Executive Summary

Resources needed to implement the Falsified Medicines Directive in hospitals across the EU and the EEA would cost more than 86 million euros, according to estimates. 

The recent report (March 2019) of the European Alliance for Access to Safe Medicines (EAASM) highlights the significant added value that the final patient safety elements of the Falsified Medicines Directive will bring. The Directive requires that every single prescription pack is serialized and has a unique identifier in the form of a barcode and a tamper evident seal. Each pack will need to be verified and decommissioned before it can be dispensed thus confirming the pack is genuine and not falsified.

In order to address the complexities of such an operation in the hospital environment, the EAASM held a meeting in the European Parliament on 19 February 2019 to encourage and support best practice in hospitals by bringing together a group of experts.

The status of the implementation, the challenges and the solutions across Europe were discussed. The purpose of the report entitled “The Falsified Medicines Directive (FMD) – implementing Practical Solutions in the Hospital Arena” aims to support the dissemination of FMD-related best practices around pharmaceutical product processes and authentication.

The report extrapolates from data compiled on the volume of prescriptions dispensed within the hospital environment and provides a comprehensive analysis of potential solutions and next steps. Specifically, the data indicates a clear need for additional human resource capacity; up to 2-4 extra Full Time Equivalents (FTEs) per large hospital. A map, by country, depicts this increase with a consolidated calculated cost of up to 86 million euros depending on the authentication process and anticipated time to scan a barcode on a prescription pack.

Opportunities for the future emphasise ways in which medicine’s authentication systems (MAS) using artificial intelligence and automation can reduce the human resource required whilst delivering safer processes.

A medicine’s authentication system, when utilised in combination with the FMD, has the potential to:     

  • Secure authenticity of all prescription packs across the EU and the EEA thus protecting patients
  • Realise potential savings due to automated stock control and inventory management
  • Reduce waste (expired medicines and medicine shortages)
  • Increase opportunities for pharmacist engagement in patient care
  • Achieve more rapid and lower cost of product recalls
  • Reduce personnel time and costs assessing product due to tamper proof seals
  • Identify improvements in pharmacy workflows
  • Support the monitoring of inappropriate antimicrobial prescribing.

Despite the significant work undertaken and given the complexities associated with setting up medicines verification systems across the EU, it is anticipated that a number of opportunities will be forthcoming. Some of these include a strengthened support from national bodies to ensure alignment and financial support across national health systems, better communication between stakeholders to standardise the processes to ensure that the technology platforms are compatible and fully integrated into existing workflows, better handling of false alerts, automated stock management systems to allow for automatic inbound scanning, storage, fetching and outbound scanning, and automation solutions via robotics and dispensing systems.

The EAASM calls upon all stakeholders to build on the implementation of the FMD by:

  • Encouraging all national and regional medical authorities to become even more involved to help ensure that any hospitals who 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;
  • Encouraging hospitals when onboarding patients to carry out a thorough discussion on the patients’ medication history to include questions around whether medicines have been bought on the Internet and thus introduce education to safeguard against patients taking themselves outside of their national health systems
  • Procedural and system improvements by embracing technology such as Artificial Intelligence and IT infrastructure to introduce automated dispensing solutions to save time and alleviate the manual actions that lead to mental burden; and
  • Introducing smart applications to help connected services (ambulance, satellite hospitals) and robotics to aid the verification process and enhance the security of the medication use process.

Please read the report to get more insights.

 

MEDIA CONTACTS

For www.eaasm.eu

Mike Isles

Mike.isles@eaasm.eu +44 7540 462867

Laura Cigolot

Laura.cigolot@eaasm.eu

+32 477534207

ABOUT EAASM

The European Alliance for Access to Safe Medicines (EAASM) is an independent, pan-European initiative dedicated to protecting patient safety by ensuring access to safe and legitimate medicines. The Alliance was formed by a cross-section of European stake-holders from a variety of backgrounds.

With patient safety at its heart, EAASM’s key activities include campaigning for the safer use of medical practices and also the exclusion of falsified and substandard medicines from the supply chain, raising public awareness around such issues, and promoting effective legislation and enforcement in relation to falsified medicines.