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Duke doctors develop ethical distribution policy for scarce drugs

As certain pharmaceuticals are becoming increasingly scarce, hospitals should create fair and consistent policies to decide how to apportion limited drugs to patients, said Dr. Philip Rosoff, director of Duke Hospital’s clinical ethics program.

In response to shrinking supply in the profit-driven pharmaceutical industry, an interdisciplinary group at Duke Hospital drafted a policy that allocates scarce drugs based on fairness and equity for all patients. The policy uses an algorithm to determine a patient’s priority in receiving drug treatment. Since the Hospital adopted the new policy a year and a half ago, the program has largely been successful, noted Rosoff, lead author of the policy.

“If there is not enough of an effective agent to go around, some people are going to go without it and some people are going to get it,” he said. “Our goal was to create a policy to allocate the dwindling supplies that we have in the most fair process that is possible.”

In a fair process, there should be no “special” patients who have priority on receiving drugs for unethical reasons, Rosoff said. Unethical reasons that sometimes result in patients receiving drug priority include ability to pay, personal connections at the hospital, hospital donor status and relative clout of doctors.

“Similar situations must be treated similarly,” Rosoff added. “Two people who are medically similar—say even an undocumented immigrant with no medical insurance and a major hospital donor—who have an equal chance of benefitting from a drug should have an equal opportunity to access that drug. That was our bedrock principle.”

Many pharmaceutical producers have recently shrunk their supply for business reasons, though demand for pharmaceuticals has remained constant, he said. The industries for generic intravenous drugs and chemotherapeutic agents have taken the largest hit because those drugs are expensive to produce and only generate large profits if they are sold in very high volumes.

Complicated single-producer drugs are also at risk for supply shock when their patents expire, Rosoff added.

“Companies are making decisions based on what is most profitable,” said Dr. Kuldip Patel, associate chief pharmacy officer and co-author of the policy.

The interdisciplinary team consisted of practicing physicians, pharmaceutical specialists and medical ethics specialists. It considered five main principles in drafting the policy, a process that started about two years ago, Rosoff said.

The policy must be completely transparent and have no secrets. There must be a way to enforce all parts of the policy. There should be a mechanism for altering the policy if needed. There should be an appeals process in which both patients and doctors have a path to appeal apportioning decisions. And the policy should be completely fair, he said.

Although each case of scarcity is unique, the policy outlines a general model. According to an article published in the Archives of Internal Medicine Sept. 24, when a hospital’s central pharmacy notices a “critical” shortage of the drug, an immediate inventory of the drug is taken. Additionally, a memorandum is sent to an allocation committee that offers advice in making a prioritization tree and conserving the drug.

This early reaction to a shortage is what makes the policy so effective, Patel said.

Some conservation methods include scheduling patients who need the same intravenous drug in the same session so leftovers can be put in a single vial and only administering scarce drugs for uses which are Food and Drug Administration-approved, meaning that a breast cancer drug would not be used to treat other forms of cancer unless extensive research is published proving the drug is useful in both instances.

Patel noted that extensive algorithms are used when creating the priority tree for a specific drug. There are a number of variables at play and it is difficult to single out a specific factor, such as patient age, as a dominating variable. In some critical shortage cases, priority has been given to patients who can most be readily cured by the drug, existing patients and new patients from the immediate referral region surrounding Duke Hospital.

“We have mostly avoided what we call a ‘tragic choice,’ meaning where we have one dose of drug and two patients who can equally benefit from it,” Rosoff said. “In that case, necessarily, one patient who really needs it gets it and the other does not get it, [but] we have not faced that situation.”

Rosoff added that the policy has not taken any criticism yet, but he said he believes it will when the hospital does inevitably have to make a “tragic choice.” He also said he sees Duke Hospital as a role model for other hospitals concerning drug-apportioning policy.

“In terms of publication, we’re the only one out there,” he said. “Every hospital in the country has to deal with this in one way or another, and I think that we are at the forefront for standardizing this and certainly publicizing it. Hopefully this policy will serve as a guide to other institutions to show this is a workable and reasonably successful way to approach this problem.”

But Duke Hospital is somewhat unique because of the extensiveness of its pharmacy, Patel noted. Duke’s pharmacy has the ability, in some—but not all—cases, to purchase raw materials and produce scarce drugs on-site, if need be. This gives Duke a leg up against some smaller hospitals that do not have this privilege.

“You’re sick and a particular drug can help you? That’s all that matters,” Rosoff said. “That’s how we’re supposed to treat everybody here.”

Correction: An earlier version of this article stated that the drug distribution policy uses a mathematical model, when it in fact does not. The Chronicle regrets the error.

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