Because blockchain maintains, records and authenticates data and transactions, it offers considerable potential as a means to improve security within pharmaceutical supply chains. Products are assigned unique identifiers which enable their entire history to be captured as they move to the end customer, and since stakeholders validate this information in real time, they would know if anyone tried to tamper with, alter or erase a record. This traceability, as two new studies show, could also be used to help prevent the flow of counterfeit medicines.
The first report, from DHL and Accenture, includes initial findings on a working prototype which tracks pharmaceuticals from the point of origin to the consumer, preventing tampering and errors. The companies created the blockchain-based serialization prototype with nodes in six geographies to track pharmaceuticals throughout the supply chain. The ledger tracking these medicines may be shared with stakeholders, including manufacturers, warehouses, distributors, pharmacies, hospitals and doctors. Lab-simulations show that blockchain could handle more than seven billion unique serial numbers and 1,500 transactions per second, the companies explain.
“We see especially exciting potential for blockchain in pharmaceuticals, which is why we focused our proof-of-concept with Accenture on the life sciences and healthcare industry,” says Keith Turner, CIO Chief Development Office, DHL Supply Chain. “By using the inherent irrefutability within blockchain technologies, we can make great strides in highlighting tampering—reducing the risk of counterfeits and actually saving lives.”
Another group working on a project to test the potential use of blockchain to “establish security and trust between trading partners” in U.S. pharmaceutical supply chains has also recently reported its first findings. The project—conducted by the Center for Supply Chain Studies—was created to establish the feasibility of incorporating blockchain into the Drug Supply Chain Security Act (DSCSA), which requires data to be generated on the movement of medicines from manufacturer to dispenser when it is fully implemented in 2023. It also will require the ability to share that data with other parties and authorized bodies. This interoperable tracking will be required at the package level, and existing advance shipping notices will likely become obsolete.
“We gained incredibly valuable data and insight from the simulated Reference Models we developed in Phase 1,” Bob Celeste, the center’s founder, says. “As an exploratory study, we experimented with the nuances of the supply chain, the DSCSA and blockchain to see how they may all fit together. The contribution of supply chain stakeholders and solution providers on the team created a rich environment that allowed us to test ideas and explore new ways to address drug traceability. Based on the success of Phase 1, it’s time to take these findings out of the virtual environment and show the industry and regulators that they may indeed hold up under real-world conditions.”
Using current blockchain technologies, database platforms and intelligence gleaned from “Phase 1”, the study, “DSCSA & Blockchain Phase 2: Proof of Concept”, will develop proof-of-concept pilots to demonstrate blockchain’s viability for the pharmaceuticals supply chain, Celeste says. Working scenarios include trading partner methods, data governance, data-persistence and other processes.
There is a clear need to address the problem of counterfeit medicine. According to Interpol, as many as one million lives are lost each year due to use of counterfeit medications, and it’s estimated that as much as up to 30 percent of pharmaceutical products sold in emerging markets are counterfeit. However, as DHL and Accenture note, moving from concepts and pilot applications to actually deploying viable solutions will require: the technology to be further developed, organizational transformation and a willingness among all stakeholders to collaborate. Success will depend on all parties working together, so it will be interesting to watch future tests and research.
What are your thoughts on the possible use of blockchain for the pharmaceutical supply chain?