Researchers Propose Plan for Managing Drug Shortages
MONDAY Sept. 24, 2012 -- Researchers at Duke University Medical Center have adopted an ethical approach for managing critical drug shortages in the United States.
They say that hospitals and health systems faced with ongoing shortfalls of key drugs for cancer and other diseases should have firm rationing policies based on transparency and fairness.
The Duke team's approach, based on models used to govern some organ donations, establishes clear-cut rules for distributing scarce drugs. It gives priority to patients with the greatest need and to those who will most likely benefit from the drugs.
The policy is outlined online Sept. 24 in the journal Archives of Internal Medicine.
In recent years, many types of drugs, including chemotherapy agents, pain medications and antibiotics, have become scarce in the United States. These shortages force doctors to switch patients to alternative drugs, delay treatment or reduce dosages.
"There's no reason to believe things will get better and, in fact, they may get worse. Hospitals will have to deal with some very dicey issues," report lead author Dr. Philip Rosoff, director of clinical ethics at Duke University Hospital in Durham, N.C., said in a university news release. "For that reason, it's important to establish and follow an ethically defensible policy for how scarce resources are rationed."
Rosoff and his colleagues outlined five essential components for managing drug shortages in an ethical manner:
- Rules are transparent and open to review both internally and externally.
- The policy and its rationale are relevant, clinically necessary and clearly stated.
- Patients and doctors have a path for appeal.
- Rules are followed and enforced by all and for all.
- No patient or doctor is allowed special consideration.
One tactic implemented at Duke was to restrict drugs for uses specifically approved by the U.S. Food and Drug Administration, rather than allow their use for "off-label" purposes.
Also, when medications were running out, hospital officials inventoried the remaining supply, cut back on usage and sought to determine when more might be available. Sometimes patients needing a certain drug were scheduled for the same day so that any leftover amounts could be collected and pooled to reduce waste.
The U.S. Food and Drug Administration has more about drug shortages.
Posted: September 2012
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