Failure to Obtain Informed Consent for Antipsychotic Medication
Penalty
Summary
The facility failed to ensure that a resident was fully informed and able to participate in her treatment decisions, specifically regarding the administration of an antipsychotic medication. Record review showed that a female resident with severe cognitive impairment, diagnosed with unspecified dementia with psychotic features and major depressive disorder, was prescribed and administered Risperdal daily. Despite facility policy and regulatory requirements, there was no documented informed consent (form 3713 Medication Consent Form) signed by the resident or her representative prior to the administration of this medication. The resident's care plan and physician orders indicated ongoing use of antipsychotic medication, and the medication administration record confirmed daily dosing. A pharmacy consultant had previously identified the lack of a signed consent form and instructed the Director of Nursing (DON) to obtain the necessary signature, but this was not completed. Interviews with nursing staff and the interim DON confirmed awareness of the requirement for informed consent and acknowledged that the process for obtaining signatures was not followed in this case. Facility policy outlined the need for clear identification of medication indications, risks, and alternatives, as well as the importance of informed consent prior to administration of high-risk medications such as antipsychotics. Despite these protocols, the required consent was not obtained, resulting in the resident receiving medication without documented agreement or understanding of the associated risks and benefits.