Sylim Patrick, Liu Fang, Marcelo Alvin, Fontelo Paul
National Library of Medicine, National Institutes of Health, Bethesda, MD, United States.
Standards and Interoperability Lab for Asia, University of the Philippines, Manila, Philippines.
JMIR Res Protoc. 2018 Sep 13;7(9):e10163. doi: 10.2196/10163.
Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network.
This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network.
We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal.
Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type-specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history.
Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability.
RR1-10.2196/10163.
药品造假是一个全球性问题，给消费者和公众带来重大风险。在菲律宾，2003年接受检查的药店中有30%被发现存在不合格/假冒/标签错误/伪造/仿冒药品。这给民众的药品支出以及政府带来了沉重的经济负担。菲律宾食品药品监督管理局（FDA）鼓励公众检查产品注册证书，并举报任何造假行为。菲律宾国家警察通过一个特别工作组对这类举报做出回应。然而，尚未发现有关其对这类药品分销影响的文献。区块链技术是一种加密账本，据称通过重复的顺序哈希是不可变的，并且通过共识算法具有容错能力。该项目将开发并测试一个药品监测区块链系统，该系统将支持沿官方药品分销网络的信息共享。
本研究旨在开发一个药品监测区块链系统，并在模拟网络中测试其功能。
我们正在开发一个将在智能合约上运行的分布式应用程序（DApp），采用Swarm作为分布式文件系统（DFS）。将开发两个实例：一个用于以太坊，另一个用于超级账本 Fabric。以太坊的工作量证明（PoW）共识算法将被修改为委托权益证明（DPoS）或实用拜占庭容错（PBFT）共识算法，因为它具有可扩展性且适合药品供应链环境。该系统将采用GS1谱系标准，并将满足美国FDA数据标准化指南中的数据点。模拟将使用以下5个节点：FDA、制造商、批发商、零售商和消费者门户。
开发工作正在进行中。系统设计将使FDA处于监督数据验证角色，每种谱系类型特定的数据源发挥主要数据验证作用。供应链流程将由制造商启动，对每笔交易进行递归验证。它将允许消费者扫描购买收据上打印的代码以查看药品分销历史。
开发和测试将在模拟网络中进行，因此结果可能与实际情况不同。所提议的项目具有颠覆性；一旦经过测试，团队打算与菲律宾FDA讨论实施计划并制定政策以促进采用和可持续性。
RR1 - 10.2196/10163
