United States

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 1000 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 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 this 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 blockchain 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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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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Focusing on health policy, telehealth and virtual care, blockchain and edge technologies, ConV2X 2021 is the premier destination community identifying new and cost effective paths forward through real world evidence, strategy, operations, research & trends.

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The Future of Patient-Centered mRPM

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Brian M. Thornley leads the global supply strategy from plant to patient. He oversees Merck’s digital supply chain strategy including blockchain enabled pharma, organization development and enterprise segmentation to optimize service, cost, earnings and return on capital employed. Previously, he was AVP Supply Chain Operations EMEA & AP, including Planning and Strategy for Merck MSD, developing the strategic approach to deliver internal efficiencies and external transformation of the supply chain from factories to end customer. Before joining MSD he was the COO of Aegate Ltd, implementing integrated data and information networks directly with pharmacies across Europe and the first commercial pharmaceutical authentication system across the European pharmacy network. Brian provided consultancy support to the PGEU, the representative body of pharmacies in Europe.

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Health Tech Analyst Commentary & Market Watch

The keynote highlights how rising healthcare costs, drivers of waste in the system, and an outdated infrastructure slow innovation and create a poor patient experience. A modern infrastructure that connects the healthcare ecosystem is needed to deliver data liquidity with security. Modernizing the infrastructure of healthcare empowers innovation in blockchain, AI, DLT, and NLP.

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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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