A shortage in some formulations of amoxicillin commonly used for children that emerged this fall is largely driven by increased demand during an early and prolific season for respiratory illnesses, according to the FDA and several manufacturers of the medication. Fortunately, several alternative antibiotics can be substituted for amoxicillin.
ASHP began receiving reports of a possible shortage in mid-October through the University of Utah Drug Information Service, said Michael Ganio, PharmD, BCPS, the senior director for Pharmacy, Practice and Quality at ASHP. The organization posted a bulletin listing the affected products, which include various amoxicillin oral powders for suspension, tablets and capsules. The FDA also posted a bulletin about the shortage on Oct. 28.
The situation appears to be driven by increased demand instead of supply disruptions, Dr. Ganio said, which is “a little bit unusual” for drug shortages. “This is going to affect just about any pharmacy that would dispense these medications,” he said. “That can even include an inpatient hospital pharmacy.”
According to Dr. Ganio, the rise in demand for amoxicillin is likely related to a mixture of bacterial infections that can co-occur with respiratory syncytial virus (RSV) and other viral infections; cases where a provider prescribes antibiotics because they cannot distinguish between a viral infection and a bacterial one; or unrelated concerns such as ear infections that are appropriately treated with amoxicillin.
An analysis by the healthcare technology company Arrive Health illustrates the growing demand for amoxicillin. The company runs about 7 million transactions per month between pharmacy benefit managers and electronic health record (EHR) prescribing workflows nationwide.
“When a doctor is pending a medication, they input the medication into the EHR, and our tool checks to see if the medication is covered under the patient’s insurance,” explained Adam Rosenberg, the company’s senior director of marketing. Arrive Health examined 801,000 medication transactions for amoxicillin suspensions since January 2021. Typically, these transactions accounted for 0.41% to 0.98% of total transactions completed in Arrive Health’s network in a given month. But last month amoxicillin transactions climbed to 1.41%, accounting for 24.52% and 19.22% of the total transactions for children aged 0 to 2 years and 3 to 12 years, respectively.
As of mid-November, amoxicillin suspensions had already reached 1.7% of total transactions for the month.
Samuel L. Aitken, PharmD, MPH, BCIDP, a clinical pharmacist specialist in infectious diseases at Michigan Medicine, in Ann Arbor, told Pharmacy Practice News he is concerned that the shortage may be caused in part by amoxicillin being overprescribed for viral illnesses. “A very, very small minority, maybe 1% or 2% of children with RSV being treated out of the hospital, will have a bacterial infection, so there are a lot of children being treated for potential infections that they very likely don’t have,” he said. “The downstream consequence of this, assuming the bad RSV season continues throughout the winter potentially alongside influenza and COVID, is that amoxicillin supplies may run dry and we won’t have it available when it is truly needed.”
Responding to the Shortage
To deal with the shortage, some manufacturers have implemented limits on how much amoxicillin pharmacies can purchase at a given time, according to the FDA and ASHP bulletins. Pharmacists may need to call other pharmacies in their area when amoxicillin supplies run low, or work with prescribers to find an appropriate alternative treatment. “There is supply out there,” Dr. Ganio said. “We’re hoping to see this resolve relatively quickly.”
Dr. Aitken said he and his colleagues first became aware of the shortage last month when local community pharmacies were unable to fill prescriptions. “We’ve so far been able to obtain adequate supplies for patients in the hospital but occasionally hear of pharmacies in the community that don’t have any,” he said. “We haven’t had to make any major changes, and most of our work has been preparation for potential issues down the road: making alternative recommendations in hospital guidelines in case we do begin to run out of amoxicillin, identifying high-priority areas, finding alternative suppliers and giving recommendations to our physicians and other providers for alternatives in case a pharmacy is not able to fill a prescription.”
It is possible that the shortage will continue into early 2023, depending on how the current surge in childhood respiratory infections continues to unfold. “The only thing that’s concerning about this is if this outbreak of respiratory infections is a sustained wave,” Dr. Ganio said.
However, alternative medications can be used if amoxicillin is not available in a given area. “This is not a type of shortage, like an Adderall [dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, Teva] situation, for example, where it’s very difficult to change a person from one medication to another,” Dr. Ganio said. “It’s important to put this shortage in perspective.”
ASHP is tracking more than 260 drug shortages in the United States, he said, and “a lot of them are less manageable than this one.”
Oral cephalosporins are effective against many of the same bacteria as amoxicillin, Dr. Ganio said. Another possibility is the combination antibiotic amoxicillin-clavulanate, although this medication is more likely to cause stomach upset. Alternatives to amoxicillin generally have more side effects, are more expensive and are broader-spectrum, which means their overuse may further contribute to the antibiotic resistance crisis, Dr. Aitken noted.
Furthermore, leaning too heavily on alternative antibiotics may eventually result in secondary shortages. “There is, unfortunately, no one ‘best’ way to deal with a shortage like this,” Dr. Aitken said. “Every hospital and pharmacy will have to make their own decisions based on their supplies, patient volumes and historic use.”
Health systems tend to be more resilient to drug shortages than independent pharmacies due to higher stocking, larger allocations and more ability to directly affect prescribing, Dr. Aitken noted, but “as shortages go on, they begin to be equally affected.” Nonetheless, pharmacies shouldn’t try to preventively overstock antibiotics. “However appealing this sounds, this tends to be a short-term fix that exacerbates shortages and prevents drug from going where it is truly needed,” he stressed.
Pharmacists should be prepared to field questions from patients and prescribers about alternatives to amoxicillin. “It’s very important to emphasize that respiratory viral illnesses, like RSV, should not routinely be treated with antibiotics unless there is a very strong suspicion of a secondary bacterial infection,” Dr. Aitken said. “This is always hard with a sick child in front of you, but there really is no benefit for the vast majority of children with RSV. Sometimes, just a bit of reinforcement to a parent or prescriber can go a long way.”
Written by Kate Baggaley for Pharmacy Practice News.