Feb. 18, 2011 -- Hospitals and outpatient centers across the country are scrambling to keep supplies of many essential drugs on hand, as a shortage of some prescription drugs continues to hamper medical practice.
Last year, the Drug Information Service at the University of Utah, which tracks drug supply issues, reported shortages of 211 prescription drugs -- more than twice as many as had run short five years previously. So far, 2011 is shaping up to be even worse, with 38 new drug shortages as of mid-February, compared with just 18 for the same time period in 2010.
The types of drugs that are frequently in short supply include anesthesia and pain medications, antibiotics, and cancer chemotherapy drugs. Most of the drugs running low fall into the category of “sterile injectables” -- the kind of medications typically administered only by doctors or nurses. But in some cases, patients have had trouble getting prescriptions filled at the local pharmacy.
Chemotherapy Drug Shortage
Oncologists in particular say that the shortage of chemotherapy medications is like nothing they’ve ever seen in the past. “It’s the worst shortage we’ve experienced in three decades,” pediatric oncologist Michael Link, MD, from the Stanford University School of Medicine told the National Cancer Institute’s NCI Cancer Bulletin in January. Link is president-elect of the American Society of Clinical Oncology.
“Every hospital has been affected by this shortage,” says Gary Little, MD, medical director of the George Washington University Hospital in Washington, D.C. “It’s an everyday job making sure that we have the drugs we need. It hasn’t hit us yet to the point where we haven’t been able to get a drug at all, but I know of institutions where it has. And we were briefly out of a chemotherapy agent called cytarabine, which is used in treating leukemia and lymphoma. We had stockpiled some, but at a certain point you can’t get anymore and we ran out for a couple of days and had to use alternative chemotherapeutic agents.”
That didn’t cause any serious problems, but at some hospitals, having to switch drugs due to a shortage has led to serious side effects and even deaths. At least six people have died as a result of the prescription drug shortage, according to Michael R. Cohen, ScD, RPh, president of The Institute for Safe Medication Practices (ISMP), which published a survey of 1,800 health care professionals last fall in which one in four respondents reported adverse events as a result of the shortage.
“For example, shortages of morphine have led hospitals to use an alternative pain relief medication, hydromorphone, for which the dosing is very different. At two institutions, there were errors that resulted in patient deaths,” Cohen says. Another patient died of a pseudomonas infection when his hospital couldn’t obtain amikacin, the only antibiotic his infection was sensitive to. “And there may be more than six deaths; these are just the ones we know of from our survey,” Cohen says.
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.
“I am very hopeful that this legislation will move forward and result in some positive actions on shortages,” says Erin Fox, PharmD, manager of the Drug Information Service at the University of Utah.
But in the meantime, doctors, pharmacists, and hospitals are still struggling to meet their patients’ needs. “This is a big problem. It didn’t evolve overnight and we’re not going to fix it overnight,” Benjamin says.