Beyond compliance: why embracing the FMD can transform medicine supply chain thinking

SINCE FEBRUARY 2019, all actors in the pharmaceutical supply chain, including medicines manufacturers, distributors, wholesalers, pharmacies and hospitals, were expected to become compliant with the Falsified Medicines Directive (FMD). The Directive’s core objective is to increase the security of the manufacturing and delivery of medicines across Europe, protect patients and prevent falsified medicines from entering the supply chain.

For many of these organisations, FMD compliance has involved a significant re-engineering of their processes in order to receive, verify and decommission serialised medicines. For hospital pharmacies, a lack of a highly efficient workflow can potentially have a significant knock-on effect on a system that is under ever-increasing pressure.

Relying on manual processes for managing serialised medicines at an individual pack level is a labour intensive and time-consuming process that can disrupt normal operations. However, rather than viewing the FMD from a compliance-only perspective, it can be argued that organisations should be embracing the regulation to facilitate a change in mindset throughout the medicines supply chain.

Enter the FMD

The main requirement mandated by the FMD is the authentication and decommissioning of medicines before dispensing to patients – including in all hospitals – together with risk-based verification and traceability of medicines at the wholesaler level.

However, many wholesalers, hospitals and pharmacies across Europe remain non-compliant. While many countries introduced post-deadline stabilisation periods to help ease the transition and prevent medicine shortages, these are now coming to an end and most countries expected full compliance by February 2020.

In line with the FMD, when medicines reach the end of the supply chain at a hospital pharmacy, the anti-tampering device (ATD) needs to be checked to ensure it is intact prior to dispensing. The status of the pack also needs to be changed in the National Medicines Verification System (NMVS) from “active” to “inactive supplied”. This involves scanning the two-dimensional (2D) barcode on each pack to verify a product’s unique identifier (UI) – as applied by the manufacturer to their pack labelling – and communicating with the NMVS. Once verified, the medicine can be decommissioned. Unlike within a community pharmacy, where medicines can only be decommissioned at the point of dispense to the patient, hospital pharmacies can decommission medicines at any point after verification.

Given the importance of this final process of the supply chain and the increasing number of highly complex, niche products that require adherence to specialised distribution and dispensing models, getting this process right is critical. It is essential that pharmacies can manage the verification and decommissioning process as seamlessly as possible, given the potential knock-on effect of scanning medicines at an individual pack level on the dispensing and discharge process.

Aggregation and consolidation

Adopting aggregation and consolidation not only addresses the compliance requirements for the FMD in the most efficient way, it presents opportunities to identify additional improvements in workflow and further optimise the medicines discharge process. In addition, the industry gets the chance to think beyond institutional and organisational boundaries and consider transparency across the broader medicines supply chain. Here are four suggested steps to make this process more efficient:

1. Aggregate

Single items are scanned at either the manufacturer or wholesaler warehouse and aggregated into boxes and/or pallets. For the wholesaler, this approach allows for advanced shipment preparation and reduces the lead time to fulfil a dispatch, while the hospital pharmacy can choose at which level they want to decommission the products.

2. Consolidate

Aggregated units are consolidated into a single, unique order number. This can be completed at any stage of the warehousing process.

3. Communicate

Aggregated units carry a barcode label with the unique order number. The dispatch process is also identified by a unique number, which can be physically placed on the transport documentation. In parallel, a digital file that contains these unique identifiers is shared with the hospital on dispatch.

4. Random check and decommission

On receipt of the shipment, the barcode numbers and digital file are available for the hospital to scan, perform random checking and automatically decommission the products at the specified level.

Conclusion

Ensuring patients have timely access to their prescribed medicines is a fundamental role of the hospital pharmacy. However, the FMD goes beyond that and companies need to ensure they have the right digital solutions to provide supply chain visibility to guarantee that patients everywhere have access to high-quality medicines without the risk of consuming a contaminated or counterfeit product.