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Translation of a-t 2023; 54: 38-9


Antibiotics in short supply - supply shortages continue to increase

In just six months, the number of medicinal products included in the official list of "published supply shortages" has increased by approximately 60%, from just over 300 (a-t 2022; 53: 89-91) to currently more than 480.1 However, the list reflects only the tip of the iceberg. It considers only prescription drugs and is based solely on the information provided voluntarily by the pharmaceutical industry. 22% of the recorded supply shortages concern antibiotics including 40 syrups (8.3%) which are needed particularly in the paediatric sector. Above all, there is a shortage of amoxicillin (also combined with clavulanic acid) and penicillin V. The Federal Institute for Drugs and Medical Devices (BfArM) blames this primarily on the sharp rise in demand, which cannot be off-set by increased capacities in line with demand. 2 Another contributing factor was the fact that suppliers scaled back antibiotic production during the COVID 19 pandemic as demand had fallen due to infection control measures and the resulting reduction of respiratory infections. Production was subsequently not ramped up to sufficient extent. In a bid to improve the supply situation, the German Federal Ministry for Health announced the "Supply shortage of Paediatric Antibiotic-based Syrups" in the Federal Gazette at the end of April 2023.3 Similar to the situation with the anti-oestrogen medication, tamoxifen, 12 months earlier (a-t 2022; 53: 11-2 and 40), this measure makes it easier to import from other countries. However, as amoxicillin (plus clavulanic acid) and penicillin V are only available to a limited extent in virtually all European Union Member States and also internationally,2 it seems unlikely that imports will significantly compensate for the supply shortage. The alternative of preparing antibiotic suspensions from tablets in pharmacies is expensive and the taste is less appealing, particularly for children. The Deutsche Gesellschaft für Kinder- und Jugenmedizin e.V. (DGKJ) (German Society for Paediatric Medicine) together with other specialist societies has published recommendations for alternative antibiotics for outpatient paediatrics to provide guidance for the best possible replacement in shortage situations.4 However, if neither the standard therapy nor the first alternative mentioned are available, second or third choice preparations may have disadvantages in terms of effective spectrum, adverse events and onset of resistance. Antibiotic therapy is often not required, however, and watchful waiting with symptomatic treatment is possible. Even today, despite positive developments, antibiotics are still prescribed relatively too often. This also exacerbates the supply situation regarding standard antibiotics.5

1PharmNet.Bund, BfArM: Published short supply announcements, dated 10 May 2023; https://a-turl.de/e322
2BfArM: Information on the limited availability of antibiotics - particularly for children; 26 Apr. 2023; https://a-turl.de/7pfe
3BMG: Announcement according to § 79 para. 5 AMG, BAnz AT 25 Apr. 2023 B4
4DGKJ et al.: Antibiotic supply shortages in outpatient paediatrics, dated 18 Dec. 2022; https://a-turl.de/2pcg
5DGPI et al: Statement dated 20 Dec. 2022; https://a-turl.de/9xu3

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