It’s been over a year since the EU referendum. I confess that I was in the remain camp, and was convinced the majority shared this view. It was therefore with absolute incredulity that I stared at my TV on the Friday morning following the vote, to learn that we had voted to leave.
So shocked was I, that I even rang Samsung to inform them that something was awry with the telly. And, for the first time ever, I seriously considered that I was unfit for work.
I did however pull myself together and, as it happened, that day attended a meeting to consider the implications on pharmacy of the latest legal straitjacket emanating from the EU – the falsified medicines directive (FMD). While this turned out to be an awful meeting, it did improve my mood, to the extent of convincing me that the UK population had come to the right decision in voting to leave the EU.
Enormous piece of legislation
The objective of the FMD is to prevent counterfeits finding their way into the EU supply chain. By February 9, 2019, every pharmacy in the UK will be required to scan barcodes, check tamper-proof devices and decommission medicines to prevent them from being reused.
No one could argue against such an objective, but the FMD would appear to be the largest of sledgehammers to crack a nut. While counterfeits do exist, the extent of any problem appears to be greatly exaggerated – something that is further helped by the scaremongering of manufacturers, who seek ways of controlling the supply chain.
Whatever the background, we now find ourselves having to implement an enormous piece of legislation that raises far more questions than it does answers.
With only 18 months to go, pharmacy is nowhere near an understanding of how it will be able to fulfill its obligations under the directive. And don’t be fooled into thinking that our exit from Europe will avoid our having to implement its requirements.
A key factor in Brexit negotiations will be a trade deal across Europe. To trade with the EU, the UK's pharmaceutical industry will need to be able to adopt common standards for medicines authentication. If the UK is not able to do this, we will be out in the cold.
There are enormous challenges associated with implementation. First, while a shortlist is under consideration, at the time of writing, the supplier for this barcode scanning system is yet to be appointed.
Then there is the old chestnut of split packs.
The UK stands apart from other EU countries in dispensing part packs. Under the FMD, packs are supposed to be scanned once, then decommissioned. So how do we deal with split pack dispensing?
One potential positive outcome of all of this may be the move to the universal use of original pack dispensing – but I won’t hold my breath. And even if we do get to patient pack dispensing, this still leaves the challenge of dealing with monitored dosage system trays and compliance packs – a feature of our process that is not common practice throughout Europe.
After authenticating and decommissioning a medicine, there will be a 10-day period when the decommissioning can be reversed. But in the UK, patients often ask their pharmacists to pre-order medicines. If they don’t pick up their prepared medicine pack within 10 days – and the medicines have already been decommissioned – medicines will be unusable.
All in all, implementation of the FMD is a dog’s breakfast.
As it is, implementation is largely incompatible with community pharmacy practice. FMD highlights the difficulty associated with an arm’s length, largely unaccountable, bureaucracy attempting to impose a “one size fits all” solution on 26 countries, each with its own pharmacy processes and arrangements. In so doing, it fetters our ability to make our own health-related decisions.
We live in a period of austerity and should be focusing on priorities, particularly when it comes to health spending – which is already out of control. FMD is way out of all proportion to the problem it seeks to fix. As such, it represents a luxury we can ill afford.
John D'Arcy is managing director of pharmacy support services provider Numark