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'FMD is days away – and still no one has explained what the point is'

"I don't understand how scanning medicines will make a difference to the supply chain"

Despite the looming deadline for compliance with the EU's medicines scanning law, The Contractor is still unprepared – and unconvinced of its benefits

As a contractor, the only thing I’ve done to prepare for the Falsified Medicines Directive (FMD) is go to a meeting held by my local pharmaceutical committee. There, I learned that not even the speaker was happy about the legislation, and was simply going through the motions.

As I scanned the room (pun intended) I noticed bewildered expressions, huffing sounds, tired questions no one could answer, and basically a blanket of doom and gloom.

"What happens if we decommission a product then the patient doesn’t want it?" Silence.

"How will the General Pharmaceutical Council use its powers to check we're compliant?" Silence.

My thoughts included: what would happen if we decommission at the point of handing out, and there’s a problem? What will we say to a patient as we try to take back their vital box of furosemide? I know that if we suddenly start suggesting "Oh, we're looking for fakes," my lovely patients will assume that all these years we have handed them counterfeit medicines. "No wonder my orlistat hasn’t worked, it’s fake!" will be ringing in my ears.

My other amusing thought was: will we then start categorising our staff as to how fast they can scan? Will the ‘budget level staff’ scan in the blink of an eye and mutter "Have a nice day!" before anyone can say "paracetamol"? Will the ‘elite level staff’ chat throughout the whole scanning process, asking all sorts of unnecessary questions, simply because they are glad that someone can still afford to pay them a visit? Hmm.

Ironically, right after the FMD talk, I went for a scan and shop at the local supermarket. I assumed my scanner would just total the cost. I also assumed the supermarket had done their necessary checks, and my apples and strawberries were indeed real. I had almost finished shopping when my scanner stopped working. It needed charging. All the data was gone. I had to use the conveyor belt.

I still don’t understand how pharmacy staff scanning medicines will make a difference to the supply chain. Does it mean it’ll stop the delivery drivers from opening the totes and adding in fakes? Or will it stop my dispensers from switching the statins to ones they bought from the back of an estate? I’m confused.

By comparison, a no-deal Brexit does look appealing – but only just.

The Contractor is an independent pharmacy owner in England

9 Comments

Kevin Western, Community pharmacist

There is, according to a recent report, a large and growing problem with deaths caused by fake Xanax in Ireland, bought off the net, I assume the Irish equivalant of the GPhC and MHRA will be inspecting the websites that sell thenm to check their scanners... given that its well known to be fake, you have to wonder..

ethyl bromide, Community pharmacist

The REAL purpose, and the reason its not being rejected as awaste of money by the DoH and large multiples, is that it opens the path to fully automated dispensing and closes the checking loop.. rx comes in electronically, is matched to fmd which scans stock, machine  applies label (which obviously doctors will have written correctly!) and off you go... 

A B, Community pharmacist

"What happens if we decommission a product then the patient doesn’t want it?" You have 10 days to put it back on the system.

"How will the General Pharmaceutical Council use its powers to check we're compliant?" They will check you have a scanner and software. If you don't they ask for an action plan to be sent to them within a couple of weeks, if you don't supply one they will contact you. A bit like they do if they find any issues during an inspection that need following up.

"what would happen if we decommission at the point of handing out, and there’s a problem?" You are supposed to verify stock when it comes into the pharmacy before decommisoning at the point of handing out, yes another scan I'm afraid.

I agree with everyone that it is a waste of time but spend about half an hour or so reading the fmd source website and you'd understand the system a lot better. Sticking your head in the sand won't make it go away.

Lucky Ex-Boots Slave, Primary care pharmacist

I bet you are going to find loads of uncollected scripts on the shelves dated months ago. You simply will not take scripts off after 10 days this is literally impractical. 

A B, Community pharmacist

You don't decomission until you give out the script to the patient, so this won't happen.

Most PMRs will be able to produce an aggregated barcode which covers all the items in the bag so you shouldn't need to empty the contents and scan each item.

You need to do a bit of research, all the information is out there.

Lucky Ex-Boots Slave, Primary care pharmacist

Provided the pmr can produce such a barcodes if not it is just chaos opening every single bag to scan every single box. Sorry I have been out of community for too long don't even know how it works anymore. But what if the wrong bag label got stuck on the wrong bag? I can imagine it can happen it's all down to human errors 

Lucky Ex-Locum, Superintendent Pharmacist

It's one of those 'Road to Hell paved with Good Intentions' things. The idea is sound but the execution is one of the biggest pigs ears I've ever come across. What is the point of spending so much time, effort and money on a system for which, as yet there are NO packs to scan (tell a lie - I have seen one, Epilim chrono). Surely it would have been better to have all the manufacturers on board first so that the majority of packs were compliant before launching in pharmacies? My other question is - if something is flagged as falsified, how do we know that it isn't just that someone dispensed a falsified pack first....?

David Moore, Locum pharmacist

FMD is totally pointless.

Roy Sinclair, Community pharmacist

To me the FMD seems designed back to front. The process can identify a genuine product and allow you to dispense it but does nothing to deal with any fake. One solution would have been to take the unique pack I..D. and allow it to be used to access a database that provded the full supply trail - from Manufacturer to Patient.  The Pharmacy and Patient could then use it to read the supply chain and so track its origins - i.e. your patient could use the I.D. and clealy see where you obtained it from. You could similarly backtrack your suppy to it's origin. This would at least identify a fake supply chain immediately - and it's possible starting point. Action could then be taken to identify the fakers. The current system only allows someone to pass on a genuine item rather than identify (and deal with) receipt of a fake.

It is speedily identifying any fake and providing minimal delays in moving forward any genuine item that should have been the priority - not just identifying the genuine item - these are not the same thing.

 

  

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