EU antibiotic shortages being monitored by MSSG

The European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), are closely monitoring and responding to current antibiotic shortages in the EU.

A recent surge in respiratory infections has led to an increase in demand for antibiotics such as amoxicillin (alone and in combination with clavulanic acid), especially as paediatric formulations.

Manufacturing delays and production capacity issues have led to supply problems affecting the majority of Member States. This has been exacerbated by geopolitical events such as war, the energy crisis and high inflation rates.

Monitoring medicine shortages

Since November 2022, MSSG and its working party, the Medicines Shortages Single Point of Contact (SPOC) working party, have been closely monitoring the EU antibiotic shortages.

They have been engaging with key players in the supply chain of amoxicillin to agree possible mitigating measures such as increasing manufacturing capacity. Through EMA’s engagement with its stakeholders, the Medicines Shortages Steering Group has received up-to-date information from community pharmacists on the situation in pharmacies across the EU.

The EC, HMA and EMA are cooperating closely, to investigate whether additional measures could be undertaken to mitigate the impact of these shortages.

Various measures have been implemented at State level to ensure that patients can receive appropriate treatment. Patients and healthcare professionals are reminded that alternatives are available in case of shortages.

EMA’s first critical medicines list for COVID-19

Regulatory flexibilities available for medicine/antibiotic shortages 

National Competent Authorities, as encouraged by the MSSG, are making use of the regulatory flexibilities available, such as:

• Allowance of the exceptional supply of certain medicines or presentations that may not be authorised in a particular State
• Granting full or partial exemptions to certain labelling and packaging requirements to ensure that patients can receive appropriate treatment.

In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

MSSG and the SPOC working party will continue to closely monitor the situation together with the EC and EU States. MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern.

Based on current information from companies and stakeholders, it is expected that the situation will improve in the coming months.