Failure to Review and Act on Drug Regimen Recommendations
Summary
The facility failed to implement policies and procedures to ensure that potential irregularities identified by the consulting pharmacist (CP) in monthly drug regimen reviews (MRRs) were timely reviewed and acted upon by the medical provider, medical director, and the director of nursing (DON). This deficiency affected four residents whose records were reviewed. The CP reported that she had not received any response to her MRR recommendations for four months, starting in January 2024, despite notifying the medical director, DON, and nursing home administrator (NHA) about the lack of response. A review of an executive summary report by the pharmaceutical company revealed that numerous MRR recommendations from January to April 2024 had not been returned to the CP to show they had been reviewed and responded to by the medical provider. During the survey, it was found that MRRs for the affected residents were not reviewed and signed by the medical provider until the survey was conducted. The MRRs included recommendations for addressing medications with anticoagulation properties, antipsychotic medications without appropriate indications, and antidepressants, among others. Interviews with the CP and review of the facility's policy and procedures indicated that the facility's leadership was aware of the problem with MRR reviews and responses. The CP had informed the medical director, another physician, the DON, and the NHA about the issue, but no corrective actions were taken until the survey revealed the deficiency. The facility's failure to ensure timely review and response to MRR recommendations created a situation of immediate jeopardy for serious resident harm due to the lack of timely oversight of the residents' medication therapies.
Removal Plan
- MRRs for Residents #51, #15, #60, and #64 were reviewed and given to residents' providers for review and follow up on recommendation. Based on physician review, appropriate changes were made to residents' medication regimens as needed.
- Family and physician notification for Resident #51, #15, #60 and #64 was completed.
- Education completed with DON and assistant director of nursing (ADON) regarding follow up with MRRs.
- DON/designee began reviewing MRRs with resident's provider to assure recommendations were reviewed by the provider. This included all residents with recommendations. All recommendations will be reviewed and completed by residents' providers.
- The DON/designee will begin reporting to the NHA and vice president (VP) of Clinical Services to ensure monthly MRR follow up has been completed. Review tool to be completed to document completing of review.
- The pharmacy consultant will email monthly reports to the attending physician, the Medical Director, DON, NHA, VP of Clinical Services, and Director of Operations for review and follow up. In addition, hard copies will be provided to providers during regular visits to the community.
- Facility pharmacy consultant will complete an Interim Medication Regimen Review (IMRR) on all new residents admitted to the facility twice per week to ensure new admissions are reviewed that would discharge from the facility prior to when monthly MRRs are completed.
- MRRs will be reviewed monthly by DON/designee to ensure recommendations have been reviewed/completed by the provider. Findings will be reported to the QAPI (quality assurance performance improvement) meeting held monthly for further review and recommendation.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
A resident with Parkinson’s disease, dementia, and hypothyroidism was prescribed levothyroxine once daily along with other medications. A consultant pharmacist’s monthly drug regimen review recommended that levothyroxine be given in the morning on an empty stomach, 30–60 minutes before food, per manufacturer instructions. The medical record contained no documented physician response to this recommendation, and the MAR showed the drug scheduled for morning administration while the resident was observed eating breakfast and receiving the medication at the same time. An LPN confirmed administering levothyroxine during the meal, and the DON verified there was no documentation explaining whether or why the pharmacist’s recommendation was or was not followed, resulting in a failure to act on and document the identified irregularity.
A resident with multiple comorbidities, including DM, CKD, morbid obesity, and mobility impairment, had a PRN order for Hydroxyzine Pamoate 25 mg. The consulting pharmacy later recommended discontinuation of this drug, and the physician signed to discontinue it, but nursing staff continued to administer the medication and the order remained active on the MAR for several weeks afterward. This resulted in the resident receiving doses of Hydroxyzine despite the documented decision to stop the medication, contrary to facility policy requiring medications to be administered in accordance with prescriber orders.
A resident with multiple chronic conditions and a documented allergy to metformin was prescribed and administered metformin for 24 days without proper identification or intervention by nursing staff or the consulting pharmacist. The allergy was inconsistently documented in the care plan, and neither the resident's representative nor the physician was notified of the new order or the allergy. The pharmacy's monthly review failed to note the irregularity, and staff interviews revealed gaps in communication and adherence to facility policy regarding allergy checks and reporting.
Two residents did not receive prescribed medications as ordered due to delays in pharmacy delivery and lack of timely follow-up by nursing staff. One resident experienced a delay in starting an antibiotic for a UTI, while another missed several doses of an antianxiety medication, with insufficient documentation and delayed action to resolve the issue.
A resident with a UTI did not receive the prescribed Cipro antibiotic as ordered due to the facility's failure to respond to a pharmacy alert about a drug interaction with tizanidine. The pharmacy withheld the medication pending clarification, but the facility did not act on the notification, resulting in the resident missing several scheduled doses. Documentation showed only partial administration, and the issue was not communicated to the nurse practitioner until days later.
A resident with cognitive impairment and multiple diagnoses continued to receive a higher dose of fluticasone nasal spray despite a pharmacy recommendation, approved by the physician, to reduce the dose or make it as needed. The recommended change was not implemented, and the original order remained active.
Failure to Act on Pharmacist Drug Regimen Recommendation for Thyroid Medication
Penalty
Summary
The deficiency involves the facility’s failure to ensure that pharmacy recommendations from the monthly drug regimen review were acted upon and documented for a resident. The resident was admitted with diagnoses including Parkinson’s disease, dementia, and hypothyroidism, and had current physician orders for levothyroxine 150 mcg once daily, buspirone 50 mg twice daily, and losartan 100 mg once daily. A medication regimen review dated 11/25/2025 included a consultant pharmacist recommendation that levothyroxine be administered consistently in the morning on an empty stomach, at least 30–60 minutes before food, per manufacturer instructions. There was no specific physician response in the medical record to this recommendation, and the facility’s policy stated that consulting pharmacist reviews are sent to nursing and addressed with the primary care provider or consulting specialist for review and follow-up. Review of the resident’s medication administration record for April 2026 showed levothyroxine scheduled for 9:00 a.m. On observation, the resident was seen eating breakfast in the dining area at 8:03 a.m., and an LPN reported administering the levothyroxine 150 mcg to the resident while the resident was in the dining area eating breakfast. The DON confirmed there was no evidence in the resident’s medical record explaining why the consultant pharmacist’s recommendation from 11/25/2025 was or was not acted upon. This lack of documented physician review and action on the pharmacist’s identified irregularity constituted noncompliance with the drug regimen review requirements.
Plan Of Correction
F756 The facility will continue to ensure the pharmacy recommendations from the monthly drug regimen review by a licensed pharmacist are acted upon for all residents, including #08. To ensure compliance with this standard the following measures have been taken: 1. Resident #08 was assessed by the registered nurse and med review completed by 4/28/26. After review of resident's drug regime's, it was discovered that resident #8 had 2 separate medication recommendations on the same form, to be reviewed by two separate practitioners, pharmacy has been instructed and agreed to separate meds on individual forms. 2. Licensed nurses re-educated to facility policy "Drug Regimen Review" by Director of nursing/designee in April 2026 and no later than 5/8/26. Licensed nurses are responsible for ensuring the reviews and recommendations are given to the physician for timely review. 3. Review of all other current residents Drug Regimen orders completed by Director of nursing/designee on 4/16/26 to ensure recommendations were followed up on/reviewed by the physician and address concerns if needed. 4. Audit of drug regime recommendations, pharmacy recommendations, and physician follow up to be completed weekly for four weeks by the Director of nursing/designee. Administrator will present results of these audits to the QAPI committee for ongoing monitoring and further direction.
Failure to Timely Implement Pharmacy and Physician Discontinuation of PRN Hydroxyzine
Penalty
Summary
The deficiency involves the facility’s failure to ensure timely implementation of pharmacy recommendations to discontinue a medication after physician approval. A resident admitted with diagnoses including a displaced right humerus fracture, gait and mobility abnormalities, type II diabetes mellitus, morbid obesity, and chronic kidney disease had a physician order dated 01/27/26 for Hydroxyzine Pamoate 25 mg to be given orally once daily as needed. The five-day admission MDS showed a BIMS score of 10, indicating moderate cognitive impairment, and documented that the resident was receiving a diuretic, opioid, antiplatelet, and antidepressant. On 02/16/26, the consulting pharmacy recommended discontinuation of Hydroxyzine Pamoate 25 mg, and on 02/20/26 the physician reviewed and agreed with this recommendation, signing to discontinue the medication. Despite the physician’s discontinuation decision, review of the February and March 2026 MARs showed that the Hydroxyzine Pamoate order remained active and the medication continued to be administered. The MAR for February 2026 documented administration of Hydroxyzine Pamoate 25 mg on 02/25/26, and the March 2026 MAR documented administrations on 03/06/26 and 03/11/26. The order itself was not discontinued until 03/16/26. During an interview on 03/17/26, the Regional Nurse confirmed that the pharmacy recommendation to discontinue the medication was made on 02/16/26, the physician signed to discontinue it on 02/20/26, but the medication continued to be given on the above dates and the order remained in place until mid-March. Facility policy on medication administration stated that medications are to be administered in accordance with prescriber orders, which did not occur in this case.
Failure to Identify and Address Resident Allergy During Medication Review
Penalty
Summary
A deficiency occurred when the facility failed to ensure that a resident's allergy to metformin was properly identified and addressed during the monthly medication regimen review by the consulting pharmacist. The resident, who had multiple diagnoses including type two diabetes mellitus, schizoaffective disorder, bipolar disorder, atrial fibrillation, hypertension, and dysphagia, had a documented allergy to metformin in the allergy alert profile. However, this allergy was not consistently reflected in the resident's care plan, and a physician order for metformin was entered and administered despite the known allergy. The medication administration record showed that metformin was given daily for 24 days by four different nurses, even though the allergy was documented in the resident's profile and flagged in the electronic physician order system. There was no documentation that the resident's representative or the physician was notified about the new order for metformin or the resident's allergy to the medication. Additionally, the pharmacy's monthly review did not document the irregularity of the metformin order in the presence of the allergy, and the consulting pharmacist assumed the allergy had been previously addressed without further investigation. Interviews with facility staff and pharmacy representatives revealed a lack of communication and follow-up regarding the allergy and the medication order. The Director of Nursing confirmed that nurses should check for allergies before administering medications and that the resident's representative should have been notified. The consulting pharmacist acknowledged that the allergy should have been investigated further during the monthly review. Facility policies required pharmacists to review medication regimens and report irregularities, as well as evaluate new medication orders for allergies, but these procedures were not followed in this case.
Failure to Ensure Timely Availability and Administration of Medications
Penalty
Summary
The facility failed to ensure that medications were available for administration to two residents, as evidenced by record reviews and staff interviews. One resident, admitted with multiple diagnoses including acute respiratory failure, dementia, and a recent urinary tract infection (UTI), experienced a delay in receiving a prescribed antibiotic (Cefdinir) for the UTI. Although the physician ordered the medication after reviewing laboratory results, documentation showed that the medication was not available from the pharmacy on the evening it was ordered, resulting in a delay until the following morning. There was no nursing note explaining the missed dose, and the delay was confirmed by the Regional Director of Clinical Service. Another resident, admitted with conditions such as pneumonia, esophageal cancer, and anxiety disorder, did not receive a prescribed antianxiety medication (Alprazolam) on several occasions. The medication was marked as pending delivery, and nursing notes indicated that the provider and pharmacy were contacted only after multiple missed doses. There was a lack of documentation regarding the missed doses on some days, and no evidence of timely action to obtain the medication. These findings were verified by facility leadership, confirming delays in medication administration for both residents.
Failure to Respond to Pharmacy Drug Interaction Alert Resulting in Missed Antibiotic Doses
Penalty
Summary
The facility failed to respond in a timely manner to a pharmacy notification regarding a drug interaction for a resident who was prescribed Cipro for a urinary tract infection (UTI). The resident, who was cognitively intact and admitted with diagnoses including UTI and urinary retention, had a new order for Cipro. The pharmacy identified a potential drug interaction between Cipro and tizanidine and notified the facility, requesting clarification or a change in medication. Despite this notification, the pharmacy did not receive a response from the facility, and as a result, did not send the Cipro to the facility. During this period, documentation showed that the resident received only three out of ten scheduled doses of Cipro, with some doses being documented as administered from prepackaged medications. The Certified Pharmacy Technician confirmed that the medication was withheld pending clarification, and the DON acknowledged that the pharmacy's recommendation was not completed. The nurse practitioner was not made aware of the missed doses until several days later. The breakdown in communication and failure to act on the pharmacy's alert led to the resident not receiving the prescribed antibiotic as ordered.
Failure to Implement Physician-Approved Pharmacy Recommendation
Penalty
Summary
The facility failed to ensure that pharmacy recommendations were addressed in a timely manner for a resident with diagnoses including dementia, depression, Alzheimer's disease, and hallucinations. The resident had an active order for fluticasone nasal spray, and the pharmacy recommended either discontinuing the medication or reducing the dose to one spray as needed for rhinitis. Although the physician approved the recommendation to change the order, the physician's order was not implemented, and the original medication regimen remained active. This deficiency was confirmed through record review and interview, affecting one of five residents reviewed for unnecessary medications.
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