F0552

E

Failure to Obtain Informed Consent for Psychotropic Antidepressant Medications

Wilmington, North Carolina Survey Completed on 03-26-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to obtain and document informed consent prior to initiating psychotropic antidepressant medications for seven residents reviewed for unnecessary medications. For each of these residents, physician orders were in place for various antidepressants, including duloxetine, sertraline, amitriptyline, trazodone, bupropion, and Prozac, and the Medication Administration Records (MARs) showed that the medications were administered as ordered. However, the electronic medical records (EMRs) contained no documentation that the residents or their responsible parties were informed in advance of the name and purpose of the medications, the risks and benefits, alternatives, or the right to refuse, and there were no signed informed consent forms or progress notes reflecting informed consent discussions.

One resident admitted with depression had an order for duloxetine 30 mg twice daily, was documented as cognitively intact on the MDS, and received the antidepressant in February and March, but there was no record of informed consent. Another resident with stroke and depression had orders for sertraline 75 mg at bedtime and later amitriptyline 25 mg at bedtime for insomnia; the resident had mild cognitive impairment and received these medications, yet the EMR lacked any documentation of informed consent for either psychotropic medication. A third resident with stroke and depression, cognitively intact per MDS, received sertraline 150 mg daily and later 100 mg daily over several months, with MARs confirming administration, but again without any EMR documentation that risks and benefits were discussed or consent obtained.

Additional residents were similarly affected. One cognitively intact resident with major depressive disorder, anxiety, falls, and muscle weakness had new orders for trazodone 50 mg at bedtime as needed for insomnia and bupropion SR 150 mg daily for depression, and received both medications, but there was no documentation of informed consent. Another cognitively intact resident with dementia and insomnia continued trazodone 50 mg at bedtime, and two cognitively intact residents with major depression received Prozac 10 mg daily and duloxetine 20 mg twice daily, respectively; in all three cases, MARs confirmed ongoing administration, but EMRs lacked any evidence that the residents or responsible parties were informed about the medications, including their purpose, risks, benefits, alternatives, or right to refuse, and there were no signed consent forms or progress notes documenting such discussions. Interviews with the Case Manager and DON confirmed they were not aware that consent was required for psychotropic medications and that the facility had not been obtaining informed consent prior to initiation, and the Physician stated she was unaware consent had not been obtained and that obtaining informed consent prior to initiating psychotropic medications was essential.