There is a shortage of antibiotics. You won't believe what European agencies are advising

The president of URPLiPB has published information on recommendations issued by the EC, HMA and EMA on measures to avoid shortages of key antibiotics for treating respiratory tract infections during the upcoming winter season.

If demand in the upcoming winter season is similar to the average level of consumption in previous years, the data collected suggests that the EU supply of oral formulations covering key first- and second-line antibiotics for the treatment of respiratory tract infections will match demand in the upcoming winter season. The EMA and the European Health Emergency Preparedness and Response Authority (HERA) will continue to work with responsible parties with marketing authorizations to strengthen measures to increase the supply of certain intravenous antibiotics.

To better prepare for the winter season, the EMA's Medication Shortage Steering Group (MSSG) has agreed on the following recommendations for proactive measures:

- Increasing production of key antibiotics: To avoid shortages in the upcoming fall/winter season, EMA and HERA recommend continuing to work with responsible parties with marketing authorizations to intensify efforts to increase production. Early action ahead of the fall/winter season should give manufacturers enough time to ensure sufficient production capacity to meet demand.

- Monitoring supply and demand: The EMA and the European Commission, together with Member States, will continue to monitor demand and supply in cooperation with companies. Given that the measures taken are aimed at ensuring sufficient supply, all stakeholders are reminded to order medicines normally, without stockpiling. Stockpiling medicines can further strain supply and cause or increase shortages.

- Public awareness and prudent use: Antibiotics should be used prudently to maintain their effectiveness and avoid antimicrobial resistance. Doctors have a key role to play, and antibiotics should only be prescribed to treat bacterial infections. They are not suitable for treating viral infections, such as the common cold and flu, where they are not effective. Initiatives to raise awareness among citizens are also recommended.

In line with the European Council conclusions of June 2023. The EMA and the European Commission, through HERA, will continue to closely monitor demand and supply and work with marketing authorization holders for the remainder of the year to detect any unexpected supply shortages early and take any necessary measures. A special meeting of the HERA Council with representatives from member states' health ministries, the Commission and the industry will be held on Thursday, July 20, to further discuss the matter and agree on possible additional steps.

The recommendations are based on data collected by the EMA and the European Commission's Health Emergency Preparedness and Response Authority (HERA) on the estimated demand and supply of a number of key antibiotics used to treat respiratory tract infections (amoxicillin, amoxicillin/clavulanic acid, penicillin V, azithromycin, clarithromycin, ceftriaxone, cefotaxime and piperacillin-tazobactam). The selected antibiotics belong to the WHO Access and Watch antibiotic groups, highlighting the importance of their proper use and availability. Supply and capacity projection data were provided by the key responsible parties with marketing authorization. They were then matched with demand estimates derived from historical EU/EEA winter season sales data for these drugs.

Source: URPL