The Drug Supply Chain Security Act requires that the pharmaceutical industry implement end-to-end traceability by 2023. Trading partners in the supply chain have chosen to implement and test GS1 Standards-based solutions in real-world pilots to meet the deadline for interoperability.
While GS1 Standards have created a hierarchy that reaches down to the product level for serialization, several industry entities have voluntarily chosen to use GS1 EPCIS even as this standard evolves to fully meet the intent of the regulation. EPCIS allows trading partners to exchange data, in concert with the products as they move through the supply chain. An industry pilot between Johnson & Johnson Supply Chain (JJSC) and AmerisourceBergen Corporation (ABC) did just that with actionable and repeatable results.
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 more efficiently. As the foundational standard, the Global Trade Item Number (GTIN) helps to automate all processes and minimize errors, ultimately increasing patient safety.
PRESCRIPTION FOR A CLEARER VISION
If the subject is pharmaceutical traceability, ABC is in the thick of it as the wholesaler positioned between more than 450 pharmaceutical manufacturers and more than 60,000 customers, including pharmacies and healthcare providers. The company is a private label manufacturer, re-packager, 3PL service provider and specialty pharmacy, effectively placing it at the origin, middle and end of a vast global supply chain.
With this breadth, it’s no wonder ABC was eager to lead a unit-level traceability pilot with trading partner, JJSC. A traceability pilot that involved serialization of individual products was sure to be instructive for the industry.
“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.
Naturally, compliance is a critical issue for the pharmaceutical industry, which is why ABC and JJSC are active in industry associations like the Pharmaceutical Distribution Security Alliance (PDSA), the Healthcare Distribution Alliance (HDA and formerly the Healthcare Distribution Management Association) and the Pharmaceutical Research and Manufacturers of America (PhRMA).
In fact, all three industry associations played a critical role in helping Congress draft and enact the FDA’s Drug Supply Chain Security Act (DSCSA), which was signed into law on Nov. 23, 2013. The DSCSA requires the industry to institute an electronic, interoperable system to identify and trace by 2023 certain prescription drugs distributed in the United States.
Both ABC and JJSC are also long-term members of the GS1 Healthcare US Standards Initiative, the voluntary user group implementing global standards to address patient safety and deliver supply chain efficiencies. With “the global language of business” supplied through GS1 Standards, traceability mandated by DSCSA is exceedingly easier.
To enable serialized product identification and end‑to‑end traceability, manufacturers such as Janssen Pharmaceuticals, a pharmaceuticals company of Johnson & Johnson, have opted to leverage GS1 Standards. On the saleable unit, a GTIN with a serial number is encoded in a GS1 DataMatrix barcode to establish global uniqueness. Per the HDA standard, both a GS1-128 linear barcode and a DataMatrix barcode is leveraged by trading partners to share information about the physical movement and status of products as they travel throughout the supply chain.
LET THE PILOTS BEGIN
ABC and JJSC decided on a four-week pilot program in a live production setting, excluding the several months of planning that preceded it.
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. The lowest saleable 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 from packaging, 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 — Electronic Product Code Information Services — 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.
As in the past, product was moved from manufacturing to distribution 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 events and inference of the contents 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.”
BENEFITS BEYOND COMPLIANCE
Serialization and traceability can bring value to the respective businesses, beyond compliance. Leveraging GS1 Standards was also intended to help JJSC improve patient safety and provide a means to investigate counterfeit and diverted products. Serialization and traceability can bring measurable improvements to 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,” says Chris Reed, JJSC’s lead for Product Serialization and Traceability. “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.”
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.”
Something as seemingly simple as labeling requires careful consideration. A case displays multiple labels — an HDA label, a two-dimensional (2D) matrix label, another put on by transport and logistics, among others. This can be a source of 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.
“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 our patients. I strongly recommend a profound emphasis on cleansing existing master data and establishing robust data governance going forward,” says Reed.
“Data formatting issues — how others were encoding data using GS1 Standards — is important,” says Matt Sample, senior director, secure supply chain, AmerisourceBergen. “You have to test it thoroughly with the right amount of volume in production. 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, participants are working with both GS1 US and HDA to update labeling guidelines.
“Don’t treat this as a side IT project; it’s not a casual exercise,” warns Sample. “It’s a business transformation project, so don’t underestimate it.”
THE CARNEGIE HALL APPROACH
JJSC is a strong believer in conducting pilots. JJSC’s Reed, who is involved with several other pilots, recommends: “Practice, practice, practice. This and other pilots have confirmed that our technological and business process implementations are sound, but the exchange of data business-to-business takes some massaging in the real world. Start now.”
“It may take 25 percent more time to receive serialized cases, and about 30 percent more time to pick serialized products,” Sample says, 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 the FDA. “Exceptions are a reality, especially with niche products, and we need to know how to deal with them.”
ABC’s Sample is a strong proponent of transparency. “It’s a unique situation: You’ve got all of these manufacturers and wholesalers and we’re all competitors. But it’s nice we have an opportunity to collaborate to work on standardization of these traceability issues.” He goes one step further: “We had fun bringing manufacturers into our distribution center, and us visiting theirs; walking the shelves together.”
Reed also recommends robust communication. “For this initiative to be successful, trading partners up and down the supply chain must collaborate and communicate. We found that collaboration with our customers was critical to helping us align on objectives and resolve issues. 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.”
The key to success in meeting any instance of regulatory compliance comes down to collaboration. It rests on the willingness of industry partners across the supply chain to work toward consensus and then drive to adoption. The pilot between Johnson & Johnson Supply Chain and AmerisourceBergen Corporation was a great example of true partnership as pharma moves to establish a meaningful standard that serves the industry and protects patients.