Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) recently collaborated on a pilot study on implementing GS1 traceability standards. PMP News asked Mike Rose, Vice President of Supply Chain Visibility, and Chris Reed, Lead, Product Serialization and Traceability, both with JJSC, a few questions about the pilot.
PMP: What were the goals of the pilot program between Johnson & Johnson Supply Chain and AmerisourceBergen? Why did the two companies decide to work together?
Rose: FDA’s 2013 Drug Supply Chain Security Act (DSCSA) requires the pharmaceutical industry to implement end-to-end traceability by 2023. Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen (ABC) are two of the largest manufacturers and wholesale distributors of prescription drugs in the United States. Both companies understood the importance of implementing and testing GS1 Standards-based solutions—in particular the GS1 Electronic Product Code Information Services (EPCIS) in a real-world pilot to meet the DSCSA deadline for interoperability.
This pilot was an opportunity to not only help develop the industry solution, but also provide insights that may help our customers use it and leverage it beyond just compliance, to introduce new efficiencies in the supply chain that will ultimately benefit all stakeholders and improve patient safety.
PMP: When did the pilot program begin? How many products and what type of products were coded? Is it still ongoing?
Rose: The pilot with AmerisourceBergen began in October 2015 and concluded December 15, 2015. JJSC opted to utilize 40 serialized SKUs comingled with unserialized product in regular, recurring shipments. The goal was to utilize full production products, shipments, and transactions. We exchanged serialized information and products in an additional pilot from June to August 2016 for six weeks as well. We intend to move this exchange of information and product to an on-going basis later in the year.
PMP: How is the pilot different from any previous pilots that JJSC had held? Why was this new pilot necessary?
Rose: JJSC initiated a pilot in 2013 with two large wholesalers. In this early pilot, JJSC opted to retrofit one manufacturing line, one product, and leverage one-off shipments with significant hand-holding. This pilot with AmerisourceBergen included additional manufacturing sites, distribution centers, and products in a full production environment.
PMP: Both a GS1-128 linear bar code and a GS1 DataMatrix bar code are used on products from the Janssen Pharmaceutical Companies of Johnson & Johnson. Is the same information included in each code, making them redundant codes? Are there any challenges to employing both codes, and if so, how are they addressed?
Rose: Our primary packaging utilizes both a UPC-A bar code, which uniquely identifies a product for retail checkout, and GS1 DataMatrix, which is a two-dimensional matrix symbol that requires image-based scanners and is currently specified for healthcare items. There are two reasons for this. First, the FDA Linear Bar Code guidance specifies the UPC must be applied in linear machine-readable format. Second, retailers are accustomed to scanning the UPC-A with their point-of-sale systems. In the short term we will continue to apply a linear bar code encoded with the GTIN-12 to ensure readability.
There are several challenges with employing both bar code formats. First, processes were put in place to ensure that what is encoded is synonymous in both symbologies. The GTIN-12 in the UPC-A on the fixed artwork is systemically aligned with the variably printed GTIN-14 in the GS1 DataMatrix. There are also significant space constraints on some of our smaller packaging. Labels contain a significant amount of regulatory data. We must get creative to apply an additional GS1 DataMatrix and human-readable GTIN, serial number, lot number, and expiry date.
PMP: Is the use of both codes a temporary solution until the supply chain can read 2D DataMatrix barcodes?
Rose: Exactly. By 2023, the law states that all serialized products must carry a DataMatrix (2D) bar code. Between now and then, until all supply-chain partners have the 2D readers, some will continue to rely upon the GS1-128 bar code for product identification. Also, products with the linear bar code that are already in the supply chain will remain in inventory until they are sold or expire. So while the market transitions to unit-level serialization, we will continue to see linear bar codes on products, and some products will have both codes at the same time.
PMP: Can you detail any packaging or labeling changes that were made to accommodate the pilot study? Were any made as a result of the study’s findings?
Reed: As our serialization efforts were already in flight for the U.S. and 45 other markets globally, no additional changes were made to the labels at the primary and case level to support this pilot specifically. As a result of this pilot though, we and AmerisourceBergen realized that the placement of one of the GS1 DataMatrix symbols on the wrap-around case sat in a very vulnerable position. During normal logistics, the corner of the corrugated shipper is often dented as it moves from node to node. The internal contents are fine but the GS1 DataMatrix sitting close to the corner of the case frequently is rendered unreadable.
Working with AmerisourceBergen and the Healthcare Distribution Alliance, the recommendation was put forward to the industry to move the GS1 DataMatrix symbol to adjacent corners, safely away from the edges of the case. We are working right now to update these labels for our U.S. products.
PMP: How is GS1 EPCIS data shared?
Reed: The GS1 Electronic Product Code Information Services (EPCIS) is an open standard that allows businesses to capture and share supply-chain information about the physical movement and status of products as they move throughout the supply chain, from business to business and ultimately to consumers. The data is stored in a cloud, administered predominantly by solution providers that contract with individual companies. If those solution providers upload the data to the GS1 Global Data Synchronization Network (GDSN), interoperability is improved through a standards-based approach to storing item information, ensuring that the information is properly defined and formatted, and keeping that information up-to-date. Trading partners have access to the same information through the GDSN.
The GS1 Healthcare US Initiative’s Rx Secure Supply Chain workgroup is acting to encourage and facilitate migration of EPCIS data to the GS1 GDSN, where interoperability can be maintained and data can be updated in real time. The GS1 Healthcare US Initiative recently updated its GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability to provide guidance on best practices.
PMP: Were any process, equipment, or product changes made as a result of the pilot findings, and why or why not?
Reed: Several. In addition to the case label change referenced above, we saw some delay in the EPCIS information arriving at AmerisourceBergen’s DC. Several times, due to the short duration of transit between our Kentucky Distribution Center and their Columbus, OH, site, the product arrived before the data. The issue stemmed from the cadence of batching that queued between three systems. The ECC, WMS, and enterprise serialization solution were adjusted to sync data exchange more efficiently and ensure the data arrived ahead of the product.
PMP: Did the pilot demonstrate benefits of serialization beyond regulatory compliance? If so, what are they?
Reed: Supply-chain stakeholders are primarily focused right now on the path to compliance, since that is a pressing need. However, there will be added benefits to standardized serialization and supply-chain visibility. Accuracy and efficiency of tracking, tracing, and managing product inventory will improve at all points throughout the supply chain.
Using EPCIS message standards provides for a more streamlined process, in that systems are established with similar data file expectations across the supply chain. Interoperability is important to provide crucial supply-chain visibility for trading partners on both ends of the transaction. It allows real-time sharing of consistent, compatible data detailing product attributes, source, current location, and destination. All of this data helps the supply chain run smoothly and efficiently. Just as important, it means that prescription drugs can be traced back to their original source and every stop along their journey to point of sale—which enables high-assurance validation of the drugs’ authenticity, preventing acceptance of counterfeit products at the pharmacy destination. It also means that if a serious problem does occur, a recall can be efficiently executed and the source of the problem can be quickly identified.
Leveraging GS1 Standards also is intended to improve patient safety and helps provide a means to investigate counterfeit and diverted products. It improves our internal and external supply-chain integrity. With the implementation of serialization and traceability, we will have the opportunity to trace a serialized product from a specific wholesaler to the end customer. We can use these capabilities to further ensure that our patients and customers receive quality, genuine products. We also believe that they will provide additional benefits to our business such as being able to more effectively manage and verify returns.
PMP: What challenges remain?
Reed: Data formatting using GS1 Standards is important. And it’s absolutely essential to begin with high-quality data. We cannot overstate the need for companies to cleanse existing master data and establish robust data governance going forward, to ensure the communication of accurate information between trading partners.
Every bit of data needs to be accurate and complete. Even a small omission like a dosage form or a letter in the product description can severely compromise the supply chain integrity and efficiency. We strongly recommend companies begin with a rigorous cleansing of existing master data and establish robust data governance going forward.
Collaboration and communication are critical to alignment on objectives and resolution of issues. Trading partners throughout the industry will have to work together to make this work, so that we all will be prepared for the DSCSA requirements and continue providing safe, effective medicines to our patients.
PMP: Will there be future pilots?
Rose: We will continue to pilot here in the U.S. and abroad to ensure we are prepared for the regulatory requirements without disrupting supply to patients.
PMP: What should other pharmaceutical companies do differently as a result of this pilot?
Reed: A key take-away from this pilot was the need for more practice and testing by all stakeholders in the industry. A lot can happen during the process of applying a unique identifier, aggregating that product to a case and pallet, exchanging that hierarchy internally, and then passing it to the customer. The more practice you have, the more tuning you can accomplish. This is a very green space and the ‘unknown unknowns’ are found almost weekly.
To learn more about the pilot, please see this case study.
GS1 Connect will be in Las Vegas June 20-22. Click here for more details.