FDA Commissioner Gottleib recently stated at the February FDA Drug Supply Chain Security Act (DSCSA) public meeting that "Making sure that every link in the U.S. Drug Supply must be secure." and that, "Full implementation of the Drug Supply Chain Security Act, and reaching that milestone is a priority for all of us."
To that end, the pharmaceutical and healthcare industries are collaborating to define the future state of an interoperable secure drug supply chain using Blockchain technologies.
Achieving this goal is not without functional and technical issues. From a functional perspective, supply chain transactions and purchasing data related to buying behaviors of healthcare providers represents significant business intelligence value to industry participants. From a technical perspective, the number of U.S. pharmaceutical transaction in a given year (Billions), the number of industry participants (Hundreds of Thousands), and the capabilities of current blockchain technologies have created an environment representing significant challenges but also an outsized opportunity for healthcare in the United States.
The Serialized and interoperable U.S. drug supply chain will unlock new value in healthcare by providing inventory transparency, streamlining the drug recall process and reducing fraud. To this end, a cross-section of industry participants including manufacturers, wholesalers, drug dispensers and solutions providers are collaborating to pilot industry blockchain systems in the context of the non-profit Center For Supply Chain Studies DSCSA and Blockchain Phase 2 Study. The industry will get its first preview of the studies finding at the end of April during an industry meeting that brings together representatives from many regulatory, pharmaceutical and healthcare segments of the market. Blockchain and distributed ledger technology have the potential to redefine healthcare operations and enable hospital systems to capitalize on their scale and influence within the pharmaceutical supply chain. The regulatory mandates defined by FDA provides the industry with a framework for required capabilities in a defined timeline. Full implementation of DSCSA not only secures the drug supply chain and protects patients from counterfeit drugs but unlocks capabilities from a cost savings perspective previously unavailable in US Healthcare.
More information about the Center For Supply Chain Studies and their April event can be found on the web at their site: https://www.c4scs.org/
About the Author
Dwight deVera is an expert in disruptive analytics, leading-edge application development, and secure supply chain solutions. He is the founder and CEO of RXTransparent