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What is FMD

The Falsified Medicines Directive (FMD)  is a series of European anti-counterfeiting measures that will see pharmacists scan medicine products to verify their authenticity before decommissioning and handing them to patients. The FMD Working Group represents the interests of UK pharmacists.

The directive introduces harmonised EU measures to fight medicine falsification, ensure medicines are safe, and that the trade in medicines is rigorously controlled. Criteria include:

  • New, compulsory safety features – including a unique identifier and an -anti-tampering device – on the outer packaging of medicines
  • A standard, EU-wide logo to identify legal online pharmacies
  • Stricter rules on the import of active pharmaceutical ingredients
  • Strengthened record-keeping requirements for wholesale distributors.

When is FMD taking place?

FMD will start in all EU member states, including the UK from February 9, 2019.

How will FMD affect your Pharmacy?

By the deadline, your pharmacy will need to have at least one barcode scanner and even an extra workstation to allow you to ‘decommission’ medicines from the European Medicines Verification System (EMVS).

In the decommissioning process, medicine will need to be authenticated: have its UI scanned and verified against a UK safety database called the National Medicines Verification System, or NMVS before it is handed to a patient). This is so a pharmacist can verify it is a genuine medicine and not a counterfeit.

To do this, new pharmacy software will be required, either as an update to existing patient medication record (PMR) systems or as a standalone system. Standard operating procedures (SOPs) will also have to be updated, to incorporate the authentication scan into the current dispensing process, and of course, staff training will have to take place. (Source C&D https://www.chemistanddruggist.co.uk/feature/are-pharmacies-ready-for-fmd)

According to the working group, pharmacists will have to bear the costs of the barcode scanners.

The Pharmaceutical Services Negotiating Committee (PSNC) said that the four national pharmacy negotiators are working on ensuring FMD-related costs – including initial set-up, IT, software and hardware and ongoing operational costs – are recognised in future NHS funding settlements.

Mr Patel said: ‘With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment.’

What is FMD?

How do you prepare for FMD?

Requirements:

The regulations dictate that as of the deadline, all in-scope medicines, inclusive of prescription medicines as well as a ‘blacklist’ of over-the-counter (OTC) medications that are deemed to be at high risk of falsification must have two safety features: a unique identifier (UI) in the form of a 2D data matrix code and an anti-tampering device (ATD).

To prevent falsified medicines from reaching patients, anyone authorised to dispense medication to the public will have to authenticate each pack at the point of dispense by checking the ATD and verifying the UI.

The more complex element for pharmacists relates to verifying the 2D matrix code. The code first needs to be scanned and validated against the respective country’s National Medicines Verification System (NMVS).

If the medicines are genuine, the pharmacists will receive a confirmation message, which will change the product status to show that it has been dispensed or ‘decommissioned’ and has left the supply chain.

What is FMD?

Considerations for compliance:

A recent assessment from the EU Commission stated the annual costs to modify software for FMD compliance, purchase new barcode scanning equipment and perform medicines authentication, can be up to €530 (£406) for community pharmacists and €750 (£574) for hospital pharmacies, sometimes more.

In figuring out how to stay compliant, many small to mid-size pharmacists are likely to turn to patient medication record (PMR) system providers for support, expecting FMD solutions to be integrated within their current PMR system.

Whilst possible, not all PMR providers will be capable of or willing to deliver a compliant solution. Therefore, some PMR providers have developed strategic partnerships with third-party suppliers that allows them to roll out a solution among their customer base.

There are further considerations for pharmacists beyond the initial hardware and ongoing software investment including the investment in employee training, disruption to workflow and stock management. Some solutions consist of a fixed workstation, which will require dedicated space, power source and data connectivity, and decommissioning at a central point could cause delays in processes.

UK pharmacists may also face additional considerations, including Brexit, when it comes to FMD compliance. As it stands, the UK is pushing ahead with implementation to meet the 9th February deadline.

Our Operations Director, Saghir Ahmed had the following to say:

‘The pharmacy sector has been slow in understanding the value and application of FMD. Though the deadline for implementation is creeping up on us, and with uncertainty caused by Brexit, FMD will happen. Therefore all Pharmacist Superintendents need to have a system in place to be implemented in store, with Standard Operational Procedures tested and ready. FMD will alter our Pharmacy operations. Rather than hide from this, we need to be ready for this significant change in our dispensary operations.’

What are your thoughts on FMD, let us know in the comments below or join in the conversation online using #GreenLifeFMD.

Sources:

http://www.thepharmacist.co.uk/brexit-uncertainties-contractors-need-to-carefully-choose-fmd-system-npa-urges/

http://www.thepharmacist.co.uk/harsh-fmd-sanctions-for-isolated-compliance-failures-inappropriate-pharmacists-say/

https://www.chemistanddruggist.co.uk/feature/are-pharmacies-ready-for-fmd

https://ec.europa.eu/health/human-use/falsified_medicines_en

https://www.chemistanddruggist.co.uk/feature/are-pharmacies-ready-for-fmd

 

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