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What Should Hospitals Do When Critical Drugs Are in Short Supply?
In an article published on the health-care website The Conversation, Dr. Philip R. Rossoff, professor of pediatrics at the Duke University Hospital, describes how his institution developed a framework for managing critical drug shortages.
“Four years ago, just before Christmas, my hospital ran out of cytarabine, an essential drug used to treat and cure certain kinds of acute leukemia,” he writes. “This drug was suddenly in short supply across the nation. At Duke, we had enough for about 10 days based upon our historical usage, but after that we could no longer treat those already on therapy or begin treatment for newly diagnosed patients. And we couldn’t ask other hospitals in the region to ‘lend’ us some since they were in the same boat.
“To figure out how to manage the cytarabine shortage, we called an emergency meeting of pharmacists, oncologists, hospital administration, and clinical ethics (that’s me). First, we immediately put all of our stock in one central location to control the supply and distribution.
“Second, we decided not to access the so-called ‘gray market’ for drugs, because the provenance of medications cannot be assured. The gray market is composed of private brokers or dealers of drugs who generally surface only during a shortage.
“Third, we asked our oncologists if they could switch things around a bit for their patients, and perhaps give a treatment course that didn’t involve cytarabine first to conserve the supply.
“Fourth, we decided that –– all things being equal –– we would prioritize giving the drug to children with acute myeloid leukemia rather than adults. This is because the cure rates are much higher in kids and they need less of the drug.
“And finally, we started to make our own cytarabine. Duke Hospital has a compounding pharmacy that was able to produce cytarabine from raw materials. Fortunately, this last move saved us from disaster. The FDA gave us special permission to import cytarabine precursor from England and we prepared sufficient quantities so that we never ran out. However, there was no guarantee we would be so lucky again.”
During recent years, unexpected drug shortages have become common in the U.S., Canada, and Western Europe, Rossoff notes. Shortages primarily affect generic sterile injectables, but a surprisingly broad range of medications have also been affected.
When a drug is scarce, it may be possible to substitute a similar medication, Rossoff says. However, when a drug has no substitution, doctors have to figure out how allocate the scarce treatment.
Rossof used his experience with cytarabine to think about how hospitals should approach rationing drugs when they are scarce, and to develop a policy to handle shortages in the future.
He and his colleagues at Duke wrote a policy that the institution has been using for 2 years and that has served as a model for many other health care centers around the country. They adopted an approach called “accountability for reasonableness.”
Rossoff and his colleagues identified four conditions that should regulate the development of a drug-rationing plan: transparency, relevance, appeals, and enforcement.
“These principles mean that the proceedings, deliberations and rules should be open to all: hospital staff, patients and the public,” Rossoff says. “The rules must be relevant and directly related to the good being rationed. There must be a mechanism for appealing any decisions that are made, and there must be a process for ensuring that the rules actually are implemented and enforced.”
To the four principles of “accountability for reasonableness,” Rossoff and his colleagues added a fifth: fairness.
“Clinically similar patients should be treated similarly,” he explains. “A patient should be no more or less important than any other. The sort of fairness we emphasized was one that spurned any attempt to distinguish patients on the basis of what are known as morally irrelevant facts about them, like their ability to pay or their insurance or who they know, all of which also had no relevance to their clinical situation.”
Rossoff and his team also created a Scarce Drug Allocation task force, which included representatives from the hospital pharmacy, risk management, and clinical ethics, as well as doctors and nurses who had to deal with drug shortages.
These experts decided to allocate scarce drugs based on both clinical need and clinical evidence. They also decided to stop using drugs for investigational purposes, unless the drug in question was being administered in a clinical trial in a non-experimental manner.
Before Rossoff and his colleagues developed their framework, Duke University Hospital had experienced more than 30 shortages affecting an array of drugs ranging from intravenous immunoglobulin to anesthetics.
“In the more than 2 years that we have used this policy, we have had to manage another 30 severe drug shortages,” Rossoff remarks. “Some were resolved by simply substituting a similar drug. Others were controlled by limiting use based on clinical evidence, thus automatically increasing the effective supply. Nevertheless, we did come very close to exposing some patients to delayed treatment.”
Although the framework for managing drug shortages has worked, there are still unresolved issues, Rossoff admits.
“Do we have a greater allegiance to our close community than to those from elsewhere even if the latter have an equal medical need?” he asks. “What about those people who, because of their socioeconomic and educational advantages, can utilize these privileges to come to Duke to get in line for a drug they can’t obtain locally? Clearly these and other thorny challenges demand answers in the real world, and we continue to discuss them.”
Source: The Conversation; January 6, 2015.