EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on January 26 to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU.
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The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA).
A recent surge in respiratory infections has driven an increase in demand for amoxicillin which combined with other issues including manufacturing delays and production capacity challenges led to shortages affecting the majority of Member States.
The MSSG and its working party, the SPOC working party, have been closely monitoring the situation since November 2022 and have been engaging with key players in the supply chain of amoxicillin to take forward possible mitigating measures.
Data are being provided by Member States through the SPOC WP, by industry associations, as well as stakeholders, allowing a clear and up-to-date understanding of the current situation.
As a result of these actions, the MSSG noted some progress since the start of the monitoring and mitigation efforts:
• Based on reports provided by Member States through the SPOC WP, a positive trend has been observed in a number of Member States, while it is acknowledged that some others still continue to experience a reduced availability of these and other antibiotics.
• EU regulators have met with the main parties involved in the supply chain of amoxicillin to provide regulatory support so as to increase production capacity (e.g. through rapid procedures to implement changes to alternative sources of raw materials, manufacturing sites, package materials…) and reviewed the possibility to increase supply to fulfil the Member States’ immediate needs.
EMA has received positive feedback from major manufacturers and supply is expected to be increased (through for example additional supply and increased production capacity) in the coming weeks and months.
• By using certain regulatory flexibilities, such as the exceptional supply of certain medicines that may not be authorised in a particular EU Member State, or full or partial exemptions to certain labelling and packaging requirements for medicines, many national competent authorities have managed to mitigate certain shortages.
• EU Member States expect the peak in infections to begin to subside soon, which is expected to lower the currently increased demand for antibiotics. Patients and healthcare professionals are reminded that in most cases alternatives are available if a certain medicine is in short supply.
The MSSG also discussed the current amoxicillin shortages and whether the ongoing situation meets the definition of a ‘major event’ as foreseen in Regulation (EU) 2022/123, and the consequences and added value that this would have in terms of mitigating those shortages.
The MSSG came to the conclusion that at present this ongoing shortage situation is not considered to be a major event and that current mitigating measures are improving the supply situation in the short-term.
In view of the improvements seen for some of the indicators by several Member States, the MSSG is of the opinion that the measures currently being taken across the EU are showing an effect and commits to both continue and intensify these efforts for a timely resolution of the situation.
The MSSG will also pursue continued collaboration across the EU throughout the year to avoid a recurrence of the situation during the next winter season.
In addition, it is important that antibiotics are used prudently to maintain their efficacy and avoid antimicrobial resistance. Antibiotics, including amoxicillin, should only be prescribed to treat bacterial infections. They are not suitable for treating viral infections such as cold and flu, where they are not effective. ■