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Falsified Medicines Directive: Prepare now

25.07.2016

Falsified Medicines Directive: Prepare now

Whatever the future holds for trade policies with the EU, the inward and outward flow of products between the Single Market means that we can't fully detach ourselves from their guidelines. This could be the case for the Falsified Medicines Directive (FMD), which is due to come into force on 9 February 2019. While the future unfolds, we look at some key considerations as they stand to help you plan for the potential changes.

  • Staff Training: Staff are a critical success factor. So introducing training early on can help to alleviate any knowledge gaps and ensure a smooth transition. Encourage your team to stay informed about the FMD, changes to packaging (2D barcode, 14-digit product code, tamper-proof seal) and new dispensing processes to ensure they know what to expect. Organisations such as the National Pharmacy Association can provide guidance on the Directive to help you support your pharmacy staff.
  • Dispensing Flow: The Directive stipulates that the majority of Prescription Only Medicines (and high-risk Over The Counter medicines) being dispensed must be scanned and tamper checked by the pharmacy before reaching the patient. These extra processes will undoubtedly impact on dispensary flow. Now is the time to explore how much time this may add and how this can be managed to avoid impacting on the customer experience.
  • Process Implemetation Cost: Technology such as software and scanners will be required to ensure data is captured at the point of dispensing. Speak to your Patient Medication Record system supplier in advance to ensure you have the technology to support the process changes. As it is not yet known whether the financial impact on pharmacies will be covered by the Government, it may be prudent to gather information around costs so that they can be factored into future budgets.

Opportunities for pharmacies

Although the potential of adhering to the FMD may come with a degree of upheaval, the benefits are clear. Ensuring patients have access to genuine, good-quality products and mitigating lost business from unscrupulous traders are some real wins. Other benefits can result from the barcoding technology, which could include capturing expired and recalled medication before dispensing, which will add extra safety measures to the dispensing process. The future looks positive, but the key to a managing the changes effectively lies in proactive pre-planning.

We will keep you up to date on the impact of the FMD as more information is released. In the meantime, visit the European Commission website for more information on the FMD.