Clinical supplies & logistics
Serialisation can allow pharma companies to collect data on drugs as they move through the supply chain.
professionals, through the hands of which every drug must pass. “We have a few outputs from projects in the industry that offer concrete uses of data, but multiple actors in the supply chain are responsible for drugs at different points, so the collection and maintenance of data must be looked at before we get into analysis and deriving insights from the data,” Soulsby explains. “Right now, there is an issue with the interoperability of data, which is collected from many logistics companies and warehouse management companies,” she adds. “There are some pharma companies that have embedded track and trace systems or temperature monitoring systems, but they are struggling to connect that to the risk-based analytical information they would like to glean from that.”
“The manufacturer has responsibility to a certain point, then it passes to the wholesalers, the distributors and the logistics companies.”
Tracking with technology 10%
US National Crime Prevention Council
28
More than this percentage of all pharmaceuticals in the global supply chain are counterfeit.
Gleaning useful insights from data is proving difficult, though the data itself is abundant. One reason is that internal silos still exist within many pharmaceutical companies. Serialisation data may, for example, highlight a medicine that ends up in a certain country, but the data never reaches the anti-counterfeiting team or the quality group to verify whether it is a legitimate shipment, or that it has been kept within the right temperature range while in transit. “There is also the issue of accountability,” Soulsby remarks. “The manufacturer has responsibility to a certain point, then it passes to the wholesalers, the distributors, the logistics companies and so on. “Personally, I believe that one party should have responsibility until the drug reaches the patient,” she adds. “There is a need to take data beyond the remit of responsibility, even when legal responsibility for
oversight has passed to something else. There should be no breaks in the chain where counterfeit drugs can enter, or temperature ranges can be exceeded.” So, what is needed to help pharmaceutical companies make better use of the data on the medicines they ship? Removing the walls between internal silos is part of the solution, but technology is the other part. Soulsby, who is soon to give a talk at the World Economic Forum on blockchain technology, believes that the tools are available but need to be embedded into the supply chain. Blockchain, for example, can create a secure ledger of the serialisation elements that are scanned and recorded at various links in the supply chain, creating a complete audit trail of a drug’s journey. This ledger can also include information from sensors to track environmental factors, such as temperature and humidity. “We are still in the early days of using artificial intelligence (AI), machine learning (ML) and blockchain, but these technologies will play important roles,” says Soulsby. “Blockchain to secure the point of origin and authenticity of that data is important, then AI and ML can be overlaid to make conclusions at scale.” “We also need data interoperability – connecting inventory systems to logistics, road network or air cargo handling systems to have the required level of visibility,” she adds. “The pandemic has highlighted the age-old need for visibility at the household level – supply chain shortages made headlines – but it has been an issue for many years. Now the media is picking up on it and pharma companies have brands to protect, so I’m seeing board-level shifts to understand distribution and to invest in technology.” Serialisation was the first step on the road to reinventing the concept of visibility in the supply chain, but there many organisational and technological changes that remain to be made if pharmaceutical companies are to have a complete view of their products as they make their journeys across the world. ●
Clinical Trials Insight /
www.worldpharmaceuticals.net
LeoWolfert/
Shutterstock.com
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