Milan, 20 Jan. (Adnkronos Health) — Shortage of antibiotics under the lens in the EU. The European Medicines Agency EMA, the European Commission and the Directors of Medicines Agencies (HMA), through the Executive Steering Group on Shortage and Safety of Medicines (MSSG), «are closely monitoring» the phenomenon «and responding to the current shortages affecting the European Union», informs a message. MSSG and the SPOC (Medicines Shortages Single Point of Contact) working group specifically dedicated to the shortages «will continue to closely monitor the situation together with the EU Commission and Member States», it reads.»Based on information from companies and stakeholders,» the forecast is that the shortfall picture «will improve in the coming months.»
A recent wave of respiratory infections has led to an increase in demand for antibiotics such as amoxicillin, alone and in combination with clavulanic acid, especially in pediatric formulations. In addition, manufacturing delays and production capacity problems have generated supply difficulties affecting most Member States, but also countries outside the EU. For this reason, EMA has also discussed with other international regulatory bodies.
MSSG and Spoc have been closely monitoring the situation since November 2022 and «several measures have been implemented at Member State level, to ensure that patients can receive adequate care», assure the organizations at work: from increasing production capacity, to regulatory flexibility tools (exceptional supplies of certain products or forms not yet authorized; total or partial derogations from particular labelling or packaging requirements), temporary distribution of unit doses.
In any case, «patients and healthcare professionals are reminded that alternatives are available in case of deficiencies» and how important it is «that antibiotics are used with caution, to maintain their effectiveness 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 colds and flu, on which they are not effective.»
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