Health systems establish rigid guidelines for Xigris

One hospital closely followed PROWESS trial inclusion criteria

The questions about cost and appropriate use of drotrecogin alfa (activated) (Xigris) for the treatment of patients with severe sepsis who have a high risk of death have resulted in health systems establishing rigid guidelines for its use.

Duke Medical Center in Durham, NC, established a rigorous process for developing usage guidelines that involved its intensive care practicing physicians and pharmacists. "That’s been a six-month process — working on where we would like this drug to be used and who can prescribe it," says Steve Dedrick, MS, director of pharmacy.

Duke has created an ordering form that guides the prescribers through a checklist of clinical issues. "We think that if physicians follow that guideline check-off sheet, they automatically self-select their patient based on the way the questions are answered," he says. At the end, the form tells the prescribers if they get the drug or not.

"We’re trying to make sure that everyone understands that this is not a drug without some risk," Dedrick says. Physicians who are not aware of these risks would learn about them after reading that part of the check-off form. "If certain conditions are present, these patients would be selected out based on their risk factors. We see that as an easier process than having some sort of phone call approval."

Duke also will include documentation in the medical record that says the physicians thought about the issues and said "yes" or "no" on the risk criteria.

A look at one hospital’s guidelines

Another hospital chose to model its guidelines (see "Guidelines for drotrecogin alfa (activated) - Xigris," in this issue) on the drug’s Phase III PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis) trial. For example, the hospital adopted the trial’s inclusion criteria almost verbatim. The hospital also restricted usage of the drug to pulmonary critical care, surgical intensive care unit consult service, and infectious disease senior staff physicians only.