The Center for Supply Chain Studies is working on its next round of research to explore how blockchain-based distributed ledger technology can be used to enhance and improve the pharmacy supply chain.

The organization is putting together teams for two studies and is actively seeking members to participate. The two studies are "DSCSA & Blockchain: Phase 2, Proof of Concept" and "Blockchain for the Cold Chain." DSCSA stands for 2013's Drug Supply Chain Security Act.

The "DSCSA & Blockchain: Phase 2, Proof of Concept" study follows on the heels of the organization's Phase 1 research, in which supply chain stakeholders – manufacturers, wholesalers, returns processors, retail pharmacies, hospital pharmacies, track and trace system vendors, blockchain solution companies, master data management system companies and regulators – created ReferenceModels, or supply chain simulations, to explore the use of blockchain technology within the pharmaceutical supply chain for the purposes of meeting 2023 requirements of the DSCSA.

[Also: The next big thing in pharmacy supply chain: Blockchain]

The ReferenceModels helped the organization account for and manage the complexity of the supply chain, blockchain technology and the law while experimenting with many ways to make it all work together.

"The Phase 2, proof of concept pilots study builds on that body of knowledge to take the ReferenceModels out of simulation and into limited pilots using actual blockchain technology," said Bob Celeste, founder of the Center for Supply Chain Studies. "So far, seven proof of concept teams have formed within the overall study team. Each proof of concept team is exercising concepts and ideas that were defined and simulated in phase 1."

The goal, he said, is to capture the pilot example and hold an event (April 30 to May 1) to perform structured walkthroughs of each proof of concept pilot and their findings. Proof of concept teams may exercise simple concepts, such as "How does a company connect with the proposed industry blockchain," or more complex concepts and scenarios such as "Establishing trust between non-adjacent trading partners" or a "Manufacturer to wholesaler to a second wholesaler to dispenser" transition.

"Blockchain technology may hold a key to establishing a trusted network of information that both industry partners and regulators can rely on to aid in maintaining the security of the legitimate supply chain and thwarting the behavior of nefarious players," said Celeste. "Proof of concept pilots will demonstrate the concepts that we have previously only viewed through the lens of our simulations.

"The pilots," he added, "may also be able to provide insights into scalability, platform response times, latency, and interoperability between different solutions."

The authors of the 2013 DSCSA law showed foresight by specifically including in the law a requirement for pilots and re-examination of the challenges in the supply chain and advances in supply chain practices and technology, said Celeste. The capabilities of blockchain technology might move the industry from sharing, evaluating and storing vast amounts of transactions to being able to achieve consensus on the interpretation of the transactions by establishing a current state for each item in the supply chain, he explained.

"This reduces risk and allows a more efficient and cost-effective process for all stakeholders, including the regulators," he said.

Participants in the study so far include manufacturers, wholesalers, returns processors, retail dispensers, hospital dispensers, regulators, wholesaler associations, pharmacist associations, pharmacy systems associations, product master data management services, track and trace system vendors, blockchain solution companies, consultancies, universities and invited experts.

"The goal of this study is twofold: First, to take the next step toward an implementable solution that works for all stakeholders; and second, to start a broader discussion on a way to achieve the overall goals of DSCSA while also providing a new way for supply chain partners to do business and exchange all sorts of data securely and confidentially," Celeste said.

Readers interested in participating in the study can contact the organization through its website, www.c4scs.org,
or they can contact Director of Study Participation Christina Scordia at cscordia@c4scs.org.

New research sought for temp-controlled environments

As for the "Blockchain for Cold Chain Study," The foundation of this study is to explore how the industry might extend the use of the architecture outlined in the DSCSA and Blockchain Phase 1 Study to manage temperature data collected from stationary or mobile temperature controlled environments, sensors, indicators and temperature controlled packaging configurations.

"We will first look to manage trading partner assertations as to whether the products have been maintained properly – or whether there is data to suggest that there has been an excursion – then we will experiment with ways of connecting temperature monitoring data with trading partners," Celeste said. "And lastly, we will explore if it's possible to coalesce this disparate data into an electronic signal or assessment of the product, from a temperature control perspective."

In the DSCSA and Blockchain Phase 1 Study, the Center for Supply Chain Studies realized that the interconnectivity, immutability and programmability of blockchain could have value beyond DSCSA. The organization polled its subscribers and a number of challenges were identified. Providing proper signals and data within the temperature sensitive (cold chain) industry was one of the highest valued concerns.

"Using ReferenceModels, simulations, we will explore the cold chain supply chain, technology and data sets and apply blockchain features to provide a common signal when excursions occur and an architecture where temperature questions can be asked and answered and temperature data can be exchanged between trading partners and solution providers," Celeste explained.

Participants in this study include the exact same kinds of participants in the "DSCA & Blockchain: Phase 2, Proof of Concept" study.

There are two challenges the organization is attempting to address the cold chain study. First, how to use blockchain technology to address the issues in cold chain operations through the supply chain. The center believes its previous studies have already shown the way and the center will be adjusting that work to address temperature data.

"The larger challenge is how to make use of disparate temperature data sets to tell the temperature story of an item as it transmits the supply chain," Celeste said. "The goal is to explore the cold chain process and demonstrate the use of industry blockchain to connect stakeholders and share alerts and data sets."

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com