AP IMPACT: Hospital drug shortages deadly, costly

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Only a half-dozen companies make the vast majority of injected generics. Even if other companies wanted to begin making a drug in short supply, they’re discouraged by the lengthy, expensive process of setting up new manufacturing lines and getting FDA approval.

Hospitals that buy scarce medicines from the “gray market” are taking a gamble.

The drugs may be stolen and hospitals can’t always tell whether a medicine was properly refrigerated _ as required for many injectable drugs _ or whether it’s past the expiration date, said Michael R. Cohen, a pharmacist and president of the institute. The active ingredient might have degraded and the drug might not work well or could even harm the patient, he said.

Cohen attributes at least 15 recent deaths to drug shortages, either because the right drug wasn’t available or because of dosing errors or other problems in administering or preparing alternative medications. But many deaths and injuries go unreported, he said.

In the worst known case, Alabama’s public health department this spring reported nine deaths and 10 patients harmed due to bacterial contamination of a hand-mixed batch of liquid nutrition given via feeding tubes because the sterile pre-mixed liquid wasn’t available.

So far this year, 210 drugs have been added to the list of those in short supply, one less than the total for all of last year, according to the University of Utah Drug Information Service, which tracks the shortages. That’s triple the roughly 70 a year from 2003 to 2006, when shortages began to climb steadily.

“The shortages aren’t resolving. They’re piling up on top of existing ones,” said Erin Fox, a pharmacist who manages the service. She said at least 55 drugs from shortages before this year are still unavailable or scarce.

The average price markup on drugs sold by secondary distributors was 650 percent, according to an Aug. 16 report by the Premier Healthcare Alliance. The figure is based on an analysis of 636 unsolicited sales offers that were faxed and emailed to hospitals from secondary distributors in April and May.

Virtually every offer was for at least double the normal price, the survey found. The drugs with the highest markups were for critically ill patients needing anesthesia or other medicines for surgery or for emergency care, cancer, infectious diseases and pain management.

In an extreme case, one vendor was offering a generic beta blocker for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

The FDA says it must uphold quality standards but also works hard to prevent shortages.

“When FDA detects a contaminant, whether it be shards of glass or metal particles or an infectious agent, we have to take action to protect the public,” said Dr. Peter Lurie, a senior adviser in the FDA commissioner’s office.

When such problems force a company to shut down production, the FDA urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of the agency’s drug shortage program. When raw materials used to make drugs are in short supply, the FDA tries to find new sources.

The agency averted 38 shortages last year, Jensen added. Another 99 have been prevented so far this year, Howard K. Koh, assistant secretary for health in the Department of Health and Human Services, told the committee.

Legislation pending in the House and Senate would increase penalties for drug thefts from warehouses and tractor-trailers. Another proposal, which has bipartisan support, would require drug manufacturers anticipating a shortage to immediately notify the FDA.

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