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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.
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Results demonstrate EFPIA anti-counterfeit product verification pilot project successful (14/04/2010)
EFPIA today published the results of their product verification system pilot project. The pilot, held in Sweden between September 2009 and January 2010, successfully demonstrated that a product verification system at the point of dispense, based on a two-dimensional data matrix, is both robust and effective.
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New medicines coding system to help address the growing risk of counterfeit medicines (20/10/2009)
EFPIA unveiled its pilot project to verify medicines helping reduce the risk of counterfeit medicines being dispensed to patients. Using a small data matrix - similar to a barcode - to individually number each pack of medicine, the system can provide the pharmacist with an almost instantaneous verification as to whether that pack has been previously dispensed.
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EFPIA Product Verification Project - Joint Final Report (April 2010)
In September 2009, EFPIA in collaboration with pharmaceutical retail chain Apoteket AB launched a coding pilot project, testing a pharmacy-based verification system using a 2D Data Matrix code (DMC) on each medicine pack dispensed. The project was carried out in cooperation with the Swedish pharmaceutical manufacturers’ association (“Läkemedelsindustriföreningen”, Lif) and the support of the pharmaceutical distributors Tamro AB and KD Pharma AB.
The pilot was run for approximately four months in 25 pharmacies, during which period more than 95,000 packs were scanned and verified before they were dispensed. The packs used in the project had been supplied by 14 leading pharmaceutical companies.
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GS1 Sweden & EFPIA Coding Project - To enable verificiation at the point of dispense as a measure to fight counterfeiting, the European Federation of Pharmaceutical Industries and Associations (EFPIA) believes mass serialisation of pharmaceuticals will become a reality in Europe over the next 4 to 5 years. EFPIA advocates the GS1 DataMatrix bar code with a unique product identifier (GTIN), batch number, expiry data and serial number, as the minimum data standard. EFPIA is currently piloting this concept in Sweden. During a 4 month period, 110,000 packs will be verified at 180 dispensing points at 25 pharmacies in the greater Stockholm area. |
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