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      Securing the Chain of Custody and Integrity of Data in a Global North–South Partnership to Monitor the Quality of Essential Medicines

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          Abstract

          Substandard and falsified (SF) pharmaceuticals account for an estimated 10% of the pharmaceutical supply chain in low- and middle-income countries (LMICs), where a lack of regulatory and laboratory resources limits the ability to conduct effective post-market surveillance and allows SF products to penetrate the supply chain. The Distributed Pharmaceutical Analysis Laboratory (DPAL) was established in 2014 to expand testing of pharmaceutical dosage forms sourced from LMICs; DPAL is an alliance of academic institutions throughout the United States and abroad that provides high-quality, validated chemical analysis of pharmaceutical dosage forms sourced from partners in LMICs. Results from analysis are reported to relevant regulatory agencies and are used to inform purchasing decisions made by in-country stakeholders. As the DPAL program has expanded to testing more than 1,000 pharmaceutical dosage forms annually, challenges have surfaced regarding data management and sample tracking. Here, we describe a pilot project between DPAL and ARTiFACTs that applies the blockchain to organize and manage key data generated during the DPAL workflow, including a sample’s progress through the workflow, its physical location, provenance of metadata, and lab reputability. Recording time and date stamps with these data will create a permanent and verifiable chain of custody for samples. This secure, distributed ledger will be linked to an easy-to-use dashboard, allowing stakeholders to view results and experimental details for each sample in real time and verify the integrity of DPAL analysis data. Introducing this blockchain-based system as a pilot will allow us to test the technology with real users analyzing real samples. Feedback from users will be recorded and necessary adjustments will be made to the system before the implementation of blockchain across all DPAL sites. Anticipated benefits of implementing the blockchain technology for managing DPAL data include efficient management for routing work, increasing throughput, creating a chain of custody for samples and their data in alignment with the distributed nature of DPAL, and using the analysis results to detect patterns of quality within and across brands of products and develop enhanced sampling techniques and best practices.

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          Most cited references18

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          Blockchain distributed ledger technologies for biomedical and health care applications

          Abstract Objectives To introduce blockchain technologies, including their benefits, pitfalls, and the latest applications, to the biomedical and health care domains. Target Audience Biomedical and health care informatics researchers who would like to learn about blockchain technologies and their applications in the biomedical/health care domains. Scope The covered topics include: (1) introduction to the famous Bitcoin crypto-currency and the underlying blockchain technology; (2) features of blockchain; (3) review of alternative blockchain technologies; (4) emerging nonfinancial distributed ledger technologies and applications; (5) benefits of blockchain for biomedical/health care applications when compared to traditional distributed databases; (6) overview of the latest biomedical/health care applications of blockchain technologies; and (7) discussion of the potential challenges and proposed solutions of adopting blockchain technologies in biomedical/health care domains.
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            Governance on the Drug Supply Chain via Gcoin Blockchain

            As a trust machine, blockchain was recently introduced to the public to provide an immutable, consensus based and transparent system in the Fintech field. However, there are ongoing efforts to apply blockchain to other fields where trust and value are essential. In this paper, we suggest Gcoin blockchain as the base of the data flow of drugs to create transparent drug transaction data. Additionally, the regulation model of the drug supply chain could be altered from the inspection and examination only model to the surveillance net model, and every unit that is involved in the drug supply chain would be able to participate simultaneously to prevent counterfeit drugs and to protect public health, including patients.
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              A review of existing and emerging digital technologies to combat the global trade in fake medicines.

              The globalization of the pharmaceutical supply chain has introduced new challenges, chief among them, fighting the international criminal trade in fake medicines. As the manufacture, supply, and distribution of drugs becomes more complex, so does the need for innovative technology-based solutions to protect patients globally. Areas covered: We conducted a multidisciplinary review of the science/health, information technology, computer science, and general academic literature with the aim of identifying cutting-edge existing and emerging 'digital' solutions to combat fake medicines. Our review identified five distinct categories of technology including mobile, radio frequency identification, advanced computational methods, online verification, and blockchain technology. Expert opinion: Digital fake medicine solutions are unifying platforms that integrate different types of anti-counterfeiting technologies as complementary solutions, improve information sharing and data collection, and are designed to overcome existing barriers of adoption and implementation. Investment in this next generation technology is essential to ensure the future security and integrity of the global drug supply chain.
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                Author and article information

                Journal
                Blockchain Healthc Today
                Blockchain Healthc Today
                BHTY
                Blockchain in Healthcare Today
                Partners in Digital Health
                2573-8240
                22 March 2022
                2022
                : 5
                : 10.30953/bhty.v5.230
                Affiliations
                [1 ]Department of Chemistry and Biochemistry, University of Notre Dame, Indiana, USA
                [2 ]Lucy Family Institute for Data & Society, University of Notre Dame, Indiana, USA
                [3 ]Center for Research Computing, University of Notre Dame, Indiana, USA
                [4 ]Department of Pharmaceutical Chemistry, School of Pharmacy, College of Health Sciences, Addis Ababa University, Ethiopia
                [5 ]Department of Chemistry, Roanoke College, Salem, Virginia, USA
                [6 ]ARTiFACTS, Cambridge, Massachusetts, USA
                Author notes
                Corresponding author: Kathleen Hayes, Email: Khayes5@ 123456nd.edu
                Author information
                https://orcid.org/0000-0003-1217-0050
                https://orcid.org/0000-0001-6441-6716
                https://orcid.org/0000-0001-8214-7177
                https://orcid.org/0000-0003-2505-899X
                https://orcid.org/0000-0003-2212-9684
                https://orcid.org/0000-0003-3968-8044
                https://orcid.org/0000-0002-3331-2751
                Article
                230
                10.30953/bhty.v5.230
                9907419
                ea7c2b89-69a1-4c24-8010-a477bf756293
                © 2022 The Authors.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License, allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material for any purpose, even commercially, provided the original work is properly cited and states its license.

                History
                : 16 December 2021
                : 21 December 2021
                : 21 February 2021
                Categories
                Proof of Concept/Pilots/Methodologies

                analytical chemistry,blockchain,ledger,pharmaceutical,quality of medicine,supply chain

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