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Best Practices for Best Outcomes
April 13, 2010
Psychotropic Medication Utilization
Medication Hab Center CMHC
Antipsychotic 55% 68%
Antidepressant 35% 70%
Benzodiazepine 50% 45%
Anticonvulsant/MS 52% 31%
Antipsychotic PatternsUsage Hab Center CMHC
Any 55% 68%
2 or More 22% 6.1%
3 or More 1.3% 0.5%
High Dose 15% 3%
FGA (typical) 29% 15%
With dyskinetic 36% 21%
Portion of Prescriptions Potentially Questionable
CMHC’s 6.3% - 17.5%CPS Special Housing 18.0% - 22.6% Hab Centers 16.6% - 36.3%
Outlier Prescribing and Psychiatry Time
Hab Center % Outlier Prescriptions
Annual HrsPsychiatry per Resident
SEMORS 36.3% Community
MHC 32.4% 0.1
NHC 30.2% Community
HHC 24.9% 2.1
SLDDTC 17.7% 7.0
BHC 16.6% 7.1
Causes of Polypharmacy
• Not Enough Psychiatry Coverage• Incorrect Diagnosis• Failed Tapers• Over reliance on medication as the sole
treatment• Desperation
Negative Outcomes Associated with Polypharmacy
• Drug Interactions• Increased Medication Errors• Increasing Difficulty Assessing Effect of
Individual Medications• Increased Side Effects• Increased Mortality• Additional Medications for Side Effects• Cost
Antipsychotic PolypharmacyMEDLINE search 1966-2007
• Categorized by Study Population– Treatment Resistant (15 studies)– Non-Treatment Resistant (15 studies)
• Included: – Randomized Controlled Trials, (9 trials)– Non- Randomized Controlled Trials (6 trials)– Non-Controlled Observational studies (15
studies)• Excluded:
– Series without statistical analysis – case reports
Limitations of Literature
Small sample Sizes
Short Duration
Limited Matching Characteristics
Treatment Resistant StudiesMethod Total
Studies
Outcome Poly –AP better
No Difference
Mono- APBetter
Observational 9 Symptoms 8 1 0
Side Effects
1 4 3
Non-Controlled Random Trial
0
RCT 6 Symptoms 2 3 1
Side Effects
0 2 4
Totals 15 Symptoms 10 4 1
Side Effects
1 6 7
Treatment Resistant Studies by Medications Utilized
Methodology Clozapine Augmentation
AP unavailable in USA
Not ClozapineAvailable in USA
RTC 5 1 0
Observational 8 0 1
Megna et. Al 2007
• Only Study to show superiority of Multiple Antipsychotics in Treatment Resistant Psychosis without Clozapine or Non-US AP
• Retrospective Chart Review of 26 patients• Second antipsychotic added after 4 months
on mono-therapy• Outcomes
– 26% reduction on BPRS and decreased PRN use– Increased side effects– None improved enough for discharge
Non-Treatment Resistant StudiesMethod Total
Studies
Outcome Poly –AP better
No Difference
Mono- APBetter
Observational
6 Symptoms 0 4 2
Side Effects
2 1 3
Non-Controlled Random Trial
6 Symptoms 0.5Low dose mono
5.5 0
Side Effects
0 2 4
RCT 3 Symptoms 0 3 0
Side Effects
1 0 2
Totals 15 Symptoms 0.5 12.5 2
Side Effects
3 3 9
Non-Treatment Resistant Studies by Medications Utilized
Methodology Clozapine Augmentation
AP unavailable in USA
Not ClozapineAvailable in USA
RTC 1 0 2
Non-ControlledRandom Trial
1 0 5
Observational 2 0 4
Nishikawa, et. al. 1985
• Only Study to show superiority of Multiple Antipsychotics in Non-Treatment Resistant Psychosis without Clozapine or Non-US AP
• Non-Randomized Controlled Trial• Compared pimozide/thioridazine
polypharmacy with both as mono-therapy• Outcomes
– Poly was superior to low dose mono– Poly was no better than higher dose mono– Signs of “overdose” more common with poly
Three Adjunctive Studies
• All in Non-Treatment Resistant Population
• All had Metabolic Syndrome reduction as Primary Outcome
• One Non-Controlled Observational Study– CLZ vs CLZ/quetiapine: poly did better
• Two Non-Controlled Random Studies– Mono-SGA vs poly-SGA : no difference– CLZ vs CLZ/RIS : CLZ/RIS did worse
Antipsychotic PolypharmacyMortality Studies
• Waddington, et. Al. 1998– 10 year prospective inpatient schizophrenia
study– RR associated with AP polypharmacy = 2.46– Adjusted for cumulative AP dose and years on
APs• Joukamaa, et. Al. 2006
– 17 year retrospective schizophrenia study– RR associated with AP polypharmacy = 2.50– Adjusted for age, gender, BMI, smoking,
education, and multiple other factors
Conclusions - What we know
Antipsychotic Polypharmacy improves when augmenting Clozapine in treatment Resistant Patients, but also increases side effects.
Antipsychotic Polypharmacy in Non-treatment Resistant Patients› No improvement in symptoms› More side effects› Higher Mortality
Adjunctive Antipsychotic Polypharmacy does not reduce metabolic side effects
Limitations- What We Don’t Know
Efficacy of non-Clozapine SGA Polypharmacy in treatment resistant psychosis
Efficacy of Clozapine polypharmacy in non-treatment resistant psychosis
Aripiprazole augmentation of Risperidone or Quetiapine
Correll, Kane, Goff et.al. June , 2008 Poster
16 week, double blind, placebo controlled RTC
323 patients on risperidone or quetiapine given aripiprazole or placebo
No improvement in symptoms with SGA polypharmacy
Mixed changes in side effects
Published Practice GuidelinesRegarding Antipsychotic Polypharmacy
Published Guide lines include› American Psychiatric Association› Expert Consensus Guideline Series› Texas Medication Algorithmns› PORT
All recommend use of more than one AP only:› After multiple trials of monotherapy› After trial of clozapine
Justifications for Antipsychotic Polypharmacy
Clozapine Augmentation A History of 3 or more failed Trials of
monotherapy Recommended Plan to taper to
monotherapy
§483.450(e) Standard: Drug Usage
(e)(1) The facility must not use drugs in doses that interfere with the individual client’s daily living activities.
(e)(2) Drugs used for control of inappropriate behavior must be approved by the interdisciplinary team and be used only as an integral part of the client’s individual program plan that is directed specifically towards the reduction of and eventual elimination of the behaviors for which the drugs are employed.
http://www.cms.gov/manuals/downloads/som107ap_j_intermcare.pdf accessed 4.09.10
§483.450(e) Standard: Drug Usage
(e)(3) Drugs used for control of inappropriate behavior must not be used until it can be justified that the harmful effects of the behavior clearly outweigh the potentially harmful effects of the drugs.
(e) (4)(i) Drugs used for control of inappropriate behavior must be monitored closely, in conjunction with the physician and the drug regimen review requirement for desired responses and adverse consequences by facility staff; and
http://www.cms.gov/manuals/downloads/som107ap_j_intermcare.pdf accessed 4.09.10
§483.450(e) Standard: Drug Usage
(e)(4)(ii) Gradually withdrawn at least annually in a carefully monitored program conducted in conjunction with the interdisciplinary team, unless clinical evidence justifies that this is contraindicated
http://www.cms.gov/manuals/downloads/som107ap_j_intermcare.pdf accessed 4.09.10
Spectrum of AP Side Effects
Sedation Sedation
Weight Gain Weight Gain
NMS NMS EPS EPS
WBC WBC
Diabetes/DKA Diabetes/DKA
Anticholinergic Anticholinergic Orthostasis Orthostasis
Lipids Lipids
ANTIPSYCHOTICAGENTS
Seizures Seizures
Prolactin Prolactin
NMS = Neuroleptic Malignant Syndrome
Professional Resources & Business Development
Drug EPS TD Prolactin Elevation
WeightGain
LipidIncrease
GlucoseChange
Antichol Sedation
High Potency Conventional AP
+++ +++ +++ + + + ++ ++
Low Potency Conventional AP
++ ++ ++ ++ + + +++ +++
Clozapine +/- +/- + +++ ++ ++ ++ +++Risperidone ++ + ++ + + + + +Olanzapine + + + +++ ++ ++ + ++Quetiapine + + + ++ ++ ++ ++ ++Ziprasidone + + + +/- +/- +/- +/- +/-Aripiprazole + + + +/- +/- +/- +/- +/-Paliperidone ++ + ++ + + + + +Asenapine + + + +/- +/- +/- +/- +/-
Relative Risk of Side Effects Among Agents
Mueser KT, Jeste DV. in Clinical Handbook of Schizophrenia, 2008, Fuller M, Sajatovic M, in Psychotropic Drug Information Handbook 2009, Drug PIs
+++ substantial risk, ++ moderate risk, + mild risk, +/- minimal risk or insufficient data
Meaningful Medication Tapers
Polypharmacy – 2 or more in same class› 25% dose reduction per month› Completely off in 6 – 9 months
Monotherapy – only one of that class› 10% dose reduction per month› Completely off in 12 – 18 months
But Our Patients are Sicker