The Falsified Medicines Directive (FMD) 2011/62/EU came into force on the 9th February 2019. The legislation aims to prevent counterfeit or unauthorised prescription medicine from entering the legal supply chain, providing greater protection for patients. At the beginning of the supply chain, the pharmaceutical license holder has responsibility for serialising cartons, sealing the product and then uploading the unique identifiers to the European Hub, known as the European Medicines Verification System (EMVS). At the end, the dispensing healthcare institution must verify and decommission that product against a national hub, known as the National Medicines Verification System (NMVS).
This leaves the middle of the supply chain, where there is also a requirement for wholesalers, distributors and logistics providers to implement a ‘risk-based’ approach to the verification and decommissioning of products passing through their operation. In order to be compliant, manufacturers, wholesalers and distributors alike will have to make changes to their supply chain operations.
When it comes to the practical application of FMD, there are many areas that still cause confusion. Organisations can no longer afford to let these areas act as barriers to implementing robust FMD solutions. Christian Taylor, Serialisation Business Consultant at Zetes, clears up some of the key pain points.
The main issue with exporting is organisations knowing when they should decommission a product, although it’s still unclear as to whether it needs to be done at goods in or goods out. The key is for organisations to choose a solution that can consolidate medicines to a single reference or shipper case, capturing data within the normal workflow. This enables automated decommissioning of a product at an appropriate point, such as fulfilling the customer order.
Consolidation allows organisations to associate “child” items with a “parent” case. Warehouse operatives will be able to scan the barcode on a case and capture the identity of all of its contents with complete confidence. Ultimately, if a business invests in an FMD solution that has the capability to provide consolidation, it will simplify the process and remove unnecessary complexities when decommissioning products for export. In addition, maximising the efficiency of operations in line with managing FMD compliance – no matter when the decommissioning needs to take place.
Managing Article 23
Article 23 outlines that the Member States may require a wholesaler and distributor to verify and decommission a medicinal product before it supplies that product to an institution other than a dispensing hospital or pharmacy. Examples of those institutions include but aren’t limited to; universities, veterinarians and government bodies all of which wouldn’t necessarily have the authority to log into the national hub to decommission a product.
The onus, therefore, is on the wholesaler and distributor to identify which of their customers fall under Article 23. To ensure compliance, organisations need to be able to look through their customer base identify them within the normal workflow and automate triggers for decommissioning. Wholesalers, distributors and logistics should invest in an FMD solution that integrates with its warehouse management system (WMS) to flag to the operator what actions need to happen on any particular pick.
If automated alerts are sent, signalling when an order is being picked for an Article 23 customer, operational staff will know that they need to decommission the product. Organisations shouldn’t find themselves in a situation where an employee on the warehouse floor is making decisions that affect the legal standing of the business.
It’s common practice for pharmaceutical organisations to send samples to medical authorities or healthcare professionals. Depending on where those samples are going they will be sent from different parts of the business. For example, if a sample is going to the Medicines and Healthcare products Regulatory Authority (MHRA) it may be sent by the quality assurance (QA) department, whereas a product going straight to a healthcare professional would come from the commercial team. Essentially, businesses will be taking medicinal products out of the usual logistics supply chain.
Regardless, FMD still applies and organisations will need to have full visibility of when those drugs have left the supply chain and confirm they’ve been decommissioned. Currently, many organisations are reliant on manual checks against multiple manufacturer systems. Under FMD, organisations will need to ensure they invest in a system that provides automated workflows, designed around the correct type of sampling for the business. If a sample is being handled, the system should be able to verify and/or decommission a product no matter where it’s coming out of the business.
Quarantine and destruction
Current destruction requirements are a lot more demanding under FMD. Before, just because a product is in quarantine that didn't mean it was going to be immediately destroyed, and this is where it can get confusing. But, contrary to what some businesses may think, they can avoid a complete overhaul of current business practice.
In order to be compliant with FMD, businesses need to have the capability to track which products have been placed in quarantine and of those, confidently report which ones have been decommissioned and destroyed. If organisations already have a solution that is capable of consolidation, the destruction can happen as a software function and the physical destruction processes needn’t change.
Putting confusion aside, organisations should proactively be looking to implement solutions that create minimum disruption to current working processes, drive efficiencies and are simple to use every day. Whilst some of the details around the legislation will require further clarification, businesses need to ensure they have a robust solution in place to ensure compliance and remove any chance for human error.
Whilst some of the details around the legislation will require further clarification, businesses need to ensure they have a robust solution in place
From Batch to Unit level visibility
The important thing for organisations to consider at this time is that currently, no one is handling the data of individual products on the line. In order to be compliant and report to the national hubs, wholesalers, distributors and logistics partners have to review current processes and ensure they can handle data for any single unit within their operations.
Behind this legislation, there are distinct efficiency and quality advantages to be found. Wholesalers, distributors and logistics partners should use this opportunity to improve capability within the warehouse and business operations. Building a comprehensive and agile visibility layer on existing processes and cross-functional systems. This will not only ensure compliance, but these infrastructures can be built upon further, putting organisations in a better position to react to any further regulation changes with ease.