The Falsified Medicines Directive (FMD) is a huge project and it is important that during the initial period medicines are not unreasonably withheld from patients, unless there is a high degree of suspicion that the pack might be falsified.
At present, there are not many FMD-compliant packs in circulation. We know that some generic medicine packs that have a 2D data matrix are not actually FMD compliant packs (one indication is that they do not have an anti-tampering device).
If you scan them the system will generate an alert. More information on identifying FMD compliant packs is available on pages 1 to 10 of UK FMD scanning packs guide. View guide at bit.ly/FMDpacks
In the initial phase of implementing FMD many “false positive” alerts are expected. This does not necessarily indicate a falsified medicine, and in most cases it will be appropriate to dispense the medicine, subject to the normal checks.
The alerts will reduce in number as more of the packs reaching pharmacy are FMD-compliant.
The most common alerts seen are likely to be:
- Product Code not recognised (NMVS_NC_PC_01) – mainly due to 2D barcodes on pre-FMD packs or FMD packs where the manufacturer has not uploaded the data.
- Failed to find batch (NMVS_FE_LOT_03) – probably due to manufacturers not uploading relevant batch data through the European Hub (EMVS).
The table below shows some of the most relevant alerts and the text that may be displayed. It offers guidance on how to respond. Ultimately professional discretion will be required.
|Message sent by National Medicine Verification System (Return Code, Description, Short Description)||Brief explanation||Suggested guidance and interpretation|
|NMVS_NC_PC_01, Product Code not recognised, Unknown Product Code||Product Code is either missing or not found in the system.||Pack not in system. Supply after normal checks.|
|NMVS_FE_LOT_03, Failed to find Batch Number, Unknown Batch Number||Batch Number is either missing or does not align with Product Code specified.||Pack not in system. Supply after normal checks.|
|NMVS_FE_LOT_12, Expiry Date does not match Batch Number, Expiry Date mismatch||Expiry Date is either missing or does not align with Batch Number specified. Note: Alerts of this type may be due to a system bug, especially for packs with YYMM expiry dates.||Quarantine pack. Expiry Date is incorrect. Refer to SOP.|
|NMVS_FE_LOT_13, The Batch Number does not match Pack Serial Number, Batch Number mismatch||Batch Number does not align with Product Code and/or Pack Serial Number specified.||Quarantine pack. Batch Number is incorrect. Refer to SOP.|
|NMVS_NC_PC_02, Pack Serial Number not recognised, Unknown Pack Serial Number||Pack Serial Number is either missing or does not align with Product Code or Batch Number, or Expiry Date.||Quarantine pack. Serial Number is incorrect. Refer to SOP.|
|NMVS_NC_PCK_06, Undo attempt doesn't match the Pack status, Undo Status mismatch||Undo transaction does not align with the existing status of the pack.||Quarantine pack. The wrong undo transaction has been used|
|NMVS_NC_PCK_19, Status is already set on pack, Invalid Status change||The pack is already set to the status that has been requested by this transaction. Note: Only applies to Non-UK pack.||Quarantine pack. Pack inactive. Refer to SOP. Non-UK pack.|
|NMVS_NC_PCK_20, Undo timeframe was exceeded, Undo Status > 10 days||Undo transaction attempted beyond the 10-day re-commissioning limit.||10 day recommissioning limit exceeded. Refer to SOP.|
|NMVS_NC_PCK_21, Undo attempted by different user, Undo/User mismatch||Undo transaction can only be executed by the same user (location and credentials).||Pack was issued at another location/credentials. Unless you have a dispensary and a WDL, Quarantine pack. Refer to SOP. Non-UK pack.|
|NMVS_NC_PCK_22, Pack is already inactive, Invalid Status change||Pack already decommissioned by another user or Double decommission limit exceeded.||Pack decommissioned many times. Unless this was at your site, Quarantine pack. Refer to SOP.|
|NMVS_NC_PCK_27, Undo attempt doesn't match the Pack status, Undo Status mismatch||Undo transaction does not align with the existing status of the pack.||Quarantine pack. Refer to SOP. The wrong undo transaction has been used. Non-UK pack.|
SOP = Standard Operating Procedure for handling FMD-related alerts and error messages and reporting suspected falsifications to National Competent Authority (i.e. MHRA) as and when necessary.