This page was last updated on 1st November 2018
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 during the dispensing process, prior to hand-over to patients. Processes will be needed to deal with any unexpected results and with reverse decommissioning, where necessary.
Who will pay for this in pharmacy?
The EU Delegated Regulation [2016/161] makes it clear that 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 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.
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, it is expected that vaccines will need to be authenticated 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.
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.
In due course, some PMR systems may 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 received from the wholesaler/manufacturer?
There is no requirement to do this, but you can 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 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] as soon as possible 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, we expect the returns process to be unaltered. 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.
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 counterfeit is detected?
You will get a message to say the medicine is not in the UK hub (and therefore a suspected counterfeit). The UK hub will automatically alert the MHRA; however, you may wish to contact the MHRA immediately in person to notify them. 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.
My internet/broadband is slow. Will that affect the system?
No. The system is designed to work on a very low internet speed.