FMD is coming – Interview with Raj Patel

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Within weeks the Falsified Medicines Directive (FMD) comes into force across the EU. As of 9 February, every pharmacy should have their system in place and be ready to scan, verify and decommission medicines. In this practical guide, we hear from Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy, who is believed to be the first pharmacist in the UK to get connected to the system.

“I believe we are the first in the country to connect. The process took about an hour. The most complex bit is actually getting into SecureMed and getting certification to access the site. ‘On-boarding’ (the process of registering) is extremely important and needs to be done before you get all your equipment ready to go, but that is about as complex as it gets.

“The system we have chosen is integrated, so it will talk to our EPOS system and, therefore, we don’t have a lot of clutter in our decommissioning area. In the first instance, we will just use the system for verifying and decommissioning (see box, overleaf), but there are additional capabilities, for example stock control. However, all that will come in time, at the moment all we want to do is certify and decommission.”

A SECURE SYSTEM

“The FMD process has been going on for many years. From the point at which it was first talked about, to the point at which it is being delivered, it must be two decades, but now it’s nearly here.

“I think there will be a gradual change as the number of FMD-compliant packs in the system increases over time. As this number rises, people will use their FMD systems more and more, so it’s not going to be a sudden shock to the system.

“Because there have been so few counterfeits introduced into the UK supply chain, there are people who see FMD as a sledgehammer to crack a nut. But we are part of the EU at present and it’s something that we’ve got to do.

“While the number of counterfeits in the UK market is very small, FMD reduces the potential of any reaching the patient even further. It’s a very secure system that we have and from 9 February it will be even securer.

“There have been mixed feelings about FMD, but it is mainly viewed as a regulatory burden for pharmacy, in terms of the cost and in terms of additional steps being required in the dispensing process, but it’s something that we need to deliver. “In terms of whether the system is going to stay or not, no one knows what is going to happen with Brexit, but I think that it will stay. If it doesn’t, then something else very similar will be put in place, because if the EU had a system and we did not, the UK could end up being the place that counterfeiters focused on to get their products into the supply chain.”

ARE YOU READY?

“There has been great progress over recent weeks, with a lot of people realising that this needs to be done, and that is borne out by reports of suppliers getting more enquiries about FMD. I think it has finally hit home that this needs to happen, there will always be some people who will not be ready in time, but the majority will manage to get there. Will every single community pharmacist have connected in time? I think that would be a cautious ‘no’.

“But it’s never too late to start. Those who haven’t taken action yet can go to the NPA for advice, they should look to get as much information as they can about FMD and once they have absorbed it all, they can look at FMD systems and which is going to best suit the way that they work and their processes – making sure that you have the right system for you is very important.

“People will have to change their processes, in terms of the ergonomics and dispensing, so this will inevitably cause some disruption. Also, decommissioning has to take place before the medication is handed over to the patient, so that is an extra step and there will be complexities if a counterfeit is discovered.

“For everything to go as smoothly as possible, it is important to ensure that there is training in the pharmacy and also that there is good integration between EPOS and FMD to streamline the process. “For those who don’t have a system in place in time, I don’t think it’s going to be the case of the GPhC coming out just to inspect FMD systems, but where there are GPhC inspections from 9 February, they will expect to see that FMD is being complied with.

“The IT and infrastructure are in place and it’s now a case of people choosing whether they want an integrated system or a standalone system and then getting connected.”

For more information, visit npa.co.uk/fmd and fmdsource.co.uk