# Presentation: 011862

## From Compliance to Alliance for the Medication Management of Clients Suffering from Psychotic Disorders

**Peter Weiden, M.D. **
**Professor of Psychiatry **
**SUNY Downstate Medical Center **
**Brooklyn, New York **

## Power Issues 

- Power imbalance between client and psychiatrist
- Implies disobedience to authority
- Socially undesirable

## Conceptualizing “Compliance”

- Disagreement
- Deviation
- Cessation
- Efficacy

## Efficacy Model

- 	Difference between prescribed treatment and actual behavior is large enough to have an adverse effect on outcome.

- © Peter Weiden, M.D.

## Relapse in Schizophrenia

**Months**

**% Not Relapsed**

**80**

**70**

**60**

**50**

**40**

**30**

**20**

**90**

**100**

**Placebo**

**Neuroleptics**

## Risk of Relapse Following Recovery in First-Episode Patients

**Cumulative Proportion Relapsed**

**Year After Recovery from First Episode**

## Efficacy and Compliance

- _STOPPING_ antipsychotic medication _COMPLETELY_ _EVENTUALLY_ leads to relapse
- Assuming diagnosis of schizophrenia is correct, no way to get around this finding

## Time until First-Episode of Medication Noncompliance

**Month after discharge **

- © Peter Weiden, M.D.

## Clinical Illusions

- Poor outcome  poor compliance
- Need to disentangle efficacy limitations from compliance problems

## Symptom Exacerbation

- Medication Noncompliance

- Relapse

- © Peter Weiden, M.D.

## Relapse and Conventional Antipsychotics

- Relapse and Conventional Antipsychotics

- Patients Receiving Oral vs Depot Fluphenazine

- Proportion remaining in the community

- Schooler et al. *Arch Gen Psychiatry. *1980;37:16.

## Symptom Exacerbation

- Medication Noncompliance

- Relapse

- © Peter Weiden, M.D.

## Hierarchy of Long-TermPharmacologic Goals

**Regain****Functioning**

- Hierarchy of Long-TermPharmacologic Goals

- © Peter Weiden, M.D.

## Hierarchy of Long-TermPharmacologic Goals

- Hierarchy of Long-TermPharmacologic Goals

## Risperidone vs Haloperidol:Time to Relapse

- Risperidone vs Haloperidol:Time to Relapse

**100**

**0**

**Survival probability**

- 		Mean Time to Relapse (SE)*
- Risperidone		452.23 days (17.68)
- Haloperidol		391.33 days (21.83)

*P*=0.001†

**Days**

**1 year **

**800**

**700**

**600**

**100**

**500**

**400**

**300**

**200**

**90**

**80**

**70**

**60**

**50**

**40**

**30**

**20**

**10**

**0**

-   Csernansky et al. *N Engl J Med*. 2002;346:16.

## Many clients have difficult lives 
They want to “get a life”
Relapse prevention does not mean “getting a life”
Many clients have trouble connecting taking medications with “getting a life”

- They want to “get a life”
- Relapse prevention does not mean “getting a life”
- Many clients have trouble connecting taking medications with “getting a life”

- Medications and Life Goals

## Hierarchy of Long-TermPharmacologic Goals

**Regain****Functioning**

- Hierarchy of Long-TermPharmacologic Goals

## “Getting a Life”: Employment Status Over 1 Year of Patients on Olanzapine vs Haloperidol

## What are your goals?
What has to happen to meet your goals?
Introduce concept of relapse – would a relapse be disruptive? 
Newer medications are much more likely to help you “get a life”

- What has to happen to meet your goals?
- Introduce concept of relapse – would a relapse be disruptive?
- Newer medications are much more likely to help you “get a life”

- Medications and Life Goals

## Factors Contributing to Fluctuating Compliance

- Time stable

- Accept-
- ability of side effects

- Change in relationships

- Substance
- Abuse

- Symptoms

## Overview of Health Belief Model  

- Perception is reality!
- Key factors
- Subjective Benefits
- Subjective “Costs”
- Behavior determined by summation of both compliance and noncompliance factors

- © Peter Weiden, M.D.

- Health Belief Model of Compliance

- Perceived Benefits

- Perceived Costs

- Tips scale towards compliance

- Tips scale towards noncompliance

- Bottom line: Perception is reality!

- © Peter Weiden, M.D.

- Rating of Medication Influences (ROMI) Scale

- Compliance
- Influence
- Prevention of illness
- Daily benefit
- Relationships with others

- Noncompliance
- Influence
- Denial
- Dysphoria
- Lack of benefit
- Stigma

- Weiden PJ et al. *Schizophr Bull.* 1994;20:297-310.

- © Peter Weiden, M.D.

## Greater PERCEIVED Benefits?

**Perceived benefits**

**Better Efficacy**

- © Peter Weiden, M.D.

## Fewer PERCEIVED Benefits?

**Perceived benefits**

**Better Efficacy**

- © Peter Weiden, M.D.

**Perceived Benefits**

**Minimzing Side Effects **

- Tips scale towards compliance

**Perceived side effects **

- Tips scale towards noncompliance

## Subjective Response to Conventional Antipsychotics 

- “Haldol brought on the most frightening side effects I’d yet experienced....Haldol made me feel like the Tin Man from the *Wizard of Oz ...*They’re strangling you, said my voices gleefully.” *

- * From *The Day the Voices Stopped *by Ken Steele Basic Books, 2001, page 93

## Subjective Response to Anticholinergic Effects

- “ ‘It may be a side effect of your new medication, Cogentin,’ she said. ‘It often causes blurred vision. Don’t worry. It’s nothing serious.’ ”
- “ Nothing serious? If I couldn’t read, I wouldn’t survive in this madhouse.” *

- * From *The Day the Voices Stopped *by Ken Steele Basic Books, 2001, page 67

##  EPS to Noncompliance Direct Path

** **EPS to Noncompliance Direct Path

- © Peter Weiden, M.D.

## Less EPS May Help Patients Learn About Benefits

**Less EPS May Help Patients Learn About Benefits**

**Perceived Benefits**

- Tips scale towards compliance

**EPS**

- Tips scale towards noncompliance

- © Peter Weiden, M.D.

## Impact of Visible EPSIndirect Path

- Visibly “Medicated”

- Family gets  distressed

- Noncompliance

- Family stops supporting medication

- Impact of Visible EPSIndirect Path

- © Peter Weiden, M.D.

## Bottom Line: Goal should be NO EPS

- Bottom Line: Goal should be NO EPS

- © Peter Weiden, M.D.

**Notes:**
It is hard to overstate the importance of this shift in thinking. We have gone 180 degrees from wanting – or expecting – EPS. Now, we don’t have to cause EPS in our patients. of course, that may not be true 100% of the time. There will be patients who require long-acting depot medications, for example. Others may respond only to a given medication that, for that patient, causes EPS. However, that said, MOST OF THE TIME IT IS POSSIBLE TO PROVIDE OPTIMAL ANTIPSYCHOTIC BENEFITS WITHOUT ANY CLINICALLY SIGNIFICANT EPS!

## Criteria for Achieving NO EPS

- No recent history of EPS
- No physical findings of EPS
- No subjective complaints of EPS
- No need for anti-EPS medications

**Notes:**
These are some suggested operational criteria for No EPS.

NO HISTORY OF EPS: The patient (or family) do not give a history of recent EPS such as tremor, muscle stiffness, dystonia, restlessness, between sessions. The reason this is important is that EPS tends to wax and wane, and may not be present all the time in physical exam. For example, acute dystonia tends to occur during times of emotional stress. Rigidity may come after repetitive muscle movements from a job. 

NO PHYSICAL FINDINGS OF EPS: This is straightforward, but highlights the need to check for subtle signs of EPS on physical exam. While the AIMS is helpful for TD, keep in mind that it does not cover any of the other EPS such as dystonia, akathisia, tremor, muscle rigidity,tremor, or akinesia.

NO SUBJECTIVE COMPLAINTS OF EPS: Many kinds of EPS present with subjective complaints or with behavioral difficulties. The most common complaints are restlessness from akathisia “I’m jumping out of my skin” or akinesia “I feel like a zombie”. One of the problems is that the behavioral/subjective components of EPS often overlap with psychiatric symptoms. Sometimes a way to distinguish between the possiblities is by the pharmacologic history – other times, it may be virtually impossible to distinguish. Nonetheless, these are often misdiagnosed and now can be treated with low-EPS agents.

NO ANTICHOLINERGIC OR OTHER ANTI-EPS MEDICATIONS: if the patient needs ot be on an anticholinergic, the patient is not really EPS free. The patient may be relieved of the worst of the EPS symptoms, but now has to continue on other treatments with their own problems and side effects. Anticholinergic agents may worsen certain cognitive domains, may worsen dyskinetic symptoms, and often are not fully effective in fully treating the subjective distress parts of the EPS.   

## What about Atypical Antipsychotics?

- New medications are better, and ...
- They are now first line in the US, but ...
- They do not solve the compliance problem

## Availability of Antipsychotic Medication: 

- One-Year Naturalistic Study

- Mahmoud RA et al. Poster presented at: 36th Annual Meeting of the ACNP;December 8-12; Kamuela, Hawaii; Data on file, Janssen Pharmaceutica Products, L.P. 1997.

**Mean number of days with no therapy**

## Reported Frequency of Side Effects*

- 0

- 10

- 20

- 30

- 40

- 50

**Restless****Jittery**

**Tremors**

- Reported Frequency of Side Effects*

*Conventional vs Atypical Antipsychotics*

- Percentage of Patients

- *Includes patients who were frequently or very frequently distressed by their side effect irrespective of frequency with which they reported it.

- Weiden P, Mackell J. Presented at: 152nd Annual Meeting of the APA; May 15-20,1999; Washington, DC.

**Atypical group**

**Conventional group **

**Atypical**

**Conventional group **

## Frequency of Patients Being Distressed by Side Effects

- 0

- 10

- 20

- 30

- 40

- 50

- Weight Gain

- Sexual

- Dysfunction

- Frequency of Patients Being Distressed by Side Effects

*Conventional vs Atypical Antipsychotics*

- Percentage of Patients

- **P* = .02.

- Weiden P, Mackell J. Presented at: 152nd Annual Meeting of the APA; May 15-20,1999; Washington, DC.

- *

**Atypical group**

**Conventional**

**Atypical group**

**Conven****tional **

## Approach to Side Effects  

- Prevention
- Tailoring medication choice using patient preference(s)
- Always ask about side effects
- Take any distress very seriously

## Approach to Side Effects  

- Collaborate with patient in side effect treatment decisions
- Educate significant others about side effects
- Consider impact of side effects on others
- Consider changing medications when side effects impact on compliance

- © Peter Weiden, M.D.

## Compliance Interventions

- Psychosocial
- Pharmacologic

## Compliance Therapy Study Methods

- Random-assignment inpatient study in London
- 4-6 sessions in the hospital lasting 20-60 minutes each
- Followed as outpatients after discharge
- “Booster” sessions at 3, 6, and 12 months

## Compliance Therapy: Estimated Rehospitalization Rates at 1-Year Follow-Up  

- *

- Compliance Therapy: *Estimated Rehospitalization Rates at 1-Year Follow-Up  *

- * 95% CI 1.16-4.18.

- Kemp R et al. *Br J Psychiatry.* 1998;172:413-419.

- Control Group n = 35

- Compliance Therapy  n = 39

## Potential Advantage of a Long-Acting Antipsychotics 

- Tracking of compliance status
- Eliminates guessing about compliance status
- “Alarm clock” – alerts clinician when noncompliance starts
- Helps disentangle reasons for poor response to medication

- © Peter Weiden, M.D.

## Conclusion

- Always put efficacy before “compliance”
- Disentangle lack of efficacy from noncompliance
- Important to frame “compliance” as a way to achieve better outcome
- Important to understand side effects in context of health belief model