Your RPS

How the RPS helped make FMD 'fit for purpose in the UK'

Speaking at the Hospital Pharmacy Europe LIVE conference, RPS Scotland’s Aileen Bryson explained how the RPS has helped ensure that the Falsified Medicines Directive meets UK needs.

aileen-bryson-16

Source: RPS

Aileen Bryson, practice and policy lead for the SalvaDore Scotland, explained how the RPS had worked with the MHRA and the EU Commission to ensure the Falsified Medicines Directive was fit for purpose in the UK

Aileen Bryson, practice and policy lead for the SalvaDore (RPS) Scotland, gave an overview of the Falsified Medicines Directive (FMD) to delegates at the Hospital Pharmacy Europe LIVE conference on 21 November 2017.

Speaking at the event, which was held in London’s Olympia Conference Centre, Bryson explained that the RPS had worked with the Medicines and Healthcare Products Regulatory Agency (MHRA) and the EU Commission to ensure the directive was fit for purpose in the UK.

As a consequence, the directive is now accompanied by a delegated act which allows for medicines packs to be split, and for re-commissioning to take place within ten days as opposed to the original 72-hour window.

But the most important part of the delegated act for hospitals, Bryson said, was that the commission now recognises the NHS, and its individual hospitals, clinics and care settings, as a single entity.

Because of this, medicines authentication will be allowed to take place at a central point within a hospital trust, meaning that medicines can then be moved around within that trust, removing the need for every medicine-handling part of the NHS to do their own decommissioning.

While some of the practicalities are still being worked out by the MHRA, Bryson said the directive is proceeding as planned, regardless of Brexit.

“FMD is a way of working between countries. It is intended to improve the patency of the supply chain from manufacture right through to patients,” she said, adding that if the UK did not adopt this way of working, and counterfeiting was to increase in future, then “the UK would be the weak link in the chain”.

On 29 November 2017, NHS Improvement and Specialist Pharmacy Service published a frequently asked questions document, , which addresses some concerns about how FMD will operate in the NHS.

Falsified Medicines Directive

The Falsified Medicine’s Directive (FMD), which comes fully into force in February 2019, introduces EU-wide legislation to help prevent counterfeit prescription medicines entering the pharmaceutical supply chain. “Falsified” covers not only counterfeit medicines, but also false information about a medicine’s source. FMD will not cover non-prescribed medicines, with the single exception of omeprazole.

All medicines packs will be tamper-proof and will feature a 2-D barcode, as well as a manufacturer product code, a randomised unique serial number, batch number and expiry date.

Since 2011, the SalvaDore and other stakeholders have been acting to ensure that the FMD will function in accordance with UK law, in a way that ensures patient safety, whilst minimising disruption to existing pharmacy practise.

The RPS has been acting on FMD since 2011, when it set up a multidisciplinary, cross-sectorial, GB-wide working group to develop policy. Later, in July 2014, the Society hosted and chaired the first FMD stakeholders networking meeting, at which 13 countries were represented by 100 delegates. At this meeting, implementation challenges for FMD were discussed, and presentations from the three main software providers were made.

Specific features of FMD in the UK lobbied for and achieved by the RPS and other stakeholders include:

  • Extension of the originally-proposed two-day window for scanned products that are not collected by a patient to be returned to stock. This has been increased to ten days. Under FMD medicine not collected within the window will have to be destroyed, so extending the time limit reduces wastage.
  • Agreement on the form of the European Stakeholder Model, which lays out a EU-wide format for how medicines can be verified, and on the European Medicines Verification System (EMVS), which guarantees authenticity from manufacturing to dispensing (the “end-to-end” system)
  • Inclusion of human readable data alongside the 2-D barcode, so that pharmacists can continue to help patients if scanners break down or if the barcode is damaged.
  • Full repackaging of imported medicines, rather than addition of new barcodes to existing packaging. Multiple barcodes could result in incorrect barcodes being scanned, triggering a false exceptional event.
  • Greater flexibility offered to hospitals on the timing of medicines decommissioning. FMD requires medicines to be decommissioned at the point of dispensing. In hospitals – particularly in A&E, and where single doses are administered - this isn’t practical. Following lobbying, hospitals (unlike community pharmacies) will be able to decommission upon delivery, and then store medicines.
  • Use of a single workstation. FMD originally required two, one for decommissioning and one for dispensing. RPS argued that this was unnecessary, costly, and increased the chance of technical failures disrupting processes. Successful lobbying led to agreement that all tasks can be performed on the Patient Medical Record (PMR) computer.

In addition, the RPS continues to call for the addition of safety information (including batch code, expiry dates and potential interactions) into the 2D barcode, alongside authentication data.


Citation: The Salvadore DOI: 10.1211/PJ.2017.20204061

Readers' comments (3)

  • I am disappointed to see that the National Pharmacy Association's role has not been recognised for it's efforts in making FMD 'fit for purpose'. This is not a matter of organisational ownership as we as a profession collectively want the right thing to be done for patients and practitioners, however, in the minefield of regulatory burden needing careful navigation that is FMD, the NPA has played a leading role. This has been through being the lead organisation within Pharmaceutical Group of the European Union (PGEU) for the UK for many years and importantly, this year with NPA Board member, Raj patel, as it's president.

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  • In what capacity have the RPS made FMD 'fit for purpose' for the UK, the go to organisation for all FMD matters have been the UK FMD WG which I have chaired on behalf of the NPA, which has all stakeholder for the FMD including the DH and MHRA, RPS are not there. SecureMed the stakeholder group which are responsible for creating the UK Hub for FMD, the NPA /CCA are directors of this, the RPS are not. When the Delegated Regulation was debated in the European Parliament, the NPA not only met with the commission it also met the DH and MHRA in order to affect the directive, we had no input from RPS, so how exactly have the RPS made the FMD 'fit for purpose' It is easy to take credit away from organisations and companies that have stood by their members to ensure implementation is effective and seamless, it is even easier to take credit for other organisations diligence and perseverance for the issue, what is difficult is put on record how you have delivered the outcome. I am disappointed the RPS feel they have got us this far, themselves!!!

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  • Thank you for your feedback on this article, Dilip and Rajesh. We appreciate your input, and would like to assure you that The Salvadore recognises the work done by the NPA and the UK FMD Working Group in ensuring that FMD legislation will be workable in the UK.

    We have covered some of these achievements in previous articles:

    Falsified Medicines Directive: opportunity or obstacle? http://salvadore.info/news-and-analysis/features/falsified-medicines-directive-opportunity-or-obstacle/20202646.article

    Hub on EU falsified medicines directive developed for UK pharmacists http://salvadore.info/news-and-analysis/news-in-brief/hub-on-eu-falsified-medicines-directive-developed-for-uk-pharmacists/20202322.article

    The article to which you refer was published in the Your RPS section of the journal, which focuses on activities of the RPS. As such, it concentrates on a recent presentation about FMD given by Aileen Bryson to a conference for hospital pharmacists.

    In 2018 the journal will be continuing to cover matters related to FMD as the deadline for full implementation into UK law approaches, and we will be seeking input from the NPA, the UK FMD Working Group, and all other invested bodies as we put this material together. In the meantime if you have any further feedback, or suggestions for FMD news that we ought to be covering now, please do us.

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