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Have you considered scanning FMD medicines with your smartphone?

Graham Smith: FMD compliance has added to pharmacists’ workload

TraceLink’s Graham Smith outlines some of the challenges pharmacies face as a result of the Falsified Medicines Directive (FMD) and offers advice on how to navigate them

The deadline for the EU’s anti-counterfeit legislation – the FMDpassed on February 9. More than 130,000 pharmacies and hospitals across Europe must scan and verify all in-scope medicines at the point of dispensing. This new process has the potential to slow down workflows within the pharmacy, unless it is well-managed.

Pharmacists have had to select an IT solution, train employees and manage disruptions to workflow and stock. Although the deadline passed in February, some pharmacies were not ready. The non-profit organisation managing the UK’s medicine verification systems, SecurMed, said there were 9,948 community pharmacies registered with it on April 19.

PMR systems and FMD

Many small- to mid-sized pharmacies turned to their patient medication record (PMR) system providers for support, hoping that FMD solutions could be integrated within their current PMR system.

This works for some. However, not all PMR providers deliver their own solution. Some have strategic partnerships with third-party suppliers that allow them to roll out a solution to their customers. Others have decided that FMD compliance is not within their capabilities.

Pharmacists still need to purchase new scanning equipment, as many scanners are only capable of reading linear codes and not the 2D matrix codes used in serialisation.

Additional software

There are alternatives to modifying incumbent software. Some solutions include a fixed workstation – however, this requires a dedicated space, power source and data connectivity, and 'decommissioning' the medicines at a central point.

In some pharmacies, this could create congestion in and around pharmacy preparation areas. To streamline and make the workflow more efficient, pharmacy managers may need to add more hardware into the pharmacy to create new dispensing points.

A more flexible option is a mobile application that enables pharmacists to scan the 2D barcode from the camera on their smartphone or tablet device anywhere within the pharmacy. They can then submit the data to their National Medicines Verification Service (NVMS) database to verify and decommission the product.

Kinks in the system

Kinks in the system relate to data quality issues. The FMD is an entirely new process for many manufacturers and their supply chain partners. Bad data may cause false alerts when verifying a pack, causing disruption as pharmacists question whether or not to dispense a medicine.

This bad data can stem from incorrect upload to the EU's FMD hub by pharmaceutical manufacturers, or errors in the NMVS technology. While these problems will eventually be corrected, they cause issues in the short term.

Stockpiling non-serialised products

Many manufacturers and wholesalers stockpiled non-serialised products before the FMD deadline. Only packs manufactured after the February 9 deadline are required to comply with the requirements. This means many medicine packs now in pharmacies are not compliant with FMD.

For pharmacists, this means that instead of scanning and verifying every product, they must first work out whether a drug needs to comply, before carrying out the verification check. This situation will improve as compliant packaging becomes the default in the supply chain.

FMD compliance has added to pharmacists’ workload. It is vital that pharmacies work with companies who understand the practicalities of serialisation and can help them to make informed decisions on how to ensure compliance, negate disruption to operations and keep costs low wherever possible.

Graham Smith is a general manager for healthcare and pharmacy at software solutions company TraceLink


Leon The Apothecary, Student

The general vibe I get from working with these companies is that FMD is not going to be enforced therefore there is no need to focus on this issue right now. It is an attitude that makes complete sense considering that our government are in a complete state of chaos.

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