Tight drug supplies endanger patients

TRENTON, N.J. – A drug for dangerously high blood pressure, normally priced at $25.90 per dose, offered to hospitals for $1,200. Fifteen deaths in 15 months blamed on shortages of life-saving medications.

A growing crisis in the availability of drugs for chemotherapy, infections and other serious ailments is endangering patients and forcing hospitals to buy from secondary suppliers at huge markups because they can’t get the medications any other way.

An Associated Press review of industry reports and interviews with nearly two dozen experts found the shortages – mainly of injected generic drugs that ordinarily are cheap – have delayed surgeries and cancer treatments, left patients in unnecessary pain and caused hospitals to give less effective treatments. That’s resulted in complications and longer hospital stays.

Just over half of the 549 U.S. hospitals responding to a survey this summer by the Institute for Safe Medication Practices, a patient safety group, said they had purchased one or more prescription drugs from “gray market vendors” – companies other than their normal wholesalers.

Most also said they’ve had to do so more often of late, and 7 percent reported side effects or other problems with those drugs.

Hospital pharmacists “are really looking at this as a crisis. They are scrambling to find drugs,” said Joseph Hill of the American Society of Health-System Pharmacists.

At a hearing Friday before the health subcommittee of the House Energy and Commerce Committee, hospital officials and other experts testified that the worsening shortages are preventing them from giving many patients the best care and are driving up costs.

“Considering the nation’s budget crisis and our skyrocketing health care bill, these markups are nothing more than profiteering at the expense of patients and providers who are struggling to afford vital medicines,” said Mike Alkire, chief operating officer of Premier Healthcare Alliance, a group that helps U.S. hospitals and other health providers improve their patient care and finances.

The shortages could cost hospitals at least $415 million a year, he said, citing data from health care providers across the nation.

On Monday, the Food and Drug Administration is holding a meeting with medical and consumer groups, researchers and industry representatives to discuss the shortages and strategies to fight them.

The FDA says the primary cause of the shortages is production shutdowns because of manufacturing problems, such as contamination and metal particles that get into medicine.

Other reasons include theft of prescription drugs from warehouses or during shipment, as well as the “gray market” vendors who buy scarce drugs from small regional wholesalers, pharmacies or other sources and then sell them to hospitals at many times the normal price. These sellers may not be licensed, authorized distributors.

In addition, many companies have stopped making generic injected drugs because the profit margins are slim. Producing them is far more expensive than stamping out pills, and it takes about three weeks to produce a batch. Making things worse, companies don’t have to notify customers or the FDA that they’ve stopped making a medicine. That means neither FDA nor competitors can fill the gap in time.

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.

‘Gray market’ a gamble

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.

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.

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 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.

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.

High prices defended

Several distributors who sent hospitals solicitations for scarce drugs didn’t return calls from the AP. One representative said he wasn’t authorized to discuss the issue.

Another company, Novis Pharmaceuticals, defended the higher prices, saying secondary distributors have to charge far more because they don’t get the big rebates manufacturers give primary distributors. They also have high costs to locate and transport batches of scarce drugs, although the company, which mainly distributes blood plasma, would not disclose its profit margin.

It’s illegal for companies to collude to create a medicine shortage and raise prices, and there’s no evidence of that. There’s no federal law against price-gouging on prescription drugs, according to the FDA, but it does urge pharmacists to report cases to its Office of Criminal Investigation.