In the hustle and bustle of everyday life in community pharmacy, it is easy to lose sight of storms brewing on the horizon. One of the biggest is the implementation of the Falsified Medicines Directive, says Steve Anderson, managing director, Phoenix Healthcare Distribution.

The aim of the directive is to prevent falsified medicines entering the legal supply chain. It is due to be implemented in UK law by February 2019. What started life as a modest initiative focused on a handful of “high risk” medicines is morphing into an expensive, impractical and bureaucratic behemoth.

Significant aspect

One of the most significant aspects of the directive is that from 2019, every prescription item will have a unique 2D barcode identifier (UI code), which will require all those in the supply chain – from manufacturers to distributors to those dispensing – to verify the status of each pack throughout its path to patients.

Manufacturers will upload valid UI codes to the European Medicines Verification System, which will interface with each country’s own verification system – the UK’s is being developed by SecureMed, a pan-sector collaboration.

In addition, separate verification IT systems will be required at every dispensing point in the UK. Each pack will need to be scanned and verified against the national database and the integrity of the anti-tamper device checked before the pack is “decommissioned” from the system and ready to dispense to the patient.

It currently looks as though wholesalers will be required to batch track every pack which, given the immense volumes processed each day, poses mind-numbing practical issues. It also calls into question why that is necessary as verification will take place at the dispensing point.

Daunting

The complexity and cost of implementing the directive are daunting. Even more worrying is the lack of detail. The MHRA draft regulations and impact assessment have yet to be published and consulted on, let alone agreed. The February 2019 deadline for implementation is looking increasingly unrealistic.

We are, in effect being asked to take a step in the semi-dark. How can we possibly make sensible, timely multi-million pound investment decisions when so many fundamental practical questions remain unanswered? Will split pack dispensing be allowed? What about MDS? What about dispensing points in prisons?

As Numark managing director John D’Arcy recently put it, FMD is becoming a bit of a “dog’s breakfast” and has the hallmark of being a complex, costly and bureaucratic sledgehammer to crack a nut, bearing in mind that by far the greatest risk to patients from falsified medicines arises from illegal internet sites, not the legitimate supply chain.

Brexit complication

Then there is Brexit to further complicate matters. Post-Brexit, what legal and regulatory relationships will exist between the UK medicines verification body and its Europe-wide counterpart, which will host the central verification database? The UK and EU have yet to discuss this as part of the Brexit negotiations.

The HDA, Phoenix and others have called on the EU and UK negotiators to make continued patient access to medicines post-Brexit one of their top priorities. The manufacture and distribution of medicines takes place at a pan-European level and that will not change post-Brexit.

If we are to avoid medicine shortages, there must be no disruption to transportation of medicines between the UK and mainland Europe due to border and customs checks. And we need clarity regarding if/how UK and EU medicines regulation and authorisation will continue to be aligned post-Brexit.

The reality is that, unless we get clarity and a common-sense approach from the MHRA, all of us could end up with costly, bureaucratic and highly disruptive changes to our supply chain which, to date, has worked well to combat counterfeits reaching patients.

Both the complexity and cost of implementing the directive are daunting