The EU Falsified Medicines Directive (FMD) was introduced into the UK on the 9th February 2019. This legislation triggered major changes for community pharmacists and their teams.
To ensure you and your team are ready for the FMD it is essential that you develop an implementation plan and start to train your staff.
| Action | Information/consideration | Resources |
|---|---|---|
| Ensure you understand the requirements | Do you understand all the elements required to be FMD compliant? | Numark support and resources FMD support (FMD source) |
| Determine which form of IT solution you wish to use | Consider the options available: • FMD integrated PMR system • Standalone system Confirm your preferred Supplier: • Current PMR provider • New IT provider Can you upgrade your chosen system if new functionality becomes available, for example an accuracy checking or stock control? Do the terms of the contract meet your business needs and include an exit clause if the final Brexit solution means that the UK is not able to connect to the EMVS? Consider the cost, community pharmacy contractors will be required to pay for all equipment , software upgrades and ongoing support costs associated with linking to the NMVS. |
Numark Assist Integrated FMD solution FMD IT suppliers (FMD source) |
| Identify the equipment you require | Do you need additional computer terminals or other computer hardware? Can you obtain enough scanners?- it is recommended to have one per PMR terminal. |
Numark Assist Integrated FMD solution FMD IT suppliers (FMD source) |
| Dispensary layout Consider the optimal location of scanners for dispensing process including verification and prescription handout |
Do you need to re-arrange your dispensary to accommodate new equipment and to facilitate a safe dispensary flow? Do you have enough space to locate a separate FMD system? Do you have enough plug sockets or electrical connections for a new FMD system? Do you need to create space on your reception or medicines counter to accommodate the FMD system? |
Numark support and resources |
| Register your pharmacy with SecurMed (termed “on-boarding”) | Each community pharmacy needs to connect to the NMVS (SecurMed UK FMD system): Check whether your IT system provider will register your pharmacy as part of your contract Register your pharmacy through SecurMed | Numark support and guidance Numark Assist Integrated FMD solution SecurMed guidance and registration (SecurMed) |
| Consider how you will revise your dispensing processes | Can you revise your dispensing processes to remove any existing issues that adversely affect the dispensary flow or safety? Verification of medicines: • Will you do this at the point of receiving stock from the wholesaler? • Will you do this during the dispensing process? • Will you do this at the same point as decommissioning? Decommissioning medicines: • Will you scan each item individually at the point of supply to the patient? • Consider how to avoid jeopardising patient privacy if decommissioning at point of supply. • Will you use aggregated codes and decommission at the point of supply to the patient? • Will you decommission medicines as part of the dispensing process? It is important to consider the 10 day rule if adopting this method. • Will you have different procedures dependent on whether the patient is waiting or collecting later? • Consider how will you avoid issues with patient confidence if medicines fail a scan. • When will you decommission medicines for delivery? • Consider how and when you will decommission medicines from packs that need to be split. • What processes do you need to put into place to identify split packs that have been decommissioned and to differentiate these medicines from those with damaged packaging? • Do you supply medicines to care homes or in compliance aids, if so consider when you will decommission these medicines? • Consider what additional processes will be required when products fail a scan. • Changes to dispensary processes must be reflected in changes to the pharmacy SOPs. |
Revised dispensary SOPs- Numark Numark SOP- FMD error and alert messages Suggested dispensary workflow using aggregated codes dispense first Suggested dispensary workflow using aggregated codes dispensing label first EU FMD scanning and error messages flowchart FMD error and alert messages guidance notes Explanation of FMD error and alert messages (PharmacyFMD) |
| Staff Training Pharmacy staff will need understand why FMD has been introduced and how it will affect your pharmacy. Pharmacy staff will need to be trained on the revised dispensary processes and also what they should do if a product fails a scan |
Confirm whether training is available through your chosen IT system supplier. Consider the scenarios where pharmacy staff may need to explain FMD processes to patients, for example why the anti-tamper device is no longer intact, when medicines have been reconstituted. How will you prepare your staff for these conversations? |
Counter Excellence/Pharmacy Excellence PSNC webinar (PSNC) |
| Information for patients | Consider using leaflets to communicate key messages. Could you incorporate FMD into your practice leaflet at the next update? How will you explain to patients why the anti-tamper device is no longer intact, for example on medicines requiring reconstitution? |
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| Additional considerations | Check with your wholesaler regarding revised processes for returning medicines following the introduction of FMD. Regulatory Inspection-include FMD compliance as part of your preparation for GPhC or PSNI inspections. Consider how you will review your processes for disposal of out of date stock. Hub and spoke dispensing will require careful consideration to determine how the process will comply with the FMD regulation: • Can the ATD be checked at the hub and the UI data stored in the IT system for final verification and decommissioning at the point of supply to the patient? |
FMD FAQs |
Numark Assist Integrated FMD solution
Our solution supports a wide variety of dispensing workflows to ensure that you can easily comply with the FMD.
Benefit from aggregated barcodes, future service requirement updates, a short notice period and much, much more.