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Drug makers' issues causing massive shortages

November 23, 2012 12:00:00 AM PST
A national drug shortage is making it difficult for many patients to get the medications they rely on.

Dr. Sandra Kweder heads the Federal Drug Administration'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, shortages have just about quadruple from 74 in 2005 to 267 in 2011.

"We are in the midst of what we see as a crisis," said Kweder.

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 has hit every drug class, but the majority are generic sterile injectables, which are 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 within the last 12-18 months," said Dr. Gene Rhea, Duke University hospital pharmacist. He 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," he 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," said Rhea.

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," he said.

Production by a Johnson & Johnson contractor ceased late last year and the shortage continues to this day. A spokeswoman says 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," said Kweder.

Rhea agrees.

"It's not going away. It's really kind of reached a steady state."

A state many can't believe America has reached.

"Who would have ever thought we'd be in this position?" said Kweeder.

Reports attribute the drug shortage to about 15 deaths in the U.S., but experts say it's hard to figure out how many have people have been impacted. One guess is in the hundreds of thousands, if not millions.


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