§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 facility policies and clinical records, as well as staff interviews, it was determined that the facility failed to respond timely to pharmacy recommendations for four of 27 residents reviewed (Residents 3, 11, 35, 36) and failed to obtain completed pharmacy recommendations for physician review for two of 27 residents reviewed (Residents 10, 29).
Findings include:
The facility's policy for drug regimen review, dated May 6, 2024, indicated that a drug regimen review is performed by a licensed pharmacist for every resident each month. The pharmacist will report any medication irregularities and recommendations to the attending physician on a pharmacy review sheet. The physician will respond to the pharmacist's recommendation on the review sheet, and it will be returned to the facility to be acted upon. The review sheet will be filed in the resident's chart in the physician progress section and will be kept in the chart for one full year.
A quarterly Minimum Data Set (MDS) (assessment of a resident's abilities and care needs) for Resident 3, dated April 12, 2024, revealed that the resident was cognitively intact, was dependent on staff for daily care needs, received insulin (a medication preperation of the hormone insulin), and had a diagnosis of diabetes (disease causing high blood sugar levels).
A pharmacy review sheet for Resident 3, dated March 5, 2024, included a recommendation that a correction needed to be made to Resident 3's orders due a change in insulin dose at bedtime. There was no documented evidence that the pharmacy recommendation was addressed timely by the physician.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendation for Resident 3 on March 5, 2024, was not addressed timely by the physician.
A quarterly MDS assessment for Resident 11, dated May 2, 2024, revealed that the resident was understood and could understand others, required assistance with daily care needs, received insulin and controlled pain medication, and had diagnoses that included diabetes.
Review of a pharmacy review sheet for Resident 11, dated March 5, 2024, revealed a recommendation that the resident may be due for blood work related to drug therapy. However, there was no documented evidence that the pharmacy recommendations were addressed timely by the physician.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendations for Resident 11 on March 5, 2024, were not addressed timely by the physician and should have been.
A quarterly Minimum Data Set (MDS) (assessment of a resident's abilities and care needs) for Resident 35, dated March 8, 2024, revealed that the resident was cognitively impaired, was dependent on staff for daily care needs, and received an antianxiety medication (a drug used to treat anxiety) and an antidepressant medication (a drug used to treat depression).
Progress notes for Resident 35, dated March 5, 2024; April 12, 2024; and May 13, 2024, revealed that a pharmacy review was done and recommendations were made. However, there was no documented evidence that the pharmacy recommendations were addressed timely by the physician.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendations for Resident 35 on March 5, 2024; April 12, 2024; and May 13, 2024, were not addressed timely by the physician and they should have been.
An annual MDS assessment for Resident 36, dated May 14, 2024, revealed that the resident was cognitively intact, was dependent on staff for daily care needs, and was receiving an antianxiety medication (used to control anxiety) and a medication for insomnia (used to control sleep).
Review of a pharmacy recommendation for Resident 36, dated March 5, 2024, revealed a recommendation that it may be appropriate to discontinue one of the medications for anxiety and insomnia and that a correction was made to Resident 3's orders. However, there was no documented evidence that the pharmacy recommendations were addressed timely by the physician.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendations for Resident 36 on March 5, 2024, were not addressed timely by the physician and they should have been.
A significant change MDS assessment for Resident 10, dated May 2, 2024, revealed that the resident was understood and could understand others, was dependent for care needs, received controlled pain medication, and had diagnoses that included atrial fibrillation (irregular heart rhythm).
A progress note for Resident 10, dated February 19, 2024, revealed that a pharmacy review was done and that recommendations were made. However, there was no documented evidence that the pharmacy recommendations were received for the physician to review.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendations for Resident 10 on February 19, 2024, were not obtained for the physician to review and should have been.
A quarterly MDS assessment for Resident 29, dated April 25, 2024, revealed that the resident was understood and could understand others and was receiving controlled pain medication, antipsychotic medications (used to treat mental health disorders), antidepressant medications (used to treat depression) and anticoagulant medications (used to treat or prevent blood clots).
A progress note for Resident 29, dated March 5, 2024, revealed that a pharmacy review was done and recommendations were made. However, there was no documented evidence that the pharmacy recommendations were obtained for physician review.
Interview with the Director of Nursing on June 5, 2024, at 1:34 p.m. confirmed that the pharmacy recommendations for Resident 29 on March 5, 2024, were not obtained for physician review and they should have been.
28 Pa. Code 211.12(d)(3)(5) Nursing Services.
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Resident 3 assessed with no ill effects and/or no noted concerns with not having her March 5, 2024 pharmacy recommendation addressed timely by her physician.
Resident 3's pharmacy review sheet recommendation, dated March 5, 2024, was reviewed and addressed by her physician and the review sheet has been filed in her clinical record.
Resident 11 assessed with no ill effects and/or no noted concerns with not having his March 5, 2024 pharmacy recommendation addressed timely by his physician.
Resident 11's pharmacy review sheet recommendation, dated March 5, 2024, was reviewed and addressed by his physician and the review sheet has been filed in his clinical record.
Resident 35 assessed with no ill effects and/or no noted concerns with not having her March 5, 2024; April 12, 2024 and May 13, 2024 pharmacy recommendations addressed timely by her physician.
Resident 35's pharmacy review sheet recommendations, dated March 5, 2024; April 12, 2024 and May 13, 2024 were reviewed and addressed by her physician and the review sheets have been filed in her clinical record.
Resident 36 assessed with no ill effects and/or no noted concerns with not having his March 5, 2024 pharmacy recommendations addressed timely by his physician.
Resident 36's pharmacy review sheet recommendations, dated March 5, 2024, were reviewed and addressed by his physician and the review sheet has been filed in his clinical record.
Resident 10 assessed with no ill effects and/or no noted concerns with not having her February 19, 2024 pharmacy recommendations addressed timely by her physician.
Resident 10's pharmacy review sheet recommendations, dated February 19, 2024, were reviewed and addressed by her physician and the review sheet has been filed in her clinical record.
Resident 29 assessed with no ill effects and/or no noted concerns with not having her March 5, 2024 pharmacy recommendations addressed timely by her physician.
Resident 29's pharmacy review sheet recommendations, dated March 5, 2024, were reviewed and addressed by her physician and the review sheet has been filed in her clinical record.
Any resident receiving medications has the ability to be affected by this alleged deficient practice.
Current pharmacy recommendations were audited to ensure physician reviewed and accepted or declined recommendations within thirty days of recommendation ensuring timely responses to pharmacy consultant reports and review sheets have been filed in resident clinical records.
Licensed nursing staff, including agency licensed staff, were re-educated on addressing pharmacy consultant reports timely.
Director of Nursing has arranged to verify the number of residents with pharmacy recommendations and the number of residents without pharmacy recommendations with the consulting pharmacist monthly after receiving the pharmacy consultant reports electronically and has created a routine monthly audit to verify current pharmacy consultant report recommendations have been addressed timely within the preceding thirty days.
The Director of Nursing/Designee will audit residents with pharmacy consultant reports to ensure recommendations were addressed timely and filed in resident clinical record monthly times four months until resolved.
Findings from audits will be reviewed by the Quality Assurance Performance Improvement Committee for recommendations and/or resolution at its regularly scheduled meetings times four months for results, areas of improvement and/or continuation of audits.
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