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The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
Since the COVID-19 pandemic struck, there has been little news of serialization breakthroughs, as manufacturers and their supply partners have focused on getting new therapeutics and vaccines to patients. However, progress has been ongoing behind the scenes, and the past two years have seen a significant increase in use of two-dimensional (2D) barcodes (1) and even adoption of blockchain, says Peter Sturtevant, senior director of community engagement at GS1 in the United States. Globally, GS1 works with pharmaceutical manufacturers, wholesalers, distributors, retail pharmacies, hospital dispensaries, trade associations, and regulatory agencies to help advance track-and-trace implementations and drive supply-chain efficiency.
“[In the US,] we have been supporting the [pharmaceutical] industry for the final milestone, the Drug Supply Chain Security Act (DSCSA) deadline of November 27, 2023,” says Sturtevant, and advances have continued through 2020 and 2021. “At this point, manufacturers are meeting requirements for 2D barcodes on packaging, and including package identifiers, National Drug Code (NDC) code embedded into the GS1 Global Trade Item Number (GTIN) for identifying products, serial numbers, lot numbers, and expiration dates. For medicines that come directly from manufacturers, you can already see the serial numbers on some products,” he reports.
COVID-19 vaccines, approved under emergency use authorization, were not required to meet serialization requirements, but they have been properly labeled to meet FDA requirements, he says, complete with 2D barcodes with GTIN, lot, and expiry date. In the future, serialization may be required.
He notes that several manufacturers, including Fresenius Kabi, opted to go beyond basic traceability requirements. The company decided to serialize its Diprovan anesthetic, a workhorse generic product, using radio frequency identification tags containing the four identifiers (2).
Although counterfeiting remains a threat, the growing use of barcoding and serialization promises to have an impact. Beyond serialization, the requirement that companies only do business with “authorized trading partners” will have a major impact, he says.
In April 2021, GS1 US issued a new implementation guideline (3), emphasizing best practices for maintaining chain of custody.This practice is particularly important for brandowner agents such as contract packagers, contract manufacturing organizations (CMOs), third-party logistics providers (3PLs), and reverse logistics providers. “If an agent is handling your product on your behalf, they need to leverage GS1 Standards including GTINs for products [and] global location numbers (GLNs) for physical locations, and share data electronically using electronic product code information services (EPCIS) to capture events from manufacturing to serialization [and] capping to shipping.EPCIS can capture those key events and share them with downstream trading partners,” Sturtevant explains.
Although the level of information technology (IT) infrastructure among contract service providers varies widely, adopting the technology may eventually become a requirement for doing business.Although GS1 Standards are not legally required of these entities, manufacturers may restrict business in the future to partners that can meet these requirements, just to avoid liability. “Some companies are still using fax machines. That’s the reality of the world,” he says, noting that cloud-based solutions have made technology more readily accessible.
Blockchain is also being evaluated and adopted where appropriate for use in product verification for resale and returns. “It’s not a panacea but another tool in the toolkit,” says Sturtevant.
Currently GS1 US’s Rx Secure Supply Chain workgroup is made up of 50 companies, including 12 manufacturers, seven dispensers, vendors, and all “Big Three” pharmaceutical whosesalers. The group is now developing new guidelines for applying GS1 Standards for serialization, which Sturtevant expects to be published later in 2021.
Generally, he sees the industry as prepared for the DSCSA deadline. “Nobody is taking it lightly. The industry is committed to it. If you look at our 2020 barcode assessment, four years ago 7% of pharma companies met requirements for labeling with 2D barcodes. By 2020 we had over 90%, both for packages and homogeneous cases, with proper barcodes.”
At the same time, on the vendor side, there has been an explosion of new technologies designed to track pharmaceutical cargo in transit. Dubbing the new market “real-time transportation visibility platforms,” as opposed to track-and-trace technology, the tech market analysts at Gartner predict that, by 2023, half of all global product-centric enterprises will have invested in these technologies (4).
In February 2020, Tive established the Open Visibility Network (OVN) with project44 and FourKites to enable open data access for mutual customers.The OVN helps connect shippers, logistics service providers (LSPs), brokers, and customers by allowing open, collaborative data sharing. Instead of each partner working separately with clients, the open platform will allow the partners’ customers to easily access data across platforms, so that Tive’s shipment data (which focuses mainly on hyper-accurate load location and condition), and project44’s or FourKites’ data (which focuses on other data facets) might be
In April 2021, Tive, Persequor, and Itrazo joined forces in a similar collaboration designed to help improve traceability in the cold chain, with an emphasis on biopharmaceuticals. “With the COVID-19 vaccine and strains on supply chains, we needed to get to a new level of visibility and traceability,” says Tive Director of Marketing Jim Waters. Companies will share data so that any of their customers can access data from any of the three platforms or their transportation, warehouse, or other management systems, bringing data on shipment load and location from Tive, from Itrazo’s data processing platform, and Persecor’s production and manufacturing data platform, so that customers needn’t switch platforms and vendors. The April announcement focused on the Asia Pacific and Australian regions, but the collaboration’s benefits are already available to users in North America and Europe, says Waters.
Tive offers non-Lithium industrial Internet of Things (IoT) trackers and software that apply machine learning and artificial intelligence to provide real-time data on shipments in transit, sending alerts when a shipment experiences an excursion, whether temperature excursion, route deviation, container breach (light), or shock. Using a cloud-based approach, Tive’s trackers upload data to its data cloud, streamed to customers using application programming interfaces (APIs), to allow users to take corrective action in real time.
Tive sees collaboration, real-time hardware, and connection to users as the crucial needs for bio/pharma traceability technology today. Without collaboration, he says, companies cannot hope to move at the velocity that this new world is going to require (i.e., getting vaccines to end users on time and in full). He also sees the need for the industry to move beyond passive data trackers, which can at best provide a post-mortem after a problem has happened with a load. There will also be a need to better serve users through services that can help companies receive alerts so that they can respond more quickly to problems. Tive has launched a 24/7 support team designed to provide an extension of customers’ teams and help it manage responses.
1. GS-1 US, “Pharmaceutical Industry Makes Steady Proress toward Meeting the 2023 DSCSA Interoperability Requirements, GSIUS.org, Feb. 28, 2021.
2. GS-1 US, “Case Study: Fresenius Kabi,” GS1US.org, 2020.
3. GS-1 US, “Implementation Guidelines,” GS1US.org, April 2021.
4. C. West and B. De Muynck, “Magic Quadrant for Real-Time Transportation Visibility Platforms,” gartner.com, Apr. 14, 2021.
Agnes Shanley is a former senior editor to BioPharm International.
Vol. 34, No. 7
When referring to this article, please cite it as A. Shanley, “Track-and-Trace Progress Benefits Supply-Chain Security Efforts,” BioPharm International, 34(7) 2021.