Minnesota hospitals and clinics are reporting episodic shortages of chemotherapy drugs, a symptom of wider disruptions in the nation's pharmaceutical supply chain.
While drug shortages happen from time to time, the chemo shortfall is worrisome because it could disrupt strict treatment regimens that give cancer patients the best odds of survival.
"It's hard to just flip [cancer patients] onto something else," said Lisa Gersema, pharmacy director at United Hospital in St. Paul. "You may not be able to do that with them, whereas we do have other ways of providing sedation and things like that" to patients.
Twin Cities cancer centers have reported varying shortages, depending on the wholesalers involved and the amount of medication they had stockpiled. United and other hospitals in the Allina health system are trading with each other when supplies run short. So are Fairview hospitals.
Minnesota Oncology, the state's largest outpatient cancer center, has provided chemotherapy drugs to other clinics and hospitals in need. It likewise relied on them when it ran out of leucovorin, a drug taken in combination with certain types of chemotherapy to improve their effectiveness.
Supplies were so limited at one point that doctors had to adjust the chemotherapy regimens for a few patients who had already started them, said Jan Merriman, clinical director of Minnesota Oncology's pharmacy services. Patients and doctors were frustrated because they deviated from chemotherapy protocols that have been proven through research to have good results.
"You don't usually stray from that," Merriman said. "Anytime you do something different, you don't know" what the impact will be.
United hasn't had to delay chemotherapy for patients or switch them to other drugs. The hospital provides a relatively small amount of chemotherapy, because most patients receive it at clinics on an outpatient basis, Gersema said.
Drug shortages are typical at this time of year due to the manufacturing cycles of most pharmaceutical companies, said Greg Kyllo of Fairview's pharmacy services. However, a series of events has made this an extreme year for generic chemotherapy drugs.
Teva Pharmaceuticals, one of the nation's largest generic-drug manufacturers, shut down a California plant that makes injectable drugs after federal regulators expressed concerns about the risk of bacterial contamination.
The shutdown meant Teva was no longer producing injectable drugs, including chemotherapy agents doxorubicin and etoposide. Other U.S. manufacturers were then swamped with orders and unable to keep pace.
Wholesalers such as AmerisourceBergen have implemented "fair use" policies to evenly distribute chemo drugs and prevent hoarding while the medications remain in short supply.
The chemo shortage is part of a growing problem in the nation's drug supply chain. The U.S. Food and Drug Administration (FDA) currently lists 50 drugs in short supply, including doxorubicin and etoposide. That's twice the number of drugs listed five years ago.
The FDA list includes only medications deemed medically necessary, which means they are the first or only options for certain diseases. Another list kept by the American Society of Health System Pharmacists lists 144 drugs, including the chemotherapy agent vincristine.
Merriman said Minnesota Oncology has received enough of that drug from another hospital to remain "good for a few more weeks." She suspects that most hospitals and clinics now have thin supplies and won't be able to support one another as much.
Pharmacy groups, manufacturers and FDA leaders have met in the past week to find ways to increase production of chemotherapy drugs.
Jeremy Olson • 612-673-7744