Friday, May 4, 2012

Drug Shortage Worries Physicians, Federal Officials

Dr. Patt
Austin oncologist Debra Patt, MD, MPH, recalls one of the scariest moments in her career. In December 2010, she discovered an Austin hospital had run out of the cytarabine she needed for a patient with acute myelogenous leukemia, a fast-progressing cancer that typically takes a patient's life within three months if he or she is not treated quickly and properly.

“I was really concerned because this particular drug has no alternative,” said Dr. Patt, chair of the Texas Medical Association’s Committee on Cancer.

Dr. Patt practices at Texas Oncology, a group she said constantly examines drug inventory to help anticipate and head off shortages. The practice also can contact other Texas Oncology pharmacies and area hospitals to find needed drugs. Oncology is one of many specialties hard hit by a nationwide drug shortage that began in 2006. “Luckily, Texas Oncology was able to acquire cytarabine and give it to the hospital. That was a close call that would have compromised patient care. It made me and other doctors nervous,” she said.

Unfortunately, many drugs linger on the Food and Drug Administration’s (FDA’s) drug shortage list.

“When a shortage occurs, patients often receive older or less desirable drugs that may have worse side-effect profiles. It’s a real pity that this is a far too frequent part of patients’ experiences now,” said surgical oncologist R.Y. Declan Fleming, MD.

Dr. Speer
TMA President-Elect Michael Speer, MD, a faculty member in the Neonatology Section of Baylor College of Medicine, said drug shortages are frustrating because “the best medication for the patient’s condition is no longer available.” He added that physicians have no choice but to make drug substitutions that may not be in the patient’s best interest.

Dr. Patt said a shortage of Doxil, used to treat ovarian cancer, forces her to use an alternative drug. She noted, however, that not all alternative drugs are as effective as the preferred drug, and some can pose different side effects for patients.

Doxil has been missing from the U.S. marketplace for more than a year because the company that makes the drug for Johnson & Johnson had to shut down production due to quality concerns. FDA acted earlier this year to replace Doxil, temporarily allowing importation of the drug Lipodox from India. The agency also approved a new supplier for a preservative-free version of methotrexate, a drug for children with acute lymphoblastic leukemia, for lymphomas, and for osteosarcoma.

Dr. Patt applauds the FDA’s actions to bring effective, lifesaving drugs onto the market. “Allowing similar drugs into the market will benefit many patients. These are tools we need to effectively treat them,” she said, adding that she hopes the federal government will take more measures to reduce the impact of the nationwide drug shortage.

Read more from Texas Medicine magazine

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