(11/05/12) - Drug shortages are affecting everyone from newborns to cancer
patients. It is a situation some experts are calling a crisis. The number of
prescription drug shortages has more than tripled in the last five years.
The reasons are many and the impact is immeasurable.
"Metal shards. Glass shards. We have seen fungus growing in IV bags. I think the public has a right to be dismayed and outraged," says Dr. Sandra Kweder.
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, as well as low profit margins on certain drugs have also added to the problem. According to the American Society of Healthcare System Pharmacists, shortages have nearly quadrupled - from 74 in 2005 - to 267 in 2011.
"We are in the midst of what we see as a crisis," Kweder says.
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 is hitting every drug class. But the majority are generic sterile injectable's- drugs used in everything from giving sick babies the nutrition they need, to surgical anesthesia, to cancer treatments. A government report finds that, while the injectable's 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," says Duke Hospital pharmacist Gene Rhea.
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. I probably spend more than 50 percent of my time managing drug shortages."
A recent survey found shortages cost American hospitals $216 million a year, primarily because they are forced to buy more expensive alternatives.
"It's kind of the new norm," Rhea says.
In some cases, including ovarian cancer patients on Doxil, he says, it's led to rationing. "Patients were put on waiting lists and it was a very difficult situation."
Production by a Johnson and Johnson contractor ceased late last year. 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, says Kweder. "It didn't get this way overnight, and we're not going to fix it overnight."
"It's not going away. It's really kind of reached a steady state," Rhea said.
It is hard to be certain how many lives have been impacted by drug shortages. Official data link them to 15 deaths in this country.
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