As pharmacists should be only too aware, the Falsified Medicines Directive has requirements, considerations and solutions for them to consider. Graham Smith explains…
The Falsified Medicines Directive (FMD) is expected to drive major changes in pharmacy operations across Europe, with over 130,000 community pharmacists, hospitals and dispensing doctors being affected by the February 9 2019 deadline.
The regulations dictate that as of the deadline, all in-scope medicines, inclusive of prescription medicines as well as a ‘blacklist’ of over-the-counter (OTC) medicines that are deemed to be at high risk of falsification must have two safety features: a unique identifier (UI) in the form of a 2D data matrix code and an anti-tampering device (ATD).
To prevent falsified medicines from reaching patients, anyone authorised to dispense medicines to the public will have to authenticate each pack at the point of dispense by checking the ATD and verifying the UI.
The more complex element for pharmacists relates to verifying the 2D matrix code. The code first needs to be scanned and verified against the respective country’s National Medicines Verification System (NMVS).
If the medicines are genuine, the pharmacists will receive a confirmation message, which will change the product status to show that it has been dispensed or ‘decommissioned’ and has left the supply chain.
Considerations for compliance
A recent assessment from the EU Commission stated the annual costs to modify software for FMD compliance, purchase new barcode scanning equipment and perform medicines authentication, can be up to €530 (£406) for community pharmacists and €750 (£574) for hospital pharmacies, sometimes more.
In figuring out how to stay compliant, many small to mid-size pharmacists are likely to turn to patient medication record (PMR) system providers for support, expecting FMD solutions to be integrated within their current PMR system.
While possible, not all PMR providers will be capable of or willing to deliver a compliant solution. Therefore, some PMR providers have developed strategic partnerships with third-party suppliers that allows them to roll-out a solution among their customer base.
There are further considerations for pharmacists beyond the initial hardware and ongoing software investment including the investment in employee training, disruption to workflow and stock management. Some solutions consist of a fixed workstation, which will require a dedicated space, power source and data connectivity, and decommissioning at a central point could cause delays in processes.
UK pharmacists may also face additional considerations, including Brexit, when it comes to FMD compliance. As it stands, the UK is pushing ahead with implementation to meet the 9th February deadline.
Mobile solutions: cost-friendly with a flexible workflow
On top of the potential investment costs for hospitals and pharmacies associated with scanning equipment, the EU FMD requirement to decommission medicines can be cumbersome and disrupt pharmacy workflows.
Decommissioning medicines at various, non-mobile workstations from different locations can not only cause confusion and lead to non-compliance but can also delay medicines in getting to patients.
A more flexible solution to help pharmacies and hospitals negate these problems are mobile applications. Mobile applications which would enable pharmacists and dispensing doctors to simply download an app onto their smartphone or tablet, scan the 2D barcode from the camera on their device from anywhere within the pharmacy, and submit the data to their NMVS, in order to verify and decommission the product.
Although the immediate need for a solution is tied to compliance, a cloud-based network approach at the pharmacy level allows for greater information sharing. More efficient data sharing and the digitalization of the supply chain will transform processes for pharmacists including recall management as well as increased patient engagement through the real-time availability of product information that can be delivered to consumers.
Whether fixed or mobile, cloud-based software is likely to be preferred as it’s infinitely upgradeable and therefore, ensures compliance. Fixed workstations connected to servers may require technician support every time an upgrade is required, another burden for pharmacists.
Without question, compliance with FMD will add to the workload of pharmacists while creating complexity and additional costs. The challenge for suppliers is to minimise disruption and keep costs low wherever possible by offering simple, mobile, low-investment solutions.
Graham Smith is general manager, healthcare and pharmacy EMEA, at TraceLink