Falsified Medicines Directive: opportunity or obstacle?

The past decade has seen some lurid headlines about falsified medicines in European countries. Fake Valium (diazepam) has been implicated in several deaths in Scotland^[1]
; stolen vials of the breast cancer drug Herceptin (trastuzumab) were potentially tampered with and reintroduced to the supply chain in Italy^[2]
[3]
; there have been ongoing reports of fake Viagra (sildenafil)^[4]
; and batches of fake Lipitor (atorvastatin) were discovered in the legitimate supply chain in the UK^[5]
[6]
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The EU’s system-wide response to the threat of counterfeit medicines entering the formal supply chain — as distinct from the threat of drugs procured via the internet or on the street — is the Falsified Medicines Directive (FMD)^[7]
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The FMD aims to provide a secure supply chain from manufacturers through wholesale and pre-wholesale to dispensers and, finally, patients. It’s been in the pipeline since 2013, when it became European law, and will go live in pharmacies by 9 February 2019. However, since the FMD is European legislation and the UK is now firmly on course to leave the EU, why is the UK continuing down the FMD path?

“The elephant in the room is Brexit,” says Jerome Bertin, managing director of SecurMed, a not-for-profit organisation that has responsibility for delivering the UK’s medicines verification system, a core requirement of the FMD (see Box).

“The Medicines and Healthcare products Regulatory Agency [MHRA, which regulates medicines and medical devices in the UK] has been given guidance by ministers that… the UK will be in the EU for the next two years, during which time [the UK] will apply all safety of medicine regulations. They want it to continue.

“Whatever happens and whatever the outcome of [Brexit] negotiations, [the UK] will remain full participants [of the FMD].”

The general view is that this is as it should be. For a start, an end-to-end secure medicines supply chain approach is now becoming global. Countries such as China, India and South Korea are all adopting the same system and the UK needs to remain part of that global market. One strong argument against opting out of the FMD is that it would make the UK a magnet for counterfeit drugs from all over the world.

However, by leaving the EU, the UK may be able to adapt the FMD to suit the unique needs of the NHS.

Aileen Bryson, interim director of the Royal Pharmaceutical Society (RPS) in Scotland, says: “We may be able to develop compromises — but that is at the end of a very long to-do list. It may well be revisited in future years.”

Just short of two years ahead of full implementation, there are more unknowns than knowns and precious little in the way of infrastructure.

Immediate steps

The MHRA has UK-wide responsibility for working out how best to put the FMD into UK law and is working on the matter through an implementation advisory board and a series of task and finish groups.

One starting point is the National Medicines Verification System (NMVS), a national data repository that will be connected to a central European hub (the European Medicines Verification System, EMVS). In the UK, delivery of the NMVS is the responsibility of SecurMed, which represents supply chain stakeholder associations, such as the Association of the British Pharmaceutical Industry, the British Association of European Pharmaceutical Distributors, the British Generics Manufacturers Association, the Company Chemists’ Association, the Healthcare Distribution Association (HDA) and the National Pharmacy Association (NPA).

The immediate task for SecurMed is to commission a software provider to build the NMVS. It will choose one of three companies listed as preferred providers by the European Medicines Verification Organisation (EMVO), which has responsibility for the formation of the EMVS — Aegate Holdings Limited, Arvato Systems GmbH and Solidsoft Reply.

“We are using the national blueprint model developed by EMVO,” says Bertin. EMVO has identified the three providers as having the capability and capacity to build national medicines verification systems for 28 EU member states and non-EU countries such as Switzerland and Norway that have elected to join the FMD — and to do so cost effectively.

An announcement about the final selection for the UK’s NMVS provider is expected imminently. “[The] SecurMed UK board has identified the preferred blueprint service provider and we are in the final stages of contract negotiation,” says Bertin. “We need to set up the system and bring on board all the different players along the supply chain ready for February 2019 when we are all obliged to comply with the FMD by law.”

And by ‘all’ he means around 15,000 community pharmacies, 11,000 dispensing doctors, 450 hospital pharmacies, 2,200 wholesale licence holders and 50–60 software suppliers.

This doesn’t include the other small-scale dispensers of medicines referred to in article 23 of the FMD, including vets, opticians, dentists, oil-rig clinics, universities, fishing trawlers, mountain rescue teams, paramedics and emergency medicine practitioners aboard ambulances, nursing and residential homes and prisons. Currently, the proposal is that wholesalers should decommission medicines on their behalf; the MHRA expects to issue a three-month public consultation on ‘article 23 exemptions’ in 2017.

Added benefits; potential problems

Once the NMVS is in place — or at least once some technical specifications are made available — pharmacy software system suppliers will need to build their interfaces to the national system. Pharmacies will need to invest in scanners and start to understand how workflows will change. New standard operating procedures will need to be written. There will be training requirements, as well as a need to understand how compliance with the FMD will be regulated.

And this is where the known unknowns come in.

Gareth Jones, head of public affairs for the NPA, a trade association representing the owners of independent pharmacies, is involved in the various European and national working groups now teasing out the detail of implementing the FMD.

He says, with what may be typically English understatement: “The wording of the legislation is challenging” and that the working groups are looking carefully at what it means.

“There are certainly opportunities but people are very much focused on the burden,” he adds. “We need to maximise the upside.”

Jones says there are three potential added benefits of implementing the FMD. With each medicine barcoded, there is an opportunity to improve supply errors, for example through electronic checking of expiry dates.

There is also the scope to build in medicine recall into whatever systems deployed at dispensing level to communicate with the NMVS. “There are systems in place already,” he says. “But this could be an extra level.” Finally, systems could support better stock control.

Shanel Raichura, a community pharmacist and director of pharmacy at healthcare software company EMIS Health, says these functions should be built into IT systems — but whether that will be possible in the short term is not clear.

“We want to achieve so much more than simply decommissioning the products. We believe we can provide businesses with better stock control and significantly increase the spotlight on improving dispensing errors. It fits nicely with the quality payment scheme [introduced as part of the new community pharmacy funding settlement for England for 2017–2018],” he says. But would it be version 1 or version 2 of any new system? It’s not clear.

Jones’ list of disadvantages is longer than his list of advantages — this is a system originating from Europe that may not take account of UK anomalies, he explains. In Europe, for example, medicine packs are generally not split. But in the UK, packs are often opened and strips of tablets are shared between patients. Such practice does not sit easily with a system where a pack must be scanned and dispensed to a patient — if a box has been scanned once and the code decommissioned, a second scan for a second patient will trigger an alert.

For similar reasons, it is not clear how the FMD will work when community pharmacists prepare a seven-day supply of multiple medications for patients with co-morbidities.

Under the ten-day rule — a hard-won concession by the RPS — a pharmacist may keep a decommissioned medicine on the shelf for up to ten days. It can be un-decommissioned by scanning it back into the system, but only within the ten-day limit.

As Bryson explains: “[The RPS] fought hard for this at European level. Originally, the EU wanted a 48-hour rule but we felt that would be completely unworkable in the UK.”

Even so, working through the implications of the ten-day rule in high street pharmacy is going to be taxing. What about the patient who orders their asthma inhaler three weeks in advance — and then does not pick it up for a fortnight?

“We fear that there will be an increase in medicines waste,” says Jones. “It all depends on how new processes work in practice and how we develop workarounds.”

One option, says Bertin, might be to verify medicines as they are bagged and create a label with an IT-system-generated code that triggers decommissioning for all contents at the time the medicines are handed to the patient.

Another hurdle, according to Jones, is that the ‘hub and spoke’ model of dispensing — whereby prescriptions are assembled at a central hub and then shipped to pharmacies where they are dispensed to the patient — is incompatible with the FMD and the ten-day rule.

If the situation in community pharmacy is complex, then the situation in hospital pharmacy is even more so. As the MHRA points out, the two sectors will handle the FMD quite differently: “The obligations on pharmacies and hospitals (considered as healthcare institutions) vary under the delegated regulation. Healthcare institutions are able to decommission medicinal products at any point once they receive them, pharmacies must decommission items at the point of supply.”

Tim Root, specialist pharmacist at the NHS Specialist Pharmacy Service, an advice service that supports medicines optimisation across the NHS, and strategic lead for medicines at the NHS London Procurement Partnership, a membership organisation set up to enhance the purchasing power of NHS organisations, offers his perspective on what is worrying the sector.

“The proposal for NHS secondary care remains the principle of FMD: decommission as close to the patient as possible. But there are so many ifs and buts generated by the complexity of the internal NHS supply chain that as soon as you start to look at this, you are forced to retreat from that quite quickly,” he says.

One simple example is ward stock, Root explains. “Despite everyone’s best efforts, wards may sometimes accumulate excess stock which needs to be sent back to the pharmacy to avoid waste and release storage space. What happens if that medicine has been decommissioned weeks earlier?”

Nevertheless, “decommission close to the patient” remains the proposal. As Root points out: “The flexibilities allowed are still relatively few. [The problem of] squaring the theoretical proposal with the reality of the NHS is very, very real.”

Input from the innovators

The people who are best equipped to come up with solutions to these potential problems — pharmacists and innovators — are worried that they are not being involved. They fear that history will repeat itself, and that lessons won’t have been learnt from the introduction of other technologies, such as the electronic prescription service.

Sanjay Ganvir, chair of Camden and Islington local pharmaceutical committee and superintendent pharmacist at Green Light Pharmacy in London, explains: “ETP [the electronic transmission of prescriptions] sounded like a great idea — and it was. But… it could have run a lot smoother. The IT did not work as well as it could have and it resulted in a lot more work for pharmacists. My concern is that this [FMD] will be the same.”

Ganvir acknowledges the MHRA’s committees and task and finish groups, but says the innovators are not on them. “Who is going to make this happen,” he asks. “It’s the innovators at the coalface and the jobbing community pharmacists who understand the processes and, as far as I can see, they are not involved in the design of the new processes that are going to be needed.”

Raichura talks about the creation of interfaces between IT systems and the NMVS as being an “operational nightmare”.

“FMD will absolutely change the operational landscape in the pharmacy,” he says. “For me, as a practising pharmacist and also working for EMIS, I want to make sure the process is as streamlined as possible.”

Raichura does not expect EMIS customers to jump from one system to another so the intention is to provide “seamless integration” across the patient medication record (PMR) system, the system used to decommission packs and other processes such as the electronic transmission of prescriptions. But he is not sure it can work. “The model as proposed is not feasible with current processes,” he says. Nor is he convinced the timetable is achievable. “We have a significant development road map and at the moment very little information.”

Bertin suggests that “end user pharmacy organisations” can get involved via their industry associations and directs them to a website — http://www.fmdsource.co.uk— set up by the UK FMD working group for community pharmacy, which includes representatives of all the main bodies in community pharmacy. The site contains information to help UK pharmacies prepare for whatever new authentication system is developed and is tailored to reflect the way UK pharmacies operate.

In terms of system development, Bertin says SecurMed will engage with pharmacy system suppliers. “It will be the PMR solution providers who will provide the pharmacy end user FMD solutions including technology, setup and operational support,” he says.

Jones’ list of challenges still stands, however. He wants to know what happens if broadband connections go down, for example, or what happens if a product fails to authenticate not because of counterfeit issues but because of barcode errors?

Then there is the cost of verification: manufacturers will bear the cost of the European and national databases but there could also be substantial costs to pharmacy, says Jones.

“The pharmacy contract says that any regulatory burden must be covered by the NHS and we will be making a strong case for the costs of implementation to be met by the NHS,” he says. “It is not insignificant. There is the cost of scanners, staff time, training, and procedures will need to change. We handle billions of packs [of medicines] a year and so while it may be true it takes two seconds to scan one pack, multiply that by billions and you have a big number.”

And last, but certainly not least, there is the matter of regulation. Who is going to be in charge of making sure pharmacists comply? What happens if they don’t? The MHRA says that this is an area where the UK can apply some flexibility to the FMD — the UK can develop its own rules. But these rules will need to be incorporated into UK law. A consultation is expected in 2017.

All change

For all this concern, some people are optimistic that the FMD is achievable and will deliver safety benefits.

Among them is Roger Nichols, head of pharmacy operations at Boots UK and the representative of the Company Chemists’ Association at SecurMed, who says that work to understand the changes that need to be made will get under way soon.

“I am sure that, as with any initiative of this type, there will be some unforeseen eventualities. There are some unknowns, but that being said, there is every reason we will be able to contract with a blueprint service provider, establish a verification system and that all actors in the supply chain will be able to undertake verification.”

Others say the timetable is not as tight as it looks. The FMD applies only to medicines manufactured after the 9 February 2019 implementation date and these won’t be in hospital or community pharmacy for quite some time. As Bryson says, “it will take years to get the system up and running”.

There is a long way to go before anyone has a clear idea of what FMD in practice will look and feel like. There’s a mountain of work to do and a deadline by which to do it. The only certainty is this: pharmacy processes are about to change — again.