未经批准:作为FDA的DSCSA试点项目计划的一部分,加州大学洛杉矶分校及其解决方案合作伙伴,LedgerDomain(以下统称为团队),专注于建立一个完整的,基于区块链的工作系统,BRUINchain,这将满足药品供应链安全法案(DSCSA)的所有关键目标,用于仅使用商业现成(COTS)技术操作的分配器。
UNASSIGNED:BRUINchain系统要求包括扫描药物包装以获取格式正确的2D条形码,标记过期产品,向制造商验证产品,在最后一英里隔离可疑和非法产品:药剂师对病人,药品供应链中最复杂的领域。作者展示了一个成功的实施,其中产品跟踪通知自动发送给关键利益相关者,提高了及时性,减轻了文书工作负担。这项工作的核心是基于区块链的解决方案,以跟踪和追踪药物保管方面的变化。作为一个不可变的,时间戳,近实时(50毫秒延迟),可审计的交易记录,BRUINchain使供应链社区有可能获得单一版本的真相。BRUINchain在美国最繁忙的药店之一使用真实护理人员向真实患者提供救生药物的真实数据进行了测试。
UNASSIGNED:除了直接与制造商沟通以进行验证之外,BRUINchain还启动了可疑产品通知。在研究期间,观察到100%的扫描成功率,过期检测,和伪造检测;文书工作从大约1小时减少到不到一分钟。
UNASSIGNED:通过使用我们基于区块链的系统自动询问制造商的关系数据库,我们的结果表明,预计DSCSA合规成本为每台17美分,而且可能更多取决于监管解释和验证速度。我们预计,通过制造商采用高性能产品,可以降低成本,基于数字分类帐技术(DLT)的全自动端到端系统。在检查这种系统的互操作性时,我们详细阐述了它能够实时验证而不会让人类陷入困境的能力,推动降低合规成本的关键功能。美国每年发放42亿张处方,DLT不仅将预计的单位成本降低到每单位13美分(每年节省1.83亿美元的劳动力成本),但也是防止不良或欺诈交易的主要堡垒,减少对安全库存的需求,并加强对药品供应链中潜在危险药物的检测和清除,以保护美国消费者。
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.