FMD

Pharmacists need answers now on FMD

With less than six months to go until the Falsified Medicines Directive comes into force, pharmacists in the UK need to know how to prepare for its implementation and what financial impact it could have on their business.

Medicine pack with unique identifier anti-tampering device, FMD

Source: Courtesy of Jonathan Buisson

The biggest IT medicines safety drive in the world begins in less than six months, but the UK is far from ready.

The Falsified Medicines Directive is designed to stop fake medicines from entering the supply chain, with a mega-database set up in Brussels that will track where drugs go around Europe. All pharmacists will be legally required to verify any medicines they receive and decommission any leaving the supply chain, for example when dispensing to patients, from 9 February 2019. It is a huge logistical challenge.

Pharmacists can prepare now by revising workflows and ing their IT supplier, but crucial information is still missing. We don’t know what sanctions pharmacists will face for not adhering to the regulations (that was only put out for consultation in July 2018), what the anti-tamper devices will look like and whether the EU hub will have all the data it requires on launch — worryingly, only 5% of pharmaceutical companies are fully connected to the hub, and a third have not even started the process.

More importantly, the whole question of who is going to pay for the new hardware required is shrouded in doubt. The Medicines and Healthcare products Regulatory Agency (MHRA) published an assessment of the impact of FMD for wholesalers, care homes, opticians and prisons in July 2018. But this assessment did not cover the potential costs to community or hospital pharmacies.

A spokesperson from the agency told The Salvadore that “the MHRA has not published a UK-specific full impact assessment, and does not intend to publish one at this point in time”. But is this really good enough? 

The only assessment of how much this is all going to take out of each pharmacy’s bottom line is a 2015 document from the European Commission, which said a community pharmacy would be expected to face costs of around €530 per year to modify software for FMD compliance, purchase new barcode scanners and perform medicines authentication. A hospital pharmacy, the report said, would face annual costs of up to €750.

Not large amounts of money, but the current advice from experts is for community pharmacies to be cautious about purchasing any new scanners or other technology before they have assurances on whether this expenditure will be reimbursed. National negotiations are ongoing, although the most recent update from the Pharmaceutical Services Negotiating Committee suggests costs will only be “recognised in future NHS funding settlements” — i.e. after the regulations are brought in.

And to compound the situation, these regulations are set to come into force just six weeks before the UK leaves the EU, with all the disruption that could bring. Indeed, some experts are questioning how long the FMD system will be needed post-Brexit as, under Article 7 of the EU withdrawal Bill, the UK could lose access to all EU networks and information systems and databases post-transition. The UK government is aiming for regulatory alignment on medicines policy that should allow for continued access, but is also talking up a ‘no deal’ scenario that could leave all FMD preparations in tatters.

The government appears to be asleep on the job, while confusion reigns. Pharmacists need immediate clarity from the Department of Health and Social Care on how these regulations are going to be brought in and a promise that all costs will be reimbursed. The time for answers on FMD is well overdue.

For more information about how to prepare for FMD, visit

Citation: The Salvadore DOI: 10.1211/PJ.2018.20205308

Readers' comments (2)

  • We would be lucky to get answers. The new pharmacy contract has not yet been negotiated and asking for answers on FMD! That's asking too much of our incompetent pharmacy bodies.
    I'm not holding my breath for a clear answer from the relevant bodies.

    Unsuitable or offensive? Report this comment

  • The importance of the Falsified Medicines Directive (FMD) is often underestimated, even when the magnitude of the task is recognised. FMD helps to prevent inauthentic, substandard or harmful medicines entering the supply chain. However, it also acts as a key enabler for other initiatives such as Scan4Safety, and other digital medicine initiatives which will have major benefits for all of us.

    While rfxcel welcomes the consultation from the MHRA in order to clarify some key outstanding aspects of the delegated regulation, by the time the consultation closes on the 23rd September 2018, less than five months will be left for the industry to implement processes and systems to ensure FMD compliance.

    We therefore endorse the most cost-effective and pragmatic approaches to the verification and decommissioning process, that will help put systems in place within the remaining timescales.

    However, underpinning any approach must be a fundamental consideration: data integrity.

    An effective solution must focus on both connectivity and data integrity. Data checking is not built into the EU FMD as tightly as it is for the US Drug Supply Chain Security Act. In the US, each actor in the supply chain is responsible for checking, adding to, and passing-on data for each product. The FMD doesn’t require that, relying mostly on end-of-chain checks during dispensing.

    Some commercial FMD compliance systems enable a connection and flow of data across and between organisations but are blind to data quality. Whoever holds responsibility for the verification and decommissioning of medicinal products (whether wholesaler or dispenser) should never assume that the data entering, or generated within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication, and smart solution providers will consistently validate data flowing through a system – in our case we do up to 70 data validation checks on incoming records to ensure their integrity.

    Unfortunately, time is running out but good solutions are already available for all the necessary use cases, including the Article 23 complexities. We urge people to act now, rather than wait for the end of the consultation period, and start to identify an FMD implementation partner. This should be a recognised provider with experience, credibility and evidence that it can implement effectively within very tight timeframes. They should have the flexibility to adapt to changes in business and the wider marketplace as they arise. The post-Brexit world could get even more complicated, but whilst the mechanics of pack verification may change, the underlying rationale does not.

    Act now. We don’t expect the results of the government’s consultation to require radically new system architecture for FMD. The best solution providers are agile enough to adapt quickly to any tweaks that may be needed.

    - Mark Davison, Chief Operations Director, Europe - rfxcel

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