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Manufacture Standards & Regulation, Technology and Equipment

Beyond Barcodes

It’s obvious that “digital” is the key word of the 21st Century. We have instant access to information, devices that connect us to people around the globe, and we even have smart devices monitoring our health. The quantity of information generated and accumulated by digital devices was the stuff of science fiction only one or two decades ago.

What about digitalization involving non-electronic objects, such as medicinal products or medical devices? Welcome to the era of serialization in the pharma industry…

About 40 years ago, GS1 was created to set global standards for product identification within supply chains. Today, our identifiers are used worldwide in various industries, including healthcare. Providing unique item identification was our first task, which resulted in the “EAN/UPC” linear barcode. Electronic catalogues have also been standardized with the GS1 Global Data Synchronization Network (GDSN), which allows trading partners to share information about the items they sell, purchase and ship. This information may include, for example, measurements, product description, characteristics and classification.

From 2015 onwards, one element is going to play an increased role: item serialization, where every item, such as a single packet of medicine, has a unique number. It is an extension of the current GS1 Global Trade Item Number (GTIN), made by appending a serial number to that GTIN.

Now, with item serialization, new processes will be enabled – for medicinal products, fighting against falsification will be a global priority.

Leveraging what GS1 has already achieved is key to making item serialization successful. It means ensuring that existing processes that do not require item serialization continue to work: ordering, stock management, shipments, cross docking, and so on. The global use of a single standardized identification system enables access to a considerable variety of products. Now, with item serialization, new processes will be enabled – for medicinal products, fighting against falsification will be a global priority. This requires production lines to be updated to a complex new process; not only does each retail pack need to carry a “unique number”, but that number should be aggregated when the retail packs are placed into one carton (which also has to be identified with a GTIN and a pseudo-randomized serial number). The “unique numbers” have to then be populated safely into a regional repository, which will be queried when dispensed(e.g., by the pharmacist).

In the pharma industry, the serialization component will be managed by each manufacturer or marketing authorization holder, using sophisticated algorithms to prevent falsifiers from reproducing sequences of serial numbers. When a very large number of actors is working to make the supply chain safer, an open system of standards is the only way to provide unique identification. In addition, standardized electronic messages exchange information to track the journey of myriad items across the globe and between trading partners, in an interoperable way. In the first stages of implementation, this might be limited to an end-to-end verification system, but the standards to be implemented should be scalable to event tracking. A large-scale pilot project that took place in Sweden in 2009 (run by the European Federation of Pharmaceutical Industries and Associations) provided insight into how this will work in reality; individuals at point of care were able to capture the unique number to look-up the price, manage the stock and query a database in which the unique numbers were verified. The latter process took less than 0.5 seconds in 95% of cases, so it did not delay the dispensation process. Combined with safety features on the packaging, the medicinal product should be safely dispensed to the patient.

Regulators understand that implementing one global supply chain standard is crucial to securing our supply chain. As serialization progresses, trading partners will develop additional benefits from this powerful technology in areas such as business intelligence – which could ultimately benefit patients worldwide.

At the end of the 20th Century, one of the ambitious visions proposed for the new millennium was the “Internet of Things”: that is, the capacity for objects to interact and generate new information without human intervention. The Internet of Things is now a reality, and with the first phase of the Drug Quality and Security Act coming into force in the US, and ever-more sophisticated serialization, our pharma industry is increasingly becoming part of this brave new world.

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About the Author
Christian Hay

Christian Hay has worked in the healthcare industry for over 20 years. He played an instrumental role in the establishment of narcotic control in Switzerland, using the GS1 system. In parallel, from 1995 onwards, elements of the GS1 System were deployed for improving accuracy and efficiency, by reducing administrative costs. “I have worked for GS1 Switzerland and other GS1 organizations since 2003, focusing on interoperability for IT standards in the healthcare industry”, says Christian. He contributes to the board of the Swiss Society for Medical Informatics and was the first chairman for IHE Suisse, which included the organization of a ‘European Connectathon’ in Bern. Christian also teaches Healthcare Logistics at the Bern University of Applied Sciences.

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