The Drug Supply Chain Security Act (DSCSA) Interoperability Pilot demonstrates how blockchain technology can be used to effectively track and trace certain prescription drugs throughout the supply chain. The visibility offered by blockchain makes it easier for pharmaceutical supply chain actors to comply with with the DSCSA (a U.S. law that goes into effect in 2024), prevent the distribution of counterfeit drugs, facilitate the drug recall process and more.
In December 2019, KPMG, Merck, Walmart and IBM completed the Drug Supply Chain Security Act (DSCSA) Interoperability Pilot as part of the U.S. Food and Drug Administration (FDA) DSCSA Pilot Project Program. The pilot’s findings demonstrate that leveraging blockchain technology can significantly reduce the time needed to trace a prescription drug — from up to 16 weeks to two seconds.
The current state of healthcare and the DSCSA
The healthcare industry continues to change rapidly, but its legacy issues remain and manifest in new ways. Though more information is available and accessible than ever before, counterfeiting continues to plague the industry.
These are but a subset of the issues that healthcare supply chains face in the context of rapid urbanization, aging global populations and increasing cost pressures.
The Drug Supply Chain Security Act (DSCSA), which was enacted in 2013 by the FDA and will be implemented in phases over the next decade, reflects the U.S. government’s increasing focus on these challenges and the essential need for visibility into the end-to-end pharmaceutical supply chain. The law requires supply chain stakeholders to digitally track and trace certain prescription drugs and their distribution within the U.S.
The FDA DSCSA Interoperability Pilot
IBM and its partners completed work for the FDA Drug Supply Chain Security Act (DSCSA) Interoperability Pilot, and aim to formally launch and scale the blockchain-enabled solution to streamline and facilitate DSCSA compliance for pharmaceutical supply chain stakeholders. To comply with the DSCSA, organizations must be able to digitally verify a drug product and its journey through the end-to-end supply chain. The pilot application uses blockchain technology to digitally store pharmaceutical product profiles and track and trace products at the serialized unit level from the point of manufacture to the point of dispense.
In addition to supply chain visibility, the pilot leverages blockchain to strengthen the protection of patients and patient safety. The application allows users the ability to quickly and effectively identify, investigate, and communicate about a relevant suspect or illegitimate drug product. This eliminates data siloes between supply chain actors and has strong potential to improve and expedite the drug recall process.
The Pharmaceutical Utility Network (PhUN)
The FDA DSCSA Interoperability Pilot represents the first application to be released on the PhUN platform. PhUN takes an open source platform-first approach — a similar concept to the Apple App Store — to empower stakeholders to comply with regulations and to use them as the basis for innovation. At scale, PhUN will integrate regulatory requirements such as the DSCSA into the platform, allowing solution developers — pharmaceutical manufacturers, distributors, dispensers, software vendors and others — to comply with ease.
This transformation of the compliance process allows innovators to focus on using the data now available to them to fuel the creation and deployment of new, cutting-edge applications onto the platform, leading to new business capabilities, business relationships and eventually business models.
PhUN is currently working with initial participants to explore five pharmaceutical industry problem areas:
- Regulatory compliance
- Cold chain efficiency
- Drug shortages
- Drug recalls
- Clinical trials
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