U.S. Facing Largest Hospital Drug Shortage in Decades

Dec. 22, 2010— -- Many hospital patients are being turned away for potentially life-saving injection treatments in what may be the largest U.S. hospital drug shortage in over two decades.

Most drugs in short supply are known as injectables and include sedation medication such as propofol, the popular blood thinner heparin, and hard-hitting chemotherapy drugs like doxorubicin.

"I've been in practice more than 30 years and this is the first time I've encountered shortages that may affect patient care," said Dr. Michael Link, president-elect of the American Society of Clinical Oncology.

Limited manufacturing, lagging production time, and lack of profits from these drugs are contributing to the shortage, according to an August 2010 editorial published in the New England Journal of Medicine. The production cost outweighs the profits for some companies. Since many firms would rather produce cheaper generic drugs, manufacturers are shunning some costly brands.

Doctors at local hospitals are frustrated and many times they're not even informed of the shortage, according to survey results released in September by the Institute for Safe Medication Practices. Of those surveyed, 85 percent said they were given little to no information on how long the shortages would last.

Responses poured in to ABC News' Medical Unit from more than a dozen doctors nationwide, many of whom confirmed they too were experiencing shortages and had to find alternative treatments for some of their patients.

"It has caused us to spend a great deal of physician and pharmacy time developing priority trees to allocate available drug if necessary as well as to scour suppliers for drug shipments," Dr. John Goldberg, pediatric oncologist at the University of Miami School of Medicine wrote in an email response to ABC News' Medical Unit.

And since these medications are mainly housed in hospitals, most patients won't know it might not be available until they really need it.

Mark McKee's doctors have spent 15 years managing his rare abdominal tumor. But in the last year and a half, his tumor grew significantly, so Dr. Craig Howe, McKee's doctor at United Hospital in St. Paul, Minn., upped his treatment to the more aggressive chemotherapy regimen that included doxorubicin.

The regimen seemed to be working, said McKee, 39, of Minneapolis. But last month, the afternoon before he was scheduled for his routine chemotherapy, McKee was told the hospital did not have enough doxorubicin that he needed for his infusion.

Something may be better than nothing, McKee said Howe told him. McKee received a quarter less than the full dose needed to regulate his tumor.

Manufacturing for doxorubicin dropped from three companies to two earlier this year after an FDA warning letter prompted TEVA Pharmaceuticals to stop manufacturing the drug. Meanwhile, the demand for the drug has only increased, according to the American Society of Health-System Pharmacists, which maintains a list of current drug shortages.

In a written statement to ABC News, Bedford Laboratories, one of only two doxorubicin manufacturers, said they are "currently facing manufacturing capacity constraints that are resulting in back orders of some products, including doxorubicin."

According to Howe, many doctors are never told exactly when some of these medications will be available again.

"Some of the shortages have gone on for a long period of time and under those circumstances, without a definite answer, we don't know how long that's going to exist and what kind of modifications we are going to make," said Howe.

Some medications in short supply offer an equivalent substitute, Link said. But in some cases insurance companies do not reimburse patients for the substituted therapies.

"Indeed it's a double whammy and sometimes patients who are unable to pay, therefore, cannot get a drug that would be a good substitute," said Link. "So this is compounding the problem for our patients for sure."

The U.S. Food and Drug Administration limits the number of doxorubicin therapy to eight rounds because of its potential harm. While the FDA can oversee imports of drugs that are in short supply, the agency cannot regulate how much a manufacturing company can make. In fact, manufacturers are not required to report shortages to the FDA.

The amount of drugs made available within a hospital is an agreement between the hospital and specific manufacturers.

"We [the FDA] are working with the manufacturers to address any quality issues, any issues that have caused these shortages as well as encouraging the other manufacturers of these products to continue making them in good supply," said Valerie Jensen, associate director of the FDA's Center for the Drug Evaluation and Research drug shortage monitoring program.

"What we hope is that firms come to us when there is a problem so we can help address it and so that we can help other manufacturers to increase production," she said.

Some doctors and hospitals are turning to a so-called grey market to get the supply they need. The equivalent of a black market, the drugs are in full supply but sell for a much higher price – a trade that may lead to the haves getting treated, and the have-nots left waiting.

"If they're buying product and selling it at a higher price, we understand that some of that is within the law," said Jensen. There's currently no federal oversight on the grey market, she said.

McKee, who has now completed four rounds of the drug, said his only options are to either stop therapy and wait for a full dose, or continue taking lower doses and monitor the progress.

"If the drug is going to constantly be a source of conflict with respect to it being available, that is very disappointing," said McKee. "We pay quite a lot in health insurance for it to be available."

His doctor Howe agreed, saying he's not sure whether taking lower doses will be an adequate treatment for McKee's tumor. But then again, Howe said he's not sure about waiting either.

"If I had to [lower the dose] consistently over the course of four to six months, then I think we really are compromising care," said Howe.