Parenteral Nutrition Ordering, Order Review, Compounding, Labeling, and Dispensing

"BACKGROUND: Parenteral nutrition (PN) is a high-alert medication available for patient care within a complex clinical process. Beyond application of best practice recommendations to guide safe use and optimize clinical outcome, several issues are better addressed through evidence-based policies, procedures, and practices. This document provides evidence-based guidance for clinical practices involving PN prescribing, order review, and preparation. METHOD: A systematic review of the best available evidence was used by an expert work group to answer a series of questions about PN prescribing, order review, compounding, labeling, and dispensing. Concepts from the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) format were applied as appropriate. The specific clinical guideline recommendations were developed using consensus prior to review and approval by the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) Board of Directors. The following questions were addressed: (1) Does education of prescribers improve PN ordering? (2) What is the maximum safe osmolarity of PN admixtures intended for peripheral vein administration? (3) What are the appropriate calcium intake and calcium-phosphate ratios in PN for optimal neonatal bone mineralization? (4) What are the clinical advantages or disadvantages of commercially available premade (""premixed"") multichambered PN formulations compared with traditional/customized PN formulations? (5) What are the clinical (infection, catheter occlusion) advantages or disadvantages of 2-in-1 compared with 3-in-1 PN admixtures? (6) What macronutrient dosing limits are expected to provide for the most stable 3-in-1 admixtures? (7) What are the most appropriate recommendations for optimizing calcium (gluconate) and (Na- or K-) phosphate compatibility in PN admixtures? (8) What micronutrient contamination is present in parenteral stock solutions currently used to compound PN admixtures? (9) Is it safe to use the PN admixture as a vehicle for non-nutrient medication delivery? (10) Should heparin be included in the PN admixture to reduce the risk of central vein thrombosis? (11) What methods of repackaging intravenous fat emulsion (IVFE) into smaller patient-specific volumes are safe? (12) What beyond-use date should be used for (a) IVFE dispensed for separate infusion in the original container and (b) repackaged IVFE?"

Analysis of the practice of nutrition support pharmacy specialists.

In 1988 the Board of Pharmaceutical Specialities (BPS) recognized nutrition support pharmacy practice (NSPP) as one of four specialty areas in pharmacy. The BPS appointed a specialty council to develop and manage the process for board certification of qualified specialists. One step was to identify and validate activities performed by the specialists. This was accomplished by conducting a study that delineated the role of these practitioners and also provided information for developing a blueprint for a certification examination. The results revealed the types of practice settings, education, and training for specialists, and the distribution of professional time devoted to nutrition support activities.

Nutrition support for lung transplant patients.

Lung transplantation has emerged as an established and accepted therapy for patients with endstage pulmonary disease. Very little information has been published about the nutrition management of these patients during the period after transplantation. We conducted a retrospective review of the nutrition support records of 52 adult patients who had undergone lung transplantation at our institution. In addition to patient demographics, data were collected on baseline nutritional status, energy and protein goals, type of specialized nutrition support therapy, length of therapy, and incidence of metabolic complications. More than 50% of the patients receiving lung transplants had a diagnosis of cystic fibrosis. Compared with patients having other diagnoses, this group of patients had a greater incidence of malnutrition. The mean energy goal was 127 +/- 0.07% of basal energy expenditure, and the protein goal was 1.37% +/- 0.25 g/kg/d. All patients received parenteral nutrition therapy, which was begun by postoperative day 2 for more than 70% of the patients. Therapy was short-term (mean, 9 days), and patients then received oral diet. The most common metabolic complications were azotemia, hyperglycemia, and hypomagnesemia. Our experience should provide assistance to other health care professionals who are involved in the nutrition and metabolic management of patients undergoing lung transplantation.

Drug-lab interactions: implications for nutrition support. Acetylcysteine interference with urine ketone test.

It is important that health care professionals be aware of the potential for medications to interfere with clinical laboratory tests. Medications can cause in vivo effects when the concentration or activity of the analyte is altered before the analysis and therefore the assay result is true and accurate. An in vitro effect occurs when the medication interferes with the assay, and the result is erroneous and cannot be interpreted. This report describes a recently identified case of interference of acetylcysteine with the urine test for ketones and demonstrates the importance of a thorough medication review in evaluating abnormal laboratory tests.

The physical mechanisms of the perception of dampness in fabrics.

The detection of dampness in hygroscopic materials has been investigated both by subjective tests and by the application of a model of the physical mechanisms involved. Subjects were asked to rate the degree of dampness of a range of materials of different moisture contents after a short period of contact with the inner forearm. Skin and fabric inner surface temperatures were recorded. It was found that highly hygroscopic wool fabrics were perceived as being dryer and maintained a higher temperature at the skin surface than polyester, a less hygroscopic fabric, during fabric-skin contact. A physical model of the sorption/desorption process in hygroscopic materials has been developed from knowledge of fibre sorption kinetics and used to study the physical processes which take place at the skin-fabric interface during transient contact. These predictions agree well with the subjective responses and the measured temperatures.

Restoring patency of long-term central venous access devices.

More patients are receiving extended and complex infusion therapies, so there is an increased need for long-term central venous access and the placement of "permanent" central venous access devices (CVADs). CVADs may be necessary for home parenteral nutrition and chronic intravenous antibiotics, chemotherapy, analgesia, and hydration therapies. The use of these catheters for multiple therapies increases the potential for catheter occlusion. Occlusions may be secondary to thrombosis, lipid deposits, or the precipitation of medications or minerals and electrolytes. Various pharmacologic agents have been used to restore patency of occluded CVADs. These agents include thrombolytics, ethyl alcohol, hydrochloric acid, and sodium bicarbonate. A thorough evaluation of the CVAD and the therapies administered via this catheter is necessary to select the most appropriate pharmacologic agent to restore catheter patency.

The excretion and characterization of intravenously administered olestra.

Although sucrose octaoleate that is consumed is neither digested or absorbed, following intravenous injection it is found mainly in the liver. Olestra is a mixture of the hexa-, hepta-, and octaesters of sucrose. To follow the metabolic fate of intravenously administered [14C]sucrose-labeled olestra, we measured its urinary elimination, and the rate of excretion of 14C in the feces, and characterized the 14C-labeled material that appeared in bile. The fecal excretion for days 4-14 after dosing was found to be first order with the half-life of the injected olestra being 5.0 +/- 0.5 days. The 14C recovered in the bile was soluble in chloroform. Two-dimensional thin-layer chromatography autoradiograms of the biliary lipid showed the pattern of the biliary 14C to be essentially the same as that of the dosed olestra. Biliary excretion and subsequent fecal egestion of essentially unhydrolyzed sucrose esters is the principal route for the removal of intravenously administered olestra. Only traces of 14C were found in the urine.

Effect of retrograde aminophylline administration on calcium and phosphate solubility in neonatal total parenteral nutrient solutions.

The effect of retrograde administration of aminophylline injection on calcium and phosphate solubility in neonatal total parenteral nutrient (TPN) solutions was studied. Neonatal TPN solutions containing two amino acids solutions in three concentrations (Travasol 1% and 2% and TrophAmine 2%) were formulated. Calcium and phosphate salts were added to achieve calcium concentrations of 10, 15, 20, 25, 30, or 40 meq/L and phosphorus concentrations of 10, 15, 20, 25, 30, or 40 mmol/L. Samples were inspected visually after 18-24 hours; solutions free of precipitation were then infused through two parallel syringe-pump systems designed to simulate clinical conditions for TPN solution administration to a 1-kg neonate. To one system, a 7.5-mg aminophylline dose was added as a manual retrograde injection; sterile water for injection was added as a manual retrograde injection to the other system. The solutions were inspected throughout a one-hour infusion period for precipitate formation in the i.v. apparatus, and the pH of the effluents was determined. Concurrent aminophylline administration resulted in visible precipitate in all but a few of the solutions tested. The solution containing Travasol 2%, calcium 10 meq/L, and phosphorus 10 mmol/L remained clear, as did the solutions containing TrophAmine 2% and the following concentrations of calcium and phosphorus: calcium 10 meq/L and phosphorus 10, 15, or 20 mmol/L; calcium 15 meq/L and phosphorus 10 or 15 mmol/L; and calcium 20 meq/L and phosphorus 10 or 15 mmol/L. An average increase in pH of 0.63 unit was noted in all solutions.(ABSTRACT TRUNCATED AT 250 WORDS)

Efficacy of tube feeding in supplying energy requirements of hospitalized patients.

During a 6-week period, all adult patients in a university hospital receiving ready-to-feed nasoenteric tube feeding formula were prospectively studied. The study objective was to determine each patient's caloric intake from tube feeding relative to their energy needs and to identify factors causing decreased feeding intake. Each of 35 patients was visited at least once daily to determine their volumetric intake of tube feeding formula. Daily review of patient care records and nursing interviews were used to identify interruptions in therapy. Patient's basal energy expenditures (BEE) were calculated using the Harris-Benedict equation. Calorie goals were set by members of the Nutrition Support Service or clinical dietitians. Intakes averaged 1095 +/- 41 Kcal (SEM) per day or 61% of their mean calorie goal of 1791 +/- 41 Kcal. Mean daily calorie intake was statistically different (p less than 0.05) from mean energy goal on patient study days 1 through 5, 7, and 8. Only 16 of the 35 patients achieved an intake of 100% of their energy goal on any day of therapy. Calorie goals averaged 1.4 times BEE. Mean daily calorie intake did not exceed BEE until study day 10. Eighteen % of potential feeding time was lost due to temporary feeding interruptions; primarily inadvertent extubation (4.6%), gastrointestinal intolerance (4.7%), medical procedures requiring discontinuation of feeding (2.8%), and feeding tube positioning difficulties (1.5%). In addition, physicians ordered only 75% of calculated energy goals. These data indicate that tube feeding therapy, when provided under usual hospital conditions, does not meet patient's energy requirements.

Effects of enteral tube feeding on the absorption and pharmacokinetic profile of carbamazepine suspension.

In a randomized, two-period crossover clinical study, eight normal male volunteers received two separate 500-mg doses of carbamazepine (CBZ) suspension 1 week apart. One dose was administered orally after an overnight fast, and the other was administered by nasogastric feeding tube during a continuous enteral feeding infusion. Serial serum CBZ concentrations were determined by high-performance liquid chromatography (HPLC) to assess the effects of the enteral feeding on CBZ absorption. Noncompartmental methods were used to estimate pharmacokinetic data. One volunteer experienced a mild hypersensitivity reaction after his first CBZ dose and was withdrawn from the study. The other subjects tolerated both doses very well, although most experienced mild drowsiness or lightheadedness. Serum CBZ concentrations were lower during enteral feeding administration, but the differences were statistically significant only at 8 h (p = 0.044). Changes in pharmacokinetic data were not significant, although the decrease in maximum serum concentration approached significance (p = 0.052). The relative bioavailability of CBZ suspension with enteral feeding administration was 90.1% of that during fasting. There was a strong correlation between CBZ dose (mg/kg) and Cmax after oral administration (r = 0.97, Y = 1.88X - 4.49, p less than 0.001) but not during enteral feeding administration. Although absorption of CBZ suspension was generally slower and slightly diminished during nasogastric feeding, this interaction may lessen unwanted side effects.

The rapid hydrolysis and efficient absorption of triglycerides with octanoic acid in the 1 and 3 positions and long-chain fatty acid in the 2 position.

We describe rapid hydrolysis of triglycerides with medium-chain fatty acids in the 1 and 3 positions and a long-chain fatty acid in the 2 position. The triglycerides, 2-linoleoyl-1,3-dioctanoyl glycerol (8L8) and 2-oleoyl-1,3-dioctanoyl glycerol, hydrolyzed more rapidly than triglycerides comprising all long-chain fatty acids. The in vitro hydrolysis rate of 8L8 was similar to that of a medium-chain triglyceride of octanoic and decanoic acids in random positions. From intestinal recovery of 14C 45 min after injection into the isolated, irrigated loop of the small intestine of an anesthetized rat, the amount of 2-[1-14C]linoleoyl-1,3-dioctanoyl glycerol absorbed was greater than 2 1/2 times that of its long-chain analog, 2-[1-14C]linoleoyl-1,3-dioleoyl glycerol. These data support the ease of hydrolysis and absorption of 1,3-dioctanoyl triglycerides with long-chain fatty acids in the 2 position.

Nonlinear ethotoin kinetics.

Five healthy subjects were given single 500-, 1500-, and 2500-mg doses of ethotoin as 250-mg tablets at 7-day intervals. Plasma samples were collected for 49 hr after dosing and were assayed by HPLC for ethotoin. The drug was more slowly absorbed after the two higher doses. There was a disproportionate increase in AUC in all subjects with the escalating doses. Individual subject data were fitted to a first-order model and one incorporating Michaelis-Menten elimination kinetics. Eleven of the 15 data sets were best described by the nonlinear model. All subjects reported visual disturbances with the two higher doses, and four of five experienced dyscoordination of gait with the 2500-mg dose. These effects did not appear to be related to plasma ethotoin concentration.

Separation of cell subpopulations from embryonic chick neural retina with fluorescence-activated cell sorting.

Fluorescence-activated cell analysis and sorting was used to characterize and separate cell subpopulations from the developing chick retina according to size, stage in the cell cycle and location in the tissue. It was shown that uptake of rhodamine B isothiocyanate (RITC) protein stain, light-scattering at large angles, and the time of flight of cells through the laser beam all correlate with cell size. Vital staining of DNA by H33342 permits cell separation according to phase in the cell cycle (G1, S, G2 + M). Further, a method was developed for separating postmitotic cells, based upon the quenching of H33342 fluorescence by the incorporation of 5-bromo-2'-deoxyuridine (BrdU) into DNA. Quantitative data reflect the decrease of DNA-synthesizing cells and the increase of postmitotic cells as the development of the retina proceeds. Isolation of cells on the basis of their location in the whole tissue is achieved by exposing the desired surface (e.g. the inner (concave) surface of the retina, which is rich in ganglion cells) to a suspension of Fluorescamine, which stains only cell layers close to the surface. Sorting out the fluorescing cells yields a high proportion of cells with the appearance, size and postmitotic characteristics of ganglion cells.