3 easy ways to optimise the EU FMD decommissioning process
By Diederik de Bruijn, Pharmacist and EU FMD consultant for OPTEL GROUP
With the European Union’s Falsified Medicines Directive (EU FMD) coming into effect on 9 February 2019, rather than simply focusing on the negatives—the extra time and costs required to achieve compliance—it’s important to also recognise that there will be benefits.
Under the FMD, every newly manufactured stock item will be encoded with a batch number and expiry date. This is data pharmacists lacked (and would have benefited from) for many years. It will help to make routine stock control and the administration of product recalls much more efficient, eliminating the need for manual processes.
Although EU FMD technology solutions exist to control the data-processing aspects of the workflow, other transactional elements affect the efficiency of busy dispensers.
What is the best solution to implement and how will it impact day-to-day operations?
Will pharmacies be able to maintain existing efficiency levels without the need to recruit additional staff?
How can the newly introduced technology and newly available data help to optimise existing projects?
Integrated, cloud-based software running on mobile devices makes it fast and simple for anyone to handle the decommissioning process. Using the right technology, there is no reason why the procedure can’t quickly become part of any pharmacy’s daily routine.
Reports of EU FMD legislation resulting in process bottlenecks are unfounded. Field studies have shown that the additional handling time required should be no longer than four seconds and depending on the stage at which the task is completed, can be as little as two seconds extra time to be added onto existing processing times. Our own estimates using test data suggest that it will take under one minute to verify and decommission 20 packages.
Exactly when to decommission an item has been the subject of debate within the sector. The legislation states that decommissioning should take place as near to the end of the supply chain and point of dispensing as possible. Some in the industry advocate that the best time to decommission is during the picking process, rather than when items first arrive from the manufacturer or distributor. This is because the items are ready to be handled at the unit level rather than multipack or boxed level, saving time on unpacking and minimising the chance that packages cannot easily be stored once any shrink wrapping has been removed. They argue that decommissioning at the picking stage, when medicines are being selected for patients, also makes it easier to integrate the whole new process into an existing workflow and to minimise disruption if the working area available is relatively small.
The alternative to decommissioning at dispensing is to verify all products at the entry point. This ensures problems are identified immediately and pharmacies can avoid a position whereby counterfeited goods are unwittingly accepted into the supply chain and stored with non-counterfeited items for potential dispensing. In our view, it is far worse to potentially have a situation whereby a patient is waiting for medication because the stocks held cannot be dispensed due to an inability to decommission for a wide range of reasons, than having to handle unboxed stocks.
We have explored both approaches and it is important to acknowledge the different arguments about when decommissioning should ideally take place. It may be simpler and more efficient to decommission at the item level just before dispensing; however it is also good practice to do so when goods first arrive on site. Instead, a dual approach may be the best option, whereby goods are verified at goods in to check their authenticity and then decommissioned at the picking stage, as close to dispensing to the patient as possible.
Another argument in support of decommissioning at the picking stage relates to the issue of product recalls and returns. There are inevitably times when pharmacy products need to be recalled, either because of a manufacturing problem or a reported theft. Some in the industry have proposed that the later a decommissioning takes place, the less likely it will result in incorrect data being collected. They add that because of the ‘10-day rule’, whereby once decommissioned, an item can then only be reintroduced into the supply chain within 10 days, later decommissioning is advisable. Pharmacies that don’t decommission as late as possible therefore run the risk of being left with excess stocks of unused items, which they can no longer sell or return to the manufacturer as surplus, if needed.
There is another important counterargument to consider in this case. Since less than one percent of items shipped to pharmacies are returned, it may be unnecessary to justify a process based on exceptions. Adopting the ‘verify at goods in, decommission at picking stage’ policy would also ensure that data held is as accurate as possible, whilst also protecting pharmacists from the impact of the ’10-day rule’.
By taking advantage of specially developed EU FMD solutions and following our pre-tested recommendations, pharmacies should not be concerned about the approaching compliance deadline. Although the new legislation will mean that working processes need to change and an element of financial investment is clearly involved, thanks to ready-made software solutions, this can be minimised.
Ultimately, the EU FMD offers a chance to significantly improve daily operating efficiencies and gives pharmacies access to real-time product and patient data. Most importantly, it will facilitate a change for the better, using traceability technology to directly improve the lives of countless people.
Leveraging nearly three decades in the pharmaceutical industry and proven expertise in traceability solutions for regulatory compliance, OPTEL has developed an effective and user-friendly EU FMD compliance solution, specifically for dispensers: OPTEL Certa™ Software.
OPTEL Certa™ Software performs barcode verification as well as decommissioning of prescription medication. With its safe and secure communication with the National Medicines Verification Systems (NMVS) of countries across the European Union, this unique web product provides healthcare professionals with an immediate solution for compliance with the EU FMD.
• A tested and proven solution for immediate EU FMD compliance
• Efficient support and online training
• A simple, multilingual interface
• Flexibility to integrate into existing systems
• A complete line of ergonomic devices designed to adapt to all work environments