U.S. Pharmacopeia Medicine Supply Map Analysis Shows Increased Shortage Risk for Antibiotics

Latest findings from USP Medicine Supply Vulnerability Insights Series highlight supply chain risks that can contribute to antimicrobial resistance

Rockville, MD, May 24, 2022 – Antibiotics are 42% 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. The findings are sourced from USP’s global Medicine Supply Map, derived from 40 external datasets and proprietary information about the use of USP quality standards, spanning 92% of generic medicines approved in the U.S.

Antibiotics, also known as antibacterials, are a type of antimicrobials, which are medicines used to prevent and treat infections. Antimicrobials also include antiviral, antifungal and antiparasitic drugs. Antimicrobial resistance (AMR)—named as one of the top 10 global health threats facing humanity by the World Health Organization—occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines. Shortages of antimicrobials threaten the emergence and exacerbation of AMR.

"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,” said Vimala Raghavendran, who leads USP’s Pharmaceutical Supply Chain Center. “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 types of antibacterial drugs, cephalosporins are at elevated risk for shortage—mainly driven by price—with 40% of active pharmaceutical ingredients (APIs) used for cephalosporins currently in shortage, according to the analysis. 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 API manufacturing; facilities in India and China have registered 67% of antimicrobial type II API active drug master files (DMFs). Furthermore, India and China combined produce 58% of antibacterial APIs and 83% of antiviral APIs. DMFs are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging and storing of human drug products. DMFs are used as a proxy for manufacturing activity in the Medicine Supply Map, but do not take volume or market share into account.

Medication shortages can lead to substandard and falsified versions entering the supply chain, sometimes reaching the patient. Poor-quality medicines drive AMR primarily through exposing microorganisms in the body to sub-therapeutic doses of medicines. A patient taking a substandard antimicrobial may not receive enough of the medication’s API, thus allowing the pathogen to evolve such that existing strains become stronger and new, more resistant strains can emerge.

According to the U.S. Centers for Disease Control and Prevention, more than 2.8 million antibiotic-resistant infections occur in the United States each year, resulting in more than 35,000 deaths. In 2019, 1.27 million deaths worldwide were directly attributable to antibacterial AMR. Without global action, AMR could lead to 10 million deaths a year by 2050.

“We know that about two thirds of medicine supply chain challenges begin as a quality issue. Shortages of medicines only exacerbate the quality issues that have been there all along,” said Ronald T. Piervincenzi, Ph.D., U.S. Pharmacopeia CEO. “This is particularly dangerous in the case of antimicrobial medications because of the deadly global public health consequences of resistance.”

For more information about the USP Medicine Supply Map visit www.usp.org/supply-chain/medicine-supply-map.