Failure to Obtain Informed Consent for Antipsychotic Medication
Penalty
Summary
A deficiency occurred when a resident with severe cognitive impairment and a diagnosis of dementia and anxiety was administered ziprasidone, an antipsychotic medication, without proper informed consent. The resident's medical record showed she was admitted for long-term care, had a BIMS score of 0 indicating severe cognitive impairment, and required total assistance with most activities of daily living. The care plan documented the use of psychotropic medications for aggressive behavior, and physician orders prescribed ziprasidone injections as needed. The consent form for antipsychotic medication was signed by the resident's representative prior to administration. However, the form lacked any information regarding the risks and benefits of the medication, and no additional documents outlining these details were attached. The resident's representative later reported being unaware of the potential side effects and believed the medication would be administered as a pill rather than an injection. Interviews with facility staff confirmed that the consent form was incomplete and did not provide the required information about the medication's risks and benefits. Facility policy required that informed consent, including specific information about the risks and benefits of psychotropic medications, be obtained and documented prior to administration. Despite this policy, the system in place failed to ensure that the resident's representative was fully informed before the medication was given. This resulted in the administration of an antipsychotic medication without the representative's understanding of its potential side effects or the intended benefits.