Are we really ready for the Falsified Medicines Directive?

It’s not long to go until the UK must be ready to comply with Europe-wide anti-counterfeiting measures. But is it really possible for pharmacists to be ready in time, asks The Pharmacist’s editor Beth Kennedy

After many years of painstaking planning, it’s now only a few short months until the UK must be compliant with pan-European anti-counterfeiting measures. Come February, every pharmacy in the country must be ready to implement the Falsified Medicines Directive (FMD), whereby pharmacists must scan packs of medication before they are dispensed to verify their authenticity. But although plans have been in the pipeline for a while now, I just can’t see this happening.

Now don’t get me wrong – I’ve got nothing against the principles behind the FMD. After all, who wouldn’t want to be sure of the authenticity of their medication?

No, the problem – well, one of the problems, if truth be told – I have with the FMD is that I’m just not convinced it’s either fair or realistic to expect pharmacists to be ready to go with the scheme by February. For that to happen specific barcode scanners must be bought and installed and pharmacy teams up and down the country must be trained in how to use them – all within just 10 months. Frankly, given the apparent lack of an action plan for community pharmacy to work to, this seems a little optimistic to say the least.

So it’s little wonder that Bharat Shah, director of wholesaler Sigma Pharmaceuticals Plc, predicted that implementation is likely to be delayed one to two years. Despite protestations to the contrary from both the Government and the National Pharmacy Association (NPA), I must admit that I remain unconvinced that we’ll be ready to meet the February deadline.

Then there’s the not inconsiderable matter of the cost of those barcode scanners – at this point unknown – and the training that’s presumably required to operate them. At a time when the sector is still recovering from the effects of millions of pounds worth of Government funding cuts and ongoing losses from stock shortages, it seems unreasonable to expect pharmacists to reach into their own pockets to pay thousands for a directive they never asked to have imposed on them.

And yet according to the UK’s FMD Working Group, that is exactly what’s going to happen. According to the group, they will also be expected to shell out for any software updates needed to keen their scanning equipment up to date. Presumably, they will also have to pay for any additional training, too, as well as for extra members of staff that may be required to tackle the added workload the FMD will inevitably bring with it.

The Working Group says: ‘The pharmacy negotiators are represented on the UK FMD Working Group and are working hard for a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies.’

Well, that’s all to the good. But with this Government’s track record in taking away, rather than giving, funding to the sector, I find it difficult to believe that reaching an agreement that suits pharmacy as much as it suits the Government's coffers will be found.

Perhaps I'm being overly pessimistic and the Medicines and Healthcare products Regulatory Agency (MHRA) – the Government's medicines watchdog leading on the directive – will pull something out the bag. Perhaps the whole operation will be far less complex and far quicker to implement than we've previously imagined.

Perhaps. But I'm yet to be convinced.

So go on, MHRA. You've got 10 months to prove me wrong. The clock is ticking.