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Optimizing the Use of Atypical Antipsychotics

Background – Variations in Care

AssumptionMost physicians will make similar diagnostic and

treatment decisions, and will offer care in similar waysRealityA wide variety of factors influence clinical decisions

made by physicians leading to high variability of clinical practice

High variability in care can lead to poor patient outcomes including unacceptably high rates of side effects and lack of efficacy

Process of Care Participants

Canada Dr. Pratap R. Chokka Dr. Pierre Chue Dr. Valerie TourjmanGermany Dr. Brita Dorn Dr. Claus-Jürgen Krafczyk Dr. Markus LewekeItaly Dr. Rocco Pollice

Spain Dr. Celso Arango Dr. Francesco Colom Dr. Jose M. OlivaresUnited Kingdom Dr. John Cookson Dr. Tonmoy SharmaUnited States Dr. Joseph Bryer

Table of ContentsHistory of Psychosis ManagementVariations in CareThe Optimal Care Process

– Overview– Barriers and Best Practices– Elements: Diagnosis, Medication Initiation,

Treatment Optimization, Continuation of Care

Putting It All Together– The Atypical Antipsychotic CareMap™

– Discussion– References

Objectives

To increase awareness of best clinical practices in the management of patients with bipolar disorder or schizophrenia

To provide practical information, keys to success, and tools to help practitioners overcome barriers to achieving high quality care

http://www.mindful-things.com/history_of_psych_home.html#120_70BC

Bipolar Disorder and Schizophrenia:A Historical Perspective

1409 - First asylum in Seville, Spain

1934 - Electroconvulsive therapy (ECT) introduced by von Meduna

1978 - Dopamine hypothesis put forward to explain schizophrenia

1985 - U.S. NIMH's Consensus Conference on ECT concluded risks virtually eliminated and best used for depression and some mania

1300 1400 1900 1990 2005

1330 - Casting out devils in common use

1911 - Bleuler introduced term "schizophrenia"

1932 - Sakel introduced insulin coma therapy for schizophrenia 1952 - French researchers

discovered chlorpromazine, marking the beginning of psychopharmacology

1983 - Researchers discover many schizophrenics cannot track moving target visually—close relatives also share this deficiency, even if not schizophrenic

1990 2005

1990 - First atypical antipsychotic introduced-clozapine

1992 - APA and CPA establish clearer guidelines and standards for using ECT

1993 - Neuroimaging studies showed frontal, temporolimbic and basal ganglia involved in schizophrenia — Same abnormalities observed with other conditions, though to a lesser degree

1994 - Saykin, et al discover temporolimbic deficits of unmedicated, first-episode schizophrenic patients

2000 - American Psychiatric Association published the DSM-IV-TR, Diagnostic and Statistical Manual of the Mental Disorders Fourth Edition, Text Revision

http://www.mindful-things.com/history_of_psych_home.html#120_70BC

Bipolar Disorder and Schizophrenia:A Historical Perspective

2005 - Genetic biomarkers identified as basis for future blood test to confirm diagnosis of schizophrenia or bipolar disease

ClinicalDecision

Factors Influencing the Variability of Clinical Practice

Clinical data

Beliefs

Peers

Experience and training Competence

Habits

Emotions

Comfort level

Factors Influencing the Variability of Clinical Practice

External Influences

Variations in Care

Can result from the following:– The capacity of the local health care system

influencing how much care is given– The practice styles of local physicians

determining the type of care delivered– Local medical opinion and resources

appearing to be more important than science in determining how medical care is delivered (Wennberg, 2002)

Variations in Care

Can lead to:– An average 17 year lag between the discovery

of more effective forms of treatment and their incorporation into routine patient care (Balas, 2003)

– Avoidable deaths of roughly 79,000/year in U.S.(National Committee for Quality Assurance, 2004)

– Only 55% of patients receiving recommended care (McGlynn, 2003)

Variations in Mental Illness Care

70% of bipolar patients are misdiagnosed before receiving a correct diagnosis (Hirschfeld, 2003)

On average, patients with bipolar disorder wait more than 8 years from the start of symptoms before receiving a correct diagnosis (Hirschfeld, 2003)

Patients get the correct mental healthcare only about 50% of the time (National Committee for Quality Assurance, 2004)

Approaches to Reducing Variability

A. Identify problems and intervene– Chart audits and compliance reports– Treatment protocols

OR

B. Identify best practices as a model– Attending physicians teaching residents– Experienced clinicians educating others

• Best clinical practices• Effective techniques • Useful tools

Reducedvariability in

patient care & outcomes through

• Delayed patient treatment • Incomplete diagnostic

assessments• Diverse treatment initiation

strategies• Degree of intensity of follow-up • Lack of continuity of care from

inpatient to outpatient• Inadequate patient education• Environmental stressors• Variations in the quality of the

patient/physician relationship

High variability in patient care & outcomes due to

Knowledgeand

Experience

Reducing Variability of CareThrough Best Practices

Barrier (Perils) Expert Approach (Pearls)

Delaying the initial diagnosis Heightened vigilance for early psychosis symptoms

Neglecting to establish a relationship with the patient Build rapport beginning with first interaction

Slow initial dose titration to avoid side effects Rapid dose initiation to gain early control over acute symptoms

Focus on acute management Think long term when selecting your acute medication

Ad hoc medication selection Rational approach to medication selection based on patient profile

Failure to give adequate therapeutic trial Commit to a treatment and stick with it

Break in continuity of care following discharge Assure continuity and coordination of care, including offering intermediate care

Lack of vigilance around relapse Stay alert for first sign(s) of relapse

Observed Barriers and Expert Approaches to Achieving Optimal Performance with Atypicals

Goal:Goal: Achieve best functional outcomes Achieve best functional outcomes by reducing frequency of relapse by reducing frequency of relapse

Overview of the Optimal Care Process



Objective: Consider acute symptom control with long-term goals

Objective: Adjust treatment program to achieve stability

Objective: Maintain care to minimize relapse

Objective: Make proper diagnosis, communicate it to patient

The Care Process: Diagnosis

Objective: Make proper diagnosis and communicate it to the patient

Perils– Delayed ⁄ Inappropriate diagnosis– Patients rarely volunteer information about

mania, mood, or anxiety symptoms– Cognitive deficits that predict poor outcomes

often overlooked – Limited patient insights

The Care Process: Diagnosis

Objective: Make proper diagnosis and communicate it to the patient

Pearls– Perform comprehensive diagnostic work-up for

organic causes and make transparent to patient to establish trust

– Assess role of drugs, alcohol, and non-adherence as contributing factors

– If patient is admitted, minimize trauma of the admission process

– Communicate using effective approaches– Establish a treatment plan that includes long-term

goals (e.g., medication compliance)

Key to Success

Build trust beginning with first interaction

Diagnosis: Support Resources

Many existing resources support diagnosis and overall management strategies– Guidelines

APA, NICE Regional, local guidelines

– Assessment instruments– Websites– DSM and ICD criteria



Objective: Consider acute symptom control with long-term goals




The Care Process: Medication InitiationObjective: Consider acute symptom control with

long- term goalsPerils

– Lack of documentation of previous of medications, their effectiveness, reported side effects, etc.

– Failure to identify patients at increased risk for some side effects

– Selecting medication only for controlling acute symptoms rather than best choice for long-term management

– Perception of need for slower titration to avoid side effects may lead to sub-therapeutic dosing

– Failure to reach therapeutic range and maximize the dose of first medication

The Care Process: Medication Initiation

Objective: Consider acute symptom control with long- term goals

Pearls– Rapid initiation and sustained use of antipsychotic

medication is the cornerstone of successful management

– Rationally select medication, keeping the end in mind Target most problematic symptoms, but side effect

profile may be prime determinant of drug choice Atypical antipsychotics are a medication choice Select medication addressing predominant symptom

and having lowest risk of long-term side effects

The Care Process: Medication Initiation

Objective: To consider acute symptom control with long-term goals

Pearls– Build early rapport with patient

Set expectations regarding side effects, effectiveness, etc.

Involve patient in medication selection process

Gain early feedback on effects of medication

Rational Medication Selection CriteriaBenefits

– Primary diagnosis– Severity of acute symptoms– Long-term adherence– Functional outcome(s)

Risks– Relative severity of possible adverse events– Patient risks for selected side effects (see slide 27)

Benefit-risk ratio– Effectiveness and side effects of past medication(s)

Rational Medication Selection:Potential Adverse Events to Consider

Symptoms to consider– EPS/Tardive Dyskinesia– Akathisia– Nausea and vomiting– Prolactin elevation/

sexual dysfunction

– Weight gain– Sedation

Signs to consider– Glucose abnormalities– Lipid abnormalities– QTc prolongation– Hypotension– Anti-cholinergic side

effects

When selecting a medication, a clinician should consider both the patient’s needs in the short and the long term and the efficacy

and side-effects of various medications

References: American Psychiatric Association. Practice Guideline for the Treatment of Patients with Schizophrenia, Second Edition: February, 2004. Bagnall AM, et. Al. A systematic review of atypical antipsychotic drugs in schizophrenia. Health Technology Assessment . 2003;7(13). National Institute for Clinical Excellence. Schizophrenia: Core interventions in the treatment and management of schizophrenia in primary and secondary care. Clinical Guideline 1,

December 2002.

External Factors Affecting Medication Selection

Drug formulary committeeAnecdotal experienceAvailability of samplesPatient preference

Key to Success

Think long term when selecting your acute medication

Medication Initiation Tool:Medication Schedule



Objective: Balance acute symptom control with long-term goals




The Care Process:Treatment Optimization


Perils– Medication prematurely deemed ineffective before

completing adequate therapeutic trial of 4-6 weeks– Unable to identify what information to provide to

cognitively challenged patients, and when to provide it– Lack of communication and inconsistency of care

between inpatient to outpatient settings Especially before first follow up visit for severe, chronic

patients



Pearls– Monitor medication effectiveness over

adequate therapeutic trial of 4-6 weeks (APA, 2004) Adjust medications to reduce

– target symptoms– residual symptoms – emerging side effects

Titrate between side effects and symptoms Establish tracking methodology



Pearls– Cognitive therapy and psychoeducation

should be continuous, but staged– Continue building physician-patient relationship

Involve caregiver ⁄ family and monitor environment for stressors (e.g., psychosocial, substance abuse, financial, etc.)

– Assess and anticipate reasons for non-adherence– Prepare patient for return to community and

orchestrate continuity of care with outpatient care providers

Key to Success

Commit to a treatment and stick with it

Treatment Optimization Tool:Treatment Plan Checklist

Treatment Optimization Tool:My Action/Monitoring Plan

The Care Process:Continuation of Care

Objective: Maintain care to minimize relapsePerils

– Failing to make plans for continued care after hospitalization leading to early relapse

– Strong propensity for substance and/or alcohol abuse – Bipolar patients may seek to achieve mood elevation – Isolation/lack of a caregiver support system

The Care Process:Continuation of Care

Objective: Maintain care to minimize relapsePearls

– Provide appropriate degree of intervention for patients prone to relapse

– Assure caregiver education and involvement– Maintain a high trust relationship– Make crisis management resources available– Assure strict vigilance to early recognition of relapse

symptoms– Reinforce medication adherence and avoidance of

drugs and alcohol– Target optimizing functional outcomes

Key to Success

Stay alert for first sign(s) of relapse

Continuation of Care Tool:Tips for Staying Well


Putting It All Together: The Care Process





Putting It All Together:The CareMap™

Pierre Chue, F Markus Leweke, Ana González-Pinto on behalf of the CareMap Research Team. Sharing best practice in the management of schizophrenia and bipolar disorder: development of an atypical antipsychotic CareMap.Int J Neuropsychopharmacol 2006; 9 (Suppl 1): S261. Abstract number P03.124

Summary

Goal: Achieve best functional outcomesKeys to success

– Build trust beginning with first interaction– Think about the long term when selecting

your acute medication – Commit to a treatment and stick with it– Stay alert for first sign(s) of relapse

Best practicesResources

Discussion

ReferencesAmerican Psychiatric Association. Practice Guideline for the Treatment of

Patients with Schizophrenia, Second Edition: February, 2004.Bagnall AM, et. Al. A systematic review of atypical antipsychotic drugs in

schizophrenia. Health Technology Assessment . 2003;7(13).Balas EA. Information Systems Can Prevent Errors and Improve Quality. J Am

Med Inform Assoc. 2001;8:398-99.Hirschfeld RM, Lewis L, Vornik LA. Perceptions and Impact of Bipolar Disorder:

How Far Have We Really Come? Results of the National Depressive and Manic-Depressive Association 2000 Survey of Individuals With Bipolar Disorder. J Clin Psychiatry. 2003;64:161-74.

Institute of Medicine. Health Professions Education: A Bridge to Quality. Washington, D.C.: National Academy Press, 2003.

McGlynn EA, Asch SM, Adams J, et al. The Quality of Health Care Delivered to Adults in the United States. N Engl J Med. 2003;348:2635-45.

National Committee for Quality Assurance. The State of Health Care Quality: Industry Trends and Analysis. Washington, D.C.: NCQA, 2004.

National Institute for Clinical Excellence. Schizophrenia: Core interventions in the treatment and management of schizophrenia in primary and secondary care. Clinical Guideline 1, December 2002.

Tsuang MT, Nossova N, Yager T, et al. Assessing the validity of blood-based gene expression profiles for the classification of schizophrenia and bipolar disorder: A preliminary report. Part B: Neuropsychiatric Genetics. Am J Med Genetics. 2005;133B:1-5.

Wennberg JE. Unwarranted Variations in Healthcare delivery: Implications for Academic Medical Centres. BMJ. 2002;325:961-64.

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