Investigating the Amoxicillin Shortage in Pennsylvania in the Era of Supply Chain Challenges: A Cross-Sectional Study

Harleen K. Sethi, DO; Timothy Fan, MD; Dan Eichorn, DO; Hye Rhee Chi, DO; Laura McDavid, DO; Keith Conti, MD; Pamela Roehm, MD, PhD St. Luke's University Health

Amoxicillin is the most common antibiotic prescribed for pediatric patients and the first line treatment for many Otolaryngologic conditions (Figure 1)1 of a “medically necessary” drug, there are no statutory definition of “medical necessity” nor penalty for failure to provide advanced notice.4,5 Thus, healthcare entities, physicians, and patients alike are often caught off guard by medication shortages.

Drug shortages have been a persistent problem in the US for many years, despite preventative efforts endeavored by public and private sectors involved in all parts of the drug supply chain.6 Common reasons for medication shortage include imbalances in supply and demand and supply chain disruptions, including raw material shortages, limited manufacturing workforce, recalls, transportation delays, lack of manufacturing incentives, and natural disasters. 7 The amoxicillin shortage at the end of 2022 coincided with the annual resurgence of influenza and respiratory syncytial virus (RSV) infections, as well as COVID-19 interference with manufacturing workflow, making the causes of the shortage unclear. In this study, we have investigated the driving force(s) behind the amoxicillin shortage in Pennsylvania.

Our cross-sectional phone/email survey study consisted of 7 pharmacies in eastern Pennsylvania, 4 amoxicillin distributors, and the only amoxicillin manufacturer located in the US (USAntibiotics, Bristol Tennessee). Companies were first contacted by phone numbers identified during google searches for company names. Follow-up calls or emails were made based on contact information given during initial contact phone interviews. Interview questions focused on inquiring as to the subjective presence of a shortage, when the shortage noticed, and reasons for the shortage (Table 1)

In October of 2022, the United States (US) Food and Drug Administration (FDA) announced a shortage of numerous amoxicillin formulations.2 Per the American Academy of Pediatrics, the shortage was anticipated to last several months, requiring the usage of alternative antibiotics to fill in the therapeutic gaps.3

Medication shortages have multifaceted impacts on healthcare leading to undermining of therapy, delaying or compromising care, and/or increasing medical error, complications, and expenditures.4 While manufacturers are required to provide FDA advanced notice in anticipation of decreased production