It has been a long time coming, but the February 9 implementation deadline for the Falsified Medicines Directive (FMD) is very nearly with us. FMD, which aims to keep ‘fake’ medicines out of the supply chain, will require pharmacies to check an anti-tamper device, scan a 2D barcode and inform SecurMedUK, the UK’s national medicines verification system, that a medicine has been supplied or ‘decommissioned’.
MPs have yet to vote on Theresa May’s Brexit deal, leaving unanswered the question of whether the UK will remain signed up to FMD after March 29 (see ‘Government position on FMD and a no deal Brexit’ below). And with 2019-20 negotiations between PSNC and the Government yet to begin, it is not clear whether the DHSC intends to pay contractors for the additional workload. PSNC says it has raised the matter with Government but there have not yet been “substantive discussions”.
What is certain is that, as of February 9, pharmacies will be required to scan and decommission the POMs they dispense (non-prescription medicines are exempt, apart from OTC omeprazole). By now, many (hopefully) will have procured software and scanners and connected to SecurMedUK, and will be ironing out any kinks around workflow. However, some will remain uncertain about what is required.
The big decision facing contractors is whether to opt for a standalone solution or one integrated with the pharmacy’s existing PMR or EPoS software. The consensus appears to be that while integrated products offer more benefits overall, standalone represents less of a commitment and so may be more appealing as a short-term option.
David Vanns, director of operations at regional multiple Weldricks, has adopted a “mixed approach” based on the prescription volume profile of each pharmacy. “We will use scanners integrated into PMR and/or EPoS systems in low volume sites and standalone in high volume sites,” he says. This is because there are “significant differences in work flows, work practices and the physical characteristics of premises between low and high volume pharmacies”.
Software company Cegedim Rx is offering the two solutions on a phased basis, having provided standalone FMD applications from mid- December and is rolling out its Pharmacy Manager integrated solution this month.
The company says that with the standalone solution, FMD scans are carried out independently of the PMR, so the touch points in each pharmacy can be selected to suit existing workflows. The integrated solution, meanwhile, “will sit within our Pharmacy Manager PMR and prompt the user to scan medicines as part of the dispensing workflow”. Cegedim says that with the integrated product, “the medicines will only need to be scanned once, at which point the unique serial number will be aggregated to the bag label barcode and automatically decommissioned as part of the handout process”. The company has also linked other activities like accuracy checking to the scanning process to help smooth out workflow.
Gareth Dunsmore of FMD IT, a software supplier the NPA has worked with to achieve a deal for its members, comments on the benefits of standalone systems: "With options to run slave terminals from the host tablet, run dedicated decommissioning scanner at EPOS, standalone offers a huge number of benefits to the pharmacy, but work flow optimisation is one of the key benefits.
"Allowing the FMD process to be dealt with outside the PMR process enables staff to disperse the workflow that this legislation WILL cause (however large or small) and reduce the chance of adding to an already existing bottle neck within the branch (the PMR terminal)."
David Vanns says FMD has been on his radar since May 2015, when the NPA assembled the UK FMD working group to become the implementation group for community pharmacy. He joined this group as an AIM director and set about reviewing all the available options, checking key criteria such as price, equipment requirements and methodology with all suppliers.
As a result of these early preparations, he feels Weldricks is ready for the February deadline. “We have purchased all the scanners we need for full implementation so our roll-out cannot be delayed by scanner out-of-stocks or thrown offbudget by price increases.”
Getting the pharmacies set up has been troublefree, he says, and his teams have “adapted very quickly to individual pack scanning” because they have been “flexible, open-minded and accepting of the need to change”. Accommodating the new practice has “improved how they relate to and manage stock in their dispensaries,” he reports.
Weldricks is also working in collaboration with NHS Digital as an early implementer site to share learning and test the guidance toolkits it has produced for healthcare providers across primary and secondary care. This experience has given the business “deep insights” into how pack scanning “affects the whole pharmacy supply chain from working practices to SOPs”, and is being used to inform plans for the coming months, Vanns says.
FMD IT's Gareth Dunsmore echoes Mr Vanns' positive remarks, saying "FMD compliance is not as disruptive as many people think".
It is difficult to get a sense of how many community pharmacies are currently compliant with the directive. The NPA told PM in early November that, based on what it had been seeing, many pharmacists were “just starting to look into this”. When contacted more recently it would not be drawn on numbers but said “many NPA members are asking questions about implementation and are still looking at the options available to them in terms of FMD systems”.
SecurMedUK told PM in early January it was “not allowed” to discuss uptake rates.
Market Pharmacy in Bolton claimed to be the first pharmacy in the UK to be fully FMD-compliant in late November, with owner (and FMD working group chair) Raj Patel declaring he was “pleased to say everything went smoothly”.
Having spoken to many pharmacists, David Vanns says the situation appears to be that “the national chains are going to be compliant. The independent regional multiples also say they will be compliant, but there is variability in preparedness among the smaller independents.”
In mid-December Cegedim told PM it anticipated that “most [pharmacies] will not be looking to order or implement their preferred solution until the New Year on account of this being the busiest season of the year”.
We have an ongoing open dialogue with our customers around FMD, Cegedim says. “We are encouraging them to think about the operational impact, potential workflow changes and other requirements well ahead.
“There are still concerns from customers about costs, funding and operational impact. Our objective is to minimise the operational impact of FMD, while wringing out every possible benefit for our customers and their patients.”
FMD IT's Gareth Dunsmore says his company has been "installing systems since Q3 2018 (after our 18 month development and testing phase was complete) but it’s fair to say the level of interest has picked up from the independent sector towards the latter part of 2018 and early January."
NPA head of corporate affairs Gareth Jones advises contractors not to be put off by concerns around a no deal Brexit. “While Brexit creates uncertainty it won’t stop FMD becoming an obligation from February 9. We do, however, advise you to avoid getting tied into long-term contracts with IT suppliers, given the uncertainty about what may happen after March 29.”
FMD IT's Gareth Dunsmore says Brexit " won’t affect FMD too much ultimately, as it is clear the UK will have a repository in the unlikely event of a no deal Brexit and immediate exit from the EMA/EMVO post March."
While Mr Dunsmore says that while he understands the challenges FMD poses, particularly the timing – which "has meant this has been a very difficult additional challenge for many to understand, fund and dedicate time for" – in the long term the Directive "will benefit the sector". Patient safety and increased efficiencies as pharmacies harness data to monitor stock and reduce wastage are the big gains as he sees it.
David Vanns points out that while the MHRA “cannot give guarantees”, it has indicated that even if the UK leaves the EU with no deal, it intends to stick with the UK Medicines Verification System, “which is fully paid for by manufacturers and connected to the European repository”.
The world is “moving to pack level traceability” and contractors ignore this at their peril, he says, as it is looking like FMD compliance will be a legal requirement with criminal sanctions for non-compliance. “Is it worth taking the risk of sanctions for the relatively small outlay of ‘out of the box’ solutions that are available for independents from FMD suppliers?”
However, he adds: “It is also assumed regulators will take a humane approach and not apply hard sanctions as long as individual pharmacies have tried to engage with FMD by the start date”. And as only around 15 per cent of all barcodes in the supply chain are expected to be FMD compliant on February 9, “it will be a gentle roll in”, Vanns says.
Full guidance for contractors at fmdsource.co.uk
In its response to the MHRA’s consultation on medicine regulation in the event of a no deal Brexit, the Government says if there is no deal, “we expect the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK”.
Packs with FMD safety features “would still be accepted in the UK, provided they are in line with other UK packaging requirements”, the Government says.
Looking beyond March 29, the Government says the UK’s position on tackling falsified medicines remains clear – “we want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines”. The Government says that in the interests of public safety, it will “evaluate the options around a future national falsified medicines framework, which would inform the detail of any short or longer-term modifications”. MPs had yet to vote on Theresa May’s Brexit deal as we published this piece.