Antibiotic supply chain issues persist, study shows
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Key takeaways:
- More than two-thirds of antibacterial agents included in a study experienced supply chain issues between 2017 and 2022.
- Antibacterial use has a seasonality, but issues did not match waves of sales.
SEATTLE — Over the course of more than 5 years, antibiotic supply chain issues have not improved, potentially impacting patient treatment and stewardship, according to a study.
Although supply chain issues decreased “significantly” for penicillins and quinolones, overall there were no changes in supply chain issues for other drugs, according to the study, which was presented at the Society for Healthcare Epidemiology of America Spring Conference.
“There are substantial risks at each point of the drug supply chain,” Katie J. Suda, PharmD, MS, professor of medicine at the University of Pittsburgh School of Medicine, said during a presentation.
“There are internal risks, which are within the manufacturing process. Some common risks that are ongoing today and every day are the inability to procure ingredients, including inactive and active ingredients within the products, as well as product quality issues, such as sterility issues, [as well as] external supply chain risks such as competition, regulations and unanticipated events, such as pandemics and natural disasters,” she said.
Supply chain issues for antimicrobial drugs are not new — in 2019, antimicrobial agents were in the top five active drug shortages by class — and in the new study, Suda said the researchers saw “almost twice as frequent supply chain issues for antibacterials.”
Suda and colleagues analyzed manufacturer reports of supply disruptions submitted to the FDA and the American Society for Health-Systems Pharmacists between Jan. 15, 2017, and June 30, 2022, merging the data on the agent-formulation level. For each month of the study period, the researchers considered a drug to have an active supply chain issue if a shortage or recall report overlapped with that month for more than 15 days or if a discontinuation had occurred in the previous 3 months.
Of 105 antibacterials purchased in the United States during the study period, 74 (70%) had a supply chain issue for more than 1 month. The 74 agents that had issues had 1,611 total months of supply chain issues during the entire study period, with penicillins the most frequently impacted and cephalosporins had the longest lasting supply chain issues. Additionally, 33 agents experienced supply chain issues for at least half the study period and seven experienced supply chain issues for the entire study period. Among the penicillin class, Suda said 90% of all agents experienced a supply chain issue at least once.
“These supply chain issues do not necessarily impact drug supply or lead to significant shortages,” Suda said. “It’s also unknown the extent to which these supply chain issue reports result in changes in medication use, [or] impact resistance or outcomes.”
According to Suda, there is seasonality to many antibacterials’ use and purchase — the data show a 30% increase during the winter months due to respiratory season — but a matching increase in supply chain issues during the winter months was not seen in the new study.
Suda said this suggests that some supply chain issues “are not actually driven by drug demand and are driven by some other factor.”
“We need to take action to improve the resiliency of the drug supply chain to ensure access to these essential medicines,” she said. “In addition, these drug supply chain issues cause significant strain on the health care system, as well as provide challenges to prescribing and use of first-line agents, which is a primary principle of antimicrobial stewardship.”
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Suda KJ, et al. Trends and duration of antibacterial drug supply chain issues in the U.S., January 2017-June 2022. Presented at: Society for Healthcare Epidemiology of America Spring Conference; April 11-15, 2023; Seattle, Washington.
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