105543
05/22/2025
St Andrews Bay Skilled Nursing and Rehabilitation
2100 Jenks Ave Panama City, FL 32405
F 0756
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
Ensure a licensed pharmacist perform a monthly drug regimen review, including the medical chart, following irregularity reporting guidelines in developed policies and procedures. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, staff interviews, and policy review, the facility failed to ensure that the consultant pharmacist identified and reported irregularities related to the long-term use of an anti-psychotic medication and thyroid medication for 1 of 5 sampled residents reviewed for unnecessary medications. (Resident #20) The findings include: Resident #20's medical record revealed the resident was admitted to the facility on [DATE] with a diagnosis of Diabetes Mellitus. The current physician's orders revealed the resident received Levothyroxine Sodium 50 mcg (thyroid medication) by mouth daily for hypothyroidism since 6/16/23 and Abilify 15 mg tablet (anti-psychotic medication) orally daily for bipolar disorder with an original start date for the medication of 11/15/22. The record revealed no current physician's orders for laboratory testing related to these medications. The physician's order history revealed no laboratory tests had ever been ordered to check the resident's thyroid stimulating hormone (TSH) or free T4 (a test to assess thyroid function and the levels of the active thyroid hormone) since the resident had started the Levothyroxine Sodium in 2023. Additionally, no physician's orders to routinely monitor the resident's fasting blood glucose related to the use of Abilify. The most recent laboratory data in the resident's record was from a hospital visit on 2/8/24. The result of the laboratory data on 2/8/24 revealed the resident's glucose was abnormal. The last 12 months of consultant pharmacist medication regimen reviews (5/2024- 4/2025) revealed no recommendation to assess a TSH, free T4, or fasting blood glucose related to the use of the Levothyroxine Sodium and Abilify. The package insert manufacturer information for Abilify tablets accessed at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021436s046s050lbl pdf#page=66 on 5/22/25 at 2:40 PM revealed the following: Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
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105543
105543
05/22/2025
St Andrews Bay Skilled Nursing and Rehabilitation
2100 Jenks Ave Panama City, FL 32405
F 0756
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Few
An interview was conducted with the Director of Nursing (DON) on 5/21/25 at 3:57 PM. The DON stated the provider was ordering stat laboratory testing and she would attempt to obtain the blood sample. The DON confirmed there was no other evidence of laboratory testing completed for the resident. A telephone interview was conducted with the Consultant Pharmacist on 5/22/25 at 9:23 AM. He stated nothing really comes to mind for any laboratory testing that should be completed for the long-term use of Abilify, but he would look it up. He would expect at least an annual TSH and T4 test with the use of Levothyroxine. He then stated he was not aware of any recommended laboratory tests to be conducted routinely with the use of Abilify. The facility's policy for Consultant Pharmacist Reports IIIA1: Medication Regimen Review (May 2022) states, The consultant pharmacist performs a comprehensive review of each resident's medication regimen and clinical record at least monthly. The medication regimen review (MRR) includes evaluating the resident's response to medication therapy to determine that the resident maintains the highest practicable level of functioning and preventing or minimizing adverse consequences related to medication therapy. The MRR also involves a thorough review of the resident records and may include collaboration with other members of the interdisciplinary team, collaboration with the resident, family members or other resident representatives. MRR also involves reporting of findings with recommendations for improvement. All
findings and recommendations are reported to the director of nursing and the attending physician, the medical director and the administrator.
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