The pharmaceutical industry is abuzz with concern over how to best meet the traceability requirements spelled out in the Drug Supply Chain Security Act (DSCSA).
Per the DSCSA, by Nov. 27, 2019 wholesale distributors will have to verify serialized product identifiers of saleable returned packages or sealed homogenous cases of product that are intended for further distribution (section 582(c)(4)(D)).
In 2018, a group of companies launched the MediLedger Project, which brings together major pharmaceutical manufacturers and distributors to create a collaborative network.
Heather Zenk, Vice President, Global Secure Supply Chain Operations at AmerisourceBergen, is a knowledgeable member of the working group. “Using blockchain, the project creates evolving solutions for track-and-trace regulations, and provides a step-function improvement in the overall operation of the supply chain,” she explains.
Part I highlighted the initiative, the role of blockchain and hurdles to overcome. Here Zenk discusses the role of regulators, the hurdles to overcome and the next steps for the project.
Q: Will regulators have access to the MediLedger platform or will the ledgers be used to show transaction data later, if needed? Will that be up to individual companies?
A: With the MediLedger platform, we anticipate manufacturers, distributors, health systems and pharmacies or any other party that could handle products to have access to data in a secure environment that does not allow visibility from unauthorized parties. Regulators would be able to request audits or request information, as needed, knowing those reports are authentic and reflective of data from across the supply chain. That is the promise of blockchain technology: to provide a platform where information, with the necessary context to interpret it meaningfully, can be shared securely.
It will be up to an individual company to determine how it establishes data access protocols. As a result, it is important that manufacturers take steps now to understand this emerging technology and how it works, the type of data that can be preserved and how to securely share it with the right parties. Manufacturers need to anticipate and understand regulators’ needs, so they can plan accordingly and build sufficient processes.
Q: What do you see is the biggest hurdle for the MediLedger Project at this point?
A: Anytime a new technology is introduced there are challenges associated with industry-wide adoption. The MediLedger Project is bringing together stakeholders to workshop solutions that enable more partners to implement blockchain technology ahead of upcoming DSCSA requirements. While many partners recognize the value of this new technology, it is critical that the barriers to entry, including the ability to migrate from an existing system to a new one, are as seamless as possible.
Ultimately, the successful use of blockchain technology for DSCSA compliance will require collaboration from all industry stakeholders including pharmaceutical manufacturers, wholesalers, dispensers, service providers and others. With education and a strong relationship with the partners that are working with this data on a daily basis, manufacturers can feel at ease as they make this transition.
Q: What are the next steps for the MediLedger platform’s industry adoption?
A: MediLedger will continue to advance and create governance for the industry as DSCSA deadlines approach. We will begin to see more testing within the system to ensure the technology is prepared to handle the data while maintaining the security required by partners.
While many members of the industry are already committed to the MediLedger platform, other members may choose to explore other partnerships. As a result, MediLedger will also develop the platform with gateways in place for other unaffiliated companies to interface and access the appropriate data they need.
Q: What’s a parting piece of advice for the industry?
A: With the full implementation of the DSCSA on the horizon, there are many benefits to harnessing blockchain’s data-sharing capabilities across the supply chain. But, it is critical that the industry also look downstream to the pharmacists, oncologists and other healthcare providers that will ultimately receive the products we are tracing. In our role, we are helping the entire supply chain prepare for the future. It will certainly help us be the best partner we can be as we strive to create healthier futures for patients.
Q: Much of pharmaceutical data is siloed among different systems within pharmaceutical companies and their trading partners. Are participating companies concerned about the shift itself, getting all this data into one place? Or is it more of a natural progression from serializing units and storing that data?
A: “In a billion-unit industry, some companies are eager to work within a platform that will break down silos while also keeping secure records of every transaction, while others are more apprehensive,” says Zenk. “Compliance with the anticipated DSCSA requirements has encouraged all companies to be mindful of how pharmaceutical products are traced throughout the supply chain with the proper serialization and secure storage of data.”
Zenk notes that while the size and scale may be daunting, AmerisourceBergen is committed to working with their partners to get them to meet upcoming DSCSA standards while also finding opportunities for improvement with emerging technology.