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RPS: Brexit poses counterfeit medicines risk as FMD benefits lost

RPS: UK will “cease to benefit” from FMD once the Brexit transition period ends
RPS: UK will “cease to benefit” from FMD once the Brexit transition period ends

The government must put “robust plans” in place to ensure counterfeit medicines don’t enter the supply chain as FMD ceases to apply across the UK post Brexit, the RPS has said.

The Royal Pharmaceutical Society (RPS) is “concerned” that removal of EU anti-counterfeit drugs legislation known as the Falsified Medicines Directive (FMD) could leave the UK “vulnerable to an influx of counterfeit medicines,” it warned yesterday (October 13).

FMD came into force in February 2019, but “under current plans”, the UK will “cease to benefit” from it once the Brexit transition period ends on December 31, the RPS said in a statement.

The RPS has therefore written to health secretary Matt Hancock emphasising the “need for robust plans to be put in place urgently to maintain formal links with the EU to help authenticate the legitimacy of medicines that move between the EU and the UK”, it explained

RPS president Sandra Gidley said it is “unacceptable that in the final months of the Brexit transition period, robust plans have not been put in place to prevent falsified or counterfeit medicines entering the UK”.

In its letter to Mr Hancock, the RPS has “emphasised that establishing technical agreements with the EU is now more critical than ever in our fight against counterfeit medicines,” she said.

Ms Gidley highlighted the “significant investment made by the NHS, pharmacy organisations and individual pharmacy owners in the infrastructure for FMD”, and stressed that the RPS is advocating for the FMD provisions to continue to apply in the UK.

A spokesperson for the Department of Health and Social Care (DH) told C+D yesterday that it is “committed to fully consulting with stakeholders on the future development of a national falsified medicines scheme that is the best fit for our national supply chain”.

“Protect the supply of medicines into Northern Ireland”


Last week (October 6), the UK FMD Working Group for Community Pharmacy - whose members include the National Pharmacy Association, the Company Chemists’ Association and the Pharmaceutical Services Negotiating Committee (PSNC) – called on the government to “protect the supply of medicines into Northern Ireland” after the end of the transition period.

Under the terms of the Northern Ireland protocol of the EU Withdrawal Agreement pharmacies in Northern Ireland will still be required to comply with FMD after December 31 as the directive will continue to apply in the country, unlike in England, Scotland and Wales

Raj Patel, chair of the UK FMD Working Group, warned that “pharmacies in Northern Ireland might quickly find themselves short of supplies and unable to service patients’ needs”, if it becomes “unviable for manufacturers and wholesalers to put stock into Northern Ireland”.

“Since medicines regulation is not a devolved responsibility, we are asking the Westminster government to clarify what arrangements it has for medicine verification in Northern Ireland after December 31,” Mr Patel said.

Leyla Hannbeck, chief executive of the Association of Independent Multiple Pharmacies (AIMp), told C+D last week (October 8) that the “potential for shortages to become worse in Northern Ireland post-Brexit is clear”. AIMp expects the UK government to “have risk-assessed this and to take proactive action to prevent it”, she added.

The PSNC announced yesterday that it has reconvened the Community Pharmacy Brexit Forum – a group that “brings together more than 20 organisations across the pharmacy, wholesale and wider primary care sectors to discuss Brexit matters”.

Forum members said were also concerned about the “lack of clarity around supplies of medicines from Great Britain to Northern Ireland after 31 December 2020, and the potential for prescribing periods to be extended ahead of the Brexit deadline”

23 Comments
Question: 
Do you think FMD should be kept after the transition period ends?

Dave Downham, Manager

Utter waste of time and effort. If you're going to buy dodgy drugs from a guy with a cement mixer in his garage, you're still going to do it. If you buy stock from major wholesalers and they're not identifying fraudulent gear, then quite frankly we're all doomed.

Matthew Edwards, Community pharmacist

The answer is no FMD should not be kept.  It was the biggest waste of money and pharmacy staff time ever invented.  If it is to be implemented should be at wholesaler level and not at the end user

Chris Locum, Locum pharmacist

Pharmacists can do this, they can do that and a whole host of other functions. "What assessment was performed by XYZ working party to predict the impact on working time, human resources and any pervasive corporate coercion?" "We did not consider the impact."

Uma Patel, Community pharmacist

FMD is a sledge hammer to crack a nut. Utter waste of resources. The biggest source of fake medicines is the internet which cannot be policed

Caroline Jones, Locum pharmacist

Too true, esp when the GPhC is asleep on the job when it comes to monitoring online pharmacies.

 

John Ellis, Community pharmacist

The majority of counterfeit medicines are mailed via off shore online pharmacies that operating outside Europe. FMD does nothing at all to counter this and is a complete waste of time, at least in the UK. I doubt it would make any difference at all when it ends, apart from the time and money it will save. If the government intends to replace it with a new system, our representatives should be arguing for proper remuneration at the outset.

Getting Shorter, Community pharmacist

We did full FMD, until covid hit and it got pretty much impossible to do basic dispensing, leave alone new bells and whistles.

It was a PITA, not least because they rolled it out to us long before getting all, or even most, of the manufacturers on board. So maybe a third of packs, at best, scanned completely properly through the system; a third gave random errors and the final third just have no code at all. If seriously slowed down and spoilt our work flow as all the boxes from every script had to go back to the PMR system to be scanned. If we had separate, portable, scanners linked by wifi, it might not have been quite so bad.

The main benefit seen was that the system could, in the third that worked at least, pick up dispensing picking errors. But even that was poorly implemented to start with on our PMR... the warning sign didn't show up against the product's highlighted bar and the system was happy for you to "ok" it without further warning - there's been an "are you sure?" box added since.

 

HOWEVER... having said all that, I firmly believe we require a system like this one way or another. Fake medicines are not produced by a person sitting in their living room - there must be proper factories, printing facilities etc involved, which means some fairly big money must be involved too. The people owning, running and seeing the profits from those industrial-level projects are not goiung to want to find that income drying up. So if it's increasingly difficult to move them into the EU market, they are going to start looking further afield for easier pickings. And if we don't have some sort of FMD system, that's going to be us. I know that historically we've had little trouble with fakes, and our culture doesn't recognise bribery/backhanders/etc as a normal, expected, thing like some places (alledgedly) do ... but moeny does talk and there may be plenty around. And that's before you consider that these are criminal operations, so nastier methods of obtaining co-operation may be used. And this could all happen at any level, at any point of the manufacture and supply - from CEOs through managers, factory workers, HGV drivers, warehouse staff, daily delivery drivers and maybe even pharmacies.

Leon The Apothecary, Student

Thing is, I thought FMD was useful, but not where it was placed, and not for the reason it was put there. It was basically checking validation, which made it useful for automated dispensing.

Bypassing that aspect though, it would have made more sense to enforce FMD at the wholesaler level. It's just basic logistics.

Kevin Western, Community pharmacist

yet again RPS shows why it struggles to attract members. Its completely out of touch with reality. Why would any Pharmacist ask for this, unless there  was a gaurantee of funding for at least the staff time involved, and that actually reaching the Pharmacy. Bonkers! 

I suspect it says more about Ms Gidleys position on Brexit than her thoughts about Pharmacists, which is telling re the PSoc actual function.

Angela Channing, Community pharmacist

I think everyone in community pharmacy knows scanning in every pack, on current staffing levels will be next to impossible.  

 

Is anyone actually doing full FMD, and if so, how goes it?? 

Leon The Apothecary, Student

For the year or so I was working as a locum across most of the bottom half of the country, I witnessed no-one use FMD.

Lloyds had their big old machines, that took up space, no-one really knew how to use, didn't work for several months, and were confused when I actually went and scanned products, some even tried to make me not do it.

Paydens were the same, special scanners to do it, an extra module on Proscript, no-one wanted to do it, or did not know why or how they had to.

Other companies just didn't bother, saying they had a solution on the way, which I suspected was a delaying tactic.

FMD was un unmitigated failure to a problem no-one really thought was an issue in the first place.

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

One, two, miss a few, three, four, miss some more.....

Mr CAUSTIC, Community pharmacist

As of 4 December 2019; approximately 44.7 million medicine packs have been dispensed through the UK national medicines verification system, since the FMD went live on 9 February 2019. and no fakes have been found .    That says it all . I wrote to Dominic Cummings earlier this year asking him to try and ensure our time was not wasted checking using this system . I pointed out i was writing to him as he could ensure the system was changed  . The civil service want him out because he wants to get things done and does not put up with "it cannot be done that way " He wants to slim down the civil service and get it more efficient and they hate him for it .  Unfortunately there is a bill in Parliament to carry it on post brexit . So we probably will not get it removed ..

Wording of UK bill to match FMD is amended on data concerns  .....

N O, Pharmaceutical Adviser

Let's get some statistics. Before FMD how many cases of illicit meds found a month average against same period post FMD. Then we will see if it has really helped. Most rcalls based on FMD are all Manufacturer's stupid mistakes. Why should a pharmacy spend so much unpaid time in correcting their mistakes? And for RPS, get grips with reality and support pharmacists from not doing unnecessary jobs.

Angela Channing, Community pharmacist

Agree. It will be a full-time job scanning in the packs for an average 7500/8000 item a month pharmacy I read in 2019, when a trial was conducted. Can't see the multiples funding this time-wasting exercise. Over 30 years I can think of just a handful of fake meds entering the supply chain. 

Nalin Patel, Community pharmacist

Get the Wholesalers to check it. How is the fake stock going to get into the supply chain once its has left the wholesaler's depot to be delivered to my pharmacy? All totes have seals on them anyway. Complete waste of our valuable time. Ps 35 years in retail pharmacy and I have not come across one single fake product to date. 

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

Exactly! We've survived this far without FMD, I'm sure we'll not go to the wall because of losing it. Most of us would probably see it as a positive from Brexit anyway.

Bob Dunkley, Locum pharmacist

"We're doomed.... Doomed I say..."

Angela Channing, Community pharmacist

Oh Bob! I bet you've been saying that for over 40 years?!!?  ;) 

Kevin Western, Community pharmacist

get the manufacturers and wholesalers to do it, and pay for it, if it gets thro to us its far too late!

a solution without a problem, thought up by manufacturers to tighten their control on supply

Tom Jerry, Community pharmacist

Ask your members fist before macking up your opinion RPS??

P M, Community pharmacist

dont bother

A.S. Singh, Community pharmacist

I think I speak for everyone when I say 'whoop de do!'

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