Public Health England (PHE) are still ‘not yet issuing’ vaccination stock that complies with the EU Falsified Medicines Directive (FMD).
The directive, which came into force on 9 February, is a pan-European regulation that requires pharmacies to decommission and verify the authenticity of medicines using barcode scanning software before they are dispensed to patients.
PHE confirmed to The Pharmacist today (2 May) that, as per a vaccine update published on 17 April, ‘PHE (via ImmForm) are not yet issuing products that are subject to the requirements of FMD’.
The document says: ‘This is due to the large volume of non-FMD compliant stock already held by PHE prior to 9 February 2019.’
PHE added that it hopes to begin distributing fully compliant vaccination packs from the summer, with some non-FMD vaccine stock ‘potentially’ in circulation until 2020.
In order to be compliant, medication packs must carry safety features including a unique barcode and anti-tamper device and have their product data registered to the European Medicines Verification System (EMVS).
The National Pharmacy Association (NPA) advised in February that contractors should dispense most medicines even if their FMD software flags a potential problem, since there would be ‘very few’ compliant packs in circulation by the implementation date.
In January, the UK FMD working group warned that pharmacists should take steps to be FMD-compliant in time for the deadline despite implementation delays in the supply chain.
However, a letter issued by NHS England in February instructed pharmacists to continue preparing for FMD ‘with appropriate caution’ given the possibility of a no-deal Brexit.
PHE advised contractors to check the Department of Health and Social Care’s (DHSC) vaccination monitoring and ordering system ImmForm regularly for FMD updates on each individual product.