UK, 22 Oct 2009 - The European pharmaceutical industry association, EFPIA, should be commended on its Swedish pilot for a mass serialisation scheme designed to reduce the risk of counterfeit medicines in the legal supply chain (scripnews.com, October 20th, 2009).
To date, very few organisations have put up the money to test a potential 2-D barcode scheme that could be harmonised across Europe like EFPIA. Early data from the scheme involving a number of pharmacies indicate that it is a workable model in the everyday running of pharmacies, but the complete results from the pilot will not be out until next year.
The full results will be carefully studied, as success will determine whether member states, the pharmaceutical industry, pharmacies and wholesalers will be willing to contribute to the costs of a larger pilot, possibly involving an entire country.
Importantly, the two key stakeholders involved in supplying the bulk of medicines to Europeans - ie, pharmacists and wholesalers -already back the scheme in principle, but they want some fine-tuning.
John Chave, the secretary general the association that represents European pharmacists, the PGEU, told Scrip: "[We] support pharmacy level authentication schemes as the best way of ensuring that counterfeit medicines don't reach patients. We observe all such schemes with interest, both the EPFIA pilot and other schemes in operation in Europe. We do have some concerns about data ownership and how such schemes would be implemented in different member states, but our top priority is of course patient safety."
While parallel traders, who supply a small proportion of drugs in Europe (some 10%), have raised concerns regarding access to the central database, this is something that will need to be worked out among all the stakeholders and funders of a long-term scheme, once one has been decided upon. It cannot be expected that EFPIA or pharmaceutical companies alone will bear the costs of a larger national pilot - patient safety should be the concern of everyone.
Any scheme would lead to costs for pharmaceutical firms as they introduce new equipment and printers; one industry estimate has been €100,000 to €250,000 per product line (as a one-off cost), with ongoing printing costs of 0.5 eurocent or less per individual medicine pack. For pharmacies, someone would need to pay for the barcode scanners (about €400 each) and the upgrade of computer software.
But cost issues aside, the scheme could have advantages that go beyond the verification of medicines. It may lead to more effective product recalls, as currently tracing medicines back in the supply chain is mostly done at batch level. It could assist pharmacists in detecting expired medicines, and it could allow faster and more accurate reimbursement procedures for pharmacists and payer authorities.
Moreover, if the scheme were combined with a national e-prescription, the unique identification of packs could reduce dispensing and dosing errors.
EFPIA stresses that it does not rule out the use of RFID in tandem with the 2-D barcode once the technology matures. However, from the early results, the scheme appears efficient, cost-effective, highly reliable and fast. It may be only a pilot, but it is a very good start.