§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 clinical record review, it was determined that the facility failed to ensure that medication irregularities were acted upon by a physician for four of five residents reviewed (Resident 16, 29, 77, and 137).
Findings include:
Review of Resident 16's Consultation Report for the Medication Regimen Review completed on September 1, 2023, revealed a recommendation to consider a trial dose reduction of Aripiprazole (anti-psychotic medication) to 2 mg at night.
Review of Resident 16's clinical record failed to reveal that the above recommendation was addressed by the physician.
Interview with the Director of Nursing on June 25, 2024, at 1:00 p.m., confirmed that the pharmacy recommendation made on September 1, 2024, was not addressed by the physician.
Review of Resident 29's Consultation Report for the Medication Regimen Review completed on February 1, 2024, revealed a recommendation for a dose reduction evaluation for the medications Clonazepam (Anti-anxiety medication), Haloperidol (Anti-psychotic medicines), and Escitalopram (ant- depressant medication).
Review of Resident 29's clinical record failed to reveal that the above recommendation was addressed by the physician.
Interview conducted with the DON on June 25, 2024, at 1:00 p.m., confirmed that the pharmacy recommendations made on February 1, 2024, were not addressed by the physician.
Review of Resident 77's Consultation report for the Medication Regimen Review completed on May 4, 2024 revealed the pharmacist recommended the facility only order as needed Xanax (anti-anxiety medication) for a duration of 14 days per CMS (Centers for Medicare and Medicaid) regulations. This recommendation was not addressed by the physician until June 24, 2024.
Interview conducted with the Director of Nursing on June 24, 2024 at 1:35 p.m. confirmed Resident 77 recommendations from the pharmacist on May 4, 2024 was not addressed timely.
Review of Resident 137's clinical record revealed Resident 137 was admitted into the facility on May 19, 2023, with a BIMS (Brief Interview of Mental Status) score of 3, indicating severely impaired cognition.
Review of Resident 137's clinical record including admission diagnoses of Dementia with Agitation, Dysphagia (swallowing disorder), Restlessness, Agitation, Psychosis, Depression, Seborrhea Capitis (skin condition), Anemia (low blood cells), and Hypokalemia (low potassium).
Review of Resident 137's clinical records revealed a physician order dated February 23, 2023, for Haloperidol Oral Tablet 1 mg. for psychosis.
Review of Resident 137's clinical records revealed a physician order dated June 2, 2023, for Olanzapine Oral Tablet 5 mg. for dementia with agitation.
Further review of Resident 137's clinical records revealed a physician order dated June 20, 2023, for Mirtazapine Tablet 7.5 mg. for depression.
Review of Resident 137's clinical record revealed that a MRR (Medication Record Review) was completed on January 4, 2024, with two recommendations, "1.) semi-annual dose reduction evaluation requested for the above medications, (Haloperidol 1mg, Olanzapine 5mg, Mirtazapine 7.5 mg). 2.) Periodically reevaluate duel antipsychotic use".
Further review of Resident 137's clinical record revealed that a MRR (Medication Record Review) was completed on May 10, 2024, with the recommendation, " trial dose reduction of the above medications requested, (Haloperidol 1mg, Olanzapine 5mg, Mirtazapine 7.5 mg)."
Review of Resident 137's clinical record failed to reveal documented evidence the pharmacist recommendations were addressed by the attending physician.
Interview with the Director of Nursing on June 24, 2024, at 1:35 p.m. confirmed there was no documented evidence of a response by the physician to the recommendations made by the consultant pharmacist.
483.45 Drug Regimen Review, Report Irregular, Act on Previously cited 11/1/21, 12/30/22, 3/24/23, 8/25/23, 10/23/23
28 Pa. Code 211.5(f) Clinical records Previously cited 11/1/21, 12/30/22, 3/24/23, 8/25/23, 10/23/23
483.45 Drug Regimen Review, Report Irregular, Act on Previously cited 11/1/21, 12/30/22, 3/24/23, 8/25/23, 10/23/23
28 Pa. Code 211.5(f) Clinical records Previously cited 11/1/21, 12/30/22, 3/24/23, 8/25/23, 10/23/23
28 Pa. Code 211.12(c) Nursing Services Previously cited 8/25/23, 10/23/23,
28 Pa. Code 211.12(d)(3) Nursing Services Previously cited 4/4/2023, 8/25/23, 10/23/23,
28 Pa. Code 211.12(d)(1)(5) Nursing Services Previously cited 8/25/23, 10/23/23
| | Plan of Correction - To be completed: 08/06/2024
Residents R16,R77 and R137 had no adverse effects related to Drug Regimen Review. Regional Nurse to re-educate DON/Unit Mangers on importance of follow up to Pharmacy Recommendation's. DON and/or designee will conduct an initial audit of all pharmacy recommendations in the last 30 days to ensure recommendations have been addressed. DON and/or designee will conduct monthly audits x3 to ensure pharmacy recommendations have been reviewed. DON and/or designee will report the findings of the audits to QAPI meetings x3 months.
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