In 2018, the world of Pharmacy faced some difficult challenges, ranging from increasing uncertainty over Brexit to further funding cuts to the sector. As 2019 begins, there is a new challenge for both pharmacy owners and pharmacists as the Falsified Medicines Directive (FMD) is set to come into force on the 9th February 2019. This article is a follow up to the one previously published in October and which raised various issues with regards to implementation of FMD in a pharmacy environment, such as equipment costs, use of computer systems and implementation of the scanning process within the workflow of a dispensary.

In 2018, the world of Pharmacy faced some difficult challenges, ranging from increasing uncertainty over Brexit to further funding cuts to the sector. As 2019 begins, there is a new challenge for both pharmacy owners and pharmacists as the Falsified Medicines Directive (FMD) is set to come into force on the 9th February 2019. This article is a follow up to the one previously published in October and which raised various issues with regards to implementation of FMD in a pharmacy environment, such as equipment costs, use of computer systems and implementation of the scanning process within the workflow of a dispensary. Three months on from that article and with less than a month to go until FMD becomes a reality in the pharmacy world, are we ready for a fundamental change in how medicines are procured, dispensed and supplied to patients?

One of the core issues surrounding FMD was the issue of pharmacy contractors having to buy equipment such as scanners and updated computer systems. This was of particular concern to community pharmacy contractors in light of the recent funding cuts to the sector which mean that pharmacy budgets are already stretched. This issue was further compounded throughout 2018 since there was no guarantee that these costs would be reimbursed to contractors. This even led to the chair of the UK FMD Working Group for Community Pharmacy urging contractors to delay the purchase of any equipment in the third quarter of 2018. However, this problem now seems close to being resolved, with both PSNC and the UK FMD Working Group for Community Pharmacy saying that they will ensure that the costs to contractors are at least recognized in future funding for the pharmacy sector.

Dispensing medicines under the FMD means that pharmacies will have to scan medicinal products various times throughout the dispensing process, which helps to audit the journey of the individual pack, as well as communicate with a central database to help prevent falsification of the individual pack. As a result, extra equipment will be required in pharmacies to allow them to be able to comply with this requirement. This includes scanners, IT hardware and software in order to comply with FMD regulations. One of the major questions raised regarding this topic was the lack of information over which computer systems were available to pharmacy contractors to allow FMD compliance. Contractors were advised to get in touch with their current system suppliers, in order to identify whether their current suppliers will be developing an update or system for FMD compliance. Halfway through 2018, a list of a small number of FMD System suppliers were released, but this did very little to ease the uncertainty that contractors were facing. However, this list has been continuously updated, and now each of the major PMR suppliers to pharmacies now offer their own FMD systems. As a result, contractors now have a plethora of options to choose from for their FMD system, and so are able to choose a more tailored system according to the business’ individual needs.

As the deadline for FMD fast approaches, community pharmacists and pharmacy staff need to be able to familiarize themselves with a new range of scenarios, in an area which they are likely to have had limited exposure to. This could include responding to patient queries regarding the new scanning processes as well as making professional decisions based on the results of a scan of an individual pack of a medicine. In order to aid with this, the Royal Pharmaceutical Society (RPS) has developed an ultimate guide to FMD, which outlines the various results that scanning a product may produce. For example, an amber result may mean that the 2-D barcode on the pack is damaged, in which case the pharmacist should exclude the possibility that this could be due to tampering before deciding to supply the individual pack to patients. Furthermore, there is now information on how to deal with split packs as part of the dispensing process. Upon first dispensing, the packs will have to be decommissioned via a scan. When the split pack is re-dispensed there is no need for it to be rescanned since it has already been decommissioned. However, there is still a requirement to check any recalls for the split pack manually, since the pack would not be scanned after initial dispensing.

Among the many uncertainties that pharmacy is facing in 2019, Brexit is perhaps one of the biggest challenges. The future of the pharmacy sector in a post-Brexit Britain is an uncertain one, with little to no information available on the impact that Brexit will have on the medicines supply chain as well as funding for the sector. There is currently no evidence that a no-deal Brexit will go ahead but if the mainstream media is to be believed, a no-deal Brexit is becoming more of a reality as time passes. Should there be a no-deal Brexit, then the FMD systems in the UK will no longer be bound by European legislation and so there is a likelihood that communication with the central Europe-wide database will be lost. The UK FMD Working Group for Community Pharmacy have attempted to clarify this situation by stating that there is an intention to maintain the FMD system after Brexit, unless it is specifically revoked in the event of a no-deal Brexit. Should the latter occur, then communication with the central European database will be lost and so there are plans to introduce a national database, in order to ensure continuity of an FMD style system.

Despite the promise shown by FMD with respect to reducing the infiltration of falsified medicines into the legitimate medicines supply chain, there are still some issues with the service. For example, in the initial stages after its introduction there is likely to be a large number of packs that are either not FMD-compliant in terms of containing a security seal and a 2-D barcode, or packs that have not yet been uploaded to the central database. As a result, FMD may be of limited use in the first few months after its enforcement. However, despite these initial teething issues, FMD provides a lot of potential with regards to preventing falsification of medicinal products and retaining patient confidence in the medicines supply chain.

Bibliography:
PSNC – Falsified Medicines Directive: A quick guide for the pharmacy team. Available at: https://psnc.org.uk/wp-content/uploads/2018/11/PSNC-Briefing-058.18-Getting-ready-for-FMD-a-quick-guide-for-the-pharmacy-team.pdf
UK FMD Working Group for Community Pharmacy – The way forward for FMD in Community Pharmacy. Available at: https://ukfmdworkinggroup.files.wordpress.com/2018/01/fmd-cp-working-group-way-forward-paper-jan-18-public-v1-0-final.pdf
The Pharmaceutical Journal – First hospital pharmacist to decommission under FMD warns of flaw in system. Available at: https://www.pharmaceutical-journal.com/news-and-analysis/news/first-hospital-pharmacist-to-decommission-under-fmd-warns-of-flaw-in-system/20205959.article
UK FMD Working Group for Community Pharmacy – List of FMD system suppliers. Available at: https://fmdsource.co.uk/suppliers/
RPS- Falsified Medicines Directive. Available at: https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd
UK FMD Working Group for Community Pharmacy – The current situation for FMD. Available at: https://fmdsource.co.uk/implementing-fmd/the-current-situation-for-fmd/
The Pharmaceutical Journal – No-deal Brexit presents risk for EU patients as well as UK, manufacturers’ representatives say. Available at: https://www.pharmaceutical-journal.com/news-and-analysis/news/no-deal-brexit-presents-risk-for-eu-patients-as-well-as-uk-manufacturers-representatives-say/20205692.article

 

Author: Raj Dhaliwal MPharm

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