This site is intended for health professionals only

Home / News / EXCLUSIVE: ‘No intention at this time’ to assess FMD impact on community pharmacy, says MHRA

EXCLUSIVE: ‘No intention at this time’ to assess FMD impact on community pharmacy, says MHRA


By Léa Legraien
Reporter

20 Jul 2018

The UK’s medicines watchdog has said it has ‘no intention at this time’ to publish an impact assessment on how the Falsified Medicines Directive (FMD) will affect community pharmacies.

The FMD is a series of anti-counterfeiting measures that will see pharmacists scan packs of medication before they are dispensed to verify their authenticity. It will come into force on 9 February in the UK.

The comments come after the Medicines and Healthcare products Regulatory Agency (MHRA) published an FMD impact assessment consultation for what are known as Article 23 providers on Monday (16 July).

The document looked at who should scan the products as well as the costs the different options for this could result in. However, community pharmacy was not mentioned in the document.

 

‘No legal flexibility’

 

An MHRA spokesperson told The Pharmacist on Wednesday (18 July) that it ‘has not published a UK-specific full impact assessment, and does not intend to publish one at this point in time’.

They added: ‘We are doing a focused impact assessment [on Article 23 providers] as we are only consulting on those areas where the UK has legal flexibility to make policy decisions.

‘Under the delegated regulation, pharmacies are required to decommission medicines and there is no legal flexibility available to the UK to make changes.’

Article 23 providers include:

 

  • People authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy
  • Veterinarians and retailers of veterinary medicinal products
  • Dental practitioners
  • Optometrists and opticians
  • Paramedics and emergency medical practitioners
  • Armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control
  • Universities and other higher education establishments using medicinal products for the purposes of research and education, with the exception of healthcare institutions
  • Prisons
  • Schools
  • Hospices
  • Nursing homes

 

Community pharmacy costs still unknown

 

According to the UK’s FMD working group, community pharmacists will have to bear the costs of the barcode scanners, although it has not been able to confirm how much these might be.

In April, Sigma Pharmaceuticals Plc director Bharat Shah predicted that pharmacists could be forced to pay up to £3,000 for the scanners, hardware and software alone.

A National Pharmacy Association (NPA) spokesperson told The Pharmacist: ‘We are very concerned about the costs that may fall on community pharmacy as a result of FMD.

‘We and other pharmacy bodies have been raising this issue with government for a long time.’

For more information on FMD, click here.


Want news like this straight to your inbox?


Latest News

Well Pharmacy appoints new superintendent as Janice Perkins steps down
The pharmacy superintendent of Well Pharmacy, Janice Perkins, has stepped down after 15 years in...
Pharmacy contractors invited to attend RSG webinar next week
Pharmacy team members have been invited to attend the Pharmacy Representation Review Steering Group (RSG)...
Exclusive: Is anxiety causing young people to faint after Covid vaccine?
There has been an increase in the number of people from younger cohorts fainting after...