RESUMO
Summary: In 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law to address the growing threat of counterfeit drugs and to ensure prescription drugs remain safe and effective for patients. As part of this law, US pharmaceutical supply chain stakeholders are required to confirm the authorized status of trading partners for transactions and information disclosures, even when there is no prior business relationship. While larger Authorized Trading Partners (ATPs) have connectivity solutions in place, newer and smaller ATPs have not traditionally participated, including tens of thousands of dispensers. To unlock the full potential of the interoperable system mandated by the DSCSA, the authors tested eXtended ATP (XATP), a blockchain-backed framework for ATP authentication and enhanced verification in a real-world pharmacy with genuine drug packages. The objective of this research study was to prove that electronic authentication and enhanced verification can be achieved between ATPs using a mobile-based solution. Moreover, we tested accurate reading of drug and associated electronic med guides, flagging of expired and recalled drugs, and correct generation of documentation to support saleable returns. Methods: This study involved two dispensers and three participating manufacturers. Dispensers were onboarded to a mobile application and used supporting documentation to authenticate their identities, and then scanned 2D drug barcodes to submit drug verification requests to manufacturers (including 11 additional, randomly selected manufacturers). Genuine and synthetic drug package barcodes were used to test workflows against genuine and synthetic manufacturer serialization data records. Manufacturers authenticated the identity of requesting dispensers with verifiable credentials and responded to verification requests. Results: Enhanced drug verification was achieved, with 100% of requests successfully delivered to participating manufacturers and 88% of requests being delivered to other manufacturers (based on the pharmacist selection of random packages from the pharmacy). Drug verification matching against synthetic serialization data records resulted in 86% accuracy, with the 14% error rate attributed to human factors. All barcodes were successfully scanned and provided package-accurate data, and 97% of randomly selected packages successfully generated drug package inserts. All synthetic recalls and expired drugs were successfully flagged. Four of the manufacturers contacted were among the top 15 pharmaceutical manufacturers globally; all four responded. Conclusions: The XATP framework provides a secure, reliable, and seamless remote method to conduct enhanced verification as required by law. Interoperability between manufacturers and dispensers with no prior business relationship can be achieved on 'day zero' using mobile devices that enable digital authentication and rapid barcode scanning. As users retain control of their own private keys, the framework also mitigates the single-point-of-attack risks associated with centrally managed systems.
RESUMO
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 products, 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 using 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 for scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute. 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). During an examination of the interoperability of such a system, we elaborate on its capacity to enable verification in real time without keeping humans 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 US consumers.
