Beyond compliance: why embracing FMD can transform the medicines supply chain

Sébastien Sliski, general manager for supply chain solutions at Zetes, outlines how digitally-enabled inventory processes can help hospital pharmacies and pharmaceutical wholesalers to meet their FMD compliance requirements in the most-efficient way and yield higher efficiency gains

Most EU countries are expecting full compliance with the Falsified Medicines Directive by the end of February, but many are likely to miss the deadline

As of 9 February 2019, all participants in the pharmaceutical supply chain, including medicines manufacturers, distributors, wholesalers, pharmacies and hospitals, had to become compliant with the Falsified Medicines Directive (FMD).

Its core objective is to increase the security of the manufacturing and delivery of medicines across Europe, protecting patients and preventing falsified medicines from entering the supply chain.

For many of these organisations, FMD compliance has involved a significant re-engineering of processes in order to receive, verify and decommission serialised medicines.

For hospital pharmacies in particular, a lack of a highly-efficient workflow can potentially have a significant knock-on effect on a system that is under ever-increasing pressure

And, for hospital pharmacies in particular, 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 which can disrupt normal operations.

Instead, rather than viewing 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 FMD

The FMD is mandatory for all hospital pharmacies in Europe. However, many hospitals, pharmacies and wholesalers across Europe still 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 are expecting full compliance by the end of February.

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 wholesaler level.

The main requirement mandated by the FMD is the authentication and decommissioning of medicines before dispensing to patients, together with risk-based verification and traceability of medicines at wholesaler level

Hospital pharmacies are required to check the anti-tampering device (ATD) to ensure it is intact prior to dispensing, and change the status of the pack in the National Medicines Verification System (NMVS) from ‘active’ to ‘inactive supplied’. This involves scanning the 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 the pharmacy dispensing process within the overall efficiency within a hospital, 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 hospital 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.

Adopting aggregation and consolidation approaches through the use of technology not only addresses the compliance requirements, but opens up opportunities to identify additional improvements in the pharmacy workflow

Aggregation and consolidation

Step 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 them to prepare shipments in advance and reduce the lead time to fulfil a dispatch, while the hospital pharmacy can choose at which level they want to decommission the products.

Step 2: Consolidate

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

Step 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.

Step 4: Random check and decommission

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

Adopting aggregation and consolidation not only addresses the compliance requirements for FMD in the most-efficient way, but it opens up opportunities to identify additional improvements in the pharmacy workflow and further optimise the medicines discharge process.

In addition, the industry as a whole gets the chance to think beyond institutional and organisational boundaries and start to consider transparency across the broader medicines supply chain.

The right digital solutions can help 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

Ensuring patient flow is maintained, by making sure that patients who are waiting to be discharged have timely access to their prescribed medicines, is a fundamental role of the hospital pharmacy. However, FMD goes beyond that.

The right digital solutions can help 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.