Pharmacies in England, Wales and Scotland will no longer be legally responsible for “verifying and decommissioning unique identifiers on prescription medicine packs” at the point of dispensing from the end of the transition period on December 31, the UK FMD Working Group for Community Pharmacy (FMDWG) said in an update to contractors yesterday (November 16).
Pharmacies will be “disconnected automatically from the UK National Medicines Verification System (UKMVS) run by SecurMed UK” at the end of the transition period. However, contractors will need to check that, if their patient medication record (PMR) systems have integrated Falsified Medicines Directive (FMD) functions, these are no longer connected to or “seeking a response from UKMVS after the end of 2020”, according to FMDWG.
“Stand-alone FMD systems can simply be turned off” after December 31, the group added.
However, contractors who have FMD integrated into their PMRs can continue to use the FMD scanner “as some functionality will still work with FMD compliant packs – such as accuracy checking or date checking”, National Pharmacy Association head of corporate affairs Gareth Jones told C+D yesterday.
FMD still applies in Northern Ireland
Under the terms of the Northern Ireland protocol of the EU Withdrawal Agreement, the FMD directive will continue to apply in Northern Ireland for “at least four years”, FMDWG said.
As part of the protocol, a 12-month “phased process” will begin after the end of the transition period, to allow businesses time “to prepare in relation to batch testing, importation and FMD requirements” the Cabinet Office announced earlier this month (November 5).
Pharmacies in Northern Ireland will continue to connect to the UKMVS and will need to comply with current FMD requirements. SecureMed UK will support Northern Ireland branches “to decommission packs with FMD identifier features into 2021 and beyond”, FMDWG said in its update.
Future of FMD in Great Britain
The Medicines and Medical Devices Bill – which is being discussed at committee stage in the House of Lords today (November 17) – could allow ministers to introduce a national system that would allow medicines to be “authenticated and identified if tampered with”, the FMD group said.
However, before introducing such a system, the government would need to consult key stakeholders, including pharmacy bodies, the group added.
Mr Jones told C+D that “it is too early to say how the national system will work” but that using a scanner at the point of dispensing is only one way of checking that medicines are not counterfeit.
While different arrangements were made to cover the cost of FMD in England, Scotland and Wales, “discussions will now have to take place to ensure that pharmacies in each of the three nations are not left out of pocket by the decisions that have led to the end of the requirement to scan”, he added.
A Department of Health and Social Care spokesperson told C+D today that the government will “explore all options for a national system” to protect the public against falsified medicines.
“We are committed to fully consulting with stakeholders on any future development of a national falsified medicines scheme that is the best fit for our national supply chain, taking into account investment made,” they added.
FMD came into force on February 9 last year, but from the start pharmacies reported having to deal with “false alerts” – error messages such “unknown product code” and “failed to find batch” that might not necessarily indicate a falsified medicine.
An impact assessment published by the Medicines and Healthcare products Regulatory Agency in 2018 estimated FMD related-costs – the “social cost” for scanners, “training and familiarisation”, and decommissioning – at £666.1 million over a 10-year period.
So, farewell then, Falsified Medicines Directive. It's been fun*.— Phil (@vento) November 16, 2020
Well, RIP Falsified Medicines Directive - you achieved nothing in GB pic.twitter.com/IHkOuX16aU— Mohammed Hussain (@DigitalPhamcist) November 16, 2020