Falsified Medicines Directive Community Pharmacy Toolkit

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).

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.

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.

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.

You can also download these in PDF format.

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.

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.

Guidance regarding contractual agreements/SLAs within community pharmacy will be added.

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.

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.

Help in understanding how to map your processes from NHS Improvement

Medicines and Healthcare products Regulatory Agency (MHRA) Implementation Guidance

FMDSource.co.uk –  the website of the UK FMD Working Group for Community Pharmacy

SecurMed Registration

AAH Pharmaceuticals Ltd (EMIS Partner)
Advansys Technologies Limited
Aln Technology Limited
CegedimRx
Codesplice Ltd
Deans Computer Services plc 
DXC.technology
EMIS Health
Falsified Medicines App Ltd
FMD IT
Invatech Health
McLernon Computers Ltd
MedAspis B. V.
Melior Solutions Ltd
Optel Group
PharmData Ltd
Positive Solutions
Quick Pharm Solutions Limited
Rfxcel Corporation
Robosol Software UK Limited
RxWeb (Clanwilliam Health)
Serialogical
Socius24 Limited
TCK GmbH
Tracelink UK Limited
Vcare Systems
Vivitech Ltd
Voyager Medical Limited
Wise Software (UK) Limited
Zetes Limited