What is the Falsified Medicines Directive (FMD)?

Whilst the pharmaceutical industry is one of the most regulated industries in the world, an estimated 1% of the two billion items annually dispensed in the UK may be counterfeit. This creates the potential for 20 million packs of falsified medicines to circulate in the UK every year.

The Falsified Medicines Directive is the EU’s response to this threat to the formal supply chain. FMD is designed to secure the UK supply chain by the checking of identity, history or source of the medications being dispensed.

What is the UK Community Pharmacy FMD Working Group?

Positive Solutions has and will continue to work with the UK Community Pharmacy FMD Working Group. The FMDWG brings together Community Pharmacy representative bodies and meets regularly to achieve practical solutions for the operation of FMD in the UK. The group, which includes representation from PSNC, NPA, AIMp, CCA, CPW, CPS and CPNI, has developed guidance and resources for pharmacy contractors. Further details are available from https://fmdsource.co.uk/

What is SecurMed?

SecurMed UK is the not-for profit organization that will manage the UK Medicines Verification System under the supervision of the MHRA and Department of Health.

Who will fund FMD?

Under the Delegated Regulation, each sector -including Pharmacy- is responsible for its own costs for connecting to the NMVS. It is anticipated that FMD-related costs, including initial set-up, IT software and hardware and any ongoing operational costs, for Pharmacy contractors may be recognised in future NHS funding settlements.

The costs of establishing the NMVS will be borne by branded and generic medicines manufacturers and parallel distributors.

Will Brexit affect FMD?

Whilst there’s a lot of clarification required between now and the introduction of the final legislation, the Medicines and Health Regulatory Association (MHRA) has been given ministerial guidance that the UK will apply all EU safety of medicine regulations prior to its planned departure from Europe. The UK FMD Working Group has also made it clear that there will be no cancellation of the regulation, no opt out by the UK and no delay in its enactment.

How will I deal with liquids?

These will be decommissioned whenever the anti-tamper device has been broken i.e. when the bottle has been opened.

How will I deal with split packs?

These will be decommissioned whenever the anti-tamper device has been broken. The pack can then be marked e.g. with a sticker to show it has been decommissioned.

How will decommissioning happen with split packs in MDS robots?

These will be decommissioned whenever the anti-tamper device has been broken i.e. when the box is opened and the tablets put in the robot.

How will I deal with large bottles containing hundreds of tablets?

These will be decommissioned whenever the anti-tamper device has been broken i.e. when the bottle has been opened.

How will dossette packs be handled?

These will be decommissioned whenever the anti-tamper device has been i.e. when the box is opened and the tablets are put in the dossette.

What about instalment dispensing in Scotland? The script may be for a period time e.g. 8 times and could also involve split packs. When would decommissioning happen?

You should decommission at each dispensing instance using the barcode on the bag label

How do I change my preferred FMD solution supplier after I’ve already registered with SecurMed?

If a pharmacy/dispensing entity wants to change the system supplier they’ve already registered with SecurMed on boarding, the following process should be followed:

  • The end user registrant should Email registration@securmed.org.uk with all the details in the primary action.
  • Depending on whether the certificates and passwords have been allocated, SecurMed will advise accordingly.
  •  If the certificates and passwords have been supplied but not entered into any system, they are still relevant and usable with the new supplier.
  • If the certificates and passwords already supplied have already been entered, it is still possible to re-use the certificate and password – however technical support may be necessary.
  • If the business has moved location new certificates and passwords need to be registered and obtained via the SecurMed registration process.
What should I include in my SOPs for FMD?

Community Pharmacy SOPs should account for the following processes in their revised SOPs

  • Checking of Anti-Tamper Devices.
  • Scanning of unique 2D codes.
  • Performing 2D barcode checks against the National Medicines Verification System.
  • Authentication and decommissioning of all relevant prescription medicines during the dispensing process, prior to hand-over to patients.
  • Unexpected results e.g. product recalls, identification of falsified medicines.

Revised SOPs must be in place by 9th February 2019.

What is likely to happen about FMD after Brexit?

There are currently no official guidelines on this matter from the PSNC or other pharmacy representative bodies.

FMD comes into effect on 9th February 2019 prior to the UK’s departure from EU legislation. Full implementation of FMD going forward, is likely to depend on the UK’s relationship with the EU post-Brexit.

Access by pharmacies and other dispensing entities to the European FMD hub is likely to continue during the transition period. If the UK government realises its aim of a close alignment on medicines policy within the Brexit agreement, access to the European FMD hub is also likely to continue after 2020 for UK end users.

In the event of a breakdown in the UK’s relationship with Europe post-Brexit, access to the Europe medicines database may no longer be available. Instead, dispensing entities registered (on-boarded) with SecurMed may be required to register with a UK medicines database.

The following points should be considered regarding what is likely to happen post-Brexit:

  1. UK consultants and sector specialists have played a considerable part in leading the development and research to set up the EU FMD legislation, with investment of significant resources and funding. The UK Government is not likely to write-off this investment by withdrawing from any FMD implementation.
  2. There is heightened awareness of the increasing number of falsified medicines entering the UK supply chain. There is likely to be a greater need to establish measures to combat the spread of illegal and harmful products.
  3. In the event of a UK withdrawal from FMD, we will be the only country in Europe without control measures in place. The UK will therefore become an easy-target for flooding the market with falsified medicines.
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