The Falsified Medicines Directive (FMD):
Your questions answered
- Q1. What is FMD?
- Q2. What is a falsified medicine?
- Q3. What does FMD apply to?
- Q4. When does FMD start?
- Q5. What will pharmacists need to do to comply with FMD?
- Q6. What happens to older stock and packs with multiple barcodes after the deadline?
- Q7. What new equipment and software will I need?
- Q8. Who will pay for the new equipment?
- Q9. When do I scan the pack?
- Q10. What if a pack is decommissioned in error or is not collected by a patient?
- Q11. What happens with split packs, monitored dosage systems and owings?
- Q12. What do I do if the pack does not return a positive verification?
- Q13. Has any time been factored into the process?
- Q14. Which standard operating procedures (SOPs) will need updating and do you have templates we could use?
- Q15. Are there any patient safety implications?
- Q16. Who will be enforcing FMD and will there be penalties for not meeting FMD requirements?
- Q17. What happens to FMD after the UK leaves the European Union?
Q1. What is FMD?
The European Falsified Medicines Directive (FMD) aims to reduce the number of potentially falsified medicines entering the European medicines supply chain. These products pose a risk to patients and undermine the genuine products supplied by manufacturers and pharmacies. The EU Directive will help to improve security across the supply chain, protecting patients from falsified products.
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.
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.
Q4. When does FMD start?
Authentication under FMD will come into effect from 9 February 2019. However, this only applies to prescription medicines bearing the two new safety features, and those that are released to the market on or after this date.
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.
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.
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.
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.
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.
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.
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.
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.
Q13. Has any time been factored into the process?
The UK Government has undertaken a full impact assessment of FMD across all parts of the medicine supply chain, and this will inform any future discussions on remuneration. The impact on your time will depend on the number of packs being scanned in the future, in comparison to your current processes.
Q14. Which standard operating procedures (SOPs) will need updating and do you have templates we could use?
This will depend on each pharmacy's workflows, but FMD will need to become a key part of your core dispensing. Your SOPs must cover anti-tampering checks and authentication scans, and you will need to create SOPs that handle any alerts and errors. Alliance Healthcare will be looking to develop further guidance before FMD comes into effect in February 2019.
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).
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.
Q17. What happens to FMD after the UK leaves the European Union?
The UK Government has stressed that it wants to keep "close regulatory alignment" with the EU after Brexit, so FMD should be covered in any withdrawal agreements and future trading relationships. In any case, with the serialisation of packs becoming the global norm, it is likely that the UK would adopt a similar system to enhance security across its medicines supply chain.