Teresa Hudson, PharmDCenter 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 Journey1998-2000:

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

-1

0

1

2

3

4

5

Pla

ce

bo

Mo

lind

on

e

Th

iori

da

zin

e

Clo

zap

ine

ola

nza

pin

e

ris

pe

rid

on

e

zip

ras

ido

ne

Weig

ht

gain

in

K

g

Allison et al Am J Psychiatry 1999

Antipsychotics &Diabetes

0

5

10

15

20

25

30

Allages

<40 40-49 50-59 60-69 >70

Typical AP

2nd Gen AP

Age (yrs)

% o

f p

ati

en

ts

wit

h D

M

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=8866Olanzapine vs no AP

OR 4.65 p<.001Olanzapine vs Traditional AP

OR 3.36 P<.0001Risperidone vs no AP

OR 1.12 p=.72Risperidone 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 studyJanuary 2001-December 200457 sites in the USPhase I : subjects randomly assigned to SGA or

perphenazinePhase 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 Journey2003:

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 Journey2003-2008

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

Metabolic Screening RatesMedicaid Paid claims from 5 states

1998-2003n=55,436 recipients with 180 days continuous enrollment

and claim for SGAEvaluated 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 RatesMale 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 monitoringMorrato et al J Clin Psych 2008

Metabolic Screening RatesQuasi-experimental design to evaluate metabolic

screening among individuals receiving SGA (atypical) antipsychotics before and after APA/ADA guidelines. Paid Claims from Commercial Insurance PlanUsed a cohort of patients with diabetes with no MH

diagnosis and no antipsychotic as comparison groupUsed 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 users38%

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 UsersMorrato et al Diabetes Care 2009

MIAMI Journey2007:

VA OIG Report: Healthcare Inspection: Atypical antipsychotic medications and diabetes screening and management

January 1 – December 31, 2006Analyses of national, VISN, and facility endocrine performance

measure scores for blood pressure, LDL-C, and HbA1c. Reviewed medical records :

MH patients Age 35-50 Rx for antipsychotic medications Diagnosis of DM or were MH patients at risk for development of the

disease

http://www4.va.gov/oig/54/reports/VAOIG-05-00680-37.pdf

OIG Findings:

OIG Findings:

OIG FindingsMonitoring for

Diabetes

MIAMI Journey: OIG Recommendationsimplement and document weight reduction strategiesimprove treatment and documentation of

interventions for elevated fasting blood glucose levelsimplement 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 Journey2008

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 InitiativeNational program to implement recommendations

from the Atypical Antipsychotics Workgroup2-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 monitoringImprove VHA facilities’ metabolic monitoring

performance measuresDecrease the percent of veterans who are prescribed

antipsychotic medications who are obeseIncrease the use of individual or group counseling among

veterans who are prescribed antipsychotic medications and are obese

MIAMI ActivitiesDevelop and Disseminate effective tools for

implementing antipsychotic monitoring programsEducate champions who will go back to their

facilities/VISNs and educate othersUtilize VHS DSS and VA Corporate Data Warehouse to

evaluate change in monitoring in VA

MIAMI Resources Technical Assistance Center (TAC)

Support sites implementing routine monitoringSites determine program design

Intranet SiteProvides access to educational materials

Data AnalysisMonitoring 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 informationOpportunity for researchers to learn what else is needed

to help with metabolic monitoring and managementMay provide a model for improve other aspects of MH

treatment for veterans