US drug shortage could threaten us health system

A growing shortage of important chemotherapy drugs, anesthetics and antibiotics, which has compromised or delayed care for some US patients and may have led to at least 15 deaths, represents a “pressing public health problem. At the same time, shortages of medications to treat cancer and infectious diseases have strained, disrupted or derailed hundreds of important research trials within the National Institutes of Health, said Dr. Howard K. Koh, assistant secretary of the Department of Health and Human Services. He called the disruptions “very troubling to us as a nation that prides itself on scientific advances.” Koh painted a picture for the House Energy and Commerce Subcommittee on Health in which even the Food and Drug Administration, the federal agency responsible for assuring the safety of the U.S. drug supply, has been caught unaware when particular drugs have become scarce — or impossible to get. “Oftentimes, the FDA does not know until it is too late, and then patients are stuck in this dire situation, and that’s just not acceptable,” Koh told lawmakers. In the last 15 months, at least 15 patients have died either because the proper or preferred drug wasn’t available, or because of complications with substitute medications, according to an Associated Press review of industry reports and interviews with nearly two dozen experts. In the worst of those cases, AP reported, nine Alabama patients on feeding tubes died and 10 others were harmed because the sterile premixed nutritional solution they would normally have received was unavailable and they instead received their nutrition from a hand-mixed batch that became contaminated by bacteria. One possible solution to the problem would be to find a way for manufacturers “to report impending supply disruptions and discontinuation of drug,” Koh said. “The sooner FDA learns of a drug shortage, the more effective it can be in helping to notify providers and minimising the impact on patients.”

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