ASPEN - EN prac recommendation - JPEN2009 - 图文 

JPEN J Parenter Enteral Nutr OnlineFirst, published on January 26, 2009 as doi:10.1177/0148607108330314

Special ReportEnteral Nutrition Practice RecommendationsJournal of Parenteral and Enteral NutritionVolume XX Number X Month XXXX xx-xx? 2009 American Society for Parenteral and Enteral Nutrition10.1177/0148607108330314http://jpen.sagepub.comhosted athttp://online.sagepub.comEnteral Nutrition Practice Recommendations Task Force: 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;

and the A.S.P.E.N. Board of Directors.

NOTICE: These 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 recommen-dations, 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 recommen-dation 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.

TABLE OF CONTENTS

Preface

I. Introduction

Ordering and Labeling of Enteral Nutrition II.

A. Formulary Selection Process B. Elements of the Order

C. Enteral Nutrition Order Forms D. Labeling of Enteral Nutrition

Enteral Formula (Medical Foods) and III.

Infant Formula Regulation A. Background B. Medical Foods C. Infant Formulas

IV. Water and Enteral Formula Safety

and Stability A. Water Safety 1. Types of Water Used in Enteral Nutrition 2. Indications for Use of Water

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B. Enteral Formula Safety 1. Contamination 2. Hang Time 3. Stability V. Enteral Access

A. Selection of Enteral Access Devices B. Insertion of Enteral Access Devices C. Maintenance Considerations D. Long-Term Enteral Access E. Initiation of Feedings after Placement of Long-Term Enteral Access Device VI. Enteral Nutrition Administration A. Initiation and Advancement of an Enteral Nutrition Regimen B. Enteral Feeding Pumps C. Patient Positioning D. Flushes E. Enteral Misconnections VII. Medication Administration A. Dosage Forms and Administration B. Gastric vs Intestinal Delivery Drug Interactions C. D. Crushing and Diluting Medication VIII. Monitoring Enteral Nutrition Administration A. Monitoring for Refeeding Syndrome Monitoring Gastric Residual Volume B. IX. Summary

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GLOSSARY OF TERMS

Beyond-Use Date: The date established by healthcare professionals from the published literature or manufacturer-specific recommendations beyond which the pharmacy-prepared or patient-specific product should not be used.1 These products include the closed enteral feeding systems that do not require pharmacy preparation, but for which

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the manufacturer’s expiration date is no longer valid once the product is spiked.

Clinical Guidelines: Systematically developed state-ments to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.2

Closed Enteral System: A closed enteral container or bag, pre-filled with sterile, liquid formula by the manufacturer, and considered ready to administer.3

Computerized Prescriber Order Entry (CPOE): A prescription ordering system in which the prescriber enters orders directly into a computer system whether or not aided by decision support.1

Distilled Water: Water that has been vaporized and recondensed but is not necessarily free of dissolved or suspended matter; used when water purity is not necessary.

Drug-Nutrient Interaction: An event that results from a physical, chemical, physiologic, or pathophysiologic relationship between a drug and nutrient(s), nutrient status, or food in general, which is clinically significant if drug response is altered or nutrition status is compromised. 4

Enteral Access Devices: Tubes placed directly into the gastrointestinal tract for the delivery of nutrients and/or drugs.1

Enteral Misconnection: An enteral misconnection is an inadvertent connection between an enteral feeding system and a non-enteral system such as a vascular access device, peritoneal dialysis catheter, tracheostomy, medical gas tubing, etc.5

Enteral Nutrition (EN): Nutrition provided through the gastrointestinal tract via a tube, catheter, or stoma that delivers nutrients distal to the oral cavity. 1

Expiration Date: The date established from scientific studies to meet U.S. Food and Drug Administration (FDA) regulatory requirements for commercially-manufactured products beyond which the product should not be used.1

Fore Milk: Human breast milk that is typically lower in fat, available at the beginning of a feeding.

Hang Time: The length of time an enteral formula is considered safe for delivery to the patient beginning with the time the formula or human breast milk (HBM) has either been reconstituted, warmed, decanted, or has had the original package seal broken.

Hind Milk: Human breast milk which has a higher fat content than the fore milk.

Medical Food: A medical food as defined in section 5(b) of the Orphan Drug Act is a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutrition requirements, based on recognized scientific principles, are established by medical evaluation.6

Modular Enteral Feeding: Feeding formulas created by combinations of separate nutrient sources or by modification of existing formulas. 1

Open Enteral System: An enteral system in which the clinician/patient/caregiver is required to decant formula into the enteral container or bag.

Purified Water: Sterile, solute-free, non-pyrogenic water that is free of any chemical or microbial contaminants; used for preparing or reconstituting commercial products, rinsing equipment and utensils; is required to produce sterile water for irrigation and sterile water for injection.1

Sentinel Event: An unexpected occurrence involving death or serious physical or psychological injury or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.7

Tap Water: Municipal or locally-available potable water that meets the Environmental Protection Agency’s (EPA) National Primary Drinking Water regulations (40 CFR Part 141-143)8 and is consistent with World Health Organization (WHO) guidelines for water safety.9

Transitional Feeding: Progression from one mode of feeding to another while continuously administering estimated nutrient requirements.

References

1. American Society for Parenteral and Enteral Nutrition Board of

Directors and Standards Committee: Teitelbaum D, Guenter P, Howell WH, Kochevar ME, Roth J, Seidner DL. Definition of terms, style, and conventions used in A.S.P.E.N. guidelines and standards. Nutr Clin Pract. 2005;20:281-285.

2. Institute of Medicine, Field MJ, Lohr KN, eds. Clinical Practice

Guidelines: Directions for a New Program. Washington, DC: National Academy Press, 1990.

3. Hsu TC, Chen NR, Sullivan MM, et al. Effect of high ambient

temperature on contamination and physical stability of one-liter ready-to-hang enteral delivery systems. Nutrition. 2000;16:165-167. 4. Santos CA, Boullata JI. An approach to evaluating drug-nutrient

interactions. Pharmacotherapy. 2005;25(12):1789-1800.

5. Guenter P, Hicks RW, Simmons D, et al. Enteral feeding

misconnections: a consortium position statement. Jt Comm J Qual Patient Saf. 2008;34:285-292.

6. U.S. Department of Health and Human Services Food and Drug

Administration Center for Food Safety and Applied Nutrition. Frequently Asked Questions About Medical Foods May 2007. Available at: http:// www .cfsan.fda.gov/~dms/medfguid.html. Accessed April 4, 2008.

7. Joint Commission on Accreditation of Healthcare Organizations.

Sentinel Event Policy and Procedures. Revised: July 2007. Available at: http://www.jointcommission.org/SentinelEvents/PolicyandProcedures/. Accessed October 15, 2008.

8. Environmental Protection Agency. National Primary Drinking

Water Regulations. 40 CFR § 141-142, 2002.

9. World Health Organization. Guidelines for drinking-water quality.

Geneva, Switzerland:WHO, 2004.

PREFACE

A.S.P.E.N. established the Enteral Nutrition Practice Recommendations Task Force to examine the available

Enteral Nutrition Practice Recommendations/Bankhead et al 3

literature related to the ordering, preparation, delivery, and monitoring of enteral nutrition and to establish evi-dence-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 know-ledge 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.1 The grading system was based on a modified version of the method used by the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services.2 After review of the litera-ture cited, the authors used the AHRQ criteria to classify the strength of the evidence supporting each recommen-dation statement. The evidence supporting each state-ment is classified as follows:

A There is good research-based evidence to support the guideline (prospective, randomized trials).B There is fair research-based evidence to support the guideline (well-designed studies without randomization).

C The guideline is based on expert opinion and editorial consensus.This document was reviewed and approved by the A.S.P.E.N. Board of Directors following review by inter-nal and external content experts and the A.S.P.E.N. Clinical Practice Committee. This document will be reviewed and updated at least every 5 years.

References

1. A.S.P.E.N. Board of Directors and the Clinical Guidelines Task

Force. Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients. JPEN J Parenter Enteral Nutr. 2002;26 (Suppl):1SA-138SA. Errata 2002;26:144.

2. Pocock SJ, Elbourne DR: Randomized trials or observational tribu-lations? New Engl J Med. 2000;342:1907–1909.

I. INTRODUCTION

Enteral nutrition (EN) in this document refers to the delivery of enteral products, including human breast milk (HBM), delivered through an enteral access device into a functioning gastrointestinal (GI) tract. Consideration is made of patients throughout the lifecycle and throughout all practice settings. The principal indication for EN is a functional GI tract with sufficient length and absorptive

capacity and the inability to take nutrients through the oral route either totally or in part. Specific indications for the use of EN are described in the Guidelines for the Use of Parenteral and Enteral Nutrition in Adult and Pediatric Patients.1

While the process of administering EN may appear less complex compared with parenteral nutrition (PN), serious harm and death can result due to potential adverse events occurring throughout the process of ordering, administering, and monitoring. There have been multiple reports of adverse events related to EN. These events include reports of enteral misconnections,2 enteral access device misplacements3 and displacements, metabolic abnormalities, mechanical tube complications, bronchopulmonary aspiration, GI intolerance related to formula contamination, and drug-nutrient interactions.4 Reports such as these and the need to promote optimal practices for EN ordering, preparation, delivery, and monitoring have prompted A.S.P.E.N. to develop this document. Therefore, the intention of the Enteral Nutrition Practice Recommendations Task Force was to investigate and compile practice guidelines and to disse-minate these recommendations to clinicians, administra-tors, educators, and researchers involved in the provision of EN. This document is not intended to serve as a complete reference guide to the administration and management of EN.

Patient safety is a national and international priority in all areas of healthcare. The goal of this document— to identify safety issues related to EN— is in keeping with this purpose. The challenge is to identify evidence-based and strong consensus practices and communicate the infor mation to the healthcare community, patients, and their caregivers. The Joint Commission has been recognized for their well-established patient safety activities in all healthcare settings through its National Patient Safety Goals (NPSG).5 These goals promote proactive improve ments in patient safety, whether based on empirical evidence or best practices. A Sentinel Event Alert released through the Joint Commission in April 2006 identified tubing misconnections as a persistent and potentially deadly occurrence, which is often under- reported.6 Reports in the media and from organiza-tions such as the Emergency Care Research Institute (ECRI), the U.S. Food and Drug Administration (FDA), the Institute for Safe Medication Practices (ISMP), and United States Pharmacopeia (USP) indicate that misconnection errors, including enteral misconnections, occur with significant frequency and can lead to deadly consequences.

Promoting patient safety in the enterally fed patient is dependent on continuous surveillance and recognition of potential areas of patient harm and medical errors. Identifying areas for potential human error, administrative and organizational conditions that are conducive to error,

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and the patient’s own tolerance to EN need to be recognized by the healthcare practitioner, and clinical and organi-zational changes implemented, if EN complications are to be decreased. This applies to all populations across the entire healthcare continuum. The administration of EN is a multidisciplinary process. Policies and procedures for patients fed enterally in the hospital and at alternate sites may not be entirely evidence-based. Compounded with the complexities of modern healthcare and decreasing staff both at the bedside and at the nutrition support level, risk of complications associated with the delivery of EN may increase.

References

1. A.S.P.E.N. Board of Directors and the Clinical Guidelines Task

Force. Guidelines for the use of parenteral and enteral nutrition in adult and pediatric patients. JPEN J Parenter Enteral Nutr. 2002;26(Suppl):1SA-138SA. Errata 2002;26:144.

2. Guenter P, Hicks RW, Simmons D, et al. Enteral feeding

misconnections: a consortium position statement. Jt Comm J Qual Patient Saf. 2008;34:285-292.

3. Bankhead RR, Fang JC. Enteral access devices. In: Gottschlich MM,

ed. The A.S.P.E.N. Nutrition Support Core Curriculum: A Case-Based Approach—The Adult Patient. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2007: 233-245.

4. Malone AM, Seres DS, Lord L. Complications of enteral nutrition.

In: Gottschlich MM, ed. The A.S.P.E.N. Nutrition Support Core Curriculum: A Case-Based Approach—The Adult Patient. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2007: 246-263.

5. The Joint Commission. National Patient Safety Goals. 2007.

http://www.jointcommission.org/PatientSafetyNationalPatientSafetyGoals/. Accessed April 4, 2008.

6. The Joint Commission Sentinel Event Alert. Tubing Misconnections—

A Persistent and Potentially Deadly Occurrence. 2006. http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm. Accessed October 15, 2008.

II. ORDERING AND LABELING OF ENTERAL NUTRITION

A. Formulary Selection Process

The first commercially produced enteral formulas were made available for use in the 1940s. The numbers of these products have expanded to include common standardized and blenderized formulas, disease-specific products, modular components, and powdered formulas, often used in infants and toddlers. Because of this increase in available products, the clinician must rely on nutrition and physical assessment, consideration of metabolic abnormalities, evaluation of GI function, overall medical condition, and expected outcomes for each individual patient to determine product selection. This systematic comparison of the patient’s condition and nutrient needs with the specific properties of the available nutritional

formulas can be used to identify the enteral formula that will most closely meet the individual’s requirements. The simple practice of correlating a medical diagnosis with a specifically marketed formula can result in the administration of inappropriate nutrition support and an increased cost of nutrient provision.1 A potential safety issue may arise if an enteral formulary is limited to products based on an institutional contract in that they might not be appropriate for the patient population or setting.

Historically, dietetic/nutrition departments have been responsible for procuring, preparing, and distributing EN formula in hospital settings. In one study published in 1989, more than 75% of the hospitals had developed enteral formularies. The documented reasons were cost containment, decreased product duplication, staff education, and inventory management.2 Another method to control costs is participation in a group purchasing organization. These groups offer significant savings opportunities for major patient care and diagnostic equipment purchases. The value of group purchasing allows healthcare facilities to control costs while providing the best patient care. Typically, an established commitment level is set for institutional compliance and results in benefits for the purchase of products and services at lower costs.3-4 A clause should allow purchase of a non-competing product outside of the contract without penalty if it better meets the patients’ needs.Practice Recommendations

1. Facilities should establish a formulary of availa-ble EN formulas specific to the institution. (C)2. A specific EN formulary should be established based on patient population and estimated nutri-ent needs rather than specific diagnosis. (C)3. When the facility participates in corporate buy-ing groups for the purchase of EN products, a clinician with expertise in nutrition support should be involved in the selection process of available formulas that best meets the patient’s nutrient requirements. (C)

References

1. Fussell ST. Enteral formulations. In: Materese LE,

Gottschlich MM. Contemporary Nutrition Support Practice.2nd Ed. Philadelphia, PA: Saunders;2004: 1

88-200.2. Coffey LM, Carey M. Evaluating an enteral nutrition formu-lary. J Am Diet Assoc. 1989;89:64-68.

3. Anderson A, Baker G, Carmody M, et al. Partnering to

improve the supply chain. Mater Manag Health Care. 2006;15(2):42-51.

4. Smith CR. Determining when integrated delivery systems should

belong to GPOs. Healthc Financ Manage. 1998;52:38-41.

Enteral Nutrition Practice Recommendations/Bankhead et al 5

B. Elements of the Order

Many problems associated with EN orders result in inadequate delivery of formula to patients in critical care settings. These problems are attributed to under-ordering, frequent cessation of the administration, and slow advancement of the EN to goal rate.1,2 Standard protocols2,3 and an algorithm4 have been implemented to address these problems. One group developed a protocol that standardized ordering, nursing procedures, rate advancement and limited administration interruptions. Use of the protocol improved delivery of goal volumes, although there was physician resistance to using a standard order form.2 A Canadian group was also able to improve delivery of the required formula volume using a protocol.3 A feeding algorithm was developed to increase the likelihood of meeting nutrition requirements. The algorithm also resulted in an increased utilization of EN (rather than PN) and in the number of patients who met EN administraton goals.4

Patient-specific EN orders should include 4 elements: 1) patient demographics, 2) formula type, 3) delivery site/device, and 4) administration method and rate. For examples, see Figures 1 and 2 (Adult and Pediatric order forms). Orders can be written as a single order representing a specific prescription, or they can be part of a larger protocol that directs advancement of EN from initiation to a goal rate or volume that represents a nutritionally adequate endpoint. The inclusion of transitional orders will direct weaning from EN, and ancillary orders may address various patient care issues. Orders may be handwritten in the medical record or entered through a Computerized Prescriber Order Entry system (CPOE).

Patient Demographics: The order should clearly state the patient’s name, date of birth, weight, location, and medical record number (MRN).

Formula: The formula should be clearly identified in the order either by a generic name or by the specific product depending on institutional policy. For example: Osmolite? (Abbott Laboratories. Abbott Park, IL) which contains 1 calorie per mL can be generically identified as “isotonic“ or “standard”; TwoCal? HN (Abbott Laboratories) which contains 2 calories per mL can be generically identified as “calorie dense”; Peptamen? 1.5 (Nestle Nutrition, Vevey, Switzerland), a partially hydro-lyzed formula, can be generically identified as “semi-el-emental” or “peptide-based.” Formula orders may also include the administration of modular products used to enhance the protein, carbohydrate, fat, or fiber content of the enteral regimen. In the adult population, these products are usually administered directly to the patient via the enteral access device in prescribed amounts and frequency with specific administration guidelines, but

are most often not added to the enteral formula. In the

neonatal and pediatric population, fluid tolerance limits are a concern, therefore the base formula is often aug-mented with a modular macronutrient. When this type of manipulation to infant formula is prescribed, the base formula, the modular product, and the base and final concentration of formula per 100 calories are all considered.5,6 If this is done in the home, it is important to teach the parents or caregivers the proper method to prepare a formula with additives.

Delivery site/device: The route and access site for for-mula administration should be clearly identified in order to prevent wrong-site administration. Enteral misconnec-tions (see later section on the same) have been reported in the literature.7 Identification of the site (eg, jejunal port of gastrojejunostomy tube) also decreases the chance of inadvertent use of the site for another therapeutic entity.

Administration method and rate: Bolus, gravity, or continuous method: volume or rate of administration, and timing of formula delivery within a specified period of time (24 hours or cyclic) should be clearly set forth in an EN order.

Additional Orders: Orders that differ from the stand-ard formula rate, route, and volume prescriptions. These can include:

Advancement orders: These orders direct the progres-sion of an EN regimen from initiation through to an endpoint or goal formula volume over a specified time period. Increases in formula volume or rate of administra-tion to achieve a goal should be clearly written. These advance ment orders also need to be coordinated with decreases in parenteral nutrition.

Transitional orders: The incremental decreases in for-mula volume over a period of time to accommodate for an increasing oral intake.

Ancillary orders: Routine or ancillary orders will depend on both the population and setting. These orders are based on institutional policies for care of the enterally fed patient, such as orders for flushing the enteral access device, head of bed (HOB) elevation, and monitoring laboratory parameters.

C. Enteral Nutrition Order Forms

The EN Order Form contains the four elements that should be part of an EN order plus suggestions for ancillary and transitional orders. The examples seen in Figures 1 and 2 should be adapted to meet the need of each individual institution and can be paper- or computer- based. Many institutional settings utilize CPOE systems, which should provide clinical decision support and address each of the elements in the figure (eg, a separate