FMD – End of ‘Use & Learn’

Now that we have exited the FMD ‘Use & Learn’ period, there are a number of key issues to bear in mind:

 

Do not scan Unlicenced Medicines (ULMs)

Strictly speaking, under the European Commission (EC) Delegated Regulation (DR) that prescribes for medicines authentication in pharmacies, you are not required to authenticate ULMs. Furthermore, it is possible that doing so could cause alerts in your pharmacy. IMVO, the Irish Medicines Verification Organisation, has the below advice:

  • If you know the pack is a ULM, don’t scan it as the IMVS may not recognise the pack;
  • If you inadvertently scan a ULM and get an alert, you may supply the pack unless you have overriding concerns that a falsified medicine is involved or believe the pack has been interfered with; or the pack is flagged as expired, recalled, withdrawn, stolen or destroyed; and
  • Always check the anti-tampering device (if there is one) – if you have any reason to believe the pack has been interfered with, please report this to the HPRA as a product quality defect and do not supply the pack.

 

Supplying Utrogestan

French packs of Utrogestan 100mg and 200mg capsules that are supplied in Ireland as ULMs. Further to the above, you are not required to authenticate ULMs. However, that said, IMVO and HPRA have issued advice on:

 

Utrogestan 200mg Capsules molle orale ou vaginale (Batch Numbers 200261 and 202225); and

Utrogestan 100mg Capsules molle orale ou vaginale (Batch Numbers 214679 and 220486).

The advice is: If pharmacies scan and receive alerts for these four utrogestan batches, they may supply the packs to patients under their existing procedures, unless they have overriding concerns that a falsified medicine is involved.

 

Investigating Alerts

Apart from triaging the elements within your control in your pharmacy – i.e. hardware, software and behaviour (explained in our FAQ) – you are not required to spend time investigating or resolving alerts. If an alert arises in your pharmacy, contact IMVO for advice on alert.support@imvo.ie or call 01 5715320.

 

Compliance – PSI Request for SOP

You may have received correspondence or even visits from the PSI regarding compliance with FMD. We know that recently some pharmacies have been asked for an FMD SOP. Currently, all pharmacies are legally required to verify the authenticity of medicinal products by checking the safety features on the packs and decommissioning them during the dispensing process. Medicinal products that generate a red alert should not be supplied to patients until the cause of the alert is identified, and falsification is ruled out. We advise you to ensure that your dispensing SOPs have been updated to reflect this change in the legislation. The SOP should accurately reflect the authentication and decommissioning practice followed at your pharmacy. The updated IPU SOP is available here.

More information is available on our dedicated FMD page.