Welcome to NGC. Skip directly to: Search Box, Navigation, Content.


Brief Summary

GUIDELINE TITLE

Identification, diagnosis, and management of anemia in adult ambulatory patients treated by primary care physicians: evidence-based and consensus recommendations.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

  • July 31, 2008, Erythropoiesis Stimulating Agents (ESAs): Amgen and the U.S. Food and Drug Administration (FDA) informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
  • November 8, 2007 and January 3, 2008 Update, Erythropoiesis Stimulating Agents (ESAs): The U.S. Food and Drug Administration (FDA) notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs) stating serious adverse events, such as tumor growth and shortened survival in patients with advanced cancer and chronic kidney failure.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The levels of recommendation (Appropriate, Uncertain, Inappropriate) are defined at the end of the "Major Recommendations" field.

Identification

The panel rated it 'appropriate' to perform a routine complete blood count (CBC) at the time of an office visit in patients with an underlying chronic condition (e.g., rheumatoid arthritis, congestive heart failure) who had not received a CBC in the past year. In patients without an underlying chronic condition, it was rated 'appropriate' to perform a CBC if a CBC had not been done in the past 5 years for all women, men aged 50 and older, or those with anemia symptoms (Table 1).

Table 1. Appropriateness of a Routine Complete Blood Count at the Time of an Office Visit

Comorbidity Interval Population Consensus
No chronic comorbidity Every 5 years Men aged 18 to 49 without anemia symptoms Uncertain
All women
Men aged 50 and older Appropriate
Men with anemia symptoms
Chronic comorbidity Yearly All Appropriate

Diagnosis

In women aged 18 to 49 with a hemoglobin (Hb) > 12 g/dL, the panel rated it 'inappropriate' to perform any diagnosis and 'appropriate' to just observe. The corresponding threshold for men or women aged 50 and older was a hemoglobin of > 13 g/dL (Table 2).

Table 2. Appropriateness of a Diagnosis Given Patient Characteristics

Population Hb level (g/dL) No intervention (just observe) Perform basic diagnosis Empiric iron Refer for GI diagnosis Refer for Hematologic work-up
Women 18 to 39 years old <12 Inappropriate* Appropriate Uncertain Inappropriate
>12 Appropriate Inappropriate
Women aged 40 to 49 years old <12 Inappropriate* Appropriate

Inappropriate

>12 Appropriate Inappropriate
Women aged >50 (or post-menopausal and 18 to 49) years old or any man <13 Inappropriate Appropriate
>13 Appropriate Inappropriate

*Uncertain is Hb 11-12 g/dL and no comorbid chronic disease

GI= gastrointestinal

A diagnosis was rated 'appropriate' in women aged 18 to 50 with hemoglobin <12 g/dL (or <13 g/dL in men or post-menopausal women). When an evaluation was indicated, the panel rated the performance of a basic evaluation 'appropriate' (e.g., test stool for occult blood and obtain routine labs or chest x-ray). However, referral to a gastroenterologist or hematologist for a work-up was rated 'inappropriate' (Table 2). The use of an empiric trial of iron therapy in the absence of a diagnostic workup was rated 'inappropriate' in all situations except for women aged 18 to 39.

Management

With respect to management, the panel rated it 'appropriate' to just observe and 'inappropriate' to transfuse or give erythropoietic growth factors in patients with a hemoglobin of >11 g/dL and no anemia symptoms or underlying cardiovascular disease (Table 3).

Table 3. Appropriateness of anemia management options given patient characteristics (non-nutritional anemia)

Hb (g/dL) Cardiovascular disease Anemia symptoms Age Management options
Observe Transfuse Epo/darbo
<8.0       Inappropriate Appropriate* Appropriate
8 to 9.4 18 to 69 Uncertain Uncertain Appropriate+
70 or older Inappropriate Appropriate
Either CVD or symptoms Appropriate++ Appropriate
9.5 to 10.9 Uncertain Inappropriate Uncertain
+ Inappropriate Uncertain Appropriate
+ 18 to 49 Inappropriate Uncertain
+ + Appropriate
Uncertain Inappropriate$ Uncertain
+ Inappropriate Uncertain Appropriate
+ 50 or older
+ + Appropriate
11 to 11.9** Appropriate

Inappropriate

Inappropriate
+ Uncertain Uncertain
+ Appropriate Inappropriate
+ + Uncertain Uncertain
12 or greater +++     Appropriate Inappropriate

*Uncertain if age 18 to 49, no CVD, and no anemia symptoms

+Uncertain if age 18 to 49

++Uncertain if no anemia symptoms

$Uncertain if age >70 years

**11 to 12.9 if age >70 years

+++ >13 if age >70 years

CVD = cardiovascular disease; epo = epoetin; darbo = darbepoetin

For patients with hemoglobin of 9.5 to 10.9 g/dL, it was rated 'inappropriate' to just observe the patient if the patient had anemia symptoms or cardiovascular disease. If the patient had anemia symptoms, the use of erythropoietic growth factors was rated 'appropriate' (or 'uncertain' if no anemia symptoms were present). The use of blood transfusion was rated 'inappropriate' if the patient had no anemia symptoms, 'uncertain' in the presence of just anemia symptoms, and 'appropriate' if the patient had anemia symptoms and underlying cardiovascular disease.

In patients with hemoglobin < 9.5 g/dL, it was rated 'inappropriate' to just observe (unless the patient had no symptoms, no cardiovascular disease, and was younger than age 70 in which case it was rated 'uncertain'). The use of an erythropoietic growth factor was rated 'appropriate'. Transfusion was considered appropriate in patients aged 70 and older and in those presenting with either anemia symptoms or underlying cardiovascular disease.

In patients with hemoglobin < 8 g/dL, the use of either transfusion or erythropoietic growth factor was rated 'appropriate' and observation was rated 'inappropriate'.

Definitions:

Rating Scheme for Strength of Recommendations

Appropriate: Median ratings between 7 and 9 (without disagreement)

Uncertain: Median ratings between 4 and 6 or if panelists disagreed (when two panelists rated the indication 'appropriate' and at least two rates the indication as 'inappropriate')

Inappropriate: Median ratings between 1 and 3 (without disagreement)

Rating Scale of Appropriateness* (1 to 9)

1 = extremely inappropriate

5 = uncertain

9 = extremely appropriate

*'Appropriateness' was defined as the expected health benefits of the therapy exceeding its expected negative health consequences by a sufficiently wide margin to justify prescribing the therapy.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of evidence supporting the recommendations is not specifically stated.

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2006 Feb

GUIDELINE DEVELOPER(S)

National Anemia Action Council - Private Nonprofit Research Organization

SOURCE(S) OF FUNDING

National Anemia Action Council

GUIDELINE COMMITTEE

Panel of Experts

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Authors: Robert W. Dubois, Cerner Health Insights, Beverly Hills, CA, USA; L. Tim Goodnough, Stanford University, Dept. of Pathology and Medicine, Stanford, CA, USA; William B. Ershler, Institute for Advanced Studies in Aging and Geriatric Medicine, Washington, DC, USA; Lloyd Van Winkle, Medina Valley Family Practice, Castroville, TX, USA; Allen R. Nissenson, David Geffen School of Medicine at UCLA, Division of Nephrology, Los Angeles, CA, USA

Panel Members: Kirkwood Adams, Jr., MD, Associate Professor of Medicine and Radiology, Director, Heart Failure Program, University of North Carolina, Chapel Hill, NC; Alan M. Adelman, MD, MS, Professor and Vice Chair for Academic Affairs and Research, Department of Family and Community Medicine, Pennsylvania State University College of Medicine, Hershey, PA; Steven Deutsch, MD, Medical Director, Cedars-Sinai Medical Care Foundation, Beverly Hills, CA; William B. Ershler, MD, Director, Institute for Advanced Studies in Aging and Geriatric Medicine, Clinical Professor of Medicine, The George Washington University College of Medicine, Washington, DC; L. Tim Goodnough, MD, Professor of Medicine and Pathology, Washington University Medical Center, Division of Laboratory Medicine, St. Louis, MO; Michael Hattwick, MD, Medical Director, Northern Virginia Healthcare, Annandale, VA; John Ingard, MD, Chief of Internal Medicine, Harvard Vanguard Medical Associates, Natick, MA; Allen R. Nissenson, MD, Professor of Medicine, University of California at Los Angeles School of Medicine, Division of Nephrology; Lloyd Van Winkle, MD, Clinical Associate Professor of Medicine, Department of Family Practice, University of Texas Health Science Center, San Antonio, TX

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

National Anemia Action Council (NAAC) has received unrestricted educational grants from Amgen, Inc.

Robert W. Dubois is Senior Vice President of Cerner Health Insights, which provided consulting services to Amgen, Inc. Kirkwood F. Adams is a member of NAAC and has received grants and research support from Amgen Inc. William Ershler is a member of NAAC. Allen Nissenson is President of NAAC. L. Tim Goodnough was Vice President of NAAC at the time the guidelines were developed, and has received honoraria for teaching and speaking from the following companies: Amgen, Watson, and American Regent.

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

Electronic copies: Available to subscribers in Portable Document Format (PDF) from the Current Medical Research and Opinion Web site.

Print copies: Available from Robert W. Dubois, MD, PhD, Senior Vice President, Cerner Health Insights, 9100 Wilshire Blvd, Suite 655 East Tower, Beverly Hills, CA 90212; Phone: +1-310-598-4563; Fax: +1-816-936-1963; Email: rdubois@cerner.com

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on January 15, 2007. The information was verified by the guideline developer on February 5, 2007. This summary was updated by ECRI Institute on July 9, 2007, following the FDA advisory on erythropoiesis stimulating agents. This summary was updated by ECRI Institute on March 21, 2008 following the FDA advisory on Erythropoiesis Stimulating Agents. This summary was updated by ECRI Institute on August 15, 2008 following the U.S. Food and Drug Administration advisory on Erythropoiesis Stimulating Agents (ESAs).

COPYRIGHT STATEMENT

This material is for personal use only and any commercial distribution is strictly prohibited.

DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.


 

 

   
DHHS Logo