§483.45(c) Drug Regimen Review. §483.45(c)(1) The drug regimen of each resident must be reviewed at least once a month by a licensed pharmacist.
§483.45(c)(2) This review must include a review of the resident's medical chart.
§483.45(c)(4) The pharmacist must report any irregularities to the attending physician and the facility's medical director and director of nursing, and these reports must be acted upon. (i) Irregularities include, but are not limited to, any drug that meets the criteria set forth in paragraph (d) of this section for an unnecessary drug. (ii) Any irregularities noted by the pharmacist during this review must be documented on a separate, written report that is sent to the attending physician and the facility's medical director and director of nursing and lists, at a minimum, the resident's name, the relevant drug, and the irregularity the pharmacist identified. (iii) The attending physician must document in the resident's medical record that the identified irregularity has been reviewed and what, if any, action has been taken to address it. If there is to be no change in the medication, the attending physician should document his or her rationale in the resident's medical record.
§483.45(c)(5) The facility must develop and maintain policies and procedures for the monthly drug regimen review that include, but are not limited to, time frames for the different steps in the process and steps the pharmacist must take when he or she identifies an irregularity that requires urgent action to protect the resident.
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Observations:
Based on a review of clinical records and staff interview that the attending physician failed to act on pharmacist identified drug irregularities in the drug regimen of three residents out of 5 sampled (Resident 21, 102, and 112).
Findings include:
Review of Resident 21's clinical record revealed she was admitted to the facility on January 31, 2023, with diagnosis to include depression, and anxiety.
A review of a Consultation Report, "Note to attending Physician/Prescriber", from the Pharmacist date printed November 16, 2023, revealed that the pharmacist identified that Resident 21 had an order for Trazodone 50 milligram (mg) for depression and this medication was due for assessment, if no dose reduction (GDR) is indicated, please include a brief, patient specific, rationale below. The physician response, dated November (illegible), "defer to meditelecare" (telehealth services).
Review of Resident 102's clinical record revealed that the resident was admitted to the facility on January 6, 2023, with diagnosis to include depression, anxiety, and bipolar.
A review of a "Note to attending Physician/Prescriber", from the Pharmacist date printed October 19, 2023, revealed that the pharmacist identified that Resident 102 had an order for Lexapro 20 mg every day (QD) for depression. The pharmacist identified that this medication was due for assessment, if no dose reduction (GDR) is indicated, please include a brief, patient specific, rationale below. The physician responded, dated October 26, (no year), "defer to psych."
A review of a "Note to attending Physician/Prescriber", from the Pharmacist date printed November 16, 2023, revealed that the pharmacist identified that Resident 102 had an order for Clonazepam oral tablet 0.5 mg, give 1 tablet by mouth two times a day for anxiety (GDR from three times a day (TID) May 2023. The pharmacist identified that this medication is due for assessment, if no dose reduction (GDR) is indicated, please include a brief, patient specific, rationale below. The physician did not respond to the identified irregularity, however, the Certified Registered Nurse Practitioner (CRNP) noted, dated November (illegible), "defer to meditelecare."
A review of a "Note to attending Physician/Prescriber", from the Pharmacist date printed November 16, 2023, revealed that the pharmacist identified that Resident 102 has an order for Lamictal 150 QD for anxiety/depression (GDR May 2023). The pharmacist reported that this medication is due for assessment, if no dose reduction (GDR) is indicated, please include a brief, patient specific, rationale below. The physician response, dated November (illegible), "defer to meditelecare."
Review of Resident 112's clinical record revealed the resident was admitted to the facility on December 14, 2023, with diagnoses to include anxiety and depression.
A review of a Consultation Report, "Note to attending Physician/Prescriber", from the pharmacist dated February 8, 2024, revealed that the pharmacist identified that Resident 112 has an order for Paroxetine (antidepressant medication) 10 mg for depression. The pharmacist reported to the physician that this medication is on the Beers List (list of potentially inappropriate medication used in older adults over age 65, and is noted as a high-risk medication for utilization in the elderly due to potential for anticholinergic effects, that include dry mouth, constipation, urinary retention, increased heart rate, sedation, and orthostatic hypertension). The pharmacist requested that the physician Please review risks versus benefits for continued utilization of the medication and consider if alternative SSRI (selective serotonin reuptake inhibitor, type of antidepressant medication) would be appropriate for the resident. The physician response dated February 14, 2024, was solely noted as "refer to psych."
The attending physician(s) failed to document their actions in response to these reports and recommendations and the rationale for their response, agreement or disagreement with each recommendation, in the residents' medical records.
Interview with the Director of Nursing (DON) on March 15, 2024, at approximately 8:25 AM confirmed there was no documentation at the time of the survey ended, that the attending physicians had acted upon these reports of drug irregularities. The attending physician and CRNP solely deferred or referred the recommendations, without documentation of the action taken or not taken to address these irregularities, which was confirmed during interview with the Nursing Home Administrator on March 15, 2024, at approximately 8:31 AM.
28 Pa. Code 211.9 (k) Pharmacy services.
28 Pa. Code 211.2 (d)(3)(8) Medical director
| | Plan of Correction - To be completed: 04/30/2024
Resident #21, 102, and 112 current GDR pharmacy recs were reviewed by the MD.
The facility will complete a review of current resident for the last 30 days who had GDR pharmacy recs. Identified recommendations that were not acted upon by the attending physician will be reviewed with MD for rationale of their response.
The DON will educate medical staff, CRNP's and MDs, that a rationale must be documented on the pharmacy rec. Monthly audits by DON/ Pharmacy / Designee will complete a review and audit the pharmacy recommendations by the physician to assure physician has addressed and supporting documentation is present for their pharmacy recommendations.
DON/designee will audit pharmacy recommendations monthly as they occur to ensure physician rationale to address identified drug irregularities were addressed. Results to QAPI monthly to determine if additional audits are needed.
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