FF11 483.45(c)(3)(e)(1)-(5):FREE FROM UNNEC PSYCHOTROPIC MEDS/PRN USE

REGULATION: §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: (i) Anti-psychotic; (ii) Anti-depressant; (iii) Anti-anxiety; and (iv) Hypnotic 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.

Scope: Isolated
Severity: Potential to cause more than minimal harm
Citation date: September 13, 2019
Corrected date: November 11, 2019

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on interview, and record review conducted during the Standard survey completed on 9/13/19, the facility did not ensure each resident's drug regimen is free from unnecessary drugs, and residents who have not used [MEDICAL CONDITION] drugs are not given these drugs unless the medication is necessary to treat a specific condition as [DIAGNOSES REDACTED]. An unnecessary drug includes drugs used without adequate indications for its use and without adequate monitoring for one (Resident #142) of four residents reviewed for unnecessary antipsychotic medications. Specifically, there was a lack of adequate indication for use, lack of revised non pharmacological interventions prior to increasing dose, and the lack of behavioral documentation to support the increased dose of [MEDICATION NAME] (antipsychotic medication). The finding is: The facility policy and procedure titled Use of Psychoactive Medications dated 11/9/15 documented antipsychotics must not be used as a matter of staff convenience (e.g. to prevent wandering that does not pose a threat to patient well-being), the lowest possible dose which adequately treats the condition must be employed, and efforts to discontinue the medication or reduce the dose to the lowest effective level must be demonstrated, unless such efforts are clinically contraindicated. 1. Resident #142 was admitted to the facility 8/6/18 with [DIAGNOSES REDACTED]. The Minimum Data Set (MDS, a resident assessment tool) dated 8/14/19 documented the resident was severely cognitively impaired, received antidepressant medication and received antipsychotic medication. Review of Physician Orders dated 8/7/18 included the following physician orders: - [MEDICATION NAME] ([MEDICATION NAME]) 5mg (milligram) tablet. Give 1 tablet (5mg) by oral route once daily at bedtime. Unspecified dementia with behaviors. - [MEDICATION NAME] 5mg tablet. Give 1 tablet (5mg) by oral route once daily PRN (as needed). PRN Agitation. Unspecified dementia with behaviors. Review of Care Plan Activity Report documented effective 8/7/18 the resident received [MEDICAL CONDITION] medicatons. Goals included the resident will remain stable on the least amount of medication through next review. Interventions documented to medicate per MD order, psych (psychiatric) consult PRN, behavior charting every week, social services will provide 1:1 PRN. Review medications and effects at BMARC (behavior Modifying Agent and Review Committee), monitor response and for adverse reactions from [MEDICAL CONDITION] medications. Review of Progress Notes dated 8/6/18 through 8/20/18 included the following: - 8/9/18 at 3:01 PM. 1:30 PM - Resident sitting on side of bed yelling and crying and hallucinating, seeing people, pointing, was very fearful. Redirected thru (sic) talking and giving much TLC for approx. (approximately) 15 mins (minutes). Resident settled and fell asleep for a short time. No further episodes this shift. - Resident weepy and tearful this AM. Unable to console. Resident was given PRN [MEDICATION NAME] (antianxiety medication) with + (positive) effects. MD in to see resident and also met with resident's husband. Physician Orders dated 8/20/18 documented an order for [REDACTED]. [MEDICAL CONDITION] with delusions. Review of the Progress Notes 8/20/18 through 9/8/18 revealed there were no documented behaviors. During an interview on 9/12/19 at 10:47 AM, Licensed Practical Nurse (LPN) Unit Manager (UM) stated, her husband was very involved with medications, he would want changes or not allow changes. On 8/20/18 the resident wasn't exhibiting any behaviors that were a danger to herself or others. She cried a lot. She was being more anxious, restless, tearful. The husband felt the [MEDICATION NAME] helped her condition the most. A Psychiatric Nurse Practitioner (NP) note dated 9/8/18 8:16 PM documented a recommendation to decrease [MEDICATION NAME] to 7.5 mg po (by mouth) Q (every) HS (bedtime) for [MEDICAL CONDITION]. Assess for exacerbation of [MEDICAL CONDITION] and follow-up in 3 months. Physician Orders dated 9/10/18 documented an order for [REDACTED]. [MEDICAL CONDITION] with delusions. Review of Care Plan Activity Report revealed there were no care plan revisions made to the [MEDICAL CONDITION] drug use focus area 8/7/19 through 4/1/19. Review of Progress Notes dated 9/10/18 through 11/12/18 included the following: - 10/19/18 10:36 AM. Resident noted to have increase in restlessness and weepy behaviors. Staff continues to sit with resident, encourage activities, encourage rest periods - family visits noted. Difficulty at times to redirect resident in hall due to increase in loud behaviors of other residents and with wandering residents. - 10/26/18 10:28 PM. At HS tonight was very weepy, was redirected several times. Staff member spent some time with her, to have her calm down and watch some tv 9television) in her room with effect. - 11/2/18 12:06 PM. Resident frequently walking up and down the hallway crying, easily redirected, when asked what is wrong immediately stops crying and says nothing is wrong. - 11/3/18 10:12 PM. Resident frequently walking up and down the hallway, easily redirected, when asked what is wrong immediately stops crying and says nothing is wrong. Mood improves when husband is in. Review of Psychiatric NP noted dated 11/12/18 at 2:13 PM included, Staff report resident has had increased weepiness throughout the days. Nursing staff report she cries easily, wanders about unit and appears sad and anxious. Increased [MEDICAL CONDITION] per staff. Staff relayed that at times she appears to be responding to internal stimuli. Increase [MEDICATION NAME] 7.5 mg po AM and HS for [MEDICAL CONDITION]. Review of Care Plan Activity Report revealed no care plan revisions were made to the [MEDICAL CONDITION] drug use focus area 8/7/19 through 4/1/19. During an interview on 9/12/19 at 1:06 PM, the Attending Physician stated, the woman was distraught, her husband wanted many changes made because treating the emotional distress seemed to have a benefit for her. 415.12(1)(2)(i)

Plan of Correction: ApprovedOctober 15, 2019

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Corrective Action For Residents Cited Herein:
Resident #142 was not living at Newfane Rehab during the survey timeframe. Record review for quality improvement was completed by the DON but the resident discharged prior to Survey.
Identify Other Residents With Potential To Be Affected and Corrective Action:
The DON or designee will audit all facility residents to determine Psychoactive Medication Use and specifically compliance with F758 including: a.) adequate indication for use and monitoring b.) behavioral documentation c.) revised non-pharmacological interventions prior to dose increase
Care plans and medication orders will be updated and corrected when necessary to comply with above requirements for all affected residents.
Measures Put In Place And/Or Systemic Changes to Prevent Recurrence:
All licensed staff will be inserviced by the DON or RN Designee on the requirements of F758 on or before 11/11/2019. In particular, the education will focus on the following areas: a.)ensuring drug regimens that are free of unnecessary drugs b.)that [MEDICAL CONDITION] drugs are not given to residents unless the medication is necessary to treat a specific condition as diagnosed and documented in the record c.)there is adequate indication for use of [MEDICAL CONDITION] medications and d.) non-pharmacological interventions are tried by the IDT prior to starting [MEDICAL CONDITION].
Furthermore, the DON or designee will audit 10 resident records monthly for residents taking [MEDICAL CONDITION] medications to ensure compliance with A thru D above. Immediate corrective action will be taken as necessary.
Monitor To Prevent Recurrence/QAPI:
The DON or designee will attend BMARC monthly, along with the pharmacy consultant and with the IDT too to ensure compliance with requirements of F758. The DON or designee will provide a summary to the QAPI Committee denoting process compliance or non-compliance with F758 based on A thru D above each month. The Committee will determine additional process improvements based on findings. This will occur monthly for 90-days minimum and then the Committee will determine ongoing need based on findings to date.
Person Responsible: DON