A shortage of Taxol, an intravenous chemotherapy workhorse for ovarian, breast, lung and colon cancers, demonstrates once again how vulnerable U.S. hospitals and clinics are to an increasingly unreliable pharmaceutical supply chain, leaving patients at risk.
Paclitaxel, the generic version of Taxol, joins 196 other drugs on a shortage list compiled by the American Society of Health-System Pharmacists in Bethesda, Md.
Although no one has been able to quantify the number of lives jeopardized by the shortages, the lengthy list underscores that the country is in the midst of a "public health crisis of drugs overall," said Cynthia Reilly, director of the group's practice development division.
Paclitaxel made the list May 13, with a June 16 update. Additions in the last month include such chemotherapy mainstays as doxorubicin, daunorubicin, carboplatin, vincristine and cytarabine; the quick-acting anesthetic propofol; the injectable painkiller Fentanyl and injectable forms of several powerful antibiotics: clindamycin, ciprofloxacin and gentamicin.
For more than a year, "we've been having a crescendoing of drugs that are in short supply. This has been going on for some time now," said Dr. Michael P. Link, a Stanford University pediatric oncologist who serves as president of the American Society of Clinical Oncology. He called the paclitaxel crunch "another add-on."
Although some drug shortages can be eased with simple substitutions, regimens that use paclitaxel often lack equally effective substitutes. "That's what makes not just this, but all of the chemotherapy shortages significant," Reilly said. "There's cancer patients who will die because of this. This could change their survival."
Some chemotherapy shortages have been making it harder to treat certain malignancies, Link said. "Without cytarabine and daunorubicin, you cannot treat leukemia," he said.
At Stanford's Lucile Packard Children's Hospital, where he practices, the daunorubicin shortage means "we are at risk for having to triage our patients; which patients we'll be able to give the drugs to. We're hoping to get more so we don't face that awful crisis. Other practices have."
Shelly Burgess, a spokeswoman for the Food and Drug Administration, said the paclitaxel shortage was "not a complete national outage" because most of the five generic manufacturers still had some of the drug on hand. Bedford Laboratories of Bedford, Ohio, had paclitaxel on back order and "plans to have supplies available again by the end of the month," she said.
Bedford, which has 20 percent of the market for three doses of the drug, expects to release paclitaxel vials into the marketplace soon, said spokesman Jason Kurtz. The company's backlog increased the pressure on the other manufacturers to expedite production.
Teva Pharmaceuticals USA, based in North Wales, Pa., anticipates "some constraint through the summer," said spokeswoman Denise Bradley.
Dan Rosenberg, a spokesman for Hospira of Lake Forest, Ill., said he didn't "have a time frame" for when Hospira could deliver more medication to the marketplace, but it was working to help fill the supply gap.
Debra Lynn Ross, a spokeswoman for APP Pharmaceuticals of Schaumburg, Ill., did not provide an immediate response to questions about the shortage.