The Facility Won’t Allow Haloperidol! - PowerPoint Presentation

The Facility Won’t Allow Haloperidol! How to confidently manage dementia-related behaviors in a red-tape environment KRISTIN SPEERPHARM.D., BCPSHOSPICE & PALLIATIVE CARE CLINICAL PHARMACISTAUGUST 16, 2018

Conflict of Interest and Disclosures of Relevant Financial Relationships The planners and presenters (spouse/domestic partner) of this educational activity have disclosed no healthcare related conflicts of interest, commercial interest, or have any related financial relationships/support. 2

Contact Hours – Nursing 1.0 Contact HourProCare Hospice Care is an approved provider by the Ohio Nurses Association an accredited approver of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. (OBN-001-91) (OH-463, 11/1/2018) 3

Successful Completion Criteria Register for the activityComplete and submit the sign in sheetView the entire presentation Complete and submit the participant evaluationCertificate will be emailed upon completion of the criteria4

Objectives Recognize some unintended negative consequences of the CMS Mega Rule on patient careSelect non-pharmacologic interventions for your dementia patient with behaviorsKnow when it is ok to use an antipsychotic or psychotropic 5

Discussion Outline Introduction“Behaviors”Contributing Factors to BehaviorsNon-Pharmacologic Approaches to BehaviorsWhat’s the Big Deal about Antipsychotics and Haloperidol? What about Prochlorperazine and Promethazine?When is it OK to use Antipsychotics in Dementia-Related Behaviors?What’s the Big Deal about Psychotropics?When is it OK to Use Psychotropics?Prescribing P sychotropics and Antipsychotics in Facilities 6

What to do with haloperidol and other antipsychotics? And p sychotropics? Intro: A Blanket Reaction to CMS 7

Intro Discussion: Should We Use an Antipsychotic? A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is confused, though never any more than baseline . No therapies for her “behaviors” have been tried yet. The facility will not allow any haloperidol for any reason. Other PMH: DM2, CHF, CKD, severe hip arthritis. For wandering? For confusion? For screaming/hollering ? For disturbing patients? For restlessness ? For agitation? 8

“Behaviors” – Be Specific! General term = non-specific/inappropriate therapies = ineffective treatments with unnecessary side effects/harmGeneral term = do not know what to monitor for improvement Drug therapies, including antipsychotics, are not appropriate for any/every “behavior”Take Away: T here are many types of “behaviors ”. O ptimal treatment and monitoring of its efficacy requires identification of specific symptoms or actions . Qualify what the “behaviors” are whenever possible. 9

“Behaviors” – Ongoing Assessment Identifying/managing contributing factors to “behaviors” is mainstay to treatment, but challenging Multi-factorialDementia often = difficult/poor communication Initial therapies/approaches often not effectiveTake Away: Identifying/managing contributing factors to “behaviors” and monitoring response to non-drug and drug therapies is an assessment process that must be ongoing . 10

“Behaviors” – Order of Therapies First: Non-pharmacologic therapies are always mainstay/first-line (unless aggression/violence/emergency)Pharmacologic therapies should be second-line, or can be along-side non-pharm therapies Take Away: For a dementia patient with behaviors, always consider non-drug approaches first. When appropriate, drug therapies can be started alongside, or after, non-drug therapies. Exception: aggressive/violent/harmful patients may require drug therapies first to calm the patient down while non-drug approaches are being established. 11

Contributing Factors to “Behaviors” Polypharmacy This is not a myth! It is real, and a likely contributor. Individual medications can be culprits, also. Consult your pharmacist! 12

Contributing Factors to “Behaviors” PAIN – INFECTION - CONSTIPATION -3 relatively easier targets to rule out -relatively accessible: PAIN-AD, analgesic trial, UA, temp, lung/breathing assessments, HR/BP, O2 saturation, bowel records, abdominal palpation/distension 13

Contributing Factors to “Behaviors” Take Away: Medications/polypharmacy can be a major player. Pain, infection, constipation are 3 relatively easy conditions to target as contributing factors. Finding contributing factors could be a long-term process, but addressing them is key to behavior management. 14

Case: Ima Punchin Question A: What could be contributing factors we need to address?A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is confused, though never any more than baseline. No therapies for her “behaviors” have been tried yet. The facility will not allow any haloperidol for any reason. Other PMH: DM2, CHF, CKD, severe hip arthritis. Medications: Glipizide 5mg PO daily Furosemide 20mg PO daily Metoprolol 25mg PO BID Acetaminophen 325mg PO q4h prn pain 15

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “ Activity Approaches for Residents with Behavioral Symptoms”“For the resident who….” disrupts group activities with behaviors such as talking loudly and being demanding…” engages in name-calling, hitting, kicking, yelling, biting, sexual behavior, or compulsive behavior…” “constantly walking…” Many others… 16

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” “For the resident who disrupts group activities with behaviors such as talking loudly and being demanding…”Slow exercises (e.g., slow tapping, clapping or drumming); rocking or swinging motions (including a rocking chair) Several others 17

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” For the resident who engages in name-calling, hitting, kicking, yelling, biting, sexual behavior, or compulsive behavior…Providing a calm, non-rushed environment, with structured, familiar activities such as folding, sorting, and matching Exchanging self-stimulatory activity for a more socially-appropriate activity that uses the hands, if in a public space. Several others 18

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” For the resident who is constantly walking…Providing a space and environmental cues that encourages physical exercise, decreases exit behavior and reduces extraneous stimulation (such as seating areas spaced along a walking path or garden; a setting in which the resident may manipulate objects; or a room with a calming atmosphere, for example, using music, light, and rocking chairs) Several others 19

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” For the resident who has withdrawn from previous activity interests/customary routines and isolates self in room/bed most of the day…Providing activities just before or after meal time and where the meal is being served (out of the room) Providing in-room volunteer visits, music or videos of choice Several others 20

Non-Pharmacologic Approaches Helpful hint: think through 3 S’s: space, speed, substitutes21

Case: Ima Punchin Question B: What could be a non-pharmacologic approach to treatment? A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is confused, though never any more than baseline. No therapies for her “behaviors” have been tried yet. The facility will not allow any haloperidol for any reason. Other PMH: DM2, CHF, CKD, severe hip arthritis. Medications: Glipizide 5mg PO daily Furosemide 20mg PO daily Metoprolol 25mg PO BID Acetaminophen 325mg PO q4h prn pain 22

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” For the resident who engages in name-calling, hitting, kicking, yelling, biting, sexual behavior, or compulsive behavior… Providing a calm, non-rushed environment, with structured, familiar activities such as folding, sorting, and matching Exchanging self-stimulatory activity for a more socially-appropriate activity that uses the hands, if in a public space. Several others 23

Non-Pharmacologic Approaches Resource: CMS Guidance F248 – “Activity Approaches for Residents with Behavioral Symptoms” For the resident who has withdrawn from previous activity interests/customary routines and isolates self in room/bed most of the day … Providing activities just before or after meal time and where the meal is being served (out of the room) Providing in-room volunteer visits, music or videos of choice Several others 24

What’s the Big Deal about Antipsychotics? The Black Box Warning (BBW):1 SUDDEN DEATH in elderly dementia population with the use of ANY antipsychotic (not just haloperidol) Facilities had been using antipsychotics like band aids… and like water (too frequently, without addressing the problem) = possibly unnecessary early deathsCMS stepped in to try to control this practice: regulated use in dementia patients in nursing homes 1 25

What’s the Big Deal about Antipsychotics? But wait – the “sudden death” BBW applies to antipsychotic use in elderly dementia patients whether you use them in a facility, or at home, or wherever2Take Away: The “sudden death” risk with antipsychotics applies to elderly dementia patients regardless of location. But CMS can only regulate what happens in facilities… for now. Good (best) practice demands application of conservative/cautious antipsychotic use to patients at home, too. 26

What is CMS “Saying” about Antipsychotics? Use antipsychotics with more care and consideration in dementia patients (in nursing homes) - due to the Black Box Warning (sudden death)Not: ban all use of antipsychotics.Not: ban use of haloperidol. Not: ban antipsychotic use in dementia patients. 27

Why Are We Just Picking on Haloperidol? CMS guidance targets ALL “antipsychotics”, not just haloperidol (just as the BBW applies to all of them)1, 3Haloperidol, risperidone, quetiapine, chlorpromazine, aripiprazole, PROCHLORPERAZINE, thioridazine, fluphenazine, etc… Policies excluding only haloperidol are misguidedTake Away: Policies should not just target haloperidol (or any specific antipsychotic). They should treat all antipsychotics the same, and/but use them all appropriately. 28

Why Are We Picking on All Antipsychotics? YES: the BBW applies to all antipsychotics, and CMS targets the entire class of antipsychoticsBUT: policies excluding ALL antipsychotics from facilities is an inappropriate “blanket” practice that disservices patients Take Away:Facilities should allow any antipsychotic, but establish policies/procedures to support appropriate use. 29

If Such a Big Deal, Why are Antipsychotics Still on the Market? Their benefits are still deemed to outweigh risks when used appropriatelyThey have better efficacy for labelled/indicated uses such as schizophrenia, hallucinations, and other psychotic disorders 1,3,430

If Such a Big Deal, Why are Antipsychotics Still on the Market? Antipsychotics are the ONLY MEDICATION CLASS that is shown to treat, and is indicated to treat, hallucinations, delusions, and other symptoms of psychosis. 31

If Such a Big Deal, Why are Antipsychotics Still on the Market? Take Away:Antipsychotics could be, or they may not be, effective for dementia-related behaviors.1,3,5 They are generally more effective for patients with diagnosed conditions that are labelled for antipsychotic use. But antipsychotics may be worth a try in certain cases of dementia-related behaviors. 32

Good Reminder about the Efficacy of Medications BIG PICTURE: The effects of most drug therapies in general are MODEST AT BEST5This includes antipsychotic therapies for dementia-related behaviors 5-9 33

Trick Question: Which of the Following are Antipsychotics? Haldol® (haloperidol) Abilify® (aripiprazole) Seroquel® (quetiapine) Risperdal® (risperidone) Compazine® (prochlorperazine ) Phenergan® ( promethazine) Thorazine® (chlorpromazine) 34

Trick Question: Which of the Following are Antipsychotics? 10Haldol® (haloperidol) – 1 st generation antipsychoticAbilify® (aripiprazole) – 2nd generation antipsychotic Seroquel® (quetiapine) – 2 nd generation antipsychotic Risperdal® (risperidone) – 2 nd generation antipsychotic, antimanic Compazine® (prochlorperazine ) - Antiemetic; 1 st generation antipsychotic; Phenothiazine derivative Phenergan® ( promethazine) - Antiemetic; Histamine H1 antagonist; Phenothiazine derivative Thorazine® (chlorpromazine) - Antimanic agent; 1 st generation antipsychotic ; Phenothiazine derivative 35

Prochlorperazine is an Antipsychotic!? …yes, and so might be promethazine, depending on how you classify.Take Away: Antipsychotics can be defined and classified in different ways. CMS Final Rule does not specify which antipsychotics the rules apply to*, nor do they define what they consider to be an ‘antipsychotic’. Bottom line: use antipsychotic medications based on labelled or established/supported off-label indications. 36 *Update 7/11/2018: CMS LTC Survey FAQs specifies prochlorperazine as an antipsychotic

When is it OK to Use Antipsychotics for Dementia-Related “Behaviors”? First line option if there is an indication Also when there is a ‘suspected’ indication (more on slides 46-47) Take Away: Can use when there is an indication, or a ‘suspected’ indication. 37

When is it OK to Use Antipsychotics for Dementia-Related “Behaviors”? Symptoms ConditionsImmediate danger to self/others; aggression/violenceOCD Mania Schizophrenia (and types) Hallucinations/Delusions Depression adjunct (not monotherapy) Paranoia Bipolar disorder Delirium Huntington’s Nausea/vomiting Tourette Syndrome PRN > Scheduled S cheduled > PRN INDICATIONS:* *includes labeled and off-label indications 38

When is it OK to Use Antipsychotics for Dementia-Related “Behaviors”? Thus, when deciding whether to use them or not, FORGET ABOUT DEMENTIA. Ask NOT about whether the patient has dementia, but whether they have any reason (indication or suspected one) to be taking an antipsychotic. 39

NOT Indications for Antipsychotic Use Behavior/Symptom Repeating phrases/behaviors Refusing care Insomnia Annoying others Cursing Speech problems Refusing to eat Poor hygiene Wandering Hollering 40

Case: Ima Punchin Question C: Is an antipsychotic indicated?A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content . She is confused, though never any more than baseline. No therapies for her “behaviors” have been tried yet. The facility will not allow any haloperidol for any reason. Other PMH: DM2, CHF, CKD, severe hip arthritis. Medications: Glipizide 5mg PO daily Furosemide 20mg PO daily Metoprolol 25mg PO BID Acetaminophen 325mg PO q4h prn pain 41

Case: Ima Punchin Question C: Is an antipsychotic indicated (tweaking the case a little)? A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She yells “they’re going to eat me alive!” and “take me back to the castle!” She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is confused , but seemingly a little more during group activities. The facility will not allow any haloperidol for any reason. Other PMH: DM2, CHF, CKD, severe hip arthritis. Psychosis (hallucinations/delusions)? Increased confusion? 42

Is Confusion an Indication? No, confusion alone is not an indicationDelirium discussed in a minute…Must consider context: in setting of confusion, use antipsychotic only when there is an indication (or suspected one) present 43

When is it OK to Use Antipsychotics in Dementia-Related Behaviors? Symptoms ConditionsImmediate danger to self/others; aggression/violenceOCD Mania Schizophrenia (and types) Hallucinations/Delusions Depression adjunct (not monotherapy) Paranoia Bipolar disorder Delirium Huntington’s Nausea/vomiting Tourette Syndrome PRN > Scheduled S cheduled > PRN INDICATIONS:* *includes labeled and off-label indications 44

Delirium vs Confusion Delirium (an indication for antipsychotic use): “An acute, reversible state of disorientation, inattention, and confusion.” -Taber’s Medical DictionaryConfusion (alone is not an indication): The state or condition of not being aware of or oriented to time, place, or oneself . -Taber’s Medical Dictionary (Again): Must consider context: in setting of confusion, use antipsychotic only when there is an indication (or suspected one) present 45

Case: Ima Punchin Question C: Is an antipsychotic indicated (tweaking the case a little MORE)? A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is somewhat confused, but never more than baseline. Patient has received/failed: scheduled acetaminophen and PRN opioids; re-direction with puzzles ; buspirone and then lorazepam for apparent anxiety. Infection and constipation have been ruled out. The facility will not allow any haloperidol for any reason. Suspected indication 46

‘Suspected’ Indication? ‘Suspected’ Indication = Initial treatment failures/unidentified causes Despite best assessment efforts, many cases have unidentified cause(s) to their behaviorsDementia patients often cannot verbalizeLabs not always appropriate or preferred while on hospice Take Away: I t is reasonable to try/titrate antipsychotic and observe response closely after other initial drug and non-drug failures... alongside continued detective work 47

When Using Antipsychotics in Dementia… If the patient has dementia, and going to use antipsychotics, need to more carefully assess and document the patient case. Assess, document, a ssess, document, assess, document, assess, document . Assess, document, a ssess, document, assess, document, assess, document . Assess, document, a ssess, document, assess, document, assess, document . Assess, document, a ssess, document, assess, document, assess, document . Assess, document, a ssess, document, assess, document, assess, document . 48

Antipsychotics: What to Assess and Document?1 Rationale, rationale, rationale:Underlying causes/contributing factors to behaviorsWhat non-pharmacologic interventions have been tried or will be tried What other medications have been tried/failed or are contraindicated Rationale for continued/increased/reduced dose (ex: why GDR is clinically contraindicated, if applicable)What specific behaviors are being targeted/are expected to improveExpected duration of useSide effects/monitoring for medications As many of the above as possible; others/more as appropriate 49

Psychotropics CMS Mega Rule (LTC/Nursing Homes):1) adds new term: “psychotropics”, AND2) no longer just applies rules to dementia patients, but to all patients in nursing homes or long term care facilities Why? 50

What is CMS “Saying” about Psychotropics? Use psychotropics less liberally and with more caution in nursing home patients. Targeted/regulated because they are used frequently and affect brain processesNot: “ban all use of psychotropics.” 51

Psychotropics “… any drug that affects brain activities associated with mental processes and behavior.”3 Broader term that includes antipsychotics3AND ALSO: benzodiazepines (ex: lorazepam), trazodone, antidepressants (ex: duloxetine, sertraline), buspirone, mirtazapine, phenobarbital, many, (most?) others… opioids 3 52

When is it OK to Use Psychotropics? We know: Psychotropic regulation does not apply to just dementia patients, but to all patients in LTC/nursing homesImpossible (malpractice?) to avoid - use them based on their indications and with good clinical judgement (like any other medication ), after/alongside non-pharm therapiesAgain, do not prohibit use, but use with more cautionGood (best) practice demands application of conservative/cautious psychotropic use to patients regardless of location. 53

Which Psychotropic to Use? For restlessness/agitation (dementia-related or not), and NO indication for an antipsychotic: start with an anxiolytic. Yes, but which one? Ask your pharmacist!Fall risk: start with buspirone (less sedating, but calming)Paradoxical reaction/allergy to lorazepam/other benzodiazepines:PRN: phenobarbital (q6h), promethazine (q4-8h), trazodone (TID ) Nighttime/sleep: melatonin (lower fall risk), phenobarbital, zolpidem (lower fall risk), promethazine, trazodone Always monitor closely for falls 54

Which Psychotropic to Use? Symptom Therapy TypeMedication ExamplesAnxiety/Restlessness, Non-Dangerous Agitation Anxiolytic * ; Antidepressant Buspirone*, SSRI (citalopram, trazodone), SNRI (venlafaxine), Benzodiazepine (lorazepam)* , Barbiturate (phenobarbital)*, promethazine* Depression Antidepressant Methylphenidate, ketamine, SSRI (citalopram), Mirtazapine, SNRI (venlafaxine), DNRI (bupropion) Mood lability (up/down; laughing/crying) Mood stabilizer, Antipsychotic Valproic acid, (lithium only if monitoring serum levels), chlorpromazine ($$$), olanzapine, risperidone Delirium Antipsychotic Haloperidol, risperidone, quetiapine, etc. Psychosis (hallucinations, delusions, paranoia) Antipsychotic Haloperidol, risperidone, quetiapine, etc. Meanness, aggression, hostile/violent agitation Antipsychotic ; Anxiolytic *; Other** Haloperidol, risperidone, quetiapine, promethazine*, Benzodiazepine (lorazepam)* , Barbiturate (phenobarbital)*, carbamazepine** *generally, anxiolytic (antianxiety)=sedative=hypnotic **neither an antipsychotic nor sedative, but specially indicated for this symptom presentation 55

Case: Ima Punchin Question D: Can/Should We Use a Psychotropic? A 77 year old dementia patient in a NH is on hospice care, and has “behaviors”. She screams and punches and is agitated when she is assisted out of her room to group activities almost every day at about 2pm. She is weak, so while she lashes out and is disruptive, she does not pose any physical harm to herself or others. All other times of the day, she is in her room laying down, and seems calm and content. She is somewhat confused , but never more than baseline. Patient has received/failed: scheduled acetaminophen and PRN opioids; re-direction with puzzles; and buspirone and then lorazepam for apparent anxiety . Infection and constipation have been ruled out. The facility will not allow any haloperidol for any reason. Medications: Glipizide 5mg PO daily Furosemide 20mg PO daily Metoprolol 25mg PO BID Acetaminophen 325mg PO q4h prn pain 56

When Prescribing Psychotropics in Facilities 314 days for PRN orders, but may renew with documented rationale and expected duration (except antipsychotics) Does not require in-person assessment for renewal (except antipsychotics)Monitor/Observe/Assess: Is it working? Dose increase appropriate? What conditions, behaviors or symptoms are we targeting ? Document… 57

When Prescribing Antipsychotics in Facilities 314 days for PRN orders (no refills on rx) In-person assessment required for another rxMonitor/Observe/Assess: Is it working? Dose increase appropriate? What conditions, behaviors or symptoms are we targeting?Document… (see specifics on slides 48-49) 58

Real Case on 7/20/18 CHIEF COMPLAINT: agitationHPI: Parkinson’s patient is confused and agitation has increased over the past week. Pain may be contributing - had a recent fall and tailbone fracture, bruises. Also seems to grab her knees in pain. Hollers out when moved or position changed. Current hydrocodone/acetaminophen does not seem to make any difference. R eaches out for things in the air. Usually nonsensical/garbled speech, though was recently able to report she sees children and dogs when there were none. Not getting out of bed; does not ambulate on her own.  Current medications : Hydrocodone 5 mg-acetaminophen 325 mg tablet; 1 tab PO q6h prn pain - taking all PRNs Sertraline 50mg tab PO daily Polyethylene glycol powder 17g PO daily prn constipation Senna-docusate 8.6-50mg tab; 1-2 tabs PO BID prn constipation Solifenacin 10mg tab PO daily Carboxymethylcellulose 0.5% ophth drops; 1 gtt both eyes BID Carbidopa-levodopa 25-100mg tab; 2 tabs PO QAM; 1 tab at lunch, 1 tab with dinner, 1 tab at HS 59

Real Case on 7/20/18 RECOMMENDATIONS:1. Increase hydrocodone/acetaminophen to 10/325mg tab; 1 tab PO QID scheduled plus current PRN orders; max 9 tabs/24h or 3g acetaminophen from all sources 2. Quetiapine 25mg PO BID for psychosis/hallucinations. Monitor for reduction in agitation/hallucinations; re-eval every 2-3 days for possible increase/decrease . 3. Rule out other potential underlying factors to current symptoms such as solifenacin , constipation , infection. 60

SUMMARY CMS guidance has unintentionally created an avoidance response by practitioners, which has diminished optimal care to patients who are eligible/appropriate for antipsychotic or psychotropic use; and which has potentially increased harm with inappropriately scheduled psychotropic/antipsychotic medications to avoid PRN renewal requirements.Non-pharmacologic therapies are a mainstay to the management of dementia-related behaviors. They are highly patient-specific and a challenge to select and employ, but there are many resources (including CMS F248) to guide selection and employment. Remember the 3 “S”s: Speed, Space, Substitutes. Whether or not a patient has dementia, antipsychotic and psychotropic medications should be employed based on their indications – labelled, and well-supported off-label ones. Generally, they should be used after or alongside non-pharmacologic therapies. 61

Questions/Discussion 62

References CMS Survey and Cert Letter 13-35 - Advanced Copy - Revised Interpretative Guidance. May 24, 2013. URL: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/SC-Letter-13-35-Advanced-Copy.pdf Schneider LS, Dagerman KS, Insel P. Risk of death with atypical antipsychotic drug treatment for dementia: meta-analysis of randomized placebo-controlled trials. JAMA. 2005 Oct 19;294(15):1934-43.CMS “Mega Rule”: Federal Register Volume 81, Issue 192 (October 4, 2016). URL: https:// www.federalregister.gov/d/2016-23503 Donald C. Goff, Peter Falkai, W. Wolfgang Fleischhacker, Ragy R. Girgis, Rene M. Kahn, Hiroyuki Uchida, Jingping Zhao, Jeffrey A. Lieberman. The Long-Term Effects of Antipsychotic Medication on Clinical Course in Schizophrenia. American Journal of Psychiatry, 2017; appi.ajp.2017.1 DOI: 10.1176/appi.ajp.2017.16091016 Stefan Leucht, Bartosz Helfer, Gerald Gartlehner and John M. Davis. “How effective are common medications: a perspective based on meta-analyses of major drugs”. BMC Medicine 2015 13 :253 Tampi RR, Tampi DJ, Balachandran S, Srinivasan S. Antipsychotic use in dementia: a systematic review of benefits and risks from meta-analyses.  Therapeutic Advances in Chronic Disease . 2016;7(5):229-245. doi:10.1177/2040622316658463 . American Psychiatric Association. ( 2016). Practice Guidelines for the Use of Antipsychotics to Treat Agitation or Psychosis in Patients With Dementia (2nd ed.). Arlington , VA: American Psychiatric Association . Corbett A, Burns A, Ballard C: Don’t use antipsychotics routinely to treat agitation and aggression in people with dementia.  BMJ  2014; 349:g6420 Kales HC, Gitlin LN, Lyketsos CG: Assessment and management of behavioral and psychological symptoms of dementia.  BMJ  2015; 350:h369 Lexicomp Online, Lexi-Drugs Online, Hudson, Ohio: Lexi-Comp, Inc.; 2018; July 19, 2018 . 63

Clinical FAQs Get rid of care pack/e-kit psychotropics/antipscyhotics? …lorazepam, promethazine, prochlorperazine, haloperidol, morphine, scopolamine, atropine, etc.What do you think?64

Clinical FAQs Is prochlorperazine subject to requirements for in-person assessment before 14-day renewal when it is only used for n/v?Yes 65

Clinical FAQs Antidepressants for short prognosis? methylphenidate, ketamine (compounded for oral administration), mirtazapine 66

Clinical FAQs What about oral steroids for depression?Psychotropic? Probably: Can increase psychotic symptoms and agitation; have been shown to increase depression and anxiety in some patientsCan try for mood/depression, but monitorMay help mood directly, or indirectly if helpful with pain/breathing/energy 67

Clinical FAQs What do guidelines say? For “Psychosis/agitation associated with dementia”: The American Psychiatric Association (APA) practice guideline on the use of antipsychotics to treat agitation or psychosis in patients with dementia recommends against the first- line use of oral haloperidol in elderly patients with dementia-related psychosis or agitation due to a potentially greater risk of harm relative to other antipsychotics. Also, it does not specifically recommend thioridazine in this population, but does state that antipsychotics may be considered for the management of this condition in certain patients. These guidelines caution that evidence for efficacy of antipsychotics is modest in this population, and use should be limited to patients whose symptoms are dangerous, severe, or cause significant patient distress due to safety risks associated with antipsychotic use. Additionally, the guidelines recommend giving preference to second generation antipsychotics [risperidone, quetiapine, etc] over first generation antipsychotics like thioridazine [and haloperidol] in elderly patients with dementia-related psychosis due to a potentially greater risk of harm relative to second generation antipsychotics. 68