The shortfalls have led to a number of changes in the way doctors and hospitals now manage cancer drugs. At Dana Farber, a member of the pharmacy staff is now dedicated full time to monitoring drug supply. When inventories start to drop, this staff member picks up the phone to call not just distributors and vendors but manufacturers themselves to glean as much information as she can about how serious the drop in supply is and how long it could last. That’s something that Sylvia Bartel, Dana Farber’s vice president of pharmacy, says the cancer center never had to worry about until recent years. The institute relied on a wholesaler who would simply take their orders and procure the drugs. “Now we are making contacts we never had to make before to ensure we have enough supply of drugs to treat our patients,” she says.
In fact, the American Society of Health-System Pharmacists reports that pharmacists now spend an average of eight to nine hours a week addressing drug shortages, compared with three hours a week in 2004. And doctors are increasingly spending more of their time drawing up alternative drug-treatment plans for their patients and managing side effects and monitoring effectiveness.
At the University of Virginia Children’s Hospital, doctors have started to pool patients to make the most efficient use of what little drugs they have. Because children use smaller doses than adults, more than one child can be treated with each vial of a chemotherapy drug like methotrexate.
(MORE: Inside America’s Drug Shortage)
But that’s not an ideal solution. So the Food and Drug Administration (FDA) stepped in last month to address the shortfalls in both Doxil and methotrexate by calling in additional U.S. manufacturers and accepting shipments of one of the drugs from an overseas manufacturer. The action has averted the immediate threat for many patients, but doctors and patients still aren’t confident that another crisis won’t occur in a few months. “I know our institution has enough drug for patients now and for probably the next month to couple of months,” says Dr. Kimberly Dunsmore, chief of pediatric hematology oncology at University of Virginia Children’s Hospital. “But I don’t know what will happen after that. These drugs are the cornerstone of treatment for patients with osteogenic sarcoma and acute lymphoblastic leukemia … It’s frightening to think of putting these patients at risk by not being able to use these vitally important medicines. I’m very nervous about the next four, five and six months.”
Most doctors feel that the actions by the FDA are merely a stopgap, a temporary fix for a potentially explosive problem that won’t go away until changes are made to the way drugs are made, regulated, sold and distributed in this country.
President Obama’s October Executive Order could be a start. The order charges the FDA with requiring all manufacturers to inform the agency of any potential shortfalls they anticipate in their supply of any drug, whether due to manufacturing problems, plant closures, business decisions to discontinue drug production or problems in obtaining adequate raw materials. Currently, only manufacturers that are the sole maker of a drug are required to report to the FDA if they experience any changes in their production schedule.
The President also asked the FDA to boost its efforts to expedite drug approvals and overseas applications to ensure that enough manufacturers are supplying drugs. That’s already happening with methotrexate; the FDA accelerated review of a pending application by Illinois-based APP Pharmaceuticals to make the preservative-free injectable form of the drug. FDA Commissioner Margaret Hamburg has also exercised the agency’s authority to grant temporary approval for unapproved drugs, in this case for a form of Doxil called Lipodox, made by India-based Sun Pharma, to address the Doxil shortage.
But why did it take the agency nearly seven months to take these actions? Hamburg says the FDA needs more authority to enforce the requirement that drugmakers alert the FDA when they anticipate production problems. The President’s order is not enough. “Additional authority for the FDA to require early notification would clearly benefit our ability to rapidly mobilize and use tools we have available to us to help address existing shortages and prevent new shortages,” she says.
But already, as media reports of the cancer-drug shortages have emerged in recent months, Hamburg says manufacturers have been more forthcoming about potential supply issues. “The FDA was able to actively engage and prevent 195 shortages in 2011,” she says, with 99 of those due to early reporting by the companies affected. However, only an act of Congress can officially grant the FDA the authority to require such reporting, and a bill has been languishing in Washington since 2011.