Duke physicians come up with a plan for 'tragic choices'

Duke University Medical Center Pharmacies is one of the few in-hospital compounding pharmacies in the country. It gives Duke Hospital an advantage in dealing with drug shortages, but even the raw ingredients they need to formulate medications can become scarce.

Duke compounding pharmacist Ken Latta says they've been out of morphine and other narcotic pain killers commonly prescribed for patients. They have been short on anesthesia drugs used in surgery and commonly used IV solutions.

"A lot of these drugs have been short at one time or another," Latta said.

But why? Often there's a temporary shortage of raw materials, or drug manufacturers stop producing a drug when it's no longer profitable.

It can all boil down to a "tragic choice," having to decide who gets a potentially life-saving drug and who is denied.

"We've gotten very close to it, but fortunately we haven't gotten to that point where we haven't had a treatment option available for the patients," said Duke pharmacist Dr. Kuldip Patel.

"You're not supposed to use the word 'rationing,' because that is a dirty word, but that is indeed actually what it is," said Duke bioethicist Dr. Philip Rosoff.

Rosoff says there is no uniform system in place in the country to decide how to ration scarce drugs. So he and a panel of physicians and pharmacists set out to create one.

"That would obey certain principles of fairness, to benefit the most people that we possibly could," Rosoff said.

The system suggests these decisions need to be free of favoritism.

"Meaning there are no special people," Rosoff said. "Patients are patients, if they are similarly medically situated."

Rosoff hopes hospitals will adopt the system, and then even adapt it to their own needs. He stressed that it must be a plan that is clearly communicated to patients and their families, and there must be an appeals process for patients who might be denied a medication.

There is a move in Congress to expand the powers of the FDA to intervene more with these shortages. But they don't have the power to prevent a manufacturer from making the decision to stop production. Rosoff says this is a public health issue that requires serious action.