Appropriate Use of Antipsychotics in the Nursing Home

1. Appropriate Use of Antipsychotics in the Nursing Home Beth VanDelinder, PharmD Pharmaceutical Care Specialist August 24, 2012

2. Learning Objectives Define the term “unnecessary drugs” in the context of nursing home regulations Review the different classes of antipsychotic medications Identify appropriate vs. inappropriate diagnosis when antipsychotics medications are used

3. Learning Objectives Identify the monitoring parameters required for antipsychotic medications Explain the gradual dose reduction (GDR) requirements for antipsychotic medications Promote a stepwise approach to treatment of an elderly patient with dementia-related behavioral problems

4. Specific Tags That Relate to Medication in Nursing Home Regulations Pharmacy Services (F 425) Drug Regimen Review (F 428) Unnecessary Drugs (F 329)

5. Pharmacy Services in the Nursing Home (F 425) • Pharmacist is to oversee all aspects of medication • Dispensing, storage, administration, and disposal of both controlled and non-controlled medications • Controlled substance accountability • Will spot check controlled counts and help the facility implement a system for reconciliation • Emergency medication availability • Will have a locked box in place with contents listed on the outside • Will ensure that all items on the list are present, in date, and available for use

6. Drug Regimen Review in the Nursing Home (F 428) • Charts must be reviewed monthly by a consultant pharmacist • The date of the visit must be noted and the pharmacist must sign off on each patient’s chart • Pharmacist reviews all medication regimens to ensure positive outcomes and minimize adverse drug events • Pharmacy consultant recommendations are given to the Director of Nursing and need to be addressed by the attending physician if necessary

7. Drug Regimen Review Goals • Assure there is appropriate medication monitoring • Lab monitoring, GDR, AIMS • Identify potential medication-related problems • Potential medication and/or disease state interactions • Medications that could be responsible for behavior changes • Cognitive decline, depression, sedation, change in function • Medications that could cause falls/dizziness • Medication side effects • Constipation/diarrhea

8. Unnecessary Medication Regulation Overview (F 329) • Each resident’s drug regimen must be free from unnecessary drugs • Defined as any drug when used: • In excessive dose (or duplication in therapy) • For excessive duration • Without adequate monitoring • Without adequate indication • In the presence of side effects

9. So Actually…….. ANY DRUG could be considered an unnecessary drug! And these unnecessary drugs could produce unwanted side effects that can show up as behaviors

10. Medication Classes That We Will Focus on Today Include: Antipsychotics medication Sedative/hypnotics medications

11. There are Two Diagnostic Categories of Use for Antipsychotics • Psychiatric diagnosis Example: Schizophrenia and adjunct treatment for bipolar and major depression disorders • Dementia type illness with associated behavioral symptoms Example: Alzheimer's Disease

12. Antipsychotic Medications—The Problem • Report by Daniel Levinson, Inspector General of the Department of Health & Human Services • 22% of antipsychotic prescriptions in nursing homes were problematic per CMS Standards • The problems were: • Excessive dose – 10.4% • Excessive duration – 9.4% • Without adequate indication – 8.0% • Without adequate monitoring – 7.7% • In the presence of adverse effects that indicated a dose reduction or discontinuation – 4.7% • Claims of 116 million did not meet Medicare coverage requirements for medically-acceptable conditions • CMS initiative to decrease the use of unnecessary antipsychotics in Nursing Homes 15% by December 2012 OIG Report Citation-OIG Transmittal: OEI-07-08-00150, May 4, 2011

13. Antipsychotic Medications—The Challenge • There are NO medications that are approved for use in patients with dementia that have behaviors • Very few drugs help with problem behaviors or psychosis in dementia • Antipsychotics are the main drug used to treat these behaviors • Effectiveness is modest • They have serious side effects, including death • Non-drug methods are preferred • Providers may feel poorly trained to use non-drug behavior management techniques • Staffing issues because these techniques do take time

14. Black Box Warning for Antipsychotics • Antipsychotics and mortality in dementia patients • Black Box Warning issued in 2004 • Elderly with dementia-related psychosis treated with these drugs at an increased risk for death compared to placebo • Consistent across all antipsychotics • Relative Risk = 1.6-1.7 • Absolute risk = 3.5% vs. 2.3% with placebo • Number needed to harm = 83 • Number needed to treat = 5-14 • For every 9-25 persons helped, 1 death is associated with antipsychotic use Jeste, et.al., Neuropsycopharmacology 2008; 33:957-70

15. Things to Consider Before Anitipsychotic Medication Use Are behaviors due to a medication side effect? Are the behaviors due to a medical condition? Are the behaviors a result of an unmet need? Have non-drug interventions been tried?

16. Things to Consider Before Medication Use • Are behaviors due to a medication side effect • Anticholinergic medications are the biggest offenders

17. Things to Consider Before Medication UseAnticholinergics (Cont.)

18. Things to Consider Before Medication UseAnticholinergic Side Effects

19. Things to Consider Before Medication Use • Are the behaviors due to a medical condition • Pain • Infection • Hypoxia • Thyroid abnormality • Low levels of folate, B12, or iron

20. Things to Consider Before Medication Use Are the behaviors a result of an unmet need

21. Things to Consider Before Medication Use What can a behavior tell us? Wandering  Boredom Calling Out  Loneliness Grabbing  Fear of pain Pushing  Desire for privacy Agitated  Over-stimulation Withdrawn  Under-stimulation Intrusiveness  Hunger, thirst

22. Important Areas to Discuss When Considering Prescribing an Antipsychotic Medication • Shared decision making • Decisions shared by physicians, family members, and patient (if appropriate) • Informed with the best evidence available • Information gathering • What are the overall patient goals and what are the specific goals of treatment • Good time to share the prognosis and correct unrealistic assumptions • Share the facts • What has been tried • The physician or care center’s goal for treatment • Offer all alternative treatments (example: if chooses not to allow an antipsychotic, behavior may warrant transfer to the hospital)

23. When an Antipsychotic Medication Is Started for a Resident • After a complete assessment of a resident, and it is appropriate for medication to be prescribed, the facility must ensure that: • Residents being prescribed an antipsychotic medication have an appropriate diagnosis documented in their chart • The resident is being appropriately monitored • For effectiveness of the medication therapy (reduction in target behaviors) as well as • For side effects that can occur with medication use • Residents who receive antipsychotic drugs receive gradual dose reductions unless clinically contraindicated

24. Appropriate Antipsychotic Treatment Target Behaviors • We need more than just the clinical diagnosis to start a resident on an antipsychotic medication • In addition to diagnosis, the clinical condition must include at least one of the following: 1) Symptoms due to mania or psychosis • Example: hallucinations, paranoia, or delusions • Be sure to note that memory problems are often mistaken for delusions (example: thinks people are stealing lost items) 2) Behaviors that present a danger to the person or others 3) Symptoms that result in persistent distress, decline in function, or the ability to receive cares

25. Inappropriate Antipsychotic Treatment Targets • Mild anxiety • Fidgeting • Uncooperativeness • Verbal expression or behaviors that do not represent a danger to the resident or others • Nervousness Wandering Unsociability Poor self-care Restlessness Impaired memory Inattention or indifference to surroundings

26. Documentation of Target Behaviors While on Antipsychotic Medication • Objective vs. Subjective • Specific • Quantitative • Documentation on every shift • Example • Hitting others 3 times during morning shift

27. Antipsychotic Monitoring for Adverse Effects • Anticholinergic effects/sedation/lethargy • Dry mouth, constipation, dizziness, confusion • Parkinsonism/Akathisia/Dystonia • Tremor, shuffling gait, restlessness • Orthostatic hypotension and falls • Metabolic syndrome • Weight gain, diabetes • Mortality • Cardiac arrhythmias, infections (pneumonia)

28. Antipsychotic Monitoring for Adverse Effects (cont.) Sedation TardiveDyskinesia Extra-Pyramidal Symptoms (EPS)—Usually dose dependent Lipid abnormalities (cholesterol and triglyceride elevation) Cognitive impairment

29. 1st Generation AntipsychoticsMaximum Daily Dose

30. 2nd Generation AntipsychoticsMaximum Daily Dose

31. AHRQ Summary of Efficacy:Atypical Antipsychotics ++ = Moderate or high evidence of efficacy + = Low or very low evidence of efficacy +/- = Mixed results

32. Antipsychotic Choice • Receptor binding—and effects • Consider adverse effect impact on patient co-morbidities when choosing an antipsychotic • Metabolic disease (diabetes, hyperlipidemia) • Avoid olanzapine • Start with a low dose

33. Antipsychotic Affinity for Neuroreceptors * 0 = very low or no affinity, dissociation constant, Kd > 5000nM; + Kd = 25-45nM; ++Kd = 8.7-24nM; +++ - Kd = 0.8-5.2; ++++ = most potent, Kd 0.1-03.nM. Richelson, J Clin Psych 2010, 71:9

34. Antipsychotic Choice

35. Sample Cost of Antipsychotics *Only medication not available generically Source: Local Minot retail pharmacy

36. Antipsychotics Gradual Dose Reduction (GDR) • GDR is required unless clinically contraindicated • Must be done within the first year in which a resident is admitted on or after the facility starts an antipsychotic medication • GDR must be attempted in two separate quarters with at least one month between attempts • After the first year, a GDR must be attempted annually

37. Antipsychotics GDR Contraindications • If the medication is being used to treat symptoms related to dementia • And the resident’s target symptoms return or worsen after the most recent GDR attempt AND • Physician has documented the clinical rationale for why additional attempts would likely impair the resident’s function or increase distressed behavior

38. Antipsychotics GDR Contraindications • When medication is used to treat a psychiatric disorder other than behavioral symptoms related to dementia (example: schizophrenia or bipolar disorder) • Continue use of medication and have physician clearly document the diagnosis

39. Unnecessary MedicationsSedative/Hypnotics • Defined as any medication used to treat insomnia • Use should be proceeded by non-pharmacological interventions • Exceptions include: • Short-term use for procedures • During the treatment of end of life

40. Before Sedative/Hypnotics Are Used • We must rule out the behaviors are not due to the following • Environmental factors • Heat, cold, light, noise • Caffeine use • Medication use (stimulants, diuretics) • Inadequate physical activity • Facility routines/provision of care • Underlying conditions • Pain, COPD, restless legs, urinary frequency

41. Sedative/Hypnotic Monitoring • Efficacy • Improvement in sleep or sleep quality • Reduction in nocturnal awakening • Adverse Effects • Falls • Morning “hung over” effect • Confusion • Forgetfulness

42. Sedative/Hypnotic Maximum Daily Dose for Benzodiazepines

43. Sedative/Hypnotic Maximum Daily Dose for Non-Benzodiazepines

44. Sedative/Hypnotics To Avoid • The following medications have an increased side effect profile and/or a long duration of action • Benadryl (diphenhydramine) • Atarax (hydroxyzine) • Dalmane (flurazepam) • Halcion (triazolam)

45. Sedative/Hypnotic Duration of Use Short-term use Not to be used daily If used routinely beyond the manufacturers recommendation of use, a gradual dose reduction (GDR) is required

46. Sedative/Hypnotic Gradual Dose Reduction For the length of time a resident remains on a sedative/hypnotic that is used outside of the manufacturer’s recommendation, a GDR is required quarterly unless clinically contraindicated

47. Sedative/Hypnotic GDR Contraindications * Target symptoms have returned or worsened after the most recent GDR AND * Physician has documented that benefits of continued use outweigh the risks of the medication

48. Mabel Case Study • Mabel • 81-year-old female • Dementia patient no longer able to reside in her home • PMH: Elevated cholesterol, history of TIA, insomnia • Home medications • Lipitor 10mg QHS • Mirtazipine 15 mg QHS • Warfarin 5mg QD • Key Problems on admission • Hallucinations of people • This was happening at home • Distractibility at meal times • Resistance to personal cares • Language deficits (that hindered her being able to communicate her needs and wants)

49. Mabel Case Study • Since admission • Her language has continued to decline • Her resistance to care has increased • Her food intake continues to decline • Staff documented additional changes in the past few weeks • Not recognizing her son, who continues to visit daily • Continues to see imaginary people but on a more frequent basis • Increased day time restlessness, pacing, alternating with napping • Poor fluid in take • More confused than on admission, not able to process simple commands

50. Mabel Case Study • Additional information • When Mable had increased difficulty sleeping on admission, Tylenol PM was prescribed for her as it had been relayed to staff by her son that she had used it in the past with success, and he didn’t want another medication prescribed. He felt this OTC was a good option. • What tests would you want ordered? • What do you think has happened?