Patients, medical bils feel pinch of drug shortages

SAN FRANCISCO — Record shortages of prescription drugs in the United States are forcing pharmacists and doctors to scramble to find medications for their patients or to delay potentially lifesaving treatments.

Medical professionals say they’ve been able to blunt the impact by turning to alternative drugs or reserving supplies of vital medications for patients who need them most.

They caution that the problem is reaching a crisis point.

“When we go to order, it’s more common to see drugs in limited quantity, on back order or completely unavailable than it is to see drugs that are completely available,” said Michelle Taymuree, clinical pharmacy manager at Diablo Valley Oncology of Pleasant Hill, Calif. “It’s a daily exercise to see what’s available and how much you can get.”

Federal recalls, production problems and corporate decisions to discontinue certain medications for financial reasons are cited as the chief causes of the dwindling drug supplies.

In 2006, 70 drugs were in short supply. By last year’s end, the number had jumped to 211, according to the University of Utah Drug Information Service, which tracks prescription drug shortages. Some 190 drugs are currently hard to come by.

More than 90 percent of U.S. hospitals polled by the American Hospital Association in June reported experiencing a drug shortage in the past six months, and nearly 45 percent said they had experienced at least 21 shortages.

The shortages tend to be medications used in hospitals — typically older, generic injectables, cancer drugs, types of anesthesia used in surgery, electrolytes, vitamins and minerals.

“Pharmacists have worked diligently to keep this from impacting physicians and patients,” said Maria Serpa, president of the California Society of Health-System Pharmacists.

A growing number of patients nationwide are reporting delays and disruptions in treatments.

A shortage of the chemotherapy drug Doxil forced Marcia Goodman of Berkeley, Calif., to get a different agent — doxorubicin, a generic label that’s also on the national shortage list — to treat her ovarian cancer.

“Of all the things on my anxiety list, that wasn’t one of them,” Goodman said of the shortage. The 56-year-old has found the replacement harder to tolerate.

Doxil’s maker, Johnson & Johnson, attributed the problem to production delays at a third-party supplier. Boehringer Ingelheim’s Ben Venue Laboratories Inc., announced it would exit the pharmaceutical contract-manufacturing business over the next several years after Canadian regulators found manufacturing deficiencies.

Most shortages are rooted in drugmakers’ decisions or manufacturing problems.

A growing list of drugs have either been recalled by the Food & Drug Administration or voluntarily pulled by the manufacturer. Some recalls result from increased FDA scrutiny, but technology has also made it easier to detect problems in drugs.

If these medications are complex but generic and inherently less profitable — like older injectables or chemotherapy agents — some manufacturers stop making them.

The Generic Pharmaceutical Association, a trade group, said it supports remedies such as requiring the FDA to expedite approvals of alternative active ingredients, for example, or creating an emergency stockpile of raw materials. The organization also recommends that the federal government offer financial incentives, such as tax credits, to drugmakers.

The shortages fuel a greater demand for alternative, often brand-name drugs, which means higher costs for pharmacies, hospitals and patients.

The drug shortages could cost U.S. hospitals at least $416 million annually, according to a labor study released last month by American Society of Health-System Pharmacists with the University of Michigan Health System, and a March survey by Premier, a national alliance of health care providers.

A new study released by Premier also showed that unofficial suppliers — vendors in the so-called gray market — have offered hospitals and other health providers hard-to-find drugs at exorbitant prices. Suppliers inflated the drug prices by an average of 650 percent — and by more than 4,500 percent in at least one case, the survey found.

The FDA can’t require a manufacturer to keep making a drug or produce more of it. But it can do things to increase the supply, such as pushing more generics into the pipeline.

Pending federal legislation could at least ensure that the government be given advanced warning. Two bills — one introduced in the Senate and the other in the House of Representatives this year — would require drugmakers to give the FDA six months’ notice if they plan to stop making a drug and immediate notice of an unplanned interruption.