The issue of counterfeit medicines is a growing concern, and the Falsified Medicines Directive (FMD) has been put in place to help solve the problem. As of February 9, GP practices are expected to comply with an initiative described as ‘the safest medicines system in the world’.
As part of the directive, medicine manufacturers have added unique 2D data barcodes and tamper-proof security seals to the packaging of their products.
Affected primary care organisations need to put the infrastructure and processes in place to be able to scan the medicines and ensure they are legitimate. When medicines are supplied to patients, the unique identifier is ‘decommissioned’ by scanning it into the FMD system.
The BMA advises that even non-dispensing practices that prescribe and administer vaccines should have the infrastructure and processes in place to decommission medicines.
The General Practitioners Committee of the BMA stated concerns that “the authentication system will result in burdensome bureaucracy for pharmacists, practices and dispensing doctors and that it will not fit in with current pharmacy/dispensary IT systems”.
There is a twist however – because this is an EU directive, the UK may no longer have to comply with it in the case of a ‘No Deal’ Brexit, adding an extra layer of uncertainty to the rollout of the new system.
Has your practice had to take steps to comply with the FMD, and have you experienced any issues with the initiative? Let us know your thoughts in the comment section below.
First Practice Management members can head to the Policies and Procedures Library now to download our new Falsified Medicines Directive (FMD) Policy.
This is an odd situation at present as we have only 2 drug packages in our dispensary that have the 2D barcodes on them. Some of the lines have had package re-design which seems to allow space for these but not yet. Strange that practices have to comply with every change in CQC, contract, NHSE, Dept Health, HMRC, HSE etc etc etc on time but 9th Feb has passed and FMD is still not active. I wonder of supply issues and Brexit have side-tracked the pharmaceutical powers that be?
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