Wednesday, February 15, 2012

How FDA Rules are Exacerbating the Drug Shortage

I've posted recently about recent drug shortages for cancer drugs. Now, it appears that antiquated rules and storage information concerning many of these drugs is making hospitals and pharmacists have to throw away drugs that are still good. From MSNBC:
Mounting shortages of crucial drugs are creating a new dilemma for the nation’s hospital pharmacists, who say they find themselves caught between following government rules for storage and safety -- or throwing away vital and lifesaving medications.

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Organizations such as the Institute for Safe Medication Practices and the American Society of Health-System Pharmacists are raising questions about federal rules they believe exacerbate a crisis that saw 267 drugs in shortage last year, up from 211 the year before, the most in U.S. history.

“It’s really a major issue,” said ISMP president Michael R. Cohen. “It’s a waste of money and it’s a waste of drugs in short supply.”

Most drugs, including those in shortage, have specific requirements for handling that limit how long and in what manner they are stored or how quickly they must be used after they're opened, industry experts say. Some must be refrigerated; others must be used within 24 hours after opening, or even immediately.

Those requirements should be listed in the official prescribing information package inserts that are approved by the federal Food and Drug Administration when a drug is cleared. But the directions may be incomplete or outdated. It can be costly and time-consuming to seek new FDA label approval, so updated science often doesn't make it into the inserts.

ISMP officials contend that pharmacists are hamstrung by Medicare regulations that require them to follow only the manufacturers’ package instructions for storage and use of medication, even when it's not current -- and even when there’s valid new scientific information available.

For instance, take the widely-used neuro-muscular blocker succinylcholine, which has been in shortage off and on for more than a year.

"The manufacturer says it's good for two weeks outside the refrigerator, but the literature says it would be good for three weeks or a month," said Allen Vaida, executive vice president for the ISMP. "That period makes a big difference when you're talking about a drug shortage."

According to CMS interpretive guidelines for the agency's standard 482.25, “drugs and biologicals are stored in accordance with manufacturers’ directions and State and Federal Requirements.”

But a recent analysis conducted at Cedars-Sinai Medical Center in Los Angeles confirmed that directions for many of the drugs in shortage are flawed or lacking. Of 50 random drugs on the national shortage list, a third lacked basic information about compatibility with diluents and half lacked information about stability, storage and expiration dates after dilution, according to an ISMP report.

When pharmacists ask the manufacturers directly, the answers still may remain unclear, ISMP officials said. In that case, pharmacists often turn to recent studies or other accepted industry documents for guidance -- or they face trashing drugs based on falsely cautious parameters.

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Some pharmacists refuse to take the risk. At Shands HealthCare, Knudsen, the pharmacy legal director, says rules are rules, even when drugs are in short supply. His hospital has been able to transfer doxorubicin patients safely to other drugs, he said.

"The Florida Board of Pharmacy and USP 797 rules were created to protect patients," Knudsen said. "Selectively choosing which rules to follow, particularly when alternatives to doxorubicin exist, seems risky."

Davidson agrees that standards should not be relaxed to accommodate the crisis of the moment.

"If it’s not drug shortages, it’s going to be something else,” she said.

At the same time, she understands the Catch-22 faced by a pharmacist who knows the drugs he discards could save someone’s life.

“Then I have to do some soul-searching,” she said. “Am I afraid of harming the patient, and that’s why I throw it away? Or am I afraid of regulatory authority?”

If it’s the latter, the pharmacist should seek guidance from the state board of pharmacy before tossing the medication, she said.

As far as experts can say, no hospital has yet faced sanctions for failing to discard drugs during the current shortages. “If someone comes in and surveys, there probably would be hell to pay,” said Burnakis, the Baptist Medical Center pharmacist.

But any sanctions, even in the case of patient harm, would have to be tempered with the reality of trying to salvage life-saving drugs in the midst of a crisis, Davidson said.

"If I were sitting on the jury and someone had to choose to stray from 797 to provide a needed drug to serve a child with cancer, I know exactly how as a juror I would vote."
Only thing is that it won't be a jury deciding an issue of fining a hospital or pharmacy. It is going to be some unaccountable bureaucrat or an investigator retained by the state board of pharmacy that will make the decision.

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