Guideline Title
Enteral formula (medical food) and infant formula regulation. In: A.S.P.E.N. enteral nutrition practice recommendations.
Bibliographic Source(s)
Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, Lyman B, Metheny NA, Mueller C, Robbins S, Wessel J. Enteral formula (medical food) and infant formula regulation. In: A.S.P.E.N. enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr 2009 Mar-Apr;33(2):131-2. [7 references] |
Guideline Status
This is the current release of the guideline.
UMLS Concepts ( what's this?)
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Disease/Condition(s)
Conditions or disease states requiring enteral nutrition
Guideline Category
Management
Clinical Specialty
Family Practice
Gastroenterology
Geriatrics
Internal Medicine
Nursing
Nutrition
Pediatrics
Pharmacology
Intended Users
Advanced Practice Nurses
Allied Health Personnel
Dietitians
Health Care Providers
Health Plans
Hospitals
Managed Care Organizations
Nurses
Pharmacists
Physician Assistants
Physicians
Utilization Management
Guideline Objective(s)
- To examine the available literature related to the accuracy and credibility of enteral nutrition labeling
- To establish evidence-based practice guidelines for the safe and effective use of enteral nutrition
Target Population
Patients in need of enteral nutrition throughout the lifecycle and throughout all practice settings
Interventions and Practices Considered
- Determination and regulation of veracity (accuracy, credibility) of enteral formula labeling and product claims
- Interpretation of enteral formula content/labeling and health claims
Major Outcomes Considered
- Accuracy and credibility of adult enteral formula labeling and product claims
- Formula recall rate
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Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence
PubMed was used to search and collect the literature. Search was limited to English language journals and abstracts were excluded. All types of literature including research, case reports, and review articles. Government, regulatory, and standard setting websites such as the United States (US) Food and Drug Administration (FDA), US Pharmacopeia, and The Joint Commission on Accreditation of Healthcare Organizations were also utilized. Search terms included enteral nutrition, tube feeding, enteral complications, enteral safety, water safety, medication administration, enteral access device, aspiration, misconnections, enteral microbial growth, infant formulas, medical foods, and enteral formulary.
Number of Source Documents
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus
Weighting According to a Rating Scheme (Scheme Not Given)
Rating Scheme for the Strength of the Evidence
Methods Used to Analyze the Evidence
Systematic Review
Description of the Methods Used to Analyze the Evidence
The literature and evidence were classified based on the Agency for Healthcare Research and Quality (AHRQ) method.
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) established the Enteral Nutrition Practice Recommendations Task Force to examine the available literature related to the ordering, preparation, delivery, and monitoring of enteral nutrition and to establish evidence- based practice guidelines. It was recognized from the onset that there was either an absence of research or the research was of limited strength to support many aspects surrounding the practice of administering enteral nutrition. Therefore, in addition to the existing literature, a consensus of expert opinion based on current knowledge and best practices was used to formulate these practice recommendations.
The strength of each practice recommendation was graded using a method consistent with the 2002 A.S.P.E.N. Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients. The grading system was based on a modified version of the method used by the Agency for Healthcare Research and Quality (AHRQ), United States (US) Department of Health and Human Services. After review of the literature cited, the authors used the AHRQ criteria to classify the strength of the evidence supporting each recommendation statement.
Rating Scheme for the Strength of the Recommendations
Grade of Recommendation
- There is good research-based evidence to support the guideline (prospective, randomized trials).
- There is fair research-based evidence to support the guideline (well-designed studies without randomization).
- The guideline is based on expert opinion and editorial consensus.
Cost Analysis
Published cost analyses were reviewed.
Method of Guideline Validation
Comparison with Guidelines from Other Groups
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
The draft document was sent to leaders of American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Clinical Practice Sections, Clinical Practice Committee, and Board of Directors for review and comment process.
The draft document was also sent to leaders of related medical organizations. Reviews were received back from the following groups: American Society of Health-System Pharmacists (ASHP), Institute of Safe Medication Practices (ISMP), North American Society for Pediatric Hepatology, Gastroenterology, and Nutrition (NASPHGAN), American Academy of Pediatrics (AAP), Dietitians in Nutrition Support, a dietetic practice group of the American Dietetics Association, and U.S. Pharmacopeia (USP).
The document was approved by the A.S.P.E.N. Board of Directors following review by internal and external content experts and the A.S.P.E.N. Clinical Practice Committee.
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Major Recommendations
Definitions of the grades of recommendations (A-C) are provided at the end of the "Major Recommendations" field.
Practice Recommendations
- The veracity (accuracy, credibility) of adult enteral formula labeling and product claims is dependent on formula vendors. (C)
- Nutrition support clinicians and consumers are responsible for determining the veracity of adult enteral formulas. (C)
- The U.S. government regulates the veracity of infant formula labeling and product claims. (C)
- Interpret enteral formula content/labeling and health claims with caution until such time as more specific regulations are in place. (C)
Summary
The complexity of enteral nutrition (EN) feedings cannot be underestimated. All healthcare professionals should be vigilant in continuous surveillance of high risk practices, products and systems as they relate to the enterally fed patient. Recognition of ordering, administration, and monitoring steps of EN delivery which may increase risk of complications to the enterally fed patient is essential.
Definitions:
Grade of Recommendation
- There is good research-based evidence to support the guideline (prospective, randomized trials).
- There is fair research-based evidence to support the guideline (well-designed studies without randomization).
- The guideline is based on expert opinion and editorial consensus.
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Evidence Supporting the Recommendations
Type of Evidence Supporting the Recommendations
The type of supporting evidence ranges from prospective randomized trials to expert opinion/consensus.
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Benefits/Harms of Implementing the Guideline Recommendations
Potential Benefits
- Standardized processes for enteral nutrition care including ordering, preparation, administration, and monitoring
- Optimal care and minimal risk of error
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Contraindications
Enteral nutrition is contraindicated in a patient with significant hemodynamic compromise.
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Qualifying Statements
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Enteral Nutrition Practice Recommendations are based upon general conclusions of health professionals who, in developing such recommendations, have balanced potential benefits to be derived from a particular mode of providing enteral nutrition with known associated risks of this therapy. The underlying judgment regarding the propriety of any specific practice recommendation or procedure shall be made by the attending health professional in light of all the circumstances presented by the individual patient and the needs and resources particular to the locality. These recommendations are not a substitute for the exercise of such judgment by the health professional, but rather are a tool to be used by the health professional in the exercise of such judgment. Use of this document is voluntary and should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed toward obtaining the same result.
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Implementation of the Guideline
Description of Implementation Strategy
An implementation strategy was not provided.
Implementation Tools
Chart Documentation/Checklists/Forms
Slide Presentation
Staff Training/Competency Material
Wall PosterFor information about availability, see the Availability of Companion Documents and Patient Resources fields below.
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Institute of Medicine (IOM) National Healthcare Quality Report Categories
IOM Care Need
Getting Better
Living with Illness
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Identifying Information and Availability
Bibliographic Source(s)
Bankhead R, Boullata J, Brantley S, Corkins M, Guenter P, Krenitsky J, Lyman B, Metheny NA, Mueller C, Robbins S, Wessel J. Enteral formula (medical food) and infant formula regulation. In: A.S.P.E.N. enteral nutrition practice recommendations. JPEN J Parenter Enteral Nutr 2009 Mar-Apr;33(2):131-2. [7 references] |
Adaptation
Not applicable: The guideline was not adapted from another source.
Guideline Developer(s)
American Society for Parenteral and Enteral Nutrition - Professional Association
Source(s) of Funding
American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.)
Guideline Committee
The Enteral Nutrition Practice Recommendations Task Force
Composition of Group That Authored the Guideline
Task Force Members: Robin Bankhead, CRNP, MS, CNSN, Chair; Joseph Boullata, PharmD, BCNSP; Susan Brantley, MS, RD, LDN, CNSD; Mark Corkins, MD, CNSP; Peggi Guenter, PhD, RN, CNSN; Joseph Krenitsky, MS, RD; Beth Lyman, RN, MSN; Norma A. Metheny, PhD, RN, FAAN; Charles Mueller, PhD, RD, CNSD; Sandra Robbins, RD, CSP, LD; Jacqueline Wessel, MEd, RD, CSP, CNSD, CLE
Financial Disclosures/Conflicts of Interest
Jacqueline Wessell is on the Abbot Nutrition Speakers Bureau. No other potential conflicts were reported.
Guideline Endorser(s)
Academy of Nutrition and Dietetics - Professional Association
American Society of Health-System Pharmacists - Professional Association
Institute for Safe Medication Practices - Professional Association
Guideline Status
This is the current release of the guideline.
Availability of Companion Documents
The following are available:
In addition, the following forms are available in the original guideline document :
- Adult Enteral Nutrition Order Form
- Pediatric Enteral Nutrition Order Form
- Standard Enteral Nutrition Label Template (Adult Patient)
- Standard Human Breast Milk Label Template (Infant Patient)
- Human Breast Milk Storage Label
NGC Status
This NGC summary was completed by ECRI Institute on February 5, 2010. The information was verified by the guideline developer on March 15, 2010.
Copyright Statement
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Reprint request/permissions should be sent to: Permissions Department, ASPEN; 8630 Fenton St. #412; Silver Spring, MD 20910; Fax: 301-587-2365.
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