Manufacturing problems, few market incentives for the production of low-profit drugs and government inaction are leaving thousands of patients without essential medicine and creating complications usually seen only in the developing world, if ever.
There are currently 300 drug, vitamin, and trace-element shortages in the U.S., the highest number ever recorded by the University of Utah Drug Information Service, which began tracking national shortages in 2001.
Experts are calling the nutrient shortage a public health crisis and a national emergency. They are “astounded” that the government and manufacturers have let the situation get so bad, Washington, D.C.-based Washingtonian magazine reports. The situation is worst for prematurely born infants, who do not have the nutritional reserves of older children and adults.
“Children are dying,” says Steve Plogsted, a clinical pharmacist who sits on the American Society for Parenteral and Enteral Nutrition’s drug shortage task force. “They’re not getting any calcium or any zinc. Or they’re not getting any phosphorous, and that can lead to heart standstill. I know of a [newborn] who had seven days without phosphorous, and her little heart stopped.”
Michael Cohen, president of the nonprofit Institute for Safe Medication Practices and a 2005 MacArthur Foundation fellow, said he’s never seen anything like this in his 40 years as a pharmacist. “This should never be allowed to happen,” he added.
Since 2010, clinicians have reported at least 15 drug shortage-caused deaths of people dependent on intravenous nutrition. Attempts to substitute unavailable drugs and nutrients have proven dangerous. Patients have woken up in the middle of surgery and infants have been burned and scarred. In 2011, nine patients died and 10 others developed infections when they were given a contaminated substitute.
Some nutrients are not substitutable. “If we run out of phosphorous, there definitely will be deaths,” said a neonatal intensive care unit dietitian in a D.C. hospital. “At this point, we’re not even trying to give enough to get patients into a normal range. We’re giving just enough to prevent them from dying.”
—Posted by Alexander Reed Kelly.
There are no substitutes for vitamins, minerals, and trace elements, though. Zinc is zinc, and without it neonates can suffer from growth and immune-system problems. A copper shortage interferes with zinc metabolism, “which will cause white-blood-cell production to fall to zero, and you have no cellular protection from infection,” Plogsted says. “You need phosphorous to make energy and as an acid-based mechanism in the body. Acidosis can prevent a child from growing, but what shows up soonest in neonates is no energy, which equals no heartbeat. No energy is pretty much the end of the trail.”
The Children’s Hospital Association (CHA) estimates that each year at least 120,000 NICU babies need parenteral nutrition, and another 370,000 other patients receive PN in the hospital, according to the Agency for Healthcare Research and Quality.
The nutrients in shortage aren’t rare. “We’re talking about zinc, phosphorous, calcium—trace elements,” says CHA president Mark Wietecha. “These aren’t the latest genetically modified drugs or something coming out of modern high-tech environments. These have been around for decades.”
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