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Directions in

Psychiatry
V O L U M E

CATEGORY 1

CME

3 4

•

I N

T H I S

2 0 1 4

•

N U M B E R

3

I S S U E

An Update on New Medications for the Treatment of Major Depressive Disorder . . . . . . .159
ASIM A. SHAH, MD; AND SANJAY J. MATHEW, MD

According to the World Health Organization, unipolar depression was the third most important cause of disease worldwide in 2004. The faculty of this lesson review available treatment options, describe unmet needs,
recommend augmentation strategies, and discuss some of the newer treatment options.

Postpartum Depression Identification, Referral, and Treatment
among Diverse Racial and Ethnic Groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .171
DEEPIKA GOYAL, PhD, FNP; BINDU GARAPATY, PsyD; AND NANCY W. GREEN, DNP, FNP, CNM, CNL

Untreated postpartum depression (PPD) poses a threat to the maternal-child bond and the well-being of the
entire family. Examine specific cultural factors and mental health help-seeking behaviors among these culturally diverse populations in an effort to improve PPD identification and treatment.

Sexual Addiction or Hypersexual Disorder: Clinical Implications
for Assessment and Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .185
AVIV WEINSTEIN, PhD

Sexual addiction, which is also known as hypersexual disorder, is associated with severe psychosocial problems and risk-taking behaviors. Although sexual addiction is not included in the Diagnostic and Statistical
Manual of Mental Disorders, several screening questionnaires have been developed for the diagnosis of sexual addiction or hypersexual disorder.

Confidentiality Protections Versus Collaborative Care in the Treatment
of Substance Use Disorders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .201
JENNIFER K. MANUEL, PhD; HOWARD NEWVILLE, PhD; SANDRA E. LARIOS, PhD, MPH; AND JAMES L. SORENSEN, PhD

The addition of electronic health records provides opportunity for more rapid and comprehensive communication between patients’ primary and SUD care providers while promoting a collaborative care environment. Consider how to protect your patients’ information in this era of collaborative care while maintaining
rapid communication among healthcare providers.

Ebola: Clinical Progression and Clinical Evidence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .215
AMERICAN HOSPITAL ASSOCIATION

This lesson provides readers with the clinical progression of the Ebola Virus Disease (EVD) as well as guidelines for management in the hospital setting. Readers will review the symptoms that present in the early, late,
and recovery phases of the disease as well as symptom management, and guidelines for protection of
healthcare providers and others who come into contact with individuals who have acquired the virus.

A HATHERLEIGH
CME JOURNAL

w w w . D i r e c t i o n s I n P s y c h i a t r y . c o m

Directions in Psychiatry
Senior Content Advisor
Leah J. Dickstein, MD, MS
Professor Emerita,
University of Louisville, Psychiatriy & Behavioral Sciences,
Louisville, KY; and Lecturer, Tufts University,
Medical Center, Psychiatry Dept., Boston, MA

Program Advisory Board
Barbaranne Branca, PhD
Michigan Head Pain & Neurological
Institute, Ann Arbor, MI
Robert L. DuPont, MD
Georgetown University, Washington, DC
Richard Elliott, MD
Mercer University School of Medicine,
Macon, GA
Joseph T. English, MD
St. Vincent’s Medical, Center of New York,
NY, NY
Deborah I. Frank, PhD, ARNP, MFT
Florida State University, College of Nursing,
Tallahassee, FL
Shervert Frazier, MD
Psychiatrist-in-Chief, Emeritus,
McLean Hospital, Belmont, MA

Wendy Packman, JD
Pacific Graduate School of Psychology,
San Francisco, CA

Mark S. Gold, MD
University of Florida, Gainesville, FL
Alison Heru, MD
University of Colorado, Denver, CO

George Papakostas, MD
Massachusetts General Hospital, Boston, MA

Robert M.A. Hirschfeld, MD
University of Texas, Galveston, TX

Gail Erlick Robinson, MD, DPsych, FRCPC
Toronto General Hospital, Toronto, Ontario

Jimmie C. Holland, MD
Memorial Sloan-Kettering, Cancer Center,
NY, NY

Michael A. Schwartz, MD
University Hospitals of Cleveland,
Cleveland, OH

Hideo Hosaki, MD
Keio University, School of Medicine,
Tokyo, Japan

Peter C. Whybrow, MD
UCLA Department of Psychiatry and
Behavioral, Sciences, Los Angeles, CA

Philip Janicak, MD
Rush University, Chicago, IL.

Robert L. Williams, MD
Baylor College of Medicine, Houston, TX

Carl P. Malmquist, MD
University of Minnesota, Minneapolis, MN
Malkah T. Notman, MD,
The Cambridge Hospital, Cambridge, MA

Managing Editor
Stacy M. Powell, MS

Founding Editor
Frederic Flach, MD, KCHS, DFLAPA

Accreditation Statement
The Hatherleigh Company, Ltd., designates this activity for a maximum of 40 AMA
PRA Category 1 Credits. Physicians should only claim credit commensurate with the
extent of their participation in the activity.

w w w. D i r e c t i o n s i n p s y c h i a t r y. c o m
62545 State Highway 10, Hobart, NY 13788

The Hatherleigh Company, Ltd., is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing medical education
for physicians.
This activity has been planned and implemented in accordance with the Essential
Areas and Policies of the Accreditation Council for Continuing Medical Education
(ACCME) by The Hatherleigh Company, Ltd.

Directions in Psychiatry
Volume 34 • Lessons 11–15

CME Lesson 11

An Update on New Medications for the
Treatment Major Depressive Disorder Page

159

Asim A Shah, MD; and Sanjay J. Mathew, MD

 
CME Lesson 12

Postpartum Depression Identification, Referral,
and Treatment among Diverse Racial and Ethnic Groups

Page

171

Page

185

Page

201

Page

215

Deepika Goyal, PhD, FNP; Bindu Garapaty, PsyD;
and Nancy W. Green, DNP, FNP, CNM, CNI

 
CME Lesson 13

Sexual Addiction or Hypersexual Disorder:
Clinical Implications for Assessment and Treatment
Aviv Weinstein, PhD

CME Lesson 14

Confidentiality Protections Versus Collaborative Care
in the Treatment of Substance Use Disorders
Jennifer K. Manuel, PhD; Howard Newville, PhD;
Sandra E. Larios, PhD, MPH; and James L. Sorenson, PhD

 
CME Lesson 15

Ebola: Clinical Progression & Clinical Evidence
American Hospital Association

 
 

 

 

 

Conflict of Interest Faculty/Board Disclosures
The authors of the lessons in this CME program are paid an honorarium to produce original manuscripts on the invited topics. The
authors were selected for their expertise and, most often, on the strength of presentations made on those topics in previously published
papers or symposia. Relationships are disclosed below, if they exist, between the Directions in Psychiatry faculty and their immediate family
members, and commercial and/or pharmaceutical companies below. Disclosure of off-label medication usage for indications that are not
approved by the FDA will be disclosed on the title page of each lesson.
No commercial support was used in the development of the enclosed CME lessons.

Faculty Disclosures:
Medication usage mentioned in the lessons for indications that are not approved by the FDA are listed on the title page of each
lesson if they exist.
Bindu Garapaty, PsyD:
Deepika Goyal, PhD, FNP:
Nancy W. Green, DNP, FNP, CNM, CNI:
Sandra E. Larios, PhD, MPH:
Jennifer K. Manuel, PhD:
Sanjay J. Mathew, MD:
Howard Newville, PhD:
Asim A. Shah, MD:
James L. Sorenson, PhD:
Aviv Weinstein, PhD:

Dr. Garapaty has no conflicting interests to disclose.
Dr. Goyal has no conflicting interests to disclose.
Ms. Green has no conflicting interests to disclose.
Dr. Larios has no conflicting interests to disclose.
Dr. Manuel has no conflicting interests to disclose.
Dr. Mathew has no conflicting interests to disclose.
Dr. Newville has no conflicting interests to disclose.
Dr. Shah has no conflicting interests to disclose.
Dr. Sorenson has no conflicting interests to disclose.
Dr. Weinstein has no conflicting interests to disclose.

Program Advisory Board Member Disclosures:
Leah Dickstein, MD:
Richard L. Elliott, MD, PhD:
Deborah I. Frank, PhD, ARNP:
Mark S. Gold, MD, PhD:
Alison Heru, MD:
Philip Janicak, MD:

George I. Papakostas, MD:

Dr. Dickstein has no conflicting interests to disclose.
Dr. Elliott has no conflicting interests to disclose.
Dr. Frank has no conflicting interests to disclose.
Dr. Gold has no conflicting interests to disclose.
Dr. Heru has no conflicting interests to disclose.
Dr. Janicak has received grant/research support from: Janssen, Neuronetics, Inc., Otsuka Pharmaceutical
Group; The Research Foundation for Mental Hygiene, Inc.; and has disclosed stock or other financial
relationships with Lippencott, Williams & Wilkins.
Dr. Papakostas has no conflicting interests to disclose.

Hatherleigh Editorial Staff:
Andrew Flach, CEO:
Mr. Flach has no conflicting interests to disclose.
Stacy M. Powell, Managing Editor:
Ms. Powell has no conflicting interests to disclose.
Rick Gallub, Customer Relations Manager: Mr. Gallub has no conflicting interests to disclose.

 
 

 

 

 

Accreditation Standards: IOM; ACGME / ABMS Competencies
Directions in Psychiatry, Vol. 34
In accordance with accreditation guidelines set forth by the ACCME, we encourage you to review the following areas of core competency
and desirable physician attributes endorsed by the Institute of Medicine (IOM); The Accreditation Council for Graduate Medical Education
(ACGME) / American Board of Medical Specialties (ABMS). Each CME lesson in this activity addresses at least one or more of the following
attributes in each of the three areas of competency as listed below.
Institute of Medicine Core Competencies:
Provide Patient-Centered Care: Identify, respect, and care about patients’ differences,
values, preferences, and expressed needs; relieve pain and suffering; coordinate continuous care; listen to,
clearly inform, communicate with, and educate patients; share decision-making and management; and
continuously advocate disease prevention, wellness, and promotion of healthy lifestyles, including a focus
on population health.
Work in Interdisciplinary Teams: Cooperate, collaborate, communicate, and integrate care
in teams to ensure that care is continuous and reliable.
Employ Evidence-Based Practice: Integrate best research with clinical expertise and patient
values for optimum care, and participate in learning and research activities to the extent feasible.
Apply Quality Improvement: Identify errors and hazards in care; understand and implement
basic safety design principles, such as standardization and simplification; continually understand and
measure quality of care in terms of structure, process, and outcomes in relation to patient and
community needs; and design and test interventions to change processes and systems of care, with the
objective of improving quality.
Utilize Informatics: Communicate, manage, knowledge, mitigate error, and support decisionmaking using Information technology.

ACGME Competencies:
Patient Care that is compassionate, appropriate, and effective for the treatment of health problems
and the promotion of health.
Medical Knowledge about established and evolving biomedical, clinical, and cognate (e.g.
epidemiological and social-behavioral) sciences and the application of this knowledge to patient care.

Practice-Based Learning and Improvement that involves investigation and evaluation of
their own patient care, appraisal and assimilation of scientific evidence, and improvements in patient
care.
Interpersonal and Communication Skills that result in effective information exchange
and teaming with patients, their families, and other health professionals.
Professionalism, as manifested through a commitment to carrying out professional responsibilities,
adherence to ethical principles, and sensitivity to a diverse patient population.
Systems-Based Practice, as manifested by actions that demonstrate an awareness of and
responsiveness to the larger context and system of health care and the ability to effectively call on
system resources to provide care that is of optimal value.

ABMS Competencies:
Part I-Professional Standing: Medical specialists must hold a valid, unrestricted medical
license in at least one state or jurisdiction in the USA, its territories or Canada.
Part II-Lifelong Learning and Self-Assessment: Physicians participate in educational
and self-assessment programs that meet specialty-specific standards that are set by their member board.
Part III-Cognitive Expertise: They demonstrate, through formalized examination, that they
have the fundamental, practice-related and practice environment-related knowledge to provide quality
care in their specialty.
Part IV-Practice Performance Assessment: They are evaluated in their clinical practice
according to specialty-specific standards for patient care. They are asked to demonstrate that they can
assess the quality of care they provide compared to peers and national benchmarks and then apply the
best evidence or consensus recommendations to improve that care using follow-up assessments.

Directions in Psychiatry, Vol. 34 * Part 3 
IOM Core Competencies

Lesson 11

Lesson 12

Lesson 13

Lesson 14

Lesson 15

X
X

X
X
X
X
 

X

Provide patient-centered care
Work in interdisciplinary teams
Employ evidence-base practice
Apply quality improvement

X
X

X

X
X

Utilize informatics

ACGME Competencies 
Patient care
Medical knowledge
Practice-based learning and improvement

X
X

X
X

X
X
X

Interpersonal and communication skills

X
X

Professionalism
System-based practice

ABMS MOC Competencies 

X

X
X

X

 
X

Professional standing
Commitment to lifelong learning

X
X

X

X
X
X

Cognitive expertise
Performance in practice

X

  

 
 

 

 

 

CME Information Page
The objective of this continuing medical education program is to present participants with an expanded clinical skill set and raised awareness of clinically
relevant issues in their profession. They will review key diagnostic criteria, cutting-edge treatment strategies, and practice points they can implement in the
challenges of daily practice while providing evidence-based care to patients and clients suffering psychiatric and comorbid medical disorders. The expected
outcomes include an increase in knowledge, competence, professionalism, and performance.

Target Audience: The primary target audience for this program includes, but is not limited to: psychiatrists, primary care physicians, psychiatric nurses,
pharmacists, clinical psychologists, and social workers. Clinicians who have caseloads composed significantly of individuals with psychiatric disorders, and
comorbid medical illnesses will find this course particularly useful.
Duration of CME Status: Directions in Psychiatry begins May 1, 2014, and the preliminary expiration date is December 31, 2017. At that point, the
Hatherleigh Medical Director and the editorial staff will review the CME material to determine whether the program continues to be consistent with
current accreditation guidelines and standards Overall Objective: of care. A determination will be made as to whether the program can be used to earn
full CME credit after that date.

Conflict of Interest Disclosure Policy
Faculty members were selected for their expertise and, most often, on the strength of their presentations from previously published papers or symposia.
Hatherleigh Medicial Education staff, contributing program faculty, and advisory board members, must disclose their relationships (also on behalf of their
immediate family members), if they exist, with commercial and/or pharmaceutical companies prior to Hatherleigh Medical Education’s distribution and
publication of their contributions to Hatherleigh Medical Education CME programs. Any aforementioned relationship that poses a potential conflict of
interest will be resolved prior to publication/distribution of the CME activity, and proper notification disclosed to program participants prior to the start of
the activity.
Disclosure of any off-label medication usage for indications that are not currently approved by the Federal Drug Administration discussed within the CME
content will be disclosed within the lesson.

Accreditation Statement * Hatherleigh’s CME Designation
The Hatherleigh Company, Ltd. designates this CME journal for a maximum of 40 AMA PRA Category 1 Credits. Physicians should only claim credit
commensurate with the extent of their participation in the activity.
The Hatherleigh Company, Ltd. is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical
education for physicians.
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical
Education (ACCME) by The Hatherleigh Company, Ltd.

How the Program Works * Needs Assessment * Evaluation
Directions in Psychiatry includes 78 CME questions focused on key learning points within the lessons. The answers to each question must be recorded on
the supplied quiz response form or via the response form at Hatherleigh’s website. All 78 questions should be answered on that form or online and
submitted to Hatherleigh via the website, fax, e-mail, or regular mail for scoring. On average, participants will take up to 40 hours or more to complete this
Hatherleigh CME program (i.e., reading and studying the lessons and answering the CME questions). Participants must complete and return the program
assessment form which is included with each program. Participants can submit these forms with the quiz response form. Upon successful completion of the
program (at least 75% correct), Hatherleigh will send participants a certificate of achievement worth 40 credit hours and a score report.
This CME program was created from a learning needs assessment of participants in previous CME programs, who are virtually all physicians and other
mental health clinicians. Their expressed needs were assessed by the Medical Director, the Program Advisory Board members, and editorial staff in the
development of this curriculum.

About The Hatherleigh Company, Ltd. * Contact Information
The Hatherleigh Company, Ltd. has published continuing medical education programs in psychiatry for more than 30 years. Dr. Frederic Flach, the
company’s founder, created Directions in Psychiatry, Hatherleigh’s flagship CME program to ensure the presence of a truly independent and highly
professional perspective on issues of immediate clinical import—ranging from pharmacotherapy to psychotherapy, from technical information to ethical
priorities. We look forward to hearing from all subscribers via e-mail at: [email protected]. For more information about Hatherleigh CME
programs, visit our website at www.hatherleigh.com, or call: 1-800-367-2550.

Directions in Psychiatry is published by The Hatherleigh Company, Ltd., 62545 State Highway 10, Hobart, NY 13788.
POSTMASTER: Please send address changes to: Directions in Psychiatry, The Hatherleigh Company, Ltd., 62545 State Highway 10, Hobart, NY 13788.
Copyright 2014, THE HATHERLEIGH COMPANY, LTD. All rights reserved. No part of this publication may be reproduced in any form or by any means, except as
permitted under sections 107 or 108 of the United States Copyright Act, without the prior written permission of the publisher. The material in this journal is not a substitute for seeking
the attention of a licensed health or medical clinician. These materials were created for professional education purposes. They may not to be duplicated or distributed or otherwise
repurposed in digital or physical form in whole or in part without the express consent of the publisher. For educational use and reprints, please contact 1-800-367-2550. Statements made
in its publications by contributing authors do not reflect the opinion of the company or its employees. The Hatherleigh Company, Ltd. does not endorse any product, therapeutic method,
and/or treatment mentioned herein. The names of medications are typically followed by TM or ® symbols, but these symbols are not stated in this publication.

 
 

 

 

 

Self-assessment Pre-test

for Maintenance of Certification as Required by
The American Board of Psychiatry and Neurology (ABPN)
This assessment is necessary only for participants using this activity to earn credit hours to satisfy their
Maintenance of Certification as required by The American Board of Psychiatry and Neurology (ABPN).
Please answer and review each self-assessment question before starting your CME program.
This self-assessment will not be scored by Hatherleigh.

Directions in Psychiatry, Vol. 34 * Part 3
13. Which of the following medications is approved by the FDA for adjunctive treatment of depression?
A.
B.
C.
D.

Quetiapine
Aripiprazole
Risperidone
Both A & B

14. Are selective serotonin reuptake inhibitors (SSRIs) interchangeable?
A. Yes
B. No
15. Which of the following is a barrier that hinders women from diverse ethnic populations from seeking mental health
services, particularly for postpartum depression?
A. Strong familial support
B. Acceptance and openness with health providers
C. Stigma of being perceived as weak
D. None of the above
16. Is sexual addiction or hypersexual disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)?
A. Yes
B. No

Self‐Assessment Answer Key 

18. What is the primary mode of transmission of the Ebola virus?
A. Direct contact with blood
B. Direct contact with bodily fluids such as tears, sweat, semen, urine, vomit, feces, and other
C. Direct contact with contaminated objects
D. All of the above
19. Early-stage symptoms in the progression of Ebola include all of the following, except:
A. weakness.
B. shock.
C. fever greater than 101.5o F.
D. hiccups.
This is the end of your self-assessment test for Part 3.
This self-test is for your reference only. Please do not submit these answers to Hatherleigh.

 
 

 

 

 

13.D, 14.B, 15.C,  16.B,  17.D,  18.D,  19.B 

17. If a clinician approaches an ethically uncomfortable and challenging situation, it is best to seek guidance from:
A. peers.
B. counselors.
C. professional associations.
D. All of the above

L003333

An Update on New Medications
for the Treatment of Major
Depressive Disorder
Asim A. Shah, MD; and Sanjay J. Mathew, MD
The following medications mentioned in this lesson are not approved by the FDA for the treatment of depression, which include:
alprazolam, aripiprazole, buspirone, ketamine, lithium, L-methyfolate, lurasidone, milnacipran,
modafinil, olanzapine, pindolol, psychostimulants, and quetiapine.
Aripiprazole and quetiapine are approved as adjuncts to antidepressants; and lurasidone is approved for bipolar depression.
No commercial support was used in the development of this CME lesson.

KEY WORDS: Major Depression • Augmentation • Response • Placebo • Pharmacology
LEARNING OBJECTIVES: This lesson will enable clinicians to: (1) understand that depression is the most common
psychiatric disease; (2) review first-line antidepressants for treating depressive episodes in major depressive disorder; (3) discuss
augmentation strategies for treating depression, and (5) utilize new treatment options for treating depression.

LESSON ABSTRACT: According to the World Health Organization, unipolar depression was the third most important
cause of disease worldwide in 2004. Unipolar depression was in “eighth place in low-income countries, but at first place in
middle- and high-income countries.”1 Despite it being such a common disorder, treatment options are not able to cure the
disease completely, and there are numerous unmet needs in the treatment of depression. In this continuing medical education
lesson, we will review the treatment options available to treat depression, describe unmet needs, recommend augmentation
strategies, and discuss new treatment options.

COMPETENCY AREAS: This lesson addresses the gap in knowledge of evidence-based practices for the treatment of
depression, including imminent and expert-based treatment options.

159

L003333 : An Update on New Medications for the Treatment of Major Depressive Disorder

Depression
According to the World Health Organization (WHO),
major depressive disorder (MDD) was the third most
important cause of disease burden worldwide in 2004.
Unipolar depression was in “eighth place in low-income
countries, but at first place in middle- and high-income
countries.”1 In a nationally representative face-to-face
household survey, 6.7% of adults in the United States
(US) experienced a major depressive episode in the
past 12 months.2 Significantly greater percentages of
lifetime major depression have been reported among
women (11.7%) than men (5.6%).3 Examining ethnic
differences reveals lifetime percentages of MDD of 6.5%
among Caucasians, 4.6% among African Americans, and
5.2% among Hispanics.4 According to the WHO, more
than 350 million people of all ages suffer from MDD
globally, and about 20 million of those live in the US.
Despite its prevalence and disease burden, treatment
options are not curative, and there remain numerous
unmet needs with respect to therapies, despite an abundance of antidepressant drug classes with varied receptor
profiles. While its use has diminished in recent years in
the US5 electroconvulsive therapy (ECT) is still considered
a more potent and rapid option for treating acute depressive episodes in medication-refractory patients.
The word placebo is derived from the Latin word
placere, which literally means “to please.”6,7 As MDD is
characterized by fluctuations in its course, spontaneous
improvements, and features “distress” as a key symptom,
it is not surprising that it is also a placebo-responsive
condition.8 The mean response rates for placebo in
antidepressant clinical trials ranges between 30% and
40%, 9,10 with a notable upward trend in placebo response
over the past several decades. Accordingly, across Phase
III registration trials performed for FDA approval, the
overall effect size for the acute efficacy of antidepressant
medications compared to placebo is relatively modest.6,10
While few would argue that antidepressants are beneficial in treating moderate to severe depression, arguments
have been made for treating mild depression with antidepressants.11 In an article published in the Journal of the
American Medical Association (JAMA)12 by Fournier et
al., the magnitude of benefit of antidepressant medication compared with placebo increases with the severity
of depression symptoms and may be minimal or nonexistent in patients with mild or moderate symptoms.
160

For patients with very severe depression, the benefit of
medications over placebo was found to be substantial.

What Should Be Used as a
First-line Treatment of Depression?
Antidepressant medication has been shown to be superior to placebo in thousands of controlled clinical trials
over the past five decades.13,14 The percentage of persons
treated with antidepressant drugs in the US increased
from 5.8% to 10.1% between 1996 and 2005; 11%–
13% of adults in the US now take these medications.15
The rate of antidepressant use increased for anxiety and
adjustment disorders in addition to depressive disorders.15 Increasing use of these medications corresponded
with decreasing rates of counseling and psychotherapy.
Of note, antidepressants are about twice as likely to
be prescribed by primary care providers (PCP) than
psychiatrists. Most clinicians will agree that selective
serotonin reuptake inhibitors (SSRIs) are the firstline treatment for depression today. While this may
be true for PCPs, most psychiatrists will also use selective
norepinephrine reuptake inhibitors (SNRIs) or bupropion
(Wellbutrin, Zyban, Aplenzin) as first-line agents. In some
cases, even atypical antidepressants such as mirtazapine
(Remeron, Remeron soltab) are used as first-line treatments by mental health providers. When choosing an
antidepressant, certain things are important to consider,
such as personal and family treatment history, ease of
use, tolerability and safety profile, and cost. The SSRIs
have effectively replaced the tricyclic antidepressants
over the past two decades because of better tolerability,
convenience, and safety. All the SSRIs are now available
as generics, with the exception of vilazodone (Viibryd).
It is important to consider that SSRIs are not interchangeable and there are tolerability, safety, and possible efficacy differences within this class. With the
recent change in FDA labeling of citalopram (Celexa;
QTc warning for doses over 40 mg), there has been
a new concern about its usage, especially by PCPs.
Usage of paroxetine (Paxil) has dropped in females
of reproductive age due to its warning about heart
defects in pregnancy and the change in its FDA pregnancy risk category to D.
It is not easy to track prescription data trends, but
IMS Health is a leading source of prescribing information of interest to clinicians, insurance payers, and

L003333 : An Update on New Medications for the Treatment of Major Depressive Disorder

policy-makers. This company draws information from
100,000 suppliers and includes insights from more than
45+ billion healthcare transactions processed annually.
According to IMS Health National Prescription Audits,
in 2009, over 469 million mental health-related prescriptions were written in the US, which increased to
519 million in 2013. Of these prescriptions, alprazolam
(Niravam, Xanax) was the top psychiatric drug prescribed in the US with 45.3 million scripts written in
2009 and 49.6 million scripts written in 2013. Most of
these scripts were written by non-psychiatrists. Sertraline
(Zoloft), which became a generic medication in the US
in June 2006, topped all antidepressant prescriptions
with 34.8 million scripts written in 2009 and 41.7 million scripts written in 2013. Citalopram was the second
most prescribed, with 27.3 million scripts written in
2009 and 39.5 million written in 2013 (even though we
would anticipate reductions in its use following the 2012
FDA advisory). While the complete 2013 list was not
available to the author, the top prescriptions for antidepressant medications in 2009 were the SSRIs escitalopram
(Lexapro) and fluoxetine (Prozac), the SNRIs venlafaxine
(Effexor) and duloxetine (Cymbalta), and the atypical
antidepressants trazodone (Oleptro) and bupropion. As
suggested by this data, psychiatrists are increasingly prescribing SNRIs as first-line treatments, perhaps due to
the common perception that antidepressants that modulate norepinephrine and serotonin directly will be more
effective than SSRIs by having greater effects on recovery
time, remission rate, and somatic symptoms.

New Antidepressants Since 2011
Three new antidepressant medications have come to the
U.S. market since 2011: vilazodone (Viibryd, 2011),
levomilnacipran (Fetzima, 2013), and vortioxetine (Brintellix, 2013). Vilazodone has a unique mode of action
as it selectively inhibits serotonin reuptake and partially
agonizes serotonin 5-HT1A receptors. It binds with high
affinity to the human serotonin (5-HT) and norepinephrine (NE) transporters (Ki = 11 and 91 nM, respectively)
and potently inhibits 5-HT and NE reuptake (IC50 =
16–19 and 11 nM, respectively). Vilazodone lacks significant affinity for any other receptors, ion channels,
or transporters tested in vitro, including serotonergic
(5HT1-7), α- and β- adrenergic, muscarinic, or histaminergic receptors, and Ca2+, Na+, K+, or Cl- channels.

Vilazodone does not inhibit monoamine oxidase (MAO).
A 3-step dose titration over several weeks is recommended
to enhance tolerability and minimize gastrointestinal side
effects (10 mg for one week, 20 mg for one week, and
then 40 mg). Although the manufacturers of vilazodone
report that the drug has a low incidence of sexual side
effects, T Laughren et al. in Journal of Clinical Psychiatry16
reported in 2011 that there is no difference in its safety
profile, including the sexual side effects from SSRIs.
Levomilnacipran is the levo enantiomer of racemic
milnacipran (Savella), and is another addition to the
SNRI class, which includes venlafaxine and venlafaxine
XR, duloxetine, and desvenlafaxine (Pristiq). It should be
noted that milnacipran is approved as an antidepressant
in Europe, but in the US, has only received regulatory
approval for the treatment of fibromyalgia.
Vortioxetine has multiple mechanisms related to
5HT: it selectively inhibits serotonin reuptake, antagonizes serotonin 5-HT3 receptors, and agonizes serotonin
5-HT1A receptors. Vortioxetine was developed as one
of a series of compounds developed from halogenated
benzenes and was intended to have combined effects on
multiple 5-HT receptors and on the serotonin transporter. It has been shown in recombinant cell lines to
combine 5-HT3 and 5-HT7 receptor antagonism,
5-HT1B receptor partial agonism, 5-HT1A receptor
agonism, and serotonin transporter inhibition. It has
an elimination half-life of over 66 hours, and data supports its efficacy in individuals with late-life depression,
according to its studies on people up to 88 years of age.
The short-term antidepressant efficacy of vortioxetine in
patients aged 18 to 75 years was demonstrated in five 6
to 8-week, placebo-controlled studies, whereas one study
showed efficacy between the ages of 64–88.
Bupropion hydrochloride came back on the market as an extended release Forfivo XL 450 mg tablet in
2012; however, this formulation does not provide any
therapeutic benefit over existing formulations. Bupropion hydrobromide (an alternative salt to the conventional hydrochloride) was introduced and is available
as Aplenzin tablets in 174 mg, 348 mg, and 522 mg
doses. Generic Budeprion was withdrawn in 2012 by
FDA after a head to head study found that this drug is
not equivalent to the brand name product. Venlafaxine
modified release or extended release 225 mg has also
been available in a single-tablet formulation for the last
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L003333 : An Update on New Medications for the Treatment of Major Depressive Disorder

several years. Finally, trazodone, was reformulated as a
once a day extended release antidepressant in 150 mg
and 300 mg doses, but prescription data doesn’t show
many prescriptions of this agent, perhaps due to its cost
of about $175 for a month’s supply and the availability
of generic trazodone.
Table 1:
Antidepressant Medications Within This Lesson
Generic

Trade Name

Alprazolam

Niravam, Xanax

Aripiprazole

Abilify

Bupropion

Wellbutrin, Zyban, Aplenzin

Citalopram

Celexa

Desvenlafaxine

Pristiq

Duloxetine

Cymbalta

Escitalopram

Lexapro

Fluoxetine

Prozac

Ketamine

—

Levomilnacipran

Fetzima

L-methylfolate

Deplin

Lurasidone

Latuda

Milnacipran

Savella

Mirtazapine

Remeron, Remeron soltab

Olanzapine

Zyprexa

Paroxetine

Paxil

S-adenosyl-methionine

SAMe

Sertraline

Zoloft

Trazodone

Oleptro

Venlafaxine

Effexor

Vilazodone

Viibryd

Vortioxetine

Brintellix

162

Augmentation Strategies for
Treating Depression
Treatment-resistant depression (TRD) refers to depression
with inadequate clinical response after taking a therapeutic dose of antidepressant therapy for an adequate duration (generally 6–8 weeks). Traditionally, the concept of
treatment resistance has focused on non-response (i.e.,
patients who do not experience at least a 50% reduction of symptoms). However, inadequate response is
increasingly viewed as a lack of symptom remission.17,18
It is increasingly common to use adjunctive medications
while treating depression, especially when adequate
results are not achieved by monotherapy.
Numerous drug combinations have been used as
augmentation strategies for difficult-to-treat depression.
SSRIs have been combined with bupropion, tricyclics, and mirtazapine. In the past when SNRI’s were
not available, clinicians used to combine desipramine
(Norpramin) with fluoxetine to make their own SNRI.
They would use fluoxetine in the daytime and low-dose
desipramine at night. The other common combinations
for augmentation are with venlafaxine. It has been
commonly combined with mirtazapine and also with
bupropion. Some have used all three, i.e., venlafaxine,
bupropion, and mirtazapine together and achieved
good results. It should be noted that the Food and Drug
Administration (FDA) has not approved any traditional
antidepressant medication for augmentation, and only
mirtazapine has two positive studies on its augmentation
effects.
Atypical antipsychotics are also used extensively for
augmentation purposes. Aripiprazole (Abilify) and
quetiapine XR are FDA-approved as adjunctive treatments for patients who have inadequately responded
to antidepressant monotherapy. Olanzapine (Zyprexa),
in combination with fluoxetine, is FDA-approved for
TRD as well as bipolar depression; in addition, quetiapine and quetiapine XR and lurasidone (Latuda)
are also FDA-approved to treat bipolar depression as
monotherapy.
The efficacy of lithium as an augmenting agent
for depression dates back to the 1980s when lithium was typically tested at divided doses of 600 mg/
day. Improvement of depression resistant to tricyclic

L003333 : An Update on New Medications for the Treatment of Major Depressive Disorder

antidepressants (TCAs) has usually followed. Lithium has
been tested for antidepressant augmentation in 11 double-blind placebo-controlled trials.19-39 A meta-analysis
performed by Bauer and Dopfmer40 revealed that the
lithium-augmentation group displayed a 45% response
rate compared with 18% in the placebo group. Lithium
augmentation has not been particularly effective when
added to SSRIs or SNRIs.36,40,42
Augmentation with thyroid hormone,43 buspirone,44
pindolol,45 psychostimulants,46-52 and modafinil53 has
been common clinical practice. Recently, with the
marketing of the folate supplement, usage of folate has
increased, especially methyltetrahydrofolate and S-adenosylmethionine (SAMe), which might have antidepressant
effects.54-55 An open-label trial of methyfolate (up to 30
mg/day) in SSRI-refractory patients suggested its usefulness as an adjunct.56 A randomized trial of 127 patients
that compared 0.5 mg/day of folic acid and fluoxetine
to fluoxetine and a placebo found that depressive symptoms improved significantly better in the folate group
in women but not in men.57 Recent open-label studies
report potentiation effects of SAMe as an augmenting
agent in SSRI-refractory patients with MDD.58-59
L-methylfolate (Deplin) is approved by the FDA as a
medicinal food for patients with an inadequate response
to antidepressants and low RBC folate.

conclusion. Ketamine has demonstrated efficacy and
safety as a rapidly-acting antidepressant when administered intravenously. However, the antidepressant effect
is time-limited, typically lasting between a week and a
month. The critical next step in future research will be to
determine the best strategy for maintenance of efficacy.
This will require experimentation with varying multiple
infusion schedules and different methods of administering ketamine in an attempt to prolong the antidepressant
effects and minimize dissociative or potential addictive
side effects. Multiple options to prolong the antidepressant effects of ketamine have been proposed. Although
ketamine does have significant abuse potential, the small
doses used to treat bipolar and unipolar depression have
not demonstrated negative effects in study participants
so far. This promising treatment, when used carefully
and at low doses, has great potential as a rapidly-acting
antidepressant. However, essential information on safety
and efficacy in long-term use, which is necessary to
justify these alternatives as viable clinical treatments,
are currently insufficient for ketamine and completely
lacking for the other glutamatergic compounds. Further
research can help to elucidate whether these treatment
options are effective.60

The Role of Ketamine

Depression can be a very devastating and crippling disease, and in most cases complete remission is not possible. While numerous medicinal options are available,
monotherapy may not always be sufficient, and combinations are used in these cases. In the last decade, no new
breakthrough treatments have made it to the market, and
the bulk of the treatment options depend on SSRI and
SNRI-related drugs. Further research is needed on drugs
that target glutamate, especially ketamine.

Antidepressant treatments that target the glutamate
system hold high promise as novel, efficacious, and
rapidly-acting treatments for MDD. Ketamine, a
glutamate N-methyl-D-aspartate (NMDA) receptor
antagonist, has shown rapid antidepressant effects,
but small study groups and inadequate control conditions in prior studies have precluded a definitive

Conclusion

About the Faculty
Asim A. Shah, MD: Dr. Shah is Associate Professor, Menninger Department of Psychiatry, Baylor College of Medicine, Houston,
TX; and Chief of Psychiatry for Ben Taub Hospital and Harris Health System.
Sanjay J. Mathew, MD: Dr. Mathew is Associate Professor, Menninger Department of Psychiatry, Baylor College of Medicine,
Houston, TX.

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40. Bauer M, Dopfmer S. Lithium augmentation in treatment-resistant depression: meta-analysis of placebo-controlled studies. J Clin Psychopharmacol. 1999;19:427–434.
41. Fava M, Rosenbaum JF, McGrath PJ, Stewart JW, Amsterdam JD, Quitkin FM. Lithium and tricyclic augmentation of fluoxetine treatment for resistant major depression:
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42. Fava M, Alpert J, Nierenberg A et al. Double-blind study of high-dose fluoxetine versus lithium or desipramine augmentation of fluoxetine in partial responders and
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44. Blier P, Ward NM. Is there a role for 5-HT1A agonists in the treatment of depression? Biological Psychiatry. 2003;53:193–203.
45. Ballesteros J, Callado LF. Effectiveness of pindolol plus serotonin uptake inhibitors in depression: a meta-analysis of early and late outcomes from randomised controlled
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46. Fawcett J, Kravitz HM, Zajecka JM, Schaff MR. CNS stimulant potentiation of monoamine oxidase inhibitors in treatment-refractory depression. J Clin Psychopharmacol.
1991;11:127–132.
47. Feighner JP, Herbstein J, Damlouji N. Combined MAOI, TCA, and direct stimulant therapy of treatment-resistant depression. Journal of Clinical Psychiatry.
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48. Linet LS. Treatment of a refractory depression with a combination of fluoxetine and d-amphetamine. Am J Psychiatry. 1989;146:803–804.
49. Masand PS, Anand VS, Tanquary JF. Psychostimulant augmentation of second generation antidepressants: a case series. Depress Anxiety. 1998;7:89–91.
50. Metz A, Shader RI. Combination of fluoxetine with pemoline in the treatment of major depressive disorder. Int Clin Psychopharmacol. 1991;6:93–96.
51. Stoll AL, Pillay SS, Diamond L, Workum SB, Cole JO. Methylphenidate augmentation of serotonin selective reuptake inhibitors: a case series. Journal of Clinical Psychiatry.
1996;57:72–76.
52. Wharton RN, Perel JM, Dayton PG, Malitz S. A potential clinical use for methylphenidate with tricyclic antidepressants. Am J Psychiatry. 1971;127:1619–1625.
53. Menza MA, Kaufman KR, Castellanos A. Modafinil augmentation of antidepressant treatment in depression. Journal of Clinical Psychiatry. 2000;61:378–381.
54. Abalan F. Primer in folic acid: folates and neuropsychiatry. Nutrition. 1999;15:595–598.
55. Alpert JE, Mischoulon D, Nierenberg AA, Fava M. Nutrition and depression: focus on folate. Nutrition. 2000;16:544–546.
56. Alpert JE, Mischoulon D, Rubenstein GE, Bottonari K, Nierenberg AA, Fava M. Folinic acid (Leucovorin) as an adjunctive treatment for SSRI-refractory depression. Ann
Clin Psychiatry. 2002;14:33–38.
57. Coppen A, Bailey J. Enhancement of the antidepressant action of fluoxetine by folic acid: a randomised, placebo controlled trial. J Affect Disord. 2000;60:121–130.
58. Rosenbaum JF, Fava M, Falk WE, Pollack MH, Cohen LS, Cohen BM, Zubenko GS. The antidepressant potential of oral S-adenosyl-l-methionine. Acta Psychiatrica
Scandinavica. 1990;81:432–436.
59 Alpert JE, Papakostas G, Mischoulon D et al. S-adenosyl-L-methionine (SAMe) as an adjunct for resistant major depressive disorder: an open trial following partial or
nonresponse to selective serotonin reuptake inhibitors or venlafaxine. J Clin Psychopharmacol. 2004;24:661–664.
60. Murrough JW, Iosifescu DV, Chang LC, Al Jurdi RK, Green CE, Perez AM, et al. “Antidepressant efficacy of ketamine in treatment-resistant major depression: a two-site
randomized controlled trial.” Am J Psychiatry. 2013;1;170(10):1134-42. doi:10.1176/appi.ajp. 2013.13030392.

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L003333 : An Update on New Medications for the Treatment of Major Depressive Disorder

L003333

Multiple-Choice Questions
41. According to the World Health Organization (WHO), major depressive disorder (MDD) was the
most important cause of disease burden worldwide in 2004.
A. First
B. Third
C. Fourth
D. Tenth

42. The mean response rates for placebo in antidepressant clinical trials range between:
A. 30% to 40%
B. 10% to 20%
C. 50%
D. 0% to 5%

43. The most common antidepressant medications used are:
A. Selective norepinephrine reuptake inhibitors
B. Selective serotonin reuptake inhibitors
C. Tricyclic antidepressants
D. Monoamine oxidase inhibitors

44. Ketamine is a:
A. GABA antagonist
B. NMDA receptor antagonist
C. Selective norepinephrine reuptake inhibitors
D. Opioid antagonist

167

Best Practices in CME
An Update on New Medications
for the Treatment of Major Depressive Disorder
By Asim A. Shah, MD; and Sanjay J. Mathew, MD
ID#: L003333

This valuable take-home reference translates evidence-based, continuing medical education
research and theory, acquired from reading the associated CME lesson, into a stepwise
approach that reviews key learning points for easy assimilation into your armamentarium
of knowledge and daily practice.

CME Lesson Overview
The information in this lesson will be helpful to general practitioners, psychiatrists, and family physicians who
require information on treating patients with depression by using antidepressant as monotherapy and using
some adjunctive agents. According to the World Health Organization, major depressive disorder (MDD) was the
third most important cause of disease burden worldwide in 2004. Unipolar depression was in “eighth place in
low-income countries, but at first place in middle- and high-income countries.”

Key Point 1: Prevalence of the Disease
Depression affects more than 20 million
people in United States. Primary care physicians (PCPs) are potential gatekeepers and
thus, should understand the disease and
start early treatment. This lesson will help
them to comfortably start treatment with
antidepressants.

Key Point 2: Meeting Unmet Needs
In spite of depression being such a common
disorder, treatment options are not able
to cure the disease completely, and there
are numerous unmet patient needs. Available options include medications, psychotherapy, ECT,TMS, etc.

Key Point 3: What Should be Used as the
First-line Treatment of Depression?
Antidepressant medication has been shown
to be superior to placebo in thousands of
controlled clinical trials over the past five
decades.The most common first-line treatment of depression includes SSRIs such as:
sertraline, fluoxetine, paroxetine, citalopram, and escitalopram.

Key Point 4: New Options Available
This lesson discusses the direction of
depression treatment whether it is ketamine or glutamate receptors and the
newer treatment options that are being
investigated.

The information presented herein is based upon the content in the associated CME lesson. If you have comments or feedback about this page,
please send your feedback via email to: [email protected] and reference the ID number under the title to which you are referring.
We will review your commentary, which may be used for publication.
The material in this journal is not a substitute for seeking the attention of a licensed health or medical clinician. These materials were created for professional education
purposes only and are not the express opinion of The Hatherleigh Company, Ltd.

Notes

L003334

Postpartum Depression Identification,
Referral, and Treatment among Diverse
Racial and Ethnic Groups
Deepika Goyal, PhD, FNP; Bindu Garapaty, PsyD;
and Nancy W. Green, DNP, FNP, CNM, CNL
No commercial support was used in the development of this CME lesson.

KEY WORDS: Postpartum Depression • Asian American • African American • Hispanic • Latina
LEARNING OBJECTIVES: This lesson will review postpartum depression among diverse populations, including African
American, Asian American, and Hispanic/Latina women. Cultural factors, mental health help-seeking behavior, identification,
and treatment will be explored. Upon completion of this lesson, clinicians will be better informed to (1) describe cultural factors related to postpartum depression health and help seeking among diverse populations, (2) identify available screening tools
for postpartum depression assessment among diverse populations, and (3) describe current referral and treatment guidelines for
postpartum depression.

LESSON ABSTRACT: Untreated postpartum depression (PPD) poses a threat to the maternal-child bond and the well-being
of the entire family. With timely identification, women from diverse racial and ethnic backgrounds are easily treated, including
those of African American, Asian American, and Hispanic/Latina descent, who are less likely to self-report depressive symptoms,
thus delaying treatment. This lesson examines specific cultural factors and mental health help-seeking behaviors among these
culturally diverse populations in an effort to improve PPD identification and treatment. Evidence-based PPD screening questionnaires and treatment options will also be discussed.
COMPETENCY AREAS: This lesson helps clinicians to provide better patient-centered care to women by helping them
identify, respect, and care about patients’ differences, values, preferences, and expressed needs; relieve pain and suffering; coordinate continuous care; listen to, clearly inform, communicate with, and educate patients; share decision making and management; and continuously advocate disease prevention, wellness, and promotion of healthy lifestyles, including a focus on population health.

171

L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

Introduction
Societal expectations often dictate that the birth of a new
baby should be a time of great joy and excitement for
new parents. However, the experiences of some parents
may not conform to such societal expectations. Parents
are often blindsided by the development of postpartum
mood disorders, including postpartum baby or maternity blues, postpartum depression (PPD), and postpartum
psychosis. Each of these affective mood disorders has a
unique presentation, a specific constellation of symptoms, and suggested treatment methodologies.
Of the three postpartum affective mood disorders,
maternity blues is the most common, affecting up to
84% of new mothers.1,2 Self-limiting in nature, the
symptoms including tearfulness, anxiety, and irritability,
present within the first 4–7 days postpartum and often
resolve without treatment.1 Symptoms that persist longer than 2 weeks or increase in severity are red flags and
reasons for prompt referral and further evaluation.
The rarest of the postpartum mood disorders,
postpartum psychosis, affects 1/1000 women.3 Symptoms include mood fluctuation, delusions, auditory
hallucinations, and insomnia, which present rapidly
after the infant’s birth.4 Postpartum psychosis requires
immediate inpatient psychiatric evaluation and treatment because this disorder may lead to suicide and
infanticide.5
Defined as a depressive episode occurring between
2 weeks and 12 months after childbirth, PPD affects 1
in 7 new mothers.6 The multiple risks to the mother,
infant, and whole family have been well documented.
When PPD is left untreated, the more serious risks
include disruption of the mother-infant bond,7 child
maltreatment,8 and infanticide.5 Although all postpartum mood disorders require diligent clinical assessment
and intervention, the focus of this lesson is on identifying and treating PPD.
According to 2013 United States (U.S.) Census
data,9 63% of the U.S. population self-identifies as white,
17% as Hispanic or Latino, 13% as African American,
and 5.3% as Asian American. Given these statistics, it
is not surprising that the majority of PPD research in
the United States to date has focused on PPD among
Caucasian women, with a lesser focus on minority
women, such as African American, Asian American,
172

and Hispanic/Latino women. In order for clinicians
to provide culturally sensitive care for all women, it is
imperative to understand the nuances related to mental
health help-seeking behavior, as well as the identification and treatment of PPD in diverse racial and ethnic
groups. The following sections will discuss childbearing
among African American, Asian American, and Hispanic/Latino populations regarding the following: (1)
cultural factors influencing mental health help-seeking
behavior, (2) PPD screening tools for use in culturally
diverse populations, (3) DSM-V guidelines and when to
refer patients, and (4) PPD treatment among culturally
diverse populations.

Cultural Factors and Mental
Health Help-Seeking
Discussing and recognizing the importance of specific
cultural nuances and practices is imperative for understanding effective treatment interventions. Terms such as
“normal” are often defined by certain cultural assumptions. However, these cultural assumptions mirror the
values of the mainstream culture.10 An ethnocentric treatment model can serve as a barrier to understanding the
experiences of people in different ethnic demographics.
Cultural understanding is the first step toward providing
effective interventions in various ethnic groups. Historical knowledge of ethnic groups’ struggles, challenges,
and cultural definitions are significant factors in working
successfully with ethnic minority persons.10 The next step
involves an increased level of awareness of the clinician’s
stereotypes and biases toward motherhood and mental
health. For example, there is distrust in the African
American community of healthcare providers in general
because of limited cultural exposure to mental health services. Therefore, when working with the African American population, it is important to enlist the support of
the maternal figurehead, which may include the help of
faith leaders, as well as informal support networks and
community organizations, in treatment interventions.11
The Model Minority, a term created by Petersen
(1966),12 was used to describe the success of ethnic
minorities despite their marginalization, which led to the
myth that potentially ALL minorities could be successful. This myth has served as a barrier and has contributed
to the lack of the provider’s cultural understanding of the

L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

Table 1:
Shifting the Multicultural Lens
African American

Asian

Hispanic

Black

Korean, Japanese, Chinese,
Indian, Vietnamese, Filipino

Chicana/Latina

Psychosocial structure

collective family structure

collective family structure, value
of time

collective family structure

Family hierarchy and values

women at the “center”
of the household

patriarchal, education is
important, plays a role, respect
for elders is key

Cultural and familial history is
important, mother plays a large
role in family, religion, enjoy
present activities, respect for
elderly, parents, and males

Ideologies of
health and healing

cultural mistrust of healthcare
providers’ racism and
microaggressions

alternative practices,
yoga, meditation,
karmic philosophies

indigenous healing practices,
feelings before facts

Emotional support

emotional support may
be provided by
community organizations

keep feelings private,
work hard, stay focused

folk healing practices, spiritual
healers

Adapted from: Ponterotto et al, Handbook of Multicultural Counseling

cultural traditions, practices, and behaviors that define
healthy behavior, which could affect the quality of care.
Moreover, the levels of acculturation and assimilation can
affect the degree of stigma associated with help-seeking
behaviors. Because of the diversity represented, clinicians
can benefit from having a general understanding of the
culture and creating a relationship with the patient that
ensures a safe environment for asking questions and sharing information.

Postpartum Depression among
Diverse Race and Ethnic Groups
Among diverse racial and ethnic groups, cultural factors, societal beliefs, and stigma contribute to maternal
mental health help-seeking behavior. An additional barrier, social shame, may affect those who self-identify as
needing help because of the perception that depression
is caused by personal weakness and is a “family problem”
rather than an illness.13,14 Although minority women
are not well represented in the literature as Caucasians
are, the findings of existing research on minority women
and PPD are alarming. Similar across all three racial
and ethnic groups, the findings indicate that minority
women are at a greater risk for developing PPD,
compared with Caucasian women, with rates up to

60%.15,16,17 Common barriers to mental health treatment
and care across all three groups include stigma,13,18-20
access to mental health care,21 and several barriers related
to socioeconomic status, finances, transportation, and
childcare issues.21,22
African American women may shy away from
actively seeking mental health care because the disclosure
of mental health symptoms may be perceived as a sign of
weakness.23 Additionally, African American women are
socialized to handle stressful events, as illustrated in the
cultural theme of “dealing with it” and staying strong.24
African American women are more likely to delay
seeking professional help, and they first try to manage
depressive symptoms on their own, relying on their faith
and upholding the image of “being strong.”24 They are
also more likely to rely on their support network (family,
friends) and spiritual guidance from clergy.11
The U.S. Asian population, including persons of
Chinese, Filipino, Indian, Japanese, Korean, and Vietnamese descent, is expected to increase to 34 million by
2050.25 As community members, Asian Americans are
less self-oriented and more family-oriented compared
with the Western perspective of individual autonomy.26
Goyal, Wang, Shen, Wong, and Palaniappan (2012)
found that Asian American women were significantly
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less likely to be diagnosed with PPD, compared with
Caucasian women.27
The term “Hispanic” includes individuals whose
ancestry originates in Mexico, Puerto Rico, Cuba, El Salvador, the Dominican Republic, and other Latin American countries. Similar to African American women, Hispanic women also seek advice from their family, friends,
and informal sources before seeking professional medical
care.19,28,29 Moreover, when Hispanic women do seek care
for PPD, they are less likely to refill their prescriptions
or receive follow-up treatment for PPD, compared with
non-Hispanic women.30

Postpartum Depression:
Screening and Referral
The effect of untreated PPD on the growth, development, and physical health of infants and children has
been well documented.31,32 Screening new mothers for
depressive symptoms has been shown to be cost-effective
in providing timely referral, diagnosis, and treatment,
all of which minimize the long-term effects of delayed/
undetected PPD.33 Given the detrimental effects of

untreated PPD on the infant, the American Academy
of Pediatrics (AAP) recommends universal screening
using the Edinburgh Postnatal Depression Scale (EPDS)
at the infant’s 1-, 2-, and 4-month visits.34 The EPDS
is the most often used and cited PPD screening questionnaire, worldwide. More recently, the Patient Health
Questionnaire-9 (PHQ-9)35 has been strongly suggested
as another option for PPD screening since it is the
most widely used depression questionnaire by mental
health and primary health-care providers. The use of a
depression questionnaire, familiar to all disciplines, will
likely decrease barriers to screening. The EPDS and the
PHQ-9 assess the severity of depressive symptoms,
are self-report Likert questionnaires, and are free for
use in the public domain. They are available and validated for use in several languages, written at the thirdgrade reading level (below the recommended sixth-grade
reading level), and are easily completed in 5-10 minutes
(see Table 2).
The 10-item EPDS has been validated for use in
pregnant and postpartum women.36 Scores can range
between 0 and 27; scores ≥10 indicate a high risk of
developing depression, warranting prompt referral for

Table 2:
Commonly Used Postpartum Depression Questionnaires
Characteristics

EPDS

PHQ-9

General purpose

designed specifically for pregnant and
postpartum women

designed for use in all adults in primary care
settings

Number of items

10 items

9 items

Symptom timeframe

previous week

previous 2 weeks

Validated for pregnant and postpartum
populations

yes, both

yes, both

Range of scores

0-30

0-27

Translated in languages other than English

27

27

Cut off scores

>10

>9

Screens for suicidal thought

yes

yes

Screens for anxiety

yes

yes

EPDS = Edinburgh Postnatal Depression Scale; PHQ-9 = Patient Health Questionnaire-9

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L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

further evaluation and treatment.37 The 9-item PHQ-9
has also been validated for use in pregnant and postpartum populations.38 The EPDS and PHQ-9 are validated for depression screening and are not diagnostic.
Therefore, immediate referral to a mental health
professional is strongly advised for the diagnosis
and treatment of any patient scoring at or above the
established cut-off points and those with suicidal or
homicidal ideation.
The Institute of Medicine39 and Mental Health
America (MHA)40 both suggest that depression screening is the most effective in a setting where immediate
professional mental health follow-up is available (e.g.,
psychologists, psychiatrists, and counseling resources).
This may include models for care delivery, such as colocated mental health services within primary care settings
or telemental health services for rural areas.
Although the EPDS and the PHQ-9 are recommended as first-line screening for PPD, they may not
always be feasible. For example, in ethnic populations or
populations with low health literacy, clinician-administered screening or using a visual scale may be preferred.41
Alternatively, the 2-item Patient Health Questionnaire-2
(PHQ-2)42,43,44 or the 2-item EPDS,44 similar to the
PHQ-2, may also be used. These questionnaires screen
for general depressive symptoms. They can be administered verbally, and a positive screen is determined by a
“yes” answer to either of the following questions:
1. Over the past 2 weeks, have you ever felt
down, depressed, or hopeless? Hopelessness
could be an indication of suicidal ideation, and
the patient should be referred to a psychiatrist.
2. Over the past 2 weeks, have you felt little interest or pleasure in doing things? Anhedonia
or loss of pleasure in usual activities is also an
indication of depression, and the patient should
be referred to a psychiatrist.

These 2-item questionnaires have the advantage of
brevity; however, they may have lower validity in detecting depression in diverse populations. This disadvantage
can be mitigated by using a 2-step process in which
screening is first performed with a 2-item questionnaire
followed by the full EPDS or the PHQ-9, based on the
patient’s answers.42

Postpartum Depression Referral
and Treatment
Contrary to the research findings, the American Psychiatric Association’s (APA)45 Diagnostic and Statistical Manual
of Mental Disorders (DSM) maintains that the diagnosis
of PPD is the same as that of major depressive disorder
(MMD), “with postpartum onset defined as the onset
within four weeks of childbirth” (DSM-IV). The new
fifth edition (DSM-5) notes a significant change
from the earlier version45; the DSM-5 now defines
“with peripartum onset” as the most recent episode
of depression occurring during pregnancy, as well as
within the 4 weeks following delivery. Whether the
onset of MMD occurs during or after the pregnancy is
not as critical as the timely referral for further evaluation
and treatment, which is imperative in mitigating the
adverse effects of untreated PPD on the entire family.
Currently, the Structured Clinical Interview (SCID) is
considered the “gold standard” for MMD diagnosis.46
However, the SCID may not always be feasible, and
screening questionnaires such as the EPDS and PHQ-9
provide a relatively quick “snapshot” of the severity of a
patient’s depressive symptoms. Referral for further evaluation and treatment should be made (a) when patients
score at or above the designated cut-off point for each
questionnaire, (b) when suicidal or infanticidal thoughts
are present or verbalized, and (c) whenever the clinician
feels further evaluation is warranted.
Stigma renders mental health treatment among
diverse populations very challenging for clinicians
because although the rate of antidepressant use in the
United States has increased by 400% over the past
20 years,47 Asian Americans, African Americans, and
Hispanic/Latinos are less likely to use or be prescribed
antidepressant drugs, compared with whites.47,48 Similar
findings relate to seeking treatment for mental health in
the form of therapy. The diverse populations discussed in
this lesson are less likely to seek or continue therapy for
mental illness, compared with Caucasians. Primary care
physicians (PCPs) are often the first point of contact
for individuals’ medical needs and may very well be
first to encounter presenting psychiatric symptoms.
The disparity in healthcare among certain ethnic
groups contributes to fewer individuals seeing a PCP
or being diagnosed with PPD. Prescribing clinicians

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L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

should consider the possible need to adjust medication dosages as the metabolic rate and other biological factors may differ between ethnic minority groups
compared with Caucasians.49 Since antidepressant
and therapy-based interventions are common first-line
treatment modalities for PPD, where feasible, clinicians
should consider alternative methods, such as yoga,50,51,52
which has been associated with improved maternal mental health outcomes. Strategies for promoting adequate
sleep53,54 and a robust social support network55 should
also be discussed with patients since the lack of both is
also associated with PPD.

2. The NP must also assess for suicidal or infanticidal ideation.

Case Study 1

4. Since poor sleep is a known risk factor for
developing PPD, the NP should inquire
about Nina’s intake of caffeine or alcohol as
well as use of any over the counter medications or Ayurvedic herbal treatments. The
NP should also include screening for sleep
disturbance, such as the General Sleep Disturbance Scale.56

Nina is a 28-year-old Southeast Asian female
who presents to the clinic 6 weeks after the
uncomplicated vaginal birth of her first baby,
a healthy infant girl. Nina and her husband
migrated to the United States from India 4
years ago after they married. Nina works as a
medical assistant in a doctor’s office; she is on
maternity leave and due back in 2 weeks. She
is breastfeeding and is at the obstetric nurse
practitioner’s office for her 6-week postpartum checkup. When asked how she is feeling,
Nina states that she is having a significant
number of anxious thoughts about going back
to work and that she is having a lot of difficulty sleeping, even when the baby is sleeping.
Further questioning by the nurse practitioner
reveals that Nina is feeling overwhelmed and
isolated because her friends, who she states are
her main support system, are back in India.
Nina states she has few friends here and feels
worried all the time, especially about leaving
her new infant in daycare when she goes back
to work. The postpartum physical exam is
without complications.
What other assessment(s) should the nurse practitioner (NP) perform at this time?
Answers
1. The NP should assess the presence of depressive symptoms using a validated questionnaire, such as the EPDS or PHQ-9*.

176

3.
Although Nina verbalizes no current
thoughts of harm to herself or others, her
EPDS score is 12/30 (cut-off score ≥10),
indicating that she has a high risk of developing PPD. The NP will refer Nina to a
psychiatrist/psychologist for further evaluation and treatment. The NP will also obtain routine lab tests to rule out anemia and
hypothyroidism, which may also contribute
to depressive symptoms.

Case Study 2
Shaundra is a 20-year-old African American
woman who presents to the postpartum clinic for her postpartum check-up at 8 weeks
because she was not able to keep a 6-week
appointment. She had a spontaneous vaginal
birth at 28 weeks gestation because of severe
pre-eclampsia and preterm labor. Her infant
weighed 2 pounds and 11 ounces at birth because of intrauterine growth restriction from
poorly controlled pre-eclampsia. The infant
boy is formula-fed and has been transferred to
a tertiary care center 4 hours from Shaundra’s
home in rural Georgia. He was hospitalized
until 38 days of life and has experienced many
health problems during his neonatal course,
including 2 readmissions to the local hospital
after initial discharge.
Shaundra works at a fast food restaurant, has
a high school education, and is covered by
Medicaid insurance. She lives with her mother, grandmother, and 4 younger siblings. She
has returned to work and has arranged that

L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

her grandmother care for her infant. During
her visit, the certified nurse midwife (CNM) observes that Shaundra’s physical exam and labs
are normal, but when asked about her infant,
she begins to cry. She says that she just simply cannot take care of this baby with all of his
problems and that she wants to run away. The
CNM administers the EPDS. Shaundra scores
16/30. Shaundra denies thoughts of self-harm
or harm to others. She reports that she cannot
focus at work and has had three occupational
injuries since returning to work. The nearest
Medicaid-approved mental health services
provider is an hour away with no appointments available for 8 weeks.
Which of the following are assessments or interventions that may help the CNM care for
Shaundra?
1. Obtain thyroid stimulating hormone (TSH),
Free T4, T3, and complete blood count
(CBC) levels.
2. The CNM should assess for suicidal or infanticidal ideation.

3. The CNM should consult with her supervising physician to develop a treatment and
follow-up plan for Shaundra.
4. An emergency referral for immediate psychiatric evaluation and treatment must be
made since Shaundra has verbalized inability to take care of her infant and wanting to
“run away.”
5. Consider the use of telemental health services
for follow-up psychiatric appointments given Shaundra’s distance from the clinic and
the limited availability of in-person mental
health appointments.
6. Patient health counseling should focus on
self-care, including obtaining daily exercise,
getting enough sleep, and taking prescribed
medications (vitamins). Shaundra should
also be encouraged to enlist the help of her
social support network to lessen her depressive symptoms.
Answer: All of the above.

About the Faculty
Deepika Goyal, PhD, FNP: Dr. Goyal is a Professor of Nursing, College of Applied Sciences and Arts, The Valley Foundation
School of Nursing, San Jose State University, San Jose, CA.
Bindu Garapaty, PsyD: Dr. Garapaty is a leader in the Maternal Child Health arena with more than 10 years of experience
within healthcare and academia.
Nancy W. Green, DNP, FNP, CNM, CNL: Dr. Green is an Assistant Professor of Nursing, School of Nursing and Health
Professions, University of San Francisco, San Francisco, CA.

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54. Goyal D, Gay CL, Lee KA. Patterns of sleep disruption and depressive symptoms in new mothers. [Research Support, N.I.H., Extramural Research Support, Non-U.S.
Gov’t]. The Journal of Perinatal & Neonatal Nursing. 2007;21(2):123-129. doi:10.1097/01. JPN. 0000270629.58746.96
55. Beck CT. Predictors of postpartum depression: An update. Nurs Res. 2001;50(5): 275-285.
56. Lee KA, Gay CL. Can modifications to the bedroom environment improve the sleep of new parents? Two randomized controlled trials. [Randomized Controlled Trial
Research Support, N.I.H., Extramural]. Research in Nursing and Health. 2011; 34(1):7-19. doi:10.1002/ nur.20413

180

L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

L003334 : Postpartum Depression Identification, Referral, and Treatment among Diverse Racial and Ethnic Groups

L003334

L003334

Multiple-Choice Questions

Multiple-Choice Questions

45. Which of the following statements are correct regarding the selection of a postpartum depression
screening tool for diverse populations?

45. Which of the following statements are correct regarding the selection of a postpartum depression
screening tool for diverse populations?

A. Neither the EPDS nor the PHQ9 is validated for use in diverse populations.

A. Neither the EPDS nor the PHQ9 is validated for use in diverse populations.

B. The EPDS and the PHQ9 are validated for use in diverse populations.

B. The EPDS and the PHQ9 are validated for use in diverse populations.

C. The EPDS is validated for use only in postpartum populations.

C. The EPDS is validated for use only in postpartum populations.

D. The PHQ9 is validated for use only in pregnant populations.

D. The PHQ9 is validated for use only in pregnant populations.

46. When should a patient be referred for a further mental health evaluation?

46. When should a patient be referred for a further mental health evaluation?

A. When a patient scores above the established cut-off point on a questionnaire

A. When a patient scores above the established cut-off point on a questionnaire

B. When a patient verbalizes suicidal ideation

B. When a patient verbalizes suicidal ideation

C. When the clinician feels that further evaluation is appropriate

C. When the clinician feels that further evaluation is appropriate

D. All of the above

D. All of the above

47. What cut-off score on the (GLQEXUJK3RVWQDWDO'HSUHVVLRQ6FDOH would prompt you to refer your
patient for further evaluation?

47. What cut-off score on the (GLQEXUJK3RVWQDWDO'HSUHVVLRQ6FDOH would prompt you to refer your
patient for further evaluation?

A. 6

A. 6

B. 4

B. 4

C. 11

C. 11

D. 8

D. 8

:KDWDUHWKHGLDJQRVWLFJXLGHOLQHVIRU33'EDVHGRQWKHQHZ'LDJQRVWLFDQG6WDWLVWLFDO0DQXDO
of Mental Disorders (DSM-5)"'LDJQRVLVVKRXOGEHEDVHGRQZKLFKRIWKHIROORZLQJ"

:KDWDUHWKHGLDJQRVWLFJXLGHOLQHVIRU33'EDVHGRQWKHQHZ'LDJQRVWLFDQG6WDWLVWLFDO0DQXDO
of Mental Disorders (DSM-5)"'LDJQRVLVVKRXOGEHEDVHGRQZKLFKRIWKHIROORZLQJ"

A. Symptom onset within 4 weeks of childbirth

A. Symptom onset within 4 weeks of childbirth

B. Symptom onset during the pregnancy as well as in the 4 weeks following delivery

B. Symptom onset during the pregnancy as well as in the 4 weeks following delivery

C. Symptom onset 18 months after childbirth

C. Symptom onset 18 months after childbirth

D. All of the above

D. All of the above

181

181

Best Practices in CME
Postpartum Depression Identification, Referral, and
Treatment among Diverse Racial and Ethnic Groups
By Deepika Goyal, PhD, FNP; Bindu Garapaty, PsyD;
and Nancy W. Green, DNP, FNP, CNM, CNL
ID#: L003334

This valuable take-home reference translates evidence-based, continuing medical education
research and theory, which is acquired from reading the associated CME lesson, into
a stepwise approach that reviews key learning points for easy assimilation into your
armamentarium of knowledge and daily practice.

CME Lesson Overview
Easily treated with timely identification, women from diverse racial and ethnic backgrounds, including those
of African American, Asian American, and Hispanic/Latino descent, are less likely to self-report depressive
symptoms delaying treatment. This lesson examines specific cultural factors and mental health help-seeking
behaviors among culturally diverse populations in an effort to improve the identification and treatment of
postpartum depression.

Key Point 1: Prevalence of Postpartum
Depression
Minority women are at an increased risk of
developing PPD.

Key Point 2: Barriers to Seeking
Treatment
The common cultural barrier to mentalhealth help-seeking across all three race/
ethnic groups is stigma associated with
mental illness and treatment.

Key Point 3: Cultural Considerations
in Treatment

Key Point 4: The Need for Patient
Education
Screening and education regarding PPD
should occur for all new mothers during
the postpartum period and at all well baby
visits.

Key Point 5: The Role of the Family
Cultural values play a significant role in
access to mental health care, and the entire family should be involved in treatment
decisions.

Clinicians must consider cultural values
versus labeling patients “non-compliant.”

The information presented herein is based upon the content in the associated CME lesson. If you have comments or feedback about this page,
please send your feedback via email to: [email protected] and reference the ID number under the title to which you are referring.
We will review your commentary, which may be used for publication.
The material in this journal is not a substitute for seeking the attention of a licensed health or medical clinician. These materials were created for professional education
purposes only and are not the express opinion of The Hatherleigh Company, Ltd.

Notes

L003335

Sexual Addiction or Hypersexual
Disorder: Clinical Implications for
Assessment and Treatment
Aviv Weinstein, PhD
Medications mentioned in this lesson are not approved by the FDA for the treatment of sexual addiction or hypersexual disorder.
No commercial support was used in the development of this CME lesson.

KEY WORDS: Sexual Addiction • Hypersexual Disorder • Compulsive Sexual Behavior • Impulsivity
LEARNING OBJECTIVES: Clinicians will review recent evidence for the assessment and the psychobiological basis and
treatment of sexual addiction, including diagnosis, comorbidity with other psychiatric disorders, and treatment studies. Instruments for assessing sexual addiction are discussed, as well as data on the neuropsychological and biological basis of this disorder.
LESSON ABSTRACT: Sexual addiction, which is also known as hypersexual disorder, is associated with severe psychosocial
problems and risk-taking behaviors. People who suffer from sexual addiction or hypersexual disorder have reported having obsessive thoughts, fantasies, and problematic behaviors, including excessive masturbation, cybersex, pornography use, sexual behavior with consenting adults, telephone sex, and strip club visitation. Sexual addiction is not included in the Diagnostic and
Statistical Manual of Mental Disorders. Several screening questionnaires have been developed over the years for the diagnosis of
sexual addiction or hypersexual disorder. Prevalence rates of sexual addiction range from 3% to 6%. There is a co-occurrence of
sexual addiction with other addictions and psychiatric disorders such as anxiety disorders, posttraumatic stress disorder (PTSD),
alcohol and drug abuse, pathological gambling, and attention deficit hyperactivity disorder (ADHD). Several treatment studies
have shown the efficacy of the combination of pharmacological treatment with cognitive-behavior therapy.

COMPETENCY AREAS: This lesson addresses the gap in learning in the area of sexual addiction or hypersexual disorder,
including diagnosis, assessment, prevalence, comorbidity, cognitive-behavioral and neurobiological mechanisms, and psychological and pharmacological treatment. Many clinicians lack understanding of how to adequately diagnose and treat sexual addiction or hypersexual disorder, which often goes underreported by patients. Pharmacological treatment with SSRIs together with
cognitive-behavior therapy may be useful for treating sexual addiction. Upon the conclusion of this lesson, readers will have a
better understanding of sexual addiction or hypersexual disorder and its diagnosis and treatment.

185

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

Introduction
History of Sexual Addiction and
Its Treatment:
Sexual addiction, which is also known as hypersexual
disorder, is associated with severe psychosocial problems and risk-taking behaviors.1-3 Various terms have
been used to name the condition, including sexual
compulsivity, sexual impulsivity,4 out-of-control
sexual behavior,5 sexual addiction, and hypersexual
behavior.6-7
In 1812, U.S. physician Benjamin Rush documented
in his book Medical Inquiries and Observations Upon the
Diseases of the Mind the case of a person with “excessive”
sexual appetite which caused him great psychological
distress.8 In 1886, German psychiatrist Dr. Richard von
Krafft-Ebbing argued that “pathological sexuality” is a
psychiatric illness that results in an impulsive series of
sexual enjoyment resulting in legal, moral, and psychological problems.9
In the mid-1970s, British psychologist Dr. Jim Orford
suggested that hypersexuality should be included in the
spectrum of addictive disorders. He argued that hypersexuality is similar to excessive drinking and gambling
in that hypersexuality is an excessive appetitive behavior
that does not have psychoactive drugs as an object.10 He
described the behavior as a maladaptive pattern of use
and impaired control of a behavior that was associated
with adverse consequences.10 Several problems with the
dependence model of sex were discussed by Orford and
Carnes,10-11 notably that it is difficult to separate normal
and abnormal sexual behavior, it is difficult to determine
when loss of control occurs, and it is difficult to assess the
role of culture in this model.
In his 2001 best-selling book, Out of the Shadows:
Understanding Sexual Addiction, Carnes described
sexual addiction as a psychopathological condition of
excessive sexual behavior.12 A distinct approach was proposed by Mick and Hollander, who argued that sexual
addiction can be conceptualized as a disorder on the
impulsive-compulsive spectrum.4 According to this view,
impulsivity and compulsivity coexist. First, an impulsive
component (pleasure, arousal, or gratification) initiates
the cycle, and then a compulsive component leads to the
persistence of the behavior.4
186

Sexual addiction, or hypersexual disorder, is not
recognized as a disorder in the Diagnostic and Statistical Manual of Mental Disorders (DSM). The DSM3-R13 referred to sexual addiction as a sexual disorder “not
otherwise specified.” The two versions of the DSM-4
omitted sexual addiction. However, the Work Group on
Sexual and Gender Identity Disorders proposed diagnostic criteria for hypersexual disorder to be considered for
inclusion in the DSM-5.7 Empirical research on sexual
addiction has increased in recent years,7,14-15 which has
led to considerable interest in developing measures
that assess sexual addiction and hypersexual disorder.16
Recently, the American Psychiatric Association Board of
Trustees rejected several proposals for the new disorder,
and therefore, hypersexual disorder does not appear
in the new DSM-5. Even though clinicians have been
treating the disorder, the Board of Trustees estimated
that there was not enough research to consider adding
the disorder to Section 3 (disorders that require further
research) of the DSM-5.17
Given the variation in definitions, conceptualizations, and assessments of sexual addiction or hypersexual
disorder and its rejection by the DSM-5, the purpose
of the current review is to emphasize the assessment,
diagnosis, clinical, and neurobiological characteristics
of the disorder and to provide clinicians with a detailed
description of treatment options available.

Diagnosis and Assessment Criteria:
In recent years, claims have emerged against the inclusion of the condition in the DSM-5. Authors have
argued that this diagnosis was unnecessary and would
be harmful to patients, whereas others suggested that
the disorder does not exist.18-19 In the 1990s, Goodman
replaced the term “substance” in the DSM-4’s definition
of “substance dependence” with “sexual behavior”20 (see
Table 1).
Kafka21 proposed to use the term “hypersexual
disorder,” and the diagnostic criteria for hypersexual
disorder showed good external validity with measures of impulsivity, emotional dysregulation, and
stress proneness, as well as good internal consistency.
Writing on behalf of the Work Group on Sexual and
Gender Identity Disorders, Kafka21 proposed the
diagnosis of hypersexual disorder (see Table 2). The
diagnosis did not require dependence, tolerance,

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

and withdrawal—Kafka’s criteria incorporated other
key aspects of addiction such as unsuccessful efforts
to cut down, greater use than intended, and serious
social and occupational consequences. Ultimately, the
DSM-5 committee decided that there was not enough
research to include hypersexual disorder as a diagnosis in
the DSM-5.

Assessment of Sexual Addiction
In recent years, research on sexual addiction has
increased, and screening instruments have been developed to diagnose or quantify the disorder.3,22-25 Currently, 22 questionnaires assess sexual addiction. These
questionnaires assess symptoms of sexual addiction and/

Table 1:
Goodman’s Proposed Sexual Addiction Diagnostic Criteria20
A maladaptive pattern of sexual behavior leading to clinically significant impairment or distress as manifested by 3 (or
more) of the following and occurring at any time in the same 12-month period:
1. Tolerance, as defined by either of the following:
(a) A need for a markedly increased amount or intensity of sexual behavior to achieve the desired effect.
(b) Markedly diminished effect with continued involvement in sexual behavior at the same level of intensity.
2. Withdrawal, as manifested by either of the following:
(a) Characteristic psychophysiological withdrawal syndromes of physiologically described changes and/or psychologically described
changes upon discontinuation of the sexual behavior.
(b) The same (or a closely related) sexual behavior is engaged in to relieve or avoid withdrawal symptoms.
3. The sexual behavior is often engaged in over a longer period, in greater quantity, or at a higher level of intensity than was intended.
4. There is a persistent desire or unsuccessful effort to cut down or control the sexual behavior.
5. A great deal of time is spent in activities necessary to prepare for the sexual behavior, to engage in the behavior, or to recover from
its effects.
6. Important social, occupational, or recreational activities are given up or reduced because of the sexual behavior.
7. The sexual behavior continues despite knowledge of a persistent or recurrent physical or psychological problem that is likely to have
been caused or exacerbated by the behavior.

Table 2:
Kafka’s Proposed Hypersexual Disorder Diagnostic Criteria21
A. Over a period of at least 6 consecutive months, recurrent and intense sexual fantasies, sexual urges, or sexual behaviors in association
with 4 or more of the following 5 criteria:
1. Excessive time consumed by sexual fantasies and urges and by planning for and engaging in sexual behavior.
2. Repetitively engaging in these sexual fantasies, urges, and behavior in response to dysphoric mood states (e.g., anxiety, depression,
boredom, irritability).
3. Repetitively engaging in sexual fantasies, urges, or behaviors in response to stressful life events.
4. Repetitive but unsuccessful efforts to control or significantly reduce the sexual fantasies, urges, and behaviors.
5. Repetitively engaging in sexual behaviors while disregarding the risk for physical or emotional harm to self or others.
B. There is clinically significant personal distress or impairment in social occupational or other important areas of functioning associated
with the frequency and intensity of the sexual fantasies, urges, and behaviors.
C. These sexual fantasies, urges, and behaviors are not due to direct physiological effects of exogenous substances (e.g., abuse of drugs or
medications) or to manic episodes.
D. The person is at least 18 years of age.
Specify if: masturbation, pornography, sexual behavior with consenting adults, cybersex, telephone sex, strip clubs.
Specify if in remission: no distress, impairment, or recurring behavior and in an uncontrolled environment, and state duration of remission in
months in a controlled environment.

187

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

or the adverse consequences of the disorder. The psychometric qualities of the existing measures are generally
low, and further validation studies are required. The primary concerns for and limitations regarding the existing
measures include (a) the absence of valid cut-off criteria
to identify sexual addiction; (b) a lack of generalizability
(e.g., some instruments have been used only in very specific samples, such as men who have sex with men); and
(c) variance in reliability, response format (dimensional
versus categorical responses), and factorial structures.3
Carnes created one of the first instruments for assessing sexual addiction—the Sexual Addiction Screening
Test (SAST).26 The SAST is composed of 25 items that
measure symptoms of sexual addiction, mostly geared
toward heterosexual men. The Cronbach’s alpha coefficients for the total score of the SAST range from 0.85 to
0.95. The SAST discriminated between male sex addicts
and non-addicts,26 and it was related to other measures
of sexual addiction.27-28 Carnes has also developed two
other versions: the WSAST (the SAST for women)29 and
the GSAST (the SAST for men who have sex with men
[MSM]).30 A new version of the SAST, the SAST-R,31
was developed, and it applies to heterosexual men and
women and MSM. Recently, Carnes and colleagues also
created the PATHOS, a short instrument that assesses
sexual addiction. The PATHOS has 6 items to preoccupation, shame, treatment-seeking, hurting others, outof-control behavior, and sadness.32
Kalichman and Rompa developed the Sexual Compulsivity Scale (SCS), which is a 10-item questionnaire
that assesses sexual compulsive behavior, sexual preoccupations, and intrusive sexual-related thoughts.33 A
cut-off score of 24 or higher has been used to indicate
problems with sexual addiction. The SCS displays good
psychometric properties with Cronbach’s alpha coefficients ranging from 0.59 to 0.92.26 The SCS has a good
convergent validity and relates to other measures of
sexual addiction.33 The SCS also has good discriminant
validity, and is unrelated to ethnicity,34-35 education, and
income.34 Miner et al reported that the SCS predicted
the practice of engaging in unprotected sex, a large number of sexual partners, the use of cocaine in HIV-positive
men, and high frequency of sex-seeking behavior on the
Internet.36

188

Prevalence Rates
To date, no large epidemiological studies of sexual
addiction have been conducted using standardized diagnostic criteria.7,37 However, some studies have estimated
the prevalence of sexual addiction to be between 3%
and 6% of the general population.38-41 The occurrence
rates of sexual addiction vary in the literature depending
on characteristics examined such as gender, sexual orientation, age, and the diagnostic criteria implemented
in the study. The prevalence of sexual addiction-related
disorders ranges from 3% to 16.8%.42-45 In a Swedish
sample of 2,450 participants from the general population, Langström and Hanson estimated that 12%
of men and 6.8% of women present with hypersexuality.46 The researchers found that 5% to 10% of
the most sexually active respondents reported higher
levels of co-occurring addictions, risk-taking behaviors, distress, and psychiatric symptoms, suggesting
a subgroup of the most sexually active who may have
psychosocial impairments.46 Traeen et al47 specifically
investigated pornography dependence in the adult Norwegian male population, and found that 1% of their
sample masturbated to ejaculation twice or more per day
while viewing pornography. Laumann et al48 reported
that 7.6% of American men (n = 1320; ages 18–59)
engaged in partnered sex 4 or more times/week for at
least 1 year, and 1.2% of the men masturbated more
than once/day during the year leading up to the survey.
Higher rates have been suggested in specific populations,
such as sexual offenders, patients with HIV,49 and people
with hypersexual disorders and paraphilias.50 The evidence suggests that men have a higher prevalence of
sexual addictions than women; the estimated ratio of
sexual addictions is between 3 and 5 men for every
1 woman.51-53 The dissimilar prevalence rates reported
can at least partially be attributed to the use of different classification criteria along with the use of different
screening instruments and/or cut-off criteria.

Psychiatric Comorbidity
The adverse consequences of sexual addiction are similar to the consequences of other addictive disorders.54
Other direct risks are associated with unprotected and
anonymous sexual encounters, such as HIV/AIDS,

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

other sexually transmitted diseases, and unwanted pregnancy.12,51-52 Hypersexual men and women also engage
in tobacco use, alcohol, and illicit drug abuse.55-56
Among men, gambling is prevalent.7 Other psychiatric comorbidities include mood disorders, depression, anxiety,55,57 social anxiety, dysthymia, attention
deficit hyperactivity disorder,4,37,58 affect dysregulation,59 and posttraumatic stress disorder.60 Finally,
some studies find that sexual addiction is associated
with or in response to dysphoric affects or stressful
life events.61-64
The co-occurrence of sexual addiction and other
addictions suggest that these disorders share etiological
mechanisms, such as neurobiological and psychosocial
factors (e.g., personality traits, cognitive deficits, or
bias).65 Carnes66 reported that the majority of a sample of
1603 sex addicts reported a lifetime prevalence of other
addictive and abusive behaviors such as substance abuse,
gambling, or eating disorders. Finally, a study of pathological gamblers67 found that 19.6% of the subjects also
met the criteria for compulsive sexual behavior (CSB). The
majority of the subjects who met the criteria for both
disorders reported that CSB had preceded their gambling
problems.

Behavioral Characteristics of
Sexual Addiction
Sexual addiction or hypersexual disorder includes various
types of problematic behaviors.37,54,68 Coleman and colleagues classified seven subtypes of impulsive-compulsive
sexual behavior: compulsive cruising and multiple
partners, compulsive fixation on an unattainable
partner, compulsive masturbation, compulsive use
of erotica, compulsive use of the Internet for sexual
purposes, multiple compulsive love relationships, and
compulsive sexuality in a relationship.69 Behavioral
symptoms may also include engaging in risky sexual
activities, paying for sexual services, and resisting
behavioral changes to avert HIV risk.69-72 Bancroft57
suggested that 2 types of sexual behavior are especially likely to become out of control: masturbation
and the new and exceedingly important development
of the sexual use of the Internet. A growing number
of men and women use the Internet for sexual purposes.

Men are more likely to access sexually explicit material
online, while women are more likely to use the Internet for interactions and cybersex.5 According to Kafka,
the various proposed subtypes of hypersexual disorder
are excessive masturbation, which is the most common
sexual outlet for single and married individuals over the
life course,73 cybersex, pornography use, sexual behavior
with consenting adults, telephone sex, strip club visitation, and other behaviors.7

Cognitive, Social, and Emotional Factors:
More than 90% of people who are categorized as having
sexual addiction or hypersexual disorder reported having
obsessive thoughts and behaviors or sexual fantasies.74
Hypersexual men and women were more likely to be
younger and to have been separated from their parents
during childhood.46 These subjects initiated sexual
behaviors at an earlier age, had a higher frequency of
sexual behaviors, and had experienced more diverse
sexual experiences than subjects who were not hypersexual. The most important gender difference was the link
between sexual addiction and a history of sexual abuse
for women.46 Sexual abuse was linked to promiscuous
or risky sexual behavior.75-76 Dysfunctional attachment
during childhood is a major risk factor for sexual addiction. Early negative childhood attachment experiences
may negatively impact individuals’ affective, cognitive,
and behavioral development and favor the development
and maintenance of sexual addiction.39,77-79
Sexual addiction can be defined as a clinical syndrome characterized by the experience of sexual urges,
fantasies, and behaviors that are recurrent and intense
and cause a distressful interference in one’s daily
functioning.80 Sexual addiction has also been associated with impulsivity,81-82 loneliness,83 low self-worth,
insecure attachment styles,84-85 personal distress,86-87
and self-hatred and shame.55,88-89 More than 70% of
sexual addiction patients report withdrawal symptoms
between sexual episodes. Withdrawal symptoms include
nervousness, insomnia, sweating, nausea, increased heart
rate, shortness of breath, and fatigue.39,90-91 Men are less
likely to feel satisfied with their sexual life, have more
relationship-associated problems, and are more likely
to have consulted professional help for their sexual
problems.51
189

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

Associated Psychobiological
Mechanisms
The sexual addictive process is described by Goodman
as an interaction of impairments in three functional systems: motivation-reward, affect regulation, and behavioral inhibition.65 Brain imaging studies of human sexual
behavior in normal subjects and subjects with sexual
disorders used positron emission tomography (PET) and
functional magnetic resonance imaging (fMRI) to identify
brain mechanisms that underlie responses to visual sexual stimuli. These studies have demonstrated that visual
sexual stimuli are associated with the activation of the
brain’s reward mechanisms, including the limbic and
paralimbic regions (the anterior cingulate gyrus and the
orbitofrontal cortex) and the striatum (the head of the
caudate nucleus and putamen). These regions contain
dopaminergic (DA) projections that are an important
part of the brain reward network. Gender effects were
found, with men showing significantly greater amygdala
activation, which perhaps reflects differences in how men
and women process sexual signals.92 Amygdala activation
in men characterizes the “appetitive” phase of sexual
behavior, whereas ejaculation, which characterizes the
“consummatory” phase of sexual behavior in men, is
associated with a decrease in amygdala activity.93
Further brain imaging studies of human subjects
during sexual arousal suggest that the frontal areas of
the brain may exert control and exercise reason over the
posterior reward centers.94-95 Brain scan studies of sexual
dimorphism may help us understand the differences
between men and women, particularly when it comes to
sexual acting-out. For instance, a sexual activity-related
PET study demonstrated that male arousal was more
often associated with activation of the visual cortices of
the brain—even when the subjects’ eyes were closed.96
Female arousal was associated with stronger activity
in the left dorsal frontoparietal regions, including the
premotor and posterior parietal areas.97 During orgasm,
male and female brain functioning appears similar with
activation in the anterior lobe of the cerebellar vermis
and deep cerebellar nuclei and deactivations in the left
ventromedial and orbitofrontal cortex. Although promising and intriguing, today’s PET and fMRI studies do
not yet provide any clinical guidance in treating sexual
addiction.2
190

The comorbidity between sexual addiction and
pathological gambling (PG) could be explained by
common neurobiological mechanisms. Grant and
Steinberg68 found that compulsive sexual behavior
occurred in 19.6% of patients with PG. In 70.5% of
those with co-occurring disorders, compulsive sexual
behavior predated pathological gambling. Furthermore, patients treated with dopaminergic agents for
idiopathic Parkinsonism sometimes developed PG
and sexual compulsivity.98 In addition, patients with
PG and sexual addiction were treated with naltrexone, an opiate antagonist commonly used to treat
opiate and alcohol addiction.98
Genetic data may also explain abnormalities in sexual
desire. In humans, the heritability of sexually promiscuous behavior in both genders has been evaluated in twin
studies.99 Human sexuality may be associated with genes
that mediate dopamine transmission, specifically the
D4 dopamine receptor, which is associated with novelty
seeking.100-103 Long alleles of the D4 dopamine receptor
(7 repeats of the allele or more) were associated with disinhibition and impulsivity,104 initiating sexual activity,105
and having had a “one-night stand,” but not in overall
sexual infidelity.106

Treatment
Pharmacological Treatment:
Currently, there is a lack of consensus and empirical
research on sexual addiction/hypersexual disorders, and
clear diagnostic criteria are needed to test the efficacy
of psychological and pharmacological treatments in
controlled studies. However, similar to other behavioral
addictions (e.g., pathological gambling and compulsive
buying), the appropriate treatment of sexual addiction
should include a combination of pharmacological and
psychological approaches.3,107
Pharmacological treatments have limited evidence
of success. To date, no large double-blind clinical trials
have been conducted in patients with sexual addiction/
hypersexual disorders. One small, 12-week randomized
trial showed an effect of selective serotonin reuptake
inhibitors (SSRIs; escitalopram 20–60 mg) on sexual desire, sexual drive, frequency of masturbation,
and pornography use.108 Escitalopram (Lexapro) has

L003335 : Sexual Addiction or Hypersexual Disorder: Clinical Implications for Assessment and Treatment

demonstrated a moderate and significant decrease
in masturbation and pornography use.109 Open-label
trials and anecdotal reports support the use of SSRIs such
as fluoxetine to reduce desire, arousal, and orgasm.110-111
Finally, naltrexone (Revia, Vivitrol) is commonly used
to treat opiate and alcohol addiction, has been reported
to be effective in reducing problem gambling, and may
be effective for some patients with sexual addiction.
Open-label studies and case reports of naltrexone112
and topiramate (Topamax)113 showed promise in
decreasing the frequency of excessive sexual behavior. In a retrospective review of 19 adult men treated
with naltrexone for compulsive sexual behavior, 89%
indicated a decrease in compulsive sexual behavior
symptoms.114

Psychological Treatment:
Motivational interviewing, cognitive-behavior therapy,
and couples and family therapy have been shown to be
efficient for treating several forms of drug and behavioral
addiction.115-117 Behavioral therapies may be associated
with reductions in substance use and may have effects
on cognitive control, impulsivity, motivation, and
attention and related brain mechanisms.118 Group-based
treatments can also be used.119 Although Sex Addicts
Anonymous is not affiliated with any other organization,
the basic principles of the group are found in the 12 steps
and 12 traditions of Alcoholics Anonymous. Treatment
consists of approaches that have been used for substance
addiction such as group and individual therapy, motivational interviewing, cognitive-behavioral techniques,
relapse prevention, insight-oriented therapy, and family
therapy. In the United States, numerous inpatient and
outpatient treatment centers use an addiction model
to treat sexual compulsivity and addiction. Carnes has
developed a task-centered approach program with a series
of operationalized workbooks appropriate for treating
sexual addiction patients.120

Conclusion
Sexual addiction or hypersexual disorder involves powerful sexual urges together with lack of control of these
urges and preoccupation or an obsession with sexual
behavior. Sexually addicted patients lack control of this
activity, which has long-term harmful consequences
functionally and socially, as well as economically. Several
screening questionnaires have been created specifically
to assess the proposed diagnostic criteria for hypersexual
disorder and are likely to be the best choice of measures
if the researcher or clinician is looking for a brief instrument. According to Womack,25 a thorough assessment of
hypersexual behavior includes (a) a self-report measure
of general symptoms, (b) a self-report measure of consequences, (c) a clinical interview, and (d) an objective
assessment of sexual behavior.
The neurobiological and psychological mechanisms of sexual addiction are under investigation, and
currently, there is no validated pharmacological or
psychological treatment for this disorder. The absence
of validated treatment is at least partly because sexual
addiction is not clearly defined and diagnosed as a clinical disorder; instead, it is a construct that covers many
different types of problematic sexual behaviors. Due to
this diversity, Kor et al.121 concluded that despite many
similarities between the features of hypersexual behavior
and substance-related disorders, the research on hypersexual disorder at this time is in its infancy and much
remains to be learned before it can be definitively characterized as an addiction. Rosenberg et al.2 anticipated
that as psychiatric research improves our understanding,
studies will support the existence of sexual addiction and
related disorders as painful and serious disorders. Hopefully, future research will be able to integrate the different types of problematic sexual behavior into a clinically
defined disorder.

About the Faculty
Aviv Weinstein, PhD: Dr. Weinstein is a senior lecturer at the Department of Behavioral Science at the University of Ariel and
a senior psychologist at the Department of Nuclear Medicine at the Tel Aviv Sourasky Medical Center in Israel.

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116. Orzack MH, Voluse AC, Wolf D, Hennen J. An ongoing study of group treatment for men involved in problematic Internet-enabled sexual behavior. Cyberpsychol
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118. DeVito EE, Worhunsky PD, Carroll KM, Rounsaville BJ, Kober H, Potenza MN. A preliminary study of the neural effects of behavioral therapy for substance use
disorders. Drug Alc Depen. 2012;122(3):228-235.
119. Southern S. Treatment of compulsive cybersex behavior. Psychiatr Clin North Am. 2008;31(4):697-712.
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2005.
121. Kor A, Fogel YA, Reid RC, Potenza MN. Should Hypersexual Disorder be Classified as an Addiction? Sex Addict Compulsivity. 2013;20:27–47.

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L003335

Multiple-Choice Questions
49. According to the lesson, all of the following statements regarding sexual addiction or hypersexual
disorder are true, except:
A. Sexual addiction, or hypersexual disorder, is often associated with risk-taking behavior and psychosocial
problems.
B. The proposed diagnosis of hypersexual disorder requires the presence of dependence, tolerance, and
withdrawal.
C. Hypersexual disorder has been associated with compulsivity, impulsivity, emotional dysregulation, and
stress proneness.
D. Hypersexual disorder is repetitively engaging in sexual fantasies, urges, and behavior in response to dysphoric
mood states (e.g., anxiety, depression, boredom, irritability).

50. Which of the following psychiatric disorders has not been frequently described as related to hypersexual disorder?
A. Depression
B. Anxiety
C. Attention and hyperactivity disorder
D. Schizophrenia

51. Hypersexual disorder has been shown to be related to all of the following, except:
A. increased activity of the dopamine reward areas to visual sexual stimuli.
B. increased impulsivity and risk-taking behavior.
C. shared comorbidity with pathological gambling.
D. there is higher prevalence of hypersexual disorder in women than men.

52. Which of the following medications has not been shown to be useful in treatment for hypersexual
disorder?
A. Escitalopram, a selective serotonin reuptake inhibitor
B. Naltrexone, an opiate antagonist
C. Topiramate, an anticonvulsant medication
D. Risperidol, an antipsychotic
197

Best Practices in CME
Sexual Addiction or Hypersexual Disorder:
Clinical Implications for Assessment and Treatment
By Aviv Weinstein, PhD

ID#: L003335

This valuable take-home reference translates evidence-based, continuing medical education
research and theory acquired from reading the associated CME lesson into a stepwise approach
that reviews key learning points for easy assimilation into your armamentarium of knowledge
and daily practice.

CME Lesson Overview
Clinicians will review recent evidence for the assessment, the psychobiological basis, and treatment of sexual
addiction, including diagnosis, comorbidity with other psychiatric disorders, and treatment studies.

Key Point 1: Diagnosis
Diagnose the disorder using valid instruments.

Key Point 2: Assessment
Assess psychiatric comorbidity using psychiatric questionnaires.

Key Point 3: Identify Circumstances

Key Point 4: Identify Physical and
Social Effects
Assess physical and cognitive effects of the
disorder using health questionnaires.

Key Point 5: Treatment
Discuss psychological and pharmacological
treatments such as CBT and SSRIs.

Identify social, behavioral, and emotional
circumstances.

The information presented herein is based upon the content in the associated CME lesson. If you have comments or feedback about this page,
please send your feedback via email to: [email protected] and reference the ID number under the title to which you are referring.
We will review your commentary, which may be used for publication.
The material in this journal is not a substitute for seeking the attention of a licensed health or medical clinician. These materials were created for professional education
purposes only and are not the express opinion of The Hatherleigh Company, Ltd.

Notes

L903336

Confidentiality Protections Versus
Collaborative Care in the Treatment
of Substance Use Disorders
Jennifer K. Manuel, PhD; Howard Newville, PhD;
Sandra E. Larios, PhD, MPH; and James L. Sorensen, PhD
No commercial support was used in the development of this CME lesson.

KEY WORDS:  Electronic Health Records  •  Substance Use Disorders Treatment  •  Patient Confidentiality
LEARNING OBJECTIVES: Clinicians will review the current policies regarding patient confidentiality issues and substance
use disorder (SUD) treatment. Readers will consider how to protect their patients in this era of collaborative care while
maintaining rapid communication among healthcare providers. As this lesson discusses substance use disorders, the implications
can be considered among other medical conditions.

LESSON ABSTRACT: Practitioners in federally-assisted substance use disorder (SUD) treatment programs are faced with
increasingly complex decisions when addressing patient confidentiality issues. Recent policy changes, intended to make
treatment more available and accessible, are having an impact on delivery of SUD treatment in the United States. The addition
of electronic health records provides opportunity for more rapid and comprehensive communication between patients’ primary
and SUD care providers while promoting a collaborative care environment. This shift toward collaborative care is complicated
by the special protections that SUD documentation receives in SUD treatment programs, which vary depending on what
care is provided and the setting where the patient is treated. This lesson explores the special protections for substance abuse
documentation, discrepancies in treatment documentation, ways to deal with these issues in clinical practice, and the need for
more knowledge about how to harmonize treatment in the SUD and primary care systems.

COMPETENCY AREAS: This lesson addresses the issue of ethical decision making for clinicians working in substance use
disorder treatment programs. With the recent changes in policies that make substance use disorder treatment more available and
the rise in the use of electronic health records to facilitate collaboration, clinicians often face questions regarding the protections
for substance use disorder documentation, the involvement of the legal system, and the involvement of other parties in the
treatment program. Upon completion of this lesson, readers will have a better understanding of the recent policy changes
regarding substance use disorder treatment and will provide clinicians with a better understanding of ethical practice regarding
collaboration and consultation.

201

L903336 : Confidentiality Protections Versus Collaborative Care in the Treatment of Substance Use Disorders

Introduction
Increasingly, substance use assessment and treatment is
occurring in health care settings such as primary care
clinics, emergency departments, and trauma units.
Furthermore, many health care settings have adopted or
plan to adopt the use of electronic health records (EHRs),
a change that can facilitate the integration of substance
use disorder (SUD) treatment with other forms of health
care. Thus, the landscape of SUD treatment has shifted
in recent years. At the same time, current regulations for
SUD treatment confidentiality have not been updated,
despite the number of changes in how and where SUD
is delivered. In this paper, the authors provide a summary of recent legislative and policy changes, the reasons
for confidentiality protections, review the degree that
substance abuse treatment documentation is protected
in different environments, and suggest several directions
for maintaining confidentiality while promoting coordination of care.

The Advance of Electronic Health
Records Systems:
The American Recovery and Reinvestment Act of
2009 (ARRA), also known as the “economic stimulus package,” provided $19.2 billion for the modernization of electronic health records.1 The Health
Information Technology for Economic and Clinical
Health (HITECH Act), contained within the ARRA,
also codified into law an executive order by President Bush from 2004 that created the Office of the
National Coordinator for Health Information Technology (ONC) as part of the Department of Health
and Human Services, which is charged with ensuring
that all patients have a certified electronic health
record by 2014. In addition, health care providers
and hospitals who adopt a “meaningful” use of EHR
will be eligible for incentive payments.2
During this period of reform the Substance Abuse
Mental Health Services Administration (SAMHSA), the
agency of the Department of Health and Human Services
(DHHS) responsible for the prevention and treatment
of substance use disorders, has provided support for the
coordination and integration of SUD treatment and
healthcare. SAMHSA lists as core consensus principles
in health reform to “eradicate fragmentation by requiring coordination and integration of care for physical,
202

mental, and substance use conditions” and “adopt and
fully utilize health information technology.”3p4 In sum,
these legislative and policy developments will increase
accessibility to behavioral health services and facilitate
the coordination of care for patients in health care
settings with the goal of improving care for patients
in the United States. Given the under-detection and
under-treatment of SUDs, coordinated care environments, such as practitioners in health care settings who
screen for and treat individuals who are engaging in risky
or problematic substance use, can increase the detection
and treatment of SUDs among patients who may not
otherwise present for specialty SUD treatment.4

Why Confidentiality Laws?
42 CFR Part 2 The federal regulations, 42 CFR Part

2,5,6 were developed during a time of independent
SUD treatment programs, to increase treatment
engagement and reduce the discrimination associated
with SUD treatment. The regulations have since been
updated but their purpose has remained intact: to
prevent law enforcement from using substance abuse
treatment patient records as a means of arresting
patients.7 Congress, wishing to make substance abuse
treatment more accessible stated, “The conferees wish to
stress their conviction that the strictest adherence to. . .
[confidentiality] is absolutely essential to the success of
all drug abuse prevention programs. Every patient and
former patient must be assured that his right to privacy
will be protected. Without that assurance, fear of public
disclosure of drug abuse or of records that will attach
for life will discourage thousands from seeking the treatment they must have if this tragic national problem is to
be overcome.”8p33
42 CFR Part 25,6 applies confidentiality regulations
to federally-assisted SUD programs, defined as an individual, entity, or unit within a general medical facility
who offers or provides substance use diagnosis, treatment or referral to treatment or medical staff in a general medical care setting “whose primary function is the
provision of alcohol or drug abuse diagnosis, treatment
or referral for treatment.”6; 2.11 To be consistent with the
42 CFR Part 2 language, substance use providers and
settings, who meet the above criteria, will be referred
to as “SUD programs” throughout our discussions of
privacy laws in SUD care. “Patient” refers to “any individual who has applied for or been given diagnosis or

L903336 : Confidentiality Protections Versus Collaborative Care in the Treatment of Substance Use Disorders

treatment for alcohol or drug abuse at a federally assisted
program and includes any individual who, after arrest
on a criminal charge, is identified as an alcohol or drug
abuser in order to determine that individual’s eligibility
to participate in a program.”6; 2.11
42 CFR Part 2 stipulates that the “records of the
identity, diagnosis, prognosis, or treatment of any
patient which are maintained in connection with
the performance of any drug abuse prevention function conducted, regulated, or directly or indirectly
assisted by any department or agency of the United
States” 6; 2.1 may not be disclosed to others unless the
patient gives prior written consent for the release of his/
her information. Thus, programs meeting the 42 CFR
Part 2 criteria may not share any information relating to
the patient without specific patient consent. Patient consent is required for each disclosure (no blanket waivers
of consent are permitted), and re-disclosure is forbidden
unless a provider receives patient consent.
While the general rule is no disclosure without
patient consent, the confidentiality regulations have
boundaries. Disclosures to medical personnel are
allowed without specific patient authorization for
medical emergencies if there is an immediate threat;
however this information must be documented in the
patient’s records. Suspected child abuse or neglect may
be reported, but restrictions still apply to the original
patient records of the SUD program; in other words a
report is allowed but disclosure that the patient is in a
SUD program is not permitted. With the patient’s consent disclosure is authorized to a qualified service organization (QSO): This is an organization that has a written
agreement (Qualified Service Organization Agreement or
“QSOA”) with the SUD treatment program, stating
that the QSO will be governed by the confidentiality
regulations, with no disclosure without consent, and will
resist judicial efforts to obtain patient records.
In recent years (2010–2011) SAMSHA set forth two
sets of Frequently Asked Questions (FAQs) to further
clarify how the existing legislation is applicable with the
current technological advances. “Applying the Substance
Abuse Confidentiality Regulations to Health Information Exchange” and “Applying the Substance Abuse
Confidentiality Regulations 42 CFR Part 2” describe
a variety of issues including the limitations of consent,
the role of HIPPA, and the relationship between 42
CFR part 2 and state laws.9 These FAQs are intended

to clarify the 42 CFR Part 2 guidelines, however many
questions remain about how to interpret the guidelines
in coordinated care environments and in the context of
an ever-changing digital era. Furthermore, while there
has been considerable improvement in the technology for documenting treatment and the integration of
SUD treatment with medical care, our current privacy
laws regarding substances use disorders remain largely
unchanged.

HIPAA Regulations:
As years passed, additional legislation was adopted
to further ensure patient privacy. In 1996, the United
States Congress passed the Health Information Portability and Accountability Act (HIPAA), which contains a
privacy rule that restricts the spread of Protected Health
Information (PHI). HIPAA regulates PHI held by “covered entities,” such as health plans, health care clearinghouses, and health care providers. HIPAA was written
for direct transfers of electronic information between
providers, rather than networks streamlining information.10 Some view HIPAA as restricting the necessary
transfer of data and needing improvements to facilitate
smoother communication10-12 whereas others suggest
that the HIPAA Privacy Rule should be augmented with
new federal regulations.13
Modifications have been proposed to address some
of the privacy issues with 42 CFR Part 2 and HIPAA.
For example, the Patient Protection Coalition, a
group aiming to reform 42 CFR Part 2, has suggested
permitting disclosures of demographic information,
diagnosis, medications, laboratory results, and current
and past treatment providers to ensure patient safety.
Additionally, they support enhancing patient protections
regarding discrimination based on having received SUD
treatment and strengthening legal ramifications for
unauthorized disclosures of information.14
Federal privacy laws are further complicated with
the advent of electronic medical records.15 Federal
privacy laws were written before the development of
electronic medical records, when all records were kept
in paper form, rendering some parts of these laws
obsolete and other parts in opposition to the electronic
changeover.16 Various groups insist on maintaining
the strict protections in 42 CFR Part 217 whereas others argue for a reform of the current confidentiality
protections.18
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Integration of SUD Treatment
and Healthcare:
Increasingly, substance use treatment services are being
offered in health care settings at the urging of groups
such as the Institute of Medicine.19 This shift reflects the
realization that many individuals drinking or using drugs
at risky levels will present for care in mainstream health
care settings rather than specialty SUD programs. These
patients may be in need of SUD treatment but may be
unwilling or unable to seek specialty substance use care.
Integrating “medically harmful substance use” information into EHRs can improve patient safety and provide
better care to patients.20 Efforts, such as the Screening
and Brief Intervention and Referral to Treatment initiative funded by SAHMSA, encourage the assessment
and treatment of substance use disorders in healthcare
settings21 and have been successful in reducing patients’
alcohol and drug use.22
The integration of SUD treatment and healthcare
settings can be an effective way of assessing and treating
patients who may not have pursued specialty SUD care
and in providing a greater continuity of care for those
patients who are receiving specialty SUD treatment.
However, combining these services is complicated, in
part due to the greater protections offered to patients
in certain settings with substance use disorders. When
general health care providers assess for and provide a brief
intervention in a general health care setting, the documentation of the pertinent substance use information
does not fall under the SUD confidentiality regulations.23
However, if a patient in a federally-funded healthcare
setting is seen or treated by a specialty substance abuse
provider whose primary job responsibility is to assess for
and treat substance use patients, this patient-provider
information does merit protection under the 42 CFR
Part 2 confidentiality regulations. At this point, providers must document only essential information within the
medical record. As Miller et al.23 note, “The problem here
is determining what is essential for primary care providers to know. Primary care providers themselves may argue
that they need to know everything in order to provide the
best care to the patient.”p.294
There is ambiguity about the documentation of
integrated substance abuse information in healthcare
settings, with no uniform method of recording this
material. For instance, when SUD treatment services
204

were implemented into a university associated primary
care clinic in New Mexico, Ernst, Miller, and Rollnick24
reported on the lack of clarity regarding confidential
protections in a primary care setting. After seeking legal
counsel, the authors decided to adhere to the regulations
because “the services were specific to substance abuse,
and psychotherapy was provided to some patients”24p3
The integration of SUD treatment and health care
raises questions about what integration means for SUD
documentation in health care settings. Integration also
highlights possibly discordant regulations regarding the
treatment of SUDs in substance use and health care
settings. If the SUD confidentiality regulations do not
apply to a general medical doctor prescribing naltrexone
in a primary care setting or talking to a patient about the
risks of drinking while pregnant what is the rationale for
the discrepancy in protections? In Table 1 we highlight
the discrepancy between the documentation of SUD
information by SUD in federally assisted SUD-focused
programs versus general medical providers in non-SUD
settings.

Confidentiality Protections in
Current Practice:
Practitioners ask as we move toward an era where medications are increasingly being prescribed for SUD, are
the current protections potentially harmful to patients?
Providers of patients who are prescribed naltrexone,
buprenorphine, or methadone may need this information in order to accurately treat their patients. While
the 42 CFR Part 2 guidelines indicate that patient
information may be disclosed in medical emergency
situations, preventing a potentially fatal drug interaction
does not necessitate a disclosure if there is not an immediate medical emergency.25 A study by Walley et al.26
found that 59% of the opioid patients on methadone
maintenance therapy (MMT) were also prescribed
medications with a potentially harmful interaction
with their MMT. In fact, 19% of the patients were
prescribed three or more medications that could
potentially interact with MMT. Currently, the patient
must serve as the intermediary between their SUD and
healthcare providers or sign an authorization of release
of information for each of their particular providers.
As a result “failure to share patient-specific information
across providers promotes uncoordinated and sometimes
unsafe care.”27, p716

L903336 : Confidentiality Protections Versus Collaborative Care in the Treatment of Substance Use Disorders

Table 1:
SUD Documentation in Specialty and General Medical Setting
Specialty SUD Provider in Federally-assisted SUD Program

Documentation and Explanation

• Patient schedules an appointment with a SUD clinic because he is
concerned about his alcohol use.

The SUD counselor documents the details of the patient’s visit
in the SUD clinic notes. These notes are protected by 42 CFR
• Patient completes a brief assessment interview and then meets with Part 2 and are therefore not accessible to others outside the
program (in particular the patient’s primary care provider),
his counselor.
without a specific release of information from the patient
• Patient and his counselor discuss the patient’s goals for treatment,
unless there is a qualifying medical emergency or an established
and patient is encouraged to attend weekly SUD sessions. Patient is not QSOA exists.
actively withdrawing from alcohol, so counselor decides that patient
does not to attend a detoxification center.
• Patient asks if there are medications to help him deal with cravings,
but counselor indicates he does not have prescription privileges.
Patient is encouraged to ask his primary care provider about the use of
naltrexone.
Medical Provider in Emergency Room

Documentation

• Patient is asked about his alcohol and drug use as part of a visit to
an emergency room for a traumatic injury. Patient indicates his injury
occurred while intoxicated and voices concern about drinking.

Provider documents the details of the patient’s visit, including
the patient’s SUD diagnosis and history of drinking. This
information is not protected by 42 CFR Part 2 because the
provider’s primary function did not include the provision of
substance use services nor did the interaction take place in an
identified substance-focused unit.

• Provider (general medical provider) assesses substance use history
and diagnoses the Patient with alcohol dependence.

Nonetheless, in a recent national survey, adults have
expressed some concerns about the potential for shared
health information. In this survey, 42% of participants
indicated that they would feel uncomfortable if their private health information was shared with other organizations, even if any identifying information was excluded.
Furthermore, 15% of participants reported that they
would hide information and 33% indicated that they
may hide information from their doctor if he/she shared
information through an HER.28 Patients with substance
use disorders or risky substance use may be more likely to
hide substance use information out of privacy concerns
and fears of stigmatization.

Solving a Clinical Conundrum:
Maintaining Confidentiality in a
Coordinated Care Environment:
In 2010 an article in Alcoholism &Drug Abuse Weekly7
asked, “Can electronic medical records and patient confidentiality coexist?” The answer appears to be “Yes, but
they need to be harmonized.” People involved in this tuning process will include legislators, judges, attorneys, and
insurance adjusters, but a major place where these issues
will be acted out is in human service programs treating
people with SUD. With that in mind, we provide some

suggested actions that staff in SUD treatment programs
can take to cope with these controversies.

Keep Context in Mind
For all providers and other healthcare personnel, it is
vital to understand the reasons why the confidentiality laws exist and also why the context is changing.
Gaining an understanding in the principles, laws,
and guidelines is important. Then when the question
arises about protection of confidentiality, ethical principles such as respect for persons, autonomy, justice,
beneficence, and non-maleficence can be part of the
decision-making process.29 The federal confidentiality
statutes need to be followed, as well as various guidelines
from legislation like HIPAA and applicable state and
municipal regulations.
Guidelines are available from several valuable
resources. CSAT/SAMHSA has developed over 50
written Treatment Improvement Protocols. These are
available online at http://www.ncbi.nlm.nih.gov/books/
NBK14119/ and were written for staff in a wide variety
of SUD treatment programs. CSAT has also published
a number of Technical Assistance Publications (TAPS),
including TAP 13, Confidentiality of patient records for
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L903336 : Confidentiality Protections Versus Collaborative Care in the Treatment of Substance Use Disorders

alcohol and drug treatment.30 TIP 40, Clinical guidelines for
the use of buprenorphine in the treatment of opioid addiction,

has specific information on the confidentiality requirements for physicians who are providing office-based opioid addiction treatment. The TIP also includes a sample
consent form to release information protected by 42 CFR
Part 2.31 Additionally the Legal Action Center (LAC) can
be an excellent resource, available online at http://www.
lac.org/. LAC is a non-profit law and policy organization
that seeks to fight discrimination against individuals with
addictions, HIV/AIDS or criminal records. They provide
on-line courses available both in basic and advanced
issues concerning confidentiality, as well as brochures,
sample forms for physicians and treatment programs,
and policy analyses, including a paper on confidentiality
of alcohol and drug records in the 21st Century.

Consider State Laws
State laws may institute additional protections on
patients’ privacy, so it is important to remain informed
about state confidential protections. While states may
require additional protections, they may not authorize
a program to disclose information that is protected by
42 CFR Part 2. Thus, state laws may provide additional
protections but they may not undermine the federal
protections.

Seek Guidance
When a provider approaches an uncomfortable situation it is wise to seek guidance. Counselors, peers,
clinical supervisors, physicians, and licensed professionals at the SUD treatment program are essential for
support, and professional associations can be helpful.
For example the NAADAC, the National Association for
Addiction Professionals (http://www.naadac.org/), offers
webinar trainings, one of which is Compliance with
Ethical Standards for Drug, Alcohol and Addictions
Counselors. We stress that the specific guidelines may
be changing constantly as new information emerges. For
example, earlier in this paper we mentioned that in July
2010 CSAT released a “Frequently Asked Questions”
paper (http://www.samhsa.gov/HealthPrivacy/docs /EHRFAQs.pdf). The paper was initially drafted by the LAC.
Enos32 documents the many points of controversy about
this document, and a month later SAMHSA sponsored
a stakeholders meeting to air different viewpoints and
clarify the “FAQs.” We also emphasize the importance of
206

seeking legal guidance, which is a vital step in situations
where rules may be changing, and new legal precedents
may be emerging. A treatment counselor is likely to
need both clear and authoritative guidance from a legal
professional.

Implement
At the clinic level, update guidelines for your patients,
staff, and referral sources, and if guidelines do not exist, it
may be wise to develop them. Examples of such guidelines
are available from the CSAT TIPS and TAPS mentioned
above, or they may be available locally or through the
single state agency that is responsible for SUD treatment.

Seek Feedback
Obtaining feedback from those affected is an obvious
suggestion, but feedback often happens only when
something has gone wrong. Encourage quality assurance
studies to understand what is working and why. Encourage research to understand how serious specific issues are
in your setting. As an example of the utility of research,
Salomon et al.33 surveyed psychiatric clinicians who had
recently switched to an electronic health record system
and found the majority opinion was that open therapeutic
communications were not interfered with. On the other
hand, once they were using the electronic health record
system the majority was less willing to record highly confidential information. In short, the clinicians indicated
that the system worked but they were more cautious than
before about recording sensitive information.

Keep Learning
At the individual level, keep up to date as guidelines
change. A 2009 CSAT TIP entitled Clinical Supervision
and Professional Development of the Substance Abuse Counselor may be helpful (TIP 52).21 At the program and

system levels attend to the needs for training among
those in your system. In addition, as the ethical standards continue to evolve in substance abuse treatment, it
is essential that providers remain up to date on the latest
ethical guidelines.

Conclusions
This [lesson] explored protecting confidentiality in
SUD treatment programs in the light of changes that
have occurred recently in the policies and regulations.

L903336 : Confidentiality Protections Versus Collaborative Care in the Treatment of Substance Use Disorders

Legislation has been enacted to make SUD treatment
more affordable and accessible to patients in need. Treatments are increasingly being offered in health care settings such as primary care clinics, emergency, and trauma
units. Technological development has fostered the development and proliferation electronic health records rather
than paper charts. In this context we acknowledge the
difficulty of maintaining patient confidentiality versus
sharing vital information with providers in a collaborative care setting. In this paper the authors provide a summary of recent legislative and policy changes, the reasons
for confidentiality protections, review the degree that
substance abuse documentation is protected in different
environments, and suggest several directions for maintaining confidentiality while promoting coordination of
care. The field of substance abuse treatment has changed
drastically since the time when the privacy laws were
first developed. SUD treatment is more widely available,
provided by a broad range of health care providers, and
is often treated by medications. The integration of SUD
care has reached patients who may not have otherwise
sought treatment.
Our paper provides guidance and advice to staff in
SUD treatment programs regarding how to negotiate
confidentiality issues in treatment programs. The issues
are changing, and the ethical principles of good health
care and professional practice will be increasingly relevant in this time when the field is undergoing significant change in its clientele, location of services, and its
technology. Until the field stabilizes again it will be the
helping professionals in the human service settings who
make the most important decisions about what is best
for their clientele.

This analysis is limited by several factors that can
be informed through further research. There is a need
for clear ethical analyses that explore the advantages and
drawbacks of topics such as protecting patient confidentiality versus promoting integrated care. It would be helpful
to understand more about the extent of stigmatization of
SUD and whether, over time the stigma has diminished
or increased. This information can inform guidance
about the extent to which confidentiality protections are
needed by those receiving treatment for SUD. Additional
research needs to provide information about what are the
most frequently occurring and most troubling ethical
confidentiality and privacy issues facing various actors in
SUD treatment and prevention. In addition we need to
know how these issues are being resolved in the field.
Further there is a need for concerted organizational
attention to resolve an increasingly acrimonious debate
about the need to keep versus revise the federal confidentiality regulations that will soon have been enacted fully
50 years ago. Our current confidentiality regulations for
SUD treatment have not been updated, despite the number of changes in location and context of care programs.
It may be that federal confidentiality guidelines will be
rewritten to reflect the changing times, or like the U.S.
Constitution, the field may look to these as enduring
adages that need to be interpreted to provide more clear
guidance to a rapidly evolving field. In either case, there
is a need for the national action to enact administrative
mechanisms that will air the many facets of the issue and
then come to a resolution. With clarity at the federal level
the state and local agencies will be able to attune their
regulations and guidelines so that a national approach to
these issues can develop.

About the Faculty
Jennifer K. Manuel, PhD: Dr. Manuel is a Postdoctoral Fellow, San Francisco General Hospital Department of Psychiatry,
University of California, San Francisco.
Howard Newville, PhD: Dr. Newville is a research scientist at St. Luke’s-Roosevelt Hospital, Behavioral Science Research Unit,
New York, NY; and a Postdoctoral Fellow, San Francisco General Hospital Department of Psychiatry, University of California,
San Francisco.
Sandra E. Larios, PhD, MPH: Dr. Larios is a Postdoctoral Fellow, San Francisco General Hospital Department of Psychiatry,
University of California, San Francisco.
James L. Sorensen, PhD: Dr. Sorensen is Professor, Department of Psychiatry, University of San Francisco, San Francisco.

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Hatherleigh’s Note: Additional typeface treatment was added to text for emphasis along with title page information, CME, and Best Practices which were not part of the original article.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
JKM drafted Confidentiality protections in current practice, Integration of SUD treatment and healthcare, and edited the manuscript. Together, JKM and SEL drafted Table 1. HN drafted
parts of The advance of electronic health records, Why confidentiality laws and HIPAA regulations. SEL drafted parts of The advance of electronic health records, Why confidentiality laws and
HIPAA regulations. JLS drafted Why Confidentiality Laws, Solving a clinical conundrum and Conclusions and edited the manuscript. All authors read and approved the final manuscript.
Acknowledgements
Supported in part by NIH/NIDA and NIH/NIMH Grants P50DA09253 (PI=Joseph Guydish; joseph.guydish@ ucsf.edu), U10DA015815 (PI=James Sorensen; [email protected]),
R01DA020781 (PI=Carmen Masson; [email protected]), R21DA020369 (PI=James Sorensen), T32DA07250 (PI=James Sorensen), T32MH018261 (PI Patricia Arean; patricia.
[email protected]), F32DA0324465 (PI=Howard Newville; [email protected]) and the Robert Wood Johnson Foundation (Dr. Sorensen).
The authors acknowledge and support the above funding sources we recognize that the views presented in this manuscript are that of the authors and not of the funding sources.
Authors’ contributions
JKM drafted Confidentiality protections in current practice, Integration of SUD treatment and healthcare, and edited the manuscript. Together, JKM and SEL drafted Table 1. HN drafted
parts of The advance of electronic health records, Why confidentiality laws and HIPAA regulations. SEL drafted parts of The advance of electronic health records, Why confidentiality laws and
HIPAA regulations. JLS drafted Why Confidentiality Laws, Solving a clinical conundrum and Conclusions and edited the manuscript. All authors read and approved the final manuscript.
Acknowledgements
Supported in part by NIH/NIDA and NIH/NIMH Grants P50DA09253 (PI=Joseph Guydish; joseph.guydish @ucsf.edu), U10DA015815 (PI=James Sorensen; [email protected]),
R01DA020781 (PI=Carmen Masson; [email protected]), R21DA020369 (PI=James Sorensen), T32DA07250 (PI=James Sorensen), T32MH018261 (PI Patricia Arean; patricia.
[email protected]), F32DA0324465 (PI=Howard Newville; [email protected]) and the Robert Wood Johnson Foundation (Dr. Sorensen).
The authors acknowledge and support the above funding sources we recognize that the views presented in this manuscript are that of the authors and not of the funding sources.
Copyright © 2013 Manuel et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution,
and reproduction in any medium, provided the original work is properly cited.

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L903336

Multiple-Choice Questions
53. The increase in the use of electronic medical records is due in large part to:
A. the invention and increased use of mobile computing technology, allowing doctors to send records with
greater ease.
B. expectations on the part of the patient that doctors should be able to access all information in their medical
history quickly and efficiently.
C. increased funding in the 2009 economic stimulus package providing for the modernization of electronic
health record-keeping systems.
D. the need for doctors to have easier access to information so that patients can be seen at a faster rate,
compensating for increased demand.

54. What is the purpose of the confidentiality laws detailed in 42 CRF Part Two?
A. To provide patients seeking mental health care protections above and beyond HIPAA
B. To prevent police from using medical records to arrest patients seeking help for substance abuse
C. To remind clinicians of their ethical responsibilities regarding confidentiality
D. To aid law enforcement in the event a criminal defendant makes a mental health-related defense

55. According to a study by Walley et al., what percentage of patients on methadone maintenance therapy
were prescribed a drug with a potentially harmful interaction?
A. 59%
B. 32%
C. 6%
D. 79%

56. According to the lesson, why is it important to understand why the confidentiality laws exist and why
the context of these laws is changing?
A. To protect the patient autonomy
B. To be able to reconcile one’s ethical concerns within the boundaries of the law
C. To be certain about what information is protected by confidentiality
D. All of the above
211

Best Practices in CME
Confidentiality Protections Versus Collaborative Care
in the Treatment of Substance Use Disorders
By Jennifer K. Manuel, PhD; Howard Newville, PhD;
Sandra E. Larios, PhD, MPH; and James L. Sorensen, PhD
ID#: L903336

This valuable take-home reference translates evidence-based, continuing medical education
research and theory, acquired from reading the associated CME lesson, into a stepwise
approach that reviews key learning points for easy assimilation into your armamentarium
of knowledge and daily practice.

CME Lesson Overview
This lesson is designed to help clinicians understand the impact of electronic health records on patients and
ethical questions in substance use disorder treatment settings.

Key Point 1: Introduction

The American Recovery and Reinvestment
Act of 2009 (ARRA), also known as the “economic stimulus package,” provided $19.2
billion for the modernization of electronic
health records.

Key Point 2: Extra Protections for
Patients in Recovery from
Substance Abuse

42 CFR Part 25,6 applies confidentiality regulations to federally-assisted SUD programs,
defined as an individual, entity, or unit within a general medical facility who offers or
provides substance use diagnosis, treatment, or referral to treatment or medical staff in a general medical care setting
“whose primary function is the provision of
alcohol or drug abuse diagnosis, treatment
or referral for treatment.”

Key Point 3: Be Mindful of Context

For all providers and other healthcare
personnel, it is vital to understand why
the confidentiality laws exist and why the
context is changing. Gaining an understanding of the principles, laws, and guidelines is

important. Then when the question arises
about protection of confidentiality, ethical
principles such as respect for persons, autonomy, justice, beneficence, and nonmaleficence can be part of the decision-making
process.29 The federal confidentiality statutes must be followed, as well as various
guidelines from legislation such as HIPAA and applicable state and municipal
regulations.

Key Point 4: Implement Guidelines

At the clinic level, update guidelines for
your patients, staff, and referral sources. If
guidelines do not exist, it is wise to develop
them.

Key Point 5: Seek Guidance and
Feedback in Ethical Confounding
Situations

When a provider approaches an uncomfortable situation, clinicians should seek
guidance. Treating clinicians, peers, clinical
supervisors, physicians, and licensed professionals at the SUD treatment program
are essential for support, and professional
associations can be helpful.

The information presented herein is based upon the content in the associated CME lesson. If you have comments or feedback about this page,
please send your feedback via email to: [email protected] and reference the ID number under the title to which you are referring.
We will review your commentary, which may be used for publication.
The material in this journal is not a substitute for seeking the attention of a licensed health or medical clinician. These materials were created for professional education
purposes only and are not the express opinion of The Hatherleigh Company, Ltd.

Notes

L903337

Ebola Facts: Clinical Progression &
Clinical Evidence
American Hospital Association
Compiled by the American Hospital Association (AHA), the Accreditation Council for Continuing Medical Education (ACCME) has disseminated this information to
all continuing medical education providers and encouraged providers to share this information in their CME series.a

KEY WORDS: Ebola Virus • Early Stages • Pathophysiology •  ZMapp
LEARNING OBJECTIVES: This lesson provides readers with the clinical progression of the Ebola Virus Disease (EVD) as
well as guidelines for management in the hospital setting. Readers will review the symptoms that present in the early, late, and
recovery phases of the disease as well as symptom management, and guidelines for protection of healthcare providers and others
who come into contact with individuals who have acquired the virus.

LESSON ABSTRACT: In response to the Ebola public health emergency, the American Hospital Association (AHA) has
provided an Ebola education package for CME providers. This package contains information that the American Hospital
Association believes would be useful to healthcare providers and institutions right now, including this FAQ. For more recent
updates, readers should refer to the Centers for Disease Control and Prevention (CDC) or other cited sources on the day they
access this information to get the most current information or version that may now be available.a

COMPETENCY AREAS: This lesson provides healthcare providers with current information released by the American
Hospital Association regarding the presentation of the Ebola virus and how to manage presenting symptoms. This lesson also
provides informatics for systematic controls in the hospital setting.

a

For more information, please visit: accme.org

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L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

Table 1:
DISEASE PROGRESSION

Table 2:
CLINICAL EVIDENCE
CARE COMPONENT

CLINICAL MANAGEMENT

Disease Pathophysiology4

Research suggests the virus first infects dendritic cells, disabling immune system, and then attacks
the vascular system, causing hemorrhage, hypotension and shock. The virus also affects the liver
(impacting coagulation proteins), the adrenal gland (affecting steroid synthesis for blood pressure
stabilization) and the gastrointestinal tract (diarrhea).

Hemodynamic
Support1,2,5-7

Hypotension/Shock: Aggressive IV fluid resuscitation resembling the approach to the septic shock
patient is identified by the CDC as one of three interventions that impact mortality through
observation and case series. Base fluid selection (Lactated Ringers or Normal Saline) on patient
electrolyte status. One animal study examined supplemental fluid resuscitation of infected,
hypotensive rhesus macaques, which resulted in improved renal parameters. Hydrocortisone may
be considered to support viral disruption in steroid synthesis.

Hypotension/shock,
hemorrhage/DIC

Hemorrhage/DIC: Management of hemorrhage is inconsistent in literature. Literature around
previous outbreak transfusion strategies includes various blood products, antifibrinolytics, and
clotting factors. One recent report suggests the use of melatonin to combat endothelial disruption,
disseminated intravascular coagulation (DIC) and multiple organ hemorrhage due to potential
benefit, high safety profile, and limited alternative therapies.
Respiratory Support1,2,8-10
Oxygen therapy,
ventilation

216

Maintain adequate oxygenation (titrate to SpO2 >90%). To protect the airway and/or treat
multisystem organ failure, standard mechanical ventilation practices should be followed with the
addition of HEPA filtration of airflow gases. Methods of non-invasive ventilation are not ideal due
to increased potential for aspiration and infection transmission. Additional measures including
placement of ventilated patients in a negative pressure room, use of video/optical laryngoscopy
for intubation, use of rapid sequence intubation with neuromuscular blockade, and use of a
ventilator-patient monitoring system interface to minimize entry into the patient room should be
considered.1-2,6-8

L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

Table 3:
CLINICAL EVIDENCE
CARE COMPONENT

CLINICAL MANAGEMENT

Infection Suppor t1,2,6,11
Fever, secondar y infection,
malaise, plasma transfusion,
antivirals

Treat fever with acetaminophen (avoid aspirin and NSAIDs due to antiplatelet activity). Identify any
additional sources of infection and treat with appropriate empiric antimicrobials. If sepsis develops,
administer broad-spectrum IV antibiotics within 1 hour and follow Sur viving Sepsis Early Goal Directed
Therapy (EGDT). Antiviral and antimalarial agents are not efficacious for Zaire Ebola virus. Consider
passive immunotherapy early in disease course by transfusing whole blood or plasma donated from a
convalescent patient.

Renal/Hepatic Suppor t1,2,4,6,12,13

Renal: Advanced stage may lead to impaired kidney function, increased creatinine and BUN, and
decreased urine output. Renal failure has been repor ted in fatal cases. Patients may experience
persistent oliguria, hematuria and proteinuria despite IV fluid resuscitation. Repor ts of peritoneal and
hemodialysis show no consistent correlation on sur vivability, and transmission risk to healthcare workers
should be considered. Hepatic: Patients demonstrate impaired liver function, hepatomegaly and elevated
liver enzymes (ALT/AST), but severity is lower than that seen in hepatitis A/B or yellow fever. One study
showed AST was several times higher than ALT in fatal cases.

Pain Management2,14-16

Treat mild pain with acetaminophen and moderate to severe pain with opioids. Avoid diclofenac,
ibuprofen and other NSAIDS due to antiplatelet activity; avoid tramadol due to seizure activity. The
management of pain resembling the approach to a critically ill patient with potential multi-organ failure
should be followed due to high risk of renal and hepatic failure.

Neurologic Suppor t1,6
Anxiety, Confusion, Seizures

Monitor the patient for confusion, anxiety and seizures. Treat anxiety and seizures with benzodiazepines.
Avoid the use of other medications that may reduce seizure threshold. Late in the disease progression,
monitor neurologic status for increased intracranial pressure and intracranial hemorrhage.

Gastrointestinal Suppor t1,10
Nutrition, Nausea/ Vomiting,
Diarrhea

Provide rehydration therapy to prevent volume depletion. Correct abnormal electrolytes. Proton pump
inhibitors should be administered for dyspepsia and gastrointestinal bleed prophylaxis. Administer
antiemetics for nausea/vomiting. Monitor for dehydration.

Sur vivability2,3

Dependent upon access to basic care and patient immune status. Current West Africa Ebola strain has
repor ted 70% mor tality rate (October 14, 2014).

Recover y2,13

Recover y (weeks to months) is highly dependent on suppor tive care and immunologic response of
patient. Men can still transmit Ebola virus through semen for up to 3 months so abstinence is
encouraged during this time. Once fully recovered, patients are no longer able to transmit the virus.
Development of antibodies last at least 10 years but it is unknown if this confers lifelong immunity or
if infection with other strains is possible. Acute complications include: generalized weakness, weight
loss, headache, sensor y distor tion, migrator y ar thralgias, skin sloughing, alopecia, and persistent anemia.
Uveitis and orchitis can occur weeks after illness, and virus can persist in aqueous humor and semen.

Experimental Therapies2,4

No experimental vaccines or antiviral medications have been fully tested for safety or efficacy. ZMapp
(Mapp Biopharmaceutical, Inc.), is an experimental treatment of three monoclonal antibodies that bind
to viral protein. All available doses have been distributed at this time. Several experimental vaccines and
treatments in animal models show promise.

217

L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

References and Evidence Classification
1.

Clinical management of patients with viral haemorrhagic fever: a pocket guide for the front-line health worker. World Health Organization. World Health Organization ,
2014. April 2014. Level 3

2.

Ebola (Ebola Virus Disease). Centers for Disease Control and Prevention website http://www.cdc.gov/vhf/ebola/. Updated October 3, 2014. Accessed October 16, 2014.

3.

WHO finds 70 percent Ebola mortality rate. Aljazeera.com Aljazeera America, 15 Oct 2014. Web. 16 Oct 2014.

4.

Ansari AA. Clinical features and pathobiology of Ebola virusinfection J Autoimmun 2014 Sep 23. Doi: 10.1016/j.jaut/2014.09.001. [Epub ahead of print] Level 3

5.

Kortepeter MG, Salwer JV, Hensley LE, et al. Real-time monitoring of cardiovascular function in rhesus macaques infected with Zaire ebolavirus. J Infect Dis 2011 Nov;204
Suppl 3:S1000-10. Animal study

Level 3

6.

Clark DV, Jahrling PB, Lawler JV. Clinical management of filovirus-infected patients. Viruses. 2012; 4, 1668-1686. Level 3

7.

Tan DX, Korkmaz A, Reiter RG, Manchester LC. Ebola virus disease: potential use of melatonin as treatment. J Pineal Res. 2014 Sep 27. doi: 10.1111/jpi.12186. [Epub
ahead of print] Level 3

8.

Ebola Clinical Care Guidelines: a guide for clinicians in Canada. http://www.ammi.ca/media/69846/Ebola%20Clinical%20Care%20Guidelines %202%20Sep%202014.
pdf. Updated August 29, 2014. Accessed October 16, 2014. Level 3

9.

Feldmann H, Geisbert TW. Ebola haemorrhagic fever. The Lancet. 2011;377(9768):849-62. Level 3

10.

Fowler RA, Fletcher T, Fischer WA, 2nd, Lamontagne F, Jacob S, Brett-Major D, et al. Caring for critically ill patients with ebola virus disease. Perspectives from west Africa.
Am J Respir Crit Care Med. 2014;190(7):733-7. Level 3

11.

Mupapa K, Massamba M, Kibadi K, Kuvala K, Bwaka, et al. Treatment of ebola hemorrhagic fever with blood transfusion from convalescent patients. J Infect Dis. 1999;
179(Suppl 1):S18-23. Level 2

12.

Roddy P, Colebunders R, Jeffs B, et al. Filovirus hemorrhagic fever outbreak case management: a review of current and future treatment options. Infect Disease. 2011; 204:
S791-S795. Level 3

13.

Kortepeter MG, Bausch DG, Bray M. Basic clinical and laboratory features of filoviral hemorrhagic fever. Infect Disease. 2011; 204: S810-S816. Level 3

14.

WHO: IMAI District Clinician Manual: Hospital Care for Adolescents and Adults- Guidelines for the Management of Common Illnesses with Limited Resources, 2011.
Available at http://apps.who.int/iris/bitstream/10665/ 77751/1/9789241548281_ Vol1_eng.pdf. Level 3

15.

Sprecher A. Filovirus haemorrhagic fever guidelines. Médecins Sans Frontières Belgium 2013. (in draft) Level 3

16.

Barr J, Fraser GL, Puntillo K, et al. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care
Med 2013; 41:263. Level 3

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L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

L903337

Multiple-Choice Questions
57. What is the first part of one’s body attacked by the Ebola virus?
A. The adrenal system
B. Vascular system causing hemorrhage
C. Immune system by infecting dendritic cells
D. Gastrointestinal tract causing diarrhea

58. To manage pain in patients with Ebola Virus Disease (EVD), clinicians should:
A. administer NSAIDS such as ibuprofen.
B. avoid tramadol due to potential seizure activity.
C. administer aspirin.
D. None of the above

59. Which of the following medications is recommended to provide neurological support to patients
with EVD who experience anxiety, confusion, and seizures?
A. Benzodiazepines
B. Opioids
C. Selective serotonin reuptake inhibitors
D. Selective norepinephrine reuptake inhibitors

60. For patients who fully recover from the Ebola viral infection:
A. patients have immunity to all known strains of the Ebola virus.
B. individuals develop antibodies for a lifetime.
C. men can still transmit the virus through semen for up to 3 months.
D. None of the above

221

Best Practices in CME
Safe Management of Patients with Ebola Virus Disease (EVD)
in U.S. Hospitals
By the American Hospital Association
ID#: L903337

This valuable take-home reference translates evidence-based, continuing medical education
research and theory, which is acquired from reading the associated CME lesson, into
a stepwise approach that reviews key learning points for easy assimilation into your
armamentarium of knowledge and daily practice.

CME Lesson Overview
In lieu of the Best Practice Key Points, we are inserting this valuable Frequently Asked Questions page which
also reviews the lesson material.

Safe Management of Patients with Ebola Virus Disease (EVD)
in U.S. Hospitals
Frequently Asked Questions
The recent EVD outbreak in West Africa has increased the possibility of patients traveling from the impacted countries
to the United States. Additionally, two American citizens with EVD were medically evacuated to the United States to
receive care at Emory University Hospital in Atlanta. The following are answers to frequently asked questions about
the safety of this medical evacuation and the necessary infection control procedures to protect patients and healthcare
providers in U.S. hospitals.

Are U.S. hospitals ready to care for patients with Ebola virus disease (EVD)?
Yes – any U.S. hospital that is following CDC’s infection control recommendations and can isolate a patient in a
private room is capable of safely managing a patient with EVD. CDC recommends that U.S. hospitals isolate the
patient in a private room and implement standard, contact, and droplet precautions.

The information presented herein is based upon the content in the associated CME lesson. If you have comments or feedback about this page,
please send your feedback via email to: [email protected] and reference the ID number under the title to which you are referring.
We will review your commentary, which may be used for publication.
The material in this journal is not a substitute for seeking the attention of a licensed health or medical clinician. These materials were created for professional education
purposes only and are not the express opinion of The Hatherleigh Company, Ltd.

L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

What should U.S. hospitals do if they have a patient with suspect EVD?
Early recognition is critical for infection control. Healthcare providers should be alert for and evaluate any patients
suspected of having EVD who have (see EVD case definition):
1. A fever of greater than 38.6 degrees Celsius or 101.5 degrees Fahrenheit, and additional symptoms such as severe
headache, muscle pain, vomiting, diarrhea, abdominal pain, or unexplained hemorrhage;
AND
2. Risk factors within the past 3 weeks before the onset of symptoms, such as contact with blood or other body fluids
of a patient known to have or suspected to have EVD; residence in—or travel to—an area where EVD transmission is
active; or direct handling of bats or nonhuman primates from disease-endemic areas. Malaria diagnostics should also
be a part of initial testing because it is the most common cause of febrile illness in persons with a travel history to the
affected countries.

When should patients with suspected EVD in U.S. hospitals be tested?
CDC recommends testing for all persons with onset of fever within 21 days of having a high-risk exposure such as
(See CDC’s laboratory testing guidance):
• percutaneous or mucous membrane exposure or direct skin contact with body fluids of a person with a confirmed or
suspected case of EVD without appropriate personal protective equipment (PPE),
• laboratory processing of body fluids of suspected or confirmed EVD cases without appropriate PPE or standard
biosafety precautions, or
• participation in funeral rites or other direct exposure to human remains in the geographic area where the outbreak is
occurring without appropriate PPE.
For persons with a high-risk exposure but without a fever, testing is recommended only if there are other compatible
clinical symptoms present and blood work findings are abnormal (i.e., thrombocytopenia <150,000 cells/µL and/or
elevated transaminases).

If a patient in a U.S. hospital is identified to have suspected or confirmed EVD, what
infection control precautions should be put into place?
If a patient in a U.S. hospital is suspected or known to have Ebola virus disease, healthcare teams should follow
standard, contact, and droplet precautions, including the following recommendations:
• Isolate the patient: Patients should be isolated in a single patient room (containing a private bathroom) with the
door closed.
• Wear appropriate PPE: Healthcare providers entering the patients room should wear: gloves, gown (fluid resistant
or impermeable), eye protection (goggles or face shield), and a facemask. Additional protective equipment might
be required in certain situations (e.g., copious amounts of blood, other body fluids, vomit, or feces present in the
environment), including but not limited to double gloving, disposable shoe covers, and leg coverings.

224

L903337 : Ebola Facts: Clinical Progression & Clinical Evidence

• Restrict visitors: Avoid entry of visitors into the patient’s room. Exceptions may be considered on a case by case basis
for those who are essential for the patient’s wellbeing. A logbook should be kept to document all persons entering the
patient’s room. See CDC’s infection control guidance on procedures for monitoring, managing, and training of visitors.
• Avoid aerosol-generating procedures: Avoid aerosol-generating procedures. If performing these procedures, PPE
should include respiratory protection (N95 or higher filtering facepiece respirator) and the procedure should be
performed in an airborne infection isolation room.
• Implement environmental infection control measures: Diligent environmental cleaning and disinfection and safe
handling of potentially contaminated materials is of paramount importance, as blood, sweat, vomit, feces, urine and
other body secretions represent potentially infectious materials should be done following hospital protocols.

Why do responders in Africa wear so much personal protective equipment (that can
include full body suits) for this Ebola outbreak when CDC says hospitals here could
safely manage the care of an Ebola patient without a full body suit?
There are important differences between providing care or performing public health tasks in Africa versus in a U.S.
hospital.
In field medical settings, additional PPE may be necessary to protect healthcare workers. In some places in Africa,
workers may not have the ability to prepare for potential exposures. For example, in some places, care may be provided
in clinics with limited resources (e.g., no running water, no climate control, no floors, inadequate medical supplies),
and workers could be in those areas for several hours with a number of Ebola infected patients. Additionally, certain
job responsibilities and tasks, such as attending to dead bodies, may also require different PPE than what is used when
providing care for infected patients in a hospital.

Content source:
Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Division of High-Consequence Pathogens and Pathology (DHCPP)
Viral Special Pathogens Branch (VSPB)

225

HATHERLEIGH’S ACCREDITATION AND CME DESIGNATION
The Hatherleigh Company, Ltd. designates this activity for a maximum of 40 AMA PRA
Category 1 Credits. Physicians should only claim credit commensurate with the extent
of their participation in the activity.
The Hatherleigh Company, Ltd. is accredited by the Accreditation Council for Continuing
Medical Education (ACCME) to provide continuing medical education for physicians.

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