Continued from page 1

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 drugs 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, a group that helps U.S. hospitals and other health providers improve their patient care and finances. The report 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 drug for dangerously high blood pressure, normally priced at $25.90 per dose, for $1,200.

So far, hospitals have been absorbing the extra costs, but they’ll soon have to start passing them on to insurers and patients, according to the American Hospital Association.

Hospitals sometimes have to cave in to save patients, according to Cohen and several hospital pharmacy directors.

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 the agency orders a production shutdown, it urges other manufacturers to boost their output and expedites any approvals needed, said Valerie Jensen, associate director of FDA’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.

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.

Sen. Amy Klobuchar, D.-Minn., the primary sponsor of the Senate version of the notification bill, said other solutions being considered include better tracking of medicine shipments, mandatory accreditation of distributors, stockpiling of key drugs and allowing routine imports of prescription drugs from countries such as Canada.

Distributors that supply about 90 percent of prescription drugs to hospitals buy direct from drug manufacturers and deliver only to customers with appropriate licenses, said John Parker, a spokesman for the Healthcare Distribution Management Association. He said HDMA members don’t participate in the “gray market” but would not comment further.

Story Continues →