§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 upon review of facility policy, clinical record review, and staff interview, it was determined that the facility failed to ensure medication regimen reviews were acted upon by a physician for five of five residents reviewed (Residents 37, 43, 59, 75, and 84).
Findings include:
Review of undated facility policy titled, "Pharmacy Medication Regimen Review", indicated that the clinical pharmacist reviews condition concerns and reviews resident's medication regimen to identify any potential causes/concerns. The clinical pharmacist then faxes recommendations back to the facility. The clinical nurse then reviews recommendations and contacts physician for further orders. The physician signs Medication Regimen Review when reviewed.
Review of Resident 37's clinical record revealed that medication regimen reviews were completed on January 15, 2025, February 12, 2025, March 13, 2025, and recommendations were made. Further review of Resident 37's clinical record revealed no evidence of the reviews, recommendations, or evidence that the recommendations were addressed by the physician.
Review of Resident 43's clinical record revealed that medication regimen reviews were completed on January 15, 2025, March 13, 2025, and recommendations were made. Further review of Resident 37's clinical record revealed no evidence of the reviews, recommendations, or evidence that the recommendations were addressed by the physician.
Review of Resident 59's clinical record revealed that medication regimen reviews were completed on July 16, 2024, August 14, 2024, and December 10, 2024, and recommendations were made. Further review of Resident 59's clinical record revealed no evidence of the reviews, recommendations, or evidence that the recommendations were addressed by the physician.
Review of Resident 75's clinical record revealed that medication regimen reviews were completed on June 24, 2024, January 1, 2025, and February 25, 2025, and recommendations were made. Further review of Resident 75's clinical record revealed no evidence of the reviews, recommendations, or evidence that the recommendations were addressed by the physician.
Review of Resident 84's clinical record revealed that medication regimen reviews were completed on July 16, 2024, and August 14, 2024, and recommendations were made. Further review of Resident 84's clinical record revealed no evidence of the reviews, recommendations, or evidence that the recommendations were addressed by the physician.
Interview with the Nursing Home Administrator on April 25, 2025, at 12:00 p.m. confirmed that there was no evidence that the pharmacy recommendations were addressed by the physician.
28 Pa. Code 211.5(f) Clinical records Previously cited 8/12/24, 3/15/24
28 Pa. Code 211.10(c) Resident care policies Previously cited 3/15/24
28 Pa. Code 211.12(d)(3)(5) Nursing services
| | Plan of Correction - To be completed: 06/12/2025
1. Residents 37, 43, 59, 75, and 84 were reviewed by pharmacist. Recommendations forwarded to physician for review and orders were written as indicated/recommended. 2. Facility performed an audit of current residents' pharmacy recommendations completed to ensure physician reviewed and orders written as indicated/recommended. 3. Pharmacy consultant was requested by DON to send pharmacy recommendations to DON, then DON will print our recommendations and present to physician for review and written orders. 4. DON, or designee, will perform random weekly audits for 2 weeks, then monthly audits for 2 months to ensure pharmacy recommendations are completed by physician and orders entered as indicated. Results of audits will be presented at monthly Quality Assurance and Improvement Plan meetings for review and recommendations.
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