Failure to Obtain Complete Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to ensure residents and/or their representatives were fully informed about specific psychotropic medications, including their names, dosages, routes, and frequencies, as required for informed consent. For one resident with orders for mirtazapine for depression, fluoxetine for depression, and alprazolam for anxiety, the psychotropic medication consent form was dated several months after the medication orders and did not list any of the prescribed psychotropic medications or their details. Another resident with orders for mirtazapine for insomnia and fluoxetine for a mood disorder had a signed psychotropic consent form that also lacked the names of the medications, their dosages, routes, or administration frequencies. A third resident had multiple psychotropic orders, including sertraline for depression, quetiapine in two different strengths for major depressive disorder and behavioral disturbances, mirtazapine for depression, and lorazepam for anxiety. The scanned psychotropic consent for this resident was unsigned and similarly did not specify any of the psychotropic medications, their dosages, routes, or frequencies. Staff interviews confirmed that informed consent was expected before starting or changing psychotropic medications and that consents were to be provided to residents and/or their legal representatives. The facility’s own policy required a signed informed consent on initiation and with any dosage increase of psychoactive medications to ensure potential adverse effects were reviewed, but the documentation reviewed for these residents did not meet those requirements.
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