FMD is going to require pharmacists to overhaul their scanning processes but there’s no need to panic just yet, says Matthew Chapman
Although unlicensed internet sales are a major reason for the public ending up with falsified medicines, regulatory authorities continue to discover counterfeit medicines in the traditional supply chain. As a consequence, the EU is bringing in the Falsified Medicines Directive (FMD) in attempt to keep tabs
on medicines moving through the supply chain.
The FMD requires pharmacists to verify the authenticity of prescription medicines through a decommissioning process, which involves scanning a unique 2D bar code.
Pharmacists will need to ensure they have a FMD-compliant scanning solution in place when the regulation comes into force on 9 February 2019.
FMD is a compulsory EU-wide initiative and could require a serious investment from pharmacists despite the UK being due to exit the EU only a month and a half later.
An EU Commission assessment from late 2015 believes the cost of FMD for community pharmacists could be approximately €530 (£393) a year.
However, uncertainty remains as to what will happen once the UK leaves the EU and as a result it would be unwise for pharmacists to needlessly lock themselves into a lengthy software contract.
In all likelihood something akin to the FMD will be retained after Brexit. It is not only EU countries that will be implementing FMD: it will also be used by the four members of the European Free Trade Area (Iceland, Norway, Liechtenstein and Switzerland). Therefore, the UK could end up keeping the FMD as it stands, but with such uncertainty over the Brexit negotiations it is anyone’s guess what could happen and it would be wise to proceed with caution.
The 2D bar codes on prescription medicines will act as a “unique identifier” for each pack of medicine and once the bar code is scanned it will send the information to a National Medicines Verification System (NMVS).
The NMVS will send back the current status of the product and if “inactive” the product can not be dispensed because the system has noted it has “already been dispensed”, “recalled”, “withdrawn”, “stolen”, or “locked” pending an investigation.
However, only certain software will be able to communicate with the NMVS, which could mean that pharmacists will be required to switch or upgrade their software.
In the UK, a National Medicines Verification Organisation was formally established under the name SecurMed in July 2016.
SecurMed has appointed service provider Arvarto to help implement the UK’s FMD system and as a result only software providers that have registered for the Arvarto software development kit should be used by pharmacists to ensure they are FMD compliant.
Fortunately, SecurMed has provided a list of software providers on its website that are currently compliant, and is leaving it up to pharmacists to determine which provider is most suitable for their needs.
Pharmacists will also need to consider hardware options alongside picking out the software.
Scanners need to be able to read the unique 2D bar code on the medicine packs. The NHS advises pharmacists to look for specific ‘decode capabilities’ when shopping around for a scanner. When looking at the ‘decode capabilities’ product information, pharmacists should only buy the scanners that list ‘DataMatrix’ among its capabilities. Scanners can be expensive to buy and may seem like an unnecessary extra expense for those who already have forked out for them.
Raj Patel, the chair of FMD working group for community pharmacy, has advised pharmacists to proceed with caution until the Government provides assurances on funding.
The PSNC is currently working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements.
However, a cheap hardware solution could be on the horizon due to a couple of companies claiming they are working on a smartphone and tablet-based scanning solution.
Healthcare tech company TraceLink has said it will launch a mobile app this month that will use a device’s in-built camera or Bluetooth to perform the scanning function.
Meanwhile, German company Technology Consulting Köln (TCK) is also offering a scanner-free FMD solution called NMVS Connect, which will be available to use on mobile devices.
There is no escaping FMD and pharmacists must make sure they are compliant in time for the implementation of the regulation in February. However, it is vital not to panic buy when considering the best solution as the threat of regulation looms. There are further solutions coming onto the market all the time such as those offered by TraceLink and TCK, and still a few months to choose the best system.
It would be foolhardy to spend a lot of needless money on new scanning equipment and splash out a fortune on a long-term software contract because there is still no knowing how requirements could change after Brexit...