Public Health England (PHE) has issued guidance on how the Falsified Medicines Directive (FMD) applies to centrally supplied vaccines for the national immunisation programme.
On 9 February 2019, legal obligations on the UK to prevent the entry of falsified medicinal products into the supply chain came into force.
The Delegated Regulation of the FMD requires that prescription-only medicines including vaccines entering the supply chain after this date carry safety features including an anti-tampering device (a seal) and a unique identifier (contained in a 2D barcode), and have their product data uploaded onto a central database.
In addition, certain parts of the supply chain will be required to perform authenticity checks, and at the end of the supply chain ‘verify and decommission’ products before they are supplied or administered to patients.
These changes will affect all healthcare institutions including general practice, pharmacies and other organisations across the UK who access centrally supplied products from PHE, except where the person or institution is captured under Article 23, it says.
For the majority of health staff working in vaccination, and in particular GPs, in practice this means that at the end of the supply chain, before a vaccine is administered to a patient, the integrity of the product seal should be checked and the barcode on the packaging should be scanned to verify authenticity and register the removal of the product from the supply chain on a central database (decommission).
NHS Digital are developing toolkits for various types of healthcare providers to help them in the implementation of FMD.
Guidance documents on the FMD are available here.