How Smartphone Scanning Simplifies EU FMD Compliance

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How Smartphone Scanning Simplifies EU FMD Compliance

Lilia Bounab, Director of Healthcare Sales, Central & Southern Europe, Scandit AG

The global counterfeit drug market is valued at more than $200 billion per year, forcing regulatory authorities around the world to take action. The EU False Medicines Directive (FMD), which came into effect in February, is a critical step forward in helping to tackle this issue. The legislation requires European pharmaceutical companies to use unique drug identifiers in the form of a 2D barcode and serialization in order to protect patients from fake drugs. Complying with EU FMD serialization requirements over the last six months has put already complex supply chains under strain, forcing firms to rethink, digitize and modernize manufacturing lines and logistics.

One solution for simplifying and driving efficiency across pharma operations is mobile barcode scanning. Here we’ll discuss how scanning from smart devices helps drive down costs, increase flexibility and improve efficiency – all while remaining compliant. For a quick overview, please see the video below.

Compliance doesn’t need to be costly or slow

EU FMD compliance is critically important for ensuring patient safety, lowering the risk of falsified medicine and protecting your business against financial penalties and brand damage. It’s doubly difficult for pharma manufacturers, who suffer from the same problems as any manufacturer, including production, quality control and supply chain issues, but who also need to manage and mitigate patient risk with traceability end-to-end.

All medication must possess a unique identifier in the form of a 2D data matrix barcode, which can be scanned at various points across the supply chain to determine its authenticity, before being dispensed to a patient. This makes the ability to quickly and accurately scan barcodes every time medicine is sold or distributed, to check the encoded details against a central database, even more critical for the largest industry in the world. When drugs are sold in different countries, resold or repackaged, this adds another layer of complexity that pharma firms are dealing with.

At Scandit, we help to modernize, fast-track and simplify manufacturing and logistics operations by turning any camera-enabled smart device into a powerful hand-held mobile scanner. It’s a smart and cost-efficient way to re-engineer routine processes to validate the authenticity of products at any stage, from production line to patient.

With speed of technology implementation often cited as a challenge in the first six months of the EU FMD, Scandit’s software-based scanning can be simply and quickly integrated into any application, any smart device and any IT infrastructure to speedily transform operations.

Make traceability cheaper and more effective with mobile scanning


Typically, pharma has relied on dedicated scanning devices within the supply chain, manufacturing and delivery workflows. These devices have a high scanning performance, but are expensive to purchase meaning most only buy the minimum amount required. Replacing these with a software-based scanning solution that works on any smart device with a camera, helps to put scanners in more places along the distribution chain, to capture more data points and improve traceability.

Smart devices, enabled with enterprise-grade scanning, are significantly cheaper to run than the dedicated scanners traditionally used by pharmacists and other distributors – and clearly more versatile. Rather than have a pool of devices shared by staff, you can equip any worker with a smart device, loaded with mobile scanning apps to streamline workflows, unlock efficiencies and still reduce the total cost of ownership for your device fleet. By reinvesting hardware cost savings into a broad digital mobile roll-out across an entire system, tracking and traceability are transformed.

Medication tracking and administration: fast, easy, accurate


The EU FMD has set up the first “end-to-end verification system” for drugs. The data matrix barcode on every medication is encoded with several pieces of key data, including GTIN, batch, expiration date and a random number to ensure it’s the correct medication. Real-time tracking can be achieved with high quality scanning, no matter what the location or where the medication is in the supply chain.

Scandit’s barcode scanning engine scans any barcode type accurately on any smart device, even in difficult environments. This could be quality control scanning and decommission/recommission boxes at awkward angles in a badly lit warehouse, or a pharmacist scanning medication with damaged or torn labels. Scandit’s software will also minimise ‘false alerts’, including ‘unknown product code’ and ‘failed to find batch’ error codes by reducing mis-scans or false positives.

Case Study:Pharmaceutical company Cardinal Health reduced errors in their order entry system by increasing scan accuracy rates from 70% to 95% using a Scandit-powered app.

Speedy seamless shipping


When shipping medication directly to hospitals, pharmacies or distributors, delivery drivers can use mobile app-based scanning to easily check for any special instructions regarding the storage of medication or be alerted to changes in the delivery destination. Scandit’s MatrixScan feature enables drivers to scan multiple barcodes in one sequence in the depot, making it quick and easy for them to identify how to load the van in the optimum delivery order using real-time information displayed on the screen using an Augmented Reality (AR) overlay.

Take the headache out of nonprescription drug ordering


Scandit enables the frictionless ordering of nonprescription drugs by eliminating the burden of extra paperwork coordinated by the pharmacist. Scandit mobile scanning captures the supply chain standard GS1 barcode, plus text and images from other document formats used within approvals – all with the same, easy scan.

Remain compliant, improve efficiency, without disruption


Ready to learn more about how mobile barcode scanning can create more intuitive and efficient workflows and underpin safe and cost effective EU FMD compliance? Then check out our whitepaper, Advancing Healthcare One Mobile Scan at a Time which explains how to inject speed, accuracy and traceability into workflows across the healthcare sector with mobile computer vision.

Be sure to contact us if you’d like more insights on finding technology for tracking & tracing medication throughout the supply chain—or the best ways to deploy these tools across your business.