|§483.45(e) Psychotropic Drugs. |
§483.45(c)(3) A psychotropic drug is any drug that affects brain activities associated with mental processes and behavior. These drugs include, but are not limited to, drugs in the following categories:
(iii) Anti-anxiety; and
Based on a comprehensive assessment of a resident, the facility must ensure that---
§483.45(e)(1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;
§483.45(e)(2) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs;
§483.45(e)(3) Residents do not receive psychotropic drugs pursuant to a PRN order unless that medication is necessary to treat a diagnosed specific condition that is documented in the clinical record; and
§483.45(e)(4) PRN orders for psychotropic drugs are limited to 14 days. Except as provided in §483.45(e)(5), if the attending physician or prescribing practitioner believes that it is appropriate for the PRN order to be extended beyond 14 days, he or she should document their rationale in the resident's medical record and indicate the duration for the PRN order.
§483.45(e)(5) PRN orders for anti-psychotic drugs are limited to 14 days and cannot be renewed unless the attending physician or prescribing practitioner evaluates the resident for the appropriateness of that medication.
Based on clinical record review and staff interviews, it was determined that the facility failed to clinically justify the use of antipsychotic medication for three resident (Resident 61, 41, and 48) out of five sampled residents.
A review of Resident 61's clinical record revealed admission to the facility on January 17, 2020, with diagnoses to include vascular dementia without disturbances.
A physician order dated June 12, 2020, included Zyprexa (an antipsychotic used to treat mental disorders) 2.5 mg daily to treat the diagnosis of mood disorder. On July 22, 2020, the medication was discontinued.
A physician order dated September 3, 2020, reinitiated Zyprexa 2.5 mg daily for vascular dementia without behavior disturbance.
Review of the resident's clinical record revealed two incidents of increased behaviors displayed the resident, one on August 28, 2020, and one on September 3, 2020. The physician was notified of these two instances and Zyprexa 2.5 mg was ordered.
There was no physician documentation of the clinical necessity of the Zyprexa to treat the resident's vascular dementia without behavioral disturbances.
During an interview with the Director of Nursing (DON), she was unable to provide resident-specific individualized documentation by the physician to clinically justify the use of the Zyprexa to treat vascular dementia without behavior disturbances.
Clinical record review revealed that Resident 41 was admitted to the facility on November 10, 2016 with diagnosis to include diabetes, dementia and chronic pain syndrome.
A review of a quarterly Minimum Data Set assessment (a comprehensive, standardized assessment of each resident's functional capabilities and health needs) dated January 21, 2021, revealed that Resident 41 was cognitively impaired and received antipsychotic and antianxiety. daily during the 7 day look back period.
A physician order, initially dated September 10, 2019, was noted for Seroquel (an antipsychotic used to treat mental disorders) 50 mg daily at 2 PM and Seroquel 100 mg at bedtime for dementia. The clinical record indicated that Resident 41 has received this medication at the same dose from the initial order date of September 10, 2019, to the time of the survey ending March 5, 2021.
Review of the resident's monthly behavior monitoring records dated October 2020 through March 2021 (survey ending March 5, 2021), revealed one incident of targeted behaviors displayed by the resident (verbal abuse, name calling) being treated with the antipsychotic medication Seroquel; these instances occurred on November 19, 2020 and October 30, 2020.
A physician order, initially dated July 25, 2019, was noted Klonopin 1 mg ( an antianxiety medication) twice a day for panic disorder/anxiety.
Review of the resident's monthly behavior monitoring records dated October 2020 through March 2021 (survey ending March 5, 2021), revealed three episodes of the targeted behaviors(yelling out and extreme tearfulness) displayed by the resident being treated with the antianxiety medication Klonopin during December (December 5, 24 and 29, 2020), twice in November 2020 (November 5 and 24, 2020) and 8 episodes during October 2020.
There was no physician documentation of the clinical necessity of the Seroquel to treat vascular dementia without behavioral disturbances and Klonopin to treat the panic disorder/anxiety.
A review of a pharmacy "note to attending Physician/prescriber" dated September 14, 2020, requesting a gradual dose reduction of Klonopin and Seroquel. The note indicated that Resident 41 had been receiving Klonopin 1 mg twice daily and Seroquel 50 mg daily and Seroquel 100 at hour of sleep. The pharmacist asked that the physician "Please consider an attempted dose reduction or trial discontinuation as you deem appropriate. If this cannot be accomplished, please document risk vs benefit of continued therapy with current regimen."
The request for a GDR was denied, signed and dated September 25, 2020 by Resident 41's attending physician. The physician statement on the form revealed "followed by psychiatry, meds necessary per psych recommendations."
A review of consultant psychiatry notes dated October 13, 2020, revealed that a GDR was considered, but contraindicated. The note stated "adequate symptom/behavior management/control on current plan and medication, recommend no adjustment at this time."
There was no indication that a gradual dose reduction had been attempted on either the Seroquel or the Klonopin in the past 12 months.
During an interview with the Director of Nursing (DON) the DON confirmed that a gradual dose reduction of the psychoactive drugs prescribed for Resident 41 was not attempted.
A review of Resident 48's clinical record revealed admission to the facility on September 14, 2020, with diagnoses to include anxiety, dementia (a decline in memory or other thinking skills severe enough to reduce a person's ability to perform everyday activities) and major depressive disorder (mental health disorder characterized by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life).
Admission physician orders included Alprazolam 0.25 mg (used to treat anxiety disorder) one tablet, as needed, every eight hours for anxiety.
On September 28, 2020, the physician renewed the order for prn Alprazolam 0.25 mg to continue until October 22, 2020.
On October 22, 2020, the physician renewed the order for prn Alprazolam 0.25 mg to continue until November 3, 2020.
On November 4, 2020, the physician renewed the order for prn Alprazolam 0.25 mg and remains in effect currently.
A review of a pharmacist's recommendation to the physician dated October 19, 2020, revealed that the pharmacist identified that "as needed psychotropic drugs are limited to 14 days and for the physician to evaluate the as needed Alprazolam to see if it can be discontinued or a 14 day stop date could be added to the order."
The physician's response indicated that the resident has been using the medication and will reevaluate in 14 days.
There was no physician documentation that the prn Alprazolam was reevaluated after the 14 days. At the time of the survey ending March 5, 2021, the Alprazolam remained an active order with no stop date.
The physician failed to document justification for the prolonged use of as needed Alprazolam.
An interview with the director of nursing on March 4, 2021, at 1:53 PM confirmed the physician failed to justify and reevaluate the as needed Alprazolam.
28 Pa. Code 211.12 (a)(c)(d)(1)(3)(5) Nursing services
| ||Plan of Correction - To be completed: 04/06/2021|
0758 Residents 61,41, and 48 will have a medication review completed by the consultant pharmacist. All recommendations will be review by the attending physician for his recommendation. The physician will document the reason for continuation or discontinue of the medication. There will be an appropriate diagnosis for each medication. There will be appropriate justification for a denied of recommendation of the pharmacist. There also will be follow up if the physician notes a follow update.
Audit will be completed on residents using anti-psychotic meds for appropriate diagnosis and physician justification of medication. This will be conducted by the consultant pharmacist.
Audit will be completed on any new orders for anti-psychotic meds for appropriate diagnosis and justification of medication, all findings will be reported to the centers QAPI team for review and recommendations times 2 months.
A monthly meeting will be held with the medical director or designee, pharmacist and the interdisciplinary team to review resident on anti-psychotic medication.
In-service and education will be completed for the medical director, pharmacist, and interdisciplinary team.