Open Learning Course: Facing Brexit and FMD - Is Europe ready for the double “storm”?







Section 1 - Introductory Statements and Governance: Statement 1.7
Section 2 - Selection, Procurement and Distribution: Statements 2.3, 2.5
Section 4 - Clinical Pharmacy Services: Statements 4.6, 4.7
Section 5 - Patient Safety and Quality Assurance: Statements 5.2, 5.9
Section 6 - Education and Research: Statement 6.5


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Two major events will take place in the European Union (EU) in 2019 and characterise the field of healthcare services and medicine supply in Europe: Brexit in combination with the relocation of European Medicine Agency (EMA) from London to Amsterdam and the implementation of the Falsified Medicines Directive (FMD). NHS trusts in England have warned that the health service is not prepared for a no-deal Brexit and that medicine supplies could well be affected as a result. The question is, how much are other EU countries affected? Will this also influence medicine policy in the EU? The implementation of the Falsified Medicines Directive is a reality in almost all EU countries and will closely coincide with Brexit. Hospital pharmacists have been working towards incorporating their verification and decommissioning obligation in their current work processes. But how prepared are they? In addition, problems caused by medicines shortages in Europe are growing and severely affecting patient care. Will Brexit and the implementation of FMD worsen the prevalence of medicines shortages in European hospitals? Many meetings have been organised among stakeholders to address these questions and to design preventive actions. But so far the impact of these major changes faced by hospitals, hospital pharmacists, patients and the whole medicine field has not been assessed globally.

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At the end of the open learning course, participants should be able to:

  • describe and discuss how Brexit and medicines shortages can affect accessibility and availability of drugs in Europe;
  • understand how the relocation of EMA may influence medicine policy in the EU;
  • assess the effect of FMD on medicine accessibility and the workload of hospital pharmacies;
  • identify new necessary procedures to prevent the possible negative effects of access to medicines.
Hospital pharmacists regularly find themselves having to manage the impact of medicines shortages. In 2019 Brexit and the implementation of FMD together with the EMA relocation may influence medicine accessibility and medicine policy in the EU. There is, therefore, an educational need for being informed about these issues and then to set up processes inside hospital pharmacy to mitigate against the negative impact that this may have upon patients' care. Speculations, proposals and good practices should be shared.

Brexit, falsified medicines directive, European Medicine Agency, hospital pharmacist, European Commission, supply chain, shortages, logistics/IT, patient care, patient, accessibility, patient safety.

Last update: 17 July 2019