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  • Comparative Effectiveness Review on Off-label Use of Atypical Antipsychotics
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This CME/CE activity is provided by PRIME Education, Inc. (PRIME®) and is accredited for a multi-disciplinary audience of health care practitioners. This activity is supported by contract number HHSA290201200021I from the Agency for Healthcare Research and Quality. User data collected through this activity will reside on PRIME's educational portal for use by AHRQ.

Summary of the Comparative Effectiveness Review on Off-label Use of Atypical Antipsychotics

Credit for this CME/CE activity has expired.

You can still access the program, but will not receive a certificate.

Program Overview

Activity Description

There are currently nine atypical antipsychotic drugs that are approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia and bipolar disorder. These drugs are being used as off-label (i.e., for indications not approved by FDA) treatments for various psychiatric conditions. The Agency for Healthcare Research and Quality (AHRQ) published a 2006 report examining the off-label uses of atypical antipsychotic medications in anxiety, attention deficit hyperactivity disorder (ADHD), dementia and severe geriatric agitation, major depressive disorder (MDD), eating disorders, insomnia, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), personality disorders, substance abuse, and Tourette's syndrome. The 2011 report updates the previous findings to include important changes and better comprehension of all the risks and benefits connected to off-label use of these medications. The key methods and results from the AHRQ systematic reviews are summarized and discussed in this educational journal supplement.

Learning Objectives

At the conclusion of this activity, the participant should be able to:

  • Summarize the trends and novel uses of off-label applications of atypical antipsychotics
  • Evaluate conclusions regarding the comparative benefits and harms of the therapy options on subpopulations of patients
  • Discuss the efficacy and comparative effectiveness of atypical antipsychotics for off-label indications

Target Audience

This CME activity is designed to meet the educational needs of physicians, psychologists, pharmacists, nurses, and case managers.

Method of Participation

To receive a certificate for this activity, you should:

  • Complete the learner assessment pretest
  • View the entire activity online
  • Complete an online evaluation & post-test
  • Print your certificate online

The estimated time to complete this activity, including review of the materials, is 1.5 hours.

Term of Approval

June 30, 2012 through September 30, 2013. Original release date: June 30, 2012.

Acknowledgement of Support

There is no fee for this CME/CE activity. This activity is sponsored by PRIME Education, Inc (PRIME®) and funded under contract HHSA290201200021I from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services (HHS).

Faculty Biographies and Disclosures

Click faculty name to view full biography.


M David Rudd, PhD, ABPP
Distinguished University Professor
University of Memphis
Memphis, Tennessee

Contributing Author

Alicia R Maher, MD
Physician adjunct with the RAND Corporation
Assistant Clinical Professor of Psychiatry at UCLA School of Medicine
Psychiatrist, Mind-Body Medicine Specialist at the Akasha Center for Integrative Medicine in Santa Monica
Santa Monica, CA

Contributing Author

George Theodore, PhD
Scientific Writer
Medical Education Researcher
PRIME Education, Inc.
Tamarac, FL


Heidi Wynn Maloni, PhD, ANP-BC, CNRN, MSCN
National Clinical Nursing Director
Department of Neurology
Multiple Sclerosis Center of Excellence
East Veterans Affairs Medical Center
Adjunct Faculty
Trinity Nursing Program School of Professional Studies
Trinity Washington University
Clinical Preceptor and Instructor
Advanced Practice Programs
The Catholic University of America School of Nursing
Washington, DC


Michele B Kaufman, PharmD, CGP, RPh
President, PRN Communications Inc.
Editor, Pharmacovigilance Forum, P&T Journal
NYCSHP Secretary
Adjunct Faculty
Touro College of Pharmacy
New York, NY

Peer Reviewer

Bradley N Gaynes, MD, MPH
Professor of Psychiatry
Department of Psychiatry
University of North Carolina School of Medicine
Chapel Hill, NC  

Peer Reviewer

Scott A Strassels, PharmD, PhD, BCPS
Healthcare Policy and Economic Outcomes
Mallinckrodt Pharmaceuticals
St. Louis, MO

Peer Reviewer

Kathleen R Roose, RN
Nurse Case Manager
Skyline Ultd.
Raleigh, NC

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Accreditation/Credit Designation

This program is no longer accredited.

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Faculty Disclosures

Faculty Name
Advisory Board Consultant Grants / Research Salary / Contractual Supported Promotional Education Stock / Shareholder Other Financial Support
M David Rudd, PhD, ABPP
None None None None None None None
Alicia R Maher, MD
None None None None None None None
George Theodore, PhD
None None None None None None None
Heidi Wynn Maloni, PhD, ANP-BC, CNRN, MSCN
sanofi-aventis None None None None None None
Michele B Kaufman, PharmD, CGP, RPh
None OrthoMcNeil Janssen None None None None None
Bradley N Gaynes, MD, MPH
None None None None None None None
Scott A Strassels, PharmD, PhD, BCPS
None None None None None None None
Kathleen R Roose, RN
None None None None None None None
Chris R Prostko, PhD
Scientific Program Director
Lynn Goldenberg, RN, BSN
Director of Accreditation & Compliance

Disclosure Policy

PRIME Education Inc (PRIME®) endorses the standards of the ACCME, as well as those of the AANP, ANCC and ACPE, that require everyone in a position to control the content of a CME/CE activity to disclose all financial relationships with commercial interests that are related to the content of the CME/CE activity. CME/CE activities must be balanced, independent of commercial bias and promote improvements or quality in healthcare. All recommendations involving clinical medicine must be based on evidence accepted within the medical profession.

A conflict of interest is created when individuals in a position to control the content of CME/CE have a relevant financial relationship with a commercial interest which therefore may bias his/her opinion and teaching. This may include receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, stocks or other financial benefits.

PRIME® willidentify, review and resolve all conflicts of interest that speakers, authors, course directors, planners, peer reviewers, or relevant staff disclose prior to an educational activity being delivered to learners. Disclosure of a relationship is not intended to suggest or condone bias in any presentation but is made to provide participants with information that might be of potential importance to their evaluation of a presentation. Disclosure information for speakers, authors, course directors, planners, peer reviewers, and/or relevant staff are provided with this activity.

Presentations that provide information in whole or in part related to non FDA approved uses of drugs and/or devices will disclose the unlabeled indications or the investigational nature of their proposed uses to the audience. Participants should refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. Participants should verify all information and data before treating patients or employing any therapies prescribed in this educational activity. The opinions expressed in the educational activity are those of the presenting faculty and do not necessarily represent the views of PRIME®, the ACCME, AANP, ACPE, ANCC and other relevant accreditation bodies.

Content validation methods are consistently utilized by PRIME® to ensure that all program content is evidence-based, fair-balanced, and developed with scientific rigor and integrity. All clinical recommendations are based on evidence accepted within the medical profession. All scientific research referred to, reported or used to support a clinical recommendation conforms to accepted standards of experimental design, data collection and analysis. In addition to review of content by course directors and expert faculty, content is also validated through independent peer reviewers selected for their expertise in the content area, as well as their experience in the intended audience. All peer reviewers, planners, course directors, faculty and relevant staff utilized by PRIME® complete disclosures which are related to their role in the educational activity.


PRIME®is committed to providing access to our CME programs for individuals with disabilities as identified in Section 508 of the Rehabilitation Act for all web-based programs. This website is 508 compliant.

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Post-Test & Evaluation

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Clinician & Consumer Summaries on Antipsychotics

Download these free summaries for your reference and/or patient handouts. You may also order bulk copies free of charge from the AHRQ Publication Clearinghouse below.

AHRQ Clearinghouse Bulk Order Form

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  • Alternatively, you can call the AHRQ Publications Clearinghouse at 1-800-358-9295. Reference the title and product number above.