The UK Government agreed to implement the EU’s falsified medicines directive from 9 February 2019, which means GP practices should now be able to demonstrate compliance.
In the event of a no-deal Brexit
If the UK leaves the EU with no deal, we expect the UK will lose access to the EU central data hub. Stakeholders will be unable to upload, verify and decommission the unique identifier on medicines in the UK. In that case, it’s unlikely the directive would apply in its current form.
Packs containing the safety features would still be accepted in the UK, but practices would not be legally obliged to track and decommission them.
Why was the directive introduced?
The falsified medicines directive (directive 2011/62/EU) introduced tougher rules to ensure medicines are safe and their trade rigorously controlled.
It responds to the increase of false products detected in EU member states’ legal supply chains; counterfeiting high-price medicines is a growing illegal business and a threat to public health worldwide.
To tackle the problem, the directive:
- introduces safety features so any prescription item is fully traceable, and it’s easier to identify false products
- improves control at EU borders where false medicinal products could enter
- ensures active pharmaceutical ingredients are high quality and not falsified.
What it entails
The directive affects all those in the pharmaceutical supply chain – including dispensing and non-dispensing GPs – and needs to be considered by manufacturers, wholesalers and dispensers with an aligned approach.
All prescription medicines are now required to carry a unique serial number, encoded in a 2D barcode and a visible anti-tampering device. This comprises:
- a product code, which identifies at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size and pack type
- a serial number which is a numeric or alphanumeric sequence of up to 20 characters randomly generated
- a batch number
- an expiry date.
Manufacturers upload the serial numbers to a system of databases linked by a European hub (although only 15% of products were expected to be compliant from February 2019). Country-based data repositories allow verification and, when each pack is dispensed to a patient, record when its unique identifier is ‘decommissioned’.
At each stage of the supply chain, products are inspected to ensure they haven’t been tampered with, haven’t previously been dispensed and have their packaging intact.
What it means for GP practices
All practices need the processes to decommission medicines, even non-dispensing practices that prescribe vaccines.
They also need to decide whether they decommission medicines at the point of dispensing or in advance, but be aware there is a 10-day window in which medicines can be recommissioned into the system.
SecurMed UK is set up to establish the UK medicines verification system required by the directive.
Costs and concerns
Creating and maintaining the data repository should be paid for by manufacturers, but they are not obliged to bear the cost of connecting to the database or the IT hardware and software required in every pharmacy. This should be provided by the NHS.
The BMA GPs committee is concerned that the authentication system creates bureaucracy for pharmacists, practices and dispensing doctors, and that it won’t fit with current pharmacy/dispensary IT systems. This is likely to increase the time taken to dispense, and increase workload.
We have met regularly with the Department of Health and Social Care and others involved in implementing the directive to ensure GPs’ interests are represented and any adverse implications mitigated. We have argued strongly that the NHS must fund the equipment required so that the impact on GPs’ and their employees’ workload is kept to a minimum.