Hospitals deal with record drug shortage

A record number of drugs are in short supply nationwide -- a crisis that is being felt by Long Island hospitals as they scramble to find medicines for patients facing serious medical conditions.

The bulk of the shortage involves generic, injectable drugs used in hospitals and clinics. More than 180 medications -- from those treating cancer and childhood leukemia to surgical anesthetics and painkillers -- have appeared on the U.S. Food and Drug Administration's list of critical shortages this year.

"It's obviously a major concern for taking care of people," said Dr. Daniel Budman, interim chief of hematology/oncology at North Shore-LIJ's Monter Cancer Center, where supplies of 16 cancer drugs are either exhausted or running out.

Thousands of patients on Long Island are affected by the shortages, with many forced to delay treatments or switch to alternative -- and potentially less effective -- drugs, hospital officials and doctors said.

"You are not able to provide the best state-of-the art care without these drugs," Budman said.

Why shortage is growing

In the past five years, the FDA's list of drugs in short supply has nearly tripled, up to 178 last year from 61 in 2005. More than half of the recent shortages are due to government inspectors finding contamination problems in drug plants in the United States and abroad, stopping production, the FDA said.

Plant closures in the United States, and a lack of raw materials, also have contributed to the shortages, the FDA said. Another factor cited is a reluctance by brand-name drug companies to produce less-profitable generic medicines, the agency said.

The problem has prompted hospital, pharmacy and physician groups across the country to call on the government to step in. One proposed solution: creation of a national stockpile of critically needed drugs.

The Generic Pharmaceutical Association, which represents manufacturers, has called on Congress to provide tax credits or other incentives to encourage companies to make the medically necessary drugs.

But in the meantime, frustrated hospital officials on Long Island say the problem is getting worse -- threatening the quality of patient care and driving up costs as hospital pharmacies sometimes resort to buying on the "gray market."

Every hospital affected

"We are all being impacted. Every single hospital, regardless of size, is being affected by this," said Marcelle Levy-Santoro, pharmacy director at Nassau University Medical Center in East Meadow.

Each week, the hospital's pharmacists tell doctors and nurses which drugs are not available and whether there are suitable alternatives, Levy-Santoro said.

FDA spokeswoman Shelly Burgess said many of the drugs in short supply are generics.

When a patent expires on a name-brand drug, other companies typically start making and selling it at lower cost. But the competition also lowers profits for the original maker, which no longer has exclusive rights, sometimes leading them to cease production, said Valerie Jensen, who tracks drug shortages for the FDA.

"FDA can't require a firm to keep making a drug it wants to discontinue," Burgess said.

Injectable generic drugs are more prone to shortages because the manufacturing process is complex and a limited number of companies are capable of it. These companies make the drugs in amounts only to meet current demand, which means the supply chain has little, if any, excess inventory, according to a report Jensen co-authored for the New England Journal of Medicine.

Big impact on cancer care

The drug shortage's impact on cancer patients could be among the most dramatic because early detection and swift treatment are often keys to survival. Several well-tested treatment plans for testicular and curable childhood cancers were developed years ago and use the older, generic drugs, oncologists say.

The continuing uncertainty over access worries patients like Nikki Abbondondelo. The Bethpage resident is battling ovarian cancer and relies on Doxil, a chemotherapy drug on the short-supply list.

Several weeks ago, when she was supposed to receive an intravenous injection during a monthly appointment, a nurse at the private oncologist's office told her there wasn't any Doxil left.

"Oh my God, what am I going to do?" Abbondondelo, 51, remembers saying. "I never thought something like that could even happen."

Midway through her treatment, she's been doing well, much better than the previous chemo regimens she's tried. She's on a waiting list for Doxil, but if she can't get it in the next week, she'll have to switch to another treatment plan.

"It's very nerve-racking when you know you're doing very well on a drug and you can't get it," Abbondondelo said. "This is life-giving treatment for me and everybody else on it."

There are reasonably effective alternatives to most drugs. But using these alternatives could mean adverse side effects and a less effective treatment plan for some patients. It also drives up health-care costs to use a brand name drug when a less-expensive generic should be available, said Brian Malone, director of pharmaceutical services at Winthrop-University Hospital in Mineola.

Some, like Doxil, are so unique there is no exact alternative, Malone said. "No one wants to change treatment mid-cycle, and right now newly diagnosed patients can't get it at all," he said.

The Doxil shortage is due to "a manufacturing problem related to capacity," said Lisa Vaga, spokeswoman for drugmaker Janssen Pharmaceuticals, a division of Johnson & Johnson. She declined to provide more details. In August, the company began enrolling mid-treatment patients on a priority wait list, Vaga said.

Besides the shortage, treatment costs are going up, hospital administrators said, because the drugs are getting more expensive.

When "gray market," or third-party sellers, learn that a drug is in short supply, they begin buying up supplies, offering them to hospitals at greatly inflated prices, the administrators said.

"I understand the concept of supply and demand, but these prices are astronomical and there's no doubt the gray market is contributing to the problem and putting patients at risk," Malone said. "It is unethical."

The anesthesia Propofol, which normally costs less than $5 per vial, is going for $69, and chemotherapy drug Doxorubicin has been marked up from $20 to more than $100, said Levy-Santoro. "We try not to go through the gray market, but sometimes there are emergencies and we have to," she said. "It is our responsibility to provide these medicines to our patients, and it's a constant race to make sure we have something available for them."