New drug coding and identification system close to pilot launch in Sweden

A new medicines coding and identification system designed to combat the growing problem of drug counterfeiting in Europe is almost ready for its trial run, according to the European Federation of Pharmaceutical Industries and Associations.

Between 30 and 50 pharmacies will participate, with 100,000 coded packs to be dispensed. The trial is expected to last between three and four months.

"We've chosen Sweden for the pilot programme and we expect to start in September," said Jean-Marc Bobee, who chairs EFPIA's committee in charge of the product verification project.

Unlike codes used in current tracing systems, this code boasts serialisation with one randomised number per box that will aid in preventing counterfeits and reimbursement fraud. The system can also detect code copying. "There are three ways to fight counterfeits: laws, enforcement of those laws and technology. This is the technology component," Bobee said.

He stressed that there is a big need for medicines traceability in Europe not only to reduce the risk of potentially fatal counterfeit drugs in the supply chain but also to ensure patient safety in other ways. "This system will automatically detect expired products, be more effective and efficient for product recalls and help governments in their reimbursement processes, as well as improve pharmacy and hospital management systems to cut down on dispensing errors," he said.

According to the EFPIA committee, two key elements in choosing the system were that it had to be quick and easy to use for pharmacists and have a high level of data base security. Each sales point in pharmacies will need a handheld code reader, which costs about Euro 400 per unit, while manufacturers installing the system's printers will need to pay €200,000-500,000 per production line. Thereafter, it will cost just a few cents per unit for printing, according to Bobee said.

Committee member Andrew Bonser said costs of the handheld readers will be absorbed by pharmacies, but noted that many already have such equipment that can be adapted to the new system. He added: "There is still the question of how much money the government and regulators would contribute. But if it ensures patient safety, it's worth it."

Serialisation is already used in Belgium, Italy, Greece and Turkey, while Spain and Serbia are working on new legislation requiring the use of a serial number on medicine packaging. It is hoped all players in the pharma sector will adopt the system.