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Long-Term Care Survey Alert

Medication Management:

Target Atypical Antipsychotic Use Now To Beat Surveyors To The Punch

Published on Sat May 28, 2005

New FDA forewarning means you need to be forearmed against F329 tags.

Using atypical antipsychotics to treat dementia-related behaviors can improve residents' outcomes in many cases - but it might also trigger new survey scrutiny in the wake of an FDA warning about these medications.

The U.S. Food & Drug Administration recently issued a public health advisory cautioning that elderly patients taking atypical antipsychotics for dementia-related behaviors have about a 70 percent increased risk of dying compared to their placebo-taking counterparts.

You can bet "surveyors will have this information," cautions Kathy Hurst, RN, JD, director of healthcare operations and human resources for Anaheim, CA-based TSW Management Group.

The drugs on the hot list include:

  •  Abilify (aripiprazole),
  •  Zyprexa (olanzapine),
  •  Seroquel (quetiapine),
  •  Risperdal (risperidone),
  •  Clozaril (clozapine),
  •  Geodon (ziprasidone) and
  •  Symbyax, a combination of an antipsychotic (olanzapine) and SSRI antidepressant (fluoxetine).

    Although the causes of death among patients taking the antipsychotics varied, most seemed to be either heart-related (such as heart failure or sudden death) or from infections (pneumonia), according to the advisory.

    Take These 4 Actions Now

    To steer clear of survey woes and litigation stemming from patients taking atypical antipsychotics who suffer a negative outcome, consider these proactive steps:

    1. Focus on OBRA requirements for Rx. Facilities should  take a close look at any resident who might be taking one of the drugs, suggests Hurst. For example, TSW-managed nursing facilities are proactively pulling the charts of every patient with dementia who is receiving an atypical antipsychotic. Staff are reviewing the medical record documentation of the risk-benefit of the medication and nonpharmacological alternatives, etc.

    Remember: To avoid F329 and other tags for inappropriate use of antipsychotics, the facility should  prescribe the medications only to treat dementia-related symptoms that interfere with the resident's functional status or well-being.

    Not all psychotic symptoms bother the patient, notes Joseph Friedman, MD, chief of neurology at Memorial Hospital of Rhode Island in Pawtucket. For example, some hallucinations don't bother patients in the least. "Yet patients who find hallucinations to be very disturbing benefit from treatment," he says.

    2. Obtain informed consent from residents' families or surrogate decision-makers. "Physicians should explain to residents' families the FDA's caution and the risks and benefits of taking the medications," advises Adam Rosenblatt, MD, a geropsychiatrist at Johns Hopkins Medical Center in Baltimore. "The resident's quality of life can be a very important issue in such cases," he adds. "The family may agree that the benefits of the drug in reducing behaviors such as agitation are worth the risks."

    3. Evaluate and document therapeutic effects of the  drugs and any adverse drug  reactions. "Nurses should ... let the physician know if the drug isn't helping the resident's targeted behaviors or if it's causing adverse drug reactions," advises Rosenblatt. "This approach will prevent the patient from being exposed to increased risk without demonstrable benefit," he adds.

    Tip: Make sure to document each step of the nursing process, from assessment to evaluation. Also note the fact that the drugs are improving targeted behaviors, if that's the case, suggests Rosenblatt.

    4. Minimize fall risks. To reduce the risks of falls associated with antipsychotic medications, consider using clozapine or quetiapine because they carry the lowest incidence of Parkinson's-induced symptoms, advises Friedman.

    Of the two, "clozapine is least likely to worsen any motor or gait problems," he says. "But nursing homes often steer away from giving it due to the requirement for blood monitoring for agranulocytosis (weekly for six months and every other week indefinitely)," he notes.

    Clinical tip: Don't assume the traditional antipsychotics, such as Haldol, are safer than the newer generation or atypicals. Limited data also suggest a similar increase in mortality for these drugs, cautions the FDA public health advisory. Traditional or first-generation antipsychotics also cause more extrapyramidal effects, which can increase the risks of falls.

    Read the advisory at     www.fda.gov/bbs/topics/ANSWERS2005/ANSO1350.html.

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