Failure to Obtain Informed Consent for Psychotropic Medication Changes
Penalty
Summary
The facility failed to educate a resident and/or their representative and obtain informed consent prior to making two changes in psychotropic medications for a resident with severe cognitive impairment. The resident had diagnoses including PTSD, depression, and adjustment disorder, and was being treated with multiple psychotropic medications. The care plan included interventions to educate the resident, family, and caregivers about the risks, benefits, and side effects of antidepressant medications. However, when the physician ordered a decrease in duloxetine and initiation and titration of sertraline, there was no documented evidence that informed consent was obtained from the resident or their representative prior to implementing these changes. Review of the electronic health record showed an attempt to notify the resident's wife by leaving a message, but there was no follow-up communication documented to confirm that the representative was informed about the medication changes. Additionally, the facility's provided policy did not address the need for informed consent prior to changes in psychotropic medications, and the informed consent form for the new antidepressant remained unsigned. Staff interviews confirmed that the expectation was for a signed informed consent document to be present when medication changes occurred, but this was not completed in this case.