Blockchain for drug traceability: Architectures and open challenges

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.

[1]  T. Mackey,et al.  The global counterfeit drug trade: patient safety and public health risks. , 2011, Journal of pharmaceutical sciences.

[2]  E. Rosenthal The "gray market" raises concerns about cost, safety, and ethics. , 2012, Journal of the National Cancer Institute.

[3]  Wook Park,et al.  Lithographically Encoded Polymer Microtaggant Using High‐Capacity and Error‐Correctable QR Code for Anti‐Counterfeiting of Drugs , 2012, Advanced materials.

[4]  R. Parker,et al.  Routledge Handbook of Global Public Health , 2012 .

[5]  A. Stergachis,et al.  Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries , 2014, PloS one.

[6]  R. Hemalatha,et al.  Electronic solutions for combating counterfeit drugs , 2015, Journal of pharmacy & bioallied sciences.

[7]  Weihua Zhou,et al.  A design method for supply chain traceability systems with aligned interests , 2015 .

[8]  Tim K. Mackey,et al.  After counterfeit Avastin®—what have we learned and what can be done? , 2015, Nature Reviews Clinical Oncology.

[9]  Fiona Clark,et al.  Rise in online pharmacies sees counterfeit drugs go global , 2015, The Lancet.

[10]  Juan M. Santos-Gago,et al.  Towards a cost-effective and reusable traceability system. A semantic approach , 2016, Comput. Ind..

[11]  T. Mackey,et al.  The disease of corruption: views on how to fight corruption to advance 21st century global health goals , 2016, BMC Medicine.

[12]  B. Venhuis,et al.  Operation resistance: A snapshot of falsified antibiotics and biopharmaceutical injectables in Europe. , 2016, Drug testing and analysis.

[13]  Christian Cachin,et al.  Architecture of the Hyperledger Blockchain Fabric , 2016 .

[14]  Burkhard Stiller,et al.  Blockchains everywhere - a use-case of blockchains in the pharma supply-chain , 2017, 2017 IFIP/IEEE Symposium on Integrated Network and Service Management (IM).

[15]  Krishnashree Achuthan,et al.  Trace and track: Enhanced pharma supply chain infrastructure to prevent fraud , 2017 .

[16]  Mark Mohammad Tehranipoor,et al.  A split manufacturing approach for unclonable chipless RFIDs for pharmaceutical supply chain security , 2017, 2017 Asian Hardware Oriented Security and Trust Symposium (AsianHOST).

[17]  Ijazul Haq,et al.  Blockchain Technology in Pharmaceutical Industry to Prevent Counterfeit Drugs , 2018 .

[18]  Birgit Clark,et al.  Blockchain, IP and the pharma industry—how distributed ledger technologies can help secure the pharma supply chain , 2018 .

[19]  Hyong S. Kim,et al.  Smartsupply: Smart Contract Based Validation for Supply Chain Blockchain , 2018, 2018 IEEE International Conference on Internet of Things (iThings) and IEEE Green Computing and Communications (GreenCom) and IEEE Cyber, Physical and Social Computing (CPSCom) and IEEE Smart Data (SmartData).

[20]  Aiqing Zhang,et al.  Towards Secure and Privacy-Preserving Data Sharing in e-Health Systems via Consortium Blockchain , 2018, Journal of Medical Systems.

[21]  Marko Vukolic,et al.  A Byzantine Fault-Tolerant Ordering Service for the Hyperledger Fabric Blockchain Platform , 2018, DSN.

[22]  Jen-Hung Tseng,et al.  Governance on the Drug Supply Chain via Gcoin Blockchain , 2018, International journal of environmental research and public health.

[23]  Marko Vukolic,et al.  Hyperledger fabric: a distributed operating system for permissioned blockchains , 2018, EuroSys.

[24]  Praneeth Babu Marella,et al.  Ancile: Privacy-Preserving Framework for Access Control and Interoperability of Electronic Health Records Using Blockchain Technology , 2018 .

[25]  David Swanson,et al.  The Supply Chain Has No Clothes: Technology Adoption of Blockchain for Supply Chain Transparency , 2018 .

[26]  Yury Yanovich,et al.  Converging blockchain and next-generation artificial intelligence technologies to decentralize and accelerate biomedical research and healthcare , 2015, Oncotarget.

[27]  Marko Hölbl,et al.  A Systematic Review of the Use of Blockchain in Healthcare , 2018, Symmetry.

[28]  V. Plotnikov,et al.  The Prospects for the Use of Digital Technology “Blockchain” in the Pharmaceutical Market , 2018 .

[29]  Alysson Bessani,et al.  A Byzantine Fault-Tolerant Ordering Service for the Hyperledger Fabric Blockchain Platform , 2017, 2018 48th Annual IEEE/IFIP International Conference on Dependable Systems and Networks (DSN).

[30]  Stephen Lee,et al.  FastFabric: Scaling Hyperledger Fabric to 20,000 Transactions per Second , 2019, 2019 IEEE International Conference on Blockchain and Cryptocurrency (ICBC).

[31]  Ronaldo Vieira da Silva,et al.  Critical Success Factors of a Drug Traceability System for Creating Value in a Pharmaceutical Supply Chain (PSC). , 2019, International journal of environmental research and public health.

[32]  Ronaldo da Silva,et al.  Critical Success Factors of a Drug Traceability System for Creating Value in a Pharmaceutical Supply Chain (PSC) , 2019, International Journal of Environmental Research and Public Health.