Pharmacists Struggling to Locate Drug Supplies

March 05--ALBANY -- A national drug shortage is forcing pharmacists to shuffle and tap dance to fill orders for critical drugs in short supply.

"It's gone beyond being a nuisance," said David Kile, director of continuing education and professional development at the Albany College of Pharmacy and Health Sciences. "There are pharmacists and buyers who every day have to scramble for new sources of supplies."

About 80 percent of the drugs in short supply are generic injectables or intravenous fluids often used in hospitals, including antibiotics that fight drug-resistant infections, painkillers, sedatives and chemotherapies, Kile said. Lesser-known shortfalls are tormenting a small group of patients whose lives depend on IV medicine.

"It's my only nutrition," said Gail Brenenstuhl of Queensbury. Most of Brenenstuhl's small bowel was removed during several surgeries, so she is unable to absorb nutrients from the food she eats.

Brenenstuhl survives by infusing IV nutrition into a port in her chest every night for 10 hours.

People on IV nutrition are dealing with shortages in vital elements like calcium, magnesium, zinc, selenium and multivitamin solutions.

"We are pulling our hair out all the time," said Dr. Ann Michalek, who oversees Albany Medical Center's program for people that take IV nutrition at home.

The IV nutrition patients who have disruptions in their supplies must take expensive blood tests more frequently to avoid nutrient deficiencies, Michalek said.

There is no single cause of the shortage, but most of the blame is falling on the manufactures of the generic fluids.

The five companies that manufacture most of the generic drugs are considered older facilities, said Kile, who is giving a lecture about the shortages at the College of Pharmacy on Monday. The Food and Drug Administration has occasionally shut down production at the facilities because of particulates and contamination in the products.

Also, some manufacturers stopped making certain products because the profit margin on the older generics is so small, Kile said.

That leaves the remaining companies to make up the difference, but each company may produce 50 to 120 medications and may not have space in their production schedule to switch over to a different product.

In 2006, there were 60 drugs in short supply, but this year it is already 346, according to a list compiled by the American Society of Health System Pharmacists, based in Bethesda, Md.

The shortages mean hospitals are spending more to buy alternatives, often brand name replacements, and expending untold hours finding work-arounds.

At Albany Med, the chief pharmacist held several meetings with cardiologists in anticipation that they would run out of papaverine. The time-tested drug is used to relax veins during a coronary artery bypass surgery. The doctors and pharmacists contacted other institutions to see how they were handling the shortage and they pored over research to find other options.

"We had an alternative, but nobody was looking forward to changing a previously successful way of doing things," said Timothy Lesar, director of pharmacy services at Albany Med.

At the last minute, they received a new shipment of the drug and never had to implement the backup plan.

"It takes up a lot of our time," Lesar said. "It's become the new reality, not just for hospitals, but for everybody."

An analysis by the Associated Press identified at least 15 patients who have died nationwide because of drug shortages. The FDA has taken some steps to ease the shortage including speeding up the approval process to allow oversea drug imports.

The federal agency recently announced that it will allow a foreign company to import a replacement drug for Doxil, a drug used in the treatment of ovarian and other cancers that has been unavailable to new patients for months. The FDA also approved a new supplier for methotrexate, a drug for bone cancer and pediatric leukemia.

In October, President Barack Obama gave an executive order that allows the FDA to expedite regulatory reviews to prevent shortages and examine whether potential shortages have led to price gouging. Last week, the FDA toughened its requirements for manufacturers to notify the agency about pending drug shortages.

Dr. Michael Kolodziej, an oncologist with New York Oncology Hematology, had to give a more toxic drug to a patient with testicular cancer because the standard drug wasn't available. Kolodziej and other physicians said patient care is being compromised because of the shortages.

"It's the government's responsibility to find a way to keep this from happening," Kolodziej said. "The market is not going to fix this."

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