Evaluating the Evidence for Reproductive Safety of Psychotropic Medications

Course Description

For ethical reasons, the safety profiles of psychotropic medications are not scrutinized with randomized clinical trials. Instead, safety data is derived from observational studies, which are susceptible to multiple sources of confounding and bias. While these concerns can be addressed by thoughtful research design and implementation, flawed studies continue to be published. Best practices regarding the use of psychotropic medications during pregnancy depend upon a critical reading of the available literature.

Learning Objectives

  1. Critique commonly used resources for psychotropic reproductive safety information.
  2. Recognize the pros and cons of alternative research designs used in reproductive safety studies.
  3. Define strategies to manage confounding in reproductive safety research.
  4. Identify sources of bias and approaches to address bias in reproductive safety studies.

Target Audience

If you are a pharmacist, nurse practitioner, or other health care professional involved in the comprehensive medication management of individuals living with mental health and/or substance use disorders, we invite you to participate in this online course.

Faculty

Jeffrey Newport, MD, MS, MDiv
View biographical information

Jeffrey Newport, MD, MS, MDiv
Professor of Psychiatry and Women's Health, Associate Chair for Research for the Department of Psychiatry & Behavioral Sciences, Director of Women’s Reproductive Mental Health
University of Texas at Austin Dell Medical School
Austin, TX

Dr. Jeffrey Newport is Professor of Psychiatry and Women’s Health at the University of Texas at Austin Dell Medical School where he serves as Associate Chair for Research for the Department of Psychiatry & Behavioral Sciences and Director of Texas Women’s Reproductive Mental Health. Dr. Newport completed a graduate theological degree before receiving his medical degree from the University of South Carolina. He subsequently completed psychiatric residency and a master’s degree in clinical research at Emory University. His awards include the NARSAD Independent and Young Investigator Awards, Young Faculty Award from the American Psychiatric Institute for Research and Education, the Society of Biological Psychiatry’s Lilly Fellowship, the American College of Psychiatrists’ Laughlin Fellowship, and the Distinguished Physician Alumnus Award from the University of South Carolina. He has published in leading journals across numerous specialties including JAMA, American Journal of Psychiatry, American Journal of Obstetrics & Gynecology, Neurology, and Pediatrics. Dr. Newport’s research focuses on women’s mental health with an emphasis on the psychobiology of perinatal psychiatric disorders, psychotropic pharmacokinetics during pregnancy and lactation, and the persistent biobehavioral impact of childhood trauma and other early life adverse experiences.

Course Requirements

To receive ACPE credit for this session, you must:

  • Register for this course.
  • Review the full content of the activity and reflect upon its teachings.
  • Complete the evaluation at the end of the activity.
  • Provide the necessary details in your profile to ensure correct reporting by AAPP to CPE Monitor.

Continuing Education Credit and Disclosures

Activity Date: 04/24/2022
ACPE Contact Hours: 1
ACPE Number: 0284-0000-22-055-H01-P (Knowledge)
Nursing Credit Reminder: Note that ACPE credit is accepted for ANCC Certification Renewal and AANPCB advanced practice provider content. For specific questions related to your organization's acceptance of ACPE continuing education units, please contact your organization directly.

ACPEThe College of Psychiatric and Neurologic Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

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View planning committee disclosures

2022 Program Committee and Recertification Editorial Board

Elayne D. Ansara, PharmD, BCPP, BCPS
Clinical Pharmacy Specialist
Veteran Health Indiana
Indianapolis, IN
No Relevant Financial Relationships to Disclose
Sarah L. Benner, PharmD, BCPS, BCPP
Clinical Pharmacy Coordinator and Psychiatric Clinical Pharmacist
Peninsula Regional Medical Center
Salisbury, MD
No Relevant Financial Relationships to Disclose
Jolene R. Bostwick, PharmD, BCPP, BCPS
Program Administrative Chair
Assistant Dean for Co-Curriculum and Professional Development & Clinical Professor
University of Michigan College of Pharmacy
Ann Arbor, MI
No Relevant Financial Relationships to Disclose

Bridget Bradley, PharmD, BCPP
Associate Professor
Pacific University School of Pharmacy
Hillsboro, OR
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: ACCP PSAP May 2021, Neurology and Psychiatry Book
Educational Grants, Research Grants or Contracts: NACDS Community Pharmacy Residency Grant

Austin R. Campbell, PharmD, BCPP
Program Committee Chair

Clinical Pharmacy Specialist - Psychiatry
University of Missouri Health Care
Columbia, MO
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Sunovion Pharmaceuticals Inc. Speakers Bureau
Financial Interests: Up To Date Contributor "Pharmacotherapy for schizophrenia: Long-acting injectable antipsychotic drugs"
Non-Financial Interests: Extension for Community Healthcare Outcomes, Show-Me ECHO Project

Chelsea N. Carr, PharmD, BCPP
Advanced Practice Pharmacist - Psychiatry
University of Maryland School of Pharmacy
Catonsville, MD
No Relevant Financial Relationships to Disclose
Dana Chiulli, PharmD, BCPP
Clinical Pharmacist - Mental Health
VISN 06 Mental Health Clinical Resource Hub
Savannah, GA
No Relevant Financial Relationships to Disclose
Andria F. Church, PharmD, BCPP, BCPS
Assistant Professor
Palm Beach Atlantic University
West Palm Beach, FL
No Relevant Financial Relationships to Disclose
Jordan Cooler, PharmD, BCPP
Clinical Assistant Professor
University of South Carolina College of Pharmacy
Columbia, SC
No Relevant Financial Relationships to Disclose
Beth DeJongh, PharmD, BCPP, BCPS
Recertification Editorial Board Chair
Pharmacist
Concordia University Wisconsin
Mequon, WI
No Relevant Financial Relationships to Disclose

Bennett J. Doughty, PharmD, BCPP, BCPS
Clinical Assistant Professor
Binghamton University School of Pharmacy and Pharmaceutical Sciences
Binghamton, NY
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Achieve CE - CE provided for compensation
Educational Grants, Research Grants or Contracts: SUNY Germination Space Grant. $50,000. Awarded July 2019.
Non-Financial Interests: New York State American College of Clinical Pharmacists Executive Board

Amber R. Douglass, PharmD, BCPS, BCPP
Clinical Pharmacy Specialist - Mental Health
VISN 1 Clinical Resource Hub - VA Connecticut Healthcare System
West Haven, CT
No Relevant Financial Relationships to Disclose
Traci M. Dutton, PharmD, BCPP, BCPS
Clinical Pharmacy Specialist - Mental Health
VA Tennessee Valley Healthcare System
Murfreesboro, TN
No Relevant Financial Relationships to Disclose

Megan J. Ehret, PharmD, BCPP, MS
BCPP Program Director

Professor
University of Maryland
Baltimore, MD
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Psych U Section Advisor, Lexi-Comp Consultant/Reviewer
Educational Grants, Research Grants or Contracts: FDA/University of Maryland CERSI, Maryland Behavioral Health Department, NIH

Kristen N. Gardner, PharmD, BCPP
Clinical Pharmacy Specialist - Behavioral Health
Kaiser Permanente Colorado
Denver, CO
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Biostrategies - one time consultant re:LAIAs (2019)
Educational Grants, Research Grants or Contracts: ACCP PSAP author (2021-2022); ACCP annual meeting speaker (2020)

Michelle L. Geier, PharmD, BCPP
Psychiatric Clinical Pharmacist Supervisor
San Francisco Department of Public Health
San Francisco, CA
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Weitzman Institute Project ECHO Faculty

Stacy L. Gould, PharmD, BCGP, BCPP
Clinical Pharmacy Specialist, Psychiatry
VISN 4 Clinical Resource Hub, Veterans Affairs
Pittsburgh, PA
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Pharmacy Subject Matter Expert for Mental Health for national Veterans Affairs
Financial Interests: none

Rebecca Graham, PharmD, BCPP
Clinical Pharmacy Specialist - Mental Health
Orlando VA Healthcare System
Orlando, FL
No Relevant Financial Relationships to Disclose
Nicole Hahn, PharmD, BCACP
Clinical Pharmacy Specialist - Neurology
Kaiser Permanente
Denver, CO
No Relevant Financial Relationships to Disclose
Abigail Hampton, PharmD, BCPP
Psychiatric Clinical Pharmacist - Ambulatory
University of Kansas Health System
Kansas City, KS
No Relevant Financial Relationships to Disclose
Courtney A. Iuppa, PharmD, BCPP
Clinical Pharmacy Manager & Residency Program Director
Center for Behavioral Medicine
Kansas City, MO
No Relevant Financial Relationships to Disclose
Archana R. Jhawar, PharmD, BCPP
Clinical Pharmacist
Jesse Brown VAMC/ UIC College of Pharmacy
Chicago, IL
No Relevant Financial Relationships to Disclose
Kayla D. Johnson, PharmD, BCPP, BCPS
Vanderbilt University Medical Center
Thompsons Station, TN
No Relevant Financial Relationships to Disclose
Dongmi Kim, PharmD, BCPP, BCPS
Assistant Clinical Professor
Fairleigh Dickinson University School of Pharmacy
Florham Park, NJ
No Relevant Financial Relationships to Disclose
Erin D. Knox, PharmD, BCPP
Director of Experiential Education
UCI School of Pharmacy & Pharmaceutical Sciences
Irvine, CA
Non-Financial Interests: Santa Ana Community College, Pharmacy Technology Program, Advisory Committee
Amber R. Lemons, PharmD, BCPP
Behavioral Health Pharmacist
Denver Health Medical Center
Denver, CO
No Relevant Financial Relationships to Disclose
Linda D. Logan, PharmD, BCACP, BCPP, BCPS
Public Service Associate
University of Georgia
Athens, GA
Educational Grants, Research Grants or Contracts: HRSA Graduate Psychology Education Grant
Marketa Marvanova, PharmD, PhD, BCGP, BCPP, FASCP
Dean and Professor
University of Montana, Skaggs School of Pharmacy
Missoula, MT
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Editorial Board member: Continuum: Lifelong Learning in Neuroilogy,
consultant for Lexicomp as a clinical specialist in neurology and psychiatry
Monica Mathys, PharmD, BCGP, BCPP
Associate Professor
Texas Tech University School of Pharmacy
Dallas, TX
Non-Financial Interests: CPNP Foundation Board member
Melissa Mitchell, PharmD, BCGP, BCPP, BCPS
Senior Clinical Pharmacist
RUHS MC
Moreno Valley , CA
External Consultant Activities, Advisory Panels, Speakers Bureaus, etc.: Neurocrine Speakers Bureau - Ingrezza,
Janssen Speakers Bureau - Spravato, Otsuka - PsychU.org Speaker
Thea R. Moore, PharmD, BCPP
Associate Professor
University of South Florida
Tampa, FL
No Relevant Financial Relationships to Disclose
Jessica L. Mulhollan, PharmD, BCPP
Clinical Pharmacy Specialist, Substance Use Disorders
Louis Stokes Cleveland VA Medical Center
Cleveland, OH
No Relevant Financial Relationships to Disclose
Kristen Neumeister, PharmD, BCPP
Clinical Pharmacist- Mental Health
John Peter Smith Hospital
Fort Worth, TX
No Relevant Financial Relationships to Disclose
Megan O'Connell, PharmD, BCPP
Advanced Practice Pharmacist - Psychiatry
University of Maryland - Clifton T. Perkins Hospital
Baltimore, MD
No Relevant Financial Relationships to Disclose
Melissa C. Palmer, PharmD, BCPP, BCPS
Clinical Pharmacy Specialist - Mental Health
Alaska VA Healthcare System
Anchorage, AK
No Relevant Financial Relationships to Disclose
Jake R. Peters, PharmD, BCPP, BCPS
Assistant Professor of Pharmacy Practice/Clinical Pharmacy Specialist - Psychiatry
Butler University College of Pharmacy/Indiana University Health
Indianapolis, IN
No Relevant Financial Relationships to Disclose
Lindsey Peters, PharmD, BCPS
Associate Professor of Pharmacy Practice
Ohio Northern University
Ada, OH
No Relevant Financial Relationships to Disclose
Sarah J. Popish, PharmD, BCPP
Academic Educator
Department of Veterans Affairs
Vallejo, CA
No Relevant Financial Relationships to Disclose
Kristina Reinstatler, PharmD, BCPP, MBA
Clinical Pharmacy Specialist
UC Health University of Cincinnati Medical Center
Cincinnati, OH
Educational Grants, Research Grants or Contracts: HEALing Communities NIH grant- pharmacy lead Athens Cty, Ohio
Michael D. Shuman, PharmD, BCPP
Staff Pharmacist
Central State Hospital
Lousiville, KY
No Relevant Financial Relationships to Disclose
Taylor A. Thomas, PharmD, BCPP
Clinical Pharmacy Specialist- Mental Health
VA Northern Indiana Health Care System
Fort Wayne, IN
No Relevant Financial Relationships to Disclose
Nina Vadiei, PharmD, BCPP
Assistant Professor
University of Arizona Colleges of Pharmacy and Medicine
Tucson, AZ
No Relevant Financial Relationships to Disclose
Kara R. Wong, PharmD, BCPP
Clinical Pharmacy Specialist, Mental Health; PGY2 Psychiatric Pharmacy Residency Program Director
Minneapolis VA Health Care System
Minneapolis, MN
No Relevant Financial Relationships to Disclose

All relevant relationships have been mitigated.

View disclaimer and disclosure of off-label use

Off-Label Use: This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA (see faculty information). The opinions expressed in the educational activity do not necessarily represent the views of AAPP and any educational partners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

View fair balance and integrity statement

It is the policy of AAPP to ensure independence, balance, objectivity, scientific rigor, and integrity in continuing education activities. Those involved in the development of this continuing education activity have made all reasonable efforts to ensure that information contained herein is accurate in accordance with the latest available scientific knowledge at the time of accreditation of this continuing education activity. Information regarding drugs (e.g., their administration, dosages, contraindications, adverse reactions, interactions, special warnings, and precautions) and drug delivery systems is subject to change, however, and the reader is advised to check the manufacturer’s package insert for information concerning recommended dosage and potential problems or cautions prior to dispensing or administering the drug or using the drug delivery systems.

Fair balance is achieved through ongoing and thorough review of all materials produced by faculty, and all educational and advertising materials produced by supporting organizations, prior to educational offerings. Approval of credit for this continuing education activity does not imply endorsement by AAPP for any product or manufacturer identified.