Clinical supplies & logistics
to see if it is counterfeit or legitimate,” says Courtney Soulsby, global director for the healthcare sector at British Standards Institution (BSI).
“From the perspective of legislation, which came in over a decade ago, it took the industry a long time to comply and get a Global Trade Item Number (GTIN) and batch number of every product on the packaging. It takes a lot of work to comply in an effective way,” she adds.
BSI exists to shape, share, support and assess industry best practice, and for 120 years it has equipped organisations with the tools and techniques they need to turn today’s challenges into tomorrow’s opportunities. Working globally, it has specialist expertise spanning a range of sectors, including healthcare, to deliver services and solutions to make organisations worldwide more trusted and resilient. Soulsby helps organisations to understand and correct the risks and vulnerabilities that exist in their global supply chains and their internal business functions. She has an in-depth understanding of the challenges faced in every healthcare vertical, from hospitals to pharmaceuticals, and supports organisations in developing the best approach towards business growth and the management of risk.
In that role, she has been able to see the effect of serialisation not only on limiting the number of counterfeit drugs on the market, but also its potential to drive operational change.
“In the past five years, there has been a sense of looking at what we can do with the information that is on the packs of drugs being shipped across the world,” she remarks. “Technology has advanced more than the industry has been able to digest and serialisation has been the foundation of many advances. Putting batch and lot numbers on the packaging doesn’t solve the problem. It is a question of what you do with that information.”
Data opens the door to visibility Having a large amount of data on the position and movement of drugs throughout a global supply chain does not, by itself, yield meaningful insight. It is the analysis of that data that can inform valuable operational decisions, and the first step in effective analysis is identifying the right questions to ask. So, to what use can the data provided by serialisation be put? The most obvious answer is the creation of more transparent supply chains. Serialisation infrastructure, including the ability to record and analyse data about the location of a specific package within the supply chain, can not only be a powerful tool in combating counterfeiting and diversion, but can also support automation in inventory management and help companies to optimise inventory levels and avoid
Clinical Trials Insight /
www.worldpharmaceuticals.net
shortages of key medicines. Another key question to ask of the data provided by serialisation is whether a medicine has been properly transported in adherence with the required environmental conditions. Supply chain data on storage and transportation conditions can, for example, be used to monitor any deviations from optimum storage conditions, principally temperature excursions in the cold chain. “Serialisation supports important insights, such as whether a medicine is in the right market or has been diverted, whether it is legitimate, whether it has been tampered with and whether temperature control has been maintained throughout the chain of custody,” says Soulsby.
Serialisation has helped to limit the number of counterfeit drugs on the market.
“I’m a supply chain traceability expert, so I understand how to leverage serialisation, and I agree the driver was to achieve visibility into where medicines go and, as a side benefit, to allow companies to see if it is counterfeit or legitimate.”
“There are even benefits in terms of sustainability,” she adds. “It can track the proper disposal or reuse at the final point of administration. And it can give an understanding of utilisation of medicine by patients, and that is important for projects we are working on concerning access to medicine in the developing world.”
Better visibility along the supply chain can help to determine, for example, whether donated medicines are being used by patients. “Right now, pharma companies don’t know that,” Soulsby continues. “The technology exists to track that, but we need all of the actors in the supply chain to be involved.” The biggest challenge in getting these insights from the mass of serialisation data generated within the industry is the sheer complexity of the global supply chain. Between the manufacturer and the patient lie many shippers, logistics providers and healthcare
$200bn
The market loss of counterfeit prescription medicines to the pharmaceutical industry.
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