FDA's bar code meeting rouses wide debate

Daphne Allen

December 30, 2015

7 Min Read
FDA's bar code meeting rouses wide debate

By Erik Swain and Daphne Allen

Hospitals, the government, and the pharmaceutical industry each appear to have a different sense of urgency toward FDA's concept of requiring bar codes on all drug packages. FDA has announced that it intends to propose a rule to widen the use of bar codes in the interest of reducing medication errors, especially in hospitals.

At a daylong public hearing, held July 26, 2002, in Bethesda, MD, FDA convened panels of hospital representatives and pharmaceutical industry representatives. The meeting drew a large crowd—one attendee reports seeing about 400 in attendance. The agency allowed a number of parties to speak on the matter, and it may incorporate some of the input received at the hearing for a proposed rule it hopes to publish later this year.

Early in the day, a five-member panel of representatives from hospital and healthcare provider groups were asked whether new rules were necessary to increase bar code use and reduce medication errors. All answered yes.

These endorsements were similar to those made by Premier Inc. and The Johns Hopkins Hospitals in statements submitted to FDA before the meeting. For instance, Premier, an alliance of not-for-profit hospitals, fully supports FDA's proposal, pointing to research conducted at the Colmery-O'Neil Veterans' Administration facility in Topeka, KS, as proof that bar codes can reduce errors. The study, conducted between 1993 and 1999, showed that bar code–labeled drugs reduced medication error rates by 64%. As a result, Premier believes that all hospital-administered drugs, biologics, and medical devices should feature bar codes incorporating the Universal Product Number (UPN) and the National Drug Code (NDC) at every level of packing, especially those that are unit doses, explains Bert Patterson, vice president for con- tracting and contract services.

The Johns Hopkins Hospital agrees, adding that codes should also include the drug strength and unit of measure as well as the lot number. Daniel Ashby, director of pharmacy, says that bar coding will ensure the accuracy of medication identification, administration, and distribution; reduce medication errors; and improve the supply system efficiency.

And, while Brigham and Women's Hospital also agrees that bar codes are needed to reduce errors, director of pharmacy services William Churchill argues that manufacturers must be charged with applying those codes. "Only 50% of our products are bar coded at the unit-of-use [level]. This means that when we implement our bar code scanning program next year, we will need to repackage approximately 2.5 million doses. This is clearly unacceptable and needs to be done at the manufacturer level."

However, hospital representatives and others at the meeting were doubtful that bar coding each unit dose will happen without government regulation to back it up, saying that the sooner something was on the books, the better. One supplier to the pharmaceutical industry says that the force that could urge wide-scale unit-dose bar code use is Secretary of Health Tommy Thompson. "FDA representatives at previous meetings have emphasized that Thompson is personally committed to making this happen. The second force, and this has yet to be heard from, I think, is the insurance industry, which has to make the payouts when people die from mistakes."

Later in the day, a five-member panel from industry, representing prescription, generic, and over-the-counter (OTC) drug manufacturers, blood banks, and medical device manufacturers was asked whether regulations were necessary to drive bar code use. The panel's response was more mixed. The panelists said that they were not sure if regulations would be required to prompt the reduction of medication errors, and that the issue needs more study, especially technical aspects such as what formats of coding would be used.

The above-mentioned supplier, though, worries that by not choosing a code format soon or by leaving code selection to each individual company, little progress will be made.

So far, FDA has revealed very little about what a proposed rule might contain. At the meeting, the agency solicited input on questions as basic as which products, from prescription drugs to OTC drugs to blood products to medical devices to vaccines, should carry a bar code, what information should be contained in a code, whether a specific symbology should be mandated, whether a specific placement on the package should be mandated, and what sorts of technologies are currently available.

One attendee who has a clear sense of what he thinks should happen— whether FDA mandates it or not—was George Wright IV, vice president of Product Identification & Processing Systems Inc (PIPS), a supplier of bar code technology and consulting services to the healthcare industry. Wright points out that the U.S. pharmaceutical industry has been encoding the 10-digit NDC in the UPC symbol on retail packages and the UCC-128 Global Trade Item Number bar code on higher packaging levels since the inception of the internationally recognized EAN.UCC system in the early 1970s.

"The healthcare marketplace should develop and maintain the use of a consistent numbering structure, or code, to identify the drug and its strength, which the NDC number does, and to encode that unique identifier in a format that is universally understood, such as the EAN.UCC system." Wright recommends UCC's Reduced Space Symbology (RSS) for primary identification (in this case, to encode the NDC) and its companion Composite Symbology to carry lot and expiration date. "Many drug market leaders have already announced publicly their commitment to put such codes on unit-dose drugs, and many others with whom we are working will do so by the end of the year."

Attendee John Roberts, director of healthcare for the Uniform Code Council (UCC), adds that "the focus of our presentation to FDA was to urge the agency to choose a system rather than a solution. The global EAN.UCC system is used by 23 major industries around the world and is well established in the healthcare industry. By selecting the EAN.UCC system, the healthcare industry will be able to leverage its existing investment, as well as use new tools, such as RSS and Composite Symbology. Using the EAN.UCC system will cause the least disruption to the healthcare supply chain and allow the industry to address the medication error issue more quickly."

For medical devices, Wright notes, one also has to consider the Health Industry Business Communications Council (HIBCC) Health Industry Barcode Supplier Labeling Standard. "When the Department of Defense (DoD) first coined the term UPN to refer to a unique item identifier, it specifically cited primary item identifiers under both the EAN.UCC system and HIBCC as being the only identifiers DoD would accept."

The debate has also prompted other groups to speak up, whether in writing or at the public hearing.

For example, the Consumer Healthcare Products Association (CHPA; Washington, DC) commented adamantly that OTC drugs should not be subject to the rule. "In the consumer setting, Drug Facts labeling is the means designed to address medication errors; bar coding would not add value in this setting," the association stated in its submission, written by R. William Soller, PhD, senior vice president and director of science and technology. "The nonprescription drug label provides all the essential information needed for the safe and effective use of the product by consumers on the package, in contradistinction to prescription drugs where the information and package are for the most part separate."

The Healthcare Compliance Packaging Council (HCPC; Falls Church, VA) supports a regulation, calling for FDA "to require that bar codes be provided by the manufacturer on each dosage unit of product intended for distribution in an in-patient setting." In fact, HCPC noted, since FDA's interest in bar code requirements was spurred in part by a 1999 report from the Institute of Medicine (IoM), the agency should remember that "the IoM actually recommends bar codes along with unit dosing—not bar codes alone—as the best way to address this serious, national health issue."

Due to a lengthy rule-development process, FDA has postponed the proposed bar code regulation until the end of the year.

About the Author(s)

Daphne Allen

Daphne Allen is editor-in-chief of Design News. She previously served as editor-in-chief of MD+DI and of Pharmaceutical & Medical Packaging News and also served as an editor for Packaging Digest. Daphne has covered design, manufacturing, materials, packaging, labeling, and regulatory issues for more than 20 years. She has also presented on these topics in several webinars and conferences, most recently discussing design and engineering trends at IME West 2024 and leading an Industry ShopTalk discussion during the show on artificial intelligence.

Follow Daphne on X at @daphneallen and reach her at [email protected].

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