European Union drug regulator determines antibiotic shortage not a ‘major event’

Europe’s drug regulator has decided not to label the antibiotic shortage on the continent a “major event”, given existing measures to tackle the shortfall were working in the short term, it said in a statement on Thursday,

A “major event” label would allow the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.

The EMA’s decision, which Reuters revealed earlier on Thursday, is focused on shortages of certain widely used antibiotics, including amoxicillin – used to treat bacterial infections and often prescribed for ear and chest infections in children – that emerged back in November.

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The EMA said it had received positive feedback from major amoxicillin manufacturers that supply is expected to be increased in the coming weeks and months, and that it expects demand for antibiotics will dampen as spring approaches.

Nearly all European countries are currently reporting antibiotic shortages, according to the EMA.

The spike in demand for antibiotics is linked to the resurgence of respiratory infections after two years of COVID-19 restrictions, which has pressured global supplies and made obtaining imports unlikely.

Drugmakers had also cut output when demand dipped at the height of the pandemic.

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A meeting of the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) took place earlier on Thursday, where the issue was discussed.

On Wednesday, a consortium of patient and consumer groups wrote to the EMA saying not enough was being done to address the shortages and that the use of alternative antibiotics was squeezing supplies of other medicines.

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The groups also recommended the EMA declare the situation a “major event”, acknowledging that although the declaration would not immediately resolve the crisis, it would offer the regulator visibility into the extent of amoxicillin and other antibiotic shortages across the continent.

Apart from using alternatives, European Union officials have encouraged member states to allow the use of medicines that may not be authorised domestically, among other recommendations.