Your Falsified Medicines Directive questions answered


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By Beth Kennedy
Editor-in-chief

23 Nov 2018

The Pharmacist’s recent roundtable sought to answer all your burning questions on the upcoming EU directive. Beth Kennedy reports

 

The Falsified Medicines Directive (FMD) is the issue on every pharmacist’s lips at the moment. With mere months to go until pharmacy teams must be ready to implement it, there are still many unknowns.

To help with this, The Pharmacist – in collaboration with NHS Digital – brought together experts from all corners of the sector for a roundtable to try and get to the bottom of all your FMD questions.

 

Meet the panel

 

Beth Kennedy – editor, The Pharmacist Magazine

Siobhan Murphy – FMD engagement lead for NHS Digital

Jerome Bertin – general manager at SecurMed UK, the UK medicines verification organisation

Mukesh Lad – CEO and superintendent pharmacist for the Mr. Pickman’s pharmacy group, chair of LIPCO health care independent pharmacy federation.

Léa Legraien – reporter at the Pharmacist Magazine.

John Preston – director of quality for the wholesaler Phoenix Medical Supplies.

Al Patel – Southeast London contractor. Lewisham local pharmaceutical committee (LPC) representative and IT lead.

Sarah Gibb – FMD program manager for McKesson UK

 

What is FMD?

 

FMD is a pan-European set of anti-counterfeiting measures designed to stop the spread of fake medicines across Europe.

From 9 February 2019, by law pharmacists will have to scan the unique bar code on every pack of medicine before they are dispensed. Each pack will also feature an anti-tamper device. It is hoped that these measures will ensure that falsified medicines don’t make it into the supply chain.

A European Union (EU) directive was published in February 2016, giving member states three years to implement it. All UK pharmacies must comply and be ready to implement FMD for the February deadline.

 

Is FMD really necessary?

 

That’s all well and good, you may be thinking, but is all of this work really necessary?

Mr Bertin pointed out that although the UK’s supply chain is considered ‘very, very safe’, the Medicines and Healthcare products Regulatory Agency (MHRA) recently discovered two million packs of falsified medicines in the UK.

Ms Gibb highlighted that unlike most other retail items from batteries to lettuces, medicines in the UK are not batch tracked. ‘Yet we are supplying medication to patients and we do not track them,’ she said. ‘As long as we can find a clear, concise way of doing it, rather than all of this ambiguity around FMD at the moment, [implementing it is] a no-brainer.’

Mr Lad agreed. He said: ‘If we can get over some of these hang-ups and get some clear information, the benefits [of FMD] for us as community pharmacy are huge.

‘Eighteen to twenty-four months after [implementation], we’ll probably say, “that’s actually quite a good idea”. But at the moment, it doesn’t feel like it.’

 

Are we ready for FMD?

 

One of the most pressing questions on everyone’s lips is whether pharmacists and, indeed, the rest of the supply chain, will be ready to implement FMD in time for the deadline.

Mr Lad said: ‘There are a lot of independent pharmacists out there who still do not have a [FMD] system or even a stand-alone system that’s integrated [organised for February], so I’m not sure if my colleagues are ready.

‘There’s such a lot of information still not there. Without a proper toolkit, you’re not sure exactly what you need to invest in – both in terms of resources and systems – and how it’s all going to work.’

Mr Preston pointed out that working out how to actually use the scanning equipment and fitting it into your team’s workflow is ‘at least as big a challenge as actually choosing which system supplier to have’.

But as Mr Lad pointed out, the directive will become law in February, meaning that it ‘has to happen’.

The overall consensus among panelists was that if contractors are seen to be doing their best to comply with FMD after the February deadline – even if they are not totally compliant – they will not necessarily face regulatory action. If, on the other hand, pharmacists are seen to be actively shirking compliance, they may find themselves in hot water.

 

How do I choose my system supplier?

 

With so many different companies offering FMD software, how are pharmacists supposed to choose which one is best for them?

Mr Patel and Mr Lad are in agreement that every pharmacy has different needs, and therefore there is no one-size-fits-all approach.

Ms Murphy advised contractors to look at the support each system supplier will offer once you go live with the FMD software to help make their decision. 

For example, suppliers offering helplines may be a good option to help contractors with any troubleshooting issues they may have once they go live with FMD.

 

What should pharmacists be doing now to prepare?

 

The panelists were in general agreement that there has been a lack of cohesive, clear guidance on how pharmacists should be readying themselves for the directive.

However, Ms Murphy advised contractors to ‘look at their existing processes – that’s your starting point. Then look at how FMD is going to fit in with those processes.’

She continued: ‘Speak to your systems supplier, start thinking about who’s going to need training in the pharmacy, where that training’s going to come from – is it going to come from the systems supplier or is it online?’

‘Just [start] making your staff aware. Maybe have a lunchtime learning session or an evening session,’ she said. ‘There is a lot of information out there. So I think it’s a case of drip-feeding [that to] your staff now over the next few weeks to get people onboard.’

 

Will FMD add to my workload?

 

Contractors are already overworked to dangerous levels, so how much extra time will FMD take up?

Mr Lad thinks it will cause significantly more work for pharmacy teams. He says: ‘There’s just going to be a lot of work, other than just the cost of having a system and having it integrated. We’ve got to teach all our staff what the optimal process and amend all our Standard Operating Procedures (SOPs).’

For Mr Preston, although he concedes that there is still ‘loads to do’, ‘it is starting to coalesce a little bit and we’re starting to see some clarity’.

 

How much will FMD cost?

 

It’s currently unclear as to how much FMD will cost contractors, given that this will depend on many factors such as how many scanners the pharmacy needs to buy and which system supplier they decide on. However, it is a certain that – at least initially – contractors will be expected to bear the costs themselves.

Mr Preston points out that FMD is likely to have a ‘hidden cost’. He says: ‘Actually, what we’ve got is an additional part of a process, There are 1.5 billion prescription items dispensed in England each year… It seems trivial, until you start multiplying any [additional time it will take to scan items] by 1.5 billion, and all of a sudden that number becomes really significant. And that’s not a one off cost. It’s not a cost that goes away, that’s a cost that’s added to the price of doing business in pharmacy.’

However, he was hopeful that the new, very technology-focused health secretary Matt Hancock can be persuaded to invest more funding in the sector to help pay for the costs of FMD.

 

What happens if you identify a falsified medicine?

 

There seems to be little in the way of concrete information on what pharmacists should to if their barcode scanner flags up a falsified medicine. It is, as Ms Gibb says, the ‘$1000 question’.

For Mr Bertin, pharmacists should, in theory, do exactly the same as they would if they came into contact with a falsified medicine right now – that being contacting the Medicines and Healthcare products Regulatory Agency (MHRA).

 

Could FMD cause delays to medicines delivery?

 

It will come as no surprise that FMD will also substantially add to wholesalers’ workloads, given that they will also have to comply with the directive.

But how could this affect contractors?

According to Ms Gibb, the sheer amount of extra work for wholesalers could cause delays to medicines deliveries. She said: ‘Well yes, it possibly will cause delays because these are additional tasks that take additional time. You could then have delivery drivers at the back of the warehouse waiting to get out, and they can’t because you’re actually trying to get additional information onto dispatch notes.’

However, both Ms Gibb and Mr Preston are both clear that wholesalers will do everything in their power to prevent delays.

Ms Preston said: ‘We will do everything in our powers to make sure that we don’t damage our delivery schedule, even if it means we have awkward conversations with a regulator.’

 

Want to know more?

 

If you want a shorter version of this roundtable, listen here to our editor-in-chief Beth Kennedy and our reporter Léa Legraien attempt to fit all the information into three minutes.

 

If you have more FMD questions, let us know by tweeting us @Pharmacist_News or by emailing bethkennedy@cogora.com

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