Rampant Infections Return: The Alarming Truth about the Continued Scarcity of a Vital Children's Antibiotic

Parents throughout the United States are starting to experience the challenges of a second winter without sufficient amoxicillin, which is the most commonly prescribed antibiotic in the country. The scarcity of liquid versions of this medication, which are typically the initial choice for treating strep throat, chest and sinus infections, and earaches in children, continues to persist, as reported by the drug shortage database of the US Food and Drug Administration. Unfortunately, no respite seems to be on the horizon.

"It's a major concern. With the impending respiratory illness season approaching, the situation is bound to become quite problematic," stated David Margraf, an expert in pharmaceutical research and a member of the Resilient Drug Supply Project at the University of Minnesota.

At Rush University Medical Center in Chicago, Pharmacist Selena Ko skillfully reconstitutes powdered antibiotic amoxicillin and accurately administers appropriate doses to pediatric patients.

According to the FDA, there is no shortage in amoxicillin capsules and tablets. However, young children who are unable to swallow pills commonly depend on liquid forms of the medication.

Some manufacturers of amoxicillin powder, used to prepare the liquid form, have not explained the reasons behind the shortages. While most manufacturers continue to produce the antibiotic, they have implemented allocation measures, restricting customers to order limited quantities.

During a drug shortage, allocation is necessary to prevent one buyer from monopolizing the available supply. However, this can lead to pharmacies running out of stock quickly, causing frustration for parents and pediatricians. They are left scrambling to find any available stock or having to switch to a different antibiotic if necessary.

Dr. Rohan Khazanchi, a pediatrician and medical resident at Brigham & Women's Hospital in Boston, explains that the increased demand for respiratory viral illness and ear infections during the winter months has surpassed our supply chains' production capacity. Consequently, shortages are occurring nationwide and impacting our patients.

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Khazanchi and Dr. Ryan Brewster conducted a recent study on the clinical impacts of the amoxicillin shortage during the previous winter. Their research revealed that following the FDA's declaration of amoxicillin shortage in October, prescriptions for the drug decreased by more than 90%. In response, doctors turned to alternative antibiotics such as augmentin and cefdinir, which in some cases may lead to more severe side effects for patients and contribute to antibiotic resistance. Moreover, this sudden shift in demand can potentially deplete supplies of substitutes, creating a ripple effect. Although amoxicillin shortages are not the most severe, doctors still have other options when it comes to prescribing antibiotics.

Khazanchi expressed concern about the generalizability of this issue, emphasizing that it is not specifically about amoxicillin but rather about the widespread shortage of essential generic medications that should be readily accessible. Teva Pharmaceuticals and other manufacturers attributed the shortfall to a surge in demand rather than common factors such as production delays or difficulties in obtaining raw materials.

Sandoz, a division of Novartis known for producing generic medications, stated that the market was witnessing an increasing number of manufacturers exiting due to the low prices, which intensified the overall pressure. A bottle of the treatment is typically priced at around $10.

ADHD medication.

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Sandoz stated that if the pricing dynamics in the marketplace are not addressed, the shortage of ADHD drugs will probably continue to increase, causing stress for families during the back-to-school season.

Other companies experiencing shortages have chosen not to disclose the causes for the limited supply. "These companies are unwilling to provide any insight into the situation," remarked Erin Fox, a drug shortage tracker at the University of Utah. "As a result, we are entering this season with inadequate stocks of oral liquid medications."

The amoxicillin shortage has remained relatively unnoticed, according to Laura Bray, CEO of the nonprofit organization Angels for Change, which aims to address drug shortages.

"From a medical perspective, there isn't as much urgency to resolve this issue due to the availability of alternatives," she explained. "That's why there isn't much discussion surrounding it compared to chemotherapy drugs, which have no substitutes, even though the underlying cause is the same."

Antibiotics like amoxicillin are 42% more likely to be in shortage than other types of drugs, according to a 2022 report from US Pharmacopeia.

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And as with many other drugs that are vulnerable to shortages, amoxicillins undoing is that it is cheap.

"These companies find them unprofitable, therefore, they prioritize their efforts on different areas. Consequently, we have no choice but to accept their own discretion in producing whatever they desire, solely based on financial considerations," explained Margraf.

Despite monitoring and reporting drug shortages, the FDA possesses limited power in resolving these issues.

The FDA expressed empathy towards individuals facing shortages, and emphasized their commitment to providing assistance. While the agency does not possess the ability to manufacture drugs or compel pharmaceutical companies to increase production or alter distribution, they reassured the public that they are actively collaborating with various manufacturers, agencies, and supply chain entities. Their primary goal is to comprehend, address, and prevent the impact of sporadic or heightened demands for specific products.

According to Bray and other experts, a crucial requirement for the United States is the establishment of a dedicated individual or government office responsible for monitoring drug supplies. This would ensure that the nation always has an ample quantity of essential medications at its disposal during critical times.

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Bray posed the question regarding the lack of a similar system for drugs, just like the one the US Department of Agriculture has for grain and corn. Several other experts also concur with this viewpoint.

"There is no single entity, be it an organization, party, government agency or otherwise, that bears sole responsibility for overseeing the entire supply chain. This lack of transparency gives rise to various problems as there is a lack of coordination," stated Matt Christian, the director of supply chain insights at US Pharmacopeia's Medicines Supply Map project.

An alternative solution being considered is to provide pharmaceutical companies with subsidies or financial incentives, such as guaranteed large volume contracts, in order to produce affordable and essential medications.

"We do it for farmers. We give them plenty of subsidies. And we dont want food shortages," Margraf said. "Now, we need to do the same with drugs."