Eleven European patient and consumer groups have sent a letter to the European Medicines Agency (EMA) to urge the organization to take more action to mitigate months-long antibiotics shortages, Reuters reports.
Some widely used antibiotics, such as amoxicillin, which is used to treat bacterial infections (particularly ear and chest infections in children) have been in shortage in Europe since October, the letter said. Amoxicillin has also been in shortage in the United States since fall, according to the American Society of Health-System Pharmacists and the US Food and Drug Administration.
The reasons behind the shortages include increased demand amid an early flu and respiratory syncytial virus (RSV) season, a drop in drug production at the height of the COVID-19 pandemic, the outsourcing of generic ingredient and drug manufacturing to lower-cost countries such as China and India, and higher input costs due to the war in Ukraine.
'Major event' declaration urged
The letter, signed by organizations such as the European Public Health Alliance and the European Consumer Organisation, asked the EMA to declare the antibiotic shortage a "major event," which would enable coordinated action across Europe and require manufacturers to report shortages sooner.
On Jan 13, EMA Chief Medical Officer Steffen Thirstrup, MD, PhD, told Reuters that the agency was tracking the situation but did not at that time plan to classify the shortages as a major event.
The letter asked the EMA to declare the antibiotic shortage a "major event," which would enable coordinated action across Europe and require manufacturers to report shortages sooner.
Attorney Charlotte Roffiaen, of the France Assos Sante patient group, told Reuters that amoxicillin isn't the only scarce antibiotic. "We don't know how many, exactly which ones, and the extent of the shortages...it would make sense to have a bigger picture," she said, suggesting that announcing a major event would increase transparency and help prevent future supply problems.
Meeting planned this week
The letter writers said that replacing amoxicillin with other antibiotics is not ideal because alternative drugs could be less effective and cause more adverse effects. Some European Union (EU) states, Reuters said, have already reported shortages of other antibiotics, such as azithromycin and cefuroxime.
EU officials have recommended increasing drug-production capacity and granting EU states permission to use drugs that don't have domestic authorization. "Nevertheless, these measures have not been sufficient to contain the crisis and to invert the trend until now," the letter said.
The EMA and the European Commission said that they knew of the letter and would discuss the issues raised on Thursday, according to Reuters.