Drug shortages in the United States reached a five-year high in 2022, with 295 active drug shortages at the end of the year. According to a new federal report, these shortages have had "devastating consequences" for patients and healthcare providers and could pose a risk to national security since most pharmaceutical ingredients are produced overseas.
Over the last few years, drug shortages have become more common in the United States. According to a new report from the Senate Committee on Homeland Security and Governmental Affairs, drug shortages increased by almost 30% between 2021 and 2022, reaching a five-year high with 295 active shortages at the end of last year.
On average, the report found that drug shortages typically last around a year and half, and more than 15 "critical" drugs have been in shortage for over a decade.
"Shortages continue to have devastating consequences for patients and health care providers, including medication errors and treatment delays, and in some cases, have led to doctors having to ration lifesaving treatments," the report said.
According to Roll Call, these drug shortages, which include common antibiotics, anesthetics, and cancer treatments, have put both physicians and pharmacists in difficult situations. Many have had to determine who will get a necessary treatment or improvise different treatment regimens based on what's available.
At a Senate committee meeting, Andrew Shuman, a cancer surgeon who holds leadership positions at the University of Michigan Medical School, said cancer drug shortages have come to "represent a tragedy that's happening in slow motion."
Just recently, Shuman said a cancer drug called etoposide was in short supply and he had to determine which patients should receive the limited number of doses his hospital had available. "As a doctor who has devoted my life to fighting cancer, it's hard to express how horrible that is," he said.
Although the hospital pharmacist was able to stretch the available supply, "our pharmacists should not be desperately trying to squeeze out a few last drops when a life may be on the line," Shuman said. "All patients affected by drug shortages deserve better."
According to Vimala Raghavendran, VP of informatics product develop at U.S. Pharmacopeia, drugs with a low price, complex manufacturing process, or quality problems with a history of recalls have a higher risk of facing shortages.
In addition, almost 90% of facilities that produce the active pharmaceutical ingredients for generic drugs are overseas, with the majority of them in India and China. This concentration of facilities in certain regions has also created "an extra layer of vulnerability to problems such as natural disasters or political unrest," the New York Times writes.
In the report, an overreliance on foreign countries for drug ingredients, along with "limited domestic manufacturing capabilities," were cited as potential causes for drug shortages in the United States.
"Taken together, these underlying causes not only present serious concerns about providing adequate care to patients, they also represent serious national security threats," said Sen. Gary Peters (D-Mich.), chair of the Senate homeland security committee.
Separately, Erin Fox, an associate chief pharmacy officer of shared services and adjunct professor at the University of Utah, said increased transparency is needed to determine which products the United States relies on come from China, especially since companies are not required to disclose which products they manufacture overseas.
"Without that information, we really are vulnerable," Fox said, also noting that there is a critical lack of data on drugmaker quality.
Going forward, the report recommended the United States invest more heavily in domestic manufacturing of critical generic drugs that frequently see shortages and partner with private companies to increase production capabilities.
"These partnerships should encourage the use of advanced manufacturing technologies for critical drugs prone to shortages and bolster ongoing collaboration between academia and industry to further build opportunities for workforce training programs that bridge the gap from research and development to commercialization,” the report said.
However, Raghavendran noted that while efforts to diversify drug manufacturing locations is important, simply bringing manufacturing to the United States would not necessarily solve the problem. In fact, the recent bankruptcy of U.S. generic drugmaker Akorn Pharmaceuticals has been linked to a worsening shortage of albuterol, a medication used to treat breathing conditions.
Overall, drug shortages in the United States deserve attention and concerted efforts to address them since "[u]nlike other products, people's lives are at stake," Fox said. (Cohen, Roll Call, 3/22; Jewett, New York Times, 3/22; Neukam, The Hill, 3/22)
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