This page was last updated on 27th March 2020
What will change for pharmacy contractors?
Community pharmacy contractors will be required to ensure that all their pharmacies are connected to the UK Medicines Verification System (the UK hub), including having appropriate software and hardware (scanners etc.) as needed.
Standard operating procedures will need to be changed to ensure that all relevant prescription medicines are authenticated and decommissioned prior to hand-over to patients. Processes will be needed to deal with any unexpected results and with recommissioning (reverse decommissioning), where necessary.
Who will pay for this in pharmacy?
The EU Delegated Regulation [2016/161] says the costs of establishing the repositories system (i.e. the European and national verification systems and their governing bodies) is to be borne by manufacturers (i.e. research-based companies, generic manufacturers and parallel traders).
Community pharmacies (and wholesalers) will be required to pay for any “physical scanning equipment” that is required for reading unique identifiers. They will also have to pay for any software upgrades that are required to connect with the UK hub and to make use of the data they receive (i.e. the status of UIs they have scanned).
Each of the four national community pharmacy negotiators (PSNC, CPS, CPW and CPNI) is working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements.
What medicines do I need to authenticate?
All prescription-only medicines, including generics, have to be authenticated. Non-prescription medicines do not need to be authenticated unless specified. At present, the only non-prescription medicines identified for medicines authentication are omeprazole 20mg and 40mg capsules only. This does not apply to omeprazole tablets or 10mg capsules. The MHRA can decide if they wish to include other non-prescription medicines in the future.
Do I have to authenticate veterinary medicines?
No. The rules apply only to medicinal products for human use. However, if you supply human medicines to an animal owner on a veterinary prescription or you supply human medicines to a vet on a requisition, you must authenticate at the time of supply.
Where and when do I have to check the ATD and decommission the product?
Pharmacies will be required to authenticate products, which means visually checking the anti-tampering device (ATD) and performing a verification and decommissioning scan, “at the time of supplying it to the public”. At the time of supply is not an instant, but a period of time, from when a pack is selected, to when the patient (or their representative) has the pack. The ATD check must take place during that period, as must the decommissioning.
One way in which the authentication process can be handled is by using an FMD system which stores the UIs of multiple packs or items dispensed on a prescription and associates this data with a single code which would be printed on a label attached to the dispensing bag. Using this approach, products would be scanned and verified during assembly, then, at the final hand-over to the patient or representative, the single code on the dispensing bag would be scanned and this would trigger the decommissioning of the products on the UK hub.
The precise process will depend on each contractor’s SOPs and may vary depending on whether the patient (or their representative) is present or not. It is important to note that the check of the ATD and the decommissioning scan may occur at different points in that process. Decommissioning should happen as close to the time of supply to the patient as possible, but there are other important considerations. Disruption to the dispensing workflow could jeopardise safety. Emptying out bags to scan packs in front of the patient could compromise patient privacy and poses problems if any pack fails to authenticate for any reason.
Will I still be able to use split packs?
Yes. Packs that are going to be split will have their ATD checked and be decommissioned at the point at which they are first opened. The remainder of the pack can be dispensed without further checking at a future point, as it will have already been decommissioned. Pharmacy staff will need to mark these packs to indicate they have already been decommissioned.
How will I deal with liquids?
These will be decommissioned whenever the anti-tamper device has been broken, i.e. when the bottle has been opened.
Do I have to authenticate vaccines?
Yes, vaccines will need to be decommissioned before they are administered.
Will I still be able to do MDS?
Yes. Packs of medicines will have to be verified and decommissioned before they are opened to be repacked in an MDS.
What happens if the ATD gets broken? What if I need to break the ATD to assemble a medicine?
If you need to open a pack, either to split the quantity or to prepare or label the product, you will need to check the ATD and decommission the pack before it is opened. The pack can then be dispensed and supplied to patients in the normal way, including in MDS.
When checking the anti-tampering device at the time of dispensing, pharmacy staff will be looking to see that the product does not appear to have been tampered with. This will depend on the nature of the device or format used to seal or secure the packaging. Products with packaging where the anti-tampering device has clearly been broken cannot be supplied to patients (unless this was done by the dispenser as part of the process of assembling the medicine).
Wholesalers have to verify products that are returned to them, including inspecting anti-tampering devices. It is unlikely that they would accept back products which have broken anti-tampering devices.
What happens if the pack doesn’t have a 2D barcode?
There will still be many packs without 2D barcodes in the supply chain when the FMD requirements come into effect on 9th February 2019. These packs will still be able to be dispensed and supplied but they will not be required to be decommissioned.
Some packs are already appearing with 2D barcodes as manufacturers make changes in advance of the FMD requirements.
What happens if a pack has a 2D barcode, but it is not recognised by the UK hub?
Some medicines marketed in the UK already have 2D barcodes, but their details will not be included in the UK hub, e.g. some generic medicines manufactured in India, where a separate medicines authentication system is already in place. If these products are scanned, the UK hub will not recognise them, but unless the dispenser has any concern about the authenticity of the product, they can continue to be supplied to patients, as now. FMD compliant packs will have an anti-tampering device and a 2D barcode, so packs with a 2D barcode but no anti-tampering device will not be FMD compliant packs and will not need to be scanned. Further advice on how to identify which packs should be scanned can be found on this page.
Will I still be able to use PI products?
Yes. Parallel traded products will have to re-packaged and re-labelled for the intended country of use. This will include applying a new unique identifier and 2D barcode (linked at batch level to the original UI) and replacing the ATD if it has been broken. They will then be treated in the same way as a pack originally manufactured for the UK market. Note that the position of parallel traded products after the UK leaves the EU has yet to be clarified.
Will this mean that I get paid for (exactly) what I scan?
The Delegated Regulation gives Member States the flexibility to use information derived from unique identifiers for the purposes of reimbursement, pharmacovigilence and pharmacoepidemiology. At present, the Department of Health and Social Care do not intend to use the flexibility for the purposes of pharmacy reimbursement.
Will I have to link scans/UIs to patient records on my PMR system?
There is not a specific requirement within the Delegated Regulation to record or link unique identifiers to particular patients. No patient-specific information will be captured or stored within the repositories system, including the UK hub.
PMR systems may in the future allow UIs to be linked to the records of patients to improve pharmacovigilence and product recalls.
How long will it take to authenticate a medicine?
The maximum response time of an individual repository, such as the UK hub, is 300 milliseconds. If the system has to check repositories in other Member States, each stage will take a maximum of 300 milliseconds.
Who owns the data held in the system?
Manufacturers, wholesalers and pharmacists only have ownership of, and access to, the data they generate when they interact with the UK hub. This means that pharmacists own the data that they create and no one else can access or use it, except the MHRA and DHSC for auditing and investigation purposes.
Who has access to the data?
The MHRA or DHSC can request access to specific data from the UK hub for supervisory purposes or when investigating potential incidents of falsification.
Will manufacturers and wholesalers be able to see data on products I have dispensed?
No. The Delegated Regulation is clear that all parties that are connected to the repositories system, including manufacturers, wholesalers and pharmacies, have sole responsibility, ownership and access to any data that they generate. This data is not shared with any other parties, other than DHSC/MHRA, where necessary.
The only exception is the status (“active”/“inactive”) of products’ UIs, which is available to any party that has a relevant pack in their possession.
The UK hub will maintain an audit trail of when and where product information was uploaded and accessed, and where and when UIs are decommissioned. This data cannot be shared with other parties, other than with the express written permission of the data owner. The only exception is when there is an investigation into an incident of potential falsification.
Can I still sell data to IMS?
Pharmacy contractors will be able to sell dispensing data generated by their PMR systems in the normal way, but it is likely that commercial restrictions will be placed on the use of individual pack data derived from the FMD system, in line with the data ownership rules outlined above.
Do I need to verify medicines when I receive them from the wholesaler/manufacturer?
There is no requirement to do this, but you can do so if you wish.
Will my wholesaler decommission for me or can I decommission stock when I receive the stock from the wholesaler?
No. Decommissioning within pharmacies has to occur “at the time of supplying it to the public”. This means that decommissioning needs to occur in the process as close to the supply to the patient as possible. Decommissioning when stock is received would not fulfil this criterion. In addition once decommissioned, stock can only be re-commissioned within 10 days. This would mean that anything decommissioned more than 10 days ago could not be returned to the wholesaler.
Wholesalers can decommission products for a range of healthcare professionals, public service bodies and other organisations that use or supply medicines as an occasional part of their work, but community and hospital pharmacies are specifically excluded from this.
I have a Wholesale Dealer’s Authorisation. What does this mean for me?
Not only will you have to abide by the regulations for pharmacies, but you will need to abide by the regulations for wholesalers as well. This will involve numerous different steps and we recommend that you read the Delegated Regulation [2016/161] to ensure that you will be familiar with the rules you will have to work to.
Will I still be able to return products to my wholesaler?
This will depend upon your wholesaler’s terms and conditions, but in general, as long as the stock has not been decommissioned and the anti-tampering device is still intact, returns processes should be unaltered by FMD. Wholesalers will have to verify the status of any products returned to them, so products that do not have an “active” status would not be accepted back.
How will the system deal with recalls?
If a medicine is recalled, the manufacturer or parallel distributor will update the system (both at European and UK hub level), marking the relevant batch numbers as being recalled. Pharmacies will also receive recall information from the manufacturer/MHRA in the normal way. If a pharmacy omits to return the recalled medicine and tries to dispense it at a later date, when the barcode is scanned, the system will indicate that the product has previously been recalled. You must not dispense such medicines to patients.
How will the system deal with expired/out-of-date medicines?
The 2D barcode contains the expiry date of the product. If you attempt to dispense the product after the expiry date has passed, the system will alert you to the fact that the medicine has expired. You must not dispense such medicines to patients.
What do I do when disposing of out-of-date or damaged stock?
If the stock is damaged, decommission the stock first before disposal. If the stock is out-of-date, you do not need to decommission it as the system will know that the stock is expired; just dispose of it as usual.
If I need to supply a medicine to a patient in an emergency, do I need to authenticate it first?
If you need to administer a medicine in an emergency, e.g. adrenaline, you may not have time to authenticate it before administration, so you should administer the medicine first and authenticate later. If you are simply making an emergency supply of a medicine, the medicine should be authenticated before being given to the patient in the normal way.
What happens if the system/internet connection fails?
If the UK hub is unavailable, the software interface or computer programme, for medicines authentication will record the scanned codes and they will be authenticated when the UK hub is back up and running. In the meantime, medicines can be supplied as normal.
If the local FMD system fails, a record of the UIs would need to be made of any products supplied to patients, so they could be decommissioned once the FMD system is operational again.
What happens if the barcode is damaged or the scanner can’t read the barcode?
The unique identifier must be visible on the medicinal product in a human-readable format in case the barcode is unreadable by the scanner. You can manually enter the code to authenticate the medicine. However, if the scanner can’t read the 2D barcode and you can’t read the human-readable code because of damage, it is recommended that the medicine is not supplied to the public.
What happens if a falsified medicine is detected?
You will get a message to say the medicine is not in the UK hub (and therefore a suspected falsified medicine). The UK hub will automatically alert the MHRA; however, you should also contact the MHRA by completing a Yellow Card report. It is also good practice to notify the wholesaler/supplier. Physically check all stock (shelves, fridge, controlled drugs cupboard, returns area, prescriptions waiting for collection etc.) for medicines with the same batch number and quarantine them until further instructions are issued by the MHRA.
What happens if upon decommissioning a medicine pack I encounter the message ‘dispensed by another organisation’ or ‘locked’ on the screen of my FMD IT system?
If you encounter a message indicating the pack is locked or already dispensed, you should urgently follow a similar process as if you had encountered another ‘falsified’ warning (as per the question above you should: contact the MHRA by completing a Yellow Card report; consider the good practice of notifying the wholesaler/supplier/manufacturer; checking other stock that could be from the same batch; and considering quarantining until further instructions from MHRA).
FMD WG’s position is that manufacturers / wholesalers / suppliers must not mark packs as ‘locked’ when the stock is not within their physical control. Locking is a form of electronic quarantine which should accompany physical quarantine. Pharmacy contractors encountering the ‘locked pack’ message is not a desirable situation.
Notes: Even for scenarios in which wholesalers are not required to verify packs or samples, they may do so as a good practice which may identify packs with bad messages before they reach pharmacies.
Note: Your FMD IT supplier may have aligned message warning with those used by SecurMed (see FMD Working Group’s alerts guidance) so that the wording you see aligns with the necessary messages you need to know about.
If I am making a Yellow Card report to the MHRA about an FMD issue with a medicine pack, can I submit images to the MHRA to support my explanation of the incident (e.g. phots taken with my phone of the pack/barcode)?
Yes. The Yellow Card report allows images to be attached. Common image formats are accepted.
Note: Not all image formats are accepted. Apple’s High Efficiency Image Coding (HEIC) images are not accepted. You may include your email address within your Yellow Card report and will then receive an email notification to confirm your ticket has been opened. You may reply back to this email with the ticket number included within the subject and attach an image if necessary.
Do I need a separate internet connection for FMD?
FMD systems will not specifically need a separate internet connection from the pharmacy’s main connection (e.g. HSCN or N3), but the systems could operate on a separate connection if desired.
My internet/broadband is slow. Will that affect the system?
No. The system is designed to work on a very low internet speed.
Will FMD impact on the way pharmacies use the English Electronic Prescription Service (EPS)?
There will be no direct impact on the way EPS operates, but PMR systems with integrated FMD functionality may be configured to link the decommissioning of products, as they are handed to a patient, to also trigger the sending of the dispensed message to the Spine.
How will FMD help identify dispensing errors?
If an integrated PMR / FMD system is used, the software will be able to check whether the products scanned match the items on the prescription/dispensing label. If there is a mismatch, the user will be alerted by the software, thus reducing the likelihood of incorrectly selected products being dispensed to patients.
Are food supplements, such as Ensure, and gluten-free foods covered by FMD?
Will we need two types of scanners – one for “normal” 1D barcodes and one for 2D barcodes?
No. 2D barcode scanners will also scan normal 1D barcodes.
Do I have to verify and decommission medicines I supply via a Patient Group Direction or as an emergency supply?
Yes, supplies of any prescription medicines will need to be verified and decommissioned before they are supplied to the patient.
How does FMD work if stock is “loaned” to another pharmacy to fulfill a prescription or stock is transferred from one pharmacy to another (within the same body corporate)?
If a full, active pack, i.e. one which has not been decommissioned, is to be loaned or transferred, the pack should be decommissioned by the receiving pharmacy when they supply the medicine to the patient. The pharmacy that loans or transfers the item does not need to use the FMD system in relation to the medicine prior to the loan or transfer, but they could choose to verify the product.
If a split pack of medicine, which has already been decommissioned, is loaned or transferred, the receiving pharmacy should be notified of this, so they do not attempt to decommission the product.