Last week, the American Society of Health-System Pharmacists (ASHP) released the results of a member survey to assess the severity of these shortages. Drug shortages are nothing new, but results from more than 1,000 pharmacists suggest that the current crisis is particularly concerning. More than 99% of respondents, nearly all of them pharmacists who work for hospitals or health systems, reported that they were facing drug shortages. In some cases, shortages are annoying but manageable.
“We're talking about things that we can easily substitute for something else. Or we can provide a different dosage or a different route of administration,” says Michael Ganio, senior director ofPharmacy Practice and Quality at ASHP. But in this latest survey, nearly a third of respondents said that current shortages had forced their hospital to ration, delay, or cancel treatments or procedures. “That's significant,” he adds.
The current cancer drug crisis stems from an incident last fall. Many of the pharmaceuticals sold in the US are manufactured overseas. In November, the Food and Drug Administration toured one of those plants in India, a facility owned by Intas Pharmaceuticals. Inspectors observed numerous violations related to quality control and data integrity. As a result, the plant halted production. It was the first domino to fall in a chain that would lead to a nationwide shortage of cancer therapy drugs..
Before the shutdown, Intas produced about 50% of US’s supply of cisplatin, a common cancer drug used to treat testicular, ovarian, bladder, head and neck, lung, and cervical cancers. When the plant halted production, other manufacturers weren’t able to ramp up enough to avoid a shortfall. Manufacturers don’t have that kind of surge capacity. If a company consistently produces 10% of the market share, “what is their incentive to have capacity to produce 30 or 40%?” says Mariana Socal, a health policy researcher at the Johns Hopkins Bloomberg School of Public Health.
As cisplatin became scarce, oncologists switched to carboplatin, another common cancer therapy, which Intas also produced. With Intas no longer producing carboplatin and increasing demand, that medicine is now also in short supply. It was “like a ripple effect in the supply chain,” Socal says.
A survey of US cancer centers in May revealed that a whopping 93% were experiencing shortages of carboplatin.
The impact on patients has been profound. Some have gotten smaller doses. Others have had to skip or delay treatments. Some medical organizations are advising doctors to reserve cisplatin and carboplatin for patients who have a chance at a cure.
“This shortage will lead to people dying,” Ravi Rao, an oncologist at a cancer center in Fresno, California, told the New York Times. “There’s just no way around it. You cannot remove these lifesaving drugs and not have bad outcomes.”