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Pharmacies may hit ‘bottleneck’ when preparing for FMD, suppliers warn

NPA: The costs of regulatory burdens should be a matter for the government
NPA: The costs of regulatory burdens should be a matter for the government

Community pharmacies that are not prepared for the implementation of an EU scanning law risk hitting a "bottleneck" as the deadline approaches, suppliers have said.

The Falsified Medicines Directive (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.

Software supplier FMD IT said an “alarmingly high” number of pharmacies – as much as a third of the sector – “don’t believe” the FMD is going to happen and “don’t understand” it, managing director Gareth Dunsmore told C+D last month (August 21).

As a result, “I suspect there will be a bottleneck as there's a last-minute rush towards compliance”, Mr Dunsmore said.

Some larger companies that have ordered “a couple of hundred scanners” through the company are waiting six weeks for them to be delivered, Mr Dunsmore added.

Another sector supplier, PharmData, estimated that “about 40% of pharmacies don’t have an idea as to what [FMD] solution they’ll put in place yet”, co-founder Oliver Staunton told C+D yesterday (September 12), and only “a very small proportion [are prepared]”, he continued.

Mr Staunton agreed there could be a bottleneck as the deadline approaches, with some pharmacies waiting until January to look for a solution.

Independents less prepared

The unprepared pharmacies are mostly independents with one branch, FMD IT’s Mr Dunsmore claimed.

Only 1% of the community pharmacies that the company has worked with are independents, with the “vast majority” of enquiries coming from groups with at least 10 branches, he said.

PharmData’s Mr Staunton warned “independents probably will be more lost” in preparing for the FMD. “A lot of independents” won’t understand it until the “last minute”. There is a “lot of confusion for pharmacies about what to do or when to do it”, he added.

“Lack of awareness and guidance”

A third supplier, EMIS Health, said there still remains a “lack of awareness and guidance” around the EU legislation.

“There needs to be a significant drive by government to raise awareness of the FMD, and support pharmacies with the implementation and change of standard operating procedures associated with the directive,” general manager Shanel Raichura said.

“One area that requires urgent review is the onboarding process that community pharmacy needs to undertake ahead of February 9, 2019.”

Another supplier, Cegedim Rx, told C+D “there are still concerns from customers about costs, funding and operational impact”.

NPA: Pharmacies must comply with FMD

The National Pharmacy Association (NPA)’s head of corporate affairs Gareth Jones stressed that “community pharmacies must comply with the FMD” by the deadline, despite the “uncertainty over Brexit”.

“Our advice is: Get ready, but avoid signing any long-term contracts,” Mr Jones said.

“Meanwhile, we’re hopeful the Pharmaceutical Services Negotiating Committee…will negotiate reimbursement. The costs of regulatory burdens should be a matter for governments.”

What happens if I don’t comply with the FMD?

Sanctions against those who fail to comply with the regulations could include “imprisonment for a term not exceeding two years”, “an unlimited fine”, or both, according to the Medicines and Healthcare products Regulatory Agency (MHRA)’s consultation on the issue – which closes on September 23. 

Sanctions could also include “written warnings, stop notices and civil fines, before the application of criminal sanctions, which would only be used for the most serious (intentionally fraudulent) breaches”, the MHRA said.

How prepared are you for the FMD?

Charles Whitfield Bott, Pharmacist Director

Has anyone worked out how much time this will take?

We dispense about 8500 items a month = to 10000 boxes? scanned both on delivery from wholesalers and giving to patient = 20000 scans a month. How long will a scan take, 0.5 second? If you have to open every bag at handing out to the patient and then rebag it will be much longer. 0.5 seconds x 20000 is 37 hours a week just scanning.


There is no way on this earth that PSNC is going to get near that amount of money back for us.


As I said before this will bankrupt pharmacies

max falconer, Superintendent Pharmacist

You may be being optimistic Charles. I know of one large group where the staff have been briefed that as the scanning is in real time, it will at least initially, be 4-5s per item but hopefully will get faster in future......

You are right about this being a burden we can do without but just to pick up on 2 points:

From what I gather we won't have to scan stock coming into pharmacy, just when it gets handed out. I might be wrong but I'm basing this on a recent meeting I attended hosted by someone from the company involved in delivering the FMD software and the fmd source website.

Secondly, PMR systems should be able to produce an aggregated barcode on the bag label so you can scan a bag of medicines and it will cover all of the items in the bag. You'd have to scan each item whilst dispensing but just once when giving out.

Unless there is some sort of massive U-turn we better get ready for this coming into force and act now, otherwise it will severely affect the service we provide.

Peed Off Superintendent, Superintendent Pharmacist

Well noted Max..... The MHRA have told me in person that a counterfeit pack has never entered the UK pharmacy chain via a major wholesaler which makes this total madness and a huge cost in additional staff time on top of having to physically claim thousands of ETP tokens and losing staff through the 'cuts'. Anyone who states this is good for pharmacy is mad or probably owns a FMD related company. Crooked pharmacists out there will still obtain and supply cheap counterfeits from wherever they get them now and don't forget your current stock with a  3 year expiry date and not packaged as secure will not be able to be scanned so what a waste of everybodies time. In fact why scan any new stock out until the new secure stock is totally present and current non-secure stock  has disappeared from your pharmacy.  


Alex Crowley, Sales

*This comment has been deleted to comply with C+D's community principles*

Charles Whitfield Bott, Pharmacist Director

Looking at the consultation document, only large oranisations will have the resorces to complete it. I think that the large intergrated companies will welcome FMD as it fits their model better than it does intipendents buying from short liners.


What the indipendent sector needs is for the NPA to step up and explain to government why this must be stopped. Unfortunatly they (the NPA and PSNC) burnt all bridges by going to court over the cuts, when they had no chance of winning.


FMD will be far worse than any cuts that have gone before.

Adam Smith, Senior Management

Your PMR or a number of Standalone providers will be able to offer you reasnable solutions here. Short liners, similar to AAH & Alliance, will have to comply their end, which shouldn't impact you as the changes are mainly Manufacturer packaging focused. Also you may recieve additionaly functionality from your FMD solution provider, and from what I can see the scare stories on cost are just that, the reality is much more reasonable, with up front costs of scanners being circa £80 a pop. 

Dave Downham, Manager

You'll do well to get any sort of reliable scanner for £80, plus how many per branch, backups needed on site, even electricity. Biggest impact will be on the time taken, not only to scan, but to wait for the reassuring beep that says your bendro wasn't made out the back in a cement mixer. Might not sound a lot but all those halfvseconds mount up over the course of a year.

As for added functionality- what is the point of a bell or a whistle if you have neither the time nor inclination to ring or blow it? Thanks for the sousaphone, but I ain't going to play it.

Adam Smith, Senior Management

So reliable scanners to exists for that amount, however appreciate backups may increase up front costs. In terms of additional functionality of course it’s anyones choice however one of the challenges Community Pharmacy needs to address is the pace of change and mordernisation. It’s a personal opinion but I think some of the additional functionality helps offer insight into how businesses are run which will empower pharmacies to be more profitable. Not a bad thing, if you have time time or inclination.

Dave Downham, Manager

Everyone loves an optimist!

Ding -a-ling! Ooompah, ooompah-pah!

Yashvant Lodhia, Pharmacy technician

Are product manufacturers ready? If not when do they expect to be ready? 

Adam Smith, Senior Management

They are working on readiness just like all other industry stakeholders. I expect them to be ready by the deadline, but until they are complete, no-one else can progress really as their product data and packaging changes are paramount to the success of the FMD being rolled out. 

Uday Thakrar, Community pharmacist

As an independent I have not seen much information to help me make a decision. First the cost and funding. Secondly is it stand alone or integrated with PMR software. How will it affect work flow and to manage it. What ar the pros and cons of various offers. We need an independent advise?

Adam Smith, Senior Management

Funding - there is no funding - the cost of implementation of FMD falls on Community Pharmacy.

Both intergrated PMR and stand alone solutions will be available. I suggest shopping around for the best solution for you. The effects on work flow are part of the dicussion you can have with potential providers. I agree indepdent advice comparing all the solutions would be great but it is unlikely as that sort of thing doesn't exist in Pharmacy at present. I suggest progressing with this yourself and coming to a conclusion based on the merits, functionality and cost of the various options available. 

max falconer, Superintendent Pharmacist

FMD IT? Hardly an unbiased source then C&D?

How about doing something more useful like pressing for a postponment for this totally unnecessary, unfunded, ill conceived, irrelevant, ineffctive imposition?

Feb 2119 seems a good goal to me? Maybe then we will be free of EU lunacy?

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