Coding & Identification of Products: towards safer medicines supply

Recent studies on dispensing and dosing errors, reimbursement issues, and cases of counterfeits in the legitimate supply chain have highlighted the need to establish more clearly and effectively the identity of each medicine pack and to trace its origin.

Various coding solutions have been implemented by Member States, each with their own objectives and motivation. The coexistence of these different systems constitutes an obstacle to enhanced tracking and tracing of medicines at an EU level and adds production costs for manufacturing.

This has led EFPIA to recommend the implementation of a standardized identification solution for pharmaceutical products across Europe. In May 2009, EFPIA agreed to run a pilot project of its coding and identification solution in Sweden later this year in partnership with Swedish retail pharmacy chain Apoteket AB and local wholesalers Tamro and KD.
Under the EFPIA solution, pharmacists will check a unique identification code on each individual pack when it is dispensed to the patient. These codes are generated and applied by manufacturers using a simple 2D data matrix barcode, which contains a unique serial number. The scan will reveal any duplication of data on packs and will trigger the system to immediately alert the pharmacist to the possibility of a counterfeit product, who can take the necessary steps.

The coding solution could provide an efficient and cost-effective method to meet the EC's new traceability requirement, recently proposed to combat the inflitration of counterfeit medicines into Europe. The pilot project is expected to last between three to four months and will be entirely financed by the pharmaceutical industry. It will be a scaled-down version of a full EFPIA solution: a key goal is to demonstrate that it is a practical and effective solution for manufacturers, pharmacists and patients alike, providing a standardized and interoperable system throughput Europe.