By Marc Blekkink, Managing Partner, Movilitas.Cloud
The EU’s Falsified Medicines Directive (EU-FMD) went into effect in February 2019. Tens of thousands of stakeholders were impacted, including wholesalers. When the regulation started there were a high number of false alerts as participating companies came online and learned the system. However, there will always be a risk of triggering an incorrect notification. So, what does this all mean for designated wholesalers who are contracted to store and distribute product for the marketing authorized holder (MAH)?
Every wholesaler must verify each package that was not acquired directly from a manufacturer or their MAH, or that was returned from another wholesale dealer, distributor or pharmacist. When a suspected false alert happens, it requires the same due diligence to research and resolve as a real alert. Constantly having to handle legitimate and system errors results in a waste of resources from staff time to, possibly, authentic product being destroyed. Therefore, wholesalers must work diligently with the other stakeholders to keep the false alert risk from impacting the bottom line. The solution? A layer of virtual technology that better handles scanning and connecting to the medical verification systems.
The European Medicines Verification Organization (EMVO) notes that “approximately 3% of all scans undertaken by supply chain stakeholders lead to a ‘false alert’ being generated[.]” Many events are related to data; incorrect or out-of-date software; or, improper procedures. Often, it is multiple reasons that trigger the false alert. Below is the EMVO’s list of common errors.
- Missing data upload into the European Hub
- Incorrect data upload
- Incorrect scanner
- Configuration of end-users
- Pharmacy/hospital software systems not updated
- Procedural reasons, such as staff interacting with the system multiple times with the same pack
- System not used properly
Even if one or more of these reasons is proven to be the cause the National Medicines Verification Organization is required to investigate so they can inform authorities when “it is clear that the alert…cannot be explained by technical issues…’.
There are solutions, such as Movilitas.Cloud, that provide an app to scan the unique 2D barcode assigned to each medicinal package for verification and dispensing the shipment. It also allows wholesalers to decommission the product and report the instance to the appropriate authorities if there is a confirmed issue. However, if after being researched, the event is determined to be a false alert, wholesalers can reactivate the code within ten days of deactivation.
When the system works, it performs well. For example, in June, a Netherlands wholesaler scanned a box of what was supposed to be Roche’s Avastin. They noticed it was a possible counterfeit and followed procedures to verify and remove the product from the system. This early interception kept the medicine from reaching pharmacy shelves where patients could have been affected.
Discover how Movilitas.Cloud can connect your wholesale operations to your MAH’s repository, by visiting our overview page here. The solution is connected to the EU Hub and all National Medicine Verification Systems in Europe so you can easily verify, decommission and reinstate prescription medicine packs.