The Falsified Medicines Directive (FMD):

Your questions answered

Q1. I'm really confused about what FMD is all about, can yopu explain it to me?

Whilst I am of course familiar with the FMD directive and know the basics, I could not say I am an expert in all procedures within it.

I would therefore like to refer you to a few different places so that you get the best advice and guidance possible on this subject:

  1. In the first instance you could have a look at our specific "FMD section on our website, which has a wealth of information we have collated in one place for your easy reference.
    www.alliance-healthcare.co.uk/fmd

  1. Secondly I strongly recommend getting professional advice from the UK FMD Working Group for Community Pharmacy which can be found at www.fmdsource.co.uk.

  1. The MHRA's page on GOV.UK contains the broadest range of up-to-date links on FMD guidance. https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features

  1. Finally as I am sure you have considered your professional body, the NPA (National Pharmacy Association) will be able to support at www.npa.co.uk/fmd or the RPS (Royal Pharmaceutical Society) - https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd

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Q2. What is a falsified medicine?

Falsified medicines include:

  • Products with little or no active ingredient(s)
  • Products with the wrong active ingredient(s)
  • Products and/or packaging that have been stolen for re-use or resale.

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Q3. What does FMD apply to?

FMD will apply to prescription-only medicines. It does not apply to over-the-counter products (OTC), medical devices, one-off specials and most specialist products.

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Q4. When does FMD start?

Sorry that you are having some problems.  For the best help, please can I advise you visit FMD Source at www.fmdsource.co.uk which is the website of the UK FMD Working Group for Community Pharmacy.  There you will find visual training guides to help and assist you with professional decision-making guidance for how to dispense medicines in scope, should you have an error messaging whilst scanning them.

You could also go to your professional body, the NPA (National Pharmacy Association) for guidance – the relevant section on their website is www.npa.co.uk/fmd or the RPS (Royal Pharmaceutical Society) - https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd

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Q5. What will pharmacists need to do to comply with FMD?

In order to comply with the new FMD requirements, you will need to check two new safety features before you dispense and supply any prescription medicines:

  • Check the anti-tampering device (ATD) is still intact
  • Authenticate the unique identifier by scanning the 2D barcode printed on the pack. The data on the barcode will then be compared to data uploaded onto a national database by the manufacturers.

If the ATD is intact and the data matches, the pack can be dispensed and handed to patients.

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Q6. What happens to older stock and packs with multiple barcodes after the deadline?

In time, all new packs of prescription medicines will only display one 2D barcode, even when they are intended for multiple markets. Products with linear barcodes will be phased out and only packs with the new FMD-compliant barcode will need to be authenticated. Older stock that is not FMD-compliant can still be dispensed until it reaches its expiry date, so there is no need to withdraw existing stock. However, your team will need to take care in dispensing these products, as they will not contain the two new safety features. As part of their training, it is important to make sure your team understands which packs will need authentication and which can be dispensed without it.

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Q7. What new equipment and software will I need?

At the very least, community pharmacies will need scanners that can read 2D data matrix barcodes, as well as a Patient Medication Record (PMR) system that can exchange data with the National Medicines Verification System and report back on the result. SecurMed UK will deliver the UK Medicines Verification System, and has a list of registered software providers.

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Q8. Who will pay for the new equipment?

All end users, including pharmacies and wholesalers, will need to pay for their own equipment, software, initial set-up, IT, connections to the National Medicines Verification System, and on-going operational costs. The central database systems are paid for by the pharmaceutical manufacturers through a system of additional fees.

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Q9. When do I scan the pack?

Packs must be scanned and decommissioned before being handed to the patients. In practice, this is expected to form part of the dispensing process. See the ‘Understanding the FMD process' flowchart.

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Q10. What if a pack is decommissioned in error or is not collected by a patient?

Once a pack has been decommissioned, you have 10 days (240 hours) to reverse the process in the same premises as it was dispensed. Additionally, the product must still be intact and neither recalled, handed to the public, or expired. After reversal, the pack can be returned to dispensing stock and used again. If a patient does not collect their medication, you have 10 days (from decommissioning) to recommission the pack.

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Q11. What happens with split packs, monitored dosage systems and owings?

You can split packs under FMD by checking the anti-tampering seal, decommissioning the pack at the time of splitting, and then opening and using it as required. Any remaining medication from a split pack can be used without further checks, as long as it is still in date. It may be helpful to mark the pack in some way, perhaps with a sticker or hand-drawn marking, to show that it has already been decommissioned.

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Q12. What do I do if the pack does not return a positive verification?

This will depend on the reason for the negative return. If the pack has been recalled or withdrawn, normal recall processes will apply. However, any packs suspected of falsification will need to be quarantined and further investigation will be required. Your pharmacy may need to contact the National Competent Authority (for the UK, this is the Medicines and Healthcare products Regulatory Agency (MHRA)), but more information is expected from the MHRA later in 2018.

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Q13. But i'm calling you now, why can't you help me?

I understand this may feel frustrating for which I can only apologise, however whilst I am familiar with the FMD directive, I am not an expert in all procedures within it.

Therefore in order for you to get the best help possible, I strongly recommend you get the professional advice from these websites who can help you with pharmacy specific queries.

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Q14. I understand that you have changed your T&C's regarding returns, why is that? 

The introduction of FMD and the requirement to de-commission and verifying products in scope has meant that ALL wholesalers have had to consider how returns are managed.  

The introduction of FMD has meant that ALL wholesalers have had to consider how returns are managed. We have updated our terms and conditions including what FMD/GDP goods can be returned and conditions of an acceptable return.  

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Q15. Are there any patient safety implications?

FMD is mandatory for all UK pharmacies and pharmacy owners. This means all those responsible for patient safety will need to consider: the integration of new and existing processes, updating standard operating procedures, training your team members, aggregation and accuracy, in order to reduce any avoidable harm to patients. For more information, read the guidance paper titled: ‘The way forward for FMD in community pharmacy', found on the FMD Source website (www.fmdsource.co.uk).

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Q16. Who will be enforcing FMD and will there be penalties for not meeting FMD requirements?

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) will be working alongside pharmacy regulators to ensure that the Falsified Medicines Directive is implemented. Failure to meet FMD requirements could result in a penalty under the Human Medicines Regulations 2012. The MHRA will be consulting on the exact nature of the penalties before FMD comes into effect.

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Q17. How do i return a prduct that is subject to FMD regualtion?

A prescription only medicine i.e. an in scope product that has the two safety features, the 2D barcode and anti-tamper device applied can only be returned if  

  • the anti-tamper device has not be damaged 

  • the FMD product has not been de-commissioned before being returned by the 

  • the product must also be returned and received back in the Service Centre within three working days

If an FMD product is returned and it does not verify on return, we shall not be able to credit customers for this returned product.

If it is returned past the three day deadline, we are not obliged to accept the products.

If you satisfy all the above criteria, then please return your product in the usual way via your driver at your earliest convenience.

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