When T.J. Grimm and his team at University Hospitals Cleveland Medical Center put in their nightly orders to fill customers’ medications, they‘re never really sure that the orders will actually get filled. It’s a problem facing health care systems across the country: Pharmacy managers have been left scrambling to find supplies as the country deals with a near-record number of shortages affecting millions of people.
“We do this over and over again, and we run through these shortages,” said Grimm, director of Retail and Ambulatory Services at the medical center. “We have to ask ourselves a question as a country, as a nation, how serious are we about drug shortages and drug supplies?”
The United States leads the world in drug discovery and spends twice as much on prescription drugs as other comparatively wealthy nations, on average. Yet basic lifesaving drugs, including older generic sterile injectables that are considered a staple in hospitals, like painkillers, anti-infectives and cancer treatments, are often in short supply.
It’s a problem that puts patients in jeopardy.
Shortages hurt patients
Dr. Stephen Schleicher, chief medical officer at Tennessee Oncology, testified before US lawmakers Tuesday with a story about a colleague’s 61-year-old patient who had stage IV lung cancer. To extend her life and its quality as much as possible, doctors needed to treat her with carboplatin, a generic drug common to many cancer treatments that has been in shortage.
“Unfortunately, after needing to stop carboplatin because we ran out of supply, her condition deteriorated rapidly, and she died soon after,” Schleicher told the US House Ways and Means Committee during a hearing on drug shortages. “Whether she could have lived an additional several months or longer to spend cherished time with family, we – and, most important, the family – will never know.”
Schleicher said his practice is large, with significant purchasing power, and if it struggled with these “severe” shortages, the problem is even more dire at small and rural practices.
Not only can patients not access their medications, doctors must find alternatives that may not work as well or could be much more expensive – if there are even alternatives available.
Although last year’s extreme shortages of carboplatin and another generic chemotherapy drug, cisplatin, have improved at his health system, he said, both are still listed in shortage in the US Food and Drug Administration database. There are now problems with another generic cancer drug, methotrexate, he said, and the FDA lists it in shortage. More drugs may become problems soon, but it is “difficult to predict.”
“I implore Congress to act to stop these drug shortages,” Schleicher said.
Although drug shortages are nothing new, 2023 saw some of the worst in nearly a decade, according to data from the American Society of Health-System Pharmacists, an association of pharmacy professionals in the US. When the group surveyed its members over the summer, nearly all said they were short the drugs they needed to treat their patients.
New drug shortages increased nearly 30% from 2021 to 2022, the association found. There are now more than 250 active medication shortages, experts testified at Tuesday’s hearing.
The average shortage affects at least half a million patients, many of them older adults, according to the Health and Human Services Office of the Assistant Secretary for Planning and Evaluation, which shared its analysis with Congress in May. The supply of drugs to treat children with cancer has also been fragile for years. They have a 90% higher likelihood of a shortage event than the average drug product, according to one analysis.
Shortages are expensive, too. The HHS office found that there is a 16.6% increase in the price of drugs in shortage. In some cases, the price of the drug that doctors must use as a substitute would be at least three times higher.
Shortages can cost health systems billions, and they’ve become so common that major systems keep full-time staffers who focus exclusively on shortages.
Why shortages happen
Shortages can happen because of high demand, as with recent shortages of weight loss drugs, but that’s not usually the main problem. The FDA also blames manufacturing and quality problems, supply chain gaps and discontinuations.
When there is even a hint of a shortage, large health systems also often preemptively place large orders, further straining the system, said Dr. Emily Tucker, a drug shortage expert and an assistant professor of industrial engineering at Clemson University.
“I don’t blame anybody. The important question is, how do we get this all moving in the right direction?” she said. “When I talk to every stakeholder – whether that’s the wholesalers, manufacturers, the government – everybody wants this problem to end.”
Transparency is lacking
Dr. Julie Gralow, chief medical officer and executive vice president at the American Society of Clinical Oncology, told the House committee Tuesday that shortages put providers in a terrible place.
“The drug shortage crisis is forcing providers to make impossible choices,” she said.
Gralow said it’s also stymied new drug development, since scientists need these older medications to compare with new drugs in clinical trials.
Transparency was among her recommendations. Currently, health systems can buy drugs only based on price, and manufacturers don’t have to disclose where they get the ingredients. The cisplatin shortage is one example of why that was a problem.
The shortage of that generic chemo drug came about because one plant in India that made the active ingredient got shut down after a surprise FDA inspection found “major quality problems.”
“We did not know,” Gralow said. “There was no transparency that company supplied the majority of active pharmaceutical ingredients for all of the manufacturers across the board. Knowing that up front, we could have reacted much, much sooner.”
Dr. Stephen Schondelmeyer, director of the University of Minnesota’s College of Pharmacy PRIME Institute, which focuses on economic and management issues, told the committee that as with defense contractors in the US, New Zealand requires manufacturers to disclose their suppliers, and that information is easily accessible in a database.
“We need a similar database in the US,” he said.
A security risk
Schondelmeyer and other experts also told the lawmakers that US reliance on foreign manufacturers is a risk.
A significant majority of the ingredients in the drugs people take in the US are produced overseas, mostly in China and India. China also makes a large portion of the world’s antibiotics, Schondelmeyer said.
“So if they went out of the market or if there was a nuclear power plant in the middle of the three or four companies that make those antibiotics and we had a Chernobyl incident, we wouldn’t have antibiotics,” he said.
Other countries could fill the gaps, he said, but they couldn’t do it immediately.
“We’re talking years down the line to develop the capacity to replace that,” Schondelmeyer said.
Little profit to be had
One reason manufacturing gets outsourced to India and to China is because makers of generic drugs operate on razor-thin margins.
Generics are 90% of the prescriptions dispensed in the US, according to the FDA, and make up the majority of what’s on the shortage list.
With little profit to be had, many drug companies aren’t always interested in making them because it’s harder to recoup the costs. Some manufacturers of generics have gone out of business or shifted production to higher-value drugs.
Gralow told the committee that the country will have to pay more for generics.
“These sterile injectables that are generic, this bottle of water costs more than some of them,” she said. But a higher price would result in better-quality manufacturing and resilience across the system.
The future
The average drug shortage lasts about a year and a half, according to government data. More than half of the treatment shortages have persisted for more than two years, according to an analysis by health consulting firm IQVIA.
A number of more common drugs that hospitals use have also been hard to find for the past two or three years, said Erin Fox, associate chief pharmacy officer at University of Utah Health. These include essentials like lidocaine injections, local anesthetic needed for surgery and even for simpler procedures like stitches.
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“It just doesn’t seem like there’s any light at the end of that tunnel,” Fox said. “Hopefully, by the middle of next year, we’ll start seeing some relief, but it’s frustrating issue for sure.”
The one hopeful note, Fox said, is that since the Covid-19 pandemic, there is more general awareness of the problem. Beyond national media coverage, there have been a handful of congressional hearings on the issue. The White House set up a special task force, and the Biden administration announced that it will invest in key starting materials that are the backbone of drug manufacturing.
“In over 20 years of working on shortages, this is the most interest I’ve seen,” Fox said. “I’m incredibly encouraged.”
Fox believes the problem is so complex, though, that it will take all players pushing on multiple fronts, rather than fixing just one element.
“This issue is very complicated,” she said. “But I am very encouraged that we could see some forward momentum.”