Understanding Blockchain for DSCSA Compliance

By Heather Zenk |

What is blockchain? How it could be used by the healthcare industry? Explore the fundamentals and learn the potential use of blockchain technology to achieve DSCSA compliance. 
The Drug Supply Chain Security Act (DSCSA) mandates complete traceability of pharmaceutical products across the national supply chain, from manufacturers to pharmacies, by the year 2023. By then, 10 years will have passed since the law was written and enacted. Today, at the halfway point, the industry is exploring how emerging technologies could enable greater traceability and verification of products through more secure data transparency.  

Blockchain, originally created for use with the digital currency Bitcoin, is now revolutionizing how the world is accessing and utilizing data. It’s a term many have heard, but few fully understand. What more healthcare stakeholders are beginning to realize is that blockchain has the potential to change how data is shared across the pharmaceutical supply chain. 

Defining Blockchain
Blockchain fundamentally stores “blocks” of information in a way that is permanent and unalterable. With each transaction, a new “block” of data is added to the blockchain. Blockchain decentralizes data storage by connecting and duplicating digital information across a network where it is available to anyone with access. The information contained is then continually reconciled across the network. And because the data is not stored in any one single location, it cannot be manipulated or corrupted. 

With the full implementation of DSCSA on the horizon, the pharmaceutical industry is exploring innovative solutions to harness blockchain’s data-sharing benefits across the supply chain.  

Blockchain in DSCSA
The industry continues to invest heavily to comply with DSCSA and secure the supply chain through the identification and tracking of medications that move through it. One of the reasons blockchain is enticing is that it is more secure than current environments. 

AmerisourceBergen started looking at blockchain for DSCSA in preparation for exchanging serialized data with manufacturers and pharmacies because of its capability for validating the authenticity of a product. The data privacy requirements of the pharmaceutical industry can be met using “zero knowledge proof” technology, developed for the healthcare industry above “base level” blockchain technology, where all transactions posted to the blockchain are fully encrypted - ensuring no confidential information is shared. 

Ultimately, the successful use of blockchain technology for DSCSA compliance will require collaboration and adoption from all industry stakeholders including pharmaceutical manufacturers, wholesalers, dispensers, service providers and others. 

Blockchain Across Healthcare
In the future, evolving technologies have the potential to dramatically disrupt and meaningfully advance the systems and processes that have defined the healthcare industry. Within healthcare there are myriad additional business applications in which blockchain can be leveraged. Data sharing for electronic health records, clinical trials or other medical research could be advanced through blockchain technology as could benefit verification, claims processing or prior authorizations. 

Shared data has value.  Blockchain enhances this by breaking down the barriers around equal sharing, while still allowing participants to create business rules regarding whom and how much data they want to share. Blockchain isn’t a cure-all, it’s a mind shift. It offers the potential to try a different, innovative solution that could ultimately improve care through the secure sharing of information.  

About the Author

Heather Zenk

Heather Zenk

Vice President, Global Secure Supply Chain Operations
AmerisourceBergen
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