A new national and European system, giving patients further protection from the threat of counterfeit medicines came into effect on Saturday, 9th February.
Throughout Europe, medicine packs will have enhanced tamper-proof measures and will now carry a barcode with a unique serial number so that each pack can be scanned in a pharmacy.
It will be checked against a central database to ensure the product is legitimate before handover to a patient.
Established and managed by the Irish Medicines Verification Organisation (IMVO), the new national system provides an additional layer of security to protect the supply of medicines at pharmacy and patient level.
Ireland is now in compliance with the EU Falsified Medicines Directive (FMD), which provides more safeguards and security to ensure Irish patients will continue to have absolute confidence in the medicines they receive from their pharmacy.
REPLACEMENT OF EXISTING STOCKS
For the next number of months, medicine packs with and without the individual serial number will be available at the same time as the existing stocks are gradually replaced by new packs with safety features.
There is also a period of time allowed to bed in the new system across the country so alerts will be monitored and managed without any impact on medicine supply during this ‘use and learn’ phase.
Patients will see the new safety features appear on medicine packs as they come onto the market this year.
Each pack will have a: Barcode (2D matrix barcode) containing data unique to that pack; and anti-tamper device to provide assurances that the pack has not been interfered with, e.g. glued flap, sticky seal, plastic break-seal.
Each pharmacy now has a scanner to check each pack before it is dispensed to the patient.
The scanner connects to a central database of prescription-only medicines manufactured, distributed and supplied for sale in Ireland.
QUALITY & SAFETY
Although there has been no risk or reported incidents at pharmacy level from counterfeit or falsified medicines in Ireland, other countries have had issues so this new system provides further security and protection for Irish patients now and into the future.
Counterfeit medicines can pose serious risks to health, as there is no guarantee of their quality or safety.
