Khalifa University, UAE.
Arizona State University, USA.
Health Informatics J. 2021 Apr-Jun;27(2):14604582211011228. doi: 10.1177/14604582211011228.
Pharmaceutical supply chain (PSC) consists of multiple stakeholders including raw material suppliers, manufacturers, distributors, regulatory authorities, pharmacies, hospitals, and patients. The complexity of product and transaction flows in PSC requires an effective traceability system to determine the current and all previous product ownerships. In addition, digitizing track and trace process provides significant benefit for regulatory oversight and ensures product safety. Blockchain-based drug traceability offers a potential solution to create a distributed shared data platform for an immutable, trustworthy, accountable and transparent system in the PSC. In this paper, we present an overview of product traceability issues in the PSC and envisage how blockchain technology can provide effective provenance, track and trace solution to mitigate counterfeit medications. We propose two potential blockchain based decentralized architectures, Hyperledger Fabric and Besu to meet critical requirements for drug traceability such as privacy, trust, transparency, security, authorization and authentication, and scalability. We propose, discuss, and compare two potential blockchain architectures for drug traceability. We identify and discuss several open research challenges related to the application of blockchain technology for drug traceability. The proposed blockchain architectures provide a valuable roadmap for Health Informatics researchers to build and deploy an end-to-end solution for the pharmaceutical industry.
医药供应链（PSC）由多个利益相关者组成，包括原材料供应商、制造商、分销商、监管机构、药店、医院和患者。PSC 中产品和交易流程的复杂性要求建立有效的可追溯性系统，以确定当前和所有先前的产品所有权。此外，数字化跟踪和追溯流程为监管监督提供了显著的好处，并确保了产品的安全性。基于区块链的药品可追溯性为创建 PSC 中一个不可变、值得信赖、可问责和透明的分布式共享数据平台提供了一个潜在的解决方案。在本文中，我们概述了 PSC 中的产品可追溯性问题，并设想了区块链技术如何提供有效的来源和跟踪追溯解决方案，以减轻假药问题。我们提出了两种基于区块链的潜在去中心化架构，即 Hyperledger Fabric 和 Besu，以满足药品可追溯性的关键要求，如隐私、信任、透明度、安全性、授权和身份验证，以及可扩展性。我们提出、讨论和比较了两种用于药品可追溯性的潜在区块链架构。我们确定并讨论了与区块链技术在药品可追溯性中的应用相关的几个开放性研究挑战。所提出的区块链架构为医疗信息学研究人员为制药行业构建和部署端到端解决方案提供了有价值的路线图。
