Consultant Pharmacist Fails to Identify Drug Irregularities
Summary
The consultant pharmacist at the facility failed to identify drug irregularities during monthly medication reviews for two residents. Resident 114, who was diagnosed with dementia with behavioral disturbances and major depressive disorder, was prescribed dual antidepressant therapy with Venlafaxine and Mirtazapine. Despite the presence of duplicate antidepressant therapy, the consultant pharmacist did not identify this irregularity or provide recommendations to assess the appropriateness of the therapy. Additionally, there was no documented clinical rationale justifying the prescribing of two antidepressants. Resident 130, diagnosed with dementia with severe agitation and depression, was prescribed Olanzapine, an antipsychotic, without documented justification for its use. The consultant pharmacist's new admission medication review failed to identify the lack of documented justification for the continued use of Olanzapine. Furthermore, the pharmacist identified a discrepancy in the dosing of Aricept, but the resident continued to receive the medication as prescribed without timely clarification or modification. The Director of Nursing confirmed that the consultant pharmacist failed to identify and address medication regimen irregularities for both residents. Additionally, Resident 130's attending physician did not timely act upon the pharmacist's recommendations and failed to provide a documented clinical rationale for the continued use of antipsychotic medication. These deficiencies were found to be in violation of specific Pennsylvania Code regulations related to pharmacy and nursing services.
Plan Of Correction
1. The facility cannot correct the untimely action to justify the prescribing of two antidepressants. However, Resident #114 has an active Gradual Dose Reduction (GDR) in place since 02/03/25 to discontinue his Venlafaxine, removing the antidepressant duplicate therapy. The facility cannot correct the delay in the physician response to pharmacist recommendation. Medication was discontinued on 01/08/2025. Resident #130 has documented clinical rationale for the continuation of Zyprexa as ordered. 2. The DON completed an audit of in-house residents presently on duplicate antidepressant medications on 02/07/2025. Listing reviewed with consulting pharmacist. Consulting pharmacist to issue medication regimen reviews to the appropriate physician to document the clinical rationale justifying the continued prescribing of duplicate antidepressant medication. 3. The DON or designee will re-educate the consulting pharmacist, attending physicians, and medical directors to Tag F 0756 and CMS 483.45(c)(1)(2)(4)(5) requirements, along with the facility's Monthly Medication Regimen Review Policy. 4. The DON or designee will review the monthly medication reviews sent to Elan Skilled by the consulting pharmacist and compare them to the listing of new residents receiving duplicate antidepressant therapy to ensure compliance with CMS 483.45(c)(1)(2)(4)(5) and facility policy. This review will take place for the next three months. Audit results will be reported to the Quality Assurance Performance Improvement committee to determine compliance.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with dementia, depression, and hospice status had an open-ended PRN Haldol order for agitation and restlessness that was administered despite repeated CP recommendations to discontinue it. The record lacked the required face-to-face provider evaluation to justify continued use, and the DON stated she believed hospice status changed the 14-day PRN psychotropic review requirement.
A resident receiving quetiapine for Parkinson’s disease and behavioral disturbance had ordered AIMS monitoring that was not documented in the medical record, despite the consultant pharmacist’s recommendation for baseline and ongoing monitoring. The TAR showed sign-offs without assessment results, a blank entry, and later no sign-off at all, while staff stated AIMS was used to monitor side effects and should be documented in the chart.
Delayed Medication Regimen Review Follow-Up: The facility did not ensure timely follow-up on MRR recommendations for multiple residents. One resident with encephalopathy, MI, and respiratory failure had a pharmacy recommendation to review a psychotropic for possible dose reduction or discontinuation that was still not addressed when reviewed later. Two other residents with depression, anxiety, heart failure, and liver failure had missing or unlocated monthly MRR documentation, and the DON stated the records could not be found after a pharmacy change.
Pharmacy recommendations were not accurately carried out for two residents. One resident with multiple neuropsychiatric diagnoses had trazodone orders that did not match the actual 150 mg tablet being supplied, despite repeated pharmacist recommendations to update the order. Another resident with dementia and other chronic conditions had multiple eye drop orders, but the pharmacist’s instruction to allow 5 minutes between different drops was not added to the MAR/orders, and the DON confirmed the omission.
A pharmacist failed to complete an accurate medication regimen review because the hospital discharge summary and medication orders were not available in time. A resident with AFib and a history of falls was returned from the hospital with Eliquis documented to be discontinued, but the medication was entered and administered twice daily for 27 doses before the error was identified. The Pharmacy Services Director relied on transcribed orders and did not review the discharge summary, and the DON stated the hospital orders were not faxed or scanned promptly.
A resident with DM II, hyperlipidemia, and long-term insulin use had a pharmacist MDRR note recommending CMP, fasting lipid panel, and A1c monitoring, but the physician/prescriber response was left blank and the record showed no order or documentation that the recommendation was reviewed or acted on. Staff confirmed there was no evidence the labs were ordered, despite the facility policy requiring physician documentation of review and action on irregularities.
Unresolved PRN Antipsychotic Order Without Required Provider Evaluation
Penalty
Summary
The facility failed to ensure consultant pharmacist recommendations regarding a psychotropic medication irregularity were addressed for a resident with moderate cognitive deficit, dementia, congestive heart failure, diabetes, and depression who was under hospice care for end-of-life status due to heart failure. The resident’s record showed an active PRN order for haloperidol 1 mg every four hours for agitation and restlessness with an open-ended end date, and the PRN MAR documented administrations on 5/19/26 and 5/26/26. The resident’s care plan noted psychotropic medication use for depression and anxiety, and staff were to document three interventions before giving the PRN medication. Consultant pharmacist recommendation forms dated 3/9/26 and 4/3/26 recommended discontinuing the PRN Haldol because PRN antipsychotic orders were limited to 14 days unless the attending physician evaluated the resident for appropriateness of renewal. The physician signed one recommendation without further response or action, and no physician response was documented for the later recommendation. The medical record lacked a face-to-face assessment by the medical provider to justify continued use of the Haldol, and the facility’s DON stated she believed the regulation had changed for hospice patients. The facility policy also stated PRN psychotropic drug orders were limited to 14 days and could not be renewed unless the attending provider evaluated the resident.
Failure to Document and Complete Ordered AIMS Monitoring for Antipsychotic Use
Penalty
Summary
The facility failed to ensure a licensed pharmacist completed a monthly drug regimen review that included the medical chart and followed irregularity reporting procedures in its policies and procedures. For 1 of 5 residents reviewed for unnecessary medications, R6, the consultant pharmacist identified concerns related to quetiapine use and recommended adding AIMS monitoring at baseline and at least every 6 months unless already ordered, and reporting significant changes to the prescriber as soon as possible. A later pharmacist review noted that an AIMS order had been placed, but documentation showing the assessment was completed was not found in the record. R6’s record showed a quarterly MDS identifying moderately impaired cognition, rejection of care one to 3 days, and dependence on staff for dressing, bed mobility, and toileting. R6 was receiving quetiapine fumarate 25 mg by mouth daily for Parkinson’s disease and behavioral disturbance with agitation, along with 50 mg by mouth daily for the same conditions. Although a nursing order was entered to complete AIMS assessments, the TAR showed the order was signed off as completed on some dates without any assessment results documented, was blank on another date, and had no sign-off or documentation on later dates. During observation, R6 was seated in a wheelchair with a flat affect and mild finger tremor. Staff interviews stated AIMS was important for monitoring side effects and that completed assessments should be documented in the medical record.
Delayed Medication Regimen Review Follow-Up
Penalty
Summary
The facility failed to ensure that Medication Regimen Review (MRR) recommendations were implemented in a timely manner for 3 of 5 sampled residents reviewed for unnecessary medications. For Resident 1, the EHR showed diagnoses of encephalopathy, myocardial infarction, and respiratory failure, and the resident was able to make needs known. The pharmacy completed an MRR on 04/23/2026 and recommended reviewing the use of a psychotropic medication for possible discontinuation or dose decrease, but the recommendation had not been addressed by the provider when reviewed on 05/20/2026. Staff B, the DNS, stated the MRR should have been reviewed and addressed timely but was not. For Resident 150, the EHR showed a readmission with diagnoses including depression, anxiety, and heart failure, and the resident was able to make needs known. Consultation reports for March and April 2026 did not list Resident 150 as having new medication recommendations from the consulting pharmacist, and Staff B stated on 05/26/2026 that they had knowledge of the resident's MRRs for those months but were unable to locate any documentation. For Resident 122, the EHR showed diagnoses of liver failure and depression, and the resident was able to make needs known. The EHR showed an MRR completed on 05/20/2026, but no other monthly reviews were found in the EHR. Staff B stated on 05/20/2026 that the facility had recently changed pharmacies and was unable to locate the March and April 2026 MRRs, and that this did not meet expectations.
Pharmacy Recommendations Not Reflected in Medication Orders
Penalty
Summary
The facility failed to ensure pharmacy recommendations were completed accurately for two residents reviewed for pharmacy recommendations. For one resident with diagnoses including metabolic encephalopathy, depression, cognitive communication deficit, anxiety, and psychotic disorder with hallucinations, the chart showed repeated trazodone orders written as 1.5 tablets of 100 mg at bedtime for insomnia even after the pharmacist recommended changing the order to match what was actually being administered. The pharmacist first noted that the supplier was sending separate 50 mg and 100 mg tablets for a total dose of 150 mg, then later noted the supplier was sending a single 150 mg tablet, but the physician order was not updated to reflect the actual 150 mg tablet until later. The Director of Nursing confirmed the order should have been changed when the pharmacy recommendation was first made and again when it was repeated, but it was not accurately changed until the later order. For another resident with diagnoses including cerebral infarction, diabetes mellitus, hypertension, dementia, anxiety, major depressive disorder, and heart failure, the physician orders included multiple ophthalmic medications for both eyes. The pharmacist recommended adding instructions to allow 5 minutes between administration of different eye drops to all eye drop orders. Review of the physician orders showed that this instruction was not added to any of the applicable orders. The Director of Nursing confirmed the instructions had not been added and stated that nursing staff had been educated about allowing five minutes between eye drop administrations.
Pharmacist Did Not Identify Eliquis Discontinuation After Hospital Return
Penalty
Summary
The facility failed to ensure that a licensed pharmacist completed a monthly drug regimen review using the resident’s medical chart and the hospital discharge summary, as required by its policies and procedures. For one resident admitted with atrial fibrillation and a history of falls, the resident was sent to the hospital for weakness, recurrent falls, and a fall with a head strike that caused increased confusion. The hospital discharge summary indicated that Eliquis was to be discontinued because of repetitive falls and bleeding risk, and the summary also contained a handwritten notation crossing out Eliquis and initialed by the facility PA. When the resident returned to the facility, an order for Eliquis 5 mg twice daily was entered into the electronic record, and the medication was administered twice daily from 3/23/26 through 4/5/26 for a total of 27 documented doses. The Pharmacy Services Director stated he completed the initial pharmacy review based on the physician orders entered into the computer and did not review the hospital discharge summary because it was frequently not available at the time of the initial review. The DON stated the hospital medication orders were not faxed to the pharmacy and were not scanned into the resident’s electronic record for several days, which prevented the pharmacist from having the orders in time to complete an accurate medication review. The PA stated she had documented that Eliquis was to be discontinued, but later discovered the resident had erroneously received the medication and that the pharmacist had not identified the error on the initial review.
Pharmacist MDRR Recommendation Not Addressed
Penalty
Summary
The facility failed to ensure that irregularities identified in the Monthly Drug Regimen Review were acted upon for one sampled resident. Resident 5 was re-admitted with diagnoses including Type 2 Diabetes Mellitus, hyperlipidemia, and long-term insulin use. The resident’s MDS dated 3/25/2026 indicated severely impaired cognition and dependence for toilet use, personal hygiene, and showers/baths. A note from the facility pharmacist, printed 3/12/2026, asked the attending physician/prescriber to consider ordering a CMP, fasting lipid panel, and A1c based on Resident 5’s medications. The physician/prescriber response section was left blank, and there was no documentation in the record showing that the physician ordered the labs or otherwise documented agreement or disagreement with the pharmacist’s recommendation. During record review, the IP stated there was no physician order or documentation showing the labs were ordered, and the RN and DON stated the pharmacist’s recommendations were important for monitoring medications. The facility policy stated that the attending physician documents in the medical record that the irregularity has been reviewed and what action, if any, was taken.
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