Growing Shortage of Some Rx Drugs
WebMD Examines the Impact of a Shortage of Chemotherapy and Other Drugs in Hospitals and Pharmacies
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In addition to deaths, the drug shortage has led to other complications. The ISMP report notes that some patients receiving rationed amounts of certain anesthesia drugs have had awareness of the operation during surgical procedures. Other adverse events due to dosing errors and treatment delays have been reported.
“Treatments have been delayed, clinical trials have been interrupted, surgeries have had to be rescheduled, and transplants postponed,” says Ali McBride, PharmD, a clinical pharmacy specialist at the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis. “It’s a horrible position to be in.”
Many cancer centers have had to prioritize who gets the available supplies of drugs like doxorubicin, carmustine, vincristine, bleomycin, and leucovorin -- all commonly used chemotherapy drugs that have been in short supply.
“When it became clear that we had a limited supply of bleomycin, and that our supply would run out if we didn’t manage it appropriately, we had to triage what patient groups and diagnoses would be the most important to make sure they had that drug,” says Jeffrey Smerage, MD, PhD, a breast oncologist at the University of Michigan’s Comprehensive Cancer Center. “What diseases is this considered a curative therapy for? Those patients are high priority, because at some point you lose that option.”
And as of the second week in February, the cancer center is completely out of carmustine, a chemotherapy drug used to treat several types of cancer. “Yes, there are other drugs that can be used, but I can’t say how good those other options are,” Smerage says.
Reasons for Drug Shortage
Why are so many drugs in such short supply? Most of the drugs that are scarce are generic medications, with only a handful of manufacturers supplying them -- sometimes only one or two. When a problem affects one company’s supply chain, such as contamination or limited raw materials, they may have to shut down production for a period of time, and other manufacturers may not be able to pick up the slack.
Part of the problem, says Bona Benjamin, director of medication use quality improvement at the American Society of Health System Pharmacists, is that drugmakers are not required by law to alert the FDA when they expect a shortage. “If the FDA knows about a shortage ahead of time, they have more latitude to get plans in place and work with other firms to start ramping up production,” she says. “We’ve heard that FDA has been able to avert about a dozen shortages after getting early word of supply problem. But that’s an exception to the rule.”
In early February, Sen. Amy Klobuchar, D-Minn. and Sen. Bob Casey, D-Pa., introduced the Preserving Access to Life-Saving Medications Act, which will require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage.