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64% of contractors unprepared for FMD, while no-deal doubts confirmed

Two thirds of contractors were unprepared for the EU’s scanning law at the end of 2018, while the MHRA has since confirmed a no-deal Brexit would kill the directive.

Of the 53 contractors who responded to the C+D Salary Survey 2018 in October – 88% of whom were based in England – 64% said they were unprepared for the Falsified Medicines Directive (FMD), which will require all pharmacies to scan barcodes on medicines packaging at the point of dispensing from February 9.

In addition, 77% of contractors said they had not yet bought the scanners required to comply with the FMD.

Over half (52%) of 42 respondents to a separate question said they had spent less than £100 per pharmacy on preparations, while 21% had spent between £100 and £500, and 17% had invested more than £1,000.

Several respondents said the price of the equipment was prohibitive. Describing it as “so expensive”, one contractor said they were “trying to see if any colleagues get better deals so I can negotiate the same”.

Uncertainty surrounding Brexit was cited by two contractors as a factor in their unwillingness to invest in preparations. One respondent said they were “waiting for more guidance and Brexit information”, while another said they were “still deciding”.

MHRA: No-deal Brexit will void FMD

In its response to a consultation on the implementation of the FMD, published last week (December 24), the Medicines and Healthcare products Regulatory Agency (MHRA) confirmed that in the case of a no-deal Brexit, UK “stakeholders” – including pharmacies – will not be able to participate in the system after the country is scheduled to leave the EU on March 29.

Following a no-deal Brexit, the UK “would not have access to the [EU’s] central data hub”, resulting in pharmacies being “unable to upload, verify and decommission the unique identifier on packs of medicines”, the MHRA said.

The medicines watchdog also said that under certain circumstances it will allow some healthcare institutions to be exempt from FMD compliance.

However, the MHRA told C+D that “there is no flexibility...for a community pharmacy to be exempt from the requirement to decommission”.

In October, government officials suggested pharmacies should prepare for the FMD regardless of a no-deal Brexit, as any UK-focused scheme would be based on a similar system.

The C+D Salary Survey 2018 – which ran throughout October – was completed by a total of 1,916 pharmacists and pharmacy staff. C+D's coverage from the survey can be found here

Is your pharmacy prepared for the FMD?

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