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Are you ready for the Falsified Medicines Directive?


By Léa Legraien
Reporter

25 May 2018

The FMD is coming to the UK in less than a year. So why are pharmacists still fearful of how it will work? Léa Legraien investigates

Did you know that it is more profitable to make fake Viagra than to traffic heroin?

In 2009, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) estimated that counterfeiting a ‘blockbuster’  – ie, a drug with annual sales of at least $1bn (£737m) – could generate a $500,000 (£368,593) profit for an initial investment of $1,000 (£737). Investing the same amount of money in heroin, on the other hand, would bring in just $20,000 (£14,744).

Counterfeiting medicines is 10 to 25 times more profitable than illegal drug trafficking, according to the Institute of Research Against Counterfeit Medicines (IRACM).

So to tackle counterfeit medicines and improve patient safety, the European Commission (EC) introduced the Falsified Medicines Directive (FMD) for 32 European countries, including the 28 current EU member states and the four European Free Trade Association (EFTA) members: Iceland, Norway, Liechtenstein and Switzerland.

The measures will see manufacturers, wholesalers and pharmacists verify the authenticity of medicines before they are dispensed by scanning a unique barcode on every pack of medication.

The measure must come into force by 9 February 2019. Regardless of whether it is welcomed or feared, all pharmacists will have to be FMD compliant by then.

But with just a few months to go and no IT solutions ready yet — are pharmacists ready?

 

Falsified medicines: a global problem

 

Falsified medicines are a widespread problem, both costly and dangerous. The World Health Organization (WHO) estimates that 1% of drug sales in developed countries are counterfeit. With around two billion items dispensed every year in the UK, this represents 200,000 drug packs.

In the EU, counterfeit drugs cost the pharmaceutical sector €10.2bn (£8.8bn) every year and causes 37,700 job losses, based on data from the European Union Intellectual Property Office (EUIPO).

In 2011, 27.4 million doses of falsified medicines were seized at EU borders, according to the UK’s medicines verification organisation SecurMed UK, a non-profit legal entity.

More recently, the Medicines and Healthcare products Regulatory Agency (MHRA) seized 6.2 million of medicine doses and medical devices in the UK worth £15.8m in 2015.

 

A costly measure?

 

The regulation stipulates that pharmacists will have to pay for any ‘physical scanning equipment’ and the software to read the two-dimensional identifier barcodes, as well as staff training, as current scanners can only read one-dimensional barcodes. The software required is being developed by non-profit entity SecurMed.

We don’t know yet how much this will cost, but wholesaler Sigma Pharmaceuticals Plc director Bharat Shah predicts that it could be as much as £3,000 just for the scanners.

Mr Shah says: ‘In my opinion, if a pharmacy has three or four scanners, hardware and software, it could be in the region of anywhere between £2,500 and £3,000 as a one-off payment.

‘Training is going to be a cost too. Probably £500-£1,000 and a few hundred pounds every year for ongoing training.’

 

The FMD explained

 

FMD builds on a 2011 directive, which set out high-level requirements to prevent falsified medicines from entering the legal supply chain. It was supplemented by the Delegated Regulation in 2016, which outlined detailed plans for the 2019 implementation.

Under the directive, most medicines will bear a unique identifier encoded with a two-dimensional barcode – for identification and authentication of individual packs – as well as an anti-tamper device (ATD).

Pharmacies will check the status of each product during the dispensing process through a national medicines verification system (NMVS), which will determine if the product has been recalled, withdrawn, stolen or tampered with.

Once scanned, the product will be decommissioned, the status of which will change from ‘active’ to ‘inactive – dispensed’, before going to the patient. This process will prevent products from being authenticated by any other dispensing entity.

 

Realistic estimates?

 

SecurMed UK general manager Jerome Bertin tells The Pharmacist that he can’t tell whether the suggested costs are ‘realistic’.

‘It’s a cost for them [pharmacists] at a time when the Government is going through rationalisation around the cost settings of community pharmacy,’ he adds.

‘I understand the challenge they have there but that’s what the regulation says, that they need to implement changes to their IT systems and train their staff.

‘It’s about patient safety. Now, to be paying £3,000 on web software that takes, on average, between 5,000 and 8,000 prescriptions managed by a pharmacy per month, that’s about 0.004 pence per pack of medicines at the expense of the pharmacy.’

National Pharmacy Association (NPA) public affairs manager Gareth Jones argues that the NHS should be bearing the costs since the FMD is a ‘regulatory requirement being imposed on community pharmacy’.

He says that the four pharmacy negotiating bodies will ‘make the case for NHS funding for this initiative’. 

 

Another ‘nail in pharmacy’s head’

 

Unsurprisingly, the FMD is not necessarily popular among pharmacists — probably because it looks at the moment as though they will have to bear the costs for a directive they never asked for.

Meir Kattan, owner of Kalmak Chemist in London, says that with the funding cuts, shortages and increases in prices over the last year, to be faced with another cost is yet ‘another nail in the head for pharmacy’.

He continues: ‘The FMD, although not new in name, came as a bit of shock when the NPA informed us that we would be responsible for the cost in applying this in our pharmacies.

‘We have some idea of how it will work but it will obviously add another layer of work to the dispensing process.’

At the moment, there is little information on the FMD and there are concerns about the added workload it will cause.

Kieran Eason, contractor of Eason Pharmacy in Tamworth, Staffordshire, says: ‘Our computer systems don’t work with it yet and I’m in the dark about how it’s supposed to slot into our workflow.

‘I’ve read up on everything available so far and still don’t know how it will work in practice. I think the rollout will be rushed and won’t work very well.

‘I don’t believe that the problem of fraudulent medicines is big enough to warrant such an over-the-top system.’

 

Increasing workload

 

Perhaps pharmacies are right to question how the FMD will work in practice.

Mr Bertin says: ‘No one really know at the moment how much [time] it might take for pharmacy staff to decommission products.’

With every pharmacy handling around 200 items every day, amounting to tens of thousands of items every year, even a few seconds to scan packs of medication multiplied by all those items mean that there will be an ‘awful lot of staff time taken up managing the FMD’, adds Mr Jones.

The repository system made by Arvato Systems, which will connect to each pharmacy’s scanners, was designed to respond to every request in a third of a second. But depending on individual systems and the internet speed, it might take even more time to establish a connection.

‘Obviously, we’ve got the internet [to think about], so it might take longer to get back to a pharmacy. It could be about up to a second or more per medicine before they [pharmacists] get a response’, says Mr Bertin.

Ade Williams, superintendent pharmacist at Bristol’s Bedminster Pharmacy, fears that the absence of details at this point increases the risk of a ‘last-minute upheaval’.

 

Will the system inadvertently increase wastage?

 

With the new system, pharmacists will know what they have in stock, which hopefully will mean ‘much better stock holding’ and allow pharmacists to ‘get rid of the dreaded quotas for products’, says Mr Jones.

However, the main implication of the FMD is that a lot of stock will be destroyed once it’s decommissioned but not taken by the patient, as there will be a 10-day deadline for them to pick up their products.

Mr Bertin says: ‘We do expect in the early years that there will be an increase in wastage. It’s going to be a painful change for pharmacies to manage the 10-day rule but I think they will find solutions.

 

Will we be ready on time?

 

The million-dollar question is, of course, whether the sector will be ready for the FMD in time for the February deadline.

According to Mr Shah, the FMD is likely to be postponed ‘for one or two years’ because pharmacists ‘aren’t ready’.

He says: ‘I don’t think the FMD is going to be implemented next February. I’m absolutely certain that there is going to be a one or two-year extension.

‘Manufacturers are ready, distributors are half ready — but retailers aren’t ready at all.

‘For the system to work, you need retailers to be ready, as they will decommission the stock – the most important people in this chain – and if they’re not ready, it can’t be implemented.’

Mr Bertin adds that the UK as a whole is running ‘late because of a number of issues related to Brexit’.

The Medicines and Healthcare products Regulatory Agency (MHRA) refutes the
claim that the UK is unlikely to be ready
by February, saying it is ‘certainly not looking to delay the rollout of the FMD in the UK’ and is ‘still working to the deadline’.

 

Facing penalties?

 

Mr Jones believes that the UK could face penalties if it is not ready on time.

He says: ‘If the UK as a whole doesn’t meet the deadline, there is a risk of court action in Europe.

‘The implications for individual pharmacies aren’t clear, this is something that will be discussed in the consultation, which is due to come out [soon].

‘The penalties for non-compliance are going to be subject to the consultation. We’ve suggested they must be proportionate and not excessive.’

A public consultation, which includes an impact assessment looking at the various costs associated with implementing the FMD in the UK, will be released in May, the MHRA tells The Pharmacist.

‘I share the sentiments of most colleagues that, since the case for these changes appears to lack any advocate with a conviction of its value, we face shouldering substantial financial and logistic burden in the absence of any merits’, says Mr Williams.

‘All the while we daily face existential pressures. [The FMD] is most unwelcome.’


Want to hear more about about FMD? Join us at Pharmacy Forward on 10 June where Raj Patel MBE, chair of the UK working group for FMD, will be speaking on what this critical subject means for you

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