Teresa Hudson, PharmD Center for Mental Healthcare and Outcomes Research South Central Mental Illness Research Education and Clinical Center

Those who cannot remember the past are condemned to repeat it George Santayana

MIAMI Journey : Recognition of the metabolic effects of antipsychotic medications - particularly the newer, “second-generation” antipsychotics (SGA) Case reports of deaths among individuals receiving atypical antipsychotics

Antipsychotics and Weight Weight gain in Kg Allison et al Am J Psychiatry 1999

Antipsychotics &Diabetes Age (yrs) % of patients with DM Sernyak et al Am J psychiatry 2002 a a p<.07 b p=.002 c p=.003 b c

Antipsychotics and Hyperlipidemia Retrospective Case/Control Study (UK) n=8866 Olanzapine vs no AP OR 4.65 p<.001 Olanzapine vs Traditional AP OR 3.36 P<.0001 Risperidone vs no AP OR 1.12 p=.72 Risperidone vs Traditional AP OR.81 p=.52 Koro et al 2002

Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Double-blind clinical compared the effectiveness of atypical antipsychotics among schizophrenia patients NIH-sponsored study January 2001-December sites in the US Phase I : subjects randomly assigned to SGA or perphenazine Phase II: People who discontinued phase I medications

CATIE (Phase II) Olanzapine patients Gained more weight than patients on other drugs Mean 1.3 lbs/month Higher proportion of patients gain >7% of their body weight 8% d/c drug because of weight gain or metabolic effects Ziprasidone: Mean loss of 1.7lbs/month No patients d/c drug because of weight gain or metabolic effects Risperidone: Negligible weight gain 5% d/c drug because of weight gain or metabolic effects Quetiapine: Neglible weight gain 10% d/c drug because of weight gain or metabolic effects Stroup et al Am J Psych 2006

MIAMI Journey 2003: VA/DOD Clinical Practice Guideline for the Management of Diabetes Mellitus in Primary Care 2004: Consensus guidelines for physical health monitoring of patients with schizophrenia (Am J Psych 2004) Consensus conference on antipsychotic drugs and obesity and diabetes (J Clin Psych 2004) Updated VA/DOD Clinical Practice Guidelines for Management of Psychosis

MIAMI Journey Emerging evidence that despite the various guidelines, rates of metabolic monitoring were fairly low

Metabolic Screening Rates Medicaid Paid claims from 5 states n=55,436 recipients with 180 days continuous enrollment and claim for SGA Evaluated predictors of blood glucose and lipid testing 14 days before or 28 days after claim for SGA Controlled for age, ethnicity, schizophrenia, preexisting metabolic disorder, index SGA and year of index prescription claim Morrato et al J Clin Psych 2008

Metabolic Screening Rates Male and non-white patients were less like to receive baseline glucose monitoring (no demographic difference for lipid screening) California recipients more likely to receive monitoring compared with recipients of other states Significant increase in testing based on year of index rx. Diagnosis of schizophrenia significantly associated with baseline glucose monitoring but not lipid screening. Preexisting diabetes and dyslipidemia associated with 2-3 fold increase in monitoring. Olanzapine patients more likely than risperidone patients to receive monitoring Morrato et al J Clin Psych 2008

Metabolic Screening Rates Quasi-experimental design to evaluate metabolic screening among individuals receiving SGA (atypical) antipsychotics before and after APA/ADA guidelines. Paid Claims from Commercial Insurance Plan Used a cohort of patients with diabetes with no MH diagnosis and no antipsychotic as comparison group Used time series models to account for temporal trends and control for pre-existing conditions (DM, hyperlipidemia before start of SGA) Morrato et al Diabetes Care 2009

Metabolic Screening Rates (GLUCOSE) Rate among all SGA users: 23% Rate among persistent users 38% Testing Rates Among Antipsychotic Users Morrato et al Diabetes Care 2009

Metabolic Screening Rates (Lipids) Rate among all SGA users: 8% Rate among persistent SGA users: 23% Testing Rates Among Antipsychotic Users Morrato et al Diabetes Care 2009

MIAMI Journey 2007: VA OIG Report: Healthcare Inspection: Atypical antipsychotic medications and diabetes screening and management January 1 – December 31, 2006 Analyses of national, VISN, and facility endocrine performance measure scores for blood pressure, LDL-C, and HbA1c. Reviewed medical records : MH patients Age Rx for antipsychotic medications Diagnosis of DM or were MH patients at risk for development of the disease

OIG Findings:

OIG Findings Monitoring for Diabetes

MIAMI Journey: OIG Recommendations implement and document weight reduction strategies improve treatment and documentation of interventions for elevated fasting blood glucose levels implement interventions to maintain blood pressures less than 140/90 for younger patients without diabetes who are prescribed atypical antipsychotic medications. achieve target blood glucose levels for younger patients with diabetes who are prescribed atypical antipsychotic medications

MIAMI Journey 2008 VA Office of Mental Health Services: Report of the Workgroup on Atypical Antipsychotic Medications and Diabetes Screening and Management. Assure access by primary care and MH clinicians to guidance documents Ensure mental health clinics are able to follow recommendations for monitoring of metabolic risk factors Improve coordination between Primary Care and Mental Health Improve referral of patients with identified metabolic risk factors

2009 MIAMI is funded VA Office of Mental Health Services Initiative National program to implement recommendations from the Atypical Antipsychotics Workgroup 2-year Initiative Goal: improve monitoring for and management of physical health problems among veterans taking atypical antipsychotic medications Administered by the VISN 22 and 16 MIRECCs in conjunction with Mental Health QUERI

MIAMI Goals: Improve Adherence to ADA/APA guidelines around antipsychotic medication monitoring Improve VHA facilities’ metabolic monitoring performance measures Decrease the percent of veterans who are prescribed antipsychotic medications who are obese Increase the use of individual or group counseling among veterans who are prescribed antipsychotic medications and are obese

MIAMI Activities Develop and Disseminate effective tools for implementing antipsychotic monitoring programs Educate champions who will go back to their facilities/VISNs and educate others Utilize VHS DSS and VA Corporate Data Warehouse to evaluate change in monitoring in VA

MIAMI Resources Technical Assistance Center (TAC) Support sites implementing routine monitoring Sites determine program design Intranet Site Provides access to educational materials Data Analysis Monitoring rates at baseline and over 1 year period

Why is MIAMI so Exciting?!!! Opportunity for researchers/clinicians/administrators to pool our resources and work together to improve care of veterans Tools are available but HOW those tools are used is a LOCAL decision Opportunities for facilities to easily share information Opportunity for researchers to learn what else is needed to help with metabolic monitoring and management May provide a model for improve other aspects of MH treatment for veterans