February 13, 2023 | Pharma and Life Sciences
Healthcare supply chain challenges have emerged across Europe as demand for antibiotics has soared due to an unseasonable upsurge in respiratory infections.
The rising demand has put huge pressure on supply, with nearly all European countries reporting antibiotic shortages. Pharmacies are dealing with shortages of amoxicillin, cephalosporins and other commonly used antibiotics required to treat diseases ranging from ear infections to pneumonia.
For example, France has been facing an amoxicillin shortage, particularly drinkable forms for children since October. Zinnat, a cephalosporin antibiotic produced by Sandoz, is in short supply until March 2023.
In a survey of pharmacies from 29 countries, nearly a quarter reported scarcity of over 600 medications, while 20% reported a shortfall of 200-300 drugs.
Seasonal diseases like influenza and RSV have begun early, with an unprecedented incidence of Strep A in children following pandemic-era restrictions.
Along with the rising demand for antibiotics, shortages are compounded by production capacity issues as well as manufacturing slowdowns. Pharmaceutical businesses that had earlier reduced production due to low demand at the height of the pandemic are now scrambling to meet rising orders.
In Belgium, the amoxicillin shortage is expected to continue into the early months of 2023 due to production delays. Manufacturers are also facing disruptions in the supply of ingredients, packaging and other components, partly because of China’s Covid-19 restrictions. Sandoz, a global leader in generics, is facing delays in filling orders due to a lack of screw caps and other components.
On the supply side, manufacturers have found it challenging to meet the current demand due to an overreliance on a small number of suppliers for active pharmaceutical ingredients (APIs) and other raw materials.
A major reason for these supply bottlenecks is a lack of deliveries from countries such as China and India, key suppliers of APIs and generic medicines. For instance, 100% of generics sold in Germany are produced in these countries, and the COVID-zero policy in China has put constraints on logistics and manufacturing output.
Moreover, rising energy costs due to geopolitical events have exacerbated these challenges by increasing production costs, leading some antibiotics manufacturers to cease production. Centrient Pharmaceuticals Netherlands BV, another major antibiotic producer, has cut production of a key ingredient because it can’t raise prices enough to offset rising electricity costs.
In response to the ongoing shortages, the European Commission (EC), Heads of Medicines Agencies (HMA) and European Medicines Agency (EMA) have begun coordinated efforts to stockpile drugs and organize joint procurement of supplies. In addition, the UK has passed multiple Serious Shortage Protocols, which let pharmacies allow for substitution of drugs in short supply with alternative drugs under less pressure.
Britain's GSK has ramped up production speed, and Sandoz has hired more staff and made investments to increase production at its Kundl site in Austria. Some countries have allowed for the exceptional supply of some medicines that may not be allowed in a specific member state, as well as offered whole or partial exemptions from certain labelling and packaging standards.
EU regulators are working with the main parties in the amoxicillin supply chain to provide regulatory support, such as increasing production capacity via quick methods to implement changes for alternative sourcing of raw materials and manufacturing sites, along with increasing supply for immediate needs in certain member states.
Major manufacturers have given a positive response to the EMA with additional supply and increased manufacturing capacity expected to help ease supply constraints.
Author: Manasi Baswe