Although the European Union’s Falsified Medicines Directive (EU FMD) comes into effect on 9 February 2019 and has been well publicised, many pharmacies have yet to formulate their plans for compliance.
Conversations with retail and hospital pharmacists tend to follow a similar vein. There is an expectation that their requirement to comply will somehow be postponed, so there’s no need to hurry to identify a suitable solution. That’s not going to happen. As the recent letter sent by the EU’s tripartite medical agencies very clearly states, “all stakeholders need to act now to ensure compliance with the new rules whilst there is still sufficient time to prepare.”
Mandatory verification and decommissioning of prescription medications will come into force as planned because of the danger presented by the underlying problem: a need to protect patients from the ever-increasing danger of falsified medicines. The World Health Organization (WHO) estimates that 10% of medicines in global circulation are actually fake and a major factor in one million preventable patient deaths every year, particularly in developing countries, and these products typically enter the supply chain from the EU.
The EU FMD is also an important first step towards the digital transformation of pharmacies. Currently, staff in many pharmacies spend a significant amount of their time performing manual tasks that could be automated using much of the technology they will invest in as part of EU FMD compliance. For instance, verifying medication at the goods-in stage completes the first phase of the decommissioning process and eliminates the need for separate inventory management processes.
Rather than having to do manual stock checks, pharmacy staff can operate a perpetual inventory check and avoid out-of-stocks since the moment an inventory item falls below a minimum level, an automatic replenishment can be triggered. As NHS Digital said recently, “Inefficient, paper-based processes increase the potential for errors and cost money, whereas digitising the prescription and distribution of medicines has an enormous potential to improve patient care and increase safety levels.”
How to complete the EU FMD compliance process—an 8-step guide for pharmacies
As the EU’s tripartite medical agencies state, retail pharmacies, hospital pharmacies and healthcare institutions all have a critical role in ensuring the authenticity of medicines dispensed to patients. It is important that all stakeholders act quickly to ensure they comply with the EU FMD regulations while there is still time to prepare.
Optel Group have developed an easy to use, online demonstrator to illustrate to pharmacists how simple the FMD compliance process can be.
OPTEL Certa™ Software performs barcode verification as well as decommissioning of prescription medication. With its safe and secure communication with the NMVS of countries across the EU, this unique web product provides healthcare professionals with an immediate solution for compliance with the EU FMD.