What’s 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.
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 - best suited for 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. In most cases staff then have to manually enter relevant data into any existing system to record dispensing activity and deduct from stock. Some of the stand-alone FMD systems may offer an API which would allow pack information to be transferred into other systems you may have, although this may require development from your other system suppliers.
Integrated system - best suited for 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.
Automated - best suited for 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, performs the FMD scanning as the pack flows through the machine. May or may not be integrated with other pharmacy systems.
Next steps - today
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 accommodating registration for single locations and a bulk registration process for organisations registering multiple locations.
Last edited: 10 March 2020 10:42 am