February 2019 Blog; Falsified Medicines Directive (FMD) – Are you Ready?

Falsified Medicines Directive (FMD) – Are you Ready?

It’s now more than six years since the FMD (Directive 2011/62/EC) came into force in a bid to combat the risk of counterfeit medicines reaching patients across Europe.

The aim continues to be the prevention of the entry of falsified medicinal products into the legal supply chain. The directive applies to almost all prescription-only medicines (POMs), including generics, but it doesn’t apply to specials and a few other products, which are unlikely to be dispensed in the community. However, there is an exception to this and over the counter (OTC) omeprazole will have to be decommissioned even though the ruling is only supposed to apply to POMs.

On or after 9 February all new prescription-only medicine packs issued into the UK market must bear FMD safety features and have pack data loaded into the UK’s National Medicines Verification System (a.k.a. the UK hub). Unfortunately, for the first couple of years following FMD implementation there will be quite a few products in the supply chain which are not FMD-compliant. This ‘old’ stock can be supplied as it was on the market before the start of FMD, but eventually everything will be used up and only FMD-compliant stock will be available in the supply chain.

FMD-compliant packs must have two safety features. The most obvious one is the anti-tampering device (ATD); you will have noticed that these have been in place for sometime now, as you will have been breaking through them when splitting packs. Secondly, every pack will have a unique identifier (UI) in the form of a 2D matrix (barcode), containing the batch number, expiry date, product identifier, and a unique serial number for the pack. The UI will be scanned, and the information checked against the database held at the UK hub.

As part of the dispensing process from 9 February ALL community pharmacists will be required when dispensing FMD-compliant stock, to check that ATDs are intact prior to dispensing and change the status of packs from “active” to “inactive-supplied” by scanning the unique 2D barcodes. Sounds simple enough, but there are a lot of practicalities to consider and, of course, you will need to follow associated Standard Operating Procedures (SOP) to ensure compliance.

What happens when the barcode is scanned? Quite a lot actually, as the UI is checked against the UK hub database to verify the pack’s serial number and to see if it’s been marked as previously dispensed, recalled or expired. If the medicine is supplied to a patient the status of the product will be flagged as “inactive-decommissioned.“ This decommissioning process prevents packs with the same UI from being authenticated – duplication of UIs could indicate falsification.

When should the packs be scanned? This will vary from pharmacy to pharmacy, so you will need to follow the appropriate SOP for the organisation you are working for. Things to consider are how the process fits in with the normal workflow and how the FMD software system has been setup. Decommissioning would normally occur at the time the medication is handed over to the patient, because otherwise the medication may have to be recommissioned if it’s not picked up within ten days.

The ten-day window allows the medication status at the UK hub to be changed back to active, if a mistake has been made and/or the patient hasn’t picked up their medication. After this time a product cannot be recommissioned and the legislation requires that any medicines not picked up must be disposed of. This could be a costly mistake, as the medication cannot then be supplied to another patient (i.e. you can’t dispense something that shows up as “inactive-decommissioned” on the UK hub database).

If an original pack is dispensed then the process is straightforward. However, when you have to split a pack to dispense the required quantity then it’s a little more complicated. The pack should be decommissioned when the first part of it is supplied to a patient, not forgetting the ten-day rule of course. Subsequently, when you dispense from the split pack there is no need to scan it again because the status has already been changed. It should be noted that, because the pack isn’t being scanned, the system would not alert you to recalls or expired medicines. Therefore, these will have to be checked manually at the time of dispensing.

What happens if the system alerts you to something that’s on the UK hub database, but has already been marked as “inactive-supplied”? Back to those SOPs again and you will need to contact the Medicines and Healthcare Regulatory Agency (MHRA) and the supplier of the product. Also, it will be worth checking other packs of the same product in case there’s more of this possible counterfeit stock.

Want to find out more about FMD? PSNC has a useful factsheet about what you need to do to prepare for FMD – see PSNC Briefing 058/18. Also, it’s worth checking out the FMD Source website, which provides UK pharmacies with authoritative and reliable information on implementing FMD. Finally, there’s SecurMed, the UK Medicine Verification Organisation, which enables FMD to be implemented.