By George Wright IV, Product Identification & Processing Systems Inc.
More than two years in development by the Healthcare Distribution Management Association (HDMA) bar code task force, the newly revised 2011 “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain” incorporate significant changes in the way globally standardized GS1 product identification bar codes are used on pharmaceutical shipping containers or “case packs.” Outdated coding and marking options have been withdrawn; the GS1-128 linear bar code data formats have been updated—in particular to foster serialization; and an additional GS1 DataMatrix 2-D symbol has been added to promote fast and efficient data capture of all data elements in a single scan.
All current pharmaceutical case pack label formats will likely have to be revised in order to become compliant. For a few companies, the changes will be simple; for others, more substantial. Whatever the case, the new guidelines represent the supply chain’s consensus “best practice” for coding and marking case packs as the industry works to firmly establish uniform bar code labeling practices and to implement case-level serialization and 2-D scanning.
As it has in the past, the HDMA guidelines also provide the single most comprehensive overview of industry and FDA-mandated coding and bar code marking requirements and practices at all levels of packaging throughout the U.S. pharmaceutical supply chain.
The new guidelines take effect immediately. All pharmaceutical manufacturers providing product within the U.S. supply chain are encouraged to adopt them as soon as it is feasible to do so. Many manufacturers, particularly those who actively participated in the HDMA task force, are already designing and evaluating the impact of new case pack label templates. They are also taking this opportunity to streamline their label sizes and formats to make case labeling more efficient and to lower costs.
“The 2011 HDMA guidelines represent significant evolutionary—but not revolutionary—changes to this long-established industry standard that will benefit the entire pharmaceutical supply chain”, says Delmar Mineard, Jr., president of DM Consulting (Dublin, OH), a certified GS1-US bar code consultant and task force participant who recently retired as a package engineering manager for Boehringer Ingelheim Roxane (Columbus, OH). “Ideally, all manufacturers will implement the new requirements on packaging lines throughout the supply chain in 2012, ahead of the “sunset” date of January 1, 2013, when GS1 ‘Application Identifier’ AI(22) is being withdrawn from use.”Typical 3 x 5 in. panels from a 3 x 10 in. wrap-around HDMA-compliant case pack product identification label. Other typical label sizes, minimum symbol X-dimensions, heights, etc. are called out in the HDMA Guidelines to accommodate different case pack sizes. The fully redundant GS1 DataMatrix 2-D symbol encodes all of the data elements from both GS1-128 symbols in exactly the same order. Examples are to scale.S-GTIN Format: Lower GS1-128 linear bar code encodes Global Trade Item Number plus Serial Number (S-GTIN) for traceability; upper symbol encodes Exp. Date, Lot/Batch and Quantity. Both GS1-128 symbols are required. The recommended GS1 DataMatrix symbol is shown in the upper right corner.GTIN Format: Lower GS1-128 linear bar code encodes Global Trade Item Number only (GTIN); upper symbol encodes Exp. Date, Lot/Batch, and Quantity. Both GS1-128 symbols are required. The recommended GS1 DataMatrix symbol is shown in the upper right corner.
AI(22) is an alternate, but widely used GS1 application identifier, representing quantity, expiration date, and lot number in a single GS1 system element string instead of the three separate, more traditional application identifiers, AI(30) for QTY, AI(17) for EXP, and AI(10) for LOT. However, use of AI(22) is no longer an option following notification from GS1 two years ago that AI(22) is being withdrawn.
AI(22) was introduced by GS1 in the early 1990s as a means to directly encode—within the GS1 system—23 of the 25 possible formats defined for “secondary” or attribute data under the Health Industry Bar Code (HIBC) “Supplier Labeling Standard.” AI(22) provided a convenient migration path for healthcare manufacturers (both pharmaceutical and medical/surgical) that needed to convert from the much less widely embraced HIBC “Supplier Labeling Standard” to the truly global GS1 product identification system. However, while potentially more compact, the AI(22) format is not always so. More importantly, with 23 allowable permutations of the three encoded data elements, AI(22) has proved to be difficult for many companies—even large multinationals with experienced labeling personnel—to encode correctly. [See “GS1 to Sunset Application Identifier AI(22) Data Structure for Secondary Attributes” in the April 2010 issue of PMP News.] Going forward, manufacturers will use the three more widely recognized (and much easier to implement) application identifiers noted above to encode these product attribute data elements.
Another milestone that was reached in the 2011 edition of the guidelines is the withdrawal of the ITF-14 bar code as a shipping case label symbology option. This 14-digit Interleaved Two of Five (hence ITF-14) linear bar code can encode only a Global Trade Item Number (GTIN). It was adopted as the foundation data carrier in the first edition of the HDMA guidelines published in 1991, prior to the adoption of GS1-128 and GS1 application identifiers. And 20 years later, ITF-14 is still used by some manufacturers. However, this symbology cannot encode any secondary data—including serial number—and therefore no longer meets the needs of the supply chain. Therefore, the use of the ITF-14 symbol is no longer an option under the 2011 guidelines.
Elimination of AI(22) and ITF-14 is expected to greatly simplify case pack label design. Major pharmaceutical distributors are hoping for a prompt and thoughtful migration to the simplified and more uniform practices called for under the new guidelines.
Dirk Rodgers works in the pharmaceutical supply chain as a senior IT consultant and was a task force participant. In his personal blog, RxTrace.com, Rodgers observed the overaching need to “generate alignment around a common approach [to bar coding] within the supply chain.” In a separate interview, he explained that even though HDMA has published its supply chain bar code guideline for more than 20 years, manufacturers have historically had a choice of which GS1 system symbologies and secondary attribute data formats for use on case labels. Now, there is only one linear symbology (GS1-128) recognized by the guidelines and only one set of straight forward application identifiers that can be used for EXP, QTY, and LOT attribute data. This, he reasoned, should make it much easier to firmly establish consistent, widespread, and “in-spec” bar codes on pharmaceutical shipping cases. As he pointed out in his blog post, anyone with “any responsibility for applying or reading bar codes in this supply chain” should obtain a copy of the new guidelines “because you will need to make changes to keep up with the direction of the technology and the industry.”
There is another important change beyond elimination of AI(22) from the GS1 system effective January 1, 2013, and recognition of the insufficiency of ITF-14 (which lacks the ability to encode any secondary attribute data—and serial number, in particular). The composition of the so called “primary” GS1-128 linear bar code has been revised to accommodate case pack serialization, on which forthcoming government mandates for pedigree and track and trace capability are predicated. In the GS1 system, AI(21) is the application identifier for serial number.
Historically, the primary GS1-128 bar code on case packs encoded GTIN for product identification plus quantity attribute data, using the AI(01)+AI(30) construct. This use is acknowledged to be not perfectly aligned with the GS1 “General Specifications” but it has been a useful and long-standing pharmaceutical supply-chain practice. This was done first to be absolutely certain that distributors could know the quantity of stock-keeping units (SKUs) or “eaches” contained in the case, and second to provide the means for this data to be captured in a single scan of the primary bar code.
However, this same quantity attribute data is also carried by AI(30) in the secondary GS1-128 bar code, and the need to capture it in a single scan of the primary symbol is no longer as important as it once was. Moreover, there is now the greater need to capture the case pack serial number (when present) in a single scan of the primary symbol. Therefore, the option to encode quantity data concatenated to the GTIN in the primary symbol has been eliminated.
Removing the quantity attribute from the primary linear bar code frees up space on the label to accommodate a serial number concatenated to the GTIN using the AI(01)+AI(21) construct. This should be done whenever a manufacturer decides to incorporate case-pack serialization, irrespective of any pedigree or track and trace mandate. If the shipping case is not serialized, the primary GS1-128 symbol at the bottom of the label will now encode GTIN alone.
For distributors, the addition of a serialized case pack or “S-GTIN” bar code—along with the EDI advance ship notice (ASN) that details the “child” SKUs aggregated into the “parent” case—is a paramount goal. While all parties acknowledge it will be months and even years before most manufacturers get to this level of coding and marking, most agree the new HDMA guidelines represent industry best practice going forward and that manufacturers need to encode GTIN plus serial number in the primary GS1-128 bar code using the AI(01)+AI(21) construct. Distributors have also emphasized that the elimination of AI(22) from the GS1 system and as an option under the HDMA guidelines should significantly enhance the quality of the data they capture from scanning the secondary GS1-128 symbol.
The last significant change is the recommended addition of a “redundant” GS1 DataMatrix two-dimensional (2-D) symbol on case pack labels. This symbol is printed in addition to the two GS1-128 linear bar codes currently used by most pharma manufacturers. Both of the GS1-128 linear bar codes are still required, but their composition has been revised as outlined above.
The goal in adding the redundant 2-D GS1 DataMatrix symbol—which duplicates exactly all of the primary GS1-128 symbol data (GTIN or S-GTIN) plus the data encoded in the secondary GS1-128 bar code—is to populate the supply chain with efficiently scannable 2-D symbols to complement and enhance scanning efficiency when camera-based (2-D) scanning is implemented by distributors for case-level receiving, put-away, picking, and distribution. Although 2-D imagers can also read linear bar codes, putting all of the GS1 data elements in a compact, quick-reading 2-D GS1 DataMatrix symbol located in a consistent position (generally in the upper right-hand corner of every case pack label) will help drive timely adoption of 2-D imaging. This technology will be essential in a few years when government mandated pedigree and track and trace regulations—predicated on uniquely serialized units of sale/SKUs and case packs—are slated to come into effect.
Other than the need to carve out about one square inch of space on the case pack label for the GS1 DataMatrix symbol (and possibly upgrade label design software), the marginal cost to add this critical new bar code element is considered to be virtually zero for most manufacturers. Here’s why. First, virtually all current pharmaceutical case pack labels will need to be redesigned to achieve conformance with this revision to the HDMA guidelines. Even if a label design software upgrade is required, 2-D bar codes will surely be an essential element in pharmaceutical supply-chain pedigree and track and trace applications in the next few years, so the expense will be incurred in any event. Second, no new information technology requirement is imposed because the data elements encoded in the GS1 DataMatrix symbol are exactly those that are encoded in the GS1-128 linear bar codes. Third, no additional thermal transfer ribbon material or label print time is required when the redundant GS1 DataMatrix symbol is included. Moreover, many companies will use this opportunity to better standardize and reduce the number of label sizes and formats, which should result in lower overall case pack labeling costs going forward.
An observation from David Colombo, Serialization Program Leader for Eli Lilly & Co. (Indianapolis, IN) and a member of the HDMA task force, seemed to reflect the broad sentiments of the group. “The updated HDMA guidelines arrive at a critical juncture, given the changes manufacturers and repackagers face as they prepare for serialization and data synchronization using GS1 global standards. The reference tables, FAQs, and illustrations in this document are the result of strong collaboration among manufacturers, wholesalers, technical consultants, and other industry experts. This document will be an essential resource for the next several years and beyond for anyone involved in pharmaceutical packaging and distribution. HDMA’s leadership and coordination in providing this guidance will help to promote accurate and efficient processing of materials and transactional data in the U.S. pharmaceutical distribution chain.”
This article highlights the most important changes incorporated in the 2011 edition of “HDMA Guidelines for Bar Coding in the Pharmaceutical Supply Chain.” Be sure to reference the complete document, available at no charge to HDMA members and for sale to other interested parties at www.HealthcareDistribution.org, for complete technical details, example labels and explanations, primary source references, and other essential information.
George Wright IV is Vice-President, Consulting & Business Development, at Product Identification & Processing Systems Inc. (PIPS) and served as principal editor and bar code subject matter expert for the 2005 and 2011 editions of the HDMA Guidelines (for which PIPS was also the corporate sponsor). He is Vice-Chair/Chair-Elect of the new AIM Unique Device Identifier Committee and Past Chair of the AIM Technical Symbology Committee (TSC); a certified GS1-US Bar Code Consultant; and a regular contributor to Pharmaceutical & Medical Packaging News. Questions, comments, or requests for application assistance may be emailed to the author at email@example.com.