Long-Term Care Survey Alert

Published on Fri Apr 13, 2007 PDF

Stay on top of the dangers of these anemia-fighting meds.

Many residents receiving chemo or dialysis may be taking ESAs to treat or stave off anemia. But the U.S. Food and Drug Administration recently sounded the alarm about the safety of these medications--a warning that you can bet surveyors will check to see that your facility is addressing.

Recent studies show "a higher chance of serious and life-threatening side effects and a greater number of deaths in patients treated with these agents," states the FDA in a March 2007 alert on ESAs. The FDA is currently re-evaluating the safe use of the medications, which include Procrit, Aranasep and Epogen, and requiring their drug-makers to update the package inserts to inform providers of the risks.

Heightened liability risk: "When there is a highly publicized alert or information about a treatment's adverse effect, the facility may have liability if it doesn't address it," cautions Donna Holshouser Stinson, JD, partner with the law firm of Broad and Cassell in Tallahassee, FL.

Be Aware of These Potential Negative Outcomes

The FDA alert cites these important study results:

• Patients with chronic kidney failure suffered an increased number of deaths and non-fatal heart attacks, strokes, heart failure, and blood clots when they received ESAs adjusted to maintain higher red blood cell levels (hemoglobin more than 12 g/dL).

• Patients with head and neck cancer receiving radiation therapy had faster tumor growth when they received ESAs adjusted to maintain hemoglobin levels higher than 12 g/dL.

• Patients with cancer not receiving chemotherapy died sooner and had no fewer blood transfusions when they received ESAs based on the dosing recommendations for cancer patients receiving chemotherapy.

• Patients scheduled for orthopedic surgery who received ESAs to reduce blood transfusions during and after surgery had more blood clots than those who didn't receive an ESA.

The bottom line: "Once the patient's hemoglobin approaches 11 g/dL, the prescribing clinician should cut back the dosage or stop the drugs," advises James Cooper, PhD, at the University of Georgia in Athens. "We used to shoot for a hemoglobin of 13 or 14 but the mortality data from recent studies and subsequent FDA alert changes that," Cooper cautions.

Tip: Keep in mind that Aranasep is longer-acting than Procrit or Epogen, says Cooper.

Nurses are on the front line in detecting physician orders related to ESA agents. "A nurse has the responsibility to question a medication order or care practice," says Stinson, who has seen survey agencies take that stance.

Head off F501 tags: "The medical director needs to work with the consulting pharmacist to ensure the nursing facility observes the latest FDA advisories," says Charles Crecelius, CMD, MD, PhD, multifacility director of Delmar Gardens in St. Louis, MO.

Report problems: The FDA asks healthcare professionals and patients to report serious side effects after using ESAs to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch.