The importance of the Falsified Medicines Directive (FMD) is often underestimated, even when the magnitude of the task is recognised. FMD helps to prevent inauthentic, substandard or harmful medicines entering the supply chain. However, it also acts as a key enabler for other initiatives such as Scan4Safety, and other digital medicine initiatives which will have major benefits for all of us.
While rfxcel welcomes the consultation from the MHRA in order to clarify some key outstanding aspects of the delegated regulation, by the time the consultation closes on the 23rd September 2018, less than five months will be left for the industry to implement processes and systems to ensure FMD compliance.
We therefore endorse the most cost-effective and pragmatic approaches to the verification and decommissioning process, that will help put systems in place within the remaining timescales.
However, underpinning any approach must be a fundamental consideration: data integrity.
An effective solution must focus on both connectivity and data integrity. Data checking is not built into the EU FMD as tightly as it is for the US Drug Supply Chain Security Act. In the US, each actor in the supply chain is responsible for checking, adding to, and passing-on data for each product. The FMD doesn’t require that, relying mostly on end-of-chain checks during dispensing.
Some commercial FMD compliance systems enable a connection and flow of data across and between organisations but are blind to data quality. Whoever holds responsibility for the verification and decommissioning of medicinal products (whether wholesaler or dispenser) should never assume that the data entering, or generated within, their systems is clean, tidy and accurate. Internal data checks are essential. The best solutions routinely monitor data to detect human error, inaccuracy and duplication, and smart solution providers will consistently validate data flowing through a system – in our case we do up to 70 data validation checks on incoming records to ensure their integrity.
Unfortunately, time is running out but good solutions are already available for all the necessary use cases, including the Article 23 complexities. We urge people to act now, rather than wait for the end of the consultation period, and start to identify an FMD implementation partner. This should be a recognised provider with experience, credibility and evidence that it can implement effectively within very tight timeframes. They should have the flexibility to adapt to changes in business and the wider marketplace as they arise. The post-Brexit world could get even more complicated, but whilst the mechanics of pack verification may change, the underlying rationale does not.
Act now. We don’t expect the results of the government’s consultation to require radically new system architecture for FMD. The best solution providers are agile enough to adapt quickly to any tweaks that may be needed.
- Mark Davison, Chief Operations Director, Europe - rfxcel