§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 clinical record reviews and staff interviews, it was determined that the facility failed to adequately monitor possible side effects and target behaviors for two of five residents reviewed for unnecessary psychotropic medications (Residents 68 and 80).
Findings include:
Review of Resident 68's clinical record revealed diagnoses that included depression, anxiety, and cerebral infarction (a stroke-damage to the brain from interruption of its blood supply). Review of Resident 68's physician orders revealed an order for lorazepam tablet 0.5 milligrams give one tablet via PEG (percutaneous endoscopic gastrostomy-a flexible feeding tube placed through the abdominal wall and into the stomach which allows nutrition to be placed directly into the stomach) tube every 6 hours as needed for anxiety for 14 days, dated February 20, 2025. Review of Resident 68's Medication Administration Records (MARs) for February 2025 and March 2025 revealed that he had received four doses of his lorazepam: February 21, 2025, at 10:54 PM; March 3, 2025, at 11:53 AM and 9:21 PM; and March 6, 2025, at 1:14 AM. Further review of Resident 68's MARs for February 2025 and March 2025, as well as his clinical record progress notes, revealed that there were no non-pharmacological interventions documented as being attempted prior to the lorazepam administration February 21, at 10:54 PM; March 3, at 11:53 AM; or March 6, at 1:14 AM. Further review failed to reveal any identified targeted behaviors, behavior monitoring, or side effect monitoring for the use of the lorazepam. During a staff interview with the Nursing Home Administrator (NHA) and Director of Nursing (DON) on March 6, 2025, at 12:02 PM, the DON confirmed that staff should have been documenting non-pharmacological interventions that were attempted prior to the administration of the lorazepam to Resident 68. She indicated that the order was entered incorrectly and did not allow supplemental documentation of non-pharmacological interventions to be documented on the MAR. The DON also confirmed that behaviors and medication side effects should have been monitored and documented.
Review of Resident 80's clinical record revealed diagnoses that include major depressive disorder (persistent low mood that significantly interferes with daily life) and dementia (a chronic disorder of the mental processes caused by brain disease and marked by memory disorders, personality changes, and impaired reasoning).
Review of Resident 80's physician orders revealed orders for Seroquel (antipsychotic medication) for dementia, buspirone for anxiety disorder, and mirtazapine for depression. Resident 80 also had orders for side effect monitoring every shift for antipsychotic use, antidepressant use, antianxiety medication use, and behavior monitoring every shift.
Review of Resident 80's medication administration record revealed no side effect monitoring documentation and no behavior monitoring documentation for the following dates and shifts: day shift - January 28, 2025; February 2, 14, 15, and 28, 2025; and March 1 and 2, 2025; evening shift - January 27, 28, 30, and 31, 2025, February 1, 2, 8, 14, 15, 22, 24, and 28, 2025; and March 1, 2, and 3, 2025; night shift - January 28 and 29, 2025; and February 2, 6, 8, 14, 16, 19, and 26, 2025.
During an interview with the NHA and DON on March 5, 2025 at 12:13 PM, it was revealed the facility had no addition information regarding the missing documentation. The DON stated it was the expectation of the facility that side effect and behavior monitoring be done as ordered.
28 Pa. Code 201.18(b)(1) Management 28 Pa. Code 211.10(d) Resident care policies 28 Pa. Code 211.12(d)(1)(2)(3)(5) Nursing services
| | Plan of Correction - To be completed: 04/09/2025
1-Unable to retroactively document non-pharmacological interventions and identified targeted behaviors prior to the administration of PRN anxiolytic on February 21st, March 3rd or March 6th for resident 68. Medication orders for any PRN psychoactive medications has been updated to ensure it allows for supplemental documentation of non-pharmacological interventions prior to the administration of PRN psychoactive medications as well as any identified side effects. For resident 80 unable to retroactively document behavior monitoring for day shift - January 28, 2025; February 2, 14, 15, and 28, 2025; and March 1 and 2, 2025; evening shift - January 27, 28, 30, and 31, 2025, February 1, 2, 8, 14, 15, 22, 24, and 28, 2025; and March 1, 2, and 3, 2025; night shift - January 28 and 29, 2025; and February 2, 6, 8, 14, 16, 19, and 26, 2025. Medication administration record for PRN psychoactive medication is set up with supplemental documentation that includes monitoring of targeted behavior, use of non-pharmacological interventions prior to medication administration and monitoring for side effects. 2-Director of Nursing/designee will conduct a facility wide audit of current residents with orders for psychoactive medications to ensure supplemental documentation is added as a requirement to ensure there is appropriate monitoring of possible side effects, non-pharmacological interventions attempted prior to the administration and the effectiveness of those interventions. 3-Director of Nursing/designee will educate facility licensed nurses on Ftag 758 and the importance of ensuring psychoactive medications include supplemental documentation with targeted behavior, non-pharmacological intervention attempted prior to the administration of medication and monitoring for side effects. 4-Director of Nursing/designee will conduct a random sample audit of 5 residents that have orders for PRN (as needed) and/or routine psychoactive medications to ensure there is supplemental documentation to reflect targeted behavior, non-pharmacological intervention attempted prior to the administration and its effectiveness as well as any side effects from the medications. These audits will be conducted weekly for 4 weeks and monthly for 2 months. Results of these audits will be reviewed by the Quality Assurance Performance Improvement Committee for recommendations.
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