Ready or not, we’re all pretty much up to speed with the objectives of the Falsified Medicines Directive (FMD), which comes into force on 9 February 2019. Created to prevent counterfeit medicines from entering the supply chain across Europe, it requires every pharmacy to scan barcodes and check tamper-proof devices in order to verify the authenticity of a medicinal product.

“The whole world is serialising,” says Martin Sawer, executive director of the Healthcare Distribution Association. He estimates that in some countries, up to 50 per cent of medicines are counterfeit. 

“Manufacturers have been preparing madly over the past couple of years,” says ABPI director, Rick Greville, with the result that all packs of prescribable medicines will have a 2D scannable matrix from 9 February onwards. Products already on the market before then can be dispensed until their expiry.

However, anecdotal evidence suggests that uncertainty around how Brexit will be orchestrated means an alarming number of pharmacies still don’t believe FMD is going to happen, or at least don’t understand it. Nonetheless, the UK FMD Working Group for Community Pharmacy remains resolute in its advice to the sector. “The working group’s position has not changed and we urge people to engage with FMD, irrespective of any Brexit confusion and whatever our post-Brexit position might be,” says chair Raj Patel. 

Practical steps

What are the practical steps to engaging with FMD, and where can contractors turn for advice? 

Pharmacist Mona Koshkouei is pursuing a doctorate in paediatric medicine at the University of Oxford. Her research focus is on the operational and clinical impact of regulatory change of FMD on healthcare systems within Europe and specifically primary and secondary care within the UK. She believes that for community pharmacies in particular the key steps are “understanding what this change will mean for them, taking into consideration their processes, customer/patient base, IT infrastructure and financial investment or impact”. 

That sounds like a lot to consider, but Ms Koshkouei says there are a number of sources of information available. “The MHRA has a dedicated email address for FMD implementation queries (FMD.safetyfeatures@mhra.gov.uk), the UKFMD Working Group for Community Pharmacy has information on its website (www.fmdsource.co.uk) and NHS Digital is in the process of creating guidance toolkits for healthcare providers across a number of sectors.” 

“With more than 130,000 community pharmacists, hospitals and doctors being impacted by the deadline, pharmacists should look to their associations for advice in meeting compliance ahead of the deadline,” says Graham Smith, general manager of healthcare and pharmacy, EMEA, at TraceLink, a SaaS (software as a service) platform for tracking and tracing pharmaceuticals. “However, because much of the information in the market is outdated or inaccurate, it is important to understand the options for cost-friendly, flexible solutions that naturally fit into existing workflows or can be added on with slight modifications.”

The bottom line is that pharmacies will need an FMD scanning system that connects into the UK’s national verification system, managed by not-for-profit third party supplier SecurMed UK. There are two options for this, both of which you have to pay for yourself. Speaking at a panel discussion on FMD at this year’s Pharmacy Show, Leon Finnerty, programme lead at NHS Digital, explained that the options were to either “go with your existing pharmacy system supplier” or choose from “a number of standalone systems”.

Getting on board

Whatever you choose, each community pharmacy in the UK will have to go through an ‘onboarding’ registration process, which identifies them as a legitimate pharmacy and grants them an account to connect to the UK FMD system.

At the time of writing, SecurMed has not yet opened up the process. “The onboarding process described at securmed.org.uk specifies the information that will be required and the process that SecurMed will take for verifying the information,” says Oliver Staunton, pharmacist, co-founder and developer at PharmData. “The end user registration process is still not available, though I believe it may be in early November.

“After onboarding, there will be a registration process between the pharmacy and whichever software provider they have chosen, so depending on the provider, there may be a site visit for installation and training, or online installation, or the pharmacy may simply set up the software themselves.”

More to do

In order to avoid disruption during the Christmas and New Year period and to allow time for staff training, the UK FMD Working Group has urged pharmacy contractors to plan to complete registration as soon as possible, but how well prepared are pharmacies?

Speaking on behalf of the FMD Working Group for Community Pharmacy, Jonathan Buisson, international pharmacy and policy manager at Walgreens Boots Alliance, says: “Most people have been well aware of FMD for a long time and it will work if everybody does their bit. The IT is in place – with about 80 companies registered now to do development, so the chances are your PMR supplier has got it in hand and most system suppliers are out of ‘the sandbox’ testing phase – plus manufacturers, wholesalers and pharmacies are beginning to gear up, although some are more advanced than others.” 

Ms Koshkouei says preliminary studies have indicated that community pharmacies are at varying stages of ensuring compliance with FMD. “With ongoing clarifications being sought by pharmacy providers and a live test with the UK Medicines Verification System pending, it would not be an unreasonable assumption that 100 per cent compliance may not be achieved across all pharmacy sectors in time for launch,” she says. 

Brexit and FMD

If this isn’t enough to be getting on with, it seems as if the MHRA is suggesting that FMD could be revoked just weeks after implementation, in the event of a no-deal Brexit.

At the Pharmacy Show, Claymore Richardson, a senior policy manager at the Department of Health and Social Care (DHSC), referred to a recent MHRA statement clarifying that in the “unlikely” event of no deal and with no agreement on the post-Brexit transition period, FMD would, by law, have to be revoked “because you can’t have something that’s legally impossible to comply with”. 

This is because continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. “From a legal point of view, if we crash out of Europe with no withdrawal agreement and no transition period, we have no right to plug into the European FMD hub and they have the right to pull the plug on anyone not in the club,” says Mr Buisson.

Malcolm Harrison, chief executive of the CCA, has said: “In the event of the UK Medicines Verification System being disconnected from the European hub after Brexit, we similarly agree with the FMD Working Group that the government should fully compensate the sector, where all or part of the system which has been invested in becomes redundant.”

Drop-dead dates

With the FMD deadline only a few months away, Mr Buisson says the time for action is now. “Serialisation is a global approach, so actually, the ‘drop-dead dates’ dropped dead months, if not years, ago,” he says. “Having said that, I expect a lot of tweaks to go on after 9 February, with software updates that build on real world experience.”

There’s going to be a long transition and Ms Koshkouei advises that, while pharmacies must be FMD compliant by 9 February 2019, “there is also a wash-out period where not all medicinal items will bear the safety features and so there will exist a natural phasing in of the verification and decommissioning workload”. 

Non-compliance 

For those who don’t – or won’t – get on board, it’ll come as no surprise that a recent DHSC and MHRA consultation contains a section on sanctions for non-compliance.

“One approach would be the sole use of criminal sanctions for failure to comply with the requirements of the Delegated Regulation, with a person liable on summary conviction to an unlimited fine or liable on conviction on indictment to a fine, or to imprisonment for a term not exceeding two years, or to both,” says Zeeshan Ahmed, global serialisation expert, director and co-founder at Sigma Advance Consulting. “However, government is minded to move to an approach that would use a mixture of criminal and civil sanctions. Such civil sanctions might include written warnings, stop notices and civil fines, before the application of criminal sanctions, which would only be used for the most serious, intentionally fraudulent, breaches.”

Mr Richardson confirmed that the MHRA is the overall enforcement agency for the Directive, but it will work with the relevant regulatory bodies (GPhC, CQC and others) to put FMD into the inspections it already has. 

Mark Davison, senior operations director, Europe, at rfxcel Corporation, which provides SaaS-based track and trace solutions for the pharmaceutical supply chain, suggests that “in theory, MHRA could start inspection and sanctions on 9 February when the FMD goes live”.

“Why would you not comply?” says Mr Buisson. “Why, in effect, would you say you are happy to supply falsified medicines? FMD is happening, so your best bet is to get informed, get on board and keep your eyes open for further information that’s coming, as well as guidance on what you do if things go wrong, which we’re working on right now.”