The Last Mile: DSCSA Solution Through Blockchain Technology: Drug Tracking, Tracing, and Verification at the Last Mile of the Pharmaceutical Supply Chain with BRUINchain

Abstract

Purpose: As part of the FDA’s DSCSA Pilot Project Program, UCLA and its solution partner, LedgerDomain (collectively referred to as the team hereafter), focused on building a complete, working blockchain-based system, BRUINchain, which would meet all the key objectives of the Drug Supply Chain Security Act (DSCSA) for a dispenser operating solely on commercial off-the-shelf (COTS) technology.
 Methods: The BRUINchain system requirements include scanning the drug package for a correctly formatted 2D barcode, flagging expired product, verifying the product with the manufacturer, and quarantining suspect and illegitimate products at the last mile: pharmacist to patient, the most complex area of the drug supply chain.
 The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States.
 Results: In addition to communicating with the manufacturer directly for verification, BRUINchain also initiated suspect product notifications. During the study, a 100% success rate was observed across scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute.
 The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States.
 
 Conclusions: By automatically interrogating the manufacturer’s relational database with our blockchain-based system, our results indicate a projected DSCSA compliance cost of 17 cents per unit, and potentially much more depending on regulatory interpretation and speed of verification. We project that this cost could be reduced with manufacturers’ adoption of a highly performant, fully automated end-to-end system based on digital ledger technology (DLT). In an examination of the interoperability of such a system, we elaborate on its capacity to enable verification in real time without a human in the loop, the key feature driving lower compliance cost. With 4.2 billion prescriptions being dispensed each year in the United States, DLT would not only reduce the projected per-unit cost to 13 cents per unit (saving $183 million in annual labor costs), but also serve as a major bulwark against bad or fraudulent transactions, reduce the need for safety stock, and enhance the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

TCMQMS System: A digital twin and blockchain-based platform for tracing the whole process of Chinese medicine quality information

“…The focus is on drug traceability, decentralised establishment and quality control (Mettler, 2016). In order to enable accurate monitoring of drugs in the "last mile", William Chien proposed the BRUINchain system as a way to improve quality control in the drug delivery chain (Chien et al, 2020). Blockchain technology is proposed to be used for inspection and pre-market evaluation of new drugs as well as to combat counterfeit drugs in less developed regions and ultimately to protect consumer rights.…”

Evaluation of Decentralized Verifiable Credentials to Authenticate Authorized Trading Partners and Verify Drug Provenance

“…Users generate and hold their own private keys, and master National Drug Code (NDC) data are held locally on the client. Leveraging prior work with UCLA Health and Biogen (16), the Oraculous Interoperability Service unlocks interoperability between existing relational database management systems and hosted nodes of the distributed ledger (17). In this way, verification requests can be submitted, routed, and processed without the need for verifying organizations to provision their own nodes.…”

The Health Care Sector’s Experience of Blockchain: A Cross-disciplinary Investigation of Its Real Transformative Potential

“…The Food and Drug Administration has actively encouraged these applications by launching a pilot project (announced in February 2019) to encourage drug supply chain stakeholders to develop digital systems to comply with the Drug Supply Chain Security Act 2013, which mandates the creation of an electronic, interoperable system that can trace and identify distributed prescription drugs across the United States. It attracted 26 participants (including several pharmaceutical supply chain stakeholders [59,60]), generating a variety of projects. These include the MediLedger Project, which sought to build a blockchain network around a tamper-proof ledger of pharmaceutical supply-chain transactions to inform responses to product ID verification requests communicated via a permissioned messaging network [61].…”