The European Federation of Pharmaceutical Industries and Associations (EFPIA) has announced that trials in Sweden are now underway with a new system which aims to tackle the growing threat of counterfeit drugs.
The pilot project of medicines verification is being trialled by EFPIA - in conjunction with Swedish pharmaceutical retailer Apoteket AB and local wholesalers Tamro and Oriola KD – in 25 retail pharmacies in and around the Stockholm area. More than 100,000 products will be verified, using a small data matrix - similar to a bar code - to individually number each pack of medicine and supply information to the pharmacist, almost instantaneously, as to whether the pack has been dispensed previously. A confirmation will immediately alert them to the risk that the pack may be counterfeit.
The data matrix enables each pack to be individually coded, providing unique information including the product code, batch number, expiry date and a randomised serial number which identifies each pack individually.
The trial of the coding and identification system was agreed between the EFPIA, Apoteket AB, Tamro and Oriola KD in May is expected to run until late November. The initiative, which will be financed entirely by the pharmaceutical industry, is part of EFPIA’s response to the European Commission’s proposal, put forward in its draft directive published last December, for a mass serialisation of medicines as part of measures to better protect European Union (EU) citizens from the serious threats posed by counterfeit drugs. EFPIA says it hopes the system can offer the basis for a cost-effective, harmonised and interoperable system across EU member states, which will help to reduce the risk of a proliferation of incompatible national systems and assist in ensuring product verification for medicines wherever they are dispensed within the EU.
“Individual product verification will not provide a complete solution to the challenge of counterfeit medicines. Nevertheless, as part of a package of measures, this type of end-to end verification system will make a significant contribution to product security and reinforce patient confidence in the legitimate supply chain,” said EFPIA director general Brian Ager.
Stefan Carlsson, chief executive of Apoteket AB, stressed the need for both pharmacists and patients to have confidence in the medical supply chain.
“Our pharmacists’ initial experience with the system confirms its ease of use, with no significant delays for patients. It offers an accessible and inclusive method of addressing the pharmacist’s role in providing product verification,” said Mr Carlsson.
