Senator seeks notification on drugs' unavailability

Joanne Schwartzberg once was a clinical nurse at what was then the Medical College of Ohio Hospital, but now she's a patient, receiving chemotherapy for lung cancer.

Twice during her course of treatment, Mrs. Schwartzberg's doctors have had to change her medication because of a supply shortage -- in one case, the result of an abrupt halt in the medicine's manufacture.

The retired nurse accompanied U.S. Sen. Sherrod Brown (D., Ohio) to a news conference Saturday afternoon at what is now the University of Toledo Medical Center, where the senator outlined a bill he is co-sponsoring that would require drug manufacturers to notify the federal government whenever a shortage or discontinuance is anticipated.

"It is difficult to understand how companies can simply cease producing a life-saving drug, or one that can help cancer patients get better," said Mrs. Schwartzberg, who still lives in Toledo.

"As a patient, it's sort of scary when you're on the preferred drug and they take it away," she later added.

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 midtreatment, Senator Brown said.

Some drugs become hard to find because of "gray-market" profiteers who buy up supplies and then jack up prices, he said, citing morphine-related painkillers as especially vulnerable.

Substitute medications are often less effective, costlier, and more difficult to administer than the drugs initially prescribed and sometimes have more difficult side effects, the senator said.

The Preserving Access to Life-Saving Medications Act would not force drug makers to continue producing medicines that lose money, Senator Brown said, but would require them to notify the Food and Drug Administration promptly once they decide to cease production or when they become aware of any impending supply disruptions.

Many patients' anxiety is "significant enough" without having to cope with a medication change, he said, "and many doctors have told me they don't see this coming."

"Mrs. Schwartzberg's story has become too common across the country. With little or no warning, drugs are simply no longer available," Senator Brown said.

Along with Mrs. Schwartzberg, Senator Brown was accompanied at the event by Dr. Roland Skeel, of the hospital's medicine, hematology, and oncology department, and Russ Smith, the hospital's director of pharmacy.

About 80 percent of shortage-prone drugs are generics, Dr. Skeel said -- many of them "standard, critical drugs" for common but serious conditions.

"Even sterile water, which is used to mix drugs, is on back-order," he said.

Mr. Smith said the problem is affecting hospitals and patients nationwide, affecting pain, blood-pressure, and cardiac medications as well as cancer treatments and causing higher costs for patients, hospitals, and insurers.

"This issue has continued to escalate" to the point that government intervention is needed, he said.

Mrs. Schwartzberg said her first chemotherapy medication, paclitaxel, was a generic that was discontinued by its manufacturer, and she's not sure why her second chemotherapy medication, docetaxel, became unavailable.

"Out of the blue, they told me it [paclitaxel] was simply no longer available," she said.