Whilst proposals for a hub-and-spoke prescription fulfilment model appear to have been pushed onto the back burner, the implementation of the Falsified Medicines Directive (FMD) is really starting to cook on gas. This affects everyone within the pharmaceutical supply chain and is a transformational change to current systems and processes.
You may be tempted to believe FMD will disappear following the EU referendum, but no one should bury their head in the sand; FMD is already incorporated into UK legislation and is certain to happen. With the legislation becoming effective 9 February 2019, the countdown is on for the pharmaceutical industry to comply with the enhanced security requirements.
With increasing fears, concerns and instances of counterfeit medicines entering the pharmaceutical supply chain, these changes should be welcomed even if they don’t come cheaply.
Collective Responsibility
Previously, I’ve encouraged all parties to take a holistic view of the industry. FMD is a prime example of an issue affecting all stakeholders and needs to be considered by manufacturers, wholesalers and dispensers with an aligned approach. The legislation requires prescription medicines for sale to carry a unique and randomised serial number encoded in a 2D-barcode and a visible anti-tampering device.
Manufacturers will be responsible for uploading the serial numbers to a system of national databases linked by a European hub and country-based national data repositories will allow verification at different times and final decommissioning when each pack is dispensed to a patient.
At each stage of the supply chain, the product will be inspected to ensure it hasn’t been tampered with, has not previously been dispensed and that the packaging is intact. Additionally, Goods Distribution Practice (GDP) guidelines will require the individual product to be scanned to record the batch number and expiry date. This check will indicate whether the product is authentic and bring up information such as whether the product has been subject to a recall.
These actions to be carried out across the pharmaceutical supply chain are vital to its integrity and minimise the opportunity for the original product to be replaced with a counterfeit.
FMD to increase patient safety
I wholeheartedly support the objective of FMD to implement end-to-end verification of the medicines supply chain for all prescription medicines, to not only enhance patient safety, but also provide greater confidence in the integrity and quality of medicines prescribed. To ensure its successful implementation, FMD will require significant investment both in financial terms and a commitment of time and resource. As one of the UK’s leading pharmaceutical wholesalers, we’ll continue to work with regulators, stakeholder bodies, our manufacturer partners and pharmacy customers to ensure all participants in the medicines supply chain are ready to safely implement the processes for medicines authentication in time.
Transformational change
February 2019 may seem a long way off, but don’t underestimate the scale of change required and in reality, we have less than two years to be ready and to develop, test and input new systems and working practices. I’d encourage everyone to familiarise themselves with the requirements and start collective discussions with stakeholders now! I have no doubt the change will be difficult and will come at a price, but I believe the long-term benefits far outweigh the short term challenges. Given that all of us either take some form of medicine or have family or friends who are dependent on medication, it may be in our best interests to deliver this solution for the benefit of all.
FMD AT A GLANCE
The FMD followed on from an EU Council Directive from 2011 and is intended to reduce the occasions on which falsified medicines enter the legitimate supply chain.
The directive will affect any medicine product with a false representation of:
* its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients
* its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder, or
* its history, including the records and documents relating to the distribution channels used
In February, details of the safety features, which set out obligations on all of those in the supply chain were published, and the UK now has three years to implement them.
These safety features include a 2D bar code with a unique identifier and tamper evident packaging: measures which will affect all prescription medicines (unless they’re exempted).
The unique identifier features:
* a sequence of alpha-numeric or numeric characters given to the individual pack
* a code allowing identification of the name
* common name, pharmaceutical form and strength as a minimum
* reimbursement information if required by MS,
* batch number, and
* expiry date