Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent and to provide required information to residents or their representatives before initiating or changing psychotropic medications, as required by facility policy. The policy states that all psychotropic medications require resident or representative consent, including awareness of the medication, side effects (including black box warnings when applicable), and risk/benefit information, and that consent must be obtained prior to administration. The policy also requires that residents or representatives be informed of any new medications or dosage increases and that progress notes show evidence of this notification, as well as that nonpharmacological interventions be attempted before obtaining an order for a psychotropic medication. For one resident with dementia and severe cognitive impairment, record review showed multiple psychotropic medications and dose increases, including Rexulti at various dosages, Trazodone, and Memantine. The clinical record lacked evidence that the resident’s representative was informed in advance of the addition of new psychotropic medications or dosage increases, and there was no documentation that the representative was informed of risks, benefits, side effects, or treatment alternatives. The record also did not show that nonpharmacological interventions were attempted prior to initiating these psychotropic therapies. In an interview, the resident’s primary representative stated they were unaware of the additions and dose increases and would have expected to be notified. For another resident with Alzheimer’s disease and severe cognitive impairment, the record showed prescriptions for Seroquel, Trazodone, and Mirtazapine, but there was no evidence that the resident’s representative was informed in advance of the addition of these psychotropic medications, nor that risks, benefits, side effects, or alternatives were discussed. Similarly, for a resident with schizoaffective disorder, the provider ordered Seroquel as needed for sleep, and the medication was administered on two occasions; however, the record did not show that the resident was informed in advance of this addition to the regimen or of associated risks, benefits, side effects, or alternatives, and there was no documentation of attempted nonpharmacological interventions prior to prescribing the PRN Seroquel. In interviews, the physician stated that staff are expected to attempt nonpharmacological interventions before drug therapy, and the DON stated that residents or representatives should be informed of risks, benefits, and side effects of psychotropic medications, but she was unable to provide evidence that such interventions or notifications occurred for the cited residents.
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