PRESS RELEASE: New report clearly demonstrates that implementing the Falsified Medicines Directive in hospitals brings about massive positive change

Brussels – On 7 April 2021, the European Alliance for Access to Safe Medicines (EAASM)
published its report ‘Patient Safety and the Implementation of the Falsified Medicines Directive in
the Hospital Environment: Practical solutions and benefits’

The Falsified Medicines Directive (FMD) was put in place to safeguard what is often termed the “legitimate” supply chain in which each prescription pack of medicine is given a unique identifier in the form of a bar code. This pack can then be tracked from manufacturer to pre-wholesaler to wholesaler or distributor and then on to the pharmacist who authenticates the medicine with a scanner.

The benefits of implementing the FMD are described in detail and the report provides a list of practical and concrete steps to ensure a good implementation. The report clearly illustrates how such benefits can be drawn out at all points across the hospital supply chain. For example, in one hospital significant cost savings in the range of 4.4 million euros per year were achieved due to better management of inventory and ordering patterns. The unique identifier on each pack acts as data anchor within the hospital and so enables greater visibility from a logistics perspective but also—and more importantly—allows for greater traceability as the pack travels on its medication journey and thus enhances patient safety as well.

Within the report are a number of practical examples of how to best implement the Directive and achieve the desired benefits across hospitals’ activities.

This report makes 5 key recommendations to stakeholders to ensure a good implementation
of the FMD:

  • Encouraging all national and regional medical authorities to become even more involved to help ensure that any hospitals that need to support the implementation of the FMD do so;
  • Implementing a continuous improvement culture that involves inclusive collaboration with all staff and parties involved to capitalise on the many opportunities to use the data collected for positive patient care;
  • Making procedural and system improvements by embracing technology such as Artificial Intelligence IT infrastructure to introduce automated dispensing solutions to save time and to alleviate manual actions that lead to mental burden and medication errors;
  • Introducing smart applications to help connected services (ambulance, satellite hospitals) and robotics aid the verification process and enhance the safety of medication use;
  • Encouraging hospitals, when onboarding patients, to carry out a thorough discussion of the patients’ medication history including questions around whether medicines have been bought on the Internet and thus to introduce education to protect patients from unwittingly purchasing falsified medicines and thereby going outside of their national health systems.

Challenges relating to the purchase of medicines are also tackled within the report. It underlines the need for patients entering the hospital environment to be asked questions in case they have bought a medicine outside of a doctor’s consultation.

Finally, the upcoming adoption of the Digital Services Act will potentially put the EU in the vanguard on new digital legislation and will make Internet intermediaries more accountable, which is expected to curtail the spread of falsified medicines online.

You can read the full FMD report here.


The European Alliance for Access to Safe Medicines (EAASM) is a non-profit, independent, pan-
European initiative which represents a multi-sectorial coalition of organisations dedicated to protecting
patient safety by ensuring access to safe and legitimate medicines. To find out more about the
EAASM, please visit the website https://eaasm.eu/en-gb/ and follow @EAASMeds on Twitter.


Contact EAASM Director Mike Isles: mike.isles@eaasm.eu or the Secretariat: laura.cigolot@