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Prescription Drug Shortage Hits U.S. Doctors and Hospitals

President directs FDA to be more involved

Why the shortages of these critical drugs?

The FDA says the problems mainly stem from manufacturing issues, such as drug production temporarily shut down because the plant wasn't sterile.

Sometimes, though, the shortages are tied to disruptions in the supply of raw materials or to increased demand for some drugs. And, the FDA says, some companies have simply stopped making older, less profitable drugs, particularly older sterile injectable drugs.

When one company has a problem or discontinues a drug, it's difficult for other manufacturers to increase production quickly. The FDA recently asked manufacturers to report production problems or changes that might cause potential shortages.

Remedies vary but the FDA can work with other U.S. manufacturers to ramp up their production of a drug in limited supply or search overseas for suitable companies willing to import the drug. It also can help drugmakers locate new supplies of raw material and certify them for import.

The drug supply glitches, which vary from region to region and week to week, have triggered congressional interest because the FDA is limited in what it can do to solve the problem. Currently, the federal agency cannot require firms to report drug shortages, give the reason for a shortage or even provide an estimate about how long the shortage might last.

Some manufacturers voluntarily report supply problems, says Cynthia Reilly, a pharmacist and a director at the American Society of Health-System Pharmacists. But, she says, a pharmacist may not know until "they open the order they just placed and it's not in there."

That group backs legislation that would require manufacturers to notify the FDA of potential supply problems involving key medicines.

Meanwhile, the FDA is asking health workers and patients to report shortages to the FDA's Center for Drug Evaluation and Research at drugshortages@fda.hhs.gov.

Also of interest: Costs of brand-name drugs soar. >>

Charlotte Huff is a freelance writer in Fort Worth, Texas, who reports on medical issues.

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