Can FDA's Bar Coding Efforts Help Standardize Healthcare?

Comments on FDA's proposed update to its Bar Code Labeling guidance regarding vaccines are in, and they all reflect the challenges inherent to any sort of change in drug product identification. Industry seems ready to move toward alternative technologies, but some end-users fear that multiple coding technologies coexisting in the supply chain could lead to chaos. Some urge FDA to standardize—even beyond vaccines—but will FDA's efforts be enough to transform healthcare practice?

With its "Draft Guidance for Industry Bar Code Label Requirements—Questions and Answers (Question 12 Update)" issued in August, FDA revised its advice concerning the use of alternative coding technologies for vaccines. FDA believes that "alternative technology such as two dimensional symbology could render the use of linear bar codes unnecessary for patient safety and could enhance health care providers’ ability to comply with the National Childhood Vaccine Injury Act of 1986." FDA would consider granting "a request for exemption to the bar code requirement pursuant to 21 CFR 201.25(d)(1)(ii) in connection with such use." The exemption will not apply to most other prescription drug products, however.

According to comments from O. Marion Burton, president of the American Academy of Pediatrics (AAP), which urges the use of automated identification of vaccine products (AIVP), FDA "pledged to work with the group to provide the regulatory support necessary to implement AIVP." AAP therefore "strongly supports this guidance," Burton writes.

GS1 US supports FDA's revised guidance, too, but would like to see it extended. "GS1 US supports the use of two dimensional bar code symbols, specifically GS1 DataMatrix for encoding GS1 System primary item identification (Global Trade item Number with embedded NDC), plus lot number and expiration for vaccines," writes Chris Adcock, President GS1 Healthcare, and Dennis Harrison, President GS1 Healthcare US. (They write that the point of contact is GS1's John Roberts.) However, "GS1 US urges the FDA to remove the regulation's linear requirement and allow GS1 DataMatrix use by all pharmaceutical and biological manufacturers for any of their unit dose products covered under the 'Bar Code Rule,' allowing the healthcare marketplace to decide what bar code symbols to use." They argue the U.S. healthcare market has changed in the six years since the original bar code label rule.

AIM Inc. would also like to see FDA "go beyond a narrow exception for vaccines and, after issuing final guidance on this question concerning vaccines . . . establish a sunrise date when manufacturers of all drug and biological products covered by the rule . . . would be permitted to use a 2-dimensional symbol specified under the GS1 System (or, consistent with the rule, the HIBCC and ISBT128 systems) instead of a linear bar code," writes Clive P Hohberger, Chairman of the Board for AIM, in a letter to FDA. "Setting an appropriate future date (at least two years after issuance of the revised FDA guidance) for the optional use of 2-dimensional symbols (in lieu of the current linear requirement) will allow hospitals and other enterprises sufficient time to ensure their scanning equipment is capable of reading the 2-dimensional symbols."

Ann Richardson Berkey of McKesson Corp., however, writes that "the healthcare industry is still in the early stages of implementing alternative technologies, such as two dimensional bar codes. The vast majority of the industry currently utilizes linear bar codes. If vaccine manufacturers begin to adopt two dimensional bar codes, distributors, pharmacies and providers . . . will need to invest in hardware, such as new scanners, to accommodate two dimensional bar codes." She writes that McKesson "supports advanced technologies and recognizes that two dimensional bar code technology has the capacity to include additional information about a product," but suggests that FDA "adopt an incremental approach" and retain "the linear bar code . . . as an alternative for at least ten years to allow all stakeholders adequate time to adopt this new technology."

Input from pharmacists supports McKesson's observation, but varies. Brian M. Meyer, director, government affairs division of The American Society of Health-System Pharmacists, writes ASHP "supports the use of a two dimensional bar code for encoding the lot number and expiration for vaccines," but points out "equipment needed to read the two dimensional bar codes is not widely used, and is unlikely to become so as long as the use of linear bar codes is permitted or required."

However, Kevin N. Nicholson, vice president, government affairs and public policy for the National Association of Chain Drug Stores (NACDS) urges FDA "to withdraw this draft guidance . . . because the amended guidance would have significant negative impacts on entities downstream in the vaccine supply chain, especially pharmacies, with no concomitant benefit." For instance, "we see little value in bar code scanning the lot number and expiration date for reporting under the Vaccine Adverse Event Reporting System (VAERS), as VAERS reporting requires the inclusion of other information that has to be obtained and entered manually, such as the identity of the person completing the form, a description of the adverse event, and date of onset of the adverse event. Scanning in lot number and expiration date information would save little time or effort."

Nicholson points out that allowing alternative technologies could hamper efficiency and safety. "We are concerned about the notion of allowing multiple forms of technology on any drug packaging or in any guidance. Standardization is important for efficiency. Pharmacies utilize linear bar codes for various purposes, such as safety validation and inventory control. Again, this would require pharmacies to accommodate potentially multiple types of bar code technologies, which would be highly inefficient and costly."

ASHP's Meyer writes that "the use of multiple bar codes potentially increases the error rate associated with bar coding, since users are not always aware of which bar code to scan."

Standardization could overcome these concerns, but it will require unified effort across the industry. AAP's Burton writes that "in order to quickly and efficiently integrate new bar code technology into pediatric practices, this technology must be (1) used in standardized format, and (2) universally implemented by vaccine manufacturers."

To this end, AIM urges FDA to "make certain that manufacturers understand that they need to comply fully with GS1 System symbology and data structure standards," writes Hohberger. "Whatever the complement of primary item identification and secondary attributes, a single GS1 System 2-dimensional symbol must include the GTIN encapsulating the NDC as the fundamental data element, with the secondary attribute data elements 'concatenated' after the GTIN in a clearly prescribed manner as set out in the GS1 General Specifications. In this way materials management, clinical and other software systems can readily differentiate the discrete data elements encoded in any properly formatted GS1 System bar code."

Drug makers Pfizer and Merck support the use of alternative technologies, but both need a bit more work from FDA. Gretchen Trout, U.S. regulatory policy from Merck, wonders whether a manufacturer could "request and receive an exemption for replacing the linear bar code (containing the NDC) with a two-dimensional bar code that encodes the NDC, lot number, and expiration date?"

Pfizer states that "FDA should permit use of 2D bar codes to carry product identifier (NDC, GTIN, etc.), and additionally where possible Lot and Expiry information, in a 2D DataMatrix code on the primary package label of an unit of use package for all products, not only vaccines, without the need for an exception filing according to 21 CFR 201.25. The same factors around patient safety for a vaccine exist with any drug."

Pfizer adds that "there are numerous benefits for healthcare providers and patients in the distribution and administration of medicines if additional Automatic Identification and Data Capture (AIDC) technologies such as 2D barcodes are permitted on product labeling in place of linear barcodes."

It may seem that, given some of the above comments, Pfizer may have to convince more than just FDA. However, Pfizer writes that "supporting and recommending a globally interoperable GS1 standards based approach will encourage consistent implementation and facilitate more rapid use of the data in the new data carrier 2D bar code for unit of use products."

In other words, if FDA supports (and enforces) a standard, others throughout the healthcare system will, too. What do you think?

You can view these comments and more at www.regulations.gov by searching for FDA-2010-D-0426; Draft Guidance for Industry: Bar Code Label Requirements—Questions and Answers (Question 12 Update).

As of press time, AIM's comments were not posted to the dockets but were provided to PMP News directly by the AIM Technical Symbology Committee.

This article was published as the December 9 ePackage Newsletter. To sign up for future newsletters, visit http://www.pmpnews.com/newsletters to register.