In an increasingly global health care marketplace, regulation changes in one country can have a ripple effect felt around the world. As the need for vital therapies and treatments to move through a global supply chain increases, so must the industry’s ability to track them to ensure safe, efficient and reliable access to all patients worldwide. However, each country has tackled the challenges and opportunities presented by creating efficient supply chains in vastly different ways, with differing degrees of success.

In the U.S., as early as 2003, the Food and Drug Administration (FDA) began outlining a program where medications would be identified (first by RFID tags but then by 2D barcodes) and tracked as they moved throughout the supply chain. This process evolved into the Drug Quality and Security Act (DQSA), officially codified into law on November 23, 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), provides guidance for building an interoperable electronic system to identify and trace prescription medication in the supply chain. The DSCSA affects stakeholders across the health care continuum with provisions for product identification, tracing, verification, fraudulent product detection and response, as well as notification, wholesaler licensing and third-party logistics provider licensing.

DSCSA deliberately allows flexibility on how to comply with the regulation. The law requires that the industry build an “electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States” that “facilitates the exchange of information at the individual package level about where a drug has been in the supply chain.” However, it does not articulate exactly how to build that system, which allows stakeholders to create the most effective and efficient system possible that still fulfills the requirements of the law.

While the industry has the opportunity to innovate, there are specific requirements that need to be achieved to comply with the DSCSA legislation. In fact, various provisions of the DSCSA have already been achieved, and full implementation will happen in 2023. Manufacturers, wholesale drug distributors, repackagers and dispensers (primarily pharmacies) have already been required to establish systems and processes to comply with the following verification requirements:

• Must be able to respond to verification requests about suspect product
• Quarantine and investigate suspect product to determine if it is illegitimate product
• Notify trading partners and FDA of illegitimate product (within 24 hours of determination)
• Respond to notifications of illegitimate product
• Keep up-to-date records of required DSCSA transactional data
• Validating Authorized Trading Partner status
• Pass transactional information, statement and history as defined 

Preparing for serialization
This November, manufacturers must be prepared for one of the more challenging requirements of the DSCSA: All prescription drug products at the saleable unit and the homogenous case level for the U.S. market must be serialized. Meaning, for a case of 24 units, manufacturers and their partners will no longer have a single tracking code, but instead, they will have 25—one for each unit and one for the case. This is an incredible change to both the supply chain process and the volume of data that will now need to be managed. While manufacturers have been preparing for this massive shift since the legislation was passed in 2013, there is still more work that needs to be done.

As a wholesaler positioned between more than 450 manufacturers and more than 60,000 customers, including pharmacies, health systems and physician offices, AmerisourceBergen is preparing for the challenges and opportunities presented by the DSCSA. But, we are also a private label manufacturer, repackager, 3PL service provider and specialty pharmacy—essentially placing us at every position in the supply chain. This breadth of services has given us an understanding of what is at stake for everyone, beyond the wholesaler and manufacturer, and has inspired us to collaborate with other industry leaders to develop cutting-edge solutions for compliance.

For example, in preparation for the upcoming requirements, we created a program in which manufacturers can submit barcodes to us for testing before they are approved to go onto drug packaging. We scan the barcodes and ensure that our systems are able to read the barcode and accurately extract data from it, thus saving the manufacturer time and money if the barcode does not work. This service proved so popular and effective that our partners at GS1 US, a standardization organization, requested we share the program more broadly, so the solution can be rolled out as standard practice across the whole supply chain. We understand that creating improvements in the overall system will help us all move forward more effectively and efficiently. 

Facing industry challenges
When beginning the process of implementing serialization, one of the initial challenges the industry faced was finding or designating key points of contact at manufacturers, technology companies, wholesalers, repackagers and distributors who would take on the responsibility of implementing serialization. Once that group was identified, the challenge then became education: How can key stakeholders share the information they have in a way that’s meaningful and digestible? We saw this as an opportunity to lead our industry and be very transparent about what has and has not worked in the past, but that was only part of the equation.

Sharing lessons learned and educating one another about each stakeholder’s needs is one thing, but finding a way to transfer large volumes of data with speed, safety and security is far more complex; the DSCSA requires the collection and aggregation of a massive amount of data, which needs to be adequately protected. In turn, this requires multiple organizations’ systems to “speak” to one another and the right balance of encryption. Data needs to move safely, but it also needs to be decipherable. Aligning security requirements was certainly a challenge. In our case, we partnered with SAP to develop an innovative data management solution called Advance Track & Trace for Pharmaceuticals.

Accurately understanding how every single member of the supply chain is impacted by the legislation is one of the challenges we still face in the DSCSA implementation. The needle is moving, but only because of the strengthening partnerships we see forming in the industry.

Understanding full implementation
The next evolution of implementation is changing how the pharmaceutical community looks at the supply chain. Previously, product could move throughout the supply chain without data attached to it. Now, product and data must move together, and while we’ve improved the ways in which data is shared in the industry, keeping it connected to its associated product is a huge paradigm shift. Fortunately, stakeholders are already testing programs in anticipation of 2023’s requirements and producing promising results.

For example, we partnered with a variety of organizations to create and test strategies for complying with the regulation’s full implementation. We executed a four week pilot program to test the serialization of individual products with multiple pharmaceutical manufacturers. Beginning at the point of manufacture, a DataMatrix barcode—or 2D barcode printed as a square or rectangle—containing a serialized Global Trade Item Number (GTIN), batch/lot number and expiration date was applied to each individual product. At different points throughout the supply chain, automated vision systems or manual barcode scanners read the barcode to capture the GTIN, serial number, batch/lot number and product expiration date. Once AmerisourceBergen placed an order and that order shipped, the pharmaceutical manufacturers issued an Electronic Product Code Information Services (EPCIS) message containing the serialized GTINs for the products in the order, which provided our distribution center with the details of the products that were in transit. When the shipment arrived, the EPCIS events allowed us to confirm receipt without opening a single case. This trial provided valuable learnings that lead to a template for future pilots, all while giving us the ability to pinpoint a solution that works across product types and manufacturers.

Acting locally but standardizing globally
Global sourcing needs a global system. The health care industry must take a worldwide view and think about establishing common core business practices that work across the spectrum. Even an independent pharmacy operating in a remote location is part of the global supply chain—the medication dispensed by that pharmacy comes from manufacturers, wholesalers and repackagers that operate around the world.

Just like identifying key points of contact, education and data security proved to be challenges when implementing DSCSA in the U.S. Countries around the world each have a unique set supply chain that functions for their country, and this presents challenges for global companies. As a collaborative partner with GS1, we are on the ground in countries all over the world, helping to shape their regulations to fit with the needs of today’s global supply chain and providing insight on best practices.

When countries don’t align with GS1 barcode standards, the ability for therapies to move from country to country safely and efficiently is threatened and implementation timelines and patient access to medication can be impacted. For example, Brazil enacted legislation that was not aligned with the standard method to use serial numbers in combination with a GTIN, they wanted the serial number to be unique by manufacturer versus unique by product. Manufacturers realized that under the Brazilian law, they would run out of unique number combinations within a shorter amount of time, and also they would have to modify the way that they managed their global data. With the help of GS1, the industry worked with Brazilian authorities to amend their law to align with globally recognized standards.

China was another county where the industry has worked closely with GS1 to move them towards using global standards. China was operating within a closed system that moved data in a non-standardized manner. This caused difficulties in importing or exporting medication, and caused manufacturers to have a completely different strategy to meet China’s requirements. China is now working closely with GS1 to implement new tracking and tracing legislation that will benefit not only manufacturers but also patients, as it will open up greater access to therapies coming in and out of the country, while also better servicing their own citizens.

More education is needed to create widespread success. Stakeholders need to educate a variety of key groups, from regulators to manufacturers, on the benefits of standardized supply chain operations. For regulators, it takes outreach from manufacturers, wholesalers and dispensers to begin to understand what a globally secure supply chain looks like and what organizations like GS1 do to help achieve those goals. From there, the industry needs to showcase the benefits of complying with global regulations, such as access, efficiency and safety for all products.

Once regulators are on board, a timeline for global implementation must be developed with manufacturers. Secure supply chain standards, while vital, take a significant amount of time and resources to implement properly. If regulators do not allow enough time for implementation, they run the risk of limiting manufacturers’ ability to comply. At the same time, the pharmaceutical industry needs to work with regulators to discuss what timelines are realistic. Sometimes, moving a deadline back by one year is the best way to ensure safe compliance and continued access for patients.

Protecting the future of the supply chain
Ultimately, developing a consistent supply chain for countries around the world is imperative for ensuring patients have better access to the therapies they need. Requiring manufacturers, wholesalers, distributors and repackagers to serialize product for several different supply chains and individual country regulations is both costly and puts patients at risk if it does not work smoothly. Using global standards to implement serialization systems protects the product and patients.

The more industry members learn from and communicate with each other, the more all of us can anticipate success in implementing global secure supply chain standards. Countries around the world are looking to the U.S. for insight on how to craft their own regulations as we work through realizing the benefits of DQSA, DSCSA and other legislation. Together, we must be forward-thinking and communicative with regulators, manufacturers, wholesalers, repackagers, distributors, health systems and pharmacies as, regardless of the countries in which we operate, we share one common goal: to deliver safe, efficient and accessible patient care. 

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Heather Zenk is vice president, secure supply chain at AmerisourceBergen Corporation. In this role, she is responsible for developing and implementing traceability business processes and technology that will enhance patient safety, further secure the pharmaceutical supply chain and create broader service offerings to manufacturer partners and AmerisourceBergen customers.