§483.45(e) Psychotropic Drugs. §483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic
Based on a comprehensive assessment of a resident, the facility must ensure that---
§483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
§483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
§483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
§483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident's medical record and indicate the duration for the PRN order. §483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.
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Observations:
Based on Food and Drug Administration (FDA) information review, facility policy review, clinical record review, and staff interviews, it was determined that the facility failed to ensure that residents were free of unnecessary psychotropic medications for one of five residents reviewed (Resident 35). Findings include:
Review of the FDA drug safety information revealed a black box warning for quetiapine (Seroquel) (antipsychotic medication) for "increased mortality in elderly patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Seroquel is not approved for elderly patients with Dementia-Related Psychoses."
Review of facility policy, titled "Antipsychotic Medication Use", with a last revised date of December 2016, and a last review date of July 3, 2023, revealed, in part, the following: "Policy Statement: Antipsychotic medications may be considered for residents with dementia but only after medical, physical, functional, psychological, emotional, psychiatric, social, and environmental causes of behavioral symptoms have been identified and addressed; 1. Residents will only receive antipsychotic medications when necessary to treat specific conditions for which they are indicated and effective; 2. The Attending Physician and other staff will gather and document information to clarify a resident's behavior, mood, function, medical condition, specific symptoms, and risks to the resident or others; 3. The Attending Physician will identify, evaluate and document, with input from other disciplines and consultants as needed, symptoms that may warrant the use of antipsychotic medications; and 11. Antipsychotic medications will not be used if the only symptoms are one or more of the following: a. wandering; b. poor self-care; c. restlessness; d. impaired memory; e. mild anxiety; f. insomnia; g. inattention or indifference to surroundings; h. sadness or crying alone that is not related to depression or other psychiatric disorders; i. fidgeting; j. nervousness; or k. uncooperativeness."
Review of Resident 35's clinical record revealed diagnoses that included Alzheimer's Dementia (a chronic disorder of the mental processes caused by brain disease, and marked by memory disorders, personality changes, and impaired reasoning) and dementia in other diseases with unspecified severity and without behavioral disturbance, psychotic disturbance, mood disturbance, and anxiety.
Review of Resident 35's physician order history revealed an order for quetiapine fumarate (Seroquel) give 12.5 milligrams by mouth at bedtime related to dementia in other diseases classified elsewhere, unspecified severity, without behavioral disturbance, psychotic disturbance, mood disturbance, and anxiety for two weeks, then discontinue.
Review of Resident 35's September Medication Administration Record revealed the Resident received their last dose of quetiapine fumarate (Seroquel) on September 11, 2023.
Review of Resident 35's care plan revealed a care plan focus for using drugs that have an altering effect on the mind characterized by problems with cardiac, neuromuscular, gastrointestinal systems as evidenced by a diagnosis of dementia with psychosis, hallucinations, delusions, with an initiated date of March 27, 2023, and a revision date of October 24, 2023.
Review of Resident 35's clinical record failed to reveal a diagnosis of dementia with psychosis, hallucinations, or delusions.
Review of Resident 35's clinical record failed to reveal any other documentation of any episodes or psychosis, hallucinations or delusions exhibited by Resident 35 between September 11, 2023, and October 20, 2023.
Review of Resident 35's clinical record progress notes revealed a physician's progress note dated October 23, 2023, at 6:09 PM, which indicated "Patient with increased behaviors, wandering and agitation since dc [discontinuation] of Seroquel; alert combative; SDAT [Senile Dementia Alzheimer's Type] with agitation resume Seroquel 25 mg HS; Failed GDR [gradual dose reduction]."
Review of Resident 35's current physician orders revealed an order for quetiapine fumarate (Seroquel) 25 milligrams (an antipsychotic medication) give one tablet by mouth at bedtime related to dementia in other diseases classified elsewhere, unspecified severity, without behavioral disturbance, psychotic disturbance, mood disturbance, and anxiety, dated October 23, 2023.
Further review of Resident 35's clinical record and care plan failed to reveal that Resident 35's target behaviors to monitor for were not identified, and that there was no documentation that behaviors were being monitored and documented since the quetiapine fumarate (Seroquel) was ordered on October 23, 2023.
Email communication received from DON on January 10, 2023, at 10:17 AM, indicated that, during Resident 35's tapering of the quetiapine fumarate (Seroquel), the Resident was noted "to be refusing meds" and "scratching at self." She also indicated that "Resident 35 began with increased agitation and exit seeking. Physician reviewed and recommended the restart of Seroquel d/t [due to] failed GDR [gradual dose reduction]." She further indicated that "after 6 days of restart" [Resident 35] was "still noted to have behaviors including uncooperative with care."
Review of Resident 35's September 2023 Point of Care documentation revealed no documentation that care was refused other than locomotion.
Review of Resident 35's October 2023 Medication Administration Record revealed no documentation that medications were refused.
Review of Resident 35's October 2023 Point of Care documentation revealed no documentation that care was refused.
During an interview with the DON and the Regional Director of Clinical Services on January 10, 2024, at 11:10 AM, the findings of Resident 35's Point of Care documentation and Medication Administration for September 2023 and October 2023 were reviewed.
During a follow-up interview with the NHA, DON, and Regional Director of Clinical Services on January 10, 2024, at 12:05 PM, the following concerns were shared: documentation indicated that Seroquel was restarted after one documented episode of wandering that was addressed with an assessment and a wanderguard being placed; there were no target behaviors identified for the use of the antipsychotic at the time it was restarted and that, as of time of meeting, there were still no target behaviors identified; review of point of care documentation and progress notes failed to reveal any documentation of any behaviors being exhibited by Resident 35 between September 11, 2023, and present; refusals of care and/or medications would not warrant the use of an antipsychotic medication; and all residents have the right to refuse medications and/or care. The Regional Director of Clinical Services indicated that Resident 35 did had behavior monitoring of sadness, withdrawn, insomnia, and somnolence in place. Surveyor shared that these had been in place since February 17, 2020, and were associated with Resident 35's antidepressant medication. It was also discussed that these are not typical behaviors to support the use of an antipsychotic. She confirmed that these are not typical behaviors for the use if an antipsychotic.
Follow-up review of Resident 35's physician orders on January 10, 2023, at 1:03 PM, revealed an order dated January 10, 2024, for Behavior Monitoring: (yelling out, agitation, exit seeking) every shift.
During a final interview with the DON on January 10, 2024, at 1:11 PM, the DON indicated that Resident 35's physician orders were revised for target behaviors and that she had no additional information to provide regarding target behaviors or the resumption of the quetiapine fumarate (Seroquel). She confirmed that the Resident's target behaviors should have been identified at the time the medication was ordered. She further indicated that she had no documentation to show that there were any behaviors that warranted the use of an antipsychotic occurring prior to the resumption of the quetiapine fumarate (Seroquel) on October 23, 2023.
28 Pa. Code 211.12(d)(1)(2)(3)(5) Nursing services
| | Plan of Correction - To be completed: 02/14/2024
Resident 35 will have her antipsychotic medications Re-evaluated for use. A house audit will be completed on all residents receiving Seroquel to ensure a supportive diagnosis and an appropriate behavior monitoring is in place. The facility DON or designee will re-educate licensed nursing personnel on the need for residents to receive antipsychotic medications only when necessary to treat specific conditions for which they are indicated and effective. Nursing administration or designee will review 10 residents on antipsychotic medications weekly for four weeks to ensure the medication is appropriate based on symptoms. Audits will be reviewed at the next QAPI meeting.
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