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Complete Summary

GUIDELINE TITLE

Anemia in the long-term care setting.

BIBLIOGRAPHIC SOURCE(S)

  • American Medical Directors Association (AMDA). Anemia in the long-term care setting. Columbia (MD): American Medical Directors Association (AMDA); 2007. 28 p. [65 references]

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 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.

COMPLETE SUMMARY CONTENT

 ** REGULATORY ALERT **
 SCOPE
 METHODOLOGY - including Rating Scheme and Cost Analysis
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
 QUALIFYING STATEMENTS
 IMPLEMENTATION OF THE GUIDELINE
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Anemia

  • Iron-deficiency anemia
  • Vitamin B12-deficiency anemia
  • Folate-deficiency anemia
  • Anemia of chronic disease/chronic inflammation
  • Unexplained anemia
  • Hemolytic anemia

GUIDELINE CATEGORY

Diagnosis
Evaluation
Management
Risk Assessment
Treatment

CLINICAL SPECIALTY

Family Practice
Geriatrics
Hematology
Internal Medicine
Nursing
Nutrition

INTENDED USERS

Advanced Practice Nurses
Allied Health Personnel
Dietitians
Nurses
Pharmacists
Physical Therapists
Physician Assistants
Physicians
Social Workers

GUIDELINE OBJECTIVE(S)

  • To improve the quality of care delivered to patients in long-term care settings
  • To offer care providers and practitioners in long-term care facilities a systematic approach to recognizing, assessing, treating, and monitoring patients with anemia

TARGET POPULATION

Elderly residents of long-term care facilities with anemia

INTERVENTIONS AND PRACTICES CONSIDERED

Recognition/Assessment

  1. Assess the patient's medical history and hematologic status (complete blood count [CBC] test, assessment of nonspecific signs and symptoms that may indicate anemia)
  2. Assess the patient for anemia risk factors
  3. Determine whether an additional diagnostic workup of anemia is appropriate
  4. Laboratory evaluation including CBC with reticulocyte count; morphology examination by peripheral smear; ferritin, serum iron, and total iron-binding capacity; serum folate and vitamin B12; hepatic and renal function; sedimentation rate; stool for occult blood; and others
  5. Identify specific characteristics and causes of the patient's anemia such as acute or chronic blood loss, chronic diseases, nutritional deficiencies, medications

Management/Treatment

  1. Manage iron-deficiency anemia (oral or parenteral iron, iron-rich foods)
  2. Manage vitamin B12-deficiency anemia (oral or parenteral vitamin B12, foods that are good sources of vitamin B12 such as liver, other meats, fish, poultry, eggs)
  3. Manage folate-deficiency anemia (oral folic acid, folic-rich foods such as leafy vegetables, nuts, whole grains)
  4. Manage anemia of chronic disease/chronic inflammation (treatment of the underlying disease)
  5. Manage anemia associated with chronic kidney disease (subcutaneous or intravenous erythropoietin-stimulating agents [ESAs])
  6. Blood transfusions

Monitoring

  1. Monitor the patients response to interventions and adjusting treatment if necessary
  2. Monitor the impact of anemia on the patient
  3. Monitor the facility's management of anemia

MAJOR OUTCOMES CONSIDERED

  • Efficacy of anemia treatment
    • Physical, social, cognitive functioning
    • Laboratory values (e.g. hemoglobin, hematocrit)
    • Quality of life
    • Signs and symptoms of anemia
    • Complications associated with anemia
  • Adverse effects of anemia treatment

METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

METHODS USED TO ANALYZE THE EVIDENCE

Review

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

This guideline was developed by an interdisciplinary workgroup, using a process that combined evidence and consensus-based approaches. Workgroups include practitioners and others involved in patient care in long-term care facilities. Beginning with a general guideline developed by an agency, association, or organization such as the Agency for Healthcare Research and Quality (AHRQ), pertinent articles and information, and a draft outline, each group works to make a concise, usable guideline that is tailored to the long-term care setting. Because scientific research in the long-term care population is limited, many recommendations are based on the expert opinion of practitioners in the field.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

External Peer Review
Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Guideline revisions are completed under the direction of the Clinical Practice Guideline Steering Committee. The committee incorporates information published in peer-reviewed journals after the original guidelines appeared, as well as comments and recommendations not only from experts in the field addressed by the guideline but also from "hands-on" long-term care practitioners and staff.

All American Medical Directors Association (AMDA) clinical practice guidelines undergo external review. The draft guideline is sent to approximately 175+ reviewers. These reviewers include AMDA physician members and independent physicians, specialists, nurse practitioners, pharmacists, consultants in the specified area, and organizations that are knowledgeable of the guideline topic and the long-term care setting.

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

The algorithm Anemia in the Long-Term Care Setting is to be used in conjunction with the clinical practice guideline. The numbers next to the different components of the algorithm correspond with the steps in the text. Refer to the "Guideline Availability" field for information on obtaining the full text guideline.

CLINICAL ALGORITHM(S)

A clinical algorithm is provided for Anemia in the Long-Term Care Setting.

An algorithm for Diagnosis of Anemia Using Red Cell Morphology is also provided in the original guideline document.

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

The guideline was developed by an interdisciplinary work group using a process that combined evidence- and consensus-based thinking.

BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

POTENTIAL BENEFITS

Outcomes that may be expected from the implementation of this guideline include the following:

  • Better recognition and more appropriate management of anemia.
  • Comprehensive evaluation of the causes of anemia when appropriate.
  • Adequate assessment and monitoring of anemia.
  • Improvement in patients' functional status, cognitive function, exercise performance, and quality of life.
  • Reduced morbidity and mortality.
  • Reduced medical care costs as a result of treatment of identifiable causes of anemia.

POTENTIAL HARMS

Adverse Effects of Anemia Treatment

  • Common side effects of oral iron include abdominal cramps, constipation, diarrhea, dyspepsia, iron overload, nausea and vomiting
  • Adverse effects of parenteral iron include allergic reactions, backache, chest pain, chills, dizziness, fever with increased sweating, flank, groin or redness of skin, headache, hypotension (refer to Table 17 in the original guideline document for additional information on adverse effects of parenteral iron). Anaphylactic or anaphylactoid reactions which are rare but potentially lethal, typically occur within several minutes of administration. Personnel trained to provide emergency treatment for severe allergic or anaphylactic reactions should be available in the event of such an emergency.
  • Folate therapy will worsen a co-existing B12 deficiency and may allow progression of neurological features of the co-existing B12 deficiency
  • Erythropoietin-stimulating agents (ESAs) may cause or worsen hypertension. Excessive dose or duration can lead to polycythemia and dangerous thrombotic events, including myocardial infarction and stroke.

    The U.S. Food and Drug Administration (FDA) currently advises practitioners to follow dosing recommendations in the labeling for ESAs and ensure that hemoglobin is maintained in a range between 10 g/dL and 12 g/dL. The FDA further advises that after initiation of an ESA or adjustment of the dose, the practitioner should measure the patient's hemoglobin twice a week for 2–6 weeks to ensure that it has stabilized. The ESA dose should be decreased if the patient's hemoglobin increases by more than 1 g/dL in any 2-week period. Practitioners should be aware that it may take between 2 and 6 weeks after a dosage adjustment for a significant change in hemoglobin to be observed.

    Patients with uncontrolled hypertension should not receive ESAs.

  • Adverse effects of blood transfusion include anaphylaxis, chills, fever, bloodborne infection, and transfusion reaction.

QUALIFYING STATEMENTS

QUALIFYING STATEMENTS

  • This clinical practice guideline is provided for discussion and educational purposes only and should not be used or in any way relied upon without consultation with and supervision of a qualified physician based on the case history and medical condition of a particular patient. The American Medical Directors Association, its heirs, executors, administrators, successors, and assigns hereby disclaim any and all liability for damages of whatever kind resulting from the use, negligent or otherwise, of this clinical practice guideline.
  • The utilization of the American Medical Director Association's Clinical Practice Guideline does not preclude compliance with State and Federal regulation as well as facility policies and procedures. They are not substitutes for the experience and judgment of clinicians and care-givers. The Clinical Practice Guidelines are not to be considered as standards of care but are developed to enhance the clinician's ability to practice.

IMPLEMENTATION OF THE GUIDELINE

DESCRIPTION OF IMPLEMENTATION STRATEGY

The implementation of all clinical practice guidelines (CPGs) is outlined in four phases. Each phase presents a series of steps, which should be carried out in the process of implementing the practices presented in this guideline. Each phase is summarized below.

  1. Recognition
    • Define the area of improvement and determine if there is a CPG available for the defined area. Then evaluate the pertinence and feasibility of implementing the CPG
  1. Assessment
    • Define the functions necessary for implementation and then educate and train staff. Assess and document performance and outcome indicators and then develop a system to measure outcomes
  1. Implementation
    • Identify and document how each step of the CPG will be carried out and develop an implementation timetable
    • Identify individual responsible for each step of the CPG
    • Identify support systems that impact the direct care
    • Educate and train appropriate individuals in specific CPG implementation and then implement the CPG
  1. Monitoring
    • Evaluate performance based on relevant indicators and identify areas for improvement
    • Evaluate the predefined performance measures and obtain and provide feedback

IMPLEMENTATION TOOLS

Clinical Algorithm

For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below.

INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

IOM CARE NEED

Getting Better
Living with Illness

IOM DOMAIN

Effectiveness
Patient-centeredness

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • American Medical Directors Association (AMDA). Anemia in the long-term care setting. Columbia (MD): American Medical Directors Association (AMDA); 2007. 28 p. [65 references]

ADAPTATION

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

DATE RELEASED

2007

GUIDELINE DEVELOPER(S)

American Medical Directors Association - Professional Association

GUIDELINE DEVELOPER COMMENT

Organizational participants included:

  • American Association of Homes and Services for the Aging
  • American College of Health Care Administrators
  • American Geriatrics Society
  • American Health Care Association
  • American Society of Consultant Pharmacists
  • National Association of Directors of Nursing Administration in Long-Term Care
  • National Association of Geriatric Nursing Assistants
  • National Conference of Gerontological Nurse Practitioners

SOURCE(S) OF FUNDING

Funding was supported by the following: Amgen, Merck & Co., Inc., Ross Products Division of Abbott Laboratories, Sanofi-Aventis

GUIDELINE COMMITTEE

Steering Committee

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Committee Members: Marjorie Berleth, MSHA RNC FADONA; Lisa Cantrell, RN, C; Sandra Fitzler, RN; Joseph Gruber, RPh, FASCP, CGP; Hosam Kamel, MD, CMD; Susan M. Levy, MD, CMD; Harlan Martin, R.Ph., CCP, FASCP; Evvie F. Munley; Jonathan Musher, MD, CMD; Barbara Resnick, PhD, CRNP; William Simonson, Pharm.D., FASCP

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

GUIDELINE STATUS

This is the current release of the guideline.

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

None available

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI Institute on July 9, 2007. The information was verified by the guideline developer on August 23, 2007. 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 NGC summary is based on the original guideline, which is copyrighted by the American Medical Directors Association (AMDA). Written permission from AMDA must be obtained to duplicate or disseminate information from the original guideline. For more information, contact AMDA at (410) 740-9743.

DISCLAIMER

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


 

 

   
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