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These recommendations will keep key antibiotics for respiratory infections available when they are needed most.
The European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) issued recommendations on July 17, 2023 for actions to prevent shortages of antibiotics (e.g., amoxicillin, amoxicillin/clavulanic acid, penicillin V, azithromycin, clarithromycin, ceftriaxone, cefotaxime and piperacillin-tazobactam) crucial in the treatment of respiratory infections . The recommendations were made to help prevent infections next winter in the European Union and were developed by the Executive Steering Group on Shortages and Safety in Medicinal Products (MSSG). The recommendations will be followed up on by the European Commission.
These recommendations reflect a new mandate for EMA (Regulation on EMA’s Reinforced Role (Regulation (EU) 2022/123)) which gives EMA new responsibilities on preventing critical medicine shortage crises. These responsibilities include monitoring events such as medicine shortages that may cause public health emergencies, reporting shortages to EU countries and coordinating responses with said countries, monitoring the supply and demand of medicinal products, and setting up two groups (MSSG and the Executive Steering Group on Shortages of Medical Devices).
EMA and the European Health Emergency Preparedness and Response Authority (HERA) will work with marketing authorization holders to ensure first and second-line antibiotics for respiratory infections will match demand. EMA and HERA recommended that marketing authorization holders increase production on these key antibiotics and take early action in the autumn and winter season to give sufficient time to manufacturers. EMA and the Commission, along with Member States, reminded stakeholders to order medicines as normal and to not stockpile medications. They also urged medical professionals to only prescribe antibiotics for bacterial infections in order to avoid antimicrobial resistance. Citizen awareness-raising initiatives were also recommended.
“Based on the data received we are working to ensure that we are better prepared for the upcoming winter season,” said Professor Karl Broich, chair of the HMA. “These early projections will allow the European medicines regulatory network to work with stakeholders to take measures in advance and prevent potential shortages for patients in the upcoming winter season.”
Going forward, EMA and HERA will continue to monitor supply and demand of key antibiotics throughout the rest of the year. “It is important that manufacturers take early action, ahead of the winter season, so that they can ramp up manufacturing capacity where necessary,” said Emer Cooke, EMA’s executive director in a EMA press release. A HERA Board meeting with representatives of the EU Member States’ Ministries of Health, the Commission, and the industry took place on July 20, 2023 to further discuss the issue and agree on future steps.