Failure to Obtain Informed Consent for Psychotropic Medications
Penalty
Summary
The facility failed to obtain informed consent prior to initiating and adjusting psychotropic medications for one resident. After admission, the resident experienced increased anger, and the neurologist ordered Valium, an antianxiety medication. The resident’s wife reported that she picked up the Valium prescription from the pharmacy and brought it to the facility, and that the only person who asked if she had any questions about the medication was the pharmacist. She stated she did not sign any informed consent for the use of Valium. Review of the clinical record showed diagnoses including Alzheimer’s disease, dementia, and anxiety. Record review revealed multiple physician orders for Valium and buspirone for anxiety, agitation, irritability, and dementia-related behaviors over several weeks, including changes in frequency and dosing, without any signed informed consent forms in the clinical record for either medication. The Social Service Director stated that signed informed consents were required for all psychotropic medications but acknowledged that buspirone did not have a black box icon in their system, so she did not realize it required informed consent. She also indicated that nursing staff were expected to notify her when psychotropic dosages increased so that new consents could be obtained. The DON stated the facility followed all state and federal regulations. The facility’s policy on behavioral management required documentation of discussions with the resident or responsible party regarding risks versus benefits of psychoactive medications, including any black box warnings, but such documentation and signed consents were not found for this resident’s Valium and buspirone orders.
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