Bracing for Drug Tracing Mandate

The need to start now to meet compliance deadlines for the Drug Supply Chain Security Act is critical. Facing new mandates, one industry pilot study has demonstrated the value of a standards-based solution in prescription drug traceability.

Legislation is transforming the pharmaceutical supply chain to improve patient safety by requiring traceability of prescription drugs. Industry members are preparing to go live with the Drug Supply Chain Security Act (DSCSA) serialization requirements for 2017, and beginning to plan for the journey to the item-level traceability requirement that lies ahead.

Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) recently collaborated on a pilot program testing a standards-based solution to meet the 2017 DSCSA mandate. The pilot results were published in a collaborative case study by GS1 US, the information standards organization, confirming actionable and repeatable results that offer valuable lessons for the entire industry.

DSCSA overview

Manufacturers, wholesalers, repackagers and pharmacies have been required to implement lot-level management since 2015. In phase two of DSCSA implementation starting in November 2017, manufacturers and repackagers must serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® [GTIN®] or FDA National Drug Code [NDC]), serial number, lot number and expiration date, and embed this information in a DataMatrix barcode. 

Beginning in November 2019, wholesalers must accept only serialized products and must verify unique product identifiers; pharmacists must meet the same requirements by November 2020. Finally, by November 2023, they will be required to make available information that would allow supply-chain partners to trace the ownership back to the initial manufacturer or repackager.

Collaborative approach

Meeting the DSCSA compliance deadlines will require significant industry collaboration to implement a common, interoperable solution affording all stakeholders clear vision throughout the supply chain. The industry is already using the GS1 standard of GTINs for product identification to comply with the first phase of DSCSA requirements. Many companies are also leveraging Electronic Product Code Information Services (EPCIS) in preparation for serialization and item-level traceability, which allows trading partners to exchange and synchronize data with products’ movement through the supply chain. 

ABC, as a major participant operating throughout the supply chain, was eager to lead a unit-level traceability pilot with JJSC that involved serialization of individual products. “This pilot was an opportunity to not only help develop the industry solution, but also provide insights that may help our patients and customers use it and leverage it beyond compliance,” says Matt Sample, senior director for secure

supply chain at ABC. 

JJSC seized the opportunity to participate. “Our collaboration with AmerisourceBergen highlights the importance of having a robust, well-implemented serialization platform-one that opens up a host of future supply chain and commercial capabilities enabling the delivery of a reliable supply of high-quality products and other services to our customers,” says Mike Rose, vice president of supply chain visibility, JJSC. 

ABC and JJSC are  long-term members of the GS1 Healthcare US Initiative, the voluntary industry group implementing global standards to address patient safety and deliver supply-chain efficiencies. The companies realize that using the common language of GS1 standards would make it easier to achieve interoperable traceability in compliance with DSCSA. The trading partners have also been active participants as subject matter experts in the Rx Secure Supply Chain workgroup, which developed the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability.                 

The pilot 

ABC and JJSC decided on a four-week pilot program in a live production setting. Beginning at the point of manufacture, a DataMatrix barcode was applied that contained a serialized GTIN, batch/lot number and expiration date to each lowest saleable unit. These units were packed into cases, and a logical relationship between the “children” and “parent” was established via aggregation. 

Product cases were then loaded onto a pallet or other logistics units, establishing yet another level of the aggregated hierarchy. At supply-chain points downstream, automated vision systems or manual barcode scanners read the DataMatrix barcode to capture the GTIN, serial number, batch/lot number and product expiration date. GS1 EPCIS was used to record business events associated with the serialized GTIN at various critical points along the supply chain, including commissioning, packing and shipping, followed by receiving and unpacking by the buyer. 

Products were moved from manufacturing to distribution as in the past, with the addition of the serialized information. After the wholesaler placed an order and the truck departed, JJSC issued an EPCIS message containing the serialized GTINs and hierarchies contained in the shipment. This provided the ABC distribution center with the details of the specific products that were on their way.

When the shipment arrived, the EPCIS data allowed ABC to confirm receipt-without opening a single case-of every single item that had begun its journey at the manufacturing site. “Using EPCIS message standards provides for a more streamlined process, in that systems are established with similar data file expectations across the supply chain,” explains Jeffery Denton, senior director of ABC’s global secure supply chain. “Most failures experienced during past pilots are avoidable if manufacturers provide DSCSA-compliant EPCIS v1.1 files that include master data for material attributes as well as valid GLNs (global location numbers) and GTINs.” 

“We have a solid playbook on how to run a pilot with more than just one manufacturer and more than just one product. We have a good repeatable process for future pilots,” says Sample.

Beyond compliance 

Serialization and traceability can bring value to the respective businesses, beyond compliance. 

“We see this as more than just a regulatory compliance effort,” says Chris Reed, JJSC’s lead for product serialization and traceability. “Leveraging GS1 standards is also 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,” continues Reed. “We can use these capabilities to further ensure that our patients and customers receive quality, genuine products. We also believe serialization and traceability will provide additional benefits to our business, like the ability to more effectively manage and verify returns.” 

He adds, “With GS1 standards, specifically the use of GLNs and GTINs, identification of a product and its unit of measure will become clearer to the entire supply chain. In the future, there’s also immense value in utilizing GTINs for ordering processes.” 

Lessons learned 

JJSC is a strong believer in conducting pilot tests. “We continue to discover ways to improve our design and processes through pilots. The pilot with ABC enabled us to validate and challenge our end-to-end business processes and architecture that grew, with significantly more internal and external manufacturing sites, regional requirements and IT complexity, since our last round of EPCIS exchange,” says Rosemary Hampton, IT manager, supply chain business systems, Johnson & Johnson Information Technology. 

“To facilitate just this relatively small pilot, our enterprise resource planning operations, warehouse management system and traceability processes needed to perform in unison,” says Reed. “We found that products were arriving on ABC’s loading docks before product data arrived, because of the way we had batched our data transmissions between these three large systems. This led us to challenge and reconfigure our old way of thinking. The pilot was a reminder of how many processes and IT systems we have in play.”

According to Reed, a missing element of data-whether it’s a dosage form or a letter in the description of the product-may seem trivial, but it can drastically impact the efficiency of the pharmaceutical supply chain, potentially leading to disruption for patients. A strong emphasis on cleansing existing master data and establishing robust data governance is critical, he says.

Sample agrees: “Data formatting issues-how others were encoding data using GS1 standards-is important. You have to test it thoroughly with the right amount of volume in production.”

 Something as seemingly simple as labeling requires careful consideration. Each case displays multiple labels-a Healthcare Distribution Alliance (HDA) label, a two-dimensional (2D) matrix label, and another applied by transport and logistics, among others. This can cause confusion at stops along the supply chain. Glare resulting from shrink wrap and flashing lights can also impede automated code capture; damage to cases can compromise label readability. 

“We found we were putting the 2D barcodes in the most vulnerable spot on the packaging, so we had to change that,” says Sample. As a result of the pilot, JJSC and ABC are working with GS1 US and HDA to update labeling guidelines. “Don’t treat this as a side IT project; it’s not a casual exercise,” he warns. “It’s a business transformation project, so don’t underestimate its importance.” 

Adjustments loom 

The ABC-JJSC pilot and others  have confirmed that industry technological and business process implementations in the supply chain are sound, but the business-to-business exchange of data requires fine-tuning in the real world. 

“It may take 25% more time to receive serialized cases, and about 30% more time to pick serialized products,” says Sample, pointing to a need for a better understanding of exceptions-how often they occur, how to deal with them and what will be deemed acceptable by FDA. “Exceptions are a reality, especially with niche products, and we need to know how to deal with them.” 

Transparency is key as well. “It’s a unique situation: you’ve got all of these manufacturers and wholesalers and we’re all competitors,” says Sample. “But we have a constructive opportunity to collaborate in working on standardization of these traceability issues.”

Building stronger communications channels will be vital to this effort, executives point out.   

“For this initiative to be successful, trading partners up and down the supply chain must collaborate and communicate,” says Reed. “If we keep the lines of communication open and continue to develop and refine industry standards together, we will all be prepared for the DSCSA requirements and continue to provide safe and effective medicines to our patients.” 

Heather Zenk, vice president of ABC’s secure supply chain, sums up the companies’ pilot in this way: “The key to success in meeting any instance of regulatory compliance really comes down to collaboration. It all rests on the willingness of our industry partners across the supply chain to work toward consensus and then drive to adoption.” 

In addition to assuring compliance and continued product access for patients and customers, serialization can potentially enable the investigation of counterfeit and diverted products, affording brand owners additional supply-chain integrity and security. End-to-end visibility means that recalls, where necessary, can be executed efficiently. As the foundational standard, the GTIN helps to automate all processes and minimize errors, ultimately increasing patient safety. 

Action plan

The pilot program demonstrated that the GS1 GTIN has value to enhance ordering processes and reduce unit-of-measure ambiguity in the future, and that clean, quality data is imperative. 

By starting now, life sciences companies can build the systems needed for successful transition to the DSCSA traceability requirements, and reap the full benefits of an electronic, interoperable system for identification and tracing of prescription drugs. The pilot confirmed the importance of treating this as the business transformation that it is, and assigning proper resources. This industry revolution presents the unusual opportunity of sharing best practices among partners, customers and even competitors. 

Greg Bylo is Vice President, Healthcare, at GS1 US. He can be reached at gbylo@gs1us.org