug, and Cosmetic Act, FDA has sufficient legal authority to mandate bar codes, the agency said.

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