Full traceability systems within an open, cross-border pharmaceutical sector supply chain are entirely feasible for Europe, and undoubtedly across other continents too, say experts.

This is the main conclusion of an evaluation report of Pharma Traceability, a pilot of the European Union (EU) BRIDGE (Building radio frequency identification solutions for the global environment) project, published this week by the European Commission. Supported with funding of 7.5 million euros under the EU’s Sixth Framework Programme (FP6) and begun in mid-2006, the Pharma Traceability pilot is the first project to implement a global supply chain-wide traceability system based on mass serialisation techniques, aimed at ensuring patient safety in the branded and generic pharmaceutical supply chain.

The pilot was conducted by a team of five technology providers working with nine supply chain participants representing pharmaceutical manufacturing, logistics and distribution. It tracked, in a live operating environment, 15 different types of drugs in different packaging forms through their supply chain journey, from manufacturing/packaging plants in Ireland and the Netherlands, to their final destination, the pharmacy department at Bart’s Hospital in London and the London NHS Trust, all based on open system standards. The mass serialisation solution, utilising a mix of GS1 Data Matrix bar codes and radio frequency identification (RFID) electronic product code (EPC) tags at patient pack, case and pallet packaging levels, was found to meet all current worldwide pharma regulations on authentication and track-and-trace and also address the current lack of supply chain visibility of goods shipments faced by the healthcare industry, say the partners.

The data set used (product code, serial number, batch number/Lot code and expiry date), coupled with the EPC Information Services (EPCIS), not only offers the required traceability for electronic pedigree but also for recall systems and enabling electronic flow of information to back office systems, with resulting efficiency gains for inventory management and financial reconciliation systems, they say.

However, they warn, these benefits will not come cheap. They will require technology investment by all supply chain parties, not least by manufacturers, plus significant effort and focus on trading partner collaboration and stringent adherence to robust processes and their management. Staff with little or no IT skills will be required to process the relevant systems whatever time of day or night in line with often demanding timescales. There will be no room for error, not least to deliver the required levels of customer service but also to maintain the traceability trails.

Therefore, high levels of training and education across the business, positive enterprise-wide communications and total commitment by the most senior levels of management are essential.

Government and other authorities will need to regulate traceability deployment at the community or national levels for sector-wide adoption, say the partners, and they suggest as an interim approach adopting the “in/out” data model – mass serialisation deployed by the manufacturer (“in”) and verification of the patient pack by the pharmacy at the point of dispensing (“out”).

Moreover, while the project’s product traceability extended only from the point of manufacture to goods-in at the hospital pharmacy, the partners point to the further significant benefits of extending the traceability trail inside the hospital to the patient’s bedside and the point of medicine administration. In this way, costs of getting something wrong can be radically reduced, they say, and therefore: “we would strongly recommend therefore that healthcare authorities and regulators undertake further pilots to demonstrate this potential.”

The partners conclude that many pharmaceutical companies may not wish to be early adopters of the technology and work required to implement traceability systems based on mass serialisation techniques, particularly in the early days, but regulatory pressures and market trends will drive them to do so. “Accordingly, we see an increasing trend towards pharmaceutical manufacturers outsourcing the packaging and encoding operations to those specialists who have already made the investment,” they say.

“The Pharma Traceability pilot has been a great success and demonstrated that full supply chain traceability is highly feasible in the pharmaceutical environment,” said John Clark, commercial director of drugmaker Athlone Laboratories, a pilot participant. “The evaluation report sets the benchmark for future projects of this type – the lessons and conclusions it describes will be invaluable to industry and the regulators alike,” he added.