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The Amoxicillin Shortage – What Happened to Care of Acute Otitis Media?

August 9, 2023

In a recently released article in Pediatrics, Dr. Ryan Brewster and colleagues report (10.1542/peds.2023-062482) on the effects of the national amoxicillin shortage on care of children with acute otitis media (AOM). High-dose (90 mg/kg/day) amoxicillin is a first-line treatment for acute otitis media in children,1 so when the U.S. Food and Drug Administration (FDA) declared a national shortage of liquid amoxicillin on October 28, 2022, an impact on prescribing patterns could be expected. As most of us recall, the shortage began relatively abruptly and was widespread, and the AAP promptly provided clinician guidance.2 Brewster and colleagues used a quasi-experimental approach to describe actual changes in prescribing decisions by comparing treatment of AOM in children before and after the shortage declaration (May 15, 2022 through October 27, 2022, as compared to October 28, 2022 through April 14, 2023) at an urban children’s hospital and affiliated community health center.

A total of 3,076 patient visits were described, with 1,399 prior to the shortage and 1,677 after the shortage declaration. The authors appropriately excluded those with recent prior otitis, amoxicillin allergy, and concomitant infections that might alter prescribing, e.g., sinusitis. Not surprisingly, individual prescriptions for amoxicillin decreased abruptly from 991 (70.8%) of the cohort pre-shortage to 671 (40.0%) during the shortage, and the proportion of prescriptions for alternative antibiotics, including amoxicillin-clavulanate and cefdinir, correspondingly increased.

What I found fascinating, though, was that the proportion of children receiving no antibiotic, i.e., the proportion treated with “watchful waiting”, was apparently not changed by the shortage (171 (12.2%) to 169 (10.1%)). While the AAP shortage guideline2 reasonably did not address non-prescribing of an antibiotic, “…observation with close follow-up based on joint decision-making with the parent(s)/caregiver…” also known as “watchful waiting,” is an important option for treatment of non-severe AOM, as described in Key Action Statements (KAS 3C and 3D).1 The authors point out that due to inclusion of those treated in the emergency department (ED), children with a higher acuity may have been better represented with fewer “non-severe” AOM being seen. I would add that the ED setting makes the KAS-required “close follow-up” very difficult to operationalize. Many of us practice in an office setting and depending on our families’ resources and ability to return, could have increased prescribing of “watchful waiting” as an amoxicillin alternative during the shortage even if this was not seen in this ED study. Take a minute to read this article and tell us if you changed your practice in this direction during the shortage. And certainly research on this topic would be an interesting follow-up to Dr. Brewster and colleagues’ well done hospital-based study!


  1. Lieberthal AS, Carroll AE, Chonmaitree T, et al. The Diagnosis and Management of Acute Otitis Media. Pediatrics. 2013;131(3):e964-e999. doi:10.1542/peds.2012-3488
  2. American Association of Pediatrics. Amoxicillin Shortage: Antibiotic Options for Common Pediatric Conditions. for-common-pediatric-conditions/ (Accessed 7/29/2023)
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