The project, which is being run in collaboration with IT services firm Siemens, will involve 25 pharmacies in Stockholm, Sweden and will apply 2D barcode labelling to 110,000 drug products over the next three to four months.
European Federation of Pharmaceutical and Industries Association (EFPIA) communications and partnerships director Colin Mackay spoke with in-PharmaTechnologist about the new project and how it will impact of drug fakers.
Mackay explained that the 2D matrix tech being used in the Swedish pilot scheme enables individual drug packs to be traced, unlike linear barcodes which hold only limited amounts of information and can only identify pharmaceuticals to batch level.
“The beauty [of the 2D approach] is that every pack’s unique serial number is fed into a database and removed when the product issued by the pharmacy, meaning that each code can only be used once.
He added that to cheat the system “[Counterfeiters] would have to create unique codes for each pharmaceutical packet, vastly increasing their workload and providing them with a much smaller return on investment.”
He also said that while monitoring the scale of the problem in Europe is outside the EFPIA’s remit, the organisation is keen to take part in anti-counterfeiting efforts because the presence of fake drugs in the supply chain damages confidence in the industry ans a whole.
Parallel trade
Mackay went on to say that the 2D labelling pilot will, if more widely applied, be only one part of a wider effort to combat the production and distribution of counterfeit pharmaceutical products in Europe.
He called for the adoption of an approach whereby drug packs are verified at both the point of manufacture and at the pharmacy and suggested that such an strategy would provide an effective means of tracking drugs from source to patient.
Mackay also suggested that there needs to be more effective Europe-wide legislation to combat trade and reiterated the EFPIA’s desire to see a ban on parallel trade and repackaging.
“Repackaging removes many of the safety features such as holographic labelling and bar codes and is a weak point in the pharmaceutical supply chain.”
"Dramatic increase in consumer safety"
A Siemens spokesman told in-PharmaTechnologist about the firm's role in the pilot scheme, first setting out the scale of the counterfeiting problem.
"According to WHO 5 – 8% of the worldwide trade in pharmaceuticals is counterfeit. My sense is that the problem in Europe is no better or worse [than] elsewhere in the world."
He explained that the firm "will provide connectivity for pharmacies and manufacturers to the EFPIA database, which is hosted by Hewlett Packard (HP).
"Manufacturers will populate the EFPIA database with the serial numbers of the saleable units shipped, and pharmacies will read those serial numbers at the point of sale (via 2D barcode) and authenticate the unit sold against the EFPIA database."
He explained that the technology Siemens is providing for the scheme is "the same coding and identification hardware and the same architecture that we provide to our clients."
"The EFPIA project is proving that pharmacies can authenticate the units sold with data provided by the manufacturer. If adopted throughout Europe and around the world, such a system should result in a dramatic increase in consumer safety."