Printed Saturday, May 26, 2012


Brown wants pharmaceuticals to declare shortages, discontinuances

BLADE STAFF

Drug shortages are complicating critical care for cancer patients and others with life-threatening illnesses, U.S. Sen. Sherrod Brown (D., Ohio) said during a news conference Saturday at which he announced a bill that would require pharmaceuticals companies to notify the federal government whenever a shortage or discontinuance is anticipated.

Quality-control problems, raw-materials shortages, or even discontinued production of certain drugs because they’re unprofitable often requires doctors to change patients’ care in mid-treatment, the senator said during a news conference at the University of Toledo Medical Center, formerly Medical College of Ohio Hospital. Substitute medications are often less effective, costlier, and more difficult to administer than the drugs initially prescribed, he said.

Flanking Senator Brown at the event were two hospital officials and Joanne Schwartzberg, a retired clinical nurse from the hospital who now is under care for lung cancer and whose chemotherapy medication has been changed twice because of drug unavailability.

“As a patient, it’s sort of scary when you’re on the preferred drug and they take it away,” said Mrs. Schwartzberg, who lives in Toledo.

She said her first medication, paclitaxel, was a generic that was discontinued by its manufacturer, while she’s not sure why her second chemotherapy medication, docetaxel, became unavailable.

Dr. Roland Skeel, of the hospital’s medicine, hematology, and oncology department, said about 80 percent of shortage-prone drugs are generics — many of them “standard, critical drugs” for common but serious conditions.

“Even sterile water, which is used to mix drugs, is on back-order,” Dr. Skeel said.

Mr. Brown said the bill he has co-sponsored, the Preserving Access to Life-Saving Medications Act, would not force drug-makers to continue producing medicines against their corporate will, but would require them to give notice to the Food and Drug Administration promptly once they decide to cease production or when they become aware of any other impending supply disruptions.