Al Patel, contractor at Lee Pharmacy in south east London, reports on how his staff have been preparing for the introduction of the Falsified Medicines Directive
At the moment, there are a lot of concerns being expressed over the effect a no-deal Brexit could have and whether this is going to have some kind of impact on counterfeit medicines as well.
When we’re talking to patients, everyone seems to know about the recent BBC coverage of medicines shortages. People aren’t just concerned with getting their supplies now, they also fear the shortages may mean more fake medicines coming into the market.
There has been an increase in supply disruptions, too. In the last two weeks, there have been new medicine shortages, for example there’s an ongoing aspirin shortage from just before Christmas. A pharmacy short of aspirin is a bit like going to the bakery and there not being any flour to make the bread – so there seem to be some strange goings on out there.
With regards to Brexit, obviously pharmacies will have no legal obligation to implement the Falsified Medicines Directive (FMD) if there is a ‘no-deal’. Last year David Davis said that there will be a fixed implementation period of [I think] 21 months, I’m not sure whether that still applies, but I know the Medicines and Healthcare products Regulatory Agency (MHRA) have now confirmed that it’s going to consider a UK version of FMD, so either way we’re still going ahead here.
‘Increased waiting times’
There’s been lots of hindrance this week. We are burdened with huge amounts of paperwork and various different deadlines comingup, including FMD, quality payments, the data security and protection toolkit. I think a lot of pharmacies have forgotten there’s a deadline for this in February – as well as medicine use reviews (MURs) and end-of-financial-year paperwork.
We’ve also been telling our patients what’s likely to be implemented. We’ve printed off information leaflets on FMD and new waiting times in the pharmacy. We’ve calculated there’s going to be an average increase in waiting time of seven to 10 minutes, depending on the number of items and the prescription. But for someone who is in a rush, that’s a big impact.
So far everyone we’ve spoken to seems to think FMD is a good idea and an advantage, but the few people we’ve told about the waiting time delays, they’re not happy.
We are still waiting for our hardware – our barcode scanners haven’t arrived yet, and they are needed for verifying medicines. We decided to go with a standalone supplier in the end. But it is going to be an extra burden for us because it’s not implemented in the normal PMR system, so we are having to look at standard operating procedures for dispensing, managing returns, decommissioning, verification of medicines, reporting exceptional events, business continuity and staff training.
But although we are working on this, nothing has actually been implemented. Hopefully it will all fit into place when the hardware arrives – but it’s really a waiting game.
‘No national help’
We’ve got our next weekly meeting coming up tomorrow (31 Janaury). We will try and go through the standard operating procedures again and discuss any queries that staff may have.
I know everyone seems to be worried about business continuity. For example, what happens if there is a power cut or the Internet is down? There’s a lot of uncertainty on the reporting aspect too and whether the light turns red or green, what to do in each case and where to go.
At this stage I can’t provide those answers – there’s no national FMD helpline number. There seems to be no help and the information we do have is very cloudy. There are no set rules and everyone seems to be passing the buck. Initially, we were told the Medicines and Healthcare products Regulatory Agency (MHRA) would be monitoring compliance, but now we’ve been told the General Pharmaceutical Council (GPhC) are doing it.
We may not be ready in time. It’s going to be a last minute shuffle if we are. But apart from the standard operating procedures, which are a big overhaul, we’ve done everything we can.
I’m left wondering whether the Government or any other body should be doing an impact assessment for the sector - looking at the European Medicines Agency (EMA), the change in regulations, the legal framework, Brexit, medicine devices, clinical trials...in effect what is going to be the impact of FMD on the UK pharmaceutical sector and manufacturing here?