Lack of Physician Documentation of Benefit/Risk Analysis for Psychotropic and Antidepressant Therapy
Penalty
Summary
The deficiency involves the facility’s failure to ensure that consultant pharmacist recommendations regarding psychotropic and other medications were reviewed and acted upon by the prescribing physicians, including documentation of a resident-specific benefit/risk analysis or rationale when recommendations were not followed. For multiple residents receiving atypical antipsychotics or antidepressants, the pharmacy recommendation summary reports documented concerns and specific recommendations, but the medical records did not contain corresponding physician documentation explaining the clinical reasoning for continuing the medications or declining gradual dose reduction (GDR). The facility’s policies required a licensed pharmacist to perform monthly drug regimen reviews and for irregularities to be addressed, but the surveyors found that this process was not completed as required at the physician documentation level. For one resident with vascular dementia, unspecified dementia, anxiety disorder, and insomnia, the physician had ordered quetiapine 200 mg at bedtime for dementia with psychotic disturbance. The pharmacy recommendation summary noted that the resident was receiving quetiapine for dementia-related psychosis and included information that patients with dementia-related psychosis treated with atypical antipsychotics have an increased risk of death and cerebrovascular adverse events compared to placebo. The pharmacist’s review stated that a benefit/risk analysis warranted continuation at the present dose, but the physician did not provide a benefit/risk analysis with patient-specific information in the medical record explaining why the resident needed to remain on the medication. For another resident with Alzheimer’s disease and dementia with behavioral disturbance, the physician had ordered quetiapine 25 mg twice daily for dementia with psychotic disturbance. The pharmacy recommendation summary similarly documented that the resident was receiving quetiapine for dementia-related psychosis and reiterated the increased risk of death and cerebrovascular adverse events associated with atypical antipsychotics in this population. The pharmacist again concluded that a benefit/risk analysis supported continuation at the current dose, yet the physician did not document a resident-specific benefit/risk analysis in the chart to justify ongoing use. A third resident with dementia and agitation had a physician’s order for Rexulti 1.5 mg once daily, later documented in the pharmacy recommendation summary as Rexulti 2 mg once daily in the evening for dementia with behavioral disturbance and agitation. The pharmacy report included the same warning about increased mortality and cerebrovascular events in elderly patients with dementia-related psychosis treated with atypical antipsychotics and stated that a benefit/risk analysis supported continuation at the present dose. However, the physician did not document a benefit/risk analysis with patient-specific information in the resident’s medical record. During an interview, the DON acknowledged that she did not see documentation in the charts specifically addressing benefit/risk analysis for these medications and stated that her expectation was that the physician would document this analysis. For a fourth resident diagnosed with depression, unspecified dementia without behavioral or psychotic disturbance, and anxiety disorder, the physician had ordered escitalopram 15 mg daily for depression and Zyprexa 5 mg daily at bedtime for dementia with psychotic disturbances. A pharmacy recommendation summary noted that the resident was receiving Zyprexa for dementia with psychotic disturbance and recommended consideration of GDR, again citing the increased risk of death and cerebrovascular adverse events in elderly patients with dementia-related psychosis treated with atypical antipsychotics. The pharmacist’s review stated that a benefit/risk analysis warranted continuation at the present dose, but the physician did not provide a resident-specific benefit/risk analysis in the record. A later pharmacy recommendation summary for the same resident indicated that escitalopram 15 mg daily was being given and recommended consideration of GDR; the physician did not provide a rationale with patient-specific information as to why a GDR was not done. In an interview, the DON confirmed that a rationale and benefit/risk analysis were not documented in this resident’s medical record and reiterated that her expectation was that such documentation should be present.
