Pilot Project to Mitigate Risk of Counterfeit Pharmaceuticals
Frisay’s post about fake parts in the supply chain is underscored by recent news from the European Federation of Pharmaceutical Industries and Associations (EFPIA). The EFPIA announced last week that it has launched a two-month pilot project to verify medicines and help reduce the risk of counterfeit pharmaceuticals being dispensed to patients.
The project, underway in 25 retail pharmacies in and around Stockholm, will verify more than 100,000 products. Each product will be coded with a small data matrix (similar to a barcode) that, once scanned, can alert the pharmacist as to whether or not a pack has been previously dispensed. The data matrix will contain information about product code, batch number, the expiry date and a unique, randomized serial number which identifies packs individually.
“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,” says Brian Ager, Director General of EFPIA.
The EFPIA hopes the system can offer the basis for a cost-effective, harmonized and interoperable system across the European Union . This will help reduce the risk of a proliferation of incompatible national systems, and help ensure product verification for medicine wherever they are dispensed within the EU.
For a thorough discussion about counterfeiting in the pharmaceutical products supply chain, I recommend this article from PharmTech.com.
Remember: a recent survey by Sparta Systems found that nearly half (45%) of industry professional at top medical device organizations feel their current quality systems are insufficient to mitigate compliance, risk and safety issues associated with their complex supply chains.
