1. Bruce Gerlich, R.Ph. Consultant Pharmacist Omnicare 6 December 2012
To Pill or Not to Pill – That is the question… (But what are the answers?)
Bruce Gerlich, R.Ph.
Consultant Pharmacist
Omnicare
6 December 2012

2. objectives
Describe the risks and benefits of antipsychotic use for residents in LTC facilities
Understand CMS quality measures on the use of antipsychotic medications in the LTC setting
Identify and recognize behaviors that may be a form of communication of a resident’s unmet needs

3. Our Daily Encounters The men and women who mistake:
Roommate for a punching bag
Another resident’s bed for a toilet
Person feeding him/her as trying to poison
Another resident for a long-dead spouse
The men and women who
Won’t eat, don’t sleep, lose weight, fall, hit, bite, scratch, scream day and night, have pain, won’t get out of bed, cough, have chronic diarrhea, bleed, vomit, always feel bad, just want to die, can’t sit still, etc. etc.

4. THE HEADLINES
Mortality Risk in Elderly Dementia Patients May Rise With Newer Antipsychotics
Antipsychotics Increase Risk for Stroke in Elders
Psych Drugs Linked to MI Risk in Dementia
Again, Higher Mortality with Antipsychotics in Patients with Dementia
Rapid Serious Adverse Events with Antipsychotics in Dementia
Antipsychotics Linked to Increased Risk for Hyperglycemia in Older Patients with Diabetes
Antipsychotics Increase Risks for Sudden Cardiac Death

5. TO PILL ????
MEDICATIONS TO CONTROL BEHAVIOR GOOD OR BAD?

6. Looking Back……. Antipsychotic medications
1954/55 – Thorazine first to be used
Within a decade, millions received it
Helped change the face of psychiatric institutionalization
As with all remarkable new drugs(cortisone, beta-blockers, antibiotics) in each decade, overenthusiastic expectations and relative minimization of risks

8. Effectiveness in Dementia
Antipsychotic effect takes 3-7 days to start working
Very sedating medication so acute effect is most likely due to sedating effect not antipsychotic effect
In RCTs, recipients do a little bit better than placebo but the effect beyond 3 months is unclear
Not everyone who receives the meds improve
A large number of people getting the placebo improve
The net effect is that 10 to 20 people out of 100 who receive the medication improve due to the medication

9. Net effectiveness
“For every 100 patients with dementia treated with an antipsychotic medication, only 9 to 25 will benefit and 1 will die”
Drs Avorn, Choudhry & Fishcher
Harvard Medical School
Dr Scheurer
Medical University of South Carolina
Source: Independent Drug Information Service (IDIS) Restrained Use of antipsychotic medications: rational management of irrationality. 2012

10. “Normal” Behaviors Associated with Degenerative Dementias Generally Unresponsive to Psychoactive Medications
Wandering*
Disrobing
Persistent disruptive vocalization (swearing, offensive comments, yelling/screaming)*
Restlessness/ repeated attempts to unsafely arise from chair or climb out of bed*
Inappropriate urination/defecation
Hiding/hoarding
Eating inedibles
Annoying repetitive activities, including “exit seeking”
Climbing into bed with other residents
Sleep disturbance, diurnal reversal*
Pushing wheelchair-bound residents
* may be related to pain or discomfort

11. Atypical Antipsychotics – Consensus?
Organization Year Country Recommendations regarding
antipsychotic use in dementia
ASCP 2011 USA - 2nd Line: “Only for the duration needed, and at the lowest
effective dose”
APA 2007 USA -2nd Line: “Recommended for the treatment of psychosis and
agitation in dementia”
AGS 2011 USA - 2nd Line: “May be needed for treatment of distressing
delusions and hallucinations”
NICE 2006 UK- 2nd Line: “Risk benefit analysis should occur prior to use”
CCSMH 2006 Canada 2nd Line:“Atypical antipsychotics should only be used if there is marked risk, disability or suffering associated with the symptoms”
EFNS 2007 Europe- 2nd Line:“Antipsychotics, conventional as well as atypical,
may be associated with significant side effects and
should be used with caution”
American Society of Consultant Pharmacists, position statement, 2011
Ageing Res Rev Jan;11(1):78-86

12. FDA approved diagnoses
Schizophrenia
Bi-polar Disorder
Irritability associated with Autistic Disorder (Aripiprazole & Risperidone)
Treatment Resistant Depression (Olanzapine)
Major Depressive Disorder (Quetiapine)
Tourettes (Orap)
When prescribed to a patient without an FDA approved diagnosis; the prescription is considered as an “off-label use”, which is allowed by FDA and Medical Boards

13. Common Off-label uses Dementia with behavior difficulties Agitation
Abusive, violent
Wandering
Acute Delirium
Obsessive-compulsive disorder
Psychotic symptoms (e.g. hallucinations, delusions) with neurological diseases
Parkinson’s disease
Stroke

14. FDA Black Box Warning Issued in 2005
Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at and increased risk of death. [Name of Antipsychotic] is not approved for the treatment of patients with dementia-related psychosis.

15. FDA Black Box Warning

16. Associated with adverse outcomes
Off-label use of antipsychotics in nursing facility residents are associated with an increase in:
Death
Hospitalization
Falls & fractures
Venothrombolic events
Conventional antipsychotics are worse than atypical antipsychotics

17. Attention on Antipsychotics
Not indicated or approved to treat most behavior
symptoms in absence of underlying psychiatric
disorder
Not part of person-centered care
Oversedated people, cause a “zombie-like” state
Used for convenience of staff, in place of adequate staffing
Limited benefits, major risks
Major increase in mortality risk
Cause strokes, MIs, hyperglycemia
Very expensive
2011: OIG investigations

18. OIG Report 2011 OIG report Major Findings
Reviewed 600 medical records
Medicare claims data for Part B and Part D and MDS data from January 1st to July 31st, 2007 was used to identify payments for atypical antipsychotic drug use for elderly nursing home residents
Major Findings
14% of elderly nursing home residents had Medicare claims for atypical antipsychotic drugs
Off-label conditions accounted for 83% of these claims
Over ½ of the Medicare claims for antipsychotic drugs for elderly nursing home resident were incorrect
Medicare reimbursement criteria was not met for 726,000 of the 1.4 million claims
22% of the atypical antipsychotic drugs were not administered in accordance with CMS standards

19. Treatment of Dementia-Related Behaviors
No FDA-approved treatment for agitation associated with dementia. The strongest and most consistent evidence for efficacy in severe dementia-related agitation/aggression is for the atypical antipsychotics
Alternatives to antipsychotics may be effective for certain target behaviors, but are not as well-studied.
Evaluate comorbid illness(s) and complex drug regimens before selecting alternative drug therapy for BPSD
Optimal treatment usually includes individualized non-drug interventions and adjustment of expectations

20. Effectiveness in Dementia is weak Meta-Analysis (JAMA 2011)
Aripiprazole, Olanzapine, and Risperidone had a small but statistically significant effect (12 – 20%) when compared to placebo
Quetiapine did not have a statistically significant effect
Antipsychotics led to an average change/difference on the NeuroPsychiatric Inventory (NPI) of
35% from a patient’s baseline
3.41 point difference from placebo group
(note: a 30% change and 4.0 difference is the minimum threshold needed for a clinically meaningful result)
No conclusive evidence was found regarding the comparative effectiveness of different antipsychotics
Source: JAMA 306: ; Meta-analysis 38 RCTs in dementia

21. F-Tag associated with off-label use F-Tag 329: Unnecessary Drugs
Residents should have drug regimens that are free of unnecessary drugs defined as
There in an excessive dose including duplicate therapy
There is an excessive duration of being on the drug
There is inadequate monitoring of the drug
There is inadequate indication for the use of the drug
There are adverse consequences
A combination of the reasons above
Specific conditions for antipsychotic drugs
The facility must ensure that residents have not used antipsychotics previously, are not given these drugs unless the drug therapy is necessary, and recorded in the clinical record
In an effort to decrease the use of antipsychotics residents must receive gradual dose reduction and alternate therapies, unless they are counter-

22. Behavioral Symptoms that May Respond to Pharmacologic Intervention
Anxiety
Depressive symptoms
Persistent physical aggression
Manic-like symptoms
Persistent and distressing delusions or hallucinations
Sleep disturbance, initial or middle insomnia
Sexually inappropriate behavior

23. Treat disease states appropriately
Dementia – behaviors can respond to cholinesterase inhibitors (Aricept, Exelon, etc) and Namenda
Treat depression if present – can be manifested by confusion, forgetfulness, anxiety, insomnia, etc – SSRIs (Lexapro, Celexa, Zoloft are preferred)
For acute behavioral problems when resident is violent and a danger to themselves and others – may consider short term use of antipsychotic medications and rule out possible causes

24. BOTTOM LINE Antipsychotic medications are only marginally effective
Have a high incidence of side effects: increase fall risk, EPS
Have an overall increased in cardiovascular death (CVA, MI) than those that do not use these agents
Can be helpful in a small percentage of our population

25. Key Points
Risperidone has the most evidence supporting efficacy in BPSD
There are no FDA-approved medications for BPSD at this time
No consensus among experts in the field
• Patient selection and monitoring is essential
Antipsychotics are 2nd line
Only use drug therapy if behaviors cause severe distress or immediate risk of harm
Always determine if behavior is a method of communication beforeassuming physiologic change

26. Reducing these agents What does the Government say? (CMS)

27. National Priority
CMS is making the reduction of off-label use of antipsychotic medications a national priority
Don Berwick, Director of CMS has asked professional associations to work together and with CMS to reduce the off-label use of antipsychotic medications in nursing homes

28. Current National Initiative CMS
Improve dementia care by
Rethinking overall approach
Using standard techniques
Using more nonpharmacological interventions in prevention and management
Prudent and limited use of antipsychotic medications
Allegedly, more to follow
What should that be?

29. CMS definition of behavior
“Distressed behavior” is behavior that reflects individual discomfort or emotional strain. It may present as crying, apathetic or withdrawn behavior, or as verbal or physical actions such as: pacing, cursing, hitting, kicking, pushing, scratching, tearing things, or grabbing others.

30. CMS National Partnership to Improve Dementia Care
CMS developed a national partnership to improve dementia care and optimize behavioral health.
By improving dementia care and person-centered, individualized interventions for behavioral health in nursing homes, CMS hopes to reduce unnecessary antipsychotic medication use in nursing homes and eventually other care settings as well.
While antipsychotic medications are the initial focus of the partnership, CMS recognizes that attention to other potentially harmful medications is also an important part of this initiative.

31. CMS
…. [CMS] is considering reviving the specific citation for antipsychotic use to encourage more scrutiny, but is concerned that homes will instead use other sedating drugs that can also be harmful.
“One of the things we want to do is to make sure that surveyors are looking out for a prescribing shift. Did a person get taken off of an antipsychotic and simply put on an antidepressant or antianxiety agent instead?’’
Alice Bonner PhD, RN CMS Director, Division of Nursing Homes
Lazar K, Carrol M. “A rampant prescription, hidden peril"; The Boston Globe, 4/29/12.

32. What will Surveyors be Looking for?
In some cases, persons with dementia may have behavioral expressions that indicate they are trying to communicate their needs (with brain dysfunction that prevents this communication from being effective in expressing a need or distress).
In other cases, behaviors may be symptoms of underlying medical issues such as delirium or medication side effects, or psychiatric symptoms.
Surveyors will be looking to see that a systematic and comprehensive process was followed that not only includes medical or clinical aspects, but also assesses whether or not the nursing home provided tools, resources and staff training on person centered care practices and environmental modification, whether families are engaged in dementia care, whether there is adequate staff, and other organizational issues.
reference:CMS

33. What should I advise my nursing home – they are asking how to “reduce our rate of antipsychotic use…”
The team may discuss specific cases in order to determine the optimal dose and duration of therapy.
Input from the nursing assistants, nurses, social workers, therapists, family and other caregivers working closely with the resident is essential.
Input from all three shifts and weekend caregivers is also important in “telling the story.”
Surveyors will look at communication between shifts, between nurses and practitioners or prescribers.
Surveyors will also look at whether medications prescribed by a covering practitioner in an urgent situation are reevaluated by the primary care team.
Surveyors will look at whether or not other psychopharmacologicals are prescribed if/when antipsychotic medications are discontinued or reduced

34. It may be helpful to refocus on the bigger picture –
What should I advise my nursing home – they are asking how to “reduce our rate of antipsychotic use…”
It may be helpful to refocus on the bigger picture –
share resources on dementia care principles: –
Remind leadership that focusing on each individual resident and using a careful, systematic process to evaluate his/her needs is what surveyors will be looking for (not the antipsychotic rate in the facility)

35. Dementia re-examined Experiencing the world in a different way
What are “behaviors”?
Medical symptoms?
Predictable human responses to the situation perceived?
Key questions to ask:
What is this person trying to tell me?
What is distressing this person?
What does he or she need to be in well-being?

36. Behaviors…
are often a rational attempt to cope with circumstances that do not make sense to a resident with dementia

37. Behavior is in the “Eye of the Beholder”
Everyone brings their own baggage with them
Personality tendencies
Life experiences
Relationships
Past roles
Education
Religious beliefs

38. Dementia is not the cause of every behavior
Don’t become complacent by assuming that behaviors are caused by dementia and that nothing except medicating the resident can be done

40. Effects of behaviors on staff
Absenteeism
Staff turnover
Decreased productivity
Increased desire to use chemical and/or
physical restraints

41. REASONS FOR BEHAVIORS
RULE THESE OUT!!!

42. Primary Challenge is Changing Beliefs !!!!
Most health care professionals and families believe
(1) dementia “behaviors” are abnormal & need to be treated
(2) antipsychotics medications are effective

43. Acute change in condition – WHAT HAPPENED???
Infection
Congestive heart failure
Respiratory distress
Fracture
Cerebrovascular accident
Myocardial infarction

44. Pain/discomfort . Seating/positioning . Diagnoses that may lead to:
chronic pain
. Past history of pain
. Indicators of pain
◦ Resistance to care
◦ Non-verbal sounds
◦ Verbal complaints of pain
◦ Protective body movements or postures
. Routine rather than PRN pain medication

45. Boredom
Some estimates reveal residents with dementia spend 60-80% of their time with nothing to do.
It is during this unstructured time that most disturbing behaviors occur. Residents are often seeking stimulation, movement, or comfort which leads to be "needs-driven dementia compromised behaviors"

46. Hunger/thirst Creative ways to deliver foods ◦ Finger foods
◦ Fanny pack
Give drink every time person passes
◦ Hydration cart
◦ Popsicles/push pops
Pack calories into foods resident will eat
Medication administration-Med Pass,Ensure

47. Elimination needs . Bladder assessment
◦ Type of incontinence identified
◦ Individualized plan
. Bowel patterns
◦ Opportunities to sit on the toilet
◦ Adequate fiber and fluids in diet

48. Sleep issues Sleep hygiene ◦ What is the resident’s usual pattern?
◦ Noise
◦ Lighting
◦ Temperature
◦ Oral care
◦ Type of mattress, pillow, blankets
◦ Usual hours of sleep

49. Medication side effects
Anticholinergic medications
Diphenydramine; hydroxyzine; cyclobenzaprine
Benzodiazepines
Lorazepam; alprazolam; diazepam;
Clonazepam
Psychotropics
Anticonvulsants
phenytoin
Corticosteroids- prednisone

50. SO WHAT CAN WE DO???!!!

51. Immediate steps to reduce antipsychotics
No role for PRN only antipsychotic medications
Evaluate the need for continuing antipsychotics at admission & those on very low doses
Evaluate need for antipsychotics started on residents during the evening/night shift or over the weekend
Look at discontinue or gradual dose reduction for residents on medications for greater than 12 weeks (3 months), particularly those with no change in dose or frequency

52. Evidence based for Discontinuing Meds at lowest dose
RCTs comparing low dose to placebo show Risperidone to be minimally effective
Olanzapine to be not effective
Aripiprazole and Quetiapine unknowns as low dose not tested
RCTs for withdrawal of medication show no difference in outcomes between placebo and continued medication
About 75% remain off the drug after the trial
Less than 25% need to be restarted on the medication
Placebo group (drug withdrawal) have fewer adverse events

53. Strategies to reduce use of antipsychotics in nursing facilities
Phase II: steps that will take longer to implement but need to be started now
Focus on implementing programs to minimize the off-label use of antipsychotics by promoting
Non-pharmacologic strategies to manage individuals with dementia
Changes to how we view dementia behaviors as attempts to communicate unmet needs
Strategies
Staff training on interacting with individuals with dementia
Adopt policy on minimal use of medications with dementia residents
Educate families about this policy
Implement consistent assignment
Compare facility off-label antipsychotic use to others
Learn from other facilities

54. The choices medicine?

55. Eliminating Antipsychotics ≠ Better Dementia Care
Inappropriate antipsychotic prescribing is only one part of a complex problem
Need systematized culture change around dementia care and the use of medications to treat behavioral and psychiatric symptoms of dementia (BPSD)

56. Training Staff – what should they be thinking about?
Nonpharmacologic Interventions
• First-line therapy for BPSD
• Ideally, non-pharmacologic interventions should be:
Targeted
Tailored
Individualized
Flexible
Adaptable
Multi-component
• Not all individuals will respond positively to interventions
VA-ESP Project #05-225, 2011
Health Technol Assess. 2006;10(26):iii,ix-108

57. Learn About the Person – What’s the story?
• Family and friends
• Sleep habits
• Childhood experiences
• Occupation
• Significant events
• Favorite foods
• Spiritual beliefs
• Unique characteristics
• Daily routine
• Likes and dislikes
• Life achievements
• Hobbies
• Communication preferences
• Physical functioning
• Sensory capabilities
• Decision-making capacity
Alzheimer’s Association, Dementia Care Practice Recommendations for Assisted Living Residences and NursingHomes,

58. Responding to Behaviors
Ground Rules:
We cannot change the person
Try to accommodate behavior not control it
We can change our behavior or the physical environment
Check with the doctor
Is there an underlying medical reason?
Behavior has a purpose
What need is the person trying to meet with their behavior?
Family Caregiver Alliance, Caregiver’s Guide to Understanding Dementia Behaviors, 2004

59. Responding to Behaviors (II)
Ground Rules:
All behavior is triggered !!!!!
The key to changing behaviors is disrupting the patterns that we create
What works today, may not tomorrow
Be creative and flexible with your strategies
Get support from others
Support groups, community resources, training
Family Caregiver Alliance, Caregiver’s Guide to Understanding Dementia Behaviors, 2004

60. . Routine . Caregiver . Room . Roommate . Number of visitors
Change
. Routine
. Caregiver
. Room
. Roommate
. Number of visitors
. Medications

61. Behavior is Communication!
• Physical discomfort
Illness or medication
• Overstimulation
Loud noises or busy environment
• Unfamiliar surroundings
New places or inability to recognize home
• Complicated tasks
Difficulty with activities or chores
• Frustrating interactions
Inability to communicate effectively
Alzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012

62. What Does a Person with Dementia Need?
• Attachment
• Inclusion
• Occupation
• Identity
• Comfort
Kitwood T. Dementia reconsidered: The person comes first. London: Open University Press; 1997

63. Quick Tips for Responding to Behaviors
• Remain flexible, patient, and calm
• Explore pain as a trigger
• Respond to the emotion, not the behavior
• Don’t argue or try to convince
• Use memory aids
• Acknowledge requests and respond to them
• Look for the reason behind each behavior
• Don’t take the behavior personally
• Share your experiences with others
Alzheimer’s Association, Behaviors–How to respond when dementia causes unpredictable behaviors, 2012

64. What would you do… EMPATHY IS KEY!!!!!!!!
If you were a mother, what would you do if you were not allowed to leave the building to pick up your children after school?
If you couldn’t remember how to put on a sweater, what would you do if someone just handed it to you?
If you couldn’t remember what time dinner is, what would you do if you were hungry?
EMPATHY IS KEY!!!!!!!!
Gould E. Understanding Behavioral Symptoms in Dementia. NASMHPD Panel Presentation, August 2012

65. Questions to ask for new Rxs
What did you do to try and figure out why the resident was doing <fill in the blank>?
What is resident trying to communicate to us about their <fill in blank>?
What is reason for resident doing <fill in blank>?
Unacceptable answer (Dementia or sun- downing)
What did you try before requesting medications?

66. What if I don’t have a lot of geriatric training or experience?
Detailed clinical practice guideline on dementia
– Multiple resources and links to other organizations, training materials
CMS staff can put you in touch with state coalition leads
and state-level resources

67. summary
Dealing with residents with dementia and behavioral problems IS A COMPLEX ISSUE WITH NO ONE ANSWER!!!
Behaviors happen for a reason and are a form of communitcation for the elderly with dementia related illnesses
Eliminating antipsychotic medications takes patience, diligence and a TOTAL team approach
Whether we like it or not antipsychotic medications will not disappear but can be dramatically reduced…..