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GB contractors can scrap FMD systems in 2021 but directive stays in NI

The Medicines and Medical Devices Bill could allow ministers to introduce an FMD substitute in Great Britain

Contractors in Britain can turn off their FMD systems after December 31, but the directive will still apply in Northern Ireland for “at least four years”, it has been highlighted.

Pharmacies in England, Wales and Scotland will no longer be legally responsible for “verifying and decommissioning unique identifiers on prescription medicine packs” at the point of dispensing from the end of the transition period on December 31, the UK FMD Working Group for Community Pharmacy (FMDWG) said in an update to contractors yesterday (November 16).

Pharmacies will be “disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK” at the end of the transition period. However, contractors will need to check that, if their patient medication record (PMR) systems have integrated Falsified Medicines Directive (FMD) functions, these are no longer connected to or “seeking a response from UKMVS after the end of 2020”, according to FMDWG.

“Stand-alone FMD systems can simply be turned off” after December 31, the group added.

However, contractors who have FMD integrated into their PMRs can continue to use the FMD scanner “as some functionality will still work with FMD compliant packs – such as accuracy checking or date checking”,  National Pharmacy Association head of corporate affairs Gareth Jones told C+D yesterday.

FMD still applies in Northern Ireland

Under the terms of the Northern Ireland protocol of the EU Withdrawal Agreement, the FMD directive will continue to apply in Northern Ireland for “at least four years”, FMDWG said.

As part of the protocol, a 12-month “phased process” will begin after the end of the transition period, to allow businesses time “to prepare in relation to batch testing, importation and FMD requirements” the Cabinet Office announced earlier this month (November 5).

Pharmacies in Northern Ireland will continue to connect to the UKMVS and will need to comply with current FMD requirements. SecureMed UK will support Northern Ireland branches “to decommission packs with FMD identifier features into 2021 and beyond”, FMDWG said in its update.

Future of FMD in Great Britain

The Medicines and Medical Devices Bill – which is being discussed at committee stage in the House of Lords today (November 17) – could allow ministers to introduce a national system that would allow medicines to be “authenticated and identified if tampered with”, the FMD group said.

However, before introducing such a system, the government would need to consult key stakeholders, including pharmacy bodies, the group added.

Mr Jones told C+D that “it is too early to say how the national system will work” but that using a scanner at the point of dispensing is only one way of checking that medicines are not counterfeit.

While different arrangements were made to cover the cost of FMD in England, Scotland and Wales, “discussions will now have to take place to ensure that pharmacies in each of the three nations are not left out of pocket by the decisions that have led to the end of the requirement to scan”, he added.

A Department of Health and Social Care spokesperson told C+D today that the government will “explore all options for a national system” to protect the public against falsified medicines.

“We are committed to fully consulting with stakeholders on any future development of a national falsified medicines scheme that is the best fit for our national supply chain, taking into account investment made,” they added.

FMD came into force on February 9 last year, but from the start pharmacies reported having to deal with “false alerts” – error messages such “unknown product code” and “failed to find batch” that might not necessarily indicate a falsified medicine.

An impact assessment published by the Medicines and Healthcare products Regulatory Agency in 2018 estimated FMD related-costs – the “social cost” for scanners, “training and familiarisation”, and decommissioning – at £666.1 million over a 10-year period.

14 Comments
Question: 
What do you make of this announcement?

David Holdsworth, Community pharmacist

Can we also abolish tamper proof packs . Look scruffy on externals when you label inner pack. Look scruffy on shelf and useless when part pack dispensed from them. Better to move to original pack dispensing .

Leon The Apothecary, Student

I'm pretty sure the majority of places aren't even using it now, to be honest, so not a lot is going to change.

Paul Dishman, Pharmaceutical Adviser

That was a total waste of time, money and effort 

Dave Downham, Manager

RIP FMD. No flowers requested. Keith Ridge to read moving obituary. Collection will be on behalf of developers of stand-alone FMD software. Thoughts and prayers to those advocates who predicted it would identify widescale counterfeiting.

FMD is survived by 2 scanners, 1 bespoke computer and a skipload of SOPs.

David Moore, Locum pharmacist

Lol! Excellent, Dave.

A.S. Singh, Community pharmacist

Probably the best news this year. I do feel for the contractors who have followed the rules and invested equipment and spent time implementing what has been the biggest load of BS to hit pharmacy in modern times

I maybe wrong but I've read somewhere that they are yet to find a counterfit product in nearly 23 months in community pharmacy. Says it all really

Oliver Staunton, Information Technology

FMD did help to identify where products were being reused or had been stolen, which could mean that products had been stored incorrectly, but I don't think any counterfeits were found.

A.S. Singh, Community pharmacist

Oliver you sound like you were part of the FMD project. Getting paid to deliver something that you have no clue running at ground level. Apologies if you were not.

D Change, Community pharmacist

Oliver, first hand I can tell you it was a good waste of everyone's time.

Watto 59, Community pharmacist

Agreed but in the BS stakes it is in a photo finish with CPCS

Oliver Staunton, Information Technology

Although standalone systems may be automatically switched off, contractors should still ensure that they are not charged any additional fees. Some contractors may also be due a refund if their system included a clause in case of Brexit.

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

Either way, still a monumental waste of time and money and is there a person out there who can hand on heart say they scanned every single pack they dispensed? I certainly didn't.

Oliver Staunton, Information Technology

There are flaws in the system which means that it could have been circumvented anyway

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

So realistically then, if someone was intent on putting fraudulent stock into the UK supply lines, they could do it easily anyway? What an utter nonsense.

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