BELGIUM —The European Commission is proactively addressing potential shortages of key antibiotics by collaborating with manufacturers and healthcare providers, aiming to prevent supply shortfalls during the upcoming winter season.
In a joint effort to mitigate shortages, the European Medicines Agency (EMA) and the European Health Emergency Preparedness and Response Authority have conducted a review of historical data on specific antibiotics.
Based on their assessment, the EMA stated that supply should meet demand this winter. To ensure an adequate supply, the organizations will work closely with drugmakers to scale up production.
Simultaneously, the EMA emphasized the importance of healthcare providers prescribing antibiotics solely for bacterial infections, rather than viral infections.
This prudent approach will help optimize antibiotic use and reduce the risk of unnecessary demand.
Earlier this year, the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products implemented similar initiatives to address antibiotic shortages within the European Union.
Germany, in particular, has been experiencing a deepening shortage of antibiotics since the beginning of the year.
Acknowledging this issue, the German Health Ministry has committed to taking measures to alleviate the problem, including allowing local authorities to purchase antibiotics more flexibly and swiftly, even from abroad, when necessary.
The global drug shortage crisis, encompassing various medications from cancer treatments to anesthetics, has underscored the vulnerabilities of supply chains, especially during the peak of the COVID-19 pandemic.
Disruptions caused by the Ukraine war have further impacted the supply of antibiotic ingredients, while rising energy costs have squeezed profit margins for antibiotic manufacturers.
The majority of active pharmaceutical ingredients are now sourced from India and China rather than Europe, leading to less transparency in the supply chain due to proprietary production processes.
This lack of visibility makes it challenging to perform a comprehensive risk assessment to identify areas of greatest vulnerability.
Sandoz, one of the largest generic antibiotics manufacturers, has increased drug production by a double-digit percentage in 2022 and hired 140 new employees since September to meet the growing demand.
However, the company faces challenges from rising costs, particularly in European markets where drug prices are regulated.
Additionally, its Asian competitors benefit from access to cheaper energy sources, placing Sandoz at a competitive disadvantage.
Costs for other crucial ingredients, such as sugar for fermentation, have also surged, further straining the manufacturing process.
Meanwhile, the United States has been grappling with a widespread shortage of penicillin since April.
Pfizer, a key supplier of penicillin, attributes the strain on supply to an increase in demand exacerbated by rising syphilis infection rates.
Pfizer has warned that all dosages of its combination penicillin syringes are expected to run out during the third quarter of this year, while its long-acting and pediatric versions will diminish by the end of the second quarter.
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