Objectives. Pre Discussion Question #2. Disparity in Care Demographics

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1 Objectives Implementation of a pharmacist driven metabolic monitoring protocol for second generation antipsychotics (SGAs) Jonathan Willett, PharmD PGY 1 Pharmacy Practice Resident Chickasaw Nation March 27, 2015 Describe the complexities of mental health care unique to Native American populations Identify current standards of practice for the monitoring of patients on SGAs Assess the challenges of implementing a metabolic monitoring protocol Pre Discussion Question #1 Long term therapy on second generation antipsychotics (SGAs) has been linked to the inducement or worsening of which of the following disease states? A. OBESITY B. DYSLIPIDEMIA C. DIABETES D. HYPERTENSION E. ALL OF THE ABOVE Pre Discussion Question #2 Which of the following SGAs is considered the worst offender when it comes to documented cases of SGA therapy induced metabolic dysfunction? A. ARIPRAZOLE (Abilify ) B. PALIPERIDONE (Invega ) C. OLANZAPINE (Zyprexa ) D. QUETIAPINE (Seroquel ) Disparity in Care Demographics Disparity in Care Demographics American Indians and Alaskan Natives (AI/AN) suffer a disproportionate burden of health issues AI/AN are at higher risk for diabetes, hypertension, cardiac complications, and early death AI/AN experience psychological distress 1.5 times more than the general population AI/ANs alcohol abuse occurs at younger ages and at higher rates than all other ethnic groups Percentage of Adults with Perceived Unmet Need for Mental Health Treatment ASIAN HISPANIC BLACK WHITE MORE THAN 1 RACE AI/AN Substance Abuse and Mental Health Services Administration. (2013) National Survey on Drug Use and Health. American Psychiatric Association. (2014) Mental health disparities: American Indians and Alaska Natives.

2 Disparity in Care Demographics Metabolic Monitoring Lack of awareness Lack of access Case reports and provider concerns quantified with CATIE Trial (2005) Economic hardship BARRIERS TO CARE Social stigma Demonstrated conclusively OLANZAPINE long term therapy was associated with: Weight gain Increased fasting blood glucose Increased lipid levels American Psychiatric Association. (2014) Mental health disparities: American Indians and Alaska Natives Manschreck TC, Boshes RA. The CATIE schizophrenia trial: results, impact, controversy. Metabolic Monitoring 2004 Consensus Statement on Antipsychotic Drugs and Obesity/Diabetes Called for baseline and routine monitoring of several metabolic measures for ALL patients initiating SGA therapy American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists and North American Association for the Study of Obesity ADA Consensus Statement Proposed Metabolic Monitoring Protocol BASELINE 4 WEEKS 8 WEEKS 12 WEEKS QUARTERLY ANNUALLY Personal/ family history X X Weight (BMI) X X X X X Waistline circumference X X Blood pressure X X X Fasting blood glucose X X X EVERY 5 YEARS Fasting lipid profile X X X American Diabetes Association, et al. Consensus development conference on antipsychotic drugs and obesity and diabetes. American Diabetes Association, et al. Consensus development conference on antipsychotic drugs and obesity and diabetes. Challenges to Implementation Current Practice Retrospective analysis Integration into EHR Provider support Nursing education DRUG Relative Metabolic Dysfunction of SGAs & Metabolic Capture Rates Weight (BMI) Fasting Glucose Fasting Lipid Number of Patients Metabolic Capture (01/14 01/15) Aripiprazole +/ +/ +/ 44 0% Lurasidone* +/ +/ +/ 34 0% Olanzapine % Paliperidone % Quetiapine % Risperidone % +++ significant; ++ intermediate; + low; +/ low or neutral; *long term data not available 11 Morrato EH, et al. Metabolic screening after the American Diabetes Association s consensus statement on antipsychotic drugs and diabetes.

3 Three requirements for integration: Protocol has clearly defined expectations of care Ordering of all components is simple and intuitive Results can be tracked over time (comparison to baseline of SGA initiation) Reeves R, Kaldany H, Lieberman J, Vyas R. Creation of a metabolic monitoring program for second generation (atypical) antipsychotics Patch 13 Continued meetings with IT/CACs Reeves R, Kaldany H, Lieberman J, Vyas R. Creation of a metabolic monitoring program for second generation (atypical) antipsychotics Challenges to Implementation Disruption of work flow/current practice Necessity for education of support staff and in take personnel Ownership burden Challenges to Implementation Great success at Chickasaw Nation Medical Center with decentralized pharmacy Current pharmacist integration to health teams: Diabetes Clinic Emergency Department/Urgent Care Family Practice Clinic Inpatient Rounding Team Pediatrics Clinic

4 Challenges to Implementation Development of patient brochures regarding medication therapies Coordination of education opportunities and in services for providers and staff Opportunities for patient education sessions (mirror of current involvement in Diabetes Clinic) Conclusion AI/AN experience significant difficulties in obtaining mental health care AI/AN experience mental health dysfunction at rates above the general population AI/AN, especially those on SGA therapy, are pre disposed to metabolic dysfunction All patients on SGA therapy should be routinely monitored for metabolic dysfunction per ADA protocol Post Discussion Question #1 ADA Consensus Statement Proposed Metabolic Monitoring Protocol Which of the following represents the current best practice guideline for metabolic management of long term SGA therapy? A ADA Consensus Statement Protocol B Metabolic Monitoring Management Guide C Guide to Diseases D Antipsychotic Therapy Management BASELINE 4 WEEKS 8 WEEKS 12 WEEKS QUARTERLY ANNUALLY Personal/ family history X X Weight (BMI) X X X X X Waistline circumference X X Blood pressure X X X Fasting blood glucose X X X EVERY 5 YEARS Fasting lipid profile X X X American Diabetes Association, et al. Consensus development conference on antipsychotic drugs and obesity and diabetes. Post Discussion Question #2 Which of the following SGAs is considered the worst offender when it comes to documented cases of SGA therapy induced metabolic dysfunction? A. ARIPRAZOLE (Abilify ) B. PALIPERIDONE (Invega ) C. RISPERIDONE (Requip ) D. QUETIAPINE (Seroquel ) Relative Metabolic Dysfunction of Second Generation Antipsychotics DRUG Weight (BMI) Fasting Glucose Fasting Lipid Aripiprazole +/ +/ +/ Lurasidone* +/ +/ +/ Olanzapine Paliperidone Quetiapine Risperidone significant; ++ intermediate; + low; +/ low or neutral; *long term data not available Morrato EH, et al. Metabolic screening after the American Diabetes Association s consensus statement on antipsychotic drugs and diabetes.

5 References 1. American Psychiatric Association. (2014) Mental health disparities: American Indians and Alaska Natives. Located at indians alaska natives. Accessed November 01, Substance Abuse and Mental Health Services Administration. (2013) National Survey on Drug Use and Health. SR200 RecoveryMonth 2014/NSDUH SR200 RecoveryMonth 2014.htm 3. Manschreck TC, Boshes RA. The CATIE schizophrenia trial: results, impact, controversy. Harv Rev Psychiatry. 2007;15(5): American Diabetes Association, et al. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care. 2004;27(2): Tarricone I, Ferrari Gozzi B, Serretti A, et al. Weight gain in antipsychotic naive patients: a review and meta analysis. Psychol Med. 2010;40(2): De Hert M, Yu W, Detraux J, et al. Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta analysis. CNS Drugs. 2012;26(9): Morrato EH, et al. Metabolic screening after the American Diabetes Association s consensus statement on antipsychotic drugs and diabetes. Diabetes Care. 2009;32(6): Reeves R, Kaldany H, Lieberman J, Vyas R. Creation of a metabolic monitoring program for second generation (atypical) antipsychotics. J Correct Health Care. 2009;15(4): De Hert M, Yu W, Detraux J, et al. Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta analysis. CNS Drugs. 2012;26(9): Stahl SM. Stahl s essential psychopharmacology, neuroscientific basis and practical applications. Oxford, United Kingdom: Cambridge University Press; Implementation of a pharmacist driven metabolic monitoring protocol for second generation antipsychotics (SGAs) Jonathan Willett, PharmD PGY 1 Pharmacy Practice Resident Chickasaw Nation March 27, 2015