Finding Description
Based on observation, interview, and record review, the facility failed to ensure the physician provided the clinical rationale when declining the consultant pharmacist's (CP) recommendations for one of 27 sampled residents (Resident 57). Also, the CP failed to identify Resident 57's seizures as a potential side effect and made recommendation to the facility for the reduction or discontinuance of the medications that may be causing the seizures.
These failures resulted in unnecessary medications and potential for unrecognized and prolonged side effects related to psychotropic medications.
Findings:
A review of Resident 57's clinical record indicated she was an elderly resident admitted to the facility with diagnoses including anxiety, unspecified dementia [impaired ability to remember, think, or make decisions that interferes with doing everyday activities], unspecified severity with other behavioral disturbance, and other seizures [sudden, uncontrolled electrical disturbance in the brain. It can cause changes in your behavior, movements or feelings, and in levels of consciousness].
Resident 57's clinical record indicated she had been receiving Seroquel (an antipsychotic medication) 25 milligrams (mg, unit of measurement) every morning and 50 mg at bedtime (total: 75 mg/day; a moderate dose; maximum dose is 150 mg/day) related to OTHER PSYCHOTIC DISORDER NOT DUE TO A SUBSTANCE OR KNOWN PHYSIOLOGICAL CONDITION since 2/18/2020 (or more than 3 years ago). The facility monitored the behaviors of agitation and verbally aggressive for its use.
Resident 57's clinical record also indicated she had been receiving trazodone (an anti-depressant) 50 mg at each bedtime (a moderate dose) related to insomnia since 11/22/18 (more than 4 years ago). The facility monitored for the hours of sleep for the effectiveness of this medication.
During the survey, Resident 57 was observed on multiple occasions: on 5/24/23 at 9:55 a.m.; on 5/24/23 at 10:01 a.m.; on 5/24/23 at 10:17 a.m.; on 5/24/23 at 11:30 a.m.; on 5/24/23 at 12:48 p.m.; on 5/24/23 at 4:47 p.m.; and on 5/26/23 at 10:28 a.m. During these observations, the resident was observed to be pleasant and quietly talking (or mumbling) to herself in an almost inaudible voice. There was no agitation, distress, or verbal aggressiveness observed.
During an interview with Certified Nursing Assistant Q (CNA Q) on 5/24/23 at 10:05 a.m., she stated the facility staff had been monitoring Resident 57 for seizures because she had multiple episodes in the past. She stated she never witnessed the resident having any behaviors including agitation or aggressive behaviors.
During an interview on 5/24/23 at 10:09 a.m., with CNA R, she stated Resident 57 did not have any behaviors except she was always mumbling in very low voice.
During an interview with the Activity Staff (AS) on 5/24/23 at 10:17 a.m., the AS stated Resident 57 had been brought to the activity room every day, and never had any behaviors while in activity.
During an interview with facility Staff G on 5/24/23 at 10:19 a.m., she stated the staff had been monitoring Resident 57 for seizure activity. She stated, [Resident 57] has been good, doesn't speak. Sometimes she mumbles. Staff G stated the resident had no agitation or any aggressiveness.
A review of the Minimum Data Set (as assessment tool, conducted at least quarterly), dated 10/21/22, 1/12/23, and 4/10/23, indicated the resident had severe cognitive impairment, and had no behaviors exhibited during these assessment periods.
A review of the quarterly Anti-psychotic Medication Care Plan Evaluation, dated 8/24/21, 1/16/23, and 4/11/23, indicated Resident 57 had zero (0) behaviors of agitation and verbal aggressiveness during the previous three months prior to the evaluation. A review of the April and May 2023 MARs (where nursing staff documented the behavior monitoring) indicated zero episodes of the monitored behaviors. In other words, the quarterly evaluation and the MARs indicated the resident had no episodes of the monitored behaviors for at least 8 months, from October 2022 to May 2023.
A review of the quarterly Psychotropic Meetings for Antidepressant, dated 9/2/21 and 4/11/23, indicated the resident had good sleep of about 6-8 hours per day all three months prior to the meeting.
A review of the care plan for seizure-like movements, initiated 11/12/19, indicated the resident had seven (7) episodes of seizure or seizure-like activity: on 4/11/2020, 4/24/2020, 8/25/21, 9/14/21, 4/11/22, 8/5/22, and on 11/30/22.
A review of the nursing progress notes, documented on 8/5/22 at 10:29 p.m., indicated, Staff heard a scream coming from her room, staff . went to check resident. Resident note[d] with seizure like movement lasting 30 secs. Noted resident twitching and stiff. Eyes wide open, noted clenching mouth, labored breathing, and non-verbal when talk to. No noted injury .
A review of another nursing progress notes, documented on 11/30/22 at 12:35 p.m., indicated, Seizure . Resident sitting upright during breakfast when she was noted with seizure like movement. Movement approx 15-20 seconds. Resident became non-responsive to verbal and tactile stimuli. Eyes open . Assisted back to bed by staff .
A review of Lexi-comp, a nationally recognized drug information resource, indicated the side effects of Seroquel included seizures. Under Disease-related concerns, it indicated, Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures . or concurrent therapy with medications which may lower seizure threshold. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.
Regarding the use of trazodone, Lexi-comp also indicated one of its potential side effects was seizures, and Use with caution in patients at risk of seizures, including those with a history of seizures concurrent therapy with medications that may lower seizure threshold. Lexi-comp indicated to monitor for seizure activity in patients receiving trazodone.
A review of the consultant pharmacist (CP)'s recommendations, called the monthly medication regimen review or MRR, indicated the CP recommended for the gradual dose reduction (GDR) of Seroquel and trazodone on 10/29/20, 3/23/21, 4/17/22, 4/14/23, and 4/30/23. The physician declined these recommendations.
A concurrent interview and record review was conducted with Nursing Supervisor H (NS H) on 5/24/23 at 11:37 a.m. A review of CP's recommendations for GDRs (as stated above) with NS H indicated the physician just checked the CP's pre-printed template of Resident with good response, maintain current dose as a response. Specifically, on 4/14/23, the CP made a recommendation for changing Seroquel to another medication, Depakote; and again on 4/30/23, the CP asked for consideration for Seroquel and/or trazodone reduction. The physician placed a check mark on the DISAGREE without providing the clinical rationale explaining why she declined the recommendations. NS H stated, The doctor usually just signs the MRRs and doesn't write the verbiage. She acknowledged the physician should document her rationale why she declined.
During a telephone interview with Resident 57's attending physician on 5/25/23 at 8:30 a.m., she stated Resident 57's seizures had not been verified; that the resident had jerkiness, and the nursing staff may have mistaken it for seizure activity. The physician stated the resident looks uncomfortable as she mumbles to herself and bounces her legs, as the reason why she did not want to make changes to the medications. When asked the reason why she did not document the rationale, as required, for no GDR of the medications, she stated, It's cumbersome. I'll write rationale from here on.
During a telephone interview with the CP on 5/26/23 at 11:41 a.m., he stated, The doctors sometimes give me a 'benefits outweigh the risk,' that's all they give me. The CP stated the facility staff write the rationale in the resident's care plan, but he acknowledged the regulations required the physician to document the clinical rationale when declining his recommendations. When asked whether he identified the resident's multiple episodes of seizures as the potential side effect from Seroquel and/or trazodone and made the recommendation to the facility, the CP stated he was not aware the resident had seizures. He acknowledged Seroquel and trazodone could lower seizure threshold and cause seizures. He stated, Normally seizure is the red flag for me. He stated again that he was not aware the resident had seizures.
A review of the facility's undated policy and procedure (P&P) titled, Tapering Medications and Gradual Dose Reduction, the P&P indicated, Residents who use antipsychotic drugs shall receive gradual dose reductions, unless clinically contraindicated, in an effort to discontinue the use of such drugs . and Attempted tapering of psychopharmacologic [those that control behavior or to treat thought disorder processes] medications . shall be considered as a way to demonstrate whether the resident is benefiting from a medication or might benefit from a lower or less frequent dose. The P&P further indicated the facility shall attempt a GDR at least annually, unless contraindicated after the first year of the resident receiving antipsychotic or psychotherapeutic medications.
A review of the facility's April 2018 P&P titled, Medication Utilization and Prescribing - Clinical Protocol, the P&P indicated, The Physician will provide and/or document a rationale when the .duration . of a prescribed medication is greater than commonly accepted practice .
A review of the facility's undated P&P titled, Medication Regimen Reviews, the P&P indicated, The Consultant Pharmacist performs a medication regimen review (MRR) for every resident in the facility receiving medication . The goal of the MRR is to promote positive outcomes while minimizing adverse consequences and potential risks associated with medication . The MRR involves a thorough review of the resident's medical record to prevent, identify, report and resolve medication related problems . and other irregularities, for example . potentially significant medication-related adverse consequences or actual signs and symptoms that could represent adverse consequences .