BOSTON (AP) -- Chronic shortages of prescription drugs are compromising the quality and safety of patient care and driving up health care costs by forcing doctors and hospitals to purchase scarce medications at exorbitant markups, medical experts told a Massachusetts legislative panel Monday.
"The amount of time and effort from our oncology staff, our doctors and our nurses and our pharmacies on a daily basis in managing this problem is huge," said Dr. David Frank, of the Dana-Farber Cancer Institute in Boston. "It is directly taking time away from our primary mission, which is taking care of cancer patients."
Frank and several other experts testified during an oversight hearing called by the Legislature's Public Health Committee to examine the impact of drug shortages in Massachusetts.
Reported drug shortages nationally have soared in recent years with many of the problems blamed on production deficiencies at U.S. pharmaceutical plants. The University of Utah Drug Information Service, which tracks national drug shortages, said there were 267 newly reported drug shortages in the U.S. in 2011, up from 211 the previous year. By contrast, only 58 drug shortages were reported in 2004.
At least 15 deaths nationally have been blamed on the shortages in the last two years.
Frank told the panel that the shortages were having a "profound effect" on patients at his and other hospitals. As an example, he cited Doxil, a drug for ovarian cancer that went into short supply last year and resulted in unequal care for patients.
"The situation at Dana-Farber today is we have women with ovarian cancer sitting next to each other in the infusion area, both of whom could benefit from Doxil, one of whom is receiving the Doxil and the other who is not," he said.
Al Patterson, director of pharmacy at Children's Hospital in Boston, said pediatric medicine is disproportionately affected by drug shortages because it represents only a small percentage of the nation's health care market.
"The shortage has really made care for patients significantly more dangerous ... particularly on the pediatric side," he said.
Patterson said eight of 10 drugs used to treat childhood leukemia are in short supply. He also said the shortage of a drug therapy used to manage a rare heart condition has forced more children to undergo riskier surgery.
Sterile injectables, which include many cancer drugs and anesthetics, account for about three quarters of drugs in short supply. They are usually made by a single supplier and can be prone to contamination or other problems related to production, experts said.
The shortages often force hospital pharmacies to purchase medications from the so-called gray market, a shadowy though legal network of secondary distributors that are able to stockpile medications and then sell them at exorbitantly high prices when they become scarce, the panel was told.
The markups are often many times the normal list price for the drugs. Patterson said Children's Hospital has paid a $500,000 differential in recent months to maintain the supply of a drug that is used to sedate babies on respirators.
While legislators on the panel expressed outrage over the shortages and price gouging, they appeared to have few options at the state level for alleviating the problem. Witnesses instead called on Congress to pass laws requiring timelier reporting by drug makers of production delays and to empower the federal Food and Drug Administration to take immediate steps to alleviate shortages — in some cases by shifting production to other plants in the U.S. and overseas, if necessary.
"We can't require any company to make a drug," noted Dr. Sandra Kweder, deputy director for the FDA's Center for Drug Evaluation and Research.
While manufacturers are required by law to notify the agency six months in advance of potential drug shortages, there are no penalties for failure to do so and the FDA largely relies on voluntary compliance, she told the committee.
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