U.S. Sen. Bob Casey of Pennsylvania and other lawmakers are calling on the federal Government Accountability Office to find out why prescription drug shortages have intensified recently—and then determine what the Food and Drug Administration can do about it.
The number of drugs on the FDA shortage list has more than tripled in the last five years, up to 178 in 2010.
Joseph Hill, of the American Society of Health System Pharmacists, said there are a host of reasons why shortages have jumped, including manufacturing problems and economic factors. Putting the scrutiny of the federal government behind the issue could be one step of many necessary to address the problem, he said.
“I think it’s a great step that they’re asking GAO to look into how the system can be improved,” Hill said. “This includes everything from addressing some of the manufacturing and quality issues, but also addressing things the FDA can be doing to manage (shortages) better or help prevent them from occurring in the first place.”
Currently, the FDA cannot require companies to report manufacturing problems that might cause future shortages. They also cannot force companies to produce drugs if those firms want to stop their manufacture because they are no longer profitable.
The current shortages are hitting injectable drugs especially hard, forcing hospitals to switch treatments to alternate methods at the last minute, which doctors say can increase the possibility of error. In the national shortage of the drug Cytarabine, which is used to treat leukemia, doctors have had to ration doses.
“Cancer centers and community oncologists particularly face constant shortages of life-saving and live-extending inejectable drugs,” said Dwight Kloth, director of pharmacy at Fox Chase Cancer Center in Philadelphia. Tracking shortages and figuring out how to keep supply ahead of demand, or shifting to drugs that are more readily available, “adds additional complexities to an already complex environment,” Casey said.
Kloth said his staff spends time every day keeping tabs on dozens of drugs on the shortage list.
This year, Casey introduced legislation that would require drug companies to tell the FDA if they were having manufacturing problems that could lead to a drug shortage.