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Information from the BfArM on the limited availability of antibiotics - especially for children

As of 25th April 2023, the Federal Ministry of Health has announced a critical supply shortage situation for syrups containing antibiotics for children. The announcement is published on the BfArM website in German language.

Since autumn 2022, an increasing number of reports on the unavailability of various antibiotics have been submitted to the BfArM supply shortage online portal. These primarily concern so-called broad-spectrum antibiotics, which are used for a variety of bacterial infections, but also penicillin V as a beta-lactam antibiotic for use with streptococci and other gram-positive pathogens. The reasons for the reported supply shortages are primarily significantly increased demand that cannot be compensated for, as even increased production capacities cannot guarantee nationwide availability in line with demand.

Up to now, the market data available to the BfArM have shown that there has been a continuous, but not completely demand-oriented supply of the market for the substance classes mentioned. The data confirm the clear increase in the use of antibiotics in recent months.

In the close-meshed exchange in the European network, it becomes clear that restrictions in the availability of antibiotics, especially for amoxicillin, amoxicillin/clavulanic acid and penicillin V (phenoxymethylpenicillin), can be observed in almost all Member States of the European Union as well as internationally. As a result, the possibility of obtaining medicinal products for compensation from these states is to be assessed as severely limited.

On December 16th 2022, an exchange was therefore initiated between the BfArM, the BMG and representatives of the German Society for Infectious Diseases, the German Society for Paediatric Infectious Diseases, Working Group of scientific medical societies and the Commission on Anti-Infectives, Resistance and Therapy.

The reports of the specialist societies suggest that in outpatient care, primarily for children, there is a tight supply situation with the active substances amoxicillin, amoxicillin/clavulanic acid and penicillin V. According to the assessment of the professional associations, hospital pharmacies have not been affected by an undersupply so far. As the observed wave of infections shows significantly higher numbers of cases than in comparable previous periods, the medical profession is appealed to use antibiotics strictly in accordance with guidelines and moderately in order to avoid supply gaps in the current winter as far as possible. A corresponding recommendation on the preferred use of the medicinal products in shortage has been drawn up by the professional societies. The recommendation can also be viewed on the website of the professional association.