Falsified Medicines Directive Community Pharmacy Toolkit
The purpose of this toolkit is to inform and prepare staff members throughout community pharmacy for the implementation of the Falsified Medicines Directive (FMD). This toolkit can be used to help identify the most suitable place to verify/decommission based on their needs and inform staff of what they need to do to successfully implement FMD and be compliant. In addition the toolkit also provides useful links to other sources of relevant FMD information.
Who this is for
The majority of healthcare settings receive and supply medication and therefore need to implement FMD for verification and decommission purposes (this includes secondary care, community pharmacies and dispensing GPs).
How to use this toolkit
The FMD toolkit will identify and outline all the possible points within community pharmacy that verification could happen, and where decommissioning should happen (in line with the EU Delegated Regulation). Due the complexity and varied landscape within community pharmacy, each individual setting will need to the apply the scenario to their own unique supply chain/business needs.
The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aimed 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.
When to decommission
Pharmacies 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 within community pharmacy, what is clear is 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 on 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.
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.
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.
has a potential increase in manual processes
has a potential increase in labour time
is the lowest cost option
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.
The benefit of this option is a reduction in manual data entry.
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.
Not all medicine can go through a robot, so an additional scanning solution is necessary.
Guidance regarding contractual agreements/SLAs within community pharmacy will be added.
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.
Next steps - 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.
We visited Ben Eaton at the Dean and Smedley Pharmacy he manages in Swadlincote, Derby in February 2019, five days after the Falsified Medicines Directive (FMD) became law, to talk with him about his experiences so far
We visited pharmacist David Broome at his pharmacy in the village of Bramhope, North Leeds in February 2019, four days after the Falsified Medicines Directive (FMD) became law, and two weeks after he first activated FMD scanning.
The Coop Pharmacy group has 49 branches across Lincolnshire, Nottinghamshire and Norfolk. The branch we visited in Lincoln Was one of the first to go live with the Falsified Medicines Directive (FMD) in November 2018. We met with area manager Robert Vaughan in March 2019 for a chat about how they introduced FMD to their branches.