Packaging About PharmaLedger
Spanning 36 months, PharmaLedger has the following stated objective: “The goal of the project is to provide a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating delivery of innovation that benefits the entire ecosystem, from manufacturers to patients.” The programme started in January 2020, before the Covid-19 crises gripped much of the world, and is being conducted in three main stages: ■ Year one: Design and foundations ■ Year two: Development and deployment ■ Year three: Validation and sustainability.
It is expected that the project will conclude by December 2022.
“Using this data, the PharmaLedger ePI solution is able to determine if the manufacturer produced this pack of medicine and then, based on the outcome of these checks, the patient could be provided with an electronic leaflet or perhaps a message or warning about the pack’s provenance. “The question often asked is if this code could be copied and then put on to different packs. The answer is yes, it could be copied – however, that is where the overt and covert anti-counterfeiting technologies come into play.”
In order for the solution to work as effectively as possible, all pharma packaging needs to become serialised. In many markets, barcodes just contain the GTIN, batch number and expiry date, meaning there are limited numbers of checks that can be performed in order to evaluate if the pack is genuine or fraudulent.
Patient-centric packaging
Novartis is leading the PharmaLedger project.
Standardising barcodes on packaging is a central part of the Novartis and the PharmaLedger consortium’s remit, with patient centricity as a guiding principle. They realise that creating individual apps to scan barcodes on packaging produced by different pharma manufacturers is unviable, as it would limit the effectiveness and reach of the solution that requires as wide an
uptake as possible to stamp out fake medicines. As a result, the PharmaLedger solution being developed allows the same app to scan products from competing pharmaceutical companies, presenting information in a consistent and user- friendly way. And beyond aiding the authentication process, the PharmaLedger ePI solution and associated universal app carry a number of additional benefits. Firstly, recalls can be managed at a batch or serial number level, operating in conjunction with existing recall procedures. Secondly, batch specific leaflets can be created and updated – for example, when an excipient changes. Third, it opens the possibility of extending shelf life through dynamic expiry date management. This is especially the case with new products – the more stability data that is forthcoming, the more possible it becomes to extend expiry dates on products.
Collaboration is critical
This is all enabled by blockchain technology, what Fritz describes as a ‘team sport’. “In order to achieve the very ambitious goal that we have set, then internal company politics and inter-company politics cannot be allowed to come into play,” he explains. “Novartis SMEs are working in collaboration with public and private industry partners as part of the PharmaLedger consortium in order to achieve this goal. “Within Novartis, the SMEs come from various internal functions such as supply chain, IT, engineering, quality, compliance, regulatory, legal and communications. “With such a diverse range of SMEs, it is important that everyone takes responsibility and ownership for their part of the puzzle. Ultimately, we need to find solutions to each of the problems, not just problems to each of the solutions.” And there is still a long way to go until PharmaLedger achieves its ambitious goal. Several challenges will need to be overcome, such as technology adoption and how to reach those who do not have a smartphone or reliable internet connection. However, the greatest set of challenges will centre around shifting mindsets towards digital. “The existing procedures and processes have been embedded in the pharmaceutical sector for many years, and they are there to protect the patient,” Fritz says. “These procedures and processes need to remain, but we need to bring them into the digital era while still maintaining the protections that they bring for the patient. “It is incumbent upon us all to eradicate fake medicines from the supply chain for all markets, and to empower consumers with patient-centric solutions that meet their needs, and not just the needs of the pharmaceutical companies, health authorities and governments.” ●
62 World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
Taljat David/
Shutterstock.com
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