The Drug Supply Chain Security Act (DSCSA) was signed into law in 2013 with the aim of combating the spread of counterfeit prescription drugs.
As part of the legislation, the U.S. Food and Drug Administration outlined a long list of traceability and security requirements for pharma stakeholders. As we approach the final milestone in November 2023, pharma must meet DSCSA’s inoperability requirements for enhanced product tracing and verification.
In a recent interview with Pharma Manufacturing, John Wirthlin, industry principal for Manufacturing, Transportation and Logistics at Zebra Technologies, shared his expertise on the challenges and opportunities presented by the DSCSA regulation — and how companies can best prepare themselves for the upcoming deadline.
Q: Can you tell us about Zebra’s efforts to help the pharma industry comply with DSCSA?
A: Zebra Technologies began researching the pharma industry about a year and a half ago and found that the DSCSA required new track and trace tools to meet regulations. Specifically, they needed to capture sellable unit, serial number, and 2D barcode information to understand the pallet’s contents and its corresponding cases. The regulation requires manufacturers to capture all serial numbers, lot codes, and expiration dates into a file transmitted with the pallet to the next entity in the supply chain, such as wholesalers. If the receiving entity does not have the correct serial numbers, the shipment must be quarantined, and an investigation is launched.
We were asked by manufacturers to develop a quick and accurate way to comply with the regulations. While barcoding using 2D barcodes on packaging is the current default, it is labor-intensive and prone to error. We’re exploring RFID as a more long-term solution and collaborating with the Axia Institute, affiliated with Michigan State University School of Packaging, to test the technical viability of RFID. They are using expired drugs, including controlled substances, provided by different manufacturers to understand RFID’s effectiveness in this area.
Q: What are some current and future solutions for DSCSA compliance in terms of capturing data from barcodes?
A: We’re looking into RFID as a long-term solution for DSCSA compliance, but also turning to other technologies to help manufacturers and wholesalers meet the requirements before the November deadline. We are doing site visits throughout the supply chain to understand the value proposition. But what’s first and foremost in the heart of the manufacturer as well as the downstream wholesalers is, “What can you do to help me between now and November 27th of this year when this regulation comes into effect?”
We’ve opened our aperture, and we’re looking at other technologies besides traditional barcoding, such as fixed industrial scanners and machine vision to be able to read those labels as they’re going through an assembly line or a packaging line to start trying to take the human factor out of it, and execute automated, more sensor-based capture of that edge data.
We’re also exploring how robotics can streamline the movement of products within facilities. Currently, many workers are charged with repetitive, labor-intensive tasks such as pushing carts or moving pallets from one place to another, which doesn’t add much value. We’re collaborating with industry leaders to identify untapped technologies that have gained importance during the pandemic and are being adopted by various industries beyond health care and pharmaceuticals.
Q: What barcoding challenges are pharma companies facing and how is Zebra Technologies addressing them?
A: First and foremost, labor is a major challenge for many industries, including pharma. The pandemic has affected the labor market, and companies are struggling to find enough workers to keep up with increased traceability requirements. In the past, companies might have hired more workers to handle the increased workload, but this is no longer a viable option. For example, our big three wholesalers are each looking to hire between 300 to 500 additional workers just to keep up with increased barcoding demands. However, they need a more immediate and mid-term solution than waiting for RFID technology to become more widely available.
Another challenge is the risk of errors that can lead to quarantining items that are suspect. These errors can occur due to line-of-sight scanning problems or master data management issues, where the sending facility has information that the receiving entity doesn’t have, causing transactions to fail. These errors can also create quarantine problems, which can delay medication delivery to patients who urgently need them. Zebra Technologies is exploring how to provide a more sensor-based approach to data capture to reduce reliance on human intervention and reduce the risk of errors.
Q. What concerns do pharma leaders have about adopting new solutions in highly regulated, GMP areas?
A. When we engage with customers in typical warehouse or manufacturing environments, we usually demonstrate our solutions using new scanners, RFID technology or robots. The customer then performs proof-of-concepts and decides whether to adopt the technology, typically within 30 to 90 days. However, in highly regulated environments such as packaging lines, changes must comply with good manufacturing processes.
For instance, if we introduce RFID into a packaging line, the entire line must be recertified. This process is lengthy and costly, but it ensures the safety of medications in the system. Therefore, any new technology that we propose to these customers must be balanced against the added steps required to make that change. The sales cycle for these customers is much longer, often ranging from six to 12 months.
Q: What solutions are available to help pharma stakeholders address concerns about quarantine delays and improve efficiency in the supply chain?
A. Given that the DSCSA regulation requires shipments with mismatched serial numbers to be placed into quarantine, segments of the supply chain are concerned about efficiently resolving these issues to ensure medications reach patients quickly.
Zebra has been in discussions with some of the big three wholesalers about how to best handle the increase in quarantine situations due to the upcoming DSCSA regulation in November. These wholesalers typically have a large warehouse, around 100,000 square feet, with a small area dedicated to quarantine products. With the new legislation, they anticipate having a lot more quarantined items that will require investigation due to increased traceability.
One of the major challenges is finding a place to put all of these products and locating them quickly. To address this, we’ve been exploring several technologies, such as using fixed industrial scanners to capture images of products and pull key data elements through 2D barcodes or Optical Character Recognition (OCR) technology. This information can then be ingested into a system for offsite workers to use in resolving the issue.
We’re also looking at using RFID to tag quarantined products and implementing handheld RFID scanners or a map to locate them quickly. Additionally, robotics could be used to move products in and out of quarantine areas to increase efficiency.
Our goal is to help workers leverage technology to resolve suspect medication investigations efficiently so that safe medications can reach patients as quickly as possible.