Drug shortage dilemma
Updated On: Dec 03 2012 06:20:00 AM EST
In the 80s, the war on drugs focused on ridding the U.S. of illegal narcotics like crack, cocaine, and heroin. In 2012 we're in the midst of a different kind of drug war, fighting to get the ones many people need. Now, experts on the front lines of the ongoing struggle with prescription drug shortages.
Metal shards, glass shards and fungus growing in IV bags.
"I think the public has a right to be dismayed and outraged," said RADM Sandra Kweder, M.D., deputy director of CDRR's FDA’ s office of new drugs.
Kweder heads the FDA’s office of new drugs. She says quality control in manufacturing plants is causing nationwide recalls and massive drug shortages. A lack of raw materials, closures and consolidations among drug-makers and low profit margins on certain drugs have also added to the problem. According to the American Society of Healthcare System-Pharmacists we've seen shortages just about quadruple from 74 in 2005 to 267 in 201.
"We are in the midst of what we see as a crisis," Kweder said.
Pharmacists and the FDA have websites to help healthcare professionals monitor the situation. Almost every day, more drugs show up in short supply. The problem’s hit every drug class, but the majority are generic sterile injectables -- medications used in everything from giving sick babies the nutrition they need to surgical anesthesia to cancer treatments.
A government report finds while the injectables make up only a small percentage of the overall prescription drug market in 2011 they accounted for 74 percent of drug shortages.
"We really saw it spike in the last 12-18 months," explained Gene Rhea, PharmD, manager: procurement, distribution and repackaging of the department of pharmacy at Duke University Hospital.
Rhea says some of his colleagues compare it to working in a third world country.
"On a daily basis, we probably only get in about 60 to 70 percent of the products that we order," Rhea said. "I probably spend more than 50 percent of my time managing drug shortages."
A recent survey found shortages cost U.S. hospitals $216 million a year as they’re forced to buy more expensive alternatives
"It's kind of the new norm," Rhea said.
Dr. Rhea says for many patients, including ovarian cancer patients on Doxil, it’s led to rationing.
"Patients were put on waiting lists and it was a very difficult situation," Rhea said.
Production by a Johnson and Johnson contractor ceased late last year. The shortage continues to this day. A spokeswoman tells us, the company regrets the circumstances and officials "Remain focused on returning a reliable source of medicine as rapidly as possible." But getting Doxil and other crucial drugs back on track will take time.
"It didn't get this way overnight, and we're not going to fix it overnight," Kweder said.
"It's not going away. It's really kind of reached a steady state," Rhea said.
A state many can't believe we've reached in America.
"Who would have ever thought we'd be in this position?" Kweder said.
Reports attribute the drug shortage to only 15 deaths in the U.S including one man who died because the only antibiotic he responded to wasn't available. But Kweder says it's hard to figure out how many have been impacted by the shortages. She guesses the number to be in the hundreds of thousands if not millions.
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