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A collection of articles based on recently released guidelines and recommendations.

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The Basics

Table of Contents14 Getting a Grip on Asthma Control, Severity, & Exacerbations — Paul Enright, MD

18 New Treatment Guidelines for ED — Amir Qaseem, MD, PhD, MHA, FACP

110 Guidelines for Use of Antiretroviral Therapies — Paul E. Sax, MD

114 Strategies to Improve Medication Adherence — Walid F. Gellad, MD

118 Helpful Guidelines on Hand Hygiene in Healthcare — Maryanne McGuckin, ScEd, MT

122 New Recommendations Managing Depression During Pregnancy

— Kimberly A. Yonkers, MD

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A Message From the EditorWe at Physician’s Weekly are excited to present you with an eBook dedicated to coverage of recently released guidelines, position statements, and recommendations from various distinguished and reputable healthcare organizations nationwide. In recent months, our publication has featured a variety of these types of news items, focusing on clinical and evidence-based research. The content in these articles relies on the expertise of our contributing physician authors. We anticipate that Physician’s Weekly will continue to feature news in this field of medicine in the coming months. We hope that you find this information useful in your practice. Please let us know your thoughts by contacting us at editor@physweekly.com.

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Publication of an advertisement or other product mention

in Physician’s Weekly should not be construed as an

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The appearance of or reference to any person or entity in

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mentioned. The reader is advised to consult appropriate

medical literature and the product information currently

provided by the manufacturer of each drug to verify

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visit www.physweekly.com 54

Paul Enright, MDResearch Professor of Medicine

The University of Arizona

A working group of experts from the European

Respiratory Society (ERS) and the American

Thoracic Society (ATS) recently published rec-

ommendations for the standardized definition and

data collection for assessing asthma severity, asthma

control, and asthma exacerbations in clinical trials

and clinical practice (www.thoracic.org). “The FDA

has traditionally required that increases in lung func-

tion (FEV1) be the primary outcome in clinical trials

of new asthma therapy, but clinicians realize that the

primary goals of patients are to minimize symptoms

and prevent asthma attacks or exacerbations,” says

Paul Enright, MD, a member of the working group.

“Improved lung function is an easily available objec-

tive measure of pre-therapy asthma severity and the

best test of bronchodilator therapy, but good, long-

term asthma control on therapy is an even more im-

portant patient-oriented outcome.”

Asthma ExacerbationsAccording to Dr. Enright, emergency room visits for

asthma indicate a failure of the healthcare system to

help patients control their asthma. Asthma exacerba-

tions occur across the spectrum of asthma severity,

risk death, and cause considerable anxiety to patients

and their families. They are also expensive and as-

sociated with significant loss of school days or work.

Only in the past decade, however, have exacerbations

been used as a primary outcome variable in research

into the efficacy of drug treatment in asthma.

Exacerbations should prompt changes in treatment,

according to the ATS/ERS guidelines. Episodes vary

considerably in speed of onset and in time to resolu-

tion, ranging from a few minutes to several weeks.

They also vary in their absolute severity, both be-

tween and within individual patients. Clinical char-

April 26, 2010 • Issue No. 16

Click here to view this article online.

Getting a Grip on

Asthma Control, Severity, &

ExacerbationsThe American Thoracic Society and European Respiratory Society

recently released recommendations to help standardize the measure­

ment of improved asthma outcomes after changes in therapy.

visit www.physweekly.com 76

nosis of asthma and estimating its severity. When the

FEV1 is low during clinic visits, it should be measured

during follow-up visits to verify that lung function

has improved as a result of therapeutic interventions.

However, normal lung function does not exclude an

asthma diagnosis because patients with mild, inter-

mittent asthma usually have normal spirometry re-

sults between exacerbations. Biomarkers of airway

inflammation, such as exhaled nitric oxide and inha-

lation challenge tests (to measure AHR) are safe and

becoming more widely available in clinical settings.

They should be considered when the differential di-

agnosis of asthma is difficult. They also provide ob-

jective measurements for asthma clinical trials.

Healthcare UtilizationWhen asthma is poorly controlled, patients often re-

quire unscheduled use of healthcare, lose work and

school productivity, and need more expensive medi-

cations. These consequences have significant impli-

cations for asthma sufferers and healthcare providers.

Measures of healthcare utilization and health-related

quality of life provide indirect measures of asthma

control (Table 2). Dr. Enright notes that “clinicians

should also consider these patient-oriented factors

when treating patients with asthma.”

References

acteristics that cause acute distress and impairment

in one patient may represent another patient’s usual

status. As such, the guidelines recommend that exac-

erbation frequency be determined as part of routine

asthma assessments (Table 1). Information about the

onset and course of previous exacerbations should be

used to refine and customize written asthma action

plans for each patient.

Asthma Control“Asthma comprises four domains,” says Dr. Enright,

“including symptoms, variable airway obstruction,

twitchy airways (airway hyperresponsiveness, or

AHR), and airway inflammation.” The ATS/ERS

guidelines note that asthma severity should be deter-

mined before treatment is started, while asthma con-

trol is the extent to which the various manifestations

of the disease are reduced or removed by treatment.

Although severe exacerbations are more common in

patients with poorly-controlled asthma, they may also

occur in patients with mild asthma. For example, an

influenza infection often overwhelms the otherwise

good control achieved by use of combination asthma

inhalers. The FDA warns that although bronchodi-

lators may control symptoms and lung function in

the short term, use of long-acting bronchodilators

without the concurrent use of an inhaled corticos-

teroid is dangerous because bronchodilators do not

reduce airway inflammation or AHR. Considering

these facts, the concept of asthma control should en-

compass patients’ recent clinical state as well as their

future risk for experiencing adverse outcomes.

Asthma Daily DiariesSince asthma symptoms vary widely from week to

week, questionnaires administered only at clinic vis-

its are limited by patient recall and often do not cap-

ture the overall morbidity experienced by patients.

Therefore, the ATS/ERS guidelines recommend

patient diaries to measure symptoms, the use of al-

buterol rescue inhalers, and peak flow or FEV1 for

all asthma clinical trials. Dr. Enright says “asthma

diaries are very helpful to confirm improved asthma

control when medications have been changed, but

they are no longer considered a practical tool for

helping make the initial diagnosis of asthma.”

Lung Function & Airway ResponsivenessAccording to the ATS/ERS guidelines, it is essential

to perform good quality spirometry tests before and

after patients inhale albuterol when making a diag-

Paul Enright, MD, has reported to Physician’s Weekly that he has worked as a consultant for Pfizer on spirom- etry quality for a smoking cessation study and Gilead for a study of interstitial lung disease. His comments to Physician’s Weekly are his own beliefs and he is not speaking on behalf of the ATS, the ERS, or any other organization.

Table 1 Managing Exacerbations

• The severity of exacerbations varies considerably from patient to patient and over time.

• Asthma exacerbations should be identified by wors ening symptoms, the need for rescue inhalers, or

reduced lung function (FEV1 or peak expiratory flow).

• Information about the probable cause and the subsequent course of exacerbations should be used

to refine and customize the “action points’’ in written

asthma action plans.

• Exacerbation frequency should be evaluated as part of routine asthma assessment.

• A standardized definition of asthma exacerbations is needed for clinical practice, but is not yet available.

- It will differ from the definition used for

clinical trials.

Source: Adapted from: Paul Enright, MD; and Reddel HK, et al. Am J Respir Crit Care Med. 2009;180:59-99.

Table 2 Indirect Measures of Asthma Control

• Indicate whether primary care consultations were scheduled or unscheduled.

• Record all hospital referrals and the outcome.

- Patients should be prompted to follow-up with

their primary care providers.

• The need for prednisone for asthma exacerbations should be recorded.

• Record medical certificates issued for absence from work due to asthma.

• Clinicians should endeavor to evaluate quality-of- life issues relating to asthma from the perspective

of the patient.

• Quality-of-life assessments may help uncover unmet needs of patients.

Source: Adapted from: Paul Enright, MD; and Reddel HK, et al. Am J Respir Crit Care Med. 2009;180:59-99.

Reddel HK, Taylor DR, Bateman ED, et al for the American Thoracic Society/European Respiratory Society Task Force on Asthma Control and

Exacerbations. Asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit

Care Med. 2009;180:59-99. Available at: www.thoracic.org/statements/resources/respiratory-disease-adults/ats-ers-asthma-control-and-

exacerbations.pdf

Bateman ED, Boushey HA, Bousquet J, et al. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study.

Am J Respir Crit Care Med. 2004;170:836-844.

Taylor DR, Bateman ED, Boulet LP, et al. A new perspective on concepts of asthma severity and control. Eur Respir J. 2008;32:545-554.

National Heart Lung and Blood Institute National Asthma Education and Prevention Program. Expert Panel Report 3: Guidelines for the

Diagnosis and Management of Asthma. 2007. Available from: www.nhlbi.nih.gov/guidelines/asthma/asthgdln.htm

Lane S, Molina J, Plusa T. An international observational prospective study to determine the cost of asthma exacerbations (COAX).

Respir Med. 2006;100:434-450.

Improved lung function is an easily available

objective measure of pre­therapy asthma severity

and the best test of bronchodilator therapy, but

good, long­term asthma control on therapy is an

even more important patient­oriented outcome.

—Paul Enright, MD

visit www.physweekly.com 98

Erectile dysfunction (ED) is a common disor-

der of male sexual function that affects all age

groups, especially older people and those with

diabetes, vascular diseases, psychiatric disorders, and

possibly hypogonadism. The general population

continues to age and life expectancy is expected to

increase. When combined with the high prevalence

of diabetes and cardiovascular disease, the healthcare

burden and quality-of-life issues associated with ED

may be substantial.

Current pharmacologic therapies for ED include

phosphodiesterase-5 (PDE-5) inhibitors and hor-

monal treatment. On November 3, 2009, the

American College of Physicians (ACP) published a

guideline in the Annals of Internal Medicine based

on systematic reviews and current evidence, which

presents recommendations on hormonal testing and

pharmacologic management for ED.

Initiating & Selecting TherapyThe ACP strongly recommends that therapy with a

PDE-5 inhibitor be initiated in men who seek treat-

ment for ED and who do not have a contraindication

for using these drugs (Table). Oral PDE-5 inhibitors

have demonstrated statistically significant and clini-

cally relevant improvements in sexual intercourse and

erectile function. Overall, PDE-5 inhibitors were well

tolerated and were associated with mild or moderate

adverse events. The incidence of adverse events did

not significantly differ among the available PDE-5

inhibitors. Nitrate therapy, however, is a contraindica-

tion for therapy with oral PDE-5 inhibitors. The ACP

also recommends that clinicians base their choices

of a specific PDE-5 inhibitor on the individual

preferences of men with ED. Evidence is in-

sufficient to compare efficacy and adverse

effects of different PDE-5 inhibitors, so

clinicians should consider individual pref-

erences such as ease of use, cost of medi-

cation, and adverse effects profiles.

Some Questions Remain The ACP does not recom-

mend for or against the

routine use of hor-

monal blood tests or

hormonal treatment

when managing ED

because there is in-

conclusive evidence

to determine the net

benefits and harms.

In studies of men

with ED, the preva-

lence of low testos-

New Treatment Guidelines for ED

terone varies widely, ranging from 12.5% to 36.0%.

The evidence is inconclusive about the effectiveness

of hormonal treatment, even in patients with low tes-

tosterone. Trials comparing testos terone (delivered in

various forms) with placebo in hypogonadal men with

ED were small, had low quality, or reported inconsis-

tent effects on erectile function. Considering these

lingering questions, clinicians should individualize

decisions to measure hormone levels. When deciding

whether or not to measure hormone levels, consider

the presence or absence of clinical symptoms of hor-

monal dysfunction (eg, decreased libido, premature

ejaculation, or fatigue) and of physical findings (eg,

testicular or muscle atrophy).

In addition to researching more deeply into hor-

monal tests and treatments, it’s also paramount that

future research endeavors improve upon the quality

of reporting. Some studies have evaluated the dose-

response effect of PDE-5 inhibitors with respect to

efficacy and harms, but more high-quality studies

would be beneficial.

Amir Qaseem, MD, PhD, MHA, FACP, has indicated to Physician’s Weekly that he is a principal investigator on unrestricted educational grants awarded to the American College of Physicians from the Agency for Healthcare Quality and Research, the Robert Wood Johnson Foundation, Atlantic Philanthropies, Endo Pharmaceuticals, Boehringer-Ingelheim, and Wellpojnt, Inc.

Amir Qaseem, MD, PhD, MHA, FACPSenior Medical Associate

Clinical Programs and Quality of Care Department

American College of Physicians

References

Table Recommendations The American College of Physicians (ACP) recommends

that clinicians initiate therapy with a PDE-5 inhib itor

in men who seek treatment for erectile dysfunction

and who do not have a contraindication to PDE-5

inhibitor use.

The ACP recommends that clinicians base the choice

of a specific PDE-5 inhibitor on the individual prefer-

ences of men with erectile dysfunction, including ease

of use, cost of medication, and adverse effects profile.

The ACP does not recommend for or against routine

use of hormonal blood tests or hormonal treatment in

the management of patients with erectile dysfunction.

Source: Adapted from: Qaseem A, et al. Ann Intern Med. 2009;639-649.

Qaseem A, Snow V, Denberg TD, et al; for the Clinical Efficacy Assessment Subcommittee of the American College of Physicians. Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2009

Oct 20;151 [Epub ahead of print]. Available at: www.annals.org/cgi/content/full/0000605-200911030-00151v1

Tsertsvadze A, Yazdi F, Fink HA, et al. Diagnosis and Treatment of Erectile Dysfunction. AHRQ Evidence Report/Technology Assessment no. 171. Bethesda, MD: Agency for Healthcare Research and Quality; May 2009. AHRQ publication no. 08(09)-E016. Available at www.ahrq.gov/downloads/

pub/evidence/pdf/erectiledys/erecdys.pdf. Accessed October 22, 2009.

Tsertsvadze A, Fink HA, Yazdi F, MacDonald R, Bella AJ, Ansari MT, et al. Oral phosphodiesterase-5 inhibitors and hormonal treatments for erectile

dysfunction: a systematic review and meta-analysis prepared for an American College of Physicians’ clinical practice guideline. Ann Intern Med.

2009;151:650-661.

Wessells H, Joyce GF, Wise M, Wilt TJ. Erectile dysfunction. J Urol. 2007;177:1675-1681.

Acar D, Cayan S, Bozlu M, Akbay E. Is routine hormonal measurement necessary in initial evaluation of men with erectile dysfunction?

Arch Androl. 2004;50:247-253.

Earle CM, Stuckey BG. Biochemical screening in the assessment of erectile dysfunction: what tests decide future therapy?

Urology. 2003;62:727-731.

April 5, 2010 • Issue No. 13

Click here to view this article online.

visit www.physweekly.com 1110

The Department of Health and Human Services

(DHHS) Panel on Antiretroviral Guidelines for

Adults and Adolescents issued new guidelines

December 1, 2009 for the use of antiretroviral agents

in HIV-1-infected adults and adolescents. The revised

recommendations update the November 3, 2008 ver-

sion of the guidelines. “The guidelines serve as a living

document and are updated regularly using electronic

distribution channels,” says Paul E. Sax, MD, who is

on the DHHS panel. In the guidelines, recommenda-

tions are based on the best evidence from prospective

trials in HIV therapy with defined endpoints.

When to StartThere are several key changes from the November 3,

2008 DHHS guidelines, and one of the most impor-

tant, in Dr. Sax’s opinion, addresses when to start

antiretroviral therapy (ART). “In recent cohort

studies, findings support that starting therapy

in patients with a higher CD4 cell count is as-

sociated with improved outcomes,” he says.

“Most of the available evidence recommends

starting ART earlier, with specific consider-

ations [Table 1]. For example, one study suggested

that treatment be started before the CD4 cell count

falls below 350 cells/mm3 while another found that

500 cells/mm3 should be the threshold. Consider-

ing data from observational studies and data from

prospective clinical trials, the panel decided that the

threshold for starting ART should be increased to be-

tween 350 cells/mm3 and 500 cells/mm3.”

While there is clearly a movement in the updated

DHHS guidelines to begin treatment earlier, Dr. Sax

says this strategy does not apply to everyone. “Some

patients are clearly not ready to start therapy because

they can’t commit to lifelong medication adherence.

Providers and patients must work together to develop

individualized treatment plans, especially in cases

where patients have higher CD4 cell counts but are

not initiating ART.”

The DHHS update continues to recommend that

ART be started in all patients who have a history of

an AIDS-defining illness or in whom CD4 counts are

less than 350 cells/mm3. Regardless of CD4 count,

ART should also be started in women who are preg-

Guidelines for Use of Antiretroviral

TherapiesRevised guidelines have been issued for the use of antiretroviral

therapy in people with HIV. Important changes have been made

in the initiation of therapy and determining which regimens

are most appropriate when starting treatment.

Paul E. Sax, MDClinical Director, HIV Program

Division of Infectious Diseases

Brigham and Women’s Hospital

Associate Professor of Medicine

Harvard Medical School

March 22, 2010 • Issue No. 12

Click here to view this article online.

visit www.physweekly.com 1312

consider pill burden, adverse event profiles, effects on

pregnancy, and other complications of treatment. It’s

also important to analyze long-term data when select-

ing regimens to ensure that HIV patients are directed

to the most appropriate ART depending on each per-

son’s individual characteristics. Clinicians should rec-

ognize that some patients will be better treated using

alternative regimens based on their preexisting condi-

tions. The guidelines can help steer these treatment

decisions for providers.”

Other Updates The updated DHHS guidelines added a new section

that reviews current knowledge on the epidemiology

and diagnosis of HIV-2 infection, and the role of ART

in the treatment of these patients. “HIV-2 infection

is most prevalent in Western Africa,” says Dr. Sax.

“There also appears to be a higher rate in countries

with strong socioeconomic ties to West Africa, such as

France, Spain, Portugal, and former Portuguese colo-

nies such as Brazil, Angola, Mozambique and parts

of India, near Goa. This can affect U.S. clinicians too

because immigrants from these regions may enter the

country. Unfortunately, we still lack data on the opti-

mal treatment of HIV-2 infection. The limited avail-

able evidence indicates that non-nucleoside reverse

transcriptase inhibitors do not appear to have activity

in these patients. For now, a regimen containing nu-

cleoside reverse transcriptase inhibitors plus a boosted

protease inhibitor is probably the best approach.”

More specific recommendations are provided con-

cerning when genotypic and phenotypic testing

should be used to guide management in both new-

ly-diagnosed patients and in treatment-experienced

patients when viremia develops during treatment.

The guidelines have updated information on drug-

resistance testing, regimens that should not be used,

the management of treatment-experienced patients,

treatment simplification, and hepatitis C coinfection.

Sections on antiretroviral-associated adverse effects,

antiretroviral drug interactions, and the prevention of

secondary transmission of HIV have also been updat-

ed. Dr. Sax says “these guidelines can provide helpful

advice for clinicians managing patients with HIV and

will continue to be updated as more evidence emerges

in the future.”

nant or in those who have HIV-associated nephropa-

thy or hepatitis B virus (HBV) coinfection for which

treatment of HBV is indicated.

What to StartThe December 1, 2009 DHHS guidelines also pro-

vide an update on what specific drug regimens should

be started in patients with HIV (Table 2). “There

have been many prospective comparative trials of

regimens—not just components of regimens—and

the panel now offers recommendations for ‘preferred’

regimens,” explains Dr. Sax. “Preferred regimens were

defined as having the most effective virologic efficacy

and tolerability and being the easiest for patients to

use.” The guidelines also have “alternative” regimens,

which have shown good virologic efficacy and toler-

ability but have some disadvantages when compared

with preferred regimens.

“The reason preferred regimens were chosen is that

direct head-to-head, randomized clinical trials have

been published,” says Dr. Sax. “These trials offer the

highest level of evidence that exists in clinical research.

When selecting preferred regimens, clinicians need to

References

Table 2 What to Start in ART-Naïve Patients

Regimens now have new classifications:

• “Preferred.”

• “Alternative.”

• “Acceptable.”

• “Regimens that may be acceptable but more definitive data are needed.”

• “Regimens to be used with caution.”

The following changes were made in the

recommendations:

• “Raltegravir + tenofovir/emtricitabine” has been added as a “Preferred” regimen based on the results of a Phase III randomized controlled trial.

• Fosamprenavir/ritonavir is now “Alternate.”

Four regimens are now listed as “Preferred” regimens for treatment-naïve patients:

• Efavirenz/tenofovir/emtricitabine.

• Ritonavir-boosted atazanavir + tenofovir/emtricitabine.

• Ritonavir-boosted darunavir + tenofovir/emtricitabine.

• Raltegravir + tenofovir/emtricitabine.

Lopinavir/ritonavir-based regimens are now listed as

“Alternative” regimens instead of “Preferred” regimens, except in pregnant women

• For pregnant women, twice-daily lopinavir/ ritonavir + zidovudine/lamivudine remains a “Preferred” regimen.

Source: Adapted from: Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents.

Department of Health and Human Services. December 1, 2009;1-161. Available at www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

Paul E. Sax, MD, has disclosed to Physician’s Weekly that he has served as an advisor or consultant to, and has received grants for educational activities from Abbott Laboratories, Bristol-Myers Squibb, Gilead Sciences, Tibotec, and Pfizer. He has also received grants for clinical research and educational activities and served as an advisor or consultant to Merck and GlaxoSmithKline.

Table 1 Initiation of Antiretroviral Therapy Earlier initiation of antiretroviral therapy (ART) is

recommended with the following specific considerations:

• ART should be initiated in all patients with a history of an AIDS-defining illness or with CD4

count <350 cells/mm3.

• ART should be initiated, regardless of CD4 count, in patients with the following conditions:

- Pregnancy.

- HIV-associated nephropathy.

- Hepatitis B virus (HBV) coinfection when treatment

of HBV is indicated.

• ART is recommended for patients with CD4 counts between 350 cells/mm3 and 500 cells/mm3. The

Panel was divided on the strength of this recom-

mendation: 55% wanted a strong recommendation

and 45% wanted a moderate recommendation.

• For patients with CD4 counts >500 cells/mm3, 50%

of Panel members favored starting ART; the other

half viewed treatment as optional in this setting.

• Patients initiating ART should be willing and able to commit to lifelong treatment and should understand

the benefits and risks of therapy and the importance

of adherence. Patients may choose to postpone

therapy, and providers, on a case-by-case basis,

may elect to defer therapy based on clinical and/or

psychosocial factors.

Included in the guidelines is a statement of benefits of re-

duction in HIV-associated inflammation and its asso ciated

complications and reduction in HIV trans mission and a

recognition of risks of short- or long-term drug-related

complications, non-adherence to lifelong therapy in asymp-

tomatic patients, and potential for development of drug

resistance may offset possible benefits of earlier initiation.

Source: Adapted from: Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adoles-

cents. Department of Health and Human Services. December 1, 2009;1-161. Available at www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf.

Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and

adolescents. Department of Health and Human Services. December 1, 2009;1-161. Available at www.aidsinfo.nih.gov/ContentFiles/Adultand

AdolescentGL.pdf

Matheron S, Pueyo S, Damond F, et al. Factors associated with clinical progression in HIV-2 infected-patients: the French ANRS cohort.

AIDS. 2003;17:2593-2601.

Branson BM, Handsfield HH, Lampe MA, et al. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in

health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17.

Stone VE, Jordan J, Tolson J, et al. Perspectives on adherence and simplicity for HIV-infected patients on antiretroviral therapy: self-report of

the relative importance of multiple attributes of highly active antiretroviral therapy (HAART) regimens in predicting adherence. J Acquir Immune

Defic Syndr. 2004;36:808-816.

U.S. Department of Health and Human Services. Public Health Service Task Force recommendations for use of antiretroviral drugs in pregnant

HIV-1-infected women for maternal health and interventions to reduce perinatal HIV-1 transmission in the United States. Available at: aidsinfo.

nih.gov/contentfiles/PerinatalGL.pdf

Gulick RM, Ribaudo HJ, Shikuma CM, et al. Three- vs four-drug antiretroviral regimens for the initial treatment of HIV-1 infection: a randomized

controlled trial. JAMA. 2006;296:769-781

Kitahata MM, Gange SJ, Abraham AG, et al; NA-ACCORD Investigators. Effect of early versus deferred antiretroviral therapy for HIV on survival.

N Engl J Med. 2009;360:1815-1826.

visit www.physweekly.com 1514

According to recent estimates, about a third to a

half of all patients in the United States fail to

comply with their prescribed pharmacotherapy

regimens. Failure to adhere to medications can re-

duce quality of care and increase medical expenses.

Costs attributable to non-adherence are about $290

billion each year, and much of this spending stems

from complications that result from not taking

medications appropriately. “Patients fail to take their

medications for many reasons, including difficulty

with dosing regimens, costs, side effects, or concerns

about drugs in general,” says Walid F. Gellad, MD.

“Providers need different strategies and interventions

to improve adherence.”

To achieve optimal medication adherence, consider-

ations must be made with regard to effective patient-

provider communication, coordination among care

providers, and active engagement and participation

by patients. “All too often, patients are lacking im-

portant information or there are gaps in their com-

munication with providers,” Dr. Gellad says. “For

these reasons, it’s critical to identify any opportuni-

ties to remove barriers that keep patients from adher-

ing to their medications.”

New Policy RecommendationsOn July 15, 2009, several organizations convened

more than 40 experts to discuss poor medication

adherence in the United States, including Glaxo-

SmithKline, the National Association of Chain Drug

Stores Foundation, the National Consumers League,

the Pharmaceutical Research and Manufacturers

of America, and the American College of Cardiol-

ogy. As a result of this meeting, consensus policy

recommendations to reduce barriers to adherence

were released on October 14, 2009. Using themes

that emerged from the July 15, 2009 conference and

considering the proposed policies under review by

Congress, the resulting recommendations focus on

the following key areas: quality improvement strat-

Strategies to Improve

Medication Adherence

A diverse group of healthcare and consumer organizations

have released recommendations to promote better adherence

to medication use and improve health outcomes for patients.

Contributing to this article:

Walid F. Gellad, MDAssociate Scientist and Policy Researcher

RAND Corporation

Assistant Professor of Medicine, Division of General Medicine

University of Pittsburgh

Staff Physician

VA Pittsburgh Center for Health Equity Research and Promotion

February 15, 2010 • Issue No. 7

Click here to view this article online.

visit www.physweekly.com 1716

improve healthcare quality. “The potential for health

IT is enormous,” says Dr. Gellad. “It can be used to

improve the flow of medication use information be-

tween patients and providers at the point of care and

during transitions of care. Importantly, health IT can

assist in identifying and addressing gaps about pa-

tients’ medication use.”

Educating & Engaging Providers & Patients Patients’ beliefs and expectations about their medi-

cations and the availability of social supports can

affect patients’ ability to adhere to treatment regi-

mens. Good patient-provider communication is also

necessary. “Physicians need to encourage patient-

centered care that is designed to help patients bet-

ter understand their conditions and recommended

treatments, including medications,” says Dr. Gellad.

“Providers need to establish clear lines of commu-

nication about medication adherence with their

patients at every encounter. Efforts should support

providers in effectively communicating the impor-

tance of following treatment plans to patients and

their caregivers.” Education, counseling, reconcilia-

tion, and other activities that fully engage patients

may further improve adherence.

More to ComeAlthough much is known about the impact of poor

medication adherence, more research is necessary to

achieve better medication use and improve clinical

outcomes (Table 2). “We have a good understand-

ing of the barriers that patients face in taking their

medications appropriately,” says Dr. Gellad, “but we

need more research that assesses the effectiveness of

interventions to improve adherence. Interventions

to reduce barriers to adherence will hopefully help

patients and providers achieve better medication use

and health outcomes.”

egies, care coordination, use of health information

technology (IT), and patient and provider education

and engagement (Table 1).

Quality Improvement & Coordination of CareDespite the U.S. having an advanced healthcare sys-

tem, further improvements in quality can and must

be achieved. “Given the role that medications play

in treating diseases—particularly chronic ones—we

must implement strategies to recognize medica-

tion adherence and appropriate drug use as critical

components of improving outcomes and quality,”

explains Dr. Gellad. He adds that care coordination

must also improve, and physicians should recognize

the importance of medications in settings where care

is coordinated for multiple providers and patients.

Technology to the RescueCongress invested over $19 billion in the American

Recovery and Reinvestment Act of 2009 to help ac-

celerate the development of a nationwide interop-

erable health IT infrastructure. Policies have been

initiated to encourage physicians to use electronic

prescribing. Other policy makers are considering dif-

ferent strategies that build upon these reforms and

utilize health IT to improve patient care and measure

adherence. This information may ultimately help to

References

Table 1 Key Recommendations

Abbreviations: OTC, over-the-counter; IT, information technology; EHR, electronic health record.

Source: Adapted from: Prescription for Healthier Patients: Real Solutions for Better Medication Adherence. Better Medication Adherence is Essential to Improve Health Care Quality, Outcomes and Value. Diverse Group of Key Stakeholders Develop Consensus Policy Recommendations. October 14, 2009.

Available at www.nacds.org/user-assets/pdfs/2009/pharmacy/Policy_Recommendations_091014.pdf. Accessed October 29, 2009.

Coordinate Care:

• Develop specified criteria for qualification as a medical home, including care teams consisting of

a broad range of providers involved in patient care

(eg, pharmacists) and active involvement of patients

and caregivers in developing and implementing

care plans.

• Establish care plans for use in a range of care coordination models that include initial medication

review of all prescription and OTC medications and

supplements.

- Use information from reviews to establish and reach

clinical goals.

- Adopt medication reconciliation processes across

healthcare providers during transitions in care.

• Use suitable incentives to support care coordination activities; deliver to pharmacists, physicians, and

other providers.

Health IT:

• Develop EHR standards that support consistent data collection, ease of use, and provider access

to comprehensive electronic medication use

information for patients.

• Create incentives for providers to use health IT to identify patients at risk for poor medication

adherence.

• Enable for patient-provider and provider-provider sharing of EHRs while ensuring patient privacy.

• Use electronic reminders and personal health records; optimize use by consumers.

Quality Improvement:

• Create validated consensus-based metrics and public reporting tools to help establish a baseline

and to set goals.

• Establish suitable provider incentives.

• Utilize prevention initiatives.

Patient/Provider Education and Engagement:

• Support public education campaigns regarding compliance with chronic disease management.

• Use electronic and telephonic reminders, packaging features, and other tools.

• Utilize case management and other services designed to help patients take their medications correctly.

• Give provider education and training on shared decision-making and other patient communication

techniques.

• Promote health plan and payor strategies to design benefits that:

- Encourage better access to recommended treatments.

- Increase patient awareness of tools to

improve adherence.

- Foster coordination of existing

community-based services.

- Disseminate best practices and interventions.

- Promote providers use of screening tools to identify

patients at risk for poor medication adherence.

Table 2 Priority Areas for Future ResearchAdditional research on medication adherence is needed.

This should include:

• Carefully designed studies of a wide range of interventions to improve medication adherence.

• Assessments of:

- The relationship between non-health related factors

(eg, language, literacy, economic status) and

medication adherence.

- Less studied aspects of medication adherence

(eg, factors that lead to failure to first fill a

prescription).

• The impact of setting and type of provider on effectiveness of alternative interventions in

addressing patient barriers and barriers faced

by different patient groups.

• Collection of additional information on patient medication use.

• Continued evaluation of the economic and clinical impact of improved medication adherence on

healthcare system costs and health status.

Source: Adapted from: Prescription for Healthier Patients: Real Solutions for Better Medication Adherence. Better Medication Adherence is Essential to Improve Health Care Quality, Outcomes and Value. Diverse Group of Key

Stakeholders Develop Consensus Policy Recommendations. October 14, 2009. Available at www.nacds.org/user-assets/pdfs/2009/pharmacy/Policy_

Recommendations_091014.pdf. Accessed October 29, 2009.

Walid F. Gellad, MD, has indicated to Physician’s Weekly that he has or has had no financial interests to report. He notes that he was a participant in the July 2009 expert panel discussed in the article, but is not an author of the ensuing policy recommendations.

Prescription for Healthier Patients: Real Solutions for Better Medication Adherence. Better Medication Adherence is Essential to Improve

Health Care Quality, Outcomes and Value. Diverse Group of Key Stakeholders Develop Consensus Policy Recommendations. October 14, 2009. Available at www.nacds.org/user-assets/pdfs/2009/pharmacy/Policy_Recommendations_091014.pdf Accessed October 29, 2009.

Osterberg L., Blaschke T. Adherence to medication. N Engl J Med. 2005:353:487-497.

Gellad WF, Haas JS, Safran DG. Race/ethnicity and nonadherence to prescription medications among seniors: results of a national study.

J Gen Intern Med. 2007;22:1572-1578.

Gellad WF, Huskamp HA, Phillips KA, Haas JS. How the new medicare drug benefit could affect vulnerable populations.

Health Aff (Millwood). 2006;25:248-255.

visit www.physweekly.com 1918

Throughout the world, surveillance and preven-

tion of healthcare-associated infections (HCAIs)

have become a greater priority for institutions

committed to making healthcare safer. These infec-

tions have been associated with prolonged hospital

stays, long-term disability, increased resistance of

microorganisms to antimicrobials, massive financial

burdens, high costs for patients and their families,

and excess deaths. One prominent reason for the

spread of HCAIs has been poor hand hygiene. In an

effort to address this issue, the World Health Organi-

zation (WHO) issued guidelines on hand hygiene in

healthcare in May 2009. Available at www.who.int,

the guidelines offer a thorough review of evidence as

well as specific recommendations to improve hand

hygiene practices and reduce transmission of patho-

genic microorganisms to patients and healthcare

workers (HCWs).

“The new WHO guidelines are an extension to rec-

ommendations issued by the CDC in 2002,” ex-

plains Maryanne McGuckin, ScEd, MT, who was on

the task force that created both the WHO and CDC

guidelines. “They provide an extensive literature

review and inform clinicians on strategies for im-

provement that have tested successfully.” The WHO

guidelines are designed to be used in any setting in

which healthcare is delivered. Individual adaptation

of the recommendations is encouraged, based on lo-

cal regulations, settings, needs, and resources.

Assessing Practices & AdherenceAccording to the WHO guidelines, understanding

hand hygiene practices among HCWs is essential

to planning interventions. Adherence by HCWs to

recommended procedures has been reported with

significant variation, reaching unacceptably poor lev-

els in some cases. Risk factors for poor adherence to

hand hygiene recommendations have been well-doc-

umented, and there appears to be an inverse relation-

ship between intensity of patient care and adherence

to hand hygiene.

Helpful Guidelines on Hand Hygiene

in HealthcareThe World Health Organization has issued guidelines

to improve hand hygiene practices and reduce the

transmission of pathogenic microorganisms.

February 8, 2010 • Issue No. 6

Click here to view this article online.

Maryanne McGuckin, ScEd, MT President and Founder

McGuckin Methods International, Inc.

Senior Scholar, Department of

Health Policy

Thomas Jefferson University

visit www.physweekly.com 2120

Perceived barriers to hand hygiene adherence recom-

mendations include skin irritation caused by hand

hygiene agents, inaccessible hand hygiene supplies,

interference with HCW-patient relationships, and

the perception that patient needs take priority over

hand hygiene. Wearing of gloves, forgetfulness, lack

of knowledge of guidelines, insufficient time for hand

hygiene, and high workload and understaffing are

other perceived barriers. Furthermore, some HCWs

have reported believing that they washed their hands

when necessary even when observations indicated

that they did not.

Enacting Real ChangeThe WHO guidelines provide many important rec-

ommendations, spanning the domains of indications

for hand hygiene; hand hygiene technique; surgical

hand preparation; selection and handling of hand

hygiene agents; skin care; use of gloves; and other as-

pects of hand hygiene. Dr. McGuckin says that most

HCWs are aware of practices that correlate with

good hand hygiene, but she notes that—despite this

fact—rates of adherence are still low. “The key for

clinicians is to understand that good hand hygiene

practices are encouraged at each and every patient

encounter. Clinicians must understand when and

how to use specific techniques. To enact real change,

multimodal approaches and complete collabora-

tion among all constituents are imperative. Guide-

lines must be disseminated, multidisciplinary efforts

aimed at improving hand hygiene must be fostered,

and explicit administrative support must be gained

and maintained.”

The guidelines outline several strategies to imple-

ment improvement efforts for hand hygiene. “Some

strategies include posting hand hygiene policies near

the point of care, conducting education and training

programs regularly, and ensuring that facilities are

equipped properly to encourage good hand hygiene,”

says Dr. McGuckin. “A helpful example is the ‘My 5

Moments for Hand Hygiene’ tool, which serves as

a reminder for clinicians on when to practice hand

hygiene [Figure]. This tool and others outlined in the

WHO guidelines should be disseminated through-

out healthcare settings.”

Empowering Patients & HCWsThere has been increasing interest in establishing

interventions to promote hand hygiene, including

(but not limited to) HCW education, performance

feedback, reminders, use of automated sinks, and the

introduction of alcohol-based handrubs. Dr. McGu-

ckin says that education of HCWs and patients alike

is one of the cornerstones of improvement in hand

hygiene practices (Table). “It’s especially critical that

patients be empowered to ask their HCWs questions

about hand hygiene. Likewise, providers need to be

proactive and inform patients that they’re practicing

good hand hygiene to protect them. Fostering and

encouraging this communication is critical, and the

issue must be brought to the forefront.”

Sustaining EffortsRegular hand hygiene monitoring and feedback on

adherence by HCWs are imperative to sustaining

hand hygiene improvements. “The ultimate goal is

to lower the rate of HCAIs,” says Dr. McGuckin.

“To do that, the impact of hand hygiene interven-

tions and promotion programs for HCWs must be

measured. The clinical focus should be on specific

factors that influence behavior. Strategies should be

multifaceted and multimodal, and include consistent

education and senior executive support.”

References

Table Programs for HCWs: Strive to Educate & Motivate

• In hand hygiene promotion programs for healthcare workers (HCWs), focus specifically on factors currently

found to have a significant influence on behavior and

not solely on the type of hand hygiene products.

- Strategies should be multifaceted and multimodal

and include education and senior executive support

for implementation.

• Educate HCWs about the type of patient-care activities that can result in hand contamination.

- Provide information about the advantages

and disadvantages of various methods used

to clean hands.

• Monitor HCWs’ adherence to recommended hand hygiene practices.

- Provide HCWs with performance feedback.

• Encourage partnerships between patients, their families, and HCWs to promote hand hygiene in

healthcare settings.

Source: Adapted from: World Health Organization. Available at: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf.

Figure My 5 Moments for Hand Hygiene

Source: Adapted from: World Health Organization. Available at: http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf.

Before

touching

a patient

After body

fluid exposure

risk

After

touching

patient

After

touching patient

surroundings

Before

clean/antiseptic

procedure

Maryanne McGuckin, ScEd, MT, has indicated to Physician’s Weekly that she has no financial disclosures to report.

World Health Organization. WHO Guidelines on Hand Hygiene in Health Care, 2009. Available at: http://whqlibdoc.who.int/publications/2009/

9789241597906_eng.pdf Accessed October 22, 2009.

McGuckin Methods International, Inc. Available at: www.hhreports.com Accessed October 28, 2009.

Boyce JM. Hand hygiene compliance monitoring: current perspectives from the USA. J Hosp Infect. 2008;70(Suppl 1):2-7.

Pittet D, Allegranzi B, Boyce J; World Health Organization World Alliance for Patient Safety First Global Patient Safety Challenge Core Group

of Experts. The World Health Organization Guidelines on Hand Hygiene in Health Care and their consensus recommendations. Infect Control

Hosp Epidemiol. 2009;30:611-622.

Sax H, Allegranzi B, Uçkay I, Larson E, Boyce J, Pittet D. ‘My five moments for hand hygiene’: a user-centred design approach to understand,

train, monitor and report hand hygiene. J Hosp Infect. 2007;67:9-21.

Pittet D, Allegranzi B, Sax H, et al; WHO Global Patient Safety Challenge, World Alliance for Patient Safety. Evidence-based model for hand

transmission during patient care and the role of improved practices. Lancet Infect Dis. 2006;6:641-652.

McGuckin M, Waterman R, Shubin A. Consumer attitudes about healthcare-acquired infections and hand hygiene. Am J Med Qual.

2006;21:342-346.

McGuckin M, Waterman R, Govednik J. Hand hygiene compliance in the U.S: a multicenter evaluation using product volume measurement

and feedback. Am J Med Qual. 2009;24:205-213.

visit www.physweekly.com 2322

It has been estimated that between 14% and 23%

of pregnant women will experience depressive

symptoms during their pregnancy. An investiga-

tion published in 2003 reported that about 13% of

women take an antidepressant at some time during

their pregnancy. “Depression in pregnant women

frequently goes unrecognized and untreated for a

host of reasons, including concerns about the safety

of some treatments for pregnant patients and their

offspring,” says Kimberly A. Yonkers, MD. “There

may be risks associated with both untreated depres-

sion and the use of antidepressants that can compli-

cate treatment decisions.”

A New ReviewAn evidence-based report from the American Psychi-

atric Association (APA) and the American College of

Obstetricians and Gynecologists (ACOG) has been

published to assist clinicians and patients as they

weigh the risks and benefits of various treatment op-

tions for depression during pregnancy. The APA and

ACOG convened a work group consisting of clinical

research experts within the fields of obstetrics and gy-

necology, psychiatry, and pediatrics, which critically

evaluated and summarized information about risks

associated with depression and the use of antidepres-

sants during pregnancy. The resulting recommenda-

tions were published jointly in the September 2009

issue of Obstetrics & Gynecology and the September/

October 2009 issue of General Hospital Psychiatry.

“Typically, OB-GYNs, nurse practitioners, and nurse

midwives are the clinicians who most often see wom-

en who are pregnant,” says Dr. Yonkers. “They can be

the first clinician to make a diagnosis of depression

in some cases. Other times, they may be the first to

observe depressive symptoms that are worsening. In

the past, reproductive health practitioners have re-

ported feeling ill-prepared to treat these patients be-

cause of the lack of evidence-based guidance. With

the publication of these recommendations, our hope

New recommendations have been unveiled to help physicians

and patients weigh the risks and benefits of various treatment

interventions for depression during pregnancy.

New Recommendations Managing Depression

During Pregnancy

Kimberly A. Yonkers, MDProfessor of Psychiatry

Professor of Obstetrics, Gynecology,

and Reproductive Sciences

Director, PMS & Perinatal Research

Program

Yale University School of Medicine

January 11, 2010 • Issue No. 2

Click here to view this article online.

visit www.physweekly.com 2524

nation with medication. “There is no one-size-fits-

all approach for managing depression during preg-

nancy,” Dr. Yonkers says. “Management approaches

should depend on specific scenarios, patient char-

acteristics, and severity of depression. The APA/

ACOG report provides algorithms to help clinicians

during their care of these women. It should be noted

that there are more ways to intervene than to sim-

ply medicate or do nothing. Pregnant women with

severe recurrent depression should be considered

for some sort of treatment, be it psychological, medi-

cal, or both.”

One of the key recommendations of the APA/ACOG

report is that there needs to be ongoing consultation

between OB-GYNs, psychiatrists, and other health-

care providers during pregnancy (Table). “A collab-

orative approach is paramount,” says Dr. Yonkers.

“The more communication there is within this triad

of providers, the better. We should seek to form a

united front when dealing with a severe depressive

disorder in this patient group.”

Physicians and providers should remember that

women taking antidepressants prior to pregnancy

received these medications for good reason, says

Dr. Yonkers. “As providers, we can’t only look at one

part of the picture in isolation and simply take all

patients off antidepressants. We need to recognize

that our treatment strategies and decisions may have

profound effects during pregnancy.”

More Data NeededDr. Yonkers says that there is some existing research

relating to antidepressant use in pregnancy, but

more data are needed. “We have yet to adequately

control for other factors that may influence birth

outcomes, including maternal illness or health be-

haviors that can adversely affect pregnancy,” she says.

“Few studies of antidepressants and birth outcomes

assessed the mothers’ psychiatric condition. Con-

founding factors that influence birth outcomes—

poor prenatal care and drug, alcohol, and nicotine

use—are often not controlled in studies. Our recom-

mendations may be utilized as a guide to foster more

in-depth research. In the meantime, our hope is that

they are used as a resource when caring for pregnant

women who have or are at risk of developing major

depressive disorder.”

is that we’ll better inform providers about cur-

rent research on various depression treatment

methods and improve clinicians’ understanding

and ability to help with decision making.”

Diagnostic Challenges & ConsequencesIdentifying depression in pregnant women can

be difficult because depressive symptoms often

mimic usual experiences of pregnancy. “Some

symptoms of depression, including changes in

mood, energy level, appetite, and cognition,

are normative in pregnancy,” explains Dr. Yon-

kers. “When these symptoms present, clinicians

should view them as a cue to ask additional

questions. We must also consider the likelihood

that patients may be reluctant to admit feelings

of depression. There is a belief that women are

supposed to be happy when they’re pregnant,

so they may be embarrassed to admit that they

aren’t. Other women may view their depressed

feelings as a character flaw rather than an ill-

ness, or they may believe that depression will

reflect negatively on their capability of being a

good mother.”

Research has shown that depressive symptoms

and use of antidepressant medications during

pregnancy have been associated with nega-

tive consequences for newborns. Infants born

to women with depression are at greater risk

for irritability, less activity and attentiveness,

and fewer facial expressions when compared

with those born to mothers without depres-

sion. Depression during pregnancy is also as-

sociated with fetal growth changes and shorter

gestation periods. Dr. Yonkers adds that some

studies have linked fetal malformations, cardiac

defects, pulmonary hypertension, and reduced

birth weight to antidepressant use during preg-

nancy. “Furthermore, depressed women are

more likely to have poor prenatal care and preg-

nancy complications (eg, nausea, vomiting, and

preeclampsia) and to use drugs, alcohol, and

nicotine,” she says.

Highlighting Key RecommendationsAccording to the APA/ACOG report, some pa-

tients with mild-to-moderate depression can be

treated with psychotherapy alone or in combi-

References

Yonkers KA, Wisner KL, Stewart DE, et al. The management of depression during pregnancy: a report from the American Psychiatric Association

and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009;114:703-713. Available at: http://journals.lww.com/

greenjournal/Citation/2009/09000/The_Management_ of_Depression_During_Pregnancy__A.44.aspx

Smith MV, Shao L, Howell H, Wang H, Poschman K, Yonkers KA. Success of mental health referral among pregnant and postpartum women with

psychiatric distress. Gen Hosp Psychiatry. 2009;31:155-162.

Yonkers KA. Parsing risk for the use of selective serotonin reuptake inhibitors in pregnancy. Am J Psychiatry. 2009;166:268-270.

Yonkers KA, Smith MV, Lin H, Howell HB, Shao L, Rosenheck RA. Depression screening of perinatal women: an evaluation of the healthy start

depression initiative. Psychiatr Serv. 2009;60:322-328.

Spoozak L, Gotman N, Smith MV, Belanger K, Yonkers KA. Evaluation of a social support measure that may indicate risk of depression during

pregnancy. J Affect Disord. 2009;114:216-223.

Yonkers KA. The treatment of women suffering from depression who are either pregnant or breastfeeding. Am J Psychiatry. 2007;164:1457-1459.

Kimberly A. Yonkers, MD, has indicated to Physician’s Weekly that in the past year she has received an investiga-tor initiated trial funded by Eli Lilly and has received study medication from Pfizer for an NIMH funded trial.

Table An Overview of Recommendations

For Women Considering Pregnancy:

• For women on medication with mild or no symptoms for 6 months or longer, it may be appropriate to taper and

discontinue medication before becoming pregnant.

• Medication discontinuation may not be appropriate in women with:

- A history of severe, recurrent depression.

- Psychosis. - Bipolar disorder.

- Other psychiatric illness requiring medication.

- A history of suicide attempts.

• Women with suicidal or acute psychotic symptoms should be referred to a psychiatrist for aggressive treatment.

For Pregnant Women Currently on Depression Medication:

• Psychiatrically stable women who prefer to stay on medication may be able to do so after consultation between their psychia-

trist and OB-GYN to discuss risks and benefits.

• Women who would like to discontinue medication may attempt medication tapering and discontinuation if they are not experi-

encing symptoms, depending on their psychiatric history.

- Women with a history of recurrent depression are at a

high risk of relapse if medication is discontinued.

• Women with recurrent depression or who have symptoms despite their medication may benefit from psychotherapy

to replace or augment medication.

• Women with severe depression (with suicide attempts, functional incapacitation, or weight loss) should remain

on medication.

- If a patient refuses medication, alternative treatment

and monitoring should be in place, preferably before

discontinuation.

For Pregnant Women Not Currently on Depression Medication:

• Psychotherapy may be beneficial in women who prefer to avoid antidepressant medication.

• For women who prefer taking medication, risks and benefits of treatment choices should be evaluated and discussed,

including factors such as:

- Stage of gestation. - Symptoms.

- History of depression.

- Other conditions and circumstances

(eg, a smoker, difficulty gaining weight).

For All Pregnant Women:

• Regardless of circumstances, a woman with suicidal or psychotic symptoms should immediately see a psychiatrist

for treatment.

Source: Adapted from: Yonkers KA, et al. Obstet Gynecol. 2009;114:703-713.