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Clozapine is underused in Ohio: How can we address this?

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1 Clozapine is underused in Ohio: How can we address this?
Dale Svendsen, MD, MS October 15, 2014

2 How I will Present This? Clozapine: Its Use, History, Indications, Efficacy, Side Effects How might we at OSU address the utilization of Clozapine in Ohio

3 Steps to address the utilization of Clozapine in Ohio
Why: Clozapine is the Best Medication Treatment for the 30% of people with Treatment Resistant Schizophrenia Spectrum Disorder yet in Ohio only about 5.8 % of this population is receiving it. How: Engage you, your feelings, thoughts, and ideas in what this why message means for you What: Implemention approaches* to address the underutilization of clozapine in Ohio * Svendsen, D., Hogan, M. & Worham-Wood, J., Transformational Leadership in Mental Health, pgs in Modern Community Mental Health an Interdisciplinary Approach, edited by Yeager, K, . Cutler, D, Svendsen, D, & Sills, GM, Oxford U. Press, 2013

4 Comprehensive Reviews Clozapine: Balancing Safety with Superior Antipsychotic Efficacy Herbert Y. Meltzer , June, 2012 Clozapine is often referred to as the gold standard for the treatment of schizophrenia…yet the most underutilized treatment. Concerns over side effects, especially 1) agranulocytosis; 2) metabolic side effects; and 3) myocarditis are responsible for much of the underutilization of clozapine. Nevertheless, clozapine two large epidemiologic studies has the lowest mortality of any antipsychotic drug and reduced ...suicide. Other reasons for limited use of clozapine include the extra effort entailed in monitoring for side effects and, possibly, minimal efforts to market it now that it is largely generic. Awareness of the benefits and risks of clozapine are essential for increasing the use of this lifesaving agent. Key Words: Schizophrenia, Clozapine, Treatment Resistant, Suicide, Agranulocytosis, Metabolic Side Effects, Myocarditis 1Professor of Psychiatry and Behavioral Sciences, Feinberg School of Medicine Address for correspondence: Dr. Herbert Y. Meltzer, Professor of Psychiatry and Behavioral Sciences, Northwestern Feinberg School of Medicine, Ward Building , 303 East Chicago Avenue, Chicago, IL 60611 Phone: ; Fax: ; Submitted: June 28, 2011; Revised: June 12, 2012; Accepted: June 16, 2012

5 What started the interest in clozapine at OSU Psychiatry?
Psychiatric Services, February 2014 What started the interest in clozapine at OSU Psychiatry?

6 State Variation in Clozapine Initiations
: 629,809 AP Tx episodes with 2.2% starts 79,934 TR with 5.5% starts

7 What Do Others @ OSU think in response to Stroup Article
What Do OSU think in response to Stroup Article? Change Starts with US! John Campo…..shares his interest in best medication practices by frequently forwarding articles on Use of Psychiatric Medications such as Sroup’s, Andreason’s article on how first episode psychosis people do better after 7 years on low dose or discontinuation and have more gray matter, invites Sandy Steingard for Grand Rounds, leads Minds Matters studies with Cynthia Fontenella, etc. Sam Guirgis has strong regard for using clozapine, considers its use in early psychosis patients and has published using sophisticated testing for a successful rechallenge. He begins a QI study of clozapine use at OSU-Harding Bob Kowatch: Clozapine very effective in adolescents when I used it in the 1990s. Wt. gain was a problem as were petit mal seizures. Metformin helps if you add it early. Several other newer approaches to consider for wt. gain Maryann Murphy: Agree with Bob. Metformin kept a lid on wt. gain in a study Gene Arnold: If there is a departmental push to prescribe more clozapine, it would be a good opportunity to study both the effect on gut flora and/or the effect of concomitant probiotic and/or metformin use Jessica Hellings: Loxapine is a “poor main’s clozapine” without agranulocytosis and weight gain. Joe Coyle recommended it as first line treatment in schizophrenia

8 What do Others Think in response to Stroup Article?
The major risk is agranulocytosis. It’s simply difficult to justify its use until a patient failed multiple other atypicals Katherine Brownlowe: As a younger psychiatrist....“those who need it most are unlikely to follow up or continue meds after discharge…and a lack of outreach services in central Ohio compared to Vermont” Tracey Skale, Medical Director at Greater Cincinnati Behavioral Health Services: “I use LOTS of clozapine and as an agency many of our folks are on clozapine. The residents coming out have negligible experience with clozapine which is a shame. So, the newer docs tend not to start clozapine. In addition, one of the hospitals has been taking our clozaril people OFF (!) clozaril if the patient happens to go in...which is very frustrating to us” Jay Carruthers, NY OMH Medical Director of clozapine initiative in NY % is too low. We’re trying to make clozapine more accessible to those that need it the most. But its culture change—institution, provider and consumer...that’s needed. Dale Svendsen: Clozapine use in Ohio’s State Hospitals….including a suggestion that OSU could be a leader in addressing the underutilization of Clozapine… followed by several suggestions for publication, a clozapine grand rounds by Herb Meltzer, me, etc.

9 Request from Dr. Campo for Clozapine Grand Rounds
…”Given its relatively unique profile, inconvenience alone, at least from the practitioner perspective, probably is not a good reason to avoid recommending and trying the drug in the setting of an appropriate and well informed patient. Your ideas about how we can mitigate the complexities of clozapine use deserve attention and further discussion, and I am hopeful that our burgeoning group of psychiatrists interested in psychosis will get together and generate some practical and actionable ideas.”

10 Clozapine: It’s Use in Ohio’s State Hospitals and in Ohio in the 1990s
Sept, 1992-June, 1994: $1 M per year from the legislature for the only atypical AP Initially over 800 patients met criteria with average LOS of > 4 years... 1177 eligible over the 22 months of the study selected... 37 % refusal.... 56 discontinued treatment...82% of these over the first 6 months 21 DC’ed because of major adverse effects...9 for wbc, 1 agranulocytosis 6 other medical reasons 20 for refusing to continue treatment 9 for failure to respond to treatment S/R: in 119 monitored and S/R reduced from 256 episodes and 33.6% of individuals to 64 episodes in 15.1% of individuals Improvement slow...but enduring. No discharges after 6 months...12 readmits Over 80 % were responders (all 3) or partial responders ( 2 of 3) 1. 20% reduction in BPRS 2. Clinician rated improvement in mental and behavioral status 3. Patient reporting benefits Celebrate the success…”Stepping Ahead” Mid 1990s: other atypical antipsychotics introduced and clozapine generic Effects on the system

11 After the Awakening, the Real Therapy Must Begin
By James Willwerth/Cleveland Monday, July 06, 1992 In Washington Irving's classic folktale, Rip Van Winkle awakes from a 20- year nap to find his youth behind him, the world radically changed and his assumptions hopelessly outmoded. Brendan Lori Schiller, “The Quiet Room”, 1996 Diann Auld Reitelbach, “Catching the Thief: A Story, A Search and Schizophrenia”

12 Clozapine: Historical Perspectives
1952--Chlorpromazine (Thorazine) synthesized in Paris and observed to control agitation, hallucinations and delusions. FDA approved in The first D2 blocker with neurologic side effects. Class termed neuroleptics. 1956—Clozapine synthesized in Switzerland. Lacked neurologic side effects, termed atypical 1961—Clozapine developed by Sandoz 1971- Clinical trials and then use in Europe 1975- After deaths from agranulocytosis withdrawn from market although still used in China without wbc monitoring 1980s-studies showed it was effective for Treatment Resistant Schizophrenia 1988--US Clozaril Study compared clozapine with chlorpromazine. 1989- FDA approves for treatment resistant schizophrenia with requirements for weekly white blood cell and absolute neutrophil counts —Clozapine becomes generic and other atypical antipsychotics introduced 2002—FDA approved for reducing the risk of suicide in patients with schizophrenia FDA approved criteria to allow reduced blood monitoring frequency.[61] 2006—CATIE and CUtLASS demonstrate clozapine better than other atypical antipsychotics for treatment resistant (TR) schizophrenia [

13 Other Important Clozapine Perspectives
Benefit for co-occurring substance use, tobacco cessation, reducing aggression and longer life compared with other antipsychotics for persons with schizophrenia. Usefulness for bipolar patients (Sue UC) Effective in low doses in Parkinson patients for psychosis, tremor, dystonia, etc. 5 Black box warnings for agranulocytosis, seizures, myocarditis, "other adverse cardiovascular and respiratory effects", and for "increased mortality in elderly patients with dementia-related psychosis.“ [

14 What is the Evidence to support clozapine’s claim to be the gold standard?
Kane JM, Honigfeld G, Singer J, Meltzer HY, the Clozaril Collaborative Study Group: Clozapine for the treatment–resistant schizophrenic: a double-blind comparison with chlorpromazine, Arch Gen Psychiatry 1988; 45:789–796 Essock SM, Hargreaves WA, Covell NH, Goethe J: Clozapine’s effectiveness for patients in state hospitals: results from a randomized trial. Psychopharmacol Bull 1996; 32:683–697 Saveanu, TI, Wellage, L,& Roth, D, Evaluation of the Impact of Use of Clozapine Treatment in the Ohio State Hospital System, New Research in Mental Health, Ohio Department of Mental Health, 1995, Volume, 12, Rosenheck R, Cramer J, Xu W, Thomas J, Henderson W, Frisman L, Fye C, Charney D, Department of Veterans Affairs Cooperative Study Group on Clozapine in Refractory Schizophrenia: A comparison of clozapine and haloperidol in hospitalized patients with refractory schizophrenia. N Engl J Med 1997; 337: 809–815 MCEVOY, LIEBERMAN, STROUP, ET AL, Effectiveness of Clozapine Versus Olanzapine, Quetiapine, and Risperidone in Patients With Chronic Schizophrenia Who Did Not Respond to Prior Atypical Antipsychotic Treatment, Am J Psychiatry 163:4, April (Greater time to all cause discontinuation) Randomized Controlled Trial of the Effect on Quality of Life of Second- vs First-generation Antipsychotic Drugs in Schizophrenia: Cost Utility of the Latest Antipsychotic Drugs in Schizophrenia Study (CUtLASS 1 Jones PB, Barnes TR, Davies L, Dunn G, Lloyd H, Hayhurst KP, Murray RM, Markwick A, Lewis SW Archives of General Psychiatry October 2006; 63:1079 – (Greater Reduction in PANNSS Scores after one year) Leucht S1, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, Samara M, Barbui C, Engel RR, Geddes JR, Kissling W, Stapf MP, Lässig B, Salanti G, Davis JM, Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet Sep 14;382(9896):940.

15 CATIE Phase 2E: Time to Discontinuation
Overall p-value= 0.028* McEvoy et al, AJP 2006

16 Symptoms Leucht et al. Lancet 2013

17 Balancing the Risks and Benefits of clozapine
Agranulocytosis...<1.0 % 1st 6 months; .o1% after 6 months Cardiovascular risks…myocarditis and cardiomyopathy…and tachycardia Metabolic side Effects…similar to olanzapine…insulin resistance Wt Gain Glucose dysregulation Lipid increases Seizures and myoclonic jerks Hypersalivation Obstipation Anticholinergic side effects Sedation

18 Clozapine Agranulocytosis Risk
Overall Risk of agranulocytosis or granulocytopenia is %. Most risk occurs between six weeks and six months. Risk: second six months 0.70/1000 patient yrs Risk: after first year is /1000 patient yrs Mandatory monitoring results in very few cases of full agranulocytosis. Five year data found 382 cases of aganulocytopenia among 99,502 patients (0.38%) and 12 deaths (0.01%) Described in Meltzer article in references

19 Weight gain Leucht et al. Lancet 2013

20 Sedation Leucht et al. Lancet 2013

21 Extrapyramidal symptoms
Leucht et al. Lancet 2013

22 How to mange the side effects of clozapine?

23 Clozapine and Cardiovascular risk
Myocarditis Symptom Checklist for Patients on Clozapine Complete before starting clozapine and then weekly for the first 8 weeks of clozapine treatment. Date of clozapine initiation __________________ Today’s Date __________________ Heart Rate __________________ Blood Pressure __________________ Temperature __________________ Complaints of:  Chest pain/pressure  Dyspnea/orthopnea  Peripheral edema  Persistent palpitations  Fatigue or decreased exercise capacity  Fever or flu-like symptoms  Nausea/vomiting  Diaphoresis Myocarditis Myocarditis is a very low risk of clozapine use. It almost always occurs in the first 2 months of clozapine treatment. Reasonable estimates of its incidence in patients started on clozapine range from 2/1000 to 1/1000. Consequences can include death (25%) and disability.

24 Guidelines: Managing Adverse Effects of Clozapine
Do not panic. Always consider the rare but serious problems associated with clozapine: e.g. Agranulocytosis, Myocarditis, Neuroleptic Malignant Syndrome(NMS) Always consider other drugs as a potential cause. Do not stop clozapine unless it is absolutely necessary. Lowering the dose is fine: Unless it is absolutely necessary (i.e. Myocarditis, agranulocytosis, NMS), clozapine should be gradually lowered and not just stopped. Abrupt discontinuation can often lead to rapid relapse that is worse than the initial psychosis. Ask for help. (See “Clozapine Phone Consultation Service” link at Clozapine Resource Center webpage) OSU Role? J. Nielsen, et al, Termination of Clozapine Treatment Due to Medical Reasons: When Is it Warranted and How Can It be Avoided?, J Clin Psychiatry, 2013: 74 (6):

25 Data specifically from New York State is very similar
Is there other data to support the Stroup article? Psychiatric Services, November 2012

26 Antipsychotic starts for Schizophrenia in NYS Medicaid 2009 (N=7035)
2% of new starts with 30% of individuals with SCZ experiencing TR symptoms

27 What is the Use of Clozapine in Ohio?
Ohio: Total population (adults with Medicaid who had at least two service claims in 2011 with a diagnosis of schizophrenia spectrum disorder)* and had at least one pharmacy claim for an antipsychotic medication): 14,801  Clozapine includes those that were identified on clozapine, Clozaril or FazaClo.          Total number of patients on clozapine alone: (2.2%)         Total number of patients on clozapine plus at least one other antipsychotic: (3.7%)          All patients on clozapine (alone or in combination): (5.8%)  Franklin County: Total number of patients from Franklin county with a diagnosis of schizophrenia spectrum disorder: 1474         - All patients on clozapine (alone or in combination): 73 (5.0%) Ohio new clozapine starts: Stroup, et al, of all antipsychotic starts ( %)  *Schizophrenia spectrum disorder (schizophrenia, schizoaffective, schizophreniform, delusional disorder, psychosis NOS) October 10th, 2014: Data courtesy of NEOMED Dept. of Psychiatry : Mark Munetz, Chris Ritter, Sara Dugan and OHMAS Carol Karstens

28 New York OMH Clozapine Utilization
denominator: patients with 295.x diagnosis receiving antipsychotic numerator: 295.x patient receiving clozapine Inpatient range: 8.45% % Clinic range: 0% % New starts in NY in , % (Stroup et al) Courtesy of Jay Carruthers, MD, Director of clozapine initiative in NY OMH Q4 2011 Q4 2013 INPATIENT 27.3% 30.0% OUTPATIENT 16.8% 17.3%

29 Clozapine: perspectives so far in the 21st Century
Underused…. Generic and little marketing Younger psychiatrists lack experience with its use and don’t get to see benefits that may take time Side effects are significant and practice settings are often not conducive to safe use As BH/PH care integration is occurring, now seems like a good time to safely prescribe and monitor. OSU could be a leader with others in addressing the underuse of clozapine and could advance the science (?wt. gain) if we begin an initiative Clozapine would likely reduce hospital readmissions for persons with TR Schizophrenia....ACA payment reform looks at hospital readmission rates Families and persons with a lived experience are not advocating as in past Awareness of the benefits and risks of clozapine is essential for increasing the use of this lifesaving agent (Meltzer)

30 What are the Special Benefits of Clozapine? (NY)

31 Clozapine is Underutilized: How Can We Address this
Clozapine is Underutilized: How Can We Address this? Transformational Leadership Keep your eye upon the star “Taking care of business” is job one Share the vision and develop it further with others. When the problem seems impossible to resolve, try reframing the issues. Mental health leadership is a team sport. Mental health leadership focus includes consumer, clinical, and administrative perspectives. “Do the right thing”: A value-based approach leads to trust. You can’t do just one thing. Change takes action on many fronts at the same time. Lead, follow, or get out of the way. Seek outside consultation to assist. Partner with your best resources Schedule time to consider, gather input, and set direction Measure and improve...Improvement Science Svendsen, D., Hogan, M. & Worham-Wood, J., Transformational Leadership in Mental Health Care, in Modern Community Mental Health: An Interdisciplinary Approach, edited by Yeager, Cutler, Svendsen & Sills, Oxford U. Press, 2013

32 Keep your eye upon the star "Start With Why”
The golden circle Simon Sinek, author & speaker Lloyd Sedder: Click here to watch the TEDTalk that inspired this post. Simon Sinek's TEDTalk has gained over 13 million viewers yet what he has to say is nothing new. But it is clear and punchy and makes it all sound so easy. Anyone can be a Steve Jobs, a Martin Luther King, an Orville or Wilbur Wright. Anyone can sell products beyond belief, gather legions of followers or master powered manned flight. What's the secret? Sinek seems to know. Sinek's message is that people buy products or enter movements on the basis of 'why', not on the basis of what is being done. He paints Apple not as a computer company but rather closer to a revolution meant to change the status quo; we are drawn to Apple because we too want to be first, creative and iconoclastic. We follow Dr. King because he speaks to what we believe; we march for ourselves, our beliefs, not his: he says "I have a dream... not I have a plan." And the Wrights? Well they wanted not to just fly; they wanted to change the course of history (by introducing manned flight). Sinek even tosses in a bit of neuroscience pointing out that while the "outside" layer of our brain, the neocortex," is rational that it is our "inner" limbic brain, feeling and instinctual, that compels our actions. What I learned from this TEDTalk was how critical it is to start an organization's message with its purpose, its mission, its humanity, and its values. I knew about how important those are, but maybe had not quite been converted to the necessity of painting those in neon at the front of every media communication and social conversation. I did not need to learn, but I was nicely reminded, that in the end we all do what serves us -- whether our aims be noble, altruistic, material or self-serving. It is a very good thing when virtue finds a cause or a leader of a cause. I suppose that is what Margaret Mead meant when she said "Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it's the only thing that ever has." I suppose that is what Gandhi meant when he inverted the change message to say "Be the change that you wish to see in the world." But, of course, it is a very bad thing when evil finds a leader who can change hearts, not just minds; history is replete with tyrants like Hitler, Stalin, and even Jim Jones (cult leader of the Jonestown, South Africa, massacre). But I do think Sinek needs a bit more neuroscience instruction since instinct has not always been a friend. Without a neocortex, a thinking brain, we would not have law, some measure of equality and civilization. Sinek's talk, however, is indeed worth the 18 minutes he entertainingly delivers. Not only to help sell more iPads, sneakers, and alcoholic beverages; not only to engage others in our mission, whatever might that be. But because we are too often programmed to start with "the what and the how" -- the service or product and the way it does its thing -- and omit the greater value of it all. In fact, starting with the purpose, the why, could very well disclose the essence of something. It could reveal whether something or someone deserves to be bought or followed. It might demand that whatever is offered demonstrate, in its small, vast or unique way, that it could elevate our society and make the world a better place. Or not. Simon O. Sinek is an author best known for popularizing the concept of "the golden circle" and to "Start With Why",described by TED as "a simple but powerful model for inspirational leadership all starting with a golden circle and the question "Why?"‘ Lloyd Sederer,MD, Huffington Post,[

33 “Keep your eye upon the star” “Do the right thing” "Start With Why”
Clozapine is the Best Medication Treatment for the 30% of people with Treatment Resistant Schizophrenia Spectrum Disorder. However in Ohio only 5.8 % of the Medicaid population with Schizophrenia Spectrum Disorder is receiving it If the diagnosis were cancer would “we” not be offering and encouraging the best known treatment despite side effects and difficulties with administration?

34 Clozapine: The why is clear...but some barriers
25 years later… a challenge for the mental health system Remains the most effective antipsychotic for TR psychosis: FDA Indicated for treatment refractory psychosis, suicide Other: violence/aggression, co-morbid substance Vastly underutilized for a number of reasons: Fragmented system of care Demands more work of everyone: prescriber, ancillary staff, and patient Prescriber bias: poly-pharmacy Consumer bias?: Side effects “front loaded” and benefits “back loaded” in some instances Should be considered after 2 failed antipsychotic trials Delay in trial of 5-10 years, if given at all The quintessential science to service gap in behavioral health?

35 HOW: To Address this? “You can’t do just one thing”
“How do you think about this? Systems Based...How can we change the system? Population based medicine... and patient centered care Culture change….change starts with us….our clinical services... our use of clozapine....our medical faculty and residents...our handoffs and partnerships Relationship, Relationship, Relationship Transformational leadership... and processes...a team sport Business Plan…put your resources where your mouth is….win/win relationships….Access new resources and approaches...MEDAPP, State, ADAMH Key Driver Diagram…global aims and smart aims Improvement Science Improve patient care by reducing the gap between what is actual and possible (Yeager) Clinical and Translational research Find a Parade and Get in Front of it Tipping Point, …Malcolm Gladwell…Law of the Few (Connectors, Mavens, and Salesmen), the Stickiness Factor, and the Power of Context... “Be a thought Leader”…and “Doer”…”Listen”…”THE” OSU Wexner Medical Center…patient care, education and research” Population-based medicine is one of managed care’s fundamental notions. The American Medical Association recently defined it as an approach “that allows one to assess the health status and health needs of a target population, implement and evaluate interventions that are designed to improve the health of that population, and efficiently and effectively provide care for members of that population in a way that is consistent with the community’s cultural, policy, and health resource values. Peter Boland wrote back in the mid-1990s, it “does not detract from individuality but rather adds another dimension, as individuals benefit from the guidelines developed for the populations to which they belong.” As for patient-centered care, definitions differ — and that’s part of the trouble. But it has been described by recent Centers for Medicare & Medicaid Services (CMS) Administrator Donald Berwick as including “transparency, individualization, recognition, respect, dignity, and choice” in the patient’s health care experience. It is also widely understood to draw on the concept of the patient-centered medical home (PCMH), in which a practice is organized to provide truly coordinated, proactive and therefore cost-effective care. ”Business Plan Anatomy of a Plan Name and description of product/service or planning goal and market for same Describe the competition and alternative goods (ways) Marketing plan Financial plan Operational plan Management and personnel plan (who will do what) Roll-out schedule with steps and timetable Critical risks and problems Evaluation and Sustainability Issues

36 Share the vision and develop it further with others Mental health leadership is a team sport Mental health leadership includes consumer, clinical, and administrative perspectives. Administration (Regulation, Payment, Systems, Business Approach, etc.) Persons & Family Clinical Care

37 WHAT: Share the vision and develop it further with others.
Today’s Grand Rounds The story of bringing clozapine to Ohio’s State Hospitals and afterwards “Find a Parade and Get in Front of it” John Naisbitt an American author and public speaker in the area of futures studies. His first book Megatrends was published in 1982 from: Svendsen, Dale Sent: Monday, February 10, :55 PM To: Campo, John; Psych Faculty; Psych Residents Cc: Hurst, Mark; 'Delaney Smith 'David Royer Subject: Regional differences in the use of clozapine John, I have many thoughts about clozapine use as well as experience and some thoughts about what we at OSU could do. Let me share.. My experience with clozapine. When I was at ODMH as Medical Director ( ) most of this time we were underutilizing clozapine in Ohio….which includes the time ( ) of this study. When Clozaril became available in Ohio I led Ohio’s clozapine introduction into the public mental health system. In 1991 ODMH received $ 1.0 M per year from the legislature for clozapine use in State Hospitals in the biennial budget. This turned out to be enough for 400 treatment resistant patients per year in our State Hospitals…and we had over 800 who met criteria! The average length of stay in the hospital for this group was 4 years! Because of limited funding we created a lottery and offered Clozaril to 400 the first year and 400 the following year. We monitored patients carefully for side effects and progress (e.g., BPRS…Brief Psychiatric Rating Scale). Side effects were common but usually manageable e.g., sialorrrhea, obstipation, fast heart rate, seizures, sedation, anti cholinergic effects, etc. Aganulocytosis was less than 1% and monitoring with weekly blood draws worked well. However, after 6 months not one of our State Hospital persons on Clozaril were discharged! I was having great doubts! Our psychologists however using the BPRS said that people were improving. However it became clear that people needed enough time on Clozaril to gain the psychosocial skills needed to live in community. For many it was not rehabilitation but habilitation since for some it was awakening after years of psychosis. I remember one 32 yo man who I had treated when 19 yo as an OSU student. He wound up spending the next dozen years in the state hospital; when his turn came to start on Clozaril he improved but although now in his 30s was developmentally still a 19 yo and had a lot of catching up to do over several months to be able to live as an adult in the community. 6 months after we started the Clozapine program discharges began to occur and became quite frequent. Over the next 6 months essentially none were readmitted! This drug really worked. We held statewide Clozapine Conferences (we called them Stepping Ahead ) where State Hospital, University and Community Mental Health Centers came together to present their research and experiences with this medication and this population It was very impressive and exciting. I had the chance to continue the Clozapine line item from the Ohio legislature for the next biennium but I felt we should include it with the medication allocation and not highlight it. In retrospect, this was a mistake…since the focus on clozapine was no longer front and center. By the way the State Hospital population was about 2400 patients in 1992 when we started this. By 2000 our population was 1100 and we had less than 100 non forensic patients who were there > 1 year! Over the years in our State Hospitals we paid attention to the additional special benefits of clozapine such as for aggression, suicidality, tobacco cessation, and communicated these to the providers in the public mental health system. We even allowed our State Hospital psychiatrists to petition the probate court to order clozapine for those who would benefit….even though we stated up front we would not be able to force the required blood draw and would have to stop it. Patients listened to the court and not once in my years do I recall a patient refusing the court order. As Medical Director I monitored clozapine use in Ohio both at the State Hospitals and via community via Medicaid. I definitely felt it was underused and we tried to increase its use. For our hospitals we provided feedback to medical staff on its use. Both in our hospitals and in the community we tried guidelines (OMAP-Ohio Medication Algorithm Program) but these were labor intensive and not effective. Scott Stroup (who was a leader in the CATIE Study) et al in this article describes many reasons for underuse…and most of them applied to Ohio. There were also other reasons I felt. Clozapine becoming generic was a reason as there was no longer a pharmaceutical company push. In community mental health settings psychiatrists found it hard to start and monitor with their limited time and no convenient and available medical assistance when needed. The increased awareness of metabolic syndrome and monitoring added another reason to not try clozapine. Also as noted above it often takes time to see meaningful results and many psychiatrists (and other treatment team members such as case managers) did not have enough experience to see the full benefits and did not want to bother with the increased hassles of monitoring and prescribing. As noted above readmission to hospital of persons on clozapine was significantly less so inpatient teams were unlikely to see the benefits of this treatment; for example my niece, an MSW/LISW at Riverside and formerly at the Buckeye Ranch, recently told me she can’t remember a patient coming into the hospital on clozapine. Community psychiatrists came to hope that clozapine would be started by an inpatient team when the patient became hospitalized. I know (from medical students and residents in the classes I teach) that we typically have at least one patient on clozapine in OSU/Harding and at least one or two at TVBH on the teaching unit. However because of short hospitalizations to stabilize patients and usual follow up in a community setting, it is often the case that the initial prescriber does not get to experience the effects of staying on this medication. The most frequent prescribers of clozapine in Ohio were first at CASE Western Reserve when Herb Meltzer headed the Clozaril Clinic there and then at CMHCs with strong medical leadership and an organizational push to use clozapine. What could OSU do to address the underutilization of Clozapine? I personally believe that there is a special role our OSU Psychiatry Programs (e.g., Outpatient, Inpatient, Partial Hospitalization, Community Psychiatry, etc.) could provide. We could offer a Specialty Clinic (Clozapine) to evaluate and recommend treatment for persons with treatment resistant schizophrenia and psychotic disorders. We could begin clozapine treatment for those who are judged to benefit and monitor and refer back to community treatment when stable on the new medication. We could train community providers in Evidence Based Approaches for Schizophrenia and related disorders across the life span. The program would be able to evaluate and research treatments and outcomes and OSU would be a thought leader in our area and beyond. It could become a key program in the Neuroscience Center and for our residents. Perhaps the ADAMH Board or another resource would be interested in supporting this. We would benefit many…and our community. My thoughts only. _____________________________________________ From: Campo, John Sent: Saturday, February 08, :37 PM To: Psych Faculty; Psych Residents Subject: Regional differences in the use of clozapine Are we using clozapine enough in the state of Ohio and at OSU Harding? I don’t know the answer, but this study suggests considerable regional variation in use of clozapine, which is lower in Ohio than in some other states. Hope you are having a nice weekend. John << File: Stroup - Geographic differences in clozapine prescription Psych Services 2014.pdf >> [ sig.png] John V. Campo, MD Professor and Chair Department of Psychiatry OSU Harding Hospital, 1670 Upham Drive, Columbus, OH, Office / Fax

38 Reasons for current interest in clozapine
Newer antipsychotic medications have not matched clozapine’s effectiveness for people with refractory symptoms Continued lack of evidence for alternative strategies, including antipsychotic polypharmacy

39 “Taking care of business” is job one Change starts with us
OSU College of Medicine Mission, Vision and Values All areas of the Ohio State College of Medicine are driven by our mission:  to improve people’s lives through innovation in research, education and patient care What is OSU Harding Use of clozapine and antipsychotic polypharmacy? Waiting for results!

40 WHAT: Partner with your best resources
Thank you for coming to North Central. We continue to enjoy our developing collegial relationship with the Ohio State University Department of Psychiatry. We have been working on the development of the clozapine outpatient treatment team. We are thinking of starting with the approximate 40 existing patients, two caseworkers and one nurse. We would use this as the initial cohort and build from that. We are wondering whether you have any estimates about the number of additions to the team that might be expected from OSU? Please let us know your thoughts. Don Wood

41 Find a Parade and Get in Front of It Partner with your best resources
OSU Psychiatry and Behavioral Health/NEOMED collaborate on BEST Practices in Pharmacotherapy In collaboration with the BeST Center……… (i.e. psychiatry and pharmacy staff and consultants):  1) Develop an implementation approach to promote the appropriate use of Clozapine  2) Clinical guidance for selection and dosing of pharmaceutical agents for:   Individuals experiencing an initial psychotic episode; Potential changes/titration Individuals having lived with a diagnosis of schizophrenia spectrum disorders over time A joint effort benefitting both Departments of Psychiatry

42 “Find a Parade and Get in Front of it”
State of Ohio “When the problem seems impossible to resolve try reframing it” Optimizing Pharmacotherapy For Schizophrenia Polypharmacy & cost Low dose antipsychotics for FEP clozapine use ?fund an initiative

43 Obstacles/resistance
KEY DRIVER DIAGRAM Project Name: Revisiting Pharmacotherapy in Schizophrenia SMART AIM KEY DRIVERS INTERVENTIONS Training Increase the evidence based utilization of antipsychotics for the treatment of schizophrenia by: Decreasing the extended use of antipsychotic polypharmacy by 20% Increasing the use of clozapine in appropriate patients by 10% Decrease mental health hospitalizations due to non-adherence by 10% Decrease rehospitalization rates within 12 weeks of previous mental health discharge due to medication related problems by 10% Decrease emergency room visits by 10% Increase the number of patients working or enrolled in school by 10% Increase documentation and evaluation by 10% Communication Public Relations/Outreach Cost Evaluation Education GLOBAL AIM: Increase the number of patients with schizophrenia that take antipsychotics who achieve functional recovery. SMART AIMS: Increase the evidence based utilization of antipsychotics for the treatment of schizophrenia by: Decreasing the extended use of antipsychotic polypharmacy by 20% Increasing the use of clozapine in appropriate patients by 10% Decrease mental health hospitalizations due to non-adherence by 10% Decrease rehospitalization rates within 12 weeks of previous mental health discharge due to medication related problems by 10% Decrease emergency room visits by 10% Increase the number of patients working or enrolled in school by 10% Increase documentation and evaluation by 10% KEY DRIVERS AND INTERVENTIONS: Obstacles or Resistance Knowledge Deficits Interventions Education Target three audiences: health care professionals, treatment team/ staff and patients, families and caregivers Evidence regarding use of clozapine Evidence regarding long acting injectable antipsychotics Evidence regarding antipsychotic polypharmacy Minimum effective dose of antipsychotics Attitude Target three audiences health care professionals, treatment team/staff; and patients, families and caregivers Address stigma and perceptions regarding antipsychotic treatments Practical obstacles (i.e. insurance, laboratory, pharmacy coverage, transportation) Resource and supportive materials Patient, family member, caregiver Treatment team/staff Health care providers Identification of partner facilities or organizations Expectations Communication Communication Training Shared decision making Motivational interviewing Cost Evaluation of Cost Education regarding costs/impact of medication regimen selection Identification/Collaboration with Partner institutions Obstacles/resistance GLOBAL AIM Resource and supportive materials •Increase the number of patients with schizophrenia that take antipsychotics who achieve functional recovery. Education

44 . Seek outside consultation to assist
NEW York has a clozapine initiative with a very thoughtful approach: Consult with Lloyd Sederer, MD, Mike Hogan, PhD, Scott Stroup, MD, Jay Carruthers, MD 1) "Considering Clozapine" - a module that prepares consumers for talking to their doctor about clozapine. (Available to all at )  2) "Motivating Clozapine Use- An Aid for Prescribers" - (Accessible to all at tabid/252/Default.aspx ) 3) Algorithm for identifying candidates for a clozapine trial 4) Prescribers' manual   5) Helpful recent article by Jimmi Nielsen and John Kane's group on discontinuation for medical reasons: when it is indicated and when it's not  6) Resident Curriculum by Freudenreich et al

45 Share the vision and develop it further with others
Share the vision and develop it further with others. Schedule time to consider, gather input, and set direction Develop an implementation approach to promote the appropriate use of Clozapine OSU Psychiatry Faculty and Residents...and new faculty?...and Clozapine Clinic Team Development NCMHS State of Ohio, Office of Health Transformation, Ohio Medicaid, OHMAS, State Hospitals NEOMED...develop the implementation approach further NY OMH...Scott Stroup, Feb. 25th, 2015 Grand Rounds and Consultation ADAMH Ohio Hospitals...e.g., OHA NAMI, MHA OHIO EMPOWERMENT COALITION and Consumer Operated Services Persons with a Lived Experience OPPA Other Universities, Disciplines, training programs Others

46 "Considering Clozapine“ if we have time

47 Thanks for listening Please share your thoughts and ideas

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