§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 clinical record review and staff interview, it was determined that the facility failed to ensure an appropriate physician response to consultant pharmacist recommendations for three of five residents reviewed for potentially unnecessary medications (Residents 22, 41, and 46).
Findings include:
Clinical record review for Resident 22 revealed a consultant pharmacist recommendation dated July 28, 2023, that requested the physician evaluate a gradual dose reduction (GDR) of Resident 22's Quetiapine Fumarate (Seroquel, an antipsychotic medication used to treat mood/mental disorders).
The physician's response on August 7, 2023, declined to reduce Resident 22's Quetiapine medication with the rationale, "Pt (patient) hasn't tolerated GDR in the past currently stable on current meds."
Physician orders active at the time of the July 28, 2023, pharmacist recommendation instructed staff to administer Seroquel 200 mg by mouth at bedtime.
Resident 22's total daily intake of Seroquel was reduced from 250 mg to 225 mg on February 11, 2023.
Resident 22's total daily intake of Seroquel was reduced from 225 mg to 200 mg on June 28, 2023.
There was no evidence of an increase in Resident 22's problematic target behaviors between February 11, 2023, and August 7, 2023, when the physician indicated Resident 22 had failed a GDR in the past.
A consultant pharmacist recommendation dated January 23, 2024, again requested that the physician evaluate a possible GDR of the Quetiapine medication. The physician disagreed with the recommendation on February 11, 2024, with the rationale, "Benefits > (greater than) Risks." The physician did not provide a clinically significant rationale as the basis for declining the consultant pharmacist's recommendations.
Interview with the Director of Nursing on February 23, 2024, at 12:09 PM confirmed the above findings for Resident 22.
Clinical record review for Resident 41 revealed a consultant pharmacist recommendation dated June 23, 2023, that requested the physician evaluate Resident 41's Seroquel medication for a GDR. The physician disagreed on June 28, 2023, with the rationale, "Pt continues to have symptoms agitation, yelling, etc."
Social services quarterly assessment documentation dated April 25, 2023, at 7:58 AM stipulated that, "(Resident 41) had 0 (zero) days of adverse behaviors throughout the review period."
Review of interdisciplinary progress note documentation dated April 25, 2023, through June 28, 2023, revealed one entry (June 24, 2023, at 6:43 PM) when staff documented Resident 41 was easily agitated but was redirected and calmed, "after short while."
Interview with the Director of Nursing on February 23, 2024, at 12:09 PM revealed that the facility could not provide evidence of Resident 41's ongoing symptoms of agitation, yelling, etc., that the physician referred to in the June 28, 2023, response.
A consultant pharmacist recommendation dated December 19, 2023, again requested that the physician evaluate Resident 41's Seroquel medication for a GDR. The physician disagreed on December 31, 2023, with the rationale, "Benefits > (greater than) risk." The physician did not provide a clinically significant rationale as the basis for declining the consultant pharmacist's recommendations.
Clinical record review for Resident 46 revealed a consultant pharmacist recommendation dated April 27, 2023, that requested the physician evaluate a possible GDR of Resident 46's Seroquel dose. The physician disagreed on May 1, 2023, with the rationale, ""Pt is still agitated, combative..." There was additional handwriting following that statement; however, the surveyor, Director of Nursing, and the Nursing Home Administrator could not decipher the comment when reviewed on February 23, 2024, at 9:45 AM.
Review of interdisciplinary progress note documentation dated March 1, 2023, through May 1, 2023, revealed numerous entries that Resident 46 was kind, smiling, had no signs or symptoms of depression, was calm, cooperative, and pleasant.
Social services documentation dated March 30, 2023, at 9:25 AM revealed that Resident 46 had one day of physical behavior and one day of care rejection throughout the review period (one quarter, approximately three months).
Care plan interdisciplinary documentation dated April 5, 2023, at 1:49 PM reiterated that Resident 46 had one day of physical behavior and one day of care rejection throughout the review period.
Interview with the Director of Nursing on February 23, 2024, at 12:09 PM revealed that the facility could not provide evidence of Resident 46's ongoing episodes of agitation and combativeness that the physician referred to in the May 1, 2023, response.
A consultant pharmacist recommendation dated October 18, 2023, again requested the physician review Resident 46's Seroquel dose for a GDR. The physician's response dated October 23, 2023, indicated that Resident 46 continued to have behavioral symptoms, i.e., combative, yelling, etc.; and that the GDR was not advised.
Interdisciplinary documentation dated October 5, 2023, at 2:10 PM indicated that Resident 46 went to the common areas to socialize with other residents and staff, he participated in group activities, and that he had only one day of physical behaviors throughout the review period.
Review of interdisciplinary progress note documentation dated October 5, 2023, through October 23, 2023, revealed several entries that staff assessed no behaviors for Resident 46. One entry dated October 7, 2023, at 3:57 indicated Resident 46 yelled if another resident and went near him; however, there was no indication of a physically aggressive action.
Progress note documentation beginning October 17, 2023, at 6:48 AM revealed that Resident 46 began abnormal respiratory symptoms such as coughing and abnormal lung sounds.
Nursing documentation dated October 20, 2023, at 5:28 PM revealed that Resident 46's physician ordered antibiotic therapy for Resident 46. Although nursing documentation dated October 20, 2023, at 11:37 PM indicated that Resident 46 had physical behaviors noted only during care, Resident 46 was experiencing acute illness at that time.
Interview with the Director of Nursing on February 23, 2024, at 12:09 PM confirmed that the facility had no behavior tracking other than the above progress note documentation. The facility could not provide evidence of ongoing behavioral symptoms referred to by the physician in his October 23, 2023, declination of the consultant pharmacist's recommendation to GDR the antipsychotic medication.
28 Pa. Code 211.2(d)(3)(8)(9) Medical director
28 Pa. Code 211.9(k) Pharmacy services
28 Pa. Code 211.12(d)(1)(3)(5) Nursing services
| | Plan of Correction - To be completed: 04/04/2024
1. Resident 22, Resident 41, and Resident 46 GDR's will be re-evaluated by MD for Seroquel usage.
2. IDT team will do a whole house audit on GDR's for the month of February to ensure appropriate rationale for accepting or declining the GDR recommendation.
3. DON/Designee will educate MD on GDR process and appropriate rationale for accepting or declining the GDR recommendation.
4. DON/Designee will complete an audit of GDR responses monthly x 3 to ensure proper rationale for accepting or declining the GDR recommendation. Results of the audit will be presented for review and recommendations at the monthly QAPI meeting.
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