Failure to Obtain and Document Informed Consent for Psychotropic Medications
Penalty
Summary
The deficiency involves the facility’s failure to obtain and document informed consent, including discussion of risks and benefits, before initiating or increasing psychotropic medications for multiple residents. For one cognitively intact resident with panic disorder, depression, and anxiety, the NP increased alprazolam from twice daily to three times daily and later increased sertraline in two separate dose changes. Physician orders and MARs showed these medications were administered as ordered over several months, but the medical record contained no documentation that the resident was informed in advance of the risks and benefits of these dose increases. In an interview, this resident reported that no provider at the facility had discussed side effects or the risks and benefits of taking or increasing alprazolam or sertraline. Another resident, who was severely cognitively impaired and admitted with anxiety disorder and major depressive disorder, was started on buspirone per physician order, and the MAR confirmed ongoing administration. The record contained no evidence that the responsible party was informed in advance of the risks and benefits of initiating buspirone. In a telephone interview, the responsible party did not recall any discussion with the provider or facility staff about the risks and benefits of this antianxiety medication at the time of admission. A third cognitively intact resident with anxiety disorder and major depressive disorder had orders for Xanax three times daily and Zoloft at bedtime, with MARs confirming administration, but the medical record lacked documentation that the resident was informed in advance of the risks and benefits of initiating either medication. This resident also did not recall any discussion with providers or staff about side effects or risks and benefits. Interviews with facility staff and leadership showed systemic gaps in the process for obtaining psychotropic medication consents. The NP stated that psychotropic consents were handled by nursing, and the Consulting Pharmacist confirmed that antidepressants and antianxiety medications are psychotropics requiring consent when initiated or increased but did not review consents during monthly medication reviews. The Medical Director reported not recalling discussions of risks and benefits for residents admitted on psychotropics and believed floor nurses and the Rounding Nurse notified residents and representatives of medication changes, expecting consents to be completed when psychotropics were initiated or increased. The Rounding Nurse stated she was responsible for obtaining psychotropic consents but only did so for residents started on antipsychotics after admission, not for residents admitted on psychotropics or for antidepressant and antianxiety medications, as she did not know these were considered psychotropics. The DON confirmed the Rounding Nurse’s role, acknowledged that all entered orders are new orders (including pre-admission medications), and stated she did not know antianxiety and antidepressant medications required consent when initiated or increased. The Informatics Nurse indicated the psychotropic policy definition, which includes antidepressants and antianxiety medications, had not changed and that nurses should know which medications are psychotropics, while the Administrator stated an expectation that psychotropic consents be obtained.
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