The majority of healthcare settings receive and administer medicines and therefore need to implement FMD for verification and decommission purposes (this includes secondary care, community pharmacies and dispensing doctors).
Falsified Medicines Directive - dispensing doctor
This toolkit prepares and informs dispensing doctors and any associated staff on the implementation of the Falsified Medicines Directive (FMD).
It can be used to help identify where to verify/decommission and it can also be used to inform users of what is needed to successfully implement FMD, ensuring compliance and signposting sources of relevant information.
Who this is for
How to use this toolkit
The FMD toolkit will identify and outline all the possible points within a doctor's dispensary that verification and decommissioning could happen. Due the varied landscape within dispensing doctors, each individual setting will need to the apply the information to their own unique supply chain and business needs.
The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aims to increase the security of the manufacturing and delivery of medicines in Europe and provide protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.
Guidance for dispensing doctors
The UK has classed GPs as health centres and therefore healthcare institutions, including both dispensing and non-dispensing GPs. This was recently reviewed alongside the consultation and it can be confirmed that this position stands, so GPs are not exempt under Article 23 and must decommission medicines.
In fulfilling their decommissioning obligations, dispensing doctors should seek to remain equitable to what pharmacies do, where appropriate. This needs to fit with the nature of the business, for example out-of-hours care decommissioning could happen when medicines are prepared and sealed in drugs bags, effectively as close to the point of supply as is reasonably possible.
GP IT Futures
The GP IT Futures framework, which will replace GPSoC, will include the capability to support FMD. We have called this capability Medicines Verification.
Suppliers have a choice whether to bid to supply this capability, but we know the existing GPSoC principal suppliers are looking to do this. This capability is quite discreet and doesn’t spread much further than what the EU law is looking for. The main feature is the integration with the FMD database.
Once suppliers have been through assurance for Medicines Verification, and are live on the GP IT Futures framework, CCGs will be able to call off this capability for their practices.
When to decommission
Dispensing doctors and/or dispensary staff will be required to authenticate products, which means visually checking the anti-tamper device and performing a verification and decommissioning scan at the time of supplying it to the public.
Although the term “time of supply” is ambiguous, it's clear that the FMD process must have been completed at the point the medicine is released to the patient or their representative. One way of doing this efficiently, where more than one product is involved, is to used and aggregated barcode on the bag label.
Aggregated barcodes are not required under the delegated regulation, but may be generated by pharmacy IT systems to link several pack identifiers together, if this functionality has been provided by the IT supplier.
They are not mandatory, but may be used to facilitate decommissioning.
Aggregated codes may be printed directly onto dispensing bags, or on a separate adhesive label to be applied to dispensing bags, and then scanned at the time of supply.
Aggregated barcodes could either contain all of the data of the pack identifiers, or simply provide a link to the data stored on the pharmacy IT system.
In and out of scope
Almost all prescription medicines with a marketing authorisation are in scope of FMD, with only a few specialist products, radionuclide kits and medicinal gases being out of scope. All non-prescription medicines are out of scope, with the exception of two omeprazole products (which were subject to falsification in the past).
Unlicensed products, including specials and clinical trial supplies, are out-of-scope, but any licensed products being incorporated into them (such as ingredients for specials) would have to be authenticated and decommissioned before they could be used.
Medical devices are out of scope, but separate changes are being made to regulation of medical devices.
Verification and decommissioning options
Potential FMD scanning error messages
The error messages below are the output of a working group combining a number of key pharmacy organisations and is likely to be favoured by the majority of system suppliers. However, as exact error messages are not mandated, these may vary slightly from supplier to supplier.
There will need to be some further work by system suppliers to match this to the error messages returned from the SecurMed system, but the image below is a good guide to start planning SOPs.
FMD solution options
Stand alone system
This option is best suited for a small volume decommission.
These systems work independently from other software solutions and support communication with the National Medicines Verification Service (NMVS) on barcode scanning facilitated by a member of staff.
Selection of any system should include a check that the system can deal appropriately with the volume of items to be scanned and the ‘cost’ of the system should include the staff time taken in scanning items for verification and decommission.
Delegated staff member scans medicines using a 2D compliant scanning device. Staff then have to manually enter relevant data into any existing system to record dispensing activity and deduct from stock.
In summary, this option:
- is totally manual
- requires increased labour time
- is the lowest cost option
This option is best suited for a medium to large volume decommission.
These systems are integrated into an existing system (such as the stock control system). Such solutions would normally incorporate the scan into the normal business process workflow and minimise the ‘additional operator’ demand or provide a business benefit that allows the increased staff time for scanning to be off-set by other benefits. System suppliers may be taking an incremental approach to offering such ‘business benefits’ but should be looking to deliver these within a reasonable timescale post February 2019.
Delegated staff member scans medicines using a 2D compliant scanning device. Existing systems used to record dispensing activity and/or stock control are automatically updated with pack information, reducing the manual data entry need.
In summary, this option reduces the amount of manual data entry needed.
This option is best suited for a small volume decommission
These are solutions such as robotic systems, where the barcode scan is a normal part of the loading of the machine and where the output from the machine can be attributed to an individual, identifiable pack. These systems have developed the links to the NMVS to support verification messages on receipt, or loading and decommission messages on supply.
There would need to be a facility to support scanning of non-robot items. Such systems minimise the staff implications of FD scans but may require further integration with stock control systems to leverage full user-benefits from the use of FMD barcodes.
Stock or order fulfilment machines, such as robotic dispensing machines, perform the FMD scanning as the pack flows through the machine. This may or may not be integrated with other pharmacy systems.
Not all medicines can go through this option, and an additional scanning solution may be necessary.
Understand your own process
Understand and map your own business process in order to consider where verification and decommissioning fits best and has the least impact on your own business processes.
Speak to system suppliers
It is important to speak with your current software solutions supplier to evaluate their readiness for FMD. It is your responsibility to be compliant and if your system supplier will not have a solution in place before February, we recommend looking at alternative solutions.
Register with SecurMed
SecurMed UK registration is now open. SecurMed will manage the process via a web-facing registration page accomodating registration for single locations and a bulk registration process for organisations registering multiple locations.
9 February 2019
Verify and decommission
Begin to scan FMD compliant medicine. In the unusual event you encounter issues with scanning, there is a manual process to verify and decommission.
Pharmacy system supplier list
AAH Pharmaceuticals Ltd (EMIS Partner)
Advansys Technologies Limited
Aln Technology Limited
Deans Computer Services plc
Falsified Medicines App Ltd
McLernon Computers Ltd
MedAspis B. V.
Melior Solutions Ltd
Quick Pharm Solutions Limited
Robosol Software UK Limited
RxWeb (Clanwilliam Health)
Tracelink UK Limited
Voyager Medical Limited
Wise Software (UK) Limited