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DH: No-deal Brexit will revoke FMD, but pharmacies must prepare anyway

Claymore Richardson (third from left) spoke on a FMD panel at the Pharmacy Show
Claymore Richardson (third from left) spoke on a FMD panel at the Pharmacy Show

The “unlikely” outcome of a no-deal Brexit would revoke the Falsified Medicines Directive (FMD), but pharmacies must prepare anyway, a government official has said.

The FMD – created to prevent counterfeit medicines from entering the supply chain – will require every pharmacy in the UK to scan barcodes and check tamper-proof devices from February 9, 2019, less than two months before the UK is due to leave the EU on March 29.

But Department of Health and Social Care (DH) senior policy manager Claymore Richardson said on Sunday (October 7) that if “we don't reach agreement on a long-term future” with the EU then “we'd have to revoke FMD, because you can't have something that's legally impossible to provide”.

Mr Richardson’s comments follow the publication of a Medicines and Healthcare products Regulatory Agency consultation last week, in which the watchdog said the “legal obligation” to comply with the FMD “would be removed” in a no-deal Brexit scenario.

In a no-deal scenario, the DH would consider a “national system” similar to that set out in the FMD, Mr Richardson said, speaking at the Pharmacy Show in Birmingham.

This new system could build upon the FMD preparations that have been made by community pharmacies and manufacturers, he added.

“The UK wants to be in the club”

Speaking to C+D after his session at the Pharmacy Show, Mr Richardson said that if the UK is going to remain part of an EU regulatory network then it “will have to demonstrate to the EU that we have done things like FMD”.

“We want to be able to say: ‘The UK wants to be in the club and we've implemented FMD even with all the uncertainty’. We don't want to be a weak link.”

There’s a “global move” in the general direction of the FMD, said Mr Richardson, citing countries such as the US and Singapore.

Mr Richardson advised pharmacies to prepare for the FMD as “we’re mandated to do it”, but to “be cautious” by not signing up to long-term contracts. This advice was echoed by the National Pharmacy Association to its members last week.

The Pharmaceutical Services Negotiating Committee said on Sunday (October 7) that the government has agreed to discuss the possibility of remuneration for pharmacies complying with FMD as part of the sector’s funding for 2019-20.

11 Comments
Question: 
Are you prepared for the FMD?

Mr CAUSTIC, Community pharmacist

What happens with part packs where one has to use 7 tablets and is left with 21 ? I do not think I have seen any guidance on that.

It must be April 1st and this is an April fools joke . Everyone has to invest in the hardware and software and if there is a hard brexit we will not use it . Why not announce the UK delays implementation until 6 months after the results of the brexit discussions .

A B, Community pharmacist

 

 

"Packs that are going to be split will have their ATD checked and be decommissioned at the point at which they are first opened [Article 28]. The remainder of the pack can be dispensed without further checking at a future point as it will have already been decommissioned" 

From the FMD source website

Richard MacLeavy, Non Pharmacist Branch Manager

Whats the point in the temper proof seal then?

Reeyah H, Community pharmacist

Note also, ‘has agreed to discuss’. Which means absolutely nothing. They’ll say we already have the funding in a bottomless pit of Practice Payment- just like we do with MDS! 

Reeyah H, Community pharmacist

Hence, I’m not going to do anything about it.Yet. 

Adam Hall, Community pharmacist

Damned if you do. Damned if you don't

Dave Downham, Manager

Common sense - remember that? - suggests that there is absolutely no point in applying the principles of FMD until there is a critical mass of compliant packs in the supply chain. Manufacturers won't be rushing to put tamper-proof seals and 2-D barcodes on a 2 bob box of bendros so there will be plenty of non-FMD stock swilling around for a good time in warehouses, not to mention on pharmacy shelves. Surely sensible to defer a few months while Brexit, the funding and stock to actually scan and check is sorted?

Sorry, that's more common sense.

Sudhir Monji, Pharmaceutical Adviser

Dave Downham makes various valid points;  a more pragmatic and senesible approach would be to ensure the manufacturers are fully FMD compliant before decommisioning goes acive at the Pharmacy level- anything less may end up creating a bottle neck, uncertainties and loss in confidence on supply chains. to add to complexity there are manufactures who already have 2D codes which are not EU 2D codes.; when trying to decommission such products this will be 'rejected' by the systsem giving the impression the medicine is 'falsified' when in practice this is not the case! Imagine patients going without medicine on top of Brexit with no Deal!

Sachin Badiani, Pharmacy owner/ Proprietor

This. Totally.

Farhat Ahmed, Locum pharmacist

I thought we had to implement during 2018-2019, so why is it being discussed for 2019-2020 contract funding? UK wants to be in the club & not be a weak link, so why not cough up the funds NOW and we can all buy scanners/equipment

 

Lucky Ex-Locum, Superintendent Pharmacist

I can see the point of FMD to protect patients but there are so many flaws. I was at the Pharmacy Show and as far as I could tell, Mr Richardson had no answers to any of the questions put to him. It seems that we are on our own with this one, with no funding (as confirmed by Mr Richardson) and no help either. And what happens when the outsourced, not for profit IT systems go down because they've been done on the cheap? Notice I said 'when' not 'if' - the scars of EPS hang large over all of this. It seems to me if we can't access the database because our broadband has gone down then we can't validate, we can't decommision and therefore we can't DISPENSE. An answer please DoH.

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