§483.45(d) Unnecessary Drugs-General.
Each resident's drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used-
§483.45(d)(1) In excessive dose (including duplicate drug therapy); or
§483.45(d)(2) For excessive duration; or
§483.45(d)(3) Without adequate monitoring; or
§483.45(d)(4) Without adequate indications for its use; or
§483.45(d)(5) In the presence of adverse consequences which indicate the dose should be reduced or discontinued; or
§483.45(d)(6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section.
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Observations:
Based on clinical record review and staff interviews, it was determined the facility failed to ensure that residents' drug regimens were free from unnecessary medications by failing to discontinue an unnecessary antibiotic for one resident (Resident 22); failing to provide clinical justification for the use of duplicate antidepressant medications for one resident (Resident 42); and failing to ensure that one resident's (Resident 48) medication regimen was free from unnecessary psychoactive medication, including administering an as-needed antianxiety medication beyond 14 days without adequate clinical justification and without documentation of attempted non-pharmacological interventions, for three of eighteen sampled residents.
Findings include:
A review of Resident 22's clinical record revealed the resident was admitted to the facility on April 7, 2022, with a diagnosis to include dementia (a decline in memory, thinking, and other cognitive abilities, significantly impacting daily life) and chronic kidney disease (a condition where kidneys are damaged and lose their ability to filter waste and fluids from the blood).
A review of a physician order dated May 4, 2025, for Bactrim DS 800-160mg tablets- Give 1 tablet by mouth every morning and at bedtime for Urinary tract infection (an infection in any part of the urinary system, usually caused by bacteria.) for 10 days.
A review of a facility policy "Antibiotic Stewardship" last reviewed by the facility on April 23, 2025, revealed appropriate indications for antibiotic include minimum criterial met for clinical definition of active infection by utilizing McGreer Criterial (a set of definitions used in long-term care facilities to standardize the identification and classification of infections)
A review of Resident 22's clinical record revealed a McGreer Criteria Checklist completed on May 5, 2025. The checklist indicated it was reviewed by the medical doctor, director of nursing, and infection control preventionist. The checklist documented that Resident 22 had no urinary tract-related symptoms and did not meet criteria for antibiotic use. A progress note dated May 9, 2025, at 6:08 PM, documented the resident was still receiving oral antibiotic therapy for a urinary tract infection while denying any symptoms. No evidence was found that a urinary specimen was obtained to confirm infection. A review of the Medication Administration Record (MAR) for May 2025 confirmed Resident 22 received twenty (20) doses of Bactrim DS without documentation of a culture or other evidence indicating infection.
During an interview with the Director of Nursing on July 1, 2025, at approximately 11:00 AM, the DON confirmed the facility could not provide any additional documentation to support the antibiotic use for Resident 22.
A clinical record review revealed that Resident 42 was admitted to the facility on November 29,2023, with diagnosis to include dementia the loss of cognitive functioning that affects a person's ability to perform everyday activities) and anxiety (a feeling of fear or dread often triggered by stressful situations).
Physician orders included Trazodone HCL, 25 mg (antidepressant) by mouth at bedtime for increased depression (initiated February 2, 2025), and Remeron, 7.5 mg (antidepressant) by mouth at bedtime for appetite/depression (initiated January 17, 2025). The clinical record did not include documentation justifying the concurrent use of duplicate antidepressant medications.
An interview was conducted with the Director of Nursing (DON) on July 1,2025, to review the above findings related to antidepressant therapy, the DON confirmed there was no clinical justification available for the duplicate antidepressant medications.
A review of Resident 48's clinical record revealed the resident was admitted to the facility on April 24, 2024, with diagnoses to include post-traumatic stress disorder (PTSD a disabling disorder that develops after exposure to a traumatic event. It is characterized by intrusive thoughts, nightmares, and flashbacks; avoidance of reminders of the trauma; negative cognitions and mood; hypervigilance and sleep disturbance) and dementia (the impaired ability to remember, think, or make decisions that interferes with doing everyday activities).
A review of Resident 48's physician orders revealed an order dated February 5, 2025, for Ativan (a benzodiazepine that work by enhancing the activity of certain neurotransmitters in the brain and used to treat anxiety disorders) 0.5 mg by mouth every twenty-four hours as needed (PRN) for agitation during care.
Review of Resident 48's electronic medication administration record (eMAR a technology that automates data entry for the administration of medication to patients in healthcare settings and the digital records contain details about the prescribed medication regimen, dosage, timing, and administering staff) dated February 5, 2025, through May 22, 2025, revealed that Ativan was administered on the following dates and times on February 8, 2025, at 1:26 PM, on March 29, 2025, at 5:52 PM, on April 12, 2025, at 6:48 AM, on April 21, 2025, at 10:01 PM, on April 23, 2025, at 10:01 PM, and on May 21, 2025, at 6:02 PM, without documentation that non-pharmacological interventions were attempted before administration. The facility failed to ensure the PRN antianxiety medication order was limited to 14 days and failed to provide documented evidence that the attending physician assessed and justified its continued use.
Additionally, the facility could not provide document evidence that licensed nursing staff attempted non-pharmacological interventions prior to administration of a PRN antianxiety/benzodiazepine medication, Ativan.
Further review of Resident 48's clinical record revealed a monthly pharmacy review completed by the consultant pharmacist dated April 6, 2025, indicated that the resident had been receiving Prazosin 2 mg by mouth daily (a medication used to treat high blood pressure, symptoms of an enlarged prostate, and nightmares related to post-traumatic stress disorder), Remeron15 mg, give one tablet daily ( medication used to treat a certain type of depression called Major Depressive Disorder in adults), Seroquel50 mg by mouth daily (a psychotropic medication used to treat certain mental/mood disorders such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder), Risperdal 25 mg by mouth daily ( atypical antipsychotic used to treat schizophrenia and bipolar disorder, as well as aggressive and self-injurious behaviors associated with autism spectrum disorder) and Ativan 0.5 mg, one tablet every twenty-four hours.
The consultant pharmacist made the request to the attending physician to review the resident's psychoactive medications and consider an attempted gradual dose reduction (GDR) or trial discontinuation, as deemed appropriate, and if deemed clinically contraindicated to please document the clinical rationale. The clinical rationale must address the reason(s) why an attempted GDR would likely impair the resident's function or cause psychiatric instability, by exacerbating an underlying medical or psychiatric disorder.
A review of the physician signed response dated April 22, 2025, revealed to disagree with the consultant pharmacist recommendation and the noted clinical rationale was, "depression, PTSD, anxiety will be impaired with a gradual dose reduction".
The facility could not provide documented evidence the resident's physician provided sufficient clinical justifications for the continued use of the psychoactive medications.
These findings were reviewed with the Director of Nursing on July 1, 2025, at 11:15 AM. The facility could not provide documented evidence to support PRN use of Ativan beyond 14 days, that non-pharmacological interventions were attempted prior to administration, or sufficient clinical justification for the continued use of multiple psychoactive medications.
28 Pa. Code 211.2(d)(3)(5) Medical Director
28 Pa. Code 211.12(d)(3)(5) Nursing services
| | Plan of Correction - To be completed: 08/11/2025
1. (Resident #22, #42, and #48):
Resident #22: Facility can not retroactively correct . The interdisciplinary team (IDT) reviewed the use of Bactrim prescribed on May 4, 2025. The McGeer Criteria Checklist was re-reviewed, . No adverse outcomes were identified. .
Resident #42: Facility can not retroactively correct . The resident's antidepressant therapy was reviewed. A psychiatric consult was obtained, and the concurrent use of Trazodone and Remeron was evaluated for indication of use.
A physician note with individualized, detailed clinical justification for continuation of psychoactive medications will be entered into EHR after review is completed.
Resident #48: The facility can not retroactively correct. The physician order for PRN Ativan is no longer active as a PRN order.
2. DON/designer will complete An audit on active residents prescribed PRN psychoactive medications (including antianxiety and antipsychotics). The audit will include a review on the following: Validation of 14-day PRN use limits, Presence of documented non-pharmacological interventions prior to PRN administration. Facility will conduct an audit of current residents with use of antidepressant therapy concurrent use of dual medication to ensure an justification for continuation of the psychoactive medications. Any issues noted will be forward for psychiatric evaluation and Medical Director review.
The IP/designee will conduct an audit of current residents recieving ABT to ensure McGeer's criteria has been met. Any issues during the audit will be forwarded to the Medical dirextor for further instruction.
3. NHA/designee will educate DON/ADON as well as Licensed nurses on: The requirement to document non-pharmacological interventions prior to administering PRN psychoactive medications. PRN psychoactive medications cannot exceed 14 days without a physician re-evaluation and written justification. The NHA/designee will educate the medical director and DON on ensuring that a physician responses to consultant pharmacist MRR recommendations must include specific clinical justifications, not generalized statements. IP/designee nurse will educate nursing staff and Medical Director on use of ABT in accordance with McGeer's criteria.
4. The DON or designee will audit 10 resident records per month for 3 months to ensure: Non-pharmacological interventions are documented prior to PRN use. PRN antianxiety medications are reassessed and updated by Day 14. Residents on concurrent psychoactive medications are justified in the record. Audit findings will be reviewed in monthly QAPI meetings. Pharmacy consultant will continue to review all psychoactive medications and submit monthly reports to the DON, NHA, and Medical Director. DON/designee will audit ABT orders to enusre McGeer's criteria is followed for 30 days then weekly x 60 days with results to QAPI for further review is necesary.
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