Reducing Antipsychotic Medications: Collaborating to Achieve Mutual Goals

1. Reducing Antipsychotic Medications: Collaborating to Achieve Mutual Goals

2. Clifford P Kibbe JR, RPH Clinical Manager, Omnicare of Massachusetts 24 years LTC consultant pharmacist…and counting!

3. Why The Focus On Antipsychotics? • OIG REPORT • In May 2011, the Office of Inspector General (OIG) released a report documenting a problem regarding the use of antipsychotic medications in nursing homes • Based on 2007 sampling of Medicare claims for atypical antipsychotics (6 months) • Focus on off-label use (dementia and related) • Did Medicare erroneously pay for these drugs based on CMS standards defining unnecessary medication?

4. OIG Perspective: Findings • Fourteen percent of elderly nursing home residents had Medicare claims for atypical antipsychotics • Eighty-three percent of claims were for antipsychotics associated with off-label conditions • Eighty-eight percent were associated with the condition specified in the FDA boxed warning • Fifty-one percent of claims for elderly nursing home residents were erroneous, amounting to $116 million • Twenty-two percent of the atypical AP claims were not administered in accordance with CMS standards regarding unnecessary drug use

5. Why The Focus On Antipsychotics? • CMS shared OIG concern • CMS (Centers for Medicare and Medicaid Services) identified reducing the off-label use of antipsychotics as top priority for 2012 • Cost • Safety • Efficacy

6. The Quality Initiative Goal 2012 • Quality Initiative Goal • Safely reduce the off-label use of antipsychotic drugs by 15% by 12/31/12. Final results expected April 2013 • 2013? CMS has not yet announced this year’s goal • 2 Distinct Measures for this Goal using MDS data- • Long Stay- % residents in facility >100 days receiving antipsychotics who do not have Schizophrenia, Huntington’s or Tourette’s syndrome- • Long stay measure will be use to track progress • Short Stay-% residents initiated on an antipsychotic within the first 100 days (same exclusions) • (this measure excludes individuals on AP med prior to admission) -

7. What Is The Boxed Warning? • Most serious warning FDA can give a medication 2005 Food and Drug: Boxed Warning: • Atypicals are associated with 60-70% increased risk of death compared to placebo in randomized controlled trials among older patients with dementia • Subsequent studies found risks at least as high among users of conventional antipsychotics and the Food and Drug Administration issued a similar warning for such drugs in 2008.

8. More On Boxed Warnings And Safety • 4.5% vs 2.6% in placebo group • Actually discovered “by accident” • Causes of death varied, but most appeared to be cardiovascular (sudden death, heart failure) • …or infectious ( aspiration pneumonia) due to dry mouth, sedation, other reasons • Other complications included orthostatic hypotension leading to falls, sedation leading to falls, EPS leading to falls, metabolic abnormalities, seizures, cognitive impairment, agranulocytosis (low WBC count) • Common sense dictates increased risk of adverse events if compromised medically prior to antipsychotic initiation • Apply Risk/Benefit very liberally here!

9. Antipsychotic Medications And Geriatric Doses • Abilify (Aripiprazole) 10mg Stelazine (Trifluoperazine) 8mg • Clozaril (Clozapine) 50mg Thorazine (Chlorpromazine) 75mg • Geodon (Ziprasidone) N/A Trilafon (Perphenazine) 8mg • Haldol (Haloperidol) 2mg Zyprexa (Olanzapine) 5mg • Invega (Paliperidone) N/A • Loxitane (Loxapine) 10mg NOTE: These are the CMS-determined • Mellaril (Thioridazine) 75mg total 24 hour geriatric (65-over) daily doses • Moban (Molindone) 10mg • Navane (Thiothixene) 7mg • Prolixin (Fluphenazine) 4mg • Risperdal (Risperidone) 2mg • Seroquel (Quetiapine) 150mg

10. February 2012 BMJ: Safety Perspective • Antipsychotics Increase Mortality in Long-Term Care Residents • 75,445 residents across 45 states age 65 or older residing in nursing home from 2001-2005 • There is variation in risk of death according to type of drug used • Effects of mortality strongest shortly after start of treatment • Dose-response relationship was observed for nearly all antipsychotics

11. February 2012 BMJ: Summary of Results • Summary of deaths within 180 days of starting antipsychotic • Haloperidol: 1 in 8 died • Aripiprazole 1 in 15 died • Olanzapine 1 in 11 died • Quetiapine 1 in 14 died • Risperidone 1 in 11 died Common causes of death included circulatory disorders (49%), cerebrovascular diseases (10%), and respiratory disorders (15%), which are consistent with causes of death discussed in the boxed warning for antipsychotics

12. Monitoring For Side Effects • Care Plan each medication: each potential side effect, exit strategy • AIMS/DISKUS at least every six months. React to increased scores. • Orthostatic hypotension on ambulatory residents at least monthly (more often at onset of therapy). • Usually a section on the Behavioral Flow Sheet reserved for side effect monitoring. Take the time to fill it out conscientiously. Again, side effects manifest often with antipsychotics soon after initiation • EPS may take months/years to develop but this one can be irreversible if not identified timely • Treat every Change in Condition with your residents as potentially caused by the antipsychotic they are receiving. These medications are that dangerous.

13. What About Efficacy? • Lack of efficacy helps to define an “Unnecessary Drug” especially for the most common uses: wandering, agitation, crying out, insomnia • These drugs are all off-label for a reason • It is likely your own Behavioral Flow Sheets will reinforce this! • Non-pharmacological AND safer non-antipsychotic alternatives • Again: Risk/Benefit is the key to determining appropriate use

14. Where Do I Start? How About Low-Dose APs? • “Low hanging fruit”-newly started low dose antipsychotics given at bedtime (ie for sundowning, evening agitation, insomnia). These are red flags • Often times you see these in your admission units. If you can determine they were started in the hospital for agitation and the medical condition/delirium has resolved they can be safely and quickly stopped shortly after admission • Any low dose antipsychotic is a candidate for immediate discontinuation. • May or may not want to keep the accompanying prn dose for “rescue” (though this could become a “crutch”) • Once you accomplish a few antipsychotic discontinuations, let the skeptics know. This is a success story you should be proud of!

15. Where Else Should We Attack? • Any time we see a side effect that is likely associated with the antipsychotic. Be vigilant for opportunities. • Polypharmacy. One off-label drug bad. Two off-label drugs indefensible. This scenario is never appropriate as you get additive side effects, and the inability to determine which medication is causing the problem (or maybe even helping). The situation is often the result of multiple prescribers getting involved or even an interrupted cross-titration. • When your behavioral flow sheet indicates the medication just isn’t working. This is a classic case of risk/benefit. If you have to think about what “behaviors” the drug is treating, that’s a problem. • Decline in condition should always precipitate a consideration for dose reduction or elimination. • PRNs: These medications rarely actually treat any kind of condition and “help” via their ability to sedate. Strongly suggest avoiding prninjectables.

16. The Lowest of the Low-hanging Fruit: PRNs • In Massachusetts, surveyors often request a list of “all residents who are receiving a prn antipsychotic” at day one of the survey • Use of a prn antipsychotic often the canary in the coal mine to a state surveyor • Even if use is “appropriate” for that individual, you run the risk someone may give it inappropriately or without adequate supporting documentation • If little or no utilization, why not just stop it? • If utilization, make sure documentation (reason, result) is present, behavior sheet and nursing notes all match • Then read again. See why it is being used. Is there an alternative non-pharmacological alternative? If not, there is almost always a logical pharmacological alternative prn that could replace an antipsychotic. • Train the staff to question any covering prescriber who writes for them

17. Other Strategies for Reducing Antipsychotics • Look at antipsychotic use in residents with “non-psychotic behaviors”. Chances are you can stop drugs used for wandering, crying out, agitation, anxiety by employing non-pharmacological interventions or non-antipsychotic medications. Residents experiencing hallucinations, delusions, or paranoia may be more difficult to reduce. • Is the behavior being treated one that results in the resident being a danger to themselves or others? If the answer is no, then that antipsychotic might immediately be a candidate for reduction/elimination. • Always consider medical reasons for behaviors: pain, infection, heart failure, anemia, thyroid disease to name a few. Make sure these conditions are adequately treated before initiating antipsychotic therapy. • Delirium can be caused by anticholinergic medications of all sorts, agitation by antidepressants, steroids (psychosis).

18. Other Suggestions For Your Consideration • Consider reviewing every single new order for a psychotropic medication for appropriateness as soon as possible. Many get started “after hours”. • Consider letters to family members explaining the reduction in antipsychotic initiative if you are just starting the process. Also consider a Family Night. • Pick your low hanging fruit first and pace yourself. Reducing the whole building at once may not be manageable. • Be patient with results, or documented failures will result in future attempts being labeled “Clinically Contraindicated”. • Go low and slow with higher dosed antipsychotics and antipsychotics that have been in use for years. These drugs were likely started gradually and may need to be titrated down gradually as well for months before being completely eliminated. Don’t get impatient.

19. Your Consultant: Team Member or Outsider? • Insist your consultant pharmacist (CP) performs an entrance meeting with you each month. Do not let a month go by without a discussion of your needs • Agree upon the best way to communicate-both while the CP is in the building and in-between visits. E-mail is a fantastic tool for this. Make sure your CP is aware of all falls, new changes in condition, and other concerns routinely. Make it clear that this is your #1 current and ongoing initiative • Consultants can provide support via: education/inservicing, tracking progress with statistical feedback, very specific recommendations regarding Gradual Dose Reduction scenarios • Dialogue with the staff: avoid “stealth consulting” • Education in Support of Family Nights • Attendance at Family Meetings • Education in support of your efforts aimed at prescribers and geropsych services

20. Behavior Meetings: A Meeting of Great Minds! • Routine (monthly?) meetings are the best. Set a schedule then stick to it. This lets everyone know you take this seriously. • Get the right folks there: a good mix might include the following: DNS, Administrator, Medical Director and/or other prescribers, Geropsych, Consultant Pharmacist, Unit Managers, Program Director, Social Services, Activities. Everybody has just a little bit different take on each situation and offer a little piece of information the others did not know/hadn’t considered • Organize and collect as much data as possible on the front end. Non-facility attendees (prescribers, consultants) often have limited time to offer. Respect everyone’s valuable time and you will get better attendance (and better attitudes) monthly • Explain at meeting #1 exactly what you are trying to accomplish. The first few meetings will likely be somewhat long but eventually…

21. Pharmacist Role in Behavior Meetings • “Interpretation” of Interpretive Guidelines: Risk Assessment • Medication “expert”-what drugs and current doses everyone is receiving • History of previous Gradual Dose Reduction attempts: when, why, and what happened • Recommendations for drug taper, replacement medications if any. The need for clinical input often depends on who else attends these meetings • Mediator. Referee. Depends on the dynamics of your particular meeting • Consultants can keep their laptop open and type up recommendations for Gradual Dose Reduction right during the meeting. Again, need for this might depend on who else attends the meeting • Required documentation

22. Summary • A good consultant pharmacist is trained to interact openly with facility management. You are the customer. Have you sat down with your consultant recently and made your needs known? You have done all the training and would not be on this call if you were not ready to take the next step toward eliminating unnecessary and inappropriate antipsychotics. Take the next step and reach out. QUESTIONS?

23. References • Ballard C, Lana MM, Theodoulou M et al. A Randomized, Blinded, Placebo-Controlled Trial in Dementia Patients Continuing or Stopping Neuroleptics (The DART-AD Trial). PLoS Medicine 2008;5(4):0587-0599. • Ballard C, Hanney ML, Theodoulou M et al. The dementia antipsychotic withdrawal trial (DART-AD): long-term follow-up of a randomised placebo-controlled trial. Lancet Neurology January 9, 2009;1-7. • Schneider LS, Tariot PN, Dagerman KS et al. Effectiveness of Atypical Antipsychotic Drugs in Patients with Alzheimer’s Disease. N Engl J Med 2006;355:1525-38. • Huybrechts KF, Gerhard T, Crystal S et al. Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: population based cohort study. BMJ; February 23 2012:1-12