September 22, 2023 – Respiratory virus season is upon us, and the amoxicillin shortage that began last fall remains to be not resolved.
Most of the drug's manufacturers have still not disclosed the explanation for the shortage or why it persists, a gaggle of doctors reported in an August Research focus published within the journal PediatricsThe powder type of amoxicillin is used to make liquid versions of the medication, that are commonly given to children who often cannot swallow tablets.
Researchers found that the likelihood of a baby being prescribed amoxicillin dropped by 91% after the drug shortage was announced.
The study compared the treatment of ear infections in children before and after the onset of amoxicillin shortage. The study included 3,076 children. All children were treated in a single health system and the typical age was 3 years. The authors identified that they selected to review ear infections since it is probably the most commonly treated childhood disease with antibiotics and amoxicillin is a first-line treatment.
“With these sharp increases in respiratory illnesses, ear infections and all the things that the winter months have brought over the last year or two, the demand is really outpacing what our supply chains can produce. And as a result, we're seeing shortages across the country that are affecting our patients,” said researcher Rohan Khazanchi, MD, MPH, a pediatrician and resident at Brigham & Women's Hospital in Boston, CNN.
The start of flu season is just just a few weeks away. Respiratory viruses aren’t treated with antibiotics. But these viruses often cause secondary problems comparable to ear infections, pneumonia or sinusitis, which in keeping with a Tip sheet for parents published by the American Academy of Pediatrics last fall when the shortage began.
The nationwide shortage of amoxicillin was announced by the FDA in late October 2022. The American Academy of Pediatrics advisable that prescribers use alternatives, comparable to splitting tablets or capsules of amoxicillin, using second-line alternatives, or just applying “watchful waiting.” The latest study found that there was no increase in watchful waiting within the health system involved within the investigation.
“What concerns us is the generalizability of this problem,” Khazanchi said, in keeping with CNN. “It's not about the amoxicillin; it's about the fact that we have a shortage of relatively important drugs that are generic and should be widely available.”
One manufacturer, a subsidiary of Novartis called Sandoz, told CNN that low prices were forcing manufacturers out of the market. Another drug company called Teva Pharmaceuticals cited increased demand as the rationale for the shortage, CNN reported.
In an announcement, the FDA noted that it “does not manufacture drugs and cannot require any pharmaceutical company to manufacture a drug, manufacture more of it, or change the distribution of a drug,” CNN reported. “The public can be assured that FDA is working closely with numerous manufacturers, regulators, and others in the supply chain to understand, mitigate, and prevent or reduce the impact of temporary or increased demand for certain products.”
The authors of the research study said the FDA should consider doing more to get the situation under control.
“Drug shortages have immediate, far-reaching effects on prescribing behavior and should be monitored and addressed by regulators, policymakers, and health systems alike,” they wrote. “The FDA should consider increasing oversight of key drugs, requiring disclosure of supply problems, and creating incentives for antibiotic production to mitigate their low profitability.”