Last week, the U.S. Food and Drug Administration declared a shortage nationwide, reporting that several companies say there is an increase in demand for the drug. The top four manufacturers, who have sold 99.8 percent of liquid amoxicillin in retail pharmacies so far this year, are struggling to supply the drug.
It is unclear whether the demand is higher because more patients get sick or because drug manufacturers are unable to keep up with normal demand. In any case, the episode illustrates the fragility of the supply chain of essential basic drugs, in particular antibiotics.
Amoxicillin isn’t the only antibiotic that’s hard to come by recently. The University of Utah Drug Information Service, which tracks shortages, reported a low supply of 32 antimicrobial drugs, including antibiotics, as of September 1.
Doctors, pharmacists coping with amoxicillin shortage
— CIDRAP (@CIDRAP) October 27, 2022
“There is concern antibiotic shortages could lead to antimicrobial resistance, as physicians may have to resort to less optimal agents”https://t.co/HQwxZ7hlml#DrugShortage @CIDRAP_RDSP #AntibioticStewardship pic.twitter.com/VYFYv2Vx9a
In fact, antibiotics are 42% more likely to be deficient in the United States than other types of drugs, according to an analysis by the U.S. Pharmacopoeia. This is a group that sets quality standards for medicines around the world and has a unique view of the drug supply chain.
Antibiotics are more at risk of deficiency than other popular medications, such as heart medications and antidepressants, according to USP. “Much of this risk is driven by market factors, particularly price,” said Matt Christian, USP’s director of supply chain information. In general, antibiotics are generic drugs that have been around for years and tend to be cheaper and have lower margins than newer drugs. This means that pharmaceutical companies have far fewer incentives to build strong and resilient supply chains and could be left short if something goes wrong with a competing supplier.
Indeed, in the case of amoxicillin, a spokesperson for pharmaceutical manufacturer Sandoz said that some of the drugs were out of stock at one of its competitors, “resulting in increased unexpected sales of our products.”
“Low-priced drugs run a greater risk of shortages,” Christian said. “No margin, no inventory.”
An FDA analysis found a similar correlation: drugs that are in short supply tend to cost less than other drugs.
Several countries, including the United States, fund programs to encourage companies to develop new antibiotics to combat the increasingly dangerous superbugs. But we don’t have those new drugs yet, so patients without amoxicillin could end up taking less appropriate antibiotics and worsening the superbug crisis.
“If a ubiquitous antibiotic like amoxicillin runs out, there is concern that is unnecessarily switching [to a more aggressive antibiotic] could cause even greater antimicrobial resistance,” Christian said.