Failure to Obtain Informed Consent for Psychotropic Medication Initiation
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent, including discussion of risks and benefits, prior to initiating the psychotropic medication divalproex sodium for three residents reviewed for unnecessary medications. For each of these residents, divalproex sodium was ordered and administered as a psychotropic/anticonvulsant and mood-stabilizing medication without evidence in the medical record that the resident or their representative had been informed in advance of the risks versus benefits or had consented to the treatment. The Medication Administration Records confirmed that the medication was given as ordered over extended periods. One resident was admitted with diagnoses including unspecified dementia, psychotic mood disturbance, anxiety, and depression, and was identified on the MDS as severely cognitively impaired and receiving antianxiety, antidepressant, and antipsychotic medications. A psychiatric NP note documented increased aggressive behavior, hoarding, and visual hallucinations, with a recommendation to start divalproex sodium. Physician orders show a series of dose escalations from 125 mg twice daily to 500 mg twice daily over time for dementia and psychotic mood disorder, yet the medical record contained no documentation that the resident’s representative was informed of the risks and benefits or provided consent before initiation. The unit manager and DON both acknowledged that consent for this psychotropic medication had been overlooked. A second resident, admitted with unspecified dementia, Alzheimer’s disease, bipolar disorder, and delusional disorder, was also severely cognitively impaired per MDS and was receiving antidepressant, anticonvulsant, and antipsychotic medications. A psychiatric NP note described increased irritability, anger, and agitation, and recommended starting divalproex sodium 125 mg daily, which was subsequently titrated up to 500 mg twice daily according to physician orders. The MAR showed the medication was administered as ordered, but there was no documentation that the resident’s representative had been informed in advance of the risks versus benefits or had consented. The unit manager and DON stated that obtaining consent for this psychotropic medication was their responsibility and that it had been overlooked. A third resident, admitted with unspecified dementia, major depressive disorder, hallucinations, and anxiety disorder, had a psychiatric NP note describing increased evening agitation, cursing, and yelling at staff and peers, with a plan to start divalproex sodium 250 mg twice daily for disturbed mood and anxiety. Physician orders documented dose increases up to 500 mg twice daily for dementia and anxiety, and the MAR confirmed ongoing administration. The resident was identified as severely cognitively impaired on the MDS and was receiving antidepressant, anticonvulsant, and antipsychotic medications. The medical record lacked any documentation that the resident’s representative was informed in advance of the risks versus benefits of divalproex sodium or had provided consent. In interviews, the unit manager and DON again stated that consents for this psychotropic medication were not obtained and were overlooked, while the administrator stated he expected informed consents, including discussion of risks and benefits, to be obtained prior to starting or changing psychotropic medications.
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