0148-6071/04/2806-0S39$03.00/0
`JOURNAL OF PARENTERAL AND ENTERAL NUTRITION
`Copyright © 2004 by the American Society for Parenteral and Enteral Nutrition
`
`Vol. 28, No. 6
`Printed in U.S.A.
`
`Special Report
`
`Safe Practices for Parenteral Nutrition
`
`Task Force for the Revision of Safe Practices for Parenteral Nutrition: Jay Mirtallo, MS, RPh, BCNSP, Chair,
`Todd Canada, PharmD, BCNSP, Deborah Johnson, MS, RN, Vanessa Kumpf, PharmD, BCNSP,
`Craig Petersen, RD, CNSD, Gordon Sacks, PharmD, BCNSP, David Seres, MD, CNSP, and
`Peggi Guenter, PhD, RN, CNSN
`
`APPROVED BY A.S.P.E.N. BOARD OF DIRECTORS JULY 21, 2004
`
`NOTICE: These A.S.P.E.N. Practice Guidelines for Safe
`Practices for Parenteral Nutrition are based upon general
`conclusions of health professionals who, in developing such
`guidelines, have balanced potential benefits to be derived
`from a particular mode of providing parenteral nutrition
`feeding formulations. The underlying judgment regarding
`the propriety for any specific practice guideline 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
`guidelines are not a substitute for the exercise of such judg-
`ment by the health professional, but rather are a tool to be
`used by the health professional in the exercise of such judg-
`ment. These guidelines are 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 .....................................................................S40
`I. Introduction..................................................S42
`II. Ordering Parenteral Nutrition
`Background...................................................S43
`Mandatory for Inclusion............................S44
`Overall Design: Clarity of the Ordering
`Form ...........................................................S44
`Specific Components ..............................S45
`Table II. Determining the Estimated Osmo-
`larity of PN Formulations .........................S45
`Strongly Recommended for Inclusion....S46
`Worthy of Consideration for Inclusion ....S46
`Adult PN Order Template .........................S46
`Figure 1. Physician Orders: Parenteral
`Nutrition-Adult.............................................S47
`Practice Guidelines.....................................S48
`Special Considerations ..........................S48
`III. Labeling Parenteral Nutrition Formulations
`Background .............................................................S48
`PN Label Template ...............................................S49
`Practice Guidelines ..............................................S51
`
`Received for publication, July 1, 2004.
`Accepted for publication, July 31, 2004.
`Correspondence: Jay M. Mirtallo, RPh, BCNSP, 2921 Braumiller
`Road, Delaware, OH 43015. Electronic mail may be sent to mirtallo-
`1@medctr.osu.edu.
`
`Special Considerations...................................S52
`Standard Label Templates..............S50, S51, S52
`IV. Nutrient Requirements
`Nutrient Requirements: Adults................S53
`Nutrient Requirements: Pediatrics.........S55
`Aluminum contamination .....................S56
`Practice Guidelines.....................................S56
`Special Considerations ..........................S57
`V. Sterile Compounding of Parenteral Nutri-
`tion Formulations
`Screening the PN Order
`Background ..............................................S57
`Practice Guidelines ................................S58
`Special Considerations .......................S58
`PN Compounding
`Background ..............................................S58
`Practice Guidelines ................................S60
`Quality Assurance of the Compounding
`Process
`Background ..............................................S60
`Gravimetric Analysis .............................S60
`Chemical Analysis...................................S60
`Refractometric Analysis........................S60
`In-Process Testing ..................................S60
`Practice Guidelines ................................S61
`Special Considerations ......................S67
`VI. Stability and Compatibility of Parenteral
`Nutrition Formulations
`PN Stability...................................................S61
`PN Compatibility .........................................S62
`Medication Administration with PN....S63
`Insulin Use with PN...........................S64
`Practice Guidelines.....................................S64
`VII. Parenteral Nutrition Administration
`Venous Access Selection, Care and Assess-
`ment ................................................................S65
`Medical Equipment for PN Administration
`Filters.........................................................S66
`Infusion Pumps and Administration
`Sets .............................................................S66
`Administration Issues Related to PN Solu-
`tion Properties .............................................S67
`Patient Response to PN Administra-
`tion ..............................................................S68
`
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`IVFE infusion in hypertriglyceridemic
`patients ......................................................S68
`Use of PN Prepared by Another Facility ...S68
`Practice Guidelines.....................................S69
`
`GLOSSARY OF TERMS
`Automated Compounding Device: A device used
`in the preparation of parenteral nutrition. It auto-
`mates the transfer of dextrose, amino acids, fat emul-
`sion, and sterile water, as well as small volume
`injectables, such as electrolytes and minerals to the
`final PN container. The device is driven by computer
`software.
`Beyond-use Date: The date established by health-
`care professionals from the published literature or
`manufacturer-specific recommendations beyond which
`the pharmacy-prepared product should not be used.
`Compatibility: The ability to combine 2 or more
`chemical products such that the physical integrity of
`the products is not altered. Incompatibility refers to
`concentration-dependent precipitation or acid-base
`reactions that result in physical alteration of the prod-
`ucts when combined together.
`Computerized Prescriber Order Entry (CPOE):
`A prescription ordering system where the prescriber
`enters orders directly into a computer.
`DEHP: Di (2-ethylhexyl) phthalate, a plasticizer
`used in various intravenous administration sets or
`plastic infusion bags.
`Dosing Weight: The weight used by the clinician in
`determining nutrient doses. Dependent on institu-
`tional or professional preference, the dosing weight
`may be the actual, ideal or adjusted body weight of the
`individual.
`Drug-nutrient Interaction: An event that occurs
`when nutrient availability is altered by a medication,
`or when a drug effect is altered or an adverse reaction
`caused by the intake of nutrients.
`Dual-chamber Bags: A bag designed to promote
`extended stability of a PN formulation by separating
`the IVFE from the rest of the formulation. It consists of
`2 chambers separated by a seal or tubing that is
`clamped. At the time of administration, the seal or
`clamp is opened to allow the contents of both chambers
`to mix and create a TNA.
`Expiration Date: The date established from scien-
`tific studies to meet FDA regulatory requirements for
`commercially manufactured products beyond which
`the product should not be used.
`Hang Time: The period of time beginning with the
`flow of a fluid through an administration set and cath-
`eter or feeding tube and ending with the completion of
`the infusion.
`Institute of Safe Medication Practices (ISMP):
`A nonprofit organization that works closely with
`healthcare practitioners and institutions, regulatory
`agencies, professional organizations and the pharma-
`ceutical industry to provide education about adverse
`drug events and their prevention. The Institute pro-
`vides an independent review of medication errors that
`have been voluntarily submitted by practitioners to a
`national Medication Errors Reporting Program
`
`(MERP) operated by the United States Pharmacopeia
`(USP).
`Intravenous Fat Emulsion (IVFE): An intrave-
`nous oil-in-water emulsion of oil(s), egg phosphatides
`and glycerin. The term should be used in preference to
`lipids.
`MEDMARX: The internet-based medication error
`reporting program operated by the U.S. Pharmacopeia
`that complements quality improvement activities at
`the local and national level. MEDMARX is available
`through subscription service only.
`Osmolarity: The number of osmotically active par-
`ticles in a solution, expressed as milliosmoles per liter
`of solution. The osmolarity of a PN formulation needs
`to be considered, when determining whether that solu-
`tion can be administered through a peripheral vein.
`Parenteral Nutrition: Nutrients provided in-
`travenously.
`Central: Parenteral nutrition delivered into a high
`flow vein, usually the superior vena cava adjacent to
`the right atrium.
`Peripheral: Parenteral nutrition delivered into a
`peripheral vein, usually of the hand or forearm.
`Percent Concentration (weight/volume): A
`standardized unit of concentration determined by the
`amount of drug or nutrient within a given volume,
`whereby 1% (w/v) is equivalent to 1 g ofdrug or nutri-
`ent per 100 mL of volume.
`Stability: The extent to which a product retains,
`within specified limits, and throughout its period of
`storage and use (i.e., its shelf-life), the same properties
`and characteristics that it possessed at the time of its
`manufacture.
`Total Nutrient Admixture (TNA): A parenteral
`nutrition formulation containing IVFE as well as the
`other components of PN (carbohydrate, amino acids,
`vitamins, minerals, trace elements, water and other
`additives) in a single container.
`Medication Error Reporting Program (MERP):
`U.S. Pharmacopeia’s spontaneous reporting program
`for medication errors that is operated in cooperation
`with the Institute for Safe Medication Practices for use
`by any healthcare professional or interested party.
`Venous Access Devices (VAD): Catheters placed
`directly into the venous system for infusion therapy
`and/or phlebotomy.
`
`PREFACE
`
`The members of the American Society for Parenteral
`and Enteral Nutrition (A.S.P.E.N.) are health care pro-
`fessionals representing the fields of medicine, nursing,
`pharmacy, and dietetics. A.S.P.E.N.’s mission is to
`serve as the preeminent, interdisciplinary nutrition
`society dedicated to patient-centered, clinical practice
`worldwide through advocacy, education, and research
`in specialized nutrition support.
`Patients may be treated with parenteral nutrition
`(PN) in any of several care settings including hospitals,
`long-term care or rehabilitation facilities, or at home.
`Because patients transfer from one health care envi-
`ronment to another, it is the opinion of the A.S.P.E.N.
`Board of Directors that the practice guidelines in the
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`“Safe Practices for Parenteral Nutrition” are the stan-
`dard of practice for the provision of PN in all health-
`care settings.
`The original ‘Safe Practice’ document was specific to
`PN and the practice of pharmacy.1 The objective of this
`revision is to deal with PN in a comprehensive manner
`realizing the interdisciplinary nature of this therapy. A
`new section is added that addresses the ‘ordering of
`parenteral nutrition’. The nutrient range section is
`expanded to provide dosage recommendations that go
`beyond normal requirements and include components
`not addressed in the initial guidelines (e.g., iron and
`the potential for developing an essential fatty acid
`deficiency). Further, the PN filtration section is re-
`named and expanded into: “Administration of paren-
`teral nutrition”. This section includes hang time for
`intravenous fat emulsion (IVFE) and PN, formula
`review prior to administration as well as institutional
`use of PN brought from home or sent with the patient
`on transfer from another facility.
`Unfortunately, practice for some of these latter areas
`have little, if any, published evidence to support good
`practice. As such, the Task Force conducted the 2003
`Survey of PN Practices. This provided an overview of
`the variance and consistency of current practices. The
`survey was organized in the following sections: demo-
`graphics, writing PN orders, computer order entry of
`PN orders and problems with PN orders. There were
`667 responses, mostly from hospitals (85%), with die-
`titians (55%) and pharmacists (32%) being the predom-
`inant professionals responding to the questionnaire. In
`the home health care environment, responses were
`from pharmacists (76%) and dietitians (17%). The
`average daily census for organizations responding was
`100 patients. Most organizations used a once daily
`nutrient infusion system (76%). The number of adult
`PN patients per day was from 0 –20 for 85% of respond-
`ers. However, 4.9% of responders reported more than
`40 adult PN patients per day. For organizations that
`had neonate and pediatric patients, the number of PN
`patients per day was 0 –5 for both.
`Over half (54%) of responders had a performance
`improvement program that monitored the appropriate
`use of PN, accuracy of PN orders, metabolic complica-
`tions and catheter and infectious complications. Phy-
`sicians and nurses selected these categories more fre-
`quently than pharmacists and dietitians. Quality
`control of PN compounding and PN costs were not
`monitored as frequently (⬍50%).
`It was noted that physicians were the professional
`group responsible for writing PN orders. However,
`there was also significant involvement by dietitians as
`well as pharmacists. It is noteworthy that nurse prac-
`titioners and physician assistants were also involved
`with writing PN orders. Oversight of writing the PN
`order was performed predominantly by the pharmacist
`with significant involvement by a nutrition support
`service, medical staff committee and nutrition and die-
`tetics department. For PN components, the base for-
`mula was ordered in terms of percent final concentra-
`tion (47%) or as the percent of stock solution (31%).
`There is no consistent method of ordering PN electro-
`lytes. Phosphorus is usually ordered as millimoles
`
`(mmol) of phosphorus or as both mmol of phosphorus
`and milliequivalents (mEq) of associated cation. Elec-
`trolytes as components of the amino acid formulation
`were not usually considered when writing PN orders
`(71%). Multiple electrolyte formulations were used in
`62% of organizations, according to the summary of
`responses, but only 46% of the time according to the
`pharmacist response (in this case, the pharmacist
`response should be more accurate). In 62% of respond-
`ers, the pharmacist adjusts the chloride and acetate
`content of the PN formulation. Trace elements are
`ordered as a standard volume (87%) with only some
`organizations adjusting the content based on the
`patient’s clinical condition (22%). Standard order
`forms are used by 87% of responders of which 96% are
`for adults and 40 – 42% are for pediatric and neonatal
`patients. Home infusion services are the outlier in this
`group where standard order forms are used in only
`32% of organizations. Standard orders for laboratory
`tests and patient care orders are used in only 54% of
`cases. Data for the hang time or maximal infusion rate
`of IVFE were more difficult to interpret since a write-in
`answer was required. The maximum hang time for a
`total nutrient admixture (TNA) was 24 hours and
`intermittent, separate IVFE infusion of 12 hours.
`Responses to minimum hang time (related to maximal
`infusion rates) were not consistent.
`Only 29% of organizations used a computerized pre-
`scriber order entry (CPOE) system for PN orders. Of
`these, 88% used it for adults and 54% and 58% used it
`for pediatric and neonatal patients. The majority of
`pharmacies (88%) used an automated compounding
`device. Order input to the automated compounding
`device was done by the pharmacist 84% of the time due
`to a lack of an interface with the CPOE system. Only
`15% of organizations outsourced PN formulations. Of
`those that did, a pharmacist at the organization
`reviewed the order where the order originated (95%)
`prior to it being sent to the compounding pharmacy.
`Problems with PN orders were queried in the follow-
`ing manner; number of PN orders written per day,
`percent of orders requiring clarification, reasons orders
`needed to be clarified, frequency of errors in PN ther-
`apy, categories of PN adverse events and severity of
`adverse events. Most (55%) organizations deal with
`0 –10 PN orders per day while 15% had more than 30
`orders per day. These orders need to be clarified ⬍25%
`of the time for 88% of responders and ⬍10% of the time
`for 61% of responders. The most frequent reasons
`orders need to be clarified are macronutrient content,
`illegible orders, incompatibility, nutrient dose outside
`the normal range, infusion rate not prescribed and
`incorrect PN volume. Seldom, if ever, were orders clar-
`ified for a pharmacy compounding error. The highest
`ranked reason, very often (5% of responders) was illeg-
`ible orders. The frequency of reported errors per month
`for PN was low (none in 26%, 1–5 in 60% and 6 –10 in
`10% of responders). These events were related to elec-
`trolytes (69%), dextrose (31%), insulin (31%), amino
`acids, vitamins and IVFE (15% and 26%). Of these
`errors, 55% of responders related them to errors in
`ordering PN in the category of 1–25%, 12% in the
`26 –50% category, 8% in the 51–75% category and 17%
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`in the 76 –100% category. For adverse events that had
`occurred in the last 2 years, 44% of responders were
`not aware of any events, 64% of the events required no
`treatment or just an increase in monitoring. Only 10%
`responded that none of these events occurred. Of inter-
`est are the reports by a few responders of harm, tem-
`porary (13%, N ⫽ 61 responders) or permanent (2%,
`N ⫽ 7 responders), near-death (3%, N⫽16 responders)
`or death (2%, N ⫽7 responders). Whether hospitals
`allowed PN formulations compounded by organizations
`other than their own was queried and results were
`mixed (43% - Yes, 58% - No).
`Realizing that the original Safe Practice guidelines
`are not consistently implemented,2 the Task Force
`used this information to identify practices pertinent to
`the revision of the Safe Practice guidelines. The survey
`results presented in this document are those findings
`pertinent to the development of the guideline. A more
`in-depth and complete analysis of the 2003 Survey of
`PN Practices will be conducted and reported by the
`Task Force within the next year. This snapshot of
`current practices and expert opinion or consensus pro-
`vided by both external and internal reviews was com-
`piled into the current Safe Practices.
`Guidelines will be presented in a format similar to
`the A.S.P.E.N. Guidelines for the Use of Parenteral and
`Enteral Nutrition in Adult and Pediatric Patient.3
`“Safe Practices for Parenteral Nutrition” is organized
`into seven sections.
`● Introduction
`● Ordering parenteral nutrition
`● Labeling parenteral nutrition formulations
`● Nutrient requirements
`● Sterile compounding of parenteral nutrition for-
`mulations
`● Stability and compatibility of parenteral nutrition
`formulations
`● Parenteral nutrition administration
`Each section includes an introduction to the practice
`area addressed, with examples where clinical data
`(including patient harm) support the need for practice
`guidelines to ensure patient safety; specific practice
`guidelines based on consensus of the Task Force mem-
`bers; summary of areas requiring special consider-
`ation; and a list of supporting references.
`The members of the Task Force for the Revision of
`Safe Practices for Parenteral Nutrition are as follows:
`
`Chairman:
`Jay Mirtallo, MS, RPh, BCNSP
`The Ohio State University Medical Center
`Columbus, Ohio
`
`Todd Canada, PharmD, BCNSP
`The University of Texas, MD Anderson Cancer
`Center
`Houston, Texas
`
`Deborah Johnson, MS, RN
`Meriter Hospital
`Madison, WI
`
`Vanessa Kumpf, PharmD, BCNSP
`Nutrishare, Inc
`Elk Grove, CA
`
`Craig Petersen, RD, CNSD
`University of California Davis Medical Center
`Sacramento, CA
`
`Gordon Sacks, PharmD, BCNSP
`University of Wisconsin
`Madison, WI
`
`David Seres, MD, CNSP
`Albert Einstein College of Medicine
`New York, NY
`
`Peggi Guenter PhD, RN, CNSN
`A.S.P.E.N.
`Silver Spring, MD
`
`This document was internally reviewed by the
`A.S.P.E.N. Standards Committee as well as the Die-
`tetic, Nursing, Medical, and Pharmacy Practice Sec-
`tions and approved by the A.S.P.E.N. Board of Direc-
`tors after external review by individuals and other
`associations of health care professionals. A.S.P.E.N.
`recognizes that the practice guidelines will have broad
`ramifications in changing clinical practice in many
`health care settings for pharmacists, physicians,
`nurses, dietitians, and technical support personnel. It
`is hoped that these guidelines will be accepted and
`used to prevent future patient harm, and will serve as
`a catalyst for future research.
`
`REFERENCES
`1. National Advisory Group on Standards and Practice Guidelines
`for Parenteral Nutrition: Safe practices for parenteral nutrition
`formulations. JPEN J Parenter Enteral Nutr. 1998;22:49 – 66.
`2. O’Neal BC, Schneider PJ, Pedersen CA, Mirtallo JM. Compli-
`ance with safe practices for preparing parenteral nutrition for-
`mulations. Am J Health-Syst Pharm. 2002;59:264 –269.
`3. 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).
`
`SECTION I: INTRODUCTION
`
`Over the past four decades, parenteral nutrition
`(PN) has become an important primary (e.g., intestinal
`failure) and adjunctive therapy in a variety of disease
`states. Parenteral nutrition refers to all PN formula-
`tions; total nutrient admixtures (TNA) are PN formu-
`lations that include intravenous fat emulsions (IVFE);
`and 2 in 1 formulations are PN formulations that do
`not include IVFE. PN benefits patients having signifi-
`cant disruption in gastrointestinal
`(GI)
`function
`becoming a lifeline for those who have a permanent
`loss of the GI tract such as patients with GI fistulas or
`short bowel syndrome. New knowledge and technology
`have improved patient selection for PN therapy.
`Refinement of PN will continue to make it a useful
`therapy in the management of patients with dysfunc-
`tional GI
`tracts. However, PN formulations are
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`extremely complex admixtures containing 40 or more
`components including amino acids, dextrose, fat emul-
`sions, water, electrolytes, trace elements, and vita-
`mins. Each of these components is a regulated pre-
`scription drug product. Serious harm and death have
`occurred from improperly prepared and administered
`PN formulations. With a potential for significant ben-
`efit to many patients, its complexity warrants an effec-
`tive process of ordering, preparation, administration
`and monitoring to assure a quality outcome from ther-
`apy. Early PN programs focused on minimizing the
`frequency, severity, and type of complications that
`could result from this therapy. The interdisciplinary
`approach was found to improve efficacy, reduce com-
`plications, and facilitate efficient, cost-effective PN
`therapy. Despite the highly successful use of PN for
`many years, the following adverse events demonstrate
`the types of PN errors that can result in serious harm
`and even death:
`● Two deaths related to errors in PN compounding led
`to a Safety Alert being issued by the U.S. Food and
`Drug Administration (FDA).1 Autopsy of the patients
`involved found diffuse microvascular pulmonary
`emboli. There were also at least two other cases of
`respiratory distress occurring in patients at the same
`institution. These patients had received total nutri-
`ent admixtures (TNA) thought to contain a precipi-
`tate of
`calcium phosphate that
`resulted from
`improper admixture practices in the pharmacy.
`● Hospital personnel misinterpreted the dextrose con-
`tent on the label of a PN formulation used in home
`care, which resulted in a pediatric patient’s death.2
`The home care label read: “300 mL of 50% dextrose.”
`The hospital pharmacy interpreted this as a final
`concentration of dextrose 50% (up to twice the con-
`centration typically used in PN therapy). The patient
`died after 2 days of receiving infusion of the incorrect
`formula.
`● Two other fatal incidents have been reported involv-
`ing pharmacy-compounding operations for pediatric
`dextrose solutions.3 One infant was overdosed with
`dextrose when the PN was prepared with amino
`acids and two bags of 50% dextrose in place of one
`bag of 50% dextrose and one bag of sterile water. The
`other infant was underdosed with dextrose while
`receiving a 1.75% final concentration of dextrose
`solution rather than a 17.5% concentration.
`● Another PN formulation was compounded with no
`dextrose, resulting in irreversible brain damage
`when administered to a neonate.4
`● An incident involving the misinterpretation of a label
`resulted in iron overload and liver toxicity in a child
`receiving PN with iron dextran.5 In this case, the PN
`label read, “iron dextran 1 mL,” the intention being
`to use a 1-mg/mL concentration prediluted by the
`pharmacy. However, the solution containing the
`undiluted, 50-mg/mL concentration was used in com-
`pounding and resulted in a 50-fold error in the dose
`administered.
`● Four children were infected, two of whom died as a
`result of receiving contaminated PN admixtures.6
`Enterobacter cloacae was cultured from disposable
`
`tubing that was used in the automated compounding
`of these PN admixtures.
`● A 2-year old child receiving home PN died after an
`excessively high level of potassium was identified in
`the PN formulation. The most likely explanation pro-
`vided for the death was human error in the manual
`preparation of the PN formulation.7
`● Two premature infants developed extreme magne-
`sium toxicity while receiving PN that was the result
`of an automated PN compounder malfunction.8
`PN has the potential for serious adverse events
`involving many PN components as well as system
`breakdowns. Analysis of data reported to the United
`States Pharmacopeia Medication Error Reporting Pro-
`gram (MERP), presented in cooperation with the
`ISMP, and the MEDMARX medication error database
`suggests that PN events are low in frequency but have
`the capacity to cause patient harm. Errors were related
`to wrong drug preparation, improper dose, labeling and
`problems with automated compounding devices. The
`PN components most commonly associated with errors
`were electrolytes, concurrent drug therapy, insulin and
`dextrose.9 It is unclear what proportion of actual PN-
`associated errors are actually reported to the USP.
`The information provided in the ‘Safe Practices for
`Parenteral Nutrition’ document provides guidelines
`along with supporting evidence to foster quality PN
`therapy. The intent is for the principles provided in the
`document to become incorporated into healthcare orga-
`nization practice for the purpose of minimizing the risk
`of PN. The complexity of this therapy cannot be under-
`stated. There is good evidence in support of practices
`that favor positive patient outcomes.
`
`REFERENCES
`1. Food and Drug Administration. Safety Alert: Hazards of precip-
`itation associated with parenteral nutrition. Am J Hosp Pharm.
`1994;51:1427–1428.
`2. Carey LC, Haffey M. Incident: Home TPN formula order misin-
`terpreted after hospital admission. Home Care Highlights. 1995;
`(spring):7.
`3. Cobel MR. Compounding pediatric dextrose solutions. Medica-
`tion error alert. ASHP Newsletter. 1995;(Aug):3.
`4. Gebbart F. Test hyperal solutions? Florida mom says yes. Hosp
`Pharm Report. 1992;(Feb):35.
`5. Iron overdose due to miscommunication of TPN order. Error
`alert. Pharmacy Today. 1995;(Sep).
`6. Two children die after receiving infected TPN solutions. Pharm
`J. 1994;(Aug):3. 2.
`7. www.hopkinsmedicine.org/Press_releases/2003/12_19_03.html.
`8. Ali A, Walentik C, Mantych GJ, Sadiq HF, Keenan WJ, Noguchi
`A. Iatrogenic acute hypermagnesemia after total parenteral
`nutrition infusion mimicking septic shock syndrome: two case
`reports. Pediatrics. 2003;112(1 Pt 1):e70 – e72.
`9. The U.S. Pharmacopeia Center for the Advancement of Patient
`Safety medication error reporting programs—MEDMARXSM and
`the Medication Errors Reporting Program.
`
`SECTION II: ORDERING PARENTERAL
`NUTRITION
`
`BACKGROUND
`As reported in the introduction to this document,
`life-threatening errors continue to occur in the prepa-
`ration and delivery of PN admixtures to patients.
`Many of the errors that occur are related to the order-
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`MIRTALLO ET AL
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`Vol. 28, No. 6
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`ing process. Responses to the 2003 Survey of PN Prac-
`tices confirm a lack of uniformity in the ordering pro-
`cess from institution to institution, and clinical errors
`were frequently related to the manner that orders were
`created and communicated, as well as incorrect units of
`measure, and errors of omission.
`Research has demonstrated the benefit of standard-
`ized order writing processes in reducing prescription
`errors.1–3 Standardized PN order forms:
`● Incorporate more precise guidelines for PN prescrib-
`ing, including standing orders for PN initiation and
`discontinuation2,4 – 6.
`● Provide physician education,2– 4,6 –7 especially impor-
`tant for clinicians unfamiliar with PN therapy.
`ⴰ Reduce prescribing errors by a range of 9% to
`82%,1,2,4,6,7 primarily by reducing the incidence of
`incompatible concentrations of electrolytes, inap-
`propriate concentrations of dextrose, amino acids
`and IVFE, and omissions of nutrients.
`ⴰ Improve efficiency and productivity of nutrition
`support, primarily in hospitalized patients.1,3,6 The
`rate of total calorie and protein overfeeding was
`decreased by 18%, imparting a 55% reduction in
`the cost of processing and preparation of an initial
`PN order for a standardized solution.
`● Allow comprehensive nursing and dietary care of the
`patient2,6,8 by reducing nursing order interpretation
`problems and improving documentation of each bag
`administered.
`ⴰ Reduce pharmacy inventory and costs1,3,6,7,9 –11 by
`reducing PN wastage, standardizing PN solutions,
`and implementing pharmacy formulary control of
`various amino acids and IVFE products, resulting
`in annual savings from $10,000 to $76,803.
`It should be noted that one study reported an
`increase in prescriber errors after a standardized PN
`form was introduced. Problems occurred with PN infu-
`sion rates, electrolyte composition, and amino acids
`concentration, when using a standardized PN order
`form.2 Therefore, creating and maintaining a stan-
`dardized PN order form that meets the needs of
`patients and minimizes errors still requires a continual
`quality assurance effort and patient safety commit-
`ment by each institution.
`Common factors associated with the majority of PN
`prescribing errors include:12
`● Inadequate knowledge regarding PN therapy
`● Certain patient characteristics related to PN therapy
`(e.g., age, impaired renal function)
`● Calculation of PN dosages
`● Specialized PN dosage formulation characteristics
`and prescribing nomenclature
`Parenteral nutrition has been reported to be second
`only to anti-infective agents as a class of medications
`associated with errors (22% of reports).12 Education
`was cited as necessary for successful implementation
`in most published reports. Therefore, the PN order
`form shall be designed to serve as an educational tool
`for prescribers.2– 4,6,7
`Finally, to minimize errors in all prescription prac-
`tices, accrediting bodies,13 USP,14 the National Coor-
`dinating Council for Medication Error Reporting and
`
`TABLE I
`Components of PN order forms
`MANDATORY FOR THE PN ORDER FORM
`Clarity of the form
`• Clearly written and understandable to anyone who might
`utilize it
`• Organized and easy to scan for completeness
`• Complete enough to address anticipated institution specific
`concerns
`• Ingredients listed in same order as PN label
`• Decimals and percent concentrations avoided
`• All components ordered in grams/milligrams/
`milliequivalents/millimoles per day or per kg per day
`Contact number for person writing the order
`Contact number for assistance with PN ordering
`Time by which orders need to be received for processing
`Location of venous access device (central or peripheral)
`Height, weight/dosing weight, diagnosis, PN indication
`Hangtime guidelines
`Institutional policy for infusion rates
`Information regarding potential incompatibilities
`STRONGLY RECOMMENDED FOR INCLUSION ON PN ORDER
`FORM
`Educational tools (e.g., dosing guidelines)
`Guidelines to assist in nutrient/v