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Harsh FMD sanctions for isolated compliance failures inappropriate, pharmacists say


By Léa Legraien
Reporter

28 Sep 2018

Applying harsh sanctions to community pharmacies that fail to comply with the Falsified Medicines Directive (FMD) requirements is ‘inappropriate’, pharmacists have said.

In its response to a Medicines and Healthcare products Regulator Agency (MHRA) consultation on implementing the FMD, the UK FMD Working Group for Community Pharmacy said that any sanctions to ‘isolated’ pharmacies failing to scan products – once the requirements come into force in February – would not be fair.

FMD is a series of European anti-counterfeiting measures that will see pharmacists scan medicine products to verify their authenticity before decommissioning and handing them to patients. The FMD Working Group represents the interests of UK pharmacists.

 

‘Inappropriate’ sanctions

 

The MHRA said that the Government is inclined to use a ‘mixture of criminal and civil sanctions’ for those who fail to comply with the measures, which could include written warnings, stop notices and fines.

But the FMD Working Group argued that it would be ‘inappropriate’ to apply any sanctions for isolated cases.

It said: ‘We agree with the proposal that, other than in exceptional circumstances, such as intentional fraud, civil rather than criminal sanctions are used to deal with non-compliance.

‘We believe that any sanctions must be fair and proportionate. Isolated non-compliance, such as failures to scan products, do not undermine the integrity of the system.’

 

Call for equity

 

The European Commission (EC) stipulated that a ‘healthcare institution’ refers to a hospital, an in or outpatient clinic and a health centre. This means these places will be able to verify the safety features and decommission the unique identifier of a medicine product earlier than the time at which it is supplied to patients.

As GPs and dispensing doctors are considered as ‘health centres’, the UK FMD Working Group highlighted the importance of having the same authentication requirements across primary care.

‘We suggest that dispensing doctors must face the same requirements as community pharmacies,’ the group said.

The group also pointed out that the proposals lead to an ‘inequity between hospital outpatient pharmacies, an ‘anomaly’ that should be ‘addressed’, it said.

 

‘Sector needs to move quickly’

 

With FMD coming into force in five months, the group chair Raj Patel said the sector needs to ‘move quickly’.

‘Irrespective of any Brexit confusion and whatever our post-Brexit position might be, we need to have a viable solution by the February 9 deadline,’ he added.

‘We recognise contractors will need to make substantial time and investment, but it is important that community pharmacy meets its obligations. I urge all community pharmacies to start planning for FMD now.’


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