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Practical Strategies for the Treatment of Patients with Schizophrenia Leslie Citrome, MD, MPH Adjunct Professor of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY. Sponsored by The France Foundation. Supported by an educational grant from Sunovion.

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slide1

Practical Strategies for the Treatment of Patients with SchizophreniaLeslie Citrome, MD, MPHAdjunct Professor of Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY

Sponsored by The France Foundation.Supported by an educational grant from Sunovion.

faculty disclosure
Faculty Disclosure

It is the policy of The France Foundation to ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All faculty, activity planners, content reviewers, and staff participating in this activity will disclose to the participants any significant financial interest or other relationship with manufacturer(s) of any commercial product(s)/device(s) and/or provider(s) of commercial services included in this educational activity.

The intent of this disclosure is not to prevent a person with a relevant financial or other relationship from participating in the activity, but rather to provide participants with information on which they can base their own judgments. The France Foundation has identified and resolved any and all conflicts of interest prior to the release of this activity.

disclosure leslie citrome md mph
DisclosureLeslie Citrome, MD, MPH

Leslie Citrome, is a consultant for, has received honoraria from, or has conducted clinical research supported by the following:

Abbott, AstraZeneca*, Avanir, Azur, Barr, Bristol-Myers Squibb*, Eli Lilly*, Forest, GlaxoSmithKline, Janssen*, Jazz, Merck*, Novartis*, Noven*, Pfizer*, Shire*, Sunovion*, Valeant*, and Vanda.

* Denotes a relationship in effect anytime during the past 12 months

learning objectives
Learning Objectives
  • Recognize criteria for remission and recovery in patients with schizophrenia. Evaluate patients for the potential to achieve these outcomes and implement strategies directed towards these goals
  • Recognize how clinical practice guidelines relate to the individualized treatment of patients with schizophrenia
  • Integrate strategies that will help to improve the effective use of medications by patients with schizophrenia
schizophrenia a set of symptoms
Poor attention

Conceptual disorganization

Difficulty in abstract thinking

Disorientation

Suspiciousness/paranoia

Grandiosity/Delusions

Unusual thought content

Blunted affect

Emotional withdrawal

Active social avoidance Lack of spontaneity

Poor rapport

Schizophrenia – A Set of Symptoms

Positive Symptoms

Negative Symptoms

“Disorganized” Symptoms

clinical and pathophysiological course of schizophrenia
Clinical and Pathophysiological Course of Schizophrenia

Lieberman JA, et al. Biol Psychiatry. 2001;50(11):884-897.

what is response
What is Response?

Speed?

Magnitude?

Proportion responding?

Effect in refractory patients?

measuring efficacy decrease in panss
Measuring Efficacy - Decrease in PANSS

Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

decrease in panss factors
Decrease in PANSS Factors

Heresco-Levy U, et al. Biological Psychiatry. 2004;55:165-171.

arbitrary categorical changes in panss
Arbitrary Categorical Changes in PANSS

Response defined as at least a 30% decrease from the baseline PANSS to the last observation

Daniel DG, et al. Neuropsychopharmacology.1999;20:491-505.

functionality
Functionality

Distribution of patients achieving ≥ 1 change in Personal and Social Performance (PSP) Scale category at end point. Intent-to-treat population; PSP scale scores at end point for individual patients to show a clinically relevant change in personal and social functioning as represented by improvement of ≥ 1 category (classified as one 10-point interval); PSP = Personal and Social Performance Scale.

Kane J, et al. Schizophr Res. 2007;90:147-161.

response vs remission
Response vs Remission

Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

remission definitions
Remission Definitions

Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

proposed criteria for remission
Proposed Criteria for Remission

Andreasen N, et al. Am J Psychiatry. 2005;162:441-449.

recovery
Recovery

SAMHSA ‘‘Fundamental

Components of Recovery’’

Consumer self-direction

Individualized and person-centered treatment

Empowerment

A holistic treatment focus

A nonlinear perspective of change

Treatment focused on strengths instead of deficits

The inclusion of peer support in treatment

Respect for consumers and consumer self-respect

Consumer acceptance of personal responsibility

Hope in recovery

Davidson’s Nine

Common Elements of Recovery

  • Renewing hope and commitment
  • Redefining self
  • Incorporating illness into life as a whole
  • Involvement in meaningful activities
  • Overcoming stigma
  • Assuming control
  • Becoming empowered and exercising citizenship
  • Managing symptoms
  • Finding social support

Peebles S, et al. Psych Clin N Am. 2007;30:567-583.

treatment effectiveness
Treatment Effectiveness

Tolerability and Safety

Does Rx cause SE?

Efficacy

Does Rx reduce Sx?

Treatment

Effectiveness

Combines all measures

Adherence/

Persistence

Will Pt take Rx?

Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

Lehman AF, et al. Am J Psychiatry. 2004;161(2 suppl):1-56.

Swartz MS, et al. Schizophr Bull. 2003;29(1):33-43.

catie primary outcome measure all cause treatment discontinuation
CATIE Primary Outcome Measure:All-Cause Treatment Discontinuation

Efficacy

Tolerability

All-Cause Discontinuation

Patient Input

Clinician Input

effectiveness time to any cause discontinuation catie clozapine pathway results
EffectivenessTime to Any-Cause Discontinuation CATIE Clozapine Pathway Results

McEvoy JP, et al. Am J Psychiatry.2006;163:600-610.

effectiveness any cause discontinuation nnt
EffectivenessAny-Cause Discontinuation: NNT

CATIE Clozapine Pathway

NNT 3

NNT 4

McEvoy JP et al. Am J Psychiatry.2006;163:600-610; Citrome L. Psychiatry MMC. 2007;4(10):23-29;

Citrome L and Stroup TS. Int J Clin Pract.2006;60:933-940.

hierarchies of outcome recovery is at top
Hierarchies of Outcome: Recovery is at Top

Recovery

Remission

Stabilization

criteria for recovery
Criteria for Recovery?
  • Symptom remission
  • Vocational functioning
  • Independent living
  • Peer relationships
  • Duration ≥ 2 years

Is recovery best viewed as an outcome or a process?

Liberman P, et al. Int Rev Psychiatry. 2002;14:256-272.

Liberman P, Kopelowicz. Psychiatr Serv. 2005;56:735-742.

recovery a matter of perspective
Recovery – A Matter of Perspective
  • Recovery from Illness
    • Cure of illness, absence of illness

versus

  • Recovery in Illness: being in recovery
    • Process of managing illness more effectively
    • Having a meaningful life in the community
    • Moving ahead with one’s life despite illness
  • Davidson L, et al. Schizophr Bull. 2008;34:5-8.
process of recovery
Process of Recovery

The Person

Play

The Illness

The Person

Friends

Work

The Person

Family

The

Illness

The

Illness

factors associated with the potential for positive clinical and functional outcomes
Factors Associated with the Potential for Positive Clinical and Functional Outcomes
  • Short duration of untreated psychosis
  • Good early response to antipsychotic treatment
  • Collaborative therapeutic alliance
  • Supportive family/caregivers
  • Access to comprehensive, coordinated, and continuous treatment
  • Opportunities to engage in functional activities and receive specialized interventions
  • Absence of substance abuse
slide29
Cognitive Deficits Are the Bridge Between Brain Functioning and Functional Impairments in Day-to-Day Life
  • Cognitive deficits are a frequent and robust feature of the illness
  • Cognitive deficits are present at illness onset and persist throughout the illness
  • Cognitive deficits directly contribute to poor functional outcome in schizophrenia
normative data compared to a schizophrenia sample on the rbans neuropsychological test
Normative Data Compared to a Schizophrenia Sample on the RBANS Neuropsychological Test

Schizophrenia (n = 575)

Normal controls (n = 540)

35

from standardization sample

30

25.0%

25.0%

25

22.8%

22.6%

20.6%

% of Cases

20

16.5%

16.0%

16.0%

15

10

7.9%

7.2%

7.0%

7.0%

0.4%

0.4%

5

2.2%

0.4%

1.6%

1.6%

0%

0%

0%

0%

0

< 50-50

51-60

61-70

71-80

81-90

91-100

101-110

111-120

121-130

131-140

140+

Total Scale Score

RBANS: Repeatable Battery for Assessment of Neuropsychological Status

Wilk CM, et al. Schizophr Res. 2004;70(2-3):175-186.

components of psychosocial rehabilitation
Components of Psychosocial Rehabilitation
  • Outcomes
  • Functional
  • Subjective
  • Motivational Aspects
  • External
  • Intrinsic
  • Social Cognition
  • Emotion processing
  • Social perception
  • Attributional bias
  • Theory of mind
  • Neurocognition
  • Attention
  • Processing
  • Memory
  • Reasoning
  • Verbal learning
  • Visual learning

Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

cognitive remediation
Cognitive Remediation
  • Behavioral treatments that specifically target:
      • Memory
      • Attention
      • Executive functioning
      • Reasoning
  • Restorative cognitive techniques – drill and practice
      • Paper & pencil tasks
      • Computerized training software
          • COGPACK, Posit Science Brain Fitness, etc.
      • Individual
      • Groups
    • Compensatory cognitive training – promote adaptive behavior
  • Enhance daily functioning
      • School, work, social interactions, independent living
  • Enhance skills pertinent to recovery goals

Medalia A, Choi J. Neuropsychol Rev. 2009;19:353-364.

work and schizophrenia
Work and Schizophrenia

~20% employed

Barriers

  • Cognitive impairments
  • Psychiatric symptoms
  • Episodes of illness
  • Stigma from employers
  • Internalized stigma/low self-confidence
  • Fear of losing disability benefits

80% Unemployed

55–70% identify employment as a goal

McGurk S, et al. Schizophr Bull. 2009;35:319-335.

Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

vocational rehabilitation
Vocational Rehabilitation
  • Skills training
  • Sheltered workshops
  • Transitional employment
  • Supported employment
  • Vocational rehabilitation + cognitive remediation → best results
  • Employment =
  • Increased self esteem
  • Reduction in symptoms and hospitalizations
  • Enhanced social functioning
  • Improvement in overall quality of life

McGurk S, et al. Schizophr Bull. 2009;35:319-335.

Kurzban S, et al. Curr Psychiatry Rep. 2010;12:345-355.

supported employment
Supported Employment

Basic Principles

Zero exclusion; eligibility based on consumer choice

Focus on competitive jobs in integrated community settings

Rapid job search

Respect for consumers’ preferences in terms of the nature of the job and types of support services

Ongoing job support

Close integration with a psychosocial rehabilitation team approach

Benefits counseling (disability benefits, social security, medical insurance)

McGurk S, et al. Schizophr Bull. 2009;35:319-335.

optimizing employment outcomes vocational rehabilitation vr cognitive remediation cr
Optimizing Employment OutcomesVocational Rehabilitation (VR) + Cognitive Remediation (CR)

VR

45

VR + CR

*

3000

40

2500

35

**

30

2000

25

*

Wages Earned

Weeks Worked

1500

20

15

1000

10

500

5

0

0

Competitive

Community

Work

Hospital-based

Internship

Competitive

Community

Work

Hospital-based

Internship

Total

Total

* P < 0.05; ** P < 0.01

VR + CR: Greater improvements in verbal learning, memory, executive functioning vs VR only

McGurk S, et al. Schizophr Bull. 2009;35:319-335.

Cognitive remediation with COGPACK training software

management of schizophrenia
Management of Schizophrenia
  • Patient-focused therapeutic alliance
  • Individualized approach
  • Reduce or eliminate symptoms
  • Optimize quality of life
  • Assist patients in attaining personal life goals (work, housing, relationships)
  • Guidelines and algorithms provide a framework for decision making
slide39

Guideline/Algorithm Recommendations

FGA: first-generation antipsychotic

SGA: second-generation (atypical) antipsychotic

C: Clozapine

C+: Clozapine augmentation

CF: Clozapine failure

Practice Guideline for the Treatment of Patients with Schizophrenia. 2nd Edition. APA. 2004.

Moore T, et al. J Clin Psychiatry. 2007;68:1751-1762.

Kreyenbuhl J, et al. Schizophr Bull. 2010;36:94-103.

port psychosocial treatment patient outcomes research team
PORT Psychosocial TreatmentPatient Outcomes Research Team

Dixon L, et al. Schizophr Bull. 2010;36:48-70.

survey of apa practice research network schizophrenia treatments
Survey of APA Practice Research Network: Schizophrenia Treatments

West J, et al. Psych Services. 2005;56:283-291.

real world antipsychotic treatment practices
Real-World Antipsychotic Treatment Practices
  • Second-generation antipsychotics are used in over 70% of individuals with schizophrenia (use may be higher in first-episode patients)
  • Rate of clozapine use is much lower than the incidence of treatment-resistant schizophrenia
  • Antipsychotic polypharmacy
      • ~10 to 30% of individuals with schizophrenia
      • FGA + SGA most common combinations
  • Use of adjunctive medications
      • Baseline data from CATIE
          • Antidepressants (38%), anxiolytics (22%), sedative hypnotics (19%), lithium (4%), other mood stabilizers (15%)
  • Dosage of antipsychotic medications within therapeutic range 64 to 83% of the time during inpatient treatment

Moore T, et al. Psychiatr Clin N Am. 2007;30:401-416.

slide45

Meta-Analyses Demonstrate the Heterogeneity for Antipsychotic Response “All antipsychotics are equal, but some are more equal than others” - Volavka J, Citrome L. J Clin Psychiatry. 2009;70:429-430.

SGA versus FGA

Amisulpride

Aripiprazole

Clozapine

Olanzapine

Quetiapine

Risperidone

Sertindole

Ziprasidone

Zotepine

Leucht S, et al. Lancet. 2009;373(9657):31-41.

slide46

Meta-Analyses Demonstrate the Heterogeneity for Antipsychotic Response “All antipsychotics are equal, but some are more equal than others” - Volavka J, Citrome L. J Clin Psychiatry. 2009;70:429-430.

SGA versus SGA

Advantages for:

Clozapine

Olanzapine

Risperidone

Leucht S, et al. Am J Psychiatry. 2008;166(2):152-163.

slide47
Antipsychotics – Heterogeneity for TolerabilityEPS, Prolactin, Weight, Glucose/Lipids, Sedation, Hypotension

Volavka J, Citrome L. Expert Opin Pharmacother. 2009;10(12):1917-1928.

catie reasons for discontinuation
CATIE – Reasons for Discontinuation

N=1432

WEIGHT GAIN - METABOLIC EFFECTS

EXTRAPYRAMIDAL EFFECTS

SEDATION

OTHER

Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

we can use evidence based medicine
We Can Use Evidence-Based Medicine

RelevantScientificEvidence

ClinicalJudgment

EBM

Patients’ Values and Preferences

Sackett DL, et al. BMJ. 1996;312(7023):71-72.

Citrome L, Ketter TA. Int J Clin Pract. 2009;63(3):353-359.

what is treatment effectiveness
What Is Treatment Effectiveness?

Tolerability and Safety

Does Rx cause SE?

Efficacy

Does Rx reduce Sx?

Treatment

Effectiveness

Combines all measures

Adherence/

Persistence

Will Pt take Rx?

Lehman AF, et al. Am J Psychiatry. 2004;161(2 suppl):1-56.

Swartz MS, et al. Schizophr Bull. 2003;29(1):33-43.

Lieberman JA, et al. N Engl J Med. 2005;353(12):1209-1223.

effective use of medication
Effective Use of Medication
  • Medication is a tool that a person with schizophrenia can use to take greater control over his or her life
  • The goal should be to maximize the effectiveness of medication to help the person live the kind of life that he or she wants to live
  • The medicine has work well enough, be tolerated well enough, and the patient has to take it
medication nonadherence
Medication Nonadherence
  • Prevalence ~30 to 50% (and higher); rates vary depending on clinical setting, definitions, study duration, study population
  • Relatively short gaps in medication coverage can increase the risk of relapse
  • Nonadherence is associated with poor outcomes
    • Relapse
    • Hospitalization
    • Suicide attempts

Lacro J, et al. J Clin Psychiatry. 2002;63:892-909.

Novick D, et al. Psychiatry Res. 2010;176:109-113.

Masand P, et al. Prim Care Companion J Clin Psychiatry. 2009;11:147-154.

we overestimate adherence
We Overestimate Adherence
  • Nonadherence viewed as failure → consistent bias to overestimate adherence/underestimate nonadherence
  • We assume lack of adequate response as “treatment-resistance” and lack of efficacy for the antipsychotic for that patient
    • This is a possible explanation for high dosing of antipsychotics, polypharmacy with other antipsychotics and combination treatment with anticonvulsants
      • This is a no-win cycle: adherence is even more of a challenge with complex regimens

Velligan DI, et al. Psychiatr Serv. 2007;58(9):1187-1192.

risk factors for nonadherence
Patient-related1

Poor insight

Negative attitude toward medication

Prior nonadherence

Substance abuse

Cognitive impairment

Treatment-related1

Side effects

Lack of efficacy/continued symptoms

Risk Factors for Nonadherence
  • Environment/Relationship-related1
  • Lack of family/social support
  • Problems with therapeutic alliance
  • Practical problems (financial, transportation, etc)
  • Societal-related2
  • Stigma attached to illness
  • Stigma caused by medication side effects

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Lee S, et al. Soc Sci Med. 2006;62(7):1685-1696.

risk factors for nonadherence1
Patient-related1

Poor insight

Negative attitude toward medication

Prior nonadherence

Substance abuse

Cognitive impairment

Treatment-related1

Side effects

Lack of efficacy/continued symptoms

Risk Factors for Nonadherence
  • Environment/Relationship-related1
  • Lack of family/social support
  • Problems with therapeutic alliance
  • Practical problems (financial, transportation, etc)
  • Societal-related2
  • Stigma attached to illness
  • Stigma caused by medication side effects

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Lee S, et al. Soc Sci Med. 2006;62(7):1685-1696.

barriers to therapeutic alliance in schizophrenia
Barriers to Therapeutic Alliancein Schizophrenia
  • Patient barriers1
    • Communication difficulties
    • Difficulty forming an alliance because of negative symptoms
    • Difficulty learning from experience because of cognitive symptoms
    • Rejection of diagnosis due to stigma
  • Clinician barriers2
    • Underestimating importance of relationship
    • Hopelessness conveyed to patient
    • Lack of interest in life goals and other issues important to patient

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Pitschel-Walz, G, et al. J Clin Psychiatry. 2006;67(3):443-452.

relationship between early alliance and later medication adherence the boston collaborative study
Relationship Between Early Alliance and Later Medication Adherence: The Boston Collaborative Study

74

80

60

Adherence After 6 Months, %

40

28a

26a

20

0

Good

Fair

Poor

Alliance at 6 Months

aP < 0.001

Frank AF, Gunderson JG. Arch Gen Psychiatry. 1990;47:228-235.

assessing medication adherence interview style
Ask for the patient’s view about medications1,2

Obtain sufficient information before responding3

Do not jump to conclusions; take comments at face value3

Explain that you want to hear what the patient really thinks, not what he/she thinks you want to hear1-3

If you want to respond, do not try to do too much and make sure you do not go beyond what the patient can accept for now

As much as you can, try to keep the discussion about medication adherence positive—even enjoyable1

Above all, try to maintain and even strengthen the alliance, even if there is disagreement about the need for medication1

Assessing Medication Adherence:Interview Style

Weiden, PJ. J Psychiatr Prac. 2002;8(6):386-392.

McCabe R, et al. BMJ. 2002;325(7373):1148-1151.

Weiden PJ. J Clin Psychiatry. 2007;68(suppl 14):14-19.

assessing medication adherence interview style1
“Have you been taking your medications?” or “You have been taking your medicines, right?”

“Everyone misses doses of their medicines. Can you give me some idea of how many doses do you usually miss in any given week? I just need a ball-park figure, you don’t have to be exact.”

This is followed by, “What doses do you miss the most – morning? evening? with meals? in between meals? This way we can figure out the best time of day to use these medications so we can minimize the number of times you may miss them.”

Assessing Medication Adherence:Interview Style
risk factors for nonadherence2
Patient-related1

Poor insight

Negative attitude toward medication

Prior nonadherence

Substance abuse

Cognitive impairment

Treatment-related1

Side effects

Lack of efficacy/continued symptoms

Risk Factors for Nonadherence
  • Environment/Relationship-related1
  • Lack of family/social support
  • Problems with therapeutic alliance
  • Practical problems (financial, transportation, etc)
  • Societal-related2
  • Stigma attached to illness
  • Stigma caused by medication side effects

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Lee S, et al. Soc Sci Med. 2006;62(7):1685-1696.

medication related side effects and nonadherence
Medication-related Side Effects and Nonadherence
  • Potential drivers
    • Level of distress rather than severity
    • Attribution to the medication
    • Vary from patient to patient
  • Most commonly associated with nonadherence
    • Weight gain
    • Sedation
    • Akathisia
    • Sexual dysfunction
    • Parkinsonian symptoms
    • Cognitive problems

Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

reverberations from side effects how patient and clinician responses may differ
Reverberations From Side Effects How Patient and Clinician Responses May Differ

Influencing patient response

Influencing clinician response

Adherence Impact

Subjective

Distress

Side effect

appears

Objective

Severity

Safety and Risk

Weiden PJ, Buckley PF. J Clin Psychiatry. 2007;68(suppl 6):14-23.

considering side effect profile when choosing treatment
Considering Side Effect Profile When Choosing Treatment

Important because side effects may1:

Contribute to treatment nonadherence

Limit return to maximal levels of social functioning

Potentially contribute to long-term morbidity

Atypical antipsychotics are better tolerated than typical antipsychotics (mainly due to decreased EPS)2

Differences in drug-specific adverse effect profiles, including metabolic effects, may impact treatment adherence and long-term outcomes1,2

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Tandon R. Psychiatr Q. 2002;73(4):297-311.

risk factors for nonadherence3
Patient-related1

Poor insight

Negative attitude toward medication

Prior nonadherence

Substance abuse

Cognitive impairment

Treatment-related1

Side effects

Lack of efficacy/continued symptoms

Risk Factors for Nonadherence
  • Environment/Relationship-related1
  • Lack of family/social support
  • Problems with therapeutic alliance
  • Practical problems (financial, transportation, etc)
  • Societal-related2
  • Stigma attached to illness
  • Stigma caused by medication side effects

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Lee S, et al. Soc Sci Med. 2006;62(7):1685-1696.

what type of intervention is appropriate
What Type of Intervention Is Appropriate?
  • If the adherence problem is that the patient WILL NOT, focus intervention on strengthening perceived benefits of medication and minimizing perceived costs
  • If the adherence problem is that the patient CANNOT, then address barriers to adherence
    • Pill boxes in obvious locations
    • Self-monitoring tools
    • Establishment of routines
    • Consider long-acting injectable antipsychotic

Weiden P. J Clin Psychiatry. 2007;68(suppl 14):14-19.

risk factors for nonadherence4
Patient-related1

Poor insight

Negative attitude toward medication

Prior nonadherence

Substance abuse

Cognitive impairment

Treatment-related1

Side effects

Lack of efficacy/continued symptoms

Risk Factors for Nonadherence
  • Environment/Relationship-related1
  • Lack of family/social support
  • Problems with therapeutic alliance
  • Practical problems (financial, transportation, etc)
  • Societal-related2
  • Stigma attached to illness
  • Stigma caused by medication side effects

1. Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

2. Lee S, et al. Soc Sci Med. 2006;62(7):1685-1696.

monitoring medication adherence
Monitoring Medication Adherence
  • There are no entirely satisfactory methods, but can count pills and measure plasma levels
  • Ask if the patient is taking his/her medications
  • Ask, are the medications doing any good?
    • Any perceived benefit (eg, sleeping better) is a treasure
    • If none, be worried
  • Ask, are the medications doing any harm?
    • Ask about being sleepy, slowed down, dulled
    • Ask about weight changes
    • Ask about constipation
    • Ask about sex

Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.

considering efficacy when choosing treatment
Considering Efficacy When Choosing Treatment

Someone who isn’t responding adequately to an oral medication is unlikely to then respond to its depot formulation

Unless they were a non-responder because of nonadherence

There is heterogeneity in efficacy outcomes among the different antipsychotics, and this heterogeneity is observed among groups in clinical trials and in individual patients

potential advantages of long acting injectable antipsychotics
Potential Advantages of Long-acting Injectable Antipsychotics

Reduces dosage deviations1

Eliminates guessing about adherence status2,3

Shows start date of nonadherence2,3

Helps disentangle reasons for poor response to medication3

Eliminates need for the patient to remember to take a pill daily1

Enables prescribers to avoid first-pass metabolism, therefore a better relationship between dose and blood level exists1

Results in predictable and stable plasma levels1

Eliminates abrupt loss of efficacy if dose missed1,3

Many patients prefer them, especially if already receiving them4

McEvoy JP. J Clin Psychiatry. 2006;67(suppl 5):15-18.

Olfson M, et al. Schizophr Bull. 2007;33(6):1379-1387.

Kane JM, et al. J Clin Psychiatry. 2003;64(suppl 12):5-19.

Patel MX, et al. J Psychiatr Ment Health Nurs. 2005;12(2):237-244.

potential obstacles to long acting injectable antipsychotics
Potential Obstacles to Long-acting Injectable Antipsychotics

Lack of infrastructure in outpatient settings

Need to refrigerate, store, reconstitute, etc.

Overburdened public agencies

Frequency of injections and consequent inconvenience for staff and patients

Need to take concomitant medications orally

Anti-shot sentiment

McEvoy JP. J Clin Psychiatry. 2006;67(suppl 5):15-18.

Kane JM, et al. J Clin Psychiatry. 2003;64(suppl 12):5-19.

determinants of depot use
Determinants of Depot Use

Citrome L, et al. Psychopharmacol Bull. 1996;32(3):321-326.

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Depot Antipsychotics Reduce Relapse

in Long-term Studies

Treatment

n/N

Control

n/N

Relative Risk

(95% CI Random)

Relative Risk

(95% CI Random)

Study

Barnes 1983 3/19 3/17

0.89 (0.21, 3.85)

Falloon 1978 8/20 5/24

1.92 (0.74, 4.95)

Hogarty 1979 22/55 32/50

0.62 (0.43, 0.92)

Quitkin 1978 5/29 4/27

1.16 (0.35, 3.89)

Rifkin 1977 1/19 4/24

0.63 (0.06, 6.45)

Crawford 1974 2/14 6/15

0.36 (0.09, 1.48)

DelGuidice 1975 21/27 59/61

0.80 (0.65, 0.99)

Schooler 1973 26/107 35/107

0.74 (0.48, 1.14)

0.78 (0.66, 0.91)

Total (95% CI) 88/290 146/325

.2

1

5

Overall effect z = 3.06; P = 0.002

.1

10

Favors Treatment

Favors Control

Mentschel C, et al. Presented at: The International Congress on Schizophrenia Research (ICOSR) 2003; March 29-April 2; Colorado Springs, Colorado.

relapse free survival rates with oral and depot fluphenazine
Relapse-free Survival Rates With Oral and Depot Fluphenazine

10

9

8

Fluphenazine decanoate (n = 55)

7

6

Proportion Surviving

5

4

3

Oral fluphenazine (n = 50)

2

1

0

0

3

6

9

12

15

18

21

24

Months in Community

Hogarty GE, et al. Arch Gen Psychiatry. 1979;36(12):1283-1294.

adherence summary
Adherence Summary
  • Strategies to improve adherence include
    • Admitting that partial or nonadherence is a possibility
    • Identifying risk factors specific to the individual
    • Addressing barriers to therapeutic alliance
    • Tailoring interventions to adherence attitudes and behavior
  • Pharmacologic strategies to improve adherence include
    • Considering patient history, efficacy, and side effect profile when choosing treatment
    • Considering utilizing long-acting injectable antipsychotics, if available, in patients with recurring relapses related to nonadherence
summary
Summary
  • Response, remission and recovery are necessary goals of treatment, but each can be interpreted differently by clinicians, patients, and their families
  • Clinical practice guidelines can provide advice regarding a comprehensive approach, unfortunately not often done
  • Treatment effectiveness is dependent on a medication being efficacious enough, tolerable enough, and the patient has to take it
  • Adherence can be the ultimate confounder regarding effectiveness
please take posttest now and complete the attestation evaluation form
Please take posttest now and complete the attestation/evaluation form
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