Some hospitals have had to discard cyatarabine, a cancer drug in such short supply that it has been rationed.
Amid ongoing shortages of critical drugs, 60 percent of hospital pharmacists surveyed said they’ve been forced to trash life-saving or expensive medications because of misguided government rules, a new poll shows.
Discarded have been more than 100 different drugs, including 80 percent that are now or have been in short supply, and costly medications such as Velcade, a cancer treatment that can go for between $1,500 and $2,500 per 3.5-milligram vial.
That’s according to a just-published survey of 715 hospital pharmacy directors, managers and clinicians nationwide who responded to queries by the Institute for Safe Medication Practices.
“We wanted to do some research and see how big of a problem it is,” said Mike Cohen, president of ISMP, a drug safety advocacy organization. “It’s really a major issue.”
Cohen said the results weren't surprising to him, given the concerns he'd previously heard. But he said they should spark new discussion.
About 61 percent of pharmacists and managers who responded said they “feel compelled” to discard injectable drugs, the survey found. Most fear facing industry or government sanctions if they don't.
Some hospitals have been cited by officials at the Centers for Medicare & Medicaid Services or by the Joint Commission, an accrediting agency, for not following explicit directions in drugmakers’ package inserts.
In the new survey, the drugs tossed include cancer medications such as cytarabine and bleomycin, which have been so scarce that some hospitals have turned patients away or resorted to rationing.
Nearly 80 percent of the pharmacists said that existing rules “often” or “always” lead to unnecessary waste, contributing to the crisis that saw a record shortage of 267 drugs last year, the survey found.
At issue are rules imposed by regulators, including CMS, which require hospital pharmacists to follow drug manufacturers’ written instructions for storage, stability and by-use-dates for injectable drugs -- even when that information is outdated or incomplete.
The most current evidence-based data about how long a drug can be used or stored is often available not from the manufacturers, but from widely used compendia, or summaries, such as the American Hospital Formulary Services drug information database.
That information is available in the package inserts that are approved by the federal Food and Drug Administration when a new drug is cleared. But it can be costly and time-consuming to seek new FDA label approval, so updated information often isn’t added to the directions.
Many times, having the latest information can mean the difference between being able to store a diluted drug for a week rather than a day, as in the case of an IV blood pressure medication, nicardipine, which has been in shortage.
The crucial neuro-muscular blocker succinylcholine can be stored for a week, according to manufacturers’ directions. But it can be used for up to a month according to updated data in Trissel’s Handbook, a widely used compendium.
Often, drugs are packaged in sizes that don't lead to easy dosing, forcing pharmacists to discard unused portions.
About 40 percent of pharmacists buck the rules and decline to discard injectable drugs based solely on manufacturers’ guidelines, the survey found. Only about half of the pharmacists said they “always” follow package instructions, when they exist.
Nearly all of the pharmacists, 97 percent, felt that CMS rules contribute to the crisis, the survey found.
"That's an alarming response," said Dr. Ana McKee, the chief medical officer for the Joint Commission.
McKee says her agency is in frequent conversations with CMS and either has or will soon consider the issue of using package instructions only to determine drug storage and stability parameters.
CMS officials did not immediately respond to requests for comment about the survey findings. Previously, Dr. Patrick Conway, CMS chief medical officer, said the agency would work with the ISMP to resolve the issue.
The survey results should help with discussions already underway, said Erin Fox, manager of the Drug Information Service at the University of Utah, which tracks drug shortages.
“Overall, I am very hopeful that the CMS rule regarding package inserts will be reversed,” she said in an email to msnbc.com.
In the meantime, she noted that stepped-up federal attention seems to be slowing reported drug shortages.
“We are at 34 new shortages for this year. Half the rate of last year!” Fox said. “I think the FDA’s efforts are paying off."