Doctors and pharmacists face shortage of amoxicillin

Doctors and pharmacists face shortage of amoxicillin

A shortage of the antibiotic amoxicillin, which has hit countries around the world since early summer, is now complicating patient care in the United States.

Amoxicillin is commonly prescribed to children to treat bacterial infections such as those that affect the ear and throat, and a shortage may have far-reaching implications for physicians, pharmacists and health care systems, especially in the outpatient setting, George Udeani , PharmD, clinical professor and chair of the pharmacy practice department at the Texas A&M Irma Rangel School of Pharmacy, told CIDRAP News.

“In outpatient and community practice settings, physicians write prescriptions for patients who fill these prescriptions at any of thousands of pharmacies across the country, some through mail-order services,” he said. “When drug shortages occur in these settings, pharmacists typically contact physicians for alternative recommendations, sometimes resulting in delayed care, especially for children with infections such as otitis media. [ear infection].”

Although amoxicillin-clavulanate and cefuroxime are good available alternatives to amoxicillin for pediatric bacterial infections, Udeani said, “there is concern that antibiotic shortages could lead to antimicrobial resistance, as clinicians may have to resort to less optimal agents to treat their patients.

The shortage appears as an early and unprecedented problem. surge demand for pediatric hospital beds for respiratory disease in young children, probably because young children were not exposed to many viruses during the COVID-19 pandemic.

Although most of those hospitalizations appear to be for respiratory syncytial virus (RSV), influenza, and enteroviruses, which cannot be treated with antibiotics, some providers may presumably treat respiratory infections first with an antibiotic.

Unavailability has also been reported in Ireland, Malaysia, RomaniaY Australia, where a government database lists the reasons as “manufacturing” and “unexpected increase in consumer demand.” This summer, Canada reported a 3-month shortage of injectable amoxicillin.

Health systems that conserve doses

The US Centers for Disease Control and Prevention lists amoxicillin as first line therapy for conditions such as bacterial pneumonia and ear, sinus, and throat infections in children. While amoxicillin capsules and tablets of various strengths are in short supply, the majority (at least 19) of the affected products are liquid forms typically used in children.

The shortage came to light in the United States on October 17, when CVS said some Massachusetts pharmacies had been “experienced isolated product shortages.” The lack has prompted at least one East Coast children’s hospital to release a treatment algorithm for use during shortages.

So far, Children’s Minnesota pharmacies in Minneapolis have been able to handle amoxicillin shortages, though supplies are low, according to a frontline staff statement shared by Public Relations/External Communications Manager Dina Elrashidy.

“To contain the situation, we had to submit a special request to increase allocations from our main wholesaler and had to connect with other sources to secure additional inventory,” the statement said. “We also sent out a system-wide communication asking all providers to prescribe alternative antibiotics where appropriate.”

“As a final step, we are temporarily discontinuing our standard procedure of dispensing the entire bottle of amoxicillin (which comes in various sizes). Instead, we are mixing and pouring the exact amount for each course of therapy, to eliminate waste.”

The health system said it is monitoring the situation very closely, “because the current shortage of amoxicillin combined with the ongoing respiratory surge could lead to additional shortages of other antibiotics. Currently, there is no projected end date for the current shortage.” , which is also impacting other pharmacies throughout the community.”

Laura Bio, PharmD, a clinical pharmacy specialist at Stanford Medicine Children’s Health, said her organization has been able to get around the shortage by purchasing different formulations of amoxicillin.

“However, we have certainly seen an increase in recent use that likely correlates with the rise in RSV and other respiratory viruses with concern for overlapping bacterial infection in our hospitalized and critically ill patient population,” he told CIDRAP News. “This emphasizes the importance of diagnostic management and evaluation of bacterial versus viral infections to reduce the use of antibiotics when it is unnecessary, that is, viral respiratory infections.”

‘A uniquely difficult situation’

According to the American Society of Health System Pharmacists (ASHP), three of the four largest manufacturers of amoxicillin report amoxicillin shortage starting October 25. The US Food and Drug Administration (FDA), as of today, has not included a shortage of amoxicillin in its drug shortage databasealthough he said Bloomberg that it is aware of “intermittent supply interruptions” and is working with manufacturers to remedy it.

UK-based Hikma Pharmaceuticals told ASHP that 14 amoxicillin products have already been assigned and that several preparations will expire in or before August 2023. Teva, an Israeli company, said its nine preparations are all pending, with estimated launch dates from late October to early December. US-based Rising Pharma, which filed for bankruptcy in 2019, reports that it has some capsules and tablets.

Hikma and Teva did not explain the shortage to ASHP, and India-based Aurobindo declined to provide availability information. Sandoz, owned by Novartis, another large supplier of amoxicillin, told Bloomberg that it lacks the drug in the United States and abroad due to “significant” demand.

“The combination in rapid succession of the impact of the pandemic and the resulting swings in demand, manufacturing capacity constraints, raw material shortages and the current energy crisis means we face an exceptionally difficult situation in the short term,” he said. Sandoz spokeswoman Leslie Pott told Bloomberg.

Udeani said there are likely other issues at play. “Amoxicillin is a cheap agent; you can buy a 7-day course of treatment for about $2.99 ​​to $4,” he said. “Therefore, there is minimal commercial incentive for pharmaceutical companies to allocate and invest resources for their production.”

Antibiotic use has also increased 46% worldwide since 2000, Udeani said. “Amoxicillin is a drug that is in high demand globally, particularly in low-income countries, given its low cost,” she said. “Unfortunately, this increased demand in global antibiotic consumption has not been met by increased supply. Only a few countries, led by China, produce the active pharmaceutical ingredient amoxicillin.”

In addition, several Asian companies that produce active pharmaceutical ingredients for amoxicillin or that manufacture amoxicillin itself have faced regulatory sanctions for poor manufacturing standards by the European Medical Agency and the US Food and Drug Administration (FDA). , which has affected supplies. “According to the American Society of Health System Pharmacists, the Asian company Ranbaxy currently has an import ban on amoxicillin tablets from the FDA,” Udeani said.

Leave a Comment