Connecting the Dots in Antipsychotic Maintenance Therapy.pdf

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SYLLABUS AND COURSE GUIDE                                                                                                                                      ARCHIVE




        Connecting the Dots in Antipsychotic
               Maintenance Therapy



   A Free, One-Hour CME/CNE/CPE/NASW/CEP/CCMC Live and On Demand Activity
                          Release Date: October 5, 2011
                      Credit Expiration Date: October 5, 2012
                     On the Web: www.neuroscienceCME.com

                FACULTY: Leslie Citrome, MD, MPH, Diana O. Perkins, MD , MPH
                            MODERATOR: Henry A. Nasrallah, MD




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                                                              Connecting the Dots in Antipsychotic Maintenance Therapy


                                                                                                    INFORMATION FOR PARTICIPANTS
Statement of Need
Medication nonadherence is common and difficult to detect in patients with schizophrenia. Roughly 50% of patients
take less than 70% of prescribed doses. Clinical management requires getting the patient on the most appropriate
medication, working with patients and families to improve adherence to medication, and then consistently measuring
efficacy and side effects. Many factors contribute to nonadherence, including poor illness insight, a negative attitude
toward medication, and adverse events such as weight gain or metabolic changes.1 Clinicians who establish functional
partnerships with their patients are able to deliver messages in a way that they are heard. Messaging includes
emphasis on the necessity of medication adherence to prevent relapse during the maintenance phase, and the
importance of using measurement-based care during all phases of treatment for schizophrenia.2
This neuroscienceCME Live and On Demand activity will support clinicians to become increasingly proactive in
managing adherence and in monitoring their patients with schizophrenia for both clinical progress and optimal
outcome.
1
    Goff DC, Hill M, Freudenreich O. Treatment adherence in schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2011;72(4):e13. PMID: 21527119.
2
    Kane JM. Transitioning from acute to long-term treatment in schizophrenia. J Clin Psychiatry. 2011;72(3):e10. PMID: 21450146.


Activity Goal
To implement actionable strategies to integrate measurement-based care and improve adherence to antipsychotic medications.
Learning Objectives
At the end of this CE activity, participants should be able to:
   D
•	 	 efine	the	critical	areas	that	affect	nonadherence	to	antipsychotic	medication	and	implement	strategies	to	address	adherence	
   in patients with schizophrenia.
•	 Review	the	available	tools	to	evaluate	patients’	progress	and	implement	regular,	measurement-based	evaluations.
•	 Implement	regular	metabolic	screening	for	patients	taking	antipsychotic	medication.			
The following learning objectives pertain only to those requesting CNE credit:
•	 Review	the	critical	areas	that	affect	nonadherence	to	antipsychotic	medication	and	define	strategies	to	address	adherence.
•	 Describe	the	available	measurement-based	tools	to	evaluate	patients’	progress	that	can	be	used	regularly	in	practice.
•	 Recognize	the	necessity	for	regular	metabolic	screening	for	patients	taking	antipsychotic	medication.	

Target Audience
Physicians, physician assistants, nurses, nurse practitioners, pharmacists, psychologists, social workers, certified case managers, and
other nonphysician health care professionals with an interest in schizophrenia.


                                                                                                                                            CREDIT INFORMATION
CME Credit (Physicians)
USF Health is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education
for physicians.
USF Health designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the
credit commensurate with the extent of their participation in the activity.
Note to Physician Assistants: AAPA accepts Category I credit from AOACCME, Prescribed credit from AAFP, and AMA Category I
CME credit for the PRA from organizations accredited by ACCME.
CNE Credit (Nurses)
Provider approved by the California Board of Registered Nursing, Provider Number CEP 15510, for 1.0 contact hour.
CEP Credit (Psychologists)
CME Outfitters is approved by the American Psychological Association to sponsor continuing education for psychologists. CME
Outfitters maintains responsibility for this program and its content. (1.0 CE credit).
NASW Credit (Social Workers)
This program was approved by the National Association of Social Workers (provider #886407722) for 1 continuing education
contact hour.


                                                                                                            2
                                          Connecting the Dots in Antipsychotic Maintenance Therapy

CCMC Credit (Certified Case Managers)
This program has been approved for 1 hour by the Commission for Case Manager Certification (CCMC).
CPE Credit (Pharmacists)
           CME Outfitters, LLC, is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing
           pharmacy education. 1.0 contact hour (0.1 CEUs)
           Universal Program Number: 0376-9999-11-019-H01-P (recorded programs)
           Activity Type: knowledge-based

Post-tests, credit request forms, and activity evaluations can be completed online at www.neuroscienceCME.com (click on the
Testing/Certification link under the Activities tab–requires free account activation), and participants can print their certificate or
statement of credit immediately (80% pass rate required). This website supports all browsers except Internet Explorer for Mac. For
complete technical requirements and privacy policy, visit www.neurosciencecme.com/technical.asp. CME/CE credit expires on
October 5, 2012. For CME questions or comments, please contact: USF Health at cpdsupport@health.usf.edu.


Financial Support
USF Health and CME Outfitters, LLC, gratefully acknowledge an educational grant from Genentech in support of this CE activity.
This activity is supported by an educational grant from Lilly, USA, LLC. For further information concerning Lilly grant funding visit
www.lillygrantoffice.com.

                                                                                   CREDIT REQUIREMENTS
Successful completion of this CE activity includes participating in the live or recorded activity, reviewing the course materials, and
following the instructions below within 30 days of completion of the activity:
To complete your credit request form, activity evaluation, and post-test online, and print your certificate or statement of credit
immediately (80% pass rate required), please visit www.neuroscienceCME.com and click on the Testing/Certification link under
the Activities tab (requires free account activation).
There is no fee for participation in this activity. The estimated time for completion is 60 minutes.
Questions? Please call 877.CME.PROS.

                                                                    FACULTY BIOS & DISCLOSURES
Henry A. Nasrallah, MD (Moderator)
Dr. Nasrallah is a widely recognized psychiatrist, educator, and researcher. He received his BS and MD degrees at the American
University of Beirut. Following his psychiatric residency at the University of Rochester and neuroscience fellowship at the NIH,
he served as a faculty member at the University of California at San Diego and the University of Iowa before assuming the chair
of the Ohio State University Department of Psychiatry for twelve years. In 2003, he joined the University of Cincinnati College of
Medicine as Associate Dean and Professor of Psychiatry and Neuroscience.
Dr. Nasrallah is the Director of the Schizophrenia Program, and his research focuses on the neurobiology and
psychopharmacology of schizophrenia and related disorders including bipolar disorder. He has published over 350 scientific
articles and 400 abstracts, as well as 10 books. He is Editor-In-Chief of two journals (Schizophrenia Research and Current
Psychiatry) and is the co-founder of the Schizophrenia International Research Society (SIRS). He has been board-certified in
both adult and geriatric psychiatry. He is a Fellow of the American College of Neuropsychopharmacology [ACNP], Fellow of
the American College of Psychiatrists, distinguished Fellow of the American Psychiatric Association, President of the Cincinnati
Psychiatric Society, and President of the Ohio Psychiatric Education and Research Foundation. He has twice received the NAMI
Exemplary Psychiatrist Award and was voted as the U.S. Teacher of the Year by the Psychiatric Times. He has received over 75
research grants and is listed in several editions of the book “Best Doctors in America”.

Leslie Citrome, MD, MPH
Dr. Citrome was the founding Director of the Clinical Research and Evaluation Facility at the Nathan S. Kline Institute for
Psychiatric Research in Orangeburg, New York, and is currently an Adjunct Professor of Psychiatry and Behavioral Sciences at New
York Medical College. After nearly two decades of government service as a researcher in the psychopharmacological treatment
of severe mental disorders, Dr. Citrome is now engaged as a consultant in clinical trial design and is a frequent lecturer on the
quantitative assessment of clinical trial results using the evidence-based medicine metrics of number needed to treat and




                                                                          3
                                      Connecting the Dots in Antipsychotic Maintenance Therapy

number needed to harm.
Dr. Citrome graduated from the McGill University Faculty of Medicine and completed a Residency and Chief Residency in
Psychiatry at the New York University School of Medicine. He went on to complete a Masters in Public Health from the Columbia
University School of Public Health.
Dr.	Citrome’s	primary	research	interests	have	centered	on	psychopharmacologic	approaches	to	schizophrenia,	management	of	
treatment-refractory schizophrenia, and the management of aggressive and violent behavior. He is the author or co-author of
over 400 research reports, reviews, chapters and abstracts in the scientific literature, is the Associate Editor for Psychiatry for the
International Journal of Clinical Practice, serves on the editorial board of 6 other medical journals, reviews for over 50 journals,
and has lectured extensively throughout the USA, Canada, Europe, and Asia.

Diana O. Perkins, MD, MPH
Dr. Perkins received her medical degree in 1984 from the University of Maryland School of Medicine in Baltimore. She completed
her psychiatric residency at the University of Maryland Hospitals and University of North Carolina (UNC) Hospitals. Dr. Perkins
obtained her MPH in epidemiology in 1992 from the UNC-Chapel Hill School of Public Health.
Dr. Perkins is currently Professor of Psychiatry at UNC-Chapel Hill School of Medicine. She is the Medical Director of OASIS
(Outreach and Support Intervention Services) at UNC Hospitals and the UNC-Chapel Hill School of Medicine. OASIS is an
innovative program for individuals recovering from a first psychotic episode or individuals at risk of psychosis. The mission
of OASIS and STEP is to enhance recovery from psychosis, to support research that investigates the causes and treatments of
psychotic disorders, and to train future clinicians to better treat psychotic disorders.
Dr.	Perkins’	primary	research	interests	include	early	identification	and	treatment	of	schizophrenia,	emphasizing	treatment	of	the	
prodromal period and early intervention of the first episode of schizophrenia. She is currently investigating pharmacological and
psychotherapeutic treatments in the treatment of psychosis; focusing on managing the side effects of atypical antipsychotic
medications, and the weight gain mechanism in patients taking psychotropic medications including the health risks associated
with weight gain. Dr. Perkins is also investigating the genetic basis of schizophrenia.

Disclosure of Relevant Financial Relationships with Commercial Interests
Moderator:
Henry A. Nasrallah, MD
Professor of Psychiatry & Neuroscience
University of Cincinnati College of Medicine
Cincinnati, OH
Disclosures:
Advisory Board or Panel: AstraZeneca; Genentech, Inc.; Janssen Pharmaceuticals, Inc.; Pfizer Inc.; Merck & Co., Inc.; Novartis
Corporation; Hoffmann-La Roche Inc.; Shire Pharmaceuticals; Sunovion Pharmaceuticals Inc.
Consultant: AstraZeneca; Genentech, Inc.; Janssen Pharmaceuticals, Inc.; Pfizer Inc.; Merck & Co., Inc.; Novartis Corporation;
Hoffmann-La Roche Inc.; Shire Pharmaceuticals; Sunovion Pharmaceuticals Inc.
Grants/Research Support: Forest Laboratories, Inc.; Genentech, Inc.; Hoffmann-La Roche Inc.; Janssen Pharmaceuticals, Inc.; Otsuka
America Pharmaceutical, Inc.; Pfizer Inc.; Hoffmann-La Roche Inc.; Shire Pharmaceuticals
Speaker’s	Bureau:	AstraZeneca;	Janssen	Pharmaceuticals,	Inc.;	Merck	&	Co.;	Inc.;	Novartis	Corporation;	Pfizer	Inc.;	Sunovion	
Pharmaceuticals Inc.

Faculty:
Diana O. Perkins, MD, MPH
Professor, Department of Psychiatry
Medical Director, Outreach and Support Intervention Services (OASIS)
University of North Carolina
Chapel Hill, NC
Disclosures:
Advisory Board or Panel: Genentech, Inc.; Merck & Co., Inc.
Consultant: Eli Lilly and Company; Endo Pharmaceuticals; Sunovion Pharmaceuticals Inc.
Speaker’s	Bureau:	Eli	Lilly	and	Company


                                                                   4
                                      Connecting the Dots in Antipsychotic Maintenance Therapy



Leslie Citrome, MD, MPH
Adjunct Professor of Psychiatry & Behavioral Sciences
New York Medical College
Valhalla, NY
Disclosures:
Advisory Board or Panel: Bristol-Myers Squibb; Novartis Corporation; Shire Pharmaceuticals; Sunovion Pharmaceuticals Inc.
Consultant: Bristol-Myers Squibb; Eli Lilly and Company; Janssen Pharmaceuticals, Inc.; Novartis Corporation; Noven
Pharmaceuticals, Inc.; Pfizer Inc.; Shire Pharmaceuticals; Sunovion Pharmaceuticals Inc.; Valeant
Grants/Research Support: AstraZeneca; Pfizer Inc.; Sunovion Pharmaceuticals Inc.
Speaker’s	Bureau:	AstraZeneca;	Eli	Lilly	and	Company;	Merck	&	Co.;	Novartis	Corporation;	Pfizer	Inc.;	Sunovion	Pharmaceuticals	Inc.
Stock/Shareholder (self-managed): Bristol-Myers Squibb; Eli Lilly and Company; Johnson & Johnson; Merck & Co.; Pfizer Inc.;
Cardinal Health; Medco Health Solutions.
Disclosures were obtained from the planning committee members and are on file in the USF Health Office of Continuing
Professional Development (OCPD) for review. Disclosures were obtained from the USF Health OCPD staff: Nothing to Disclose.
Sharon Tordoff, CCMEP (planning committee) has no disclosures to report.
Howard Bliwise, MD (Content/Peer Reviewer) has no disclosures to report.
Nancy Jennings, MSN, MBS, MHA, RNC (Content/Peer Reviewer) has no disclosures to report.
Ruth Cody, BSN, RN-BC (Content/Peer Reviewer) has no disclosures to report.
Robert Kennedy (planning committee) has no disclosures to report.
Unlabeled Use Disclosure
Faculty of this CE activity may include discussions of products or devices that are not currently labeled for use by the FDA. The
faculty have been informed of their responsibility to disclose to the audience if they will be discussing off-label or investigational
uses (any uses not approved by the FDA) of products or devices.
USF Health, CME Outfitters, LLC, the faculty, Genetech, and Lilly, USA, LLC do not endorse the use of any product outside of the
FDA labeled indications. Medical professionals should not utilize the procedures, products, or diagnosis techniques discussed
during this activity without evaluation of their patient for contraindications or dangers of use.

Activity Slides
The slides that are presented in this activity are available for download and printout at the neuroscienceCME website:
www.neuroscienceCME.com. Activity slides may also be obtained via fax or email by calling 877.CME.PROS.




                                                                  5
              Connecting the Dots in Antipsychotic Maintenance Therapy


                                                                         Abbreviation List
     ADA     American Diabetes Association
     AIDS    Acquired immunodeficiency syndrome
     BARS    Brief Adherence Rating Scale
      BMI    Body mass index
    CATIE    Clinical Antipsychotic Trials of Intervention Effectiveness
      CGI    Clinical Global Impression Scale
  CGI-SCH    Clinical Global Impression—Schizophrenia Scale
       CV    Cardiovascular
      HDL    High-density lipoprotein
      HIV    Human immunodeficiency virus
     HTN     Hypertension
       Hx    History
    MEMS     Medication event monitoring system
NHANES III   Third National Health and Nutrition Examination Survey
       PK    Pharmacokinetics
     SMR     Standardized mortality ratio




                                         6
               Connecting the Dots in Antipsychotic Maintenance Therapy




                                                            USF Health and
                                                       CME Outfitters gratefully
    Co-sponsored by                                  acknowledge an educational
                                                   grant from Genentech in support
                                                           of this CE activity

                                                    This activity is supported by an
                                                   educational grant from Lilly USA,
                                                      LLC. For further information
                                                     concerning Lilly grant funding
                                                     visit www.lillygrantoffice.com




The course guide for this
 activity includes slides,
  disclosures of faculty                           To receive CME/CE credits
 financial relationships,                                for this activity,
and biographical profiles.                         participants must complete
                                                        the post-test and
  For additional copies of                             evaluation online at
  these materials, please                          neuroscienceCME.com/test
visit neuroscienceCME.com
  or call 877.CME.PROS.




                                          7
                                      Connecting the Dots in Antipsychotic Maintenance Therapy




  The faculty have been
     informed of their                                                               Moderator:
 responsibility to disclose                                                     Henry A. Nasrallah, MD
to the audience if they will                                                Professor of Psychiatry & Neuroscience
  be discussing off-label                                                        Vice Chairman for Education
                                                                           Department of Psychiatry and Behavioral
  or investigational uses                                                                Neuroscience
  (any use not approved                                                       University of Cincinnati College of
 by the FDA) of products                                                                    Medicine
                                                                                         Cincinnati, OH
        or devices.




        Henry A. Nasrallah, MD
                     Disclosures
 Research/Grants: Forest Laboratories, Inc.; Genentech,
 Inc.; Hoffmann-La Roche Inc.; Janssen Pharmaceuticals, Inc.;
 Otsuka America Pharmaceutical, Inc.; Pfizer Inc.; Hoffmann-La
                                                                                      Faculty:
 Roche Inc.; Shire Pharmaceuticals                                           Diana O. Perkins, MD, MPH
 Speaker’s Bureau: AstraZeneca; Janssen Pharmaceuticals,
 Inc.; Merck & Co.; Inc.; Novartis Corporation; Pfizer Inc.;                 Professor, Department of Psychiatry
 Sunovion Pharmaceuticals Inc.
                                                                            Medical Director, Outreach and Support
 Consultant: AstraZeneca; Genentech, Inc.; Janssen
 Pharmaceuticals, Inc.; Pfizer Inc.; Merck & Co., Inc.; Novartis                Intervention Services (OASIS)
 Corporation; Hoffmann-La Roche Inc.; Shire Pharmaceuticals;
 Sunovion Pharmaceuticals Inc.                                                   University of North Carolina
 Stockholder: None                                                                      Chapel Hill, NC
 Other Financial Interest: None

 Advisory Board: AstraZeneca; Genentech, Inc.; Janssen
 Pharmaceuticals, Inc.; Pfizer Inc.; Merck & Co., Inc.; Novartis
 Corporation; Hoffmann-La Roche Inc.; Shire Pharmaceuticals;
 Sunovion Pharmaceuticals Inc.




                                                                   8
                                   Connecting the Dots in Antipsychotic Maintenance Therapy




Diana O. Perkins, MD, MPH
                 Disclosures
Research/Grants: None
                                                                                     Faculty:
                                                                            Leslie Citrome, MD, MPH
Speakers Bureau: Eli Lilly and Company
Consultant: Eli Lilly and Company; Endo                                             Adjunct Professor of
Pharmaceuticals; Sunovion                                                     Psychiatry & Behavioral Sciences
Pharmaceuticals Inc.                                                             New York Medical College
Stockholder: None                                                                       Valhalla, NY
Other Financial Interest: None
Advisory Board: Genentech, Inc.; Merck
& Co., Inc.




                                                                         Learning
                                                                                                      1
  Leslie Citrome, MD, MPH
                 Disclosures

                                                                         Objective
Research/Grants: AstraZeneca; Pfizer Inc.; Sunovion
Pharmaceuticals Inc.
Speaker’s Bureau: AstraZeneca; Eli Lilly and Company; Merck
& Co.; Novartis Corporation; Pfizer Inc.; Sunovion
Pharmaceuticals Inc.

Consultant: Bristol-Myers Squibb; Eli Lilly and Company;
Janssen Pharmaceuticals, Inc.; Novartis Corporation; Noven
Pharmaceuticals, Inc.; Pfizer Inc.; Shire Pharmaceuticals;
                                                                       Define the critical areas that
Sunovion Pharmaceuticals Inc.; Valeant                                 affect nonadherence to
Stock/Shareholder (self-managed): Bristol-Myers Squibb; Eli
Lilly and Company; Johnson & Johnson; Merck & Co.; Pfizer Inc.;        antipsychotic medication and
Cardinal Health; Medco Health Solutions
                                                                       implement strategies to
                                                                       address adherence
Other Financial Interest: None

Advisory Board or Panel: Bristol-Myers Squibb; Novartis
Corporation; Shire Pharmaceuticals; Sunovion Pharmaceuticals
Inc.




                                                                  9
                  Connecting the Dots in Antipsychotic Maintenance Therapy




Learning
Objective               2
Review the available tools to
                                                        Learning
                                                        Objective            3
                                                       Implement regular
evaluate patients’ progress                            metabolic screening for
and implement regular,                                 patients taking
measurement based
evaluations                                            antipsychotic medication




                                            10
                                             Connecting the Dots in Antipsychotic Maintenance Therapy




                         Definitions                                                                        Partial Adherence and
    Persistence: staying in treatment;
                                                                                                               Hospitalization
    measured as days taking medication
    without exceeding permissible gap
    Compliance: patient following                                                                                                                           (n = 1122)




                                                                                Patients hospitalized (%)
    recommended treatment plan; measured
    as % of doses taken as prescribed                                                                                                       (n = 1166)


    Adherence: synonymous with compliance                                                                                   (n = 1710)

    but considered by some to be less
    derogatory when referring to                                                                            (n = 327)

    nonadherence vs. noncompliance.
      Implies self-driven behavior and
      includes healthy behaviors, keeping
      appointments                                                                                              0             1 - 10          11 - 30            >30
                                                                                                                 Longest medication gap (days within one year)
  Cramer JA, et al. Value in Health. 2008;11:44-47.                                         Weiden PJ, et al. Psychiatric Services. 2004;55:886-891.




     Relapse Fuels Deterioration in
            Schizophrenia
  With each relapse:
  •Progressive gray and white matter loss
  •Response will be slower, less complete
  •Illness can become more resistant to tx
  •More frequent admissions to hospital
  •Increased risk of self-harm and homelessness
  •Regaining previous level of functioning harder
  •Recovery derailed: patient has a loss of self-
  esteem and social and vocational disruption
  •Greater consumption of healthcare resources
  •Increased burden on families, caregivers
 Nasrallah HA, et al. Contemporary Diagnosis and Management of the
Patient with Schizophrenia. 2003




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                  Connecting the Dots in Antipsychotic Maintenance Therapy




                                                               Clinician Estimates of
                                                                     Adherence
                                                        25 subjects with schizophrenia or schizoaffective
                                                        disorder, 3-month follow-up
                                                        Clinician rating vs electronic monitoring
                                                         • Clinician rating: On a scale ranging from 1
                                                           (complete refusal) to 7 (active participation,
                                                           readily accepts and shows some responsibility
                                                           for regimen)
                                                            • Score of 5 (passive acceptance) or greater
                                                              indicating “adherence”
                                                           Electronic monitoring: Non-adherence
                                                           detected in 48% (12/25) by MEMS and 0% by
                                                           clinician ratings




                                                        Byerly M, et al. Psychiatry Res 2005;133:129-133.




Learning
                        2
                                                       Measurement-based Care
                                                           and Adherence
Objective                                               Importance of measurement
                                                            Baseline
                                                            Ongoing
Review the available tools to                           When to evaluate?
evaluate patients’ progress                             How long does it take?
and implement regular,
measurement based
evaluations




                                            12
                                                  Connecting the Dots in Antipsychotic Maintenance Therapy




                                                                                           Clinical Global Impression -
  Brief Adherence Rating Scale
    Clinician Administered1,2                                                             Schizophrenia (CGI-SCH) Scale
                                                                                        Severity of Illness: Considering your total clinical experience with pts
  (Modified from the CATIE Study)                                                       with schizophrenia, how severely ill has the pt been during the last wk?

                                                                                                      Normal    Min Ill   Mildly Ill   Mod Ill   Markedly   Severely    Among
 How many pills/capsules do you take each day?                                                        Not Ill                                       Ill        Ill       Most
 Over the past month on how many days did you not take this                                                                                                            Severely
 medication?                                                                                                                                                              Ill
                                                                                          Positive
 Over the past month how many days did you take less than the                            Symptoms       1         2           3          4          5          6          7
 prescribed number of pills/capsules?
                                                                                          Negative
                                                                                         Symptoms       1         2           3          4          5          6          7
 To summarize, over the past month you took this medication as prescribed:
                                                                                         Depressive
                                                                                         Symptoms       1         2           3          4          5          6          7
    Never/            Sometimes         Usually           Always/
 Almost never                                           Almost always
                                                                                         Cognitive
 __________________________________________________________________
                                                                                         Symptoms       1         2           3          4          5          6          7
 0%           25%           50%              75%            100%
                                                                                          Overall
                                                                                          Severity      1         2           3          4          5          6          7
1. Byerly MJ, et al. Schizophr Res 2008 100:60-69.
    2. Lieberman JA, et al. N Engl J Med 2005;353:1209-1223.
                                                                                        Haro JM, et al. Acta Psychiatr Scand Suppl. 2003;(416):16-23.




      Clinical Global Impression -                                                         What Type of Intervention
    Schizophrenia (CGI-SCH) Scale                                                              Is Appropriate?
  Degree of Change: Compared to the previous evaluation, how much has
  the patient changed? Rate improvement whether or not, in your                         • If the adherence problem is that the patient
  judgment is entirely due to treatment.
                                                                                          WILL NOT, focus intervention on
                  Very       Much        No       Min    Much      Very      N/A          strengthening perceived benefits of
                  Much     Improved    Change    Worse   Worse     Much
                Improved                                           Worse                  medication and minimizing perceived costs

                                                                                        • If the adherence problem is that the patient
    Positive
   Symptoms
                   1           2          3        4        5         6      7

    Negative
                   1           2          3        4        5         6      7
                                                                                          CANNOT, then address barriers to
   Symptoms
                                                                                          adherence
   Depressive
   Symptoms
                   1           2          3        4        5         6      7            Pill boxes in obvious locations
    Cognitive
                                                                                          Self-monitoring tools
   Symptoms
                   1           2          3        4        5         6      7            Establishment of routines
    Overall
                   1           2          3        4        5         6      7
                                                                                          Consider long-acting injectable antipsychotic
    Severity


  Haro JM, et al. Acta Psychiatr Scand Suppl. 2003;(416):16-23.                         Weiden P. J Clin Psychiatry. 2007;68(suppl 14):14-19.




                                                                                   13
                                              Connecting the Dots in Antipsychotic Maintenance Therapy




          Monitoring Medication                                                           Potential Advantages of
               Adherence                                                                  Long-Acting Injectable
    There are no entirely satisfactory methods, but                                           Antipsychotics
    can count pills and measure plasma levels
                                                                                  • Reduces dosage deviations1
    Ask if the patient is taking his/her medications
                                                                                  • Eliminates guessing about adherence
    Ask, are the medications doing any good?                                        status2,3
    •• Any perceived benefit (eg, sleeping better) is a
       treasure                                                                   • Shows start date of nonadherence2,3
    •• If none, be worried                                                        • Helps disentangle reasons for poor response
    Ask, are the medications doing any harm?                                        to medication3
    •• Ask about being sleepy, slowed down, dulled                                • Eliminates need for the patient to remember
    •• Ask about weight changes                                                     to take a pill daily1
    •• Ask about constipation                                                     • Avoids the waste of pills lost or not taken1
    •• Ask about sex                                                              1. McEvoy JP. J Clin Psychiatry. 2006;67(suppl 5):15-18.
                                                                                  2. Olfson M, et al. Schizophr Bull. 2007;33(6):1379-1387.
Velligan DI, et al. J Clin Psychiatry. 2009;70(suppl 4):1-46.                     3. Kane JM, et al. J Clin Psychiatry. 2003;64(suppl 12):5-19.




   Potential Advantages of Long-                                                      Potential Obstacles to Long-
  Acting Injectable Antipsychotics                                                  Acting Injectable Antipsychotics
• Avoids first-pass metabolism, therefore a better                                • Lack of infrastructure in outpatient
  relationship between dose and blood level1
                                                                                    settings
• Results in predictable and stable plasma levels1
• Eliminates abrupt loss of efficacy if dose
                                                                                  • Need to refrigerate, store, reconstitute,
  missed1,3                                                                         etc.
• Many patients prefer them, especially if already                                • Overburdened public agencies
  receiving them4                                                                 • Frequency of injections and consequent
• Lowers the high cost of hospitalization3                                          inconvenience for staff and patients
• Reduces harm to self (self neglect or suicide)
  and others with the recurrence of psychosis2                                    • Need to take concomitant meds orally
                                                                                  • Aversion to injections
1. McEvoy JP. J Clin Psychiatry. 2006;67(suppl 5):15-18.
2. Olfson M, et al. Schizophr Bull. 2007;33(6):1379-1387.
3. Kane JM, et al. J Clin Psychiatry. 2003;64(suppl 12):5-19.                      McEvoy JP. J Clin Psychiatry. 2006;67(suppl 5):15-18.
4. Patel MX, et al. J Psychiatr Ment Health Nurs. 2005;12(2):237-244.              Kane JM, et al. J Clin Psychiatry. 2003;64(suppl 12):5-19.




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                                                              Connecting the Dots in Antipsychotic Maintenance Therapy




                                                                                                                         3
                               Family Psychoeducation
                                      Research
12 Studies: Effects of family intervention on 2-yr cumulative relapse
                                                                                                   Learning
                        rates in schizophrenia
                              100                                                                  Objective
Cumulative Relapse Rate (%)




                              75
                                      59


                                                                                                  Implement regular
                              50
                                                  29         28
                                                                                                  metabolic screening for
                                                                      26
                              25


                                0
                                                                                                  patients taking
                                    Standard
                                      Care
                                                 Single
                                                     Single &
                                               Family Tx
                                                           Multiple
                                                     Multiple
                                                           Family                                 antipsychotic medication
                                    (n=203)     (n=231)
                                                     FamilyGroup Tx
                                                     Group Tx
                                                           (n=266)
                                                     (n=266)
McFarlane WR et al. J Marital Fam Ther. 2003;29:223-245.




                                                                                        15
                                            Connecting the Dots in Antipsychotic Maintenance Therapy




                Common Medical                                                  Medical Morbidity in Schizophrenia
                 Comorbidities
                        Cancer       Prolactin
                                                                                   40% are obese vs 27% in general
                                                  Obesity                          population1
            Substance
              Abuse
                                                                                   70%-80% smoke vs 25% in
                          Schizophrenia                 Depression
                                                                                   general population2
                                                                                   47% have history of substance
               HIV/
               AIDS                                     CV
                                                                                   abuse2
                                                      Disease
                          Diabetes                                                 Incidence of diabetes may be 2-3
                                         Lipids
                                                                                   times

                                                                                1.Harris EC et al. Br J Psychiatry. 1998;173:11.
    Lambert T, et al. Med J Aust. 2003;178:S67-S70.
                                                                                2.Kaplan H, et al. Synopsis Psychiatry: Behavioral Sciences Clinical
                                                                                Psychiatry. 1994.




          Mortality in Schizophrenia
   Loss of 25-30 years of normal life span
   compared to general population1
   50% increased risk of death from medical
   causes2,3,4
     Sudden death is 3 times higher
     Cardiovascular death is 2 times higher
       Significant   in cardiovascular
       mortality among men (P<0.001) and
       women (P = 0.002) with schizophrenia
       between 1976 and 1995
       Greatest    in SMRs (8.3 males/5.0
       females) occurred from 1991 to 1995
SMR = standardized mortality ratio (observed/expected deaths)
1.Colton CW, et al. Prev Chronic Dis 2006;3:A42
2.Harris EC, et al. Br J Psychiatry. 1998;173:11.
3.Osby U, et al. Arch Gen Psychiatry. 2001;58:844-850
4.Osby U, et al. BMJ. 2000;321:483-484.




                                                                      16
                                        Connecting the Dots in Antipsychotic Maintenance Therapy




                                                                            ADA/APA Consensus on Antipsychotic
                                                                                  Drugs and Obesity and
                                                                               Diabetes Monitoring Protocol*
                                                                                                               4   8  12        12              5
                                                                                                      Start               Qtrly
                                                                                                              wks wks wks       mos            yrs

                                                                             Personal/family Hx         X                                  X
                                                                                Weight (BMI)            X      X     X     X     X
                                                                            Waist circumference         X                                  X
                                                                               Blood pressure           X                  X               X
                                                                               Fasting glucose          X                  X               X
                                                                             Fasting lipid profile      X                  X               X   X

                                                                            * More frequent assessments may be warranted based on clinical status
                                                                            ADA/APA Consensus Conference. Diabetes Care 2004;27:596-601.




     Undertreatment of
 Hypertension, Dyslipidemia,                                                   Are We Monitoring Appropriately?
                                                                             Pattern of monitoring patients DURING treatment with an
and Diabetes in Schizophrenia                                                                  atypical antipsychotic
                      N= 1460 CATIE subjects




                                                                                                                                  N=258


Nasrallah HA, et al. Schizophr Res. 2006;86(1-3):15-22                       Buckley PF, et al . Schizophr Res. 2005;15;79(2-3):281-288.




                                                                  17
                         Connecting the Dots in Antipsychotic Maintenance Therapy




         Case Discussion                                                    Case Discussion
 James is a 25-year-old man who was                              3 subsequent psychiatric admissions
 diagnosed with paranoid schizophrenia                           with same symptoms - no clear
 approximately 6 years ago.                                      precipitant.
 Lives with and cares for physically                             Outpatient clinicians stated that he
 disabled mother. Family history of                              “seemed to be taking the medication”
 psychiatric illness and diabetes.                               and was “fairly active in rehabilitation
                                                                 programs.”
 He was first admitted to psychiatric unit
 with hallucinations and delusions.                              Patient referred for psychiatric
 Symptoms stabilized with an atypical                            consultation by mother's primary care
 antipsychotic. Referred to outpatient
 clinic for follow up.                                           physician at mother's request.




                                                                         Clinical Connections
         Case Discussion                                   •• Adherence includes keeping appointments, abiding by
                                                              diet and exercise regimen as well as medications
•• Patient states that he took medications
   ~ 50% of the time                                       •• Strategies to improve adherence include
•• Taking medications did not resolve                          •• Admitting that partial or nonadherence is a
   symptoms (hallucinations, paranoia)                            possibility
                                                               •• Identifying risk factors specific to the individual
•• Side effects bothersome –– drowsiness,                      •• Tailoring interventions to adherence attitudes and
   increased appetite, fatigue, dry mouth.                        behavior
•• Last hospitalization 1.5 years ago.
                                                            ••    Pharmacologic strategies to improve adherence
   Discharged with different atypical                             include
   antipsychotic and now has gained 35                           •• Considering patient history, efficacy, and side effect
   pounds. Has not had a medical workup                             profile when choosing treatment
   since discharge.                                              •• Considering utilizing long-acting injectable
                                                                    antipsychotics, if available, in patients with recurring
                                                                    relapses related to nonadherence




                                                   18
                      Connecting the Dots in Antipsychotic Maintenance Therapy




       Clinical Connection                                                     Resources
                                                          Clinical Global Impression Schizophrenia (CGI-SCH)
•• Use of measurement-based tools can                     Scale
                                                          Haro JM, Kamath SA, Ochoa S, et al. The Clinical Global Impression-
   assist clinicians in measuring                         Schizophrenia scale: a simple instrument to measure the diversity
                                                          of symptoms present in schizophrenia. Acta Psychiatr Scand Suppl.
   symptoms, functional ability,                          2003;(416):16-23.


   adherence and treatment progress                       Clinical Global Impression (CGI) Scale
                                                          Guy W (ed). ECDEU Assessment Manual for Psychopharmacology.
•• Regular metabolic monitoring for                       Rockville, MD: US Department of Heath, Education, and Welfare
                                                          Public Health Service Alcohol, Drug Abuse, and Mental Health
   patients taking antipsychotic                          Administration, 1976. http://miksa.ils.unc.edu/unc-
                                                          hit/media/CGI.pdf. Accessed September 20, 2011

   medications should be part of an                       The Brief Adherence Rating Scale (BARS)
   ongoing treatment strategy                             Byerly MJ, Nakonezny PA, Rush AJ. The Brief Adherence Rating
                                                          Scale (BARS) validated against electronic monitoring in assessing
                                                          the antipsychotic medication adherence of outpatients with
                                                          schizophrenia and schizoaffective disorder. Schizophr Res.
                                                          2008;100(1-3):60-69.




                                                                   Additional Resources

                                                                            Visit
                                                                 neuroscienceCME.com
                                                              for clinical information and
                                                             certified educational activities
                                                              on antipsychotic medication
                                                                        adherence




                                                19
                    Connecting the Dots in Antipsychotic Maintenance Therapy




   After the live broadcast,
 this activity will be available                                 Co-sponsored by
      as a web archive at




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                                              20
                                      Connecting the Dots in Antipsychotic Maintenance Therapy


                                                                                                           Bibliography
[No author listed]. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on
Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001;285(19):2486-
2497. PMID: 11368702.

[No author listed]. Consensus development conference on antipsychotic drugs and obesity and diabetes. Diabetes Care.
2004;27(2):596-601. PMID: 14747245.

Buckley	PF,	Miller	DD,	Singer	B,	Arena	J,	Stirewalt	EM.	Clinicians’	recognition	of	the	metabolic	adverse	effects	of	antipsychotic	
medications. Schizophr Res. 2005;79(2-3):281-288. PMID: 15964743.

Byerly M, Fisher R, Whatley K, et al. A comparison of electronic monitoring vs. clinician rating of antipsychotic adherence in
outpatients with schizophrenia. Psychiatry Res. 2005;133(2-3):129-133. PMID: 15740989.

Byerly MJ, Nakonezny PA, Rush AJ. The Brief Adherence Rating Scale (BARS) validated against electronic monitoring in assessing
the antipsychotic medication adherence of outpatients with schizophrenia and schizoaffective disorder. Schizophr Res.
2008;100(1-3):60-69. PMID: 18255269.

Citrome L. Patient perspectives in the development and use of long-acting antipsychotics in schizophrenia: focus on olanzapine
long-acting injection. Patient Prefer Adherence. 2009;3:345-355. PMID: 20016798.

Colom F, Vieta E. Treatment adherence in bipolar patients. Clin Approach Bipolar Disorder. 2002;1:49-56. [No PMID].

Colton CW, Manderscheid RW. Congruencies in increased mortality rates, years of potential life lost, and causes of death among
public mental health clients in eight states. Prev Chronic Dis. 2006;3(2):A42. PMID: 16539783.

Cramer JA, Roy A, Burrell A, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11(1):44-
47. PMID: 18237359.

Grundy SM, Cleeman JI, Daniels SR, et al. Diagnosis and management of the metabolic syndrome: an American Heart Association/
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Guy W. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Heath, Education, and Welfare Public
Health Service Alcohol, Drug Abuse, and Mental Health Administration; 1976. http://miksa.ils.unc.edu/unc-hit/media/CGI.pdf.
Accessed September 20, 2011.

Haro JM, Kamath SA, Ochoa S, et al. The Clinical Global Impression-Schizophrenia scale: a simple instrument to measure the
diversity of symptoms present in schizophrenia. Acta Psychiatr Scand Suppl. 2003(416):16-23. PMID: 12755850.

Harris EC, Barraclough B. Excess mortality of mental disorder. Br J Psychiatry. 1998;173:11-53. PMID: 9850203.

Kane JM. Review of treatments that can ameliorate nonadherence in patients with schizophrenia. J Clin Psychiatry. 2006;67(Suppl
5):9-14. PMID: 16822091.

Kane JM, Leucht S, Carpenter D, Docherty JP. The expert consensus guideline series. Optimizing pharmacologic treatment of
psychotic disorders. Introduction: methods, commentary, and summary. J Clin Psychiatry. 2003;64(Suppl 12):5-19. PMID: 14640142.

Kaplan HI, Sadock BJ. Synopsis Psychiatry: Behavioral Sciences Clinical Psychiatry. Philadelphia, PA: Lippincott, Williams & Wilkins;
1994: p. 486.

Lacro JP, Dunn LB, Dolder CR, Leckband SG, Jeste DV. Prevalence of and risk factors for medication nonadherence in patients with
schizophrenia: a comprehensive review of recent literature. J Clin Psychiatry. 2002;63(10):892-909. PMID: 12416599.

Lambert TJ, Velakoulis D, Pantelis C. Medical comorbidity in schizophrenia. Med J Aust. 2003;178(Suppl):S67-S70. PMID: 12720526.

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of schizophrenia in Hong Kong. Soc Sci Med. 2006;62(7):1685-1696. PMID: 16174547.

Masand PS, Roca M, Turner MS, Kane JM. Partial adherence to antipsychotic medication impacts the course of illness in patients

                                                                  21
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with schizophrenia: a review. Prim Care Companion J Clin Psychiatry. 2009;11(4):147-154. PMID: 19750066.

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the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial and comparison with national estimates
from NHANES III. Schizophr Res. 2005;80(1):19-32. PMID: 16137860.

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Velligan DI, Weiden PJ, Sajatovic M, et al. The expert consensus guideline series: adherence problems in patients with serious and
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Weiden PJ. Understanding and addressing adherence issues in schizophrenia: from theory to practice. J Clin Psychiatry.
2007;68(Suppl 14):14-19. PMID: 18284273.

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schizophrenia. Psychiatr Serv. 2004;55(8):886-891. PMID: 15292538.




                                                                 22
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