News and Events

Announcement of extension to FMD ‘use and learn’ period in Ireland beyond September

02nd September 2019

New Falsified Medicines Directive (FMD) safety feature requirements came into effect on 9th February 2019. Since then the system in Ireland has been in a ‘use and learn’ phase to ensure the continuity of safe supply of medicines to patients while all parties gained a better understanding of the new system.

Significant progress has been made on several fronts since 9th February:

  • The vast majority of pharmacies, hospitals and wholesalers have registered with the Irish Medicines Verification Organisation (IMVO) and are connected to the national system.
  • Almost 11.3 million scans of packs of medicines have taken place in Irish pharmacies, hospitals and wholesalers since February and the number of scans is growing weekly.
  • Barcode data for over 180 million packs has been uploaded to the national system by manufacturers. The number of packs bearing 2D barcodes in pharmacies will increase quickly as these packs work their way through the supply chain.
  • Extensive analysis of alerts is taking place across Europe, resulting in greater understanding of their root causes and the rollout of initiatives to reduce the number of alerts being generated. These initiatives are taking effect and the rate of alerts vs scans continues to fall in and now stands at 3.5% in Ireland (down from a high of 20%).

The National Safety Features Oversight Group comprising the IMVO, the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the Health Service Executive (HSE) and the Private Hospitals Association (PHA) has been closely monitoring progress since go live on 9th February. Taking all factors into account, the group has decided that the use and learn period will be further extended to allow additional time for the system to stabilise and to ensure that everyone is ready when it becomes mandatory to investigate and close out all alerts before supplying the packs. The use and learn period will end on a phased basis, and a detailed plan as to how this will be done, including dates, will be published at the end of September.

In the meantime, pharmacies, hospitals, wholesalers and manufacturers/MAHs are asked to continue following the instructions given to them when the use and learn period was last extended in May (see news item below). In particular, pharmacies, hospitals and wholesalers must scan packs where obliged to do so. The data generated from these scans is critical for identifying root causes of alerts and other issues that need to be resolved in order to ensure an orderly ending of the use and learn period, with minimal disruption to end-user workflow and patient supply. FMD is an important patient safety initiative and end-users’ support at this stage by way of scanning is vital for its successful implementation.