The Falsified Medicines Directive (FMD) could cause wholesalers delays in delivering medicines to pharmacies.

In a roundtable organised by The Pharmacist on 30 October – in collaboration with NHS Digital – Phoenix Medical Supplies and McKesson UK warned that FMD will add to wholesaler’s workload.

It is feared this could cause possible delays in the delivery of medicines.

FMD is a pan-European set of anti-counterfeiting measures designed to stop falsified medicines from entering the supply chain. From 9 February 2019, pharmacists will have to scan the unique bar code on every pack of medicine before they are dispensed.


Potential delays in deliveries


Asked whether FMD will add to wholesaler’s workload, McKesson UK’s – previously known as Celesio UK – FMD program manager Sarah Gibb confirmed that it ‘could cause delays’ given the ‘additional tasks’ that will add to wholesalers’ current workload.

She said: ‘You could have delivery drivers at the back of the warehouse waiting to get out but [they couldn’t] because you would actually be trying to get additional information onto dispatch notes.

‘You've got to capture the batch on a certain list of products. Then at dispatch, you’ve also got to capture the batch because it's got to go onto the dispatch note or invoice.

‘All those things are additional tasks in a very busy, fast moving, productive environment. To pile that on, it's huge. You've got to train the staff and have the right systems in place to identify the product, and that’s just to start with.’

However, Ms Gibb stressed that the company is ‘absolutely’ taking steps to avoid delays.


Intensity of the supply chain


Under FMD, which is an end-to-end verification system, wholesalers will only have to verify products they receive from a marketing authorisation (MA) holder.

According to Phoenix Medical Supplies quality director John Preston, the Government medicines watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) will expect wholesalers to batch track only a ‘limited number of products’.

Mr Preston argued that UK wholesalers are uniquely placed in Europe, with products being delivered to pharmacies twice a day.

He said: ‘In the UK, you've got a cut-off time of 11am or 11.30am. It might take half an hour or an hour to get from the wholesaler distribution depot to a pharmacy. Think how long you've got to pack that and we're packing a million of units a day.

‘We've got that intensity of that supply, particularly at lunchtime, so it's a really big issue for wholesalers because we've got an awful lot of units going out all at once.’