Scarcity of Drugs Alarms Doctors
From St. Louis Post-Dispatch (MO) (October 27, 2011)
Oct. 27--A cancer diagnosis can come as a shock, but what happens next may be even more surprising. The country faces a critical shortage of many chemotherapy drugs, forcing some patients to delay their treatments or switch medications.
And it's not just cancer drugs. There are more than 200 drugs on the U.S. Food and Drug Administration's shortage list -- including antibiotics, nausea medication and drugs to treat high blood pressure. The number of drugs on the list has tripled in the last five years.
Most of the drugs on the shortage list are generic intravenous or injectable drugs given to patients in hospitals.
Virtually every hospital in the country is scrambling to come up with enough of the drugs to treat their patients, said Terry Seaton, professor of pharmacy practice at the St. Louis College of Pharmacy.
"A real runaround is occurring with hospitals and other health care providers trying to locate drugs, spending an average of a couple hours a day trying to find sources of drugs they really need," he said.
About half of the country's hospitals report having to resort to buying drugs off the "gray market" -- third-party suppliers known for steep price markups, according to a recent survey from the Institute for Safe Medication Practices.
The average patient might not know about the behind-the-scenes finagling taking place, but the potential for harm is clear. About 12 percent of the 549 hospitals that responded to the institute's survey reported adverse events from the gray market drugs including dosage errors, improper storage and counterfeit drugs.
In March, Alabama health officials reported nine deaths and 10 other patients sickened in six hospitals when a batch of liquid nutrition for feeding tubes became contaminated in the compounding process after the sterilized version wasn't available.
Injectable drugs are more susceptible to shortages and recalls because the manufacturing and storage process is more complex, along with the greater potential for contamination. They're also more expensive to make than oral medications, with a lower profit margin for companies.
"There's no real incentive for manufacturers to make them," Seaton said.
The shortage of cancer drugs extends to those used in clinical research trials. Often, scientists perform trials on existing drugs to try to find applications for other diseases or more effective dosages for the same types of cancers.
Deborah Katz-Downie, a plant biologist from Urbana, Ill., was diagnosed with a form of leukemia in June and wanted to enroll in a clinical trial at Barnes-Jewish Hospital for the drug Daunorubicin. The drug is on the shortage list because of manufacturing delays.
"I was pretty shocked," Katz-Downie, 51, said. "I had to have the Daunorubicin to participate and I really felt that was the best option."
Pharmacists were able to track down the drug for Katz-Downie, who is now awaiting a stem cell transplant.
"Drugs have become a commodity," she said. "I think it's really important that people are aware that this is happening."
Officials at the FDA say there's only so much they can do to prevent drug shortages, including finding and regulating drugs from overseas. They also try to work with companies that voluntarily report manufacturing problems and encourage other drugmakers to pick up the slack. But they can't force companies to make the drugs, and they can't regulate the price of drugs.
Companies are not required to report most manufacturing delays or stoppages to the FDA, although proposed federal legislation would open those lines of communication.
Ali McBride, a clinical pharmacist for oncology at Barnes-Jewish, has testified in Washington about the problem. He compares the choices doctors and patients make when switching, reducing or delaying drug treatments to having to use a spoon when you would rather use a fork.
But for some serious illnesses and cancers, only one drug is known to be safe and effective.
"That's really what's scary," McBride said. "What's going to happen when it dries up?"
(c)2011 the St. Louis Post-Dispatch
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Posted: October 2011