New tougher rules to stop counterfeit medicines could cause extra workload and IT upheaval for GPs, the BMA has warned.
The Falsified Medicines Directive (FMD), which is being rolled out across Europe, will bring in new measures such as unique barcodes and visible anti-tampering devices on all prescription medicines, including vaccines.
Under the changes – set to be adopted by the Government in February 2019 – GPs will have to scan all medicines and vaccines before they are given or administered to patients, to check they are legitimate.
The BMA has warned this is set to cause ‘burdensome bureaucracy’ for both dispensing and non-dispensing GPs across the UK.
GPs will end up spending more time dispensing and their IT systems will need to be updated to allow the medicines to be scanned, it said.
The FMD is aimed at controlling the medicines trade by implementing stricter rules to stop falsified medicines from entering the supply chain. It is being introduced by the European Union Parliament following a significant increase in false medicinal products across the EU.
In practice, the new rules mean that from February, GPs and pharmacists must scan medicines using the FMD system to check they are legitimate and then ‘decommission’ them so they can be given to a patient. This stops the medicine’s unique barcode from being taken off that product and used on a falsified medicine.
All GP practices will need to have the infrastructure and processes in place to scan and decommission medicines, including non-dispensing practices that prescribe and administer vaccines.
In guidance to GPs, the BMA said: ‘The GP Committee has concerns 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.
‘This is likely to result in an increase in the time taken to dispense, thereby representing an increase in workload.’
‘The BMA has argued strongly that the NHS must fund the equipment required and make the necessary IT equipment available to facilitate the FMD so that the impact on the workload of GPs and their employees is kept to a minimum,’ it added.
The BMA said it has been meeting regularly with the Department of Health and Social Care and others involved in the implementation of the FMD to ‘ensure that the interests of GPs are represented and any adverse implications of its introduction on practices are mitigated’.
The new measures are likely to be brought in whether or not the UK leaves the EU with a Brexit deal, according to the BMA, which added that GPs should assume the FMD will be implemented fully in February and ‘prepare accordingly’.
NHS Digital has been commissioned to develop guidance toolkits for healthcare providers to help them prepare for the implementation of FMD, but a toolkit for general practice has not yet been completed.
The Falsified Medicines Directive
The Falsified Medicines Directive is legislation passed by the EU Parliament is aimed at increasing the security of the manufacturing and delivery of medicines in Europe. It is designed to ensure prescribed medicines are safe, legitimate and not copied to be resold illegally to patients.
The directive will come into force in the UK from 9 February 2019 and under the FMD, all new packs of prescription medicines placed on the market in Europe will have to bear two safety features:
- a unique identifier in the form of a 2D barcode that will comprise of a product code to allow identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size and the pack type, a serial number which will be a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated, a batch number, and an expiry date
- anti-tampering device.
Manufacturers have the responsibility to upload the serial numbers to a system of national databases linked by a European hub, while country-based national data repositories will allow verification at different times and final decommissioning when each pack is dispensed to a patient.
All GP practices will need to have infrastructure and processes in place to decommission medicines, even non-dispensing practices that prescribe and administer vaccines.
13 May 2022