Traceability of medicines in EU: feasible, but challenging

A project funded by the European Union has provided clear evidence that serialisation of medicines with a unique code is a feasible way of achieving full traceability within the EU pharmaceutical supply chain.

However, John Jenkins of JJ Associates, one of the architects of the project, believes that the high investment in terms not only of money but also effort in maintaining high levels of collaboration and stringent adherence to robust processes and management may make it more feasible to adopt a less-ambitious approach in the near-term.

The BRIDGE (Building Radio frequency Identification solutions for the Global Environment) project combined the use of data matrix RFID tags, and involved pharmaceutical manufacturers, distributors, transport companies, wholesalers and pharmacies.

The project tracked 15 different types of drugs in a range of packaging forms, in a live supply chain environment. Starting from drug manufacturing and packaging plants in Ireland and the Netherlands, medicines were monitored to their final destination, the pharmacy department at St. Bartholomew’s Hospital and the London NHS Trust in London, UK.

Crucially, the technology used in the pilot was all based on open system standards, i.e. GS1 for the data matrix barcodes and EPCglobal for the RFID tags.

“Each product not only had a product code, but was also associated with a unique serial number, batch number and expiry data, known as a serialised GTIN or SGTIN” said Jenkins. “We adopted that coding philosophy at the pack, case and pallet level,” he added.

The overall objectives of the pilot were to see if full traceability using RFID and serialisation was feasible. The hope is that using this approach it may be possible to reduce medication errors and prevent the threat of counterfeit medicines, although assessing this was beyond the scope of the project.

The patient pack carried a data matrix code only, while on the cases and pallets both data matrix and RFID tags were included. These were added on the production line of the pharmaceutical manufacturer, and scanned in and out at each node in the distribution chain through to arrival at the hospital pharmacy.

“What we have is a system where each partner in the supply chain has access to the same ‘kernel’ of traceability data,” said Jenkins. With suitable application interfaces, that data has multiple uses, including authentication of product, electronic pedigree, product recalls, inventory management and financial reconciliation.

Three pharmaceutical manufacturers (Sandoz, Athlone Labs and Actavis) joined the pilot, along with one contract packer (Tjoapack), a pre-wholesaler (CPG Logistics), two distributor/storage partners (Actavis and Ken Pharmaceuticals), a transport company (Movianto), wholesaler (Unichem) and of course the hospital pharmacy at Barts.

The technology was provided by Domino (inline printing equipment), GS1 (standards and RFID consultancy), JJ Associates (project management), Melior Solutions (technical design and software development) and Verisign (EPCglobal database provision).

The system under test was able to generate, apply and read codes at a rate of around 130 packs a minute, which is effectively production speeds, said Jenkins.

And while in the pilot the codes were only applied to labels, subsequent work by one of the programme partners has demonstrated that it is possible to add codes to the blister packs and even unit dose packaging levels.

There were some issues to be overcome, Jenkins told a recent conference organised by SMi. Current pack designs meant that in some cases it was difficult to accommodate the GS1 data matrix codes, and tight control over printing was required. Too much wobble on the conveyor and the codes could be rendered unreadable.

The EPCglobal architecture worked well for information gathering, but there were some problems with response times when querying the database for on-line product verification.

The RFID component worked well in the pilot, he said, but the currently-available, low-cost gen 2 RFID tags do not at present have the capacity to accommodate all the data that needed to be included.

EPCglobal is currently working on updating the standards that would allow all the data to be encoded within these tags.

‘In-and-out’ approach

But while the project has clearly demonstrated that full traceability down to the package level can be achieved, in the absence of a mandate handed down by governments or other authorities, it may be advisable to opt for an interim approach, according to Jenkins.

“A traceability system such as the one we have deployed will inevitably touch almost every aspect of an organisation’s business,” he said. “The project must command total commitment and buy-in of management at the most senior level.”

An interim stage could be the adoption of an ‘in-and-out’ system, such as the approach taken by the European Federation of Pharmaceutical Industry Associations (EFPIA) in its Swedish pilot programme.

“Mass serialisation deployed by the manufacturer (the ‘in’ phase) and verification of the patient pack by the pharmacy at the point of dispense (the ‘out’ phase) is perhaps a practical model for today,” he said.

The final conclusion document from the BRIDGE Pharma Traceability Pilot is available for download here.