EU antibiotics shortage not a 'major event,' says EMA

EU antibiotics shortage not a 'major event,' says EMA
Credit: Belga

The European Medicines Agency (EMA) has decided not to label the EU's ongoing shortage of antibiotics – specifically amoxicillin – a "major event," meaning that no additional measures are needed.

A recent surge in respiratory infections has driven demand for amoxicillin (antibiotic) which, combined with other issues including manufacturing delays and production capacity challenges, led to shortages in the majority of Member States.

The EU regulator came to the conclusion that at present, the situation is "not considered to be a 'major event'," and that current mitigating measures are improving the supply situation in the short term.

"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," EMA stated in a press release.

Past the critical moment

Since November 2022, the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) have been closely monitoring the situation and has engaged with "key players in the supply chain" of this drug to take "possible mitigating measures" going forward.

While some Member States continue to experience reduced availability of amoxicillin and other antibiotics, others are seeing the situation improve.

EU regulators have met with the main parties involved in the supply chain to provide support to increase production capacity (through rapid procedures to implement changes to alternative sources of raw materials, manufacturing sites, and packaging materials).

Many national authorities have managed to mitigate shortages by relaxing normal regulations: for instance, permitting the exceptional supply of certain medicines that may not be authorised in a particular EU Member State. Partial or full exemptions to certain labelling and packaging requirements for medicines have also been eased.

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"Member States expect the peak in infections to begin to subside soon, bringing down the high demand currently seen for antibiotics," the Agency said. "Patients and healthcare professionals are reminded that in most cases alternatives are available."

Throughout the year, the EMA will continue to collaborate with national agencies to avoid a repeat of the situation during the next winter season. It stressed the importance of using antibiotics prudently to maintain their efficacy and avoid antimicrobial resistance.

Antibiotics, including amoxicillin, should only be prescribed to treat bacterial infections and are not suitable for treating viral infections such as cold and flu, where they are not effective.

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