6 Journal of Parenteral and Enteral Nutrition / Vol. XX, No. X, Month XXXX
Figure 1. Adult Enteral Nutrition Order Form
Patient Name: _________________ Medical Record No: ____________ DOB:_________Room Number: ____________ Dosing Weight: ____________FORMULA
[select one]
[ ]Standard [ ]Standard/Fiber[ ]Protein-rich[ ]Reduced-calorie[ ]Calorie-rich[ ]Peptide-based[ ]Low Electrolytes[ ]Substrate-enriched
[ ] Modular Product: Pro:______________CHO:_________________Fat:_____________[ ] Other:_____________________________________________________DELIVERY SITERoute:
[ ]Gastric[ ]Post-pyloric
[select a route and an access]
Access:
[ ] Nasogastric[ ] Oralgastric [ ] Gastrostomy[ ] Nasoduodenal [ ] Oralduodenal [ ] Nasojejunal[ ] Oraljejunal[ ] Jejunostomy
[select a method and then a rate]
METHOD OF ADMINISTRATIONMethod:
[ ]Pump-assisted[ ]
Gravity-assisted(30-60 min)Bolus (Syringe)(10-20 min)
Rate:
[ ] Initial ___ mL/h
[ ] Advance by ___ mL/h every ___ h to goal of ___ mL/h[ ] Initial ___ mL bolus over ___ min ___ times daily[ ] Advance by ___ mL each day to a goal of ____ mL feeding over ___ min ___ times daily[ ] Initial ___ mL bolus over ___ min ___ times daily[ ] Advance by ___ mL each day to a goal of ____mL feeding over ___ min ___ times daily
[ ]
OTHER ORDERS[based on institutional protocol](For example)
[ ]Flush the feeding tube with ___ mL of water every ___ hour[ ]Keep head of bed elevated to 30°-45°
MONITORING[based on institutional protocol](For example)
[ ] Check GRV every ____ hour(s)
If GRV greater than___ mL →hold administration for ___ hour(s)and re-check
If GRV greater than 500 mL →hold administration indefinitely (will require a new order to re-start feedings)
[ ] Confirm HOB elevation to 30°-45°
[ ] Observe for abdominal distension, firmness or discomfort every ___ hour(s)[ ] Tube site care and assessment every _____hour(s)[ ] Intake and Output every _______hour(s)[ ] Weigh once daily[ ] Labs:
Prescriber: Date: Time:________
CHO, carbohydrate; DOB, date of birth; GRV, gastric residual volume; HOB, head-of-bed; Pro, protein.
Enteral Nutrition Practice Recommendations/Bankhead et al 7
Figure 2. Pediatric Enteral Nutrition Order Form
Patient Name: ______________ Medical Record No: ___________ DOB:___________Room Number:_________________ Dosing Weight:___________FORMULA:
________________ at concentration: _____________ kcal/30mL
Additional Nutritional Additive: ________________________________________ Final concentration: ________________________________ kcal/30mL
Other additives/medications: _______________________________________________DELIVERY SITE
Oral: PO ad lib or __________ mL
Feeding tube:
Nasogastric___ Gastrostomy____ Nasojejunal____ Gastrojejunal_____ Jejunostomy___ METHOD OF ADMINISTRATION:[select a method and then a rate]MethodRate[ ]Pump-assisted[ ] Initial ___ mL/h
[ ] Advance by ___ mL/h every ___ hour(s) to goal of ___ mL/h[ ]
Gravity-assisted(30-60 min)Bolus (Syringe)(10-20 min)
[ ] Initial ___ mL bolus over ___ min ___ time(s) daily
[ ] Advance by ___ mL each day to a goal of ___ mL feeding
over ___ min ___ time(s) daily [ ] Initial ___ mL bolus over ___ min ___ time(s) daily
[ ] Advance by ___ mL each day to a goal of ___ mL bolus
over ___ min ___ time(s) daily Offer PO every _______ minute(s), then give remaining via tube
[ ]
[ ]Oral
OTHER ORDERS[based on institutional protocol](For example)
[ ]Flush the feeding tube with ___ mL of water every ___ hour(s)[ ]Keep head of bed elevated to 30°-45°
MONITORING[based on institutional protocol](For example)
[ ] Observe for abdominal distension every ___ hour(s)[ ] Tube site care and assessment every _____hour(s)[ ] Intake and Output every _______hour(s)[ ] Weigh daily[ ] Labs:
Prescriber: Date: Time:________
DOB, date of birth; PO ad lib, by mouth at will.
screen for each element; for example, if a post-pyloric enteral access device order is selected then the intermittent administration delivery screen(s) would not be an option). These systems should be designed with detailed order sets that promote safety by using drop-down menus within each element of an EN order, including required fields. Such menus may facilitate standardized advancement of initial administrations to goal volumes, uniform enteral access device flushing volumes and methods, and population-specific ancillary orders.
8 Journal of Parenteral and Enteral Nutrition / Vol. XX, No. X, Month XXXX
Practice Recommendations
1. Standardized order forms (paper or CPOE) should be developed and designed for adult and pediatric EN regimens to aid prescribers in meeting each patient’s nutrition needs and to improve order clarity. (C)
2. EN orders should include 4 elements: 1) patient identifiers, 2) the formula, 3) the enteral access delivery site/device, and 4) the administration method and rate. (C)
3. Order protocols may also incorporate feeding advancement, transitional orders, and imple-mentation of ancillary orders.(C)
4. The use of generic terms to describe EN formu-las is encouraged. (C)
5. Avoid the use of dangerous abbreviations or inappropriate numerical expressions. (C)
6. All elements of the EN order must be completed when EN is modified or re-ordered. (C)
References
1. McClave SA, Sexton LK, Spain DA, et al. Enteral tube feeding in
the intensive care unit: factors impeding adequate delivery. Crit Care Med. 1999;27:1252-1256.
2. Spain DA, McClave SA, Sexton LK, et al. Infusion protocol
improves delivery of enteral tube feeding in the critical care unit. JPEN J Parenter Enteral Nutr. 1999;23:288-292.
3. Mackenzie SL, Zygun DA, Whitmore BL, Doig CJ, Hameed SM.
Implementation of a nutrition support protocol increases the proportion of mechanically ventilated patients reaching enteral nutrition targets in the adult intensive care unit. JPEN J Parenter Enteral Nutr. 2005;29:74-80.
4. Woien H, Bjork IT. Nutrition of the critically ill patient and effects
of implementing a nutritional support algorithm in ICU. J Clin Nurs. 2006;15:168-177.
5. Klein CJ. Nutrient requirements for preterm infant formulas. J
Nutr. 2002;132(6 Suppl 1):1395S-1577S.
6. Raiten DJ. Assessment of nutrient requirements for formulas.
LSRO Report. 1998;128(11S):2059S-2094S.
7. 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.
D. Labeling of Enteral Nutrition
To avoid misinterpretation, a label should be affixed to all EN formula administration containers (bags, bottles, syringes used in syringe pumps). The label should reflect the four elements of the order form and therefore contain the following: patient demographics, formula type, enteral access delivery site/access, administration method, individuals responsible for preparing and hanging the formula, and time and date formula is prepared and hung.1,2 See Figures 3 through 6 for examples which may also include nutrient information if the label is computer
generated. Furthermore, the labels for all EN formula containers, bags, or syringes should be standardized. All EN labels in any healthcare environment shall express clearly and accurately what the patient is receiving at any time. Having standard components on a label decreases potential confusion when a patient is transferred to a different unit within a facility, or when a new staff member takes over a patient’s care (see Table 1).3 Clear labeling that the container is “Not for IV Use” helps decrease the risk for an enteral misconnection. Proper labeling also allows for a final check of that enteral formula against the prescriber’s order.1 Care should be taken in developing a label that is clear and concise and of a size that fits neatly on the container.
Special consideration with the labeling of HBM: Clear and concise labeling of HBM is essential to prevent errors in the delivery of breast milk to the infant. The label of milk stored in the hospital must include the following: contents in container (HBM), infant’s name, medical record number, date and time of milk expressed, medications or supplements taken by the mother, whether milk is fresh or frozen, date and time milk was thawed, and expiration date based on whether milk is fresh or frozen.4 If the mother is separating fore and hind milk, this designation should appear on the label. Unique identifiers may be used to describe other factors such as colostrum, transitional, and mature milk. The HBM label may also include information on fortification and caloric density if additives have been mixed with the milk. Hospitals have developed novel approaches to this process. Unique identifiers, such as bar codes, special colors, or symbols, may be used to further identify the HBM. Hospitals may use computer generated or handwritten labels4 (see Figures 5 and 6).
Practice Recommendations
1. The labels for EN formula administration contain-ers, bags, or syringes should be standardized. (C)2. Patient transfer between and within healthcare environments require clinician-to-clinician com-munication to promote the accurate transfer of the EN prescription. (C)
3. All EN labels in any healthcare environment shall express clearly and accurately what the patient is receiving at any time. (C)
4. The EN label should be compared with the EN order for accuracy and hang time or beyond-use date before administration. (C)
5. Clearly label human breast milk (HBM) with the patient’s name and medical record number in order to prevent errors in delivery of HBM to infant. Preprinted labels and/or bar coding sys-tems may help avoid breast milk mixups. (C)
Enteral Nutrition Practice Recommendations/Bankhead et al 9
Figure 3. Standard Enteral Nutrition Label Template (Adult Patient)
Institution and Department Name—Contact Information
Patient Name___________________ Patient ID_____________ Room Number _____________
Generic(Brand)FormulaName
Formula: ____________________________
______ grams of protein / _____ kcal / container
_____ mL / containerPrepared by: ________________
Date: ________
Time: _____
ENTERAL USE ONLY
DeliverySite
Route of Delivery:________________ Enteral Access Site:______________
_________________________________________________________________AdministrationIVIV
Method of Administration: Bolus Intermittent Continuous Rate of Administration:___________mL/hFormula Hung by: __________________,NurseDate: ________Time: _____Expiration vs Beyond Use Date: ____________ Time: __________
Figure 4. Standard Enteral Nutrition Label Template (Neonatal or Pediatric Patient)
InstitutionandDepartmentName–ContactInformation
Patient Name___________________ Room Number _____________
Patient ID
_____________
ENTERAL USE ONLY
Generic(Brand)FormulaName
Base Formula: _________________________ _____ kcal /100 mL
_____ mL / container
Fortifier: ______________________________ Final Concentration: _____ kcal /100 mL____ mL / containerPrepared by: _________________
Date: ________
Time: _____
DeliverySite
Route of Delivery:__________________
Enteral Access Site:_________________
_______________________________________________________Administration
IVIVMethod of Administration: Bolus Continuous
Rate of Administration:______mL/h
Formula Hung By: ____________, NurseDate: ____Time: _____
Expiration Date: ________
Time: _____
10 Journal of Parenteral and Enteral Nutrition / Vol. XX, No. X, Month XXXX
References
1. Perry AG, Potter PA. Clinical Nursing Skills & Techniques. 6th ed.
St. Louis, MO: Mosby; 2006:1032.
2. Stamps DC. Enteral nutrition. In: Wiegand DJL, Carlson KK, eds.
AACN Procedure Manual for Critical Care. St. Louis, MO:Elsevier; 2005:1142.
3. Mirtallo J, Canada T, Johnson D, et al; Task Force for the Revision
of Safe Practices for Parenteral Nutrition. Safe practices for parenteral nutrition. JPEN J Parenter Enteral Nutr 2004;28: S39–S70. Errata 2006;30:177.
4. Robbins ST, Beker LT, eds. Infant Feedings: Guidelines for Preparation
of Formula and Breastmilk in Health Care Facilities. Chicago, IL: American Dietetic Association, 2004.
III. ENTERAL FORMULA (MEDICAL FOOD) AND INFANT FORMULA
REGULATION
A. Background
Enteral formulas, including adult and pediatric formulas, are classified by the U.S. Food and Drug Administration (FDA) under the heading of medical foods. Currently, the FDA defines medical foods as “a food which is formulated to be consumed or administered enterally under the super-vision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”1 Infant formulas, used in bottle-feeding and in enteral (tube) feeding when required, are regulated by the FDA. This is not the case with medical foods. Manufacturers have sought to take advantage of the relatively unregulated status of medical foods to develop and market products under the classification of medical food, although the regula-tions, or lack thereof, are so confusing that even potential manufacturers confuse the legal differences between medical foods, infant formulas, and parenteral products which are classified and regulated as drugs by the FDA.2,3 Thus, the public (patients) and healthcare professionals must give special attention to the veracity (accuracy, credibility) of enteral formula manufac turers on the labeled content and health claims attributed to formulas.
B. Medical Foods
Medical foods have been defined, but they are not regulated as either conventional food or as drugs. In fact, they are essentially without regulation other than those that apply to Good Manufacturing Practices for conventional foods. These require vendors to ensure clean manufacturing facilities, inclusion of required ingredients, and provision of appropriate concentrations of ingredients in processed foods. Vendors also fall under regulations that ensure the sterility of
low-acid thermally processed foods.4 But they are exempt from regulations on labeling (including Nutrition Facts) and health claims that apply to conventional foods as well as regulations that apply to drugs. The current legal definition of medical foods provided above dates to the Orphan Drug Act of 1988. In addition to defining medical foods, the Act introduced a subcategory called orphan medical foods to be used in the management of “…any disease or condition that occurs so infrequently in the United States that there is no reasonable expectation that a medical food for such a disease or condition will be developed without assistance.”1 This is similar to the provision that applied to drugs in the original Orphans Drug Act of 1973, to ease normally required development costs for those drugs (orphan drugs) not anticipated to return development costs due to minimal need for rare diseases. However, there are no developmental regulations for medical foods that would require the creation of an orphan category.5
C. Infant formulas
Infant formulas were distinguished from foods (and medical foods) for special dietary use in 1980. In 1979, two infant formulas designed to be low in sodium chloride caused multiple cases of failure to thrive associated with metabolic alkalosis attributed to the formula. This incident incited Congress to pass the Infant Formula Act of 1980, which placed infant formulas in a new category of foods for special dietary use. More recently, the FDA has issued a Health Information Advisory related to Chinese manufactured formulas that may be contaminated with melamine. These formulas are not approved for sale in the U.S. and specialty Asian markets in the U.S. are being investigated for sale of these products manufactured in China.6 Infant formulas designed for uncommon medical conditions were classified as “exempt” because the nutritional requirements of infants with rare conditions differ from those of healthy infants.5 Infant formulas are subject to regulations applying to quality control, labeling, nutrient requirements, formula recall, notification (for new products), and exempt products.7
Practice Recommendations
1. The veracity (accuracy, credibility) of adult enteral formula labeling and product claims is dependent on formula vendors. (C)
2. Nutrition support clinicians and consumers are responsible for determining the veracity of adult enteral formulas. (C)
3. The U.S. government regulates the veracity of infant formula labeling and product claims. (C) 4. Interpret enteral formula content/labeling and health claims with caution until such time as more specific regulations are in place. (C)
ASPEN - EN prac recommendation - JPEN2009 - 图文
