Debra Brown, PharmD, FASCP

Pharmaceutical Consultant II Specialist

HMS Training Webinar January 27, 2017

1

Describe nationwide prevalence and types of elderly dementia + define BPSD

Define “psychotropic medications;” delineate potential antipsychotic adverse effects

Identify current CMS regulatory guidance/survey tools to evaluate antipsychotic medication use

Summarize the current national focus on antipsychotic reduction in nursing homes

2

14% of people age 71 and older in the US have dementia

60 – 80% of dementia cases are Alzheimer’s

10% of cases are vascular dementia ◦ However, 50% of elderly with dementia have

evidence of infarcts

Other dementia types: Lewy Body, Parkinson’s, Frontotemporal Lobar Degeneration, Creutzfeld-Jakob, Normal Pressure Hydrocephalus

Source: Alzheimer’s Disease 2016 Facts and Figures, Alzheimer’s Association

3

“Behavioral or Psychological Symptoms of Dementia”

Fluctuate over the course of dementia illness

Reflects consensus by the International Psychogeriatric Association with regard to description of dementia symptom clusters, specifically: ◦ Behavioral: verbal/physical aggression,

disinhibition

◦ Psychological: hallucinations, delusions, paranoia, anxiety, depressed mood, sleep disturbance

4

5

6

Each resident’s drug regimen must be free from unnecessary drugs. An unnecessary drug is any drug when used --

(1) In excessive dose (including duplicate drug therapy); or

(2) For excessive duration; or (3) Without adequate monitoring; or (4) Without adequate indications for its use; or (5) In the presence of adverse consequences which

indicate the dose should be reduced or discontinued; or

(6) Any combinations of the reasons stated in paragraphs (d)(1) through (5) of this section.

Based on comprehensive resident review, the facility must ensure that -- ◦ (1) Residents are not given psychotropic drugs unless

necessary to treat a specific documented condition;

◦ (2) Residents who use psychotropic drugs receive GDRs and behavioral interventions (unless clinically contraindicated) in an effort to discontinue these drugs;

◦ (3) Residents do not receive PRN psychotropic drugs unless necessary to treat a specific documented condition; and

◦ (4) PRN psychotropic drugs are limited to 14 days – if beyond 14 days prescriber documents rationale.

◦ (5) PRN antipsychotic orders are limited to 14 days and cannot be renewed unless the prescriber evaluates the resident for appropriateness of the medication.

7

Definition (CMS Final Rule dated 10/4/16):

“Any drug that affects brain activities associated with mental processes and behavior”

8

Antipsychotics

Antidepressants

Anxiolytics

Sedative-hypnotics

CMS has the authority to add other drugs to the definition through sub-regulatory guidance.

9

Rule out potentially reversible causes of impaired cognition ◦ Delirium, dehydration, electrolyte imbalances,

hypothyroidism, pain, constipation, etc.

◦ Review of current medications/minimize those that can impair cognition

Trial of non-pharmacologic behavior interventions

10

chlorpromazine (generic only)

fluphenazine (generic only)

Haldol (haloperidol)

Loxitane (loxapine)

Moban (molindone)

Navane (thiothixene)

perphenazine (generic only)

thioridazine (generic only)

trifluoperazine (generic only)

11

Abilify (aripiprazole)

Clozaril (clozapine)

Fanapt (iloperidone)

Geodon (ziprasidone)

Invega (paliperidone)

Risperdal (risperidone)

Seroquel (quetiapine)

Zyprexa (olanzapine)

Nuplazid (pimavanserin)

Combination antidepressant and atypical antipsychotic medication:

Symbyax (Prozac & Zyprexa) fluoxetine & olanzapine

12

13

Identified, documented clinical rationale for administering a medication… ◦ Based on assessment of the resident’s condition +

therapeutic goals ◦ Consistent with

Manufacturer’s recommendations and/or clinical practice guidelines

Clinical standards of practice

Medication references

Clinical studies or evidence-based review articles that are published in medical and/or pharmacy journals

Source: Appendix PP, F329

14

Were other potential causes for the symptoms ruled out?

Were physical and/or psychosocial signs, symptoms persistent or significant enough to warrant therapy?

Were non-pharmacological interventions tried? Was the medication clinically indicated to

manage the symptom or condition? and Does the intended or actual benefit justify the

potential risk(s) or adverse consequences associated with the medication, dose, and duration?

14

Within the first year a resident is admitted on an antipsychotic or after facility has initiated: ◦ Facility must attempt GDR in two separate

quarters (with at least one month between attempts) unless clinically contraindicated.

After the first year: ◦ GDR must be attempted annually, unless clinically

contraindicated.

15

For behavioral symptoms related to dementia: ◦ Resident’s target symptoms returned/worsened

after the most recent GDR attempt within the facility; and

◦ The physician has documented the clinical rationale for why any additional attempt at reduction would likely impair the resident’s function or increase distressed behavior.

16

For psychiatric disorder other than dementia: ◦ Continued use is in accordance with relevant current

standards of practice and the physician has documented why attempted reduction would be likely to impair function or cause psychiatric instability by exacerbating an underlying psychiatric disorder; or

◦ Resident’s target symptoms returned/worsened after the most recent GDR attempt within the facility and the physician has documented the clinical rationale for why any additional reduction attempts would be likely to impair the resident’s function or cause psychiatric instability by exacerbating an underlying medical or psychiatric disorder.

17

Elderly are at increased risk for adverse effects and mortality. ◦ Sedation, postural hypotension and falls.

Dementia patients should be assessed for type, frequency, severity, pattern and timing of symptoms.

Dementia patients should be assessed for pain and other potentially modifiable contributors to symptoms.

Comprehensive treatment plan: person-centered non-pharmacological and pharmacological interventions.

Nonemergency use of AP only when symptoms severe, dangerous and/or cause significant distress to the patient + assess risk/benefit.

If risk/benefit favors use of AP, initiate low dose + titrate to minimum effective dose. If no response after 4-week trial, taper and DC.

Source: The American Psychiatric Association Practice Guideline on the Use of

Antipsychotics to Treat Agitation or Psychosis in Dementia, Am J Psychiatry 173:5, May 2016

18

Form CMS-20082 (7/2015) ◦ Has facility met unnecessary medication

requirements for each resident?

◦ System for monitoring/addressing AE + GDR considerations?

◦ Investigation focus (O/I/RR)

◦ Critical Elements for citing assessment, care planning, unnecessary meds and MRR

◦ Refers to Checklist “Care for a Resident with Dementia”

19

For use with Interpretive Guidance at F309

Key considerations for compliance related to: ◦ Assessment and underlying cause identification

◦ Care planning

◦ Implementation of the care plan

◦ Care plan revision/monitoring and follow up

◦ Quality assessment and assurance

20

Utilized during Task 5C resident review ◦ In conjunction with Assessment of Drug

Therapies

Links unnecessary medications with the medication regimen review

Identifies s/sx that may be medication-related adverse effects (AEs) ◦ How did facility assess need + care plan resident

medications?

Did pharmacist identify actual/potential medication AEs as irregularity during MRR?

21

Survey probes ◦ Medical symptoms leading to chemical restraint?

◦ Used to restrict function or freedom of movement?

◦ Has facility attempted less restrictive alternative?

◦ Did resident/representative make an informed choice regarding the medication (risk/benefit/alternatives)?

◦ Does facility use the Care Area Assessments to evaluate the appropriateness of the medication?

◦ Has facility re-evaluated the need for a chemical restraint?

22

CMS S & C Letter 16-15-NH

Issued March 25, 2016

Provided list of F tags with revised guidance to emphasize risk of psychosocial harm

Included F329 Draft Revision, highlighting guidance related to how unnecessary medication use can cause psychosocial harm

Included language revision in the Psychosocial Outcome Severity Guide (Appendix P)

23

May 2012: CMS National Initiative to Improve Dementia Care ◦ Goal: reduce NH antipsychotic use by 15% end of

2012

◦ Focus on non-pharmacologic behavior interventions

◦ “Nursing Home Compare” website posted MDS 3.0 QM antipsychotic use data beginning July 2012

Baseline Q4 2011: 23.9% antipsychotic use (L)

End of Q2 2016: 16.3% antipsychotic use (L)

Relative reduction 31.8% for the time period

24

CA Partnership to Improve Dementia Care and Reduce Unnecessary Antipsychotic Use

Kick-off stakeholder summit 8/17/12 CMS Region IX (CDPH co-sponsor) ◦ Achievements:

Baseline (Q4 2011) 21.6% antipsychotic use (L)

End of Q2 2016: 12.75% antipsychotic use (L)

Relative reduction 40.9% for the time period

CA ranks 8th in the nation (Source: September 2016 CMS data)

25

Multiple training programs/materials available for providers, clinicians, consumers and surveyors on the CMS National Nursing Home Quality Improvement Campaign website: https://www.nhqualitycampaign.org/dementiaCare.aspx

26

Manufacturer’s usage recommendations ◦ FDA

◦ NIH/DailyMed: https://dailymed.nlm.nih.gov/dailymed/index.cfm

Relevant clinical guidelines (partial list) ◦ American Psychiatric Association

◦ Agency for Healthcare Research and Quality (AHRQ)

◦ American Association for Geriatric Psychiatry

27

Debra Brown, PharmD, Pharmaceutical Consultant II

California Department of Public Health

◦ Center for Healthcare Quality/Licensing and Certification Program

Email: debra.brown@cdph.ca.gov

Phone: (916) 319 - 9239

28