Falsified Medicines Directive out-of-hours GP Toolkit

This toolkit can be used to help identify the most suitable place(s) to verify/decommission based on user needs and the EU Delegated Regulation. This toolkit can also be used to inform users of what is needed to successfully implement FMD ensuring compliance, in addition to signposting sources of relevant FMD information.

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 GP practices).

The FMD toolkit will identify and outline all the possible points within out-of-hours services where verification and decommissioning could happen. Due the potentially varied landscape within out-of-hours services, each individual service will need to the apply the information 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.

The UK has classed General Practitioners (GPs) as health centres and therefore healthcare institutions – that includes both dispensing and non-dispensing GP practices. This was recently reviewed alongside the consultation and it can be confirmed that this position stands; GPs are not exempt under Article 23 and must decommission medicines. In fulfilling their obligations on decommissioning, because of the nature of their activity, dispensing doctors should seek to remain equitable to what community 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.

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.

The delegated regulation allows for the decommissioning of products within a healthcare institution to take place at any point whilst the product is in the possession of the institution provided that no sale takes place between the organisation who receives the product and the organisation who supplies to the public (Article 25(2)). It would therefore be for the healthcare institution to consider, given the operational procedures within its organisation, when it would be best for products to be scanned and decommissioned.

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.

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.

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 

SecurMed