Drug shortages improve but significant problem persists

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The number of U.S. drugs that have been placed on a list of those in short supply is less than half what it was last year, only about 100 so far in 2012, compared with 221 when it peaked last year. The FDA says that it has prevented the shortage of about 150 drugs this year by working with the industry to find solutions to a potential dearth of a particular med. Still, 100 is a lot, and the fact that so many are hard to come by has forced healthcare providers to make hard choices and change methods in the face of those shortages.

The Cleveland Clinic, The New York Times points out, has hired a pharmacist whose only job is to track down hard-to-find drugs. In another case, an ambulance driver acknowledged that he withheld morphine from one patient in pain because he had only one vial left and another patient might need it more.

The FDA recently said the voluntary shutdown of Ameridose, a company with ownership ties to the New England Compounding Center (NECC), could affect supplies of 6 drugs. NECC is the company whose steroid injections are tied to the meningitis infections of about 460 patients and the deaths of 33. Ameridose closed down after FDA inspectors raised concerns about sterility in its plant.

Much of the national shortage problem can be traced to production disruptions when drugmakers initiate improvements after the FDA has sent them warning letters about problems inspectors found. A House subcommittee report earlier this year criticized the FDA for being too aggressive in that regard. However, another House committee recently chastised FDA Commissioner Margaret Hamburg for not acting aggressively enough against NECC.

Still, there has been some good news from several companies about drugs in short supply. Just last week, Genzyme said that a new plant was now producing all of the supply needed for its thyroid cancer treatment, Thyrogen. And Hospira ($HSP), which has been at the heart of a number of drug shortages as it works through improvements to its manufacturing plants, said it expects to soon have sufficient supplies to re-enter the market with propofol. The anesthetic is one of the drugs hospitals had turned to Ameridose for because it was hard to come by.

Hamburg told the newspaper that these kinds of strides by drugmakers are making a significant difference. While the problem of drug shortages is far from resolved, she said, "we're in the midst of a period of really, very significant change that offers great promise for the future."

Still, when drugs become hard to get, they tend to remain hard to get, says Erin Fox, who tracks drug shortages at the University of Utah. Her group is keeping an eye on the supplies of 282 difficult-to-come-by drugs, she tells the newspaper. "The shortages we have aren't going away--they're not resolving," she said. "But the good news is we're not piling more shortages on top."

- read The New York Times piece

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