Antibiotics are 42 percent more likely to be in shortage compared to all other drugs, according to the latest analysis from the U.S. Pharmacopeia’s (USP) Medicine Supply Vulnerability Insights Series.
These findings are sourced from the USP’s own global Medicine Supply Map, which is derived from 40 external datasets and proprietary information about the use of USP quality standards. This repository spans 92 percent of generic medicines approved in the U.S.
Antibiotics are one type of antimicrobial, and one used as a medicine to prevent and treat bacterial infections. Antimicrobials also include antiviral, antifungal and antiparasitic drugs. Antimicrobial resistance is one of the top 10 global health threats facing humanity by the World Health Organization. This occurs when bacteria, viruses, fungi and parasites change over time and develop resistance to commonly used antimicrobial compounds. In other words, they no longer respond to medicines.
The emergence of antibiotic resistance is a complex problem that is driven by many interconnected factors, of which the use and misuse of antimicrobial agents (antibiotics, antiseptics, disinfectants, and preservatives) amongst other factors.
The acquired resistance means there are fewer medication to select to help patients and it follows that shortages of antimicrobials threaten the continued emergence and further exacerbation of antimicrobial resistance. In 2019, 1.27 million deaths worldwide were directly attributable to antimicrobial resistance and, without global action, resistance could lead to 10 million deaths a year by 2050.
According to Vimala Raghavendran (from the USP’s Pharmaceutical Supply Chain Center), the recent research is telling and builds on established concerns about the future of medicine.
However, there are benefits that can aid the circumspect use of antimicrobials as Raghavendran notes: “Insights from the Medicine Supply Map can help to guide policymakers who are facing difficult decisions to ensure access to essential, quality medications – including antimicrobials.”
This is important, Raghavendran explains, because: “Understanding where risks exist and what drives risk are critical first steps to ensuring a resilient supply chain.”
The Medicine Supply Map can be used to assess five indicators that contribute to a risk of shortage: geographic concentration, manufacturing complexity, market competition, price, and quality.
Of all various types of antibacterial drugs, cephalosporins are at elevated risk for shortage—a factor mainly driven by price—with 40 percent of active pharmaceutical ingredients used for cephalosporins currently in shortage. Cephalosporins are listed among the WHO’s critically important antimicrobials for human medicine.
There is also a geographic concentration of the registration sites for antimicrobial manufacturing facilities in India and China with the two counties combined producing 58 percent of antibacterial active pharmaceutical ingredients. This indicates the area of greatest regulatory scrutiny.
Medication shortages carry the risk of more substandard and falsified versions entering the supply chain. Poor-quality medicines also drive antimicrobial resistance, especially where microorganisms in the body are exposed to sub-therapeutic doses. This situation enables pathogens to evolve and to develop resistance.
