Parenteral Nutrition Products Research Articles

Effect of a designed nursing protocol on nurse's knowledge and practice regarding Intravenous Therapy

Background: Peripheral venous cannulation is the commonest method used for intravenous therapy. There are numerous well recognized indications such as intravenous fluids, limited parenteral nutrition, blood and blood products, drug administration (continuous or intermittent). The aim of the present study is 3-folds: the first is to assess nurse's knowledge and practice regarding intravenous therapy, the second is to design nursing protocol for nurses about intravenous therapy and the third is to evaluate the effect of implementing the designed nursing protocol on nurse's knowledge and practice regarding intravenous therapy. Hypotheses: Three hypotheses were formulated: (1) the post mean knowledge scores of nurses who will be exposed to designed nursing protocol will be higher than their pre mean knowledge scores. (2) The post mean practice score of nurses who will be exposed to a designed nursing protocol will be higher than their pre mean practice scores. (3) A positive relationship will exist between knowledge and practice score obtained by nurses receiving the designed nursing protocol. Research design: Aquasi-experimental research design was utilized in this study on a convenient sample of 55 nurses. The study will be conducted in general medical departments (B and C) and blood diseases unite of Assiut university hospital. Tools: utilize for data collection were a) Questionnaire sheet. b) Observation checklist sheet. c) Construction of designed nursing protocol. Results: The first and the second hypotheses were supported as a good improvement in the mean knowledge & practice scores were found after the implementing of designed nursing protocol. The third hypothesis was supported as a negative relationship was found between nurse's knowledge and practice scores immediately after application of the designed nursing protocol. Conclusion: implementing the designed nursing protocol on nurse's knowledge and practice regarding intravenous therapy shows a significant improvement in nurses' knowledge and practice. Recommendation: Continued nursing education and in-service training programs should be well organized within Assiut University Hospital.

TCH-038 Shortage of Sterile Calcium Gluconate Stock Solution For Parenteral Nutrition: What is the Alternative and How Much Does It Cost?

BackgroundThe Total Parenteral Nutrition (TPN) production facility of our children’s hospital produces around 20,000 units per year with 2 Baxa EM2400 compounders. In June 2012, a shortage of the calcium...

CPC-115 Prevention and Treatment of Intraluminal Catheter Thrombosis in Children Hospitalised in a Paediatric Intensive Care Unit

BackgroundPlacing central venous access devices (CVADs) is essential in the management of critically ill children. Used for the administration of fluids, medicines, total parenteral nutrition or blood products they may,...

TCH-051 Validation of an Automated Compounder Set Up Once a Week For Parenteral Nutrition Solutions

BackgroundOur parenteral nutrition production (PN) decreased after we introduced standard solutions. To keep just a small number of daily PN items cost-effective, we decided to validate a once a week...

Which lumen is the source of catheter-related bloodstream infection in patients with multi-lumen central venous catheters?

Paired blood cultures, drawn from the catheter and a peripheral vein, used for calculation of the differential time to positivity (DTP), have been proposed for the detection of catheter-related bloodstream infections (CRBSIs). The most relevant catheter lumen to be sampled in multi-lumen central venous catheters (CVCs) has not been recommended. Forty-four febrile neutropaenic patients, following haematopoietic stem cell transplantation (HSCT) and with multi-lumen CVCs in place, were investigated using the DTP method of blood samples drawn from every lumen of the CVC and a peripheral vein. Twelve of 44 patients (27 %) had CRBSIs, as determined by the DTP method. In 10 of 12 (83 %) febrile neutropaenic patients, after HSCT, CRBSIs originated from the CVC lumen used for parenteral nutrition and blood products only. 17 % had CRBSI originating from the other CVC lumen (p = 0.039). In most patients, CRBSIs originated from the CVC lumen used for parenteral nutrition and blood products, indicating that this lumen is the main source of CRBSI. However, since 17 % of patients had CRBSIs originating from another lumen, each lumen of multi-lumen CVCs has to be considered as a potential source of CRBSI and should, ideally, be sampled in order to avoid failure in diagnostic procedures.

Proline Supplementation to Parenteral Nutrition Results in Greater Rates of Protein Synthesis in the Muscle, Skin, and Small Intestine in Neonatal Yucatan Miniature Piglets1–3

Proline and arginine are each indispensable during parenteral feeding due to limited interconversion by an atrophied gut. Commercial amino acid parenteral products designed for neonates contain proline concentrations that differ by almost 4-fold. To assess the adequacy of the lowest concentration of proline provided in commercial total parenteral nutrition (TPN) products, we compared rates of tissue-specific protein synthesis and nitrogen balance in neonatal piglets provided TPN at 2 different proline concentrations. Yucatan miniature piglets (9–11 d old, n = 12) were randomized to complete isonitrogenous TPN diets with low proline (LP; L-proline as 3% of amino acids) or proline supplemented (PS; 9%). After 7 d of receiving TPN, rates of protein synthesis in liver, gastrocnemius muscle, jejunal mucosa, and skin were determined by the flooding dose technique and tissue free amino acids were measured. Nitrogen balance was assessed during the last 3 d. The LP TPN resulted in lower free proline concentrations in plasma, muscle, and skin (P < 0.05) and lower rates of protein synthesis in the jejunum (by 25%; P = 0.02), muscle (by 45%; P = 0.015), and skin (by 60%; P = 0.01); there was no difference in liver. Nitrogen retention was 20% lower in the LP group (P = 0.01). In conclusion, muscle and skin protein synthesis was profoundly sensitive to parenteral proline supply and the reduced protein synthesis in the intestine could affect intestinal integrity. Low-proline TPN solutions that are currently in wide use in neonatal care may result in impaired tissue growth.

Building and Maintaining Best Practices to decrease Vascular Access-Associated Infections in the Use of Peripherally Inserted Central Catheters

Central venous catheters are indispensable devices in oncology that are used to administer intravenous therapies, parenteral nutrition or blood products. The advantages of PICC include: easy insertion and removal, long term usability (up to six months), and insertion with local anesthesia. In this study we ascertain infection rates of PICCs, and report the results of introducing best practices and continuous quality improvement in inserting and caring for this type of catheter.

Parenteral Nutrition Product Shortages

Product (drug) shortages have had a significant impact on the healthcare system, particularly on patients and clinicians. This has been especially true with patients requiring parenteral nutrition (PN). The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) has dealt with PN product shortages in the past on behalf of its members and their patients. However, the shortage severity and duration have made dealing with the PN product shortages in 2010-2012 extremely challenging.

Low Iodine Content in the Diets of Hospitalized Preterm Infants

Iodine is critical for normal thyroid hormone synthesis and brain development during infancy, and preterm infants are particularly vulnerable to the effects of both iodine deficiency and excess. Use of iodine-containing skin antiseptics in intensive care nurseries has declined substantially in recent years, but whether the current dietary iodine intake meets the requirement for hospitalized preterm infants is unknown. The aim of the study was to measure the iodine content of enteral and parenteral nutrition products commonly used for hospitalized preterm infants and estimate the daily iodine intake for a hypothetical 1-kg infant. We used mass spectrometry to measure the iodine concentration of seven preterm infant formulas, 10 samples of pooled donor human milk, two human milk fortifiers (HMF) and other enteral supplements, and a parenteral amino acid solution and soy-based lipid emulsion. We calculated the iodine provided by typical diets based on 150 ml/kg · d of formula, donor human milk with or without HMF, and parenteral nutrition. Preterm formula provided 16.4-28.5 μg/d of iodine, whereas unfortified donor human milk provided only 5.0-17.6 μg/d. Adding two servings (six packets) of Similac HMF to human milk increased iodine intake by 11.7 μg/d, whereas adding two servings of Enfamil HMF increased iodine intake by only 0.9 μg/d. The other enteral supplements contained almost no iodine, nor did a parenteral nutrition-based diet. Typical enteral diets for hospitalized preterm infants, particularly those based on donor human milk, provide less than the recommended 30 μg/d of iodine, and parenteral nutrition provides almost no iodine. Additional iodine fortification should be considered.

Compounding vs Standardized Commercial Parenteral Nutrition Product

Standardized commercial parenteral nutrition (PN) formulations have advantages and disadvantages as compared with PN formulations compounded using an automated compounding device. These advantages and disadvantages are discussed along with the supporting available research.

Parenteral Nutrition Product Shortages

The drug shortage crisis continues in the United States and threatens the integrity of the pharmaceutical supply chain and compromises patient care, especially patients requiring parenteral nutrition (PN) therapy. The number of new drug shortages has increased rapidly over the past 5 years, with the most significant increase in sterile injectable products. The most common reason for a shortage of a sterile injectable medication is a product quality issue. Two surveys of healthcare professionals have assessed the impact of drug shortages on patient safety. Participants in one survey reported over 1000 medication errors or patient adverse events as the result of shortages. The American Society for Parenteral and Enteral Nutrition also conducted a survey of healthcare professionals regarding PN product shortages and the associated patient care implications. Safety risks were reported throughout the entire PN process, from procurement of PN products to patient outcomes. Providing PN therapy during product shortages requires vigilance and continuous assessment of the entire PN process to optimize patient care quality and avoid patient harm.

A Prescription for Drug Shortages

THE ACCELERATING USE OF GENERIC DRUGS, WHICH now account for 70% or more of prescriptions in the United States, has been greeted with great approbation. But the lack of market forces in the highly regulated pharmaceutical industry is resulting in a worrisome trend—shortages of drugs are occurring with increasing frequency. In the last few years, the shortages are no longer limited to orphan drugs but have begun to affect familiar medications that play a central role in current treatment. On October 31, 2011, President Obama signed an executive order allowing the US Food and Drug Administration (FDA) broader latitude in its efforts to contain drug shortages. But the problem is complex and will not be easily remedied. In 2005, the Center for Drug Evaluation and Research reported 62 drug shortages, defined by the FDA as “a situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the patient level.” There were 157 shortages in 2009, including 72 shortages of sterile injectables. By 2010, the number of shortages had increased to 178, with 132 shortages affecting sterile injectables. This number was already exceeded by the end of the third quarter of 2011, and some predictions are between 200 and 300 drug shortages by the end of 2011. An increasing percentage of the drugs in short supply is in the category of older, generic “sterile injectables,” which includes intravenous medications used for chemotherapy or for anesthesia. Approximately 75% of the shortages in 2010 were in this group. The process of manufacturing sterile injectable drugs is complicated. The FDA attributed more than 50% of the shortages of sterile injectables in 2010 to issues with product quality (presence of particulates, microbial contamination, impurities, and crystallization). A shortage of the anesthetic propofol, only recently resolved, developed when 2 of the 3 manufacturers were affected by product recalls— Hospira, for particulate matter, and Teva, for possible microbial contamination. Similarly, the recall and resultant shortage of cytarabine (Ara-C) was related to a product quality issue of crystal formation. Because there is no substitute for cytarabine in protocols for acute myelogenous leukemia (AML), unavailability of this drug presented major problems for oncologists and their patients. However, it was found that the crystals dissolved if the vial containing cytarabine was warmed, and the FDA subsequently permitted use of available product with this advisory. Unlike propofol and cytarabine, which are made by multiple companies, many drugs are manufactured at one site by one company. In addition, drugs may have a single supplier of active pharmaceutical ingredient. Information about the sources of pharmaceutical ingredients is proprietary, but an estimated 80% of raw material for drug manufacturing comes from foreign countries. Thus, the supply chain can be quite tenuous and it is only sluggishly responsive to changes in demand. Hospitals and outpatient surgical centers have been the first affected by the shortages of sterile injectables. Premier Healthcare Alliance surveyed 228 hospitals in the second half of 2010 and found that 80% of them had experienced shortages that led to “delay or cancellation of patient care intervention.” Attempts to work around a shortage are fraught with hazard. When hospitals substituted etomidate for propofol, at least 8 cases of phlebitis were documented. Instances of multiple use of single-use vials of propofol led to contamination and infection with hepatitis C in Nevada. There were 9 deaths in Alabama due to bacterial contamination of hand-mixed total parenteral nutrition products when the sterile premix was unavailable. In the case of chemotherapy, there are often no reasonable substitutes for the drugs in short supply. There were 23 chemotherapy shortages in 2010 and there were already 22 shortages by August 2011, according to the Hematology/Oncology Pharmacy Association. The National Cancer Institute has been forced to place some studies on hold, and individual patients have experienced interruptions in their treatment cycles. It is tempting to resort to “gray market” vendors of drugs, but the drugs they offer at substantial markups have an unknown provenance, a very risky situation. The common denominator for problems with these drugs is that they are older, off patent, difficult to formulate, and have a defined shelf life. “Just-in-time” inventory control

Capillary electrophoresis for the determination ofN-Acetyltyrosine andN-acetylcysteine in products for parenteral nutrition: Method development and comparison of two CE systems

Summary Because of the problems with stability and solubility, some of the amino acids (AAs) used in parenteral nutrition products are often replaced by their acetylated forms. These include N-acetyltyrosine (NAT) and N-acetylcysteine (NAC). This leads to a need to develop new analytical methods for rapid and easy determination of these substances in the presence of common AAs. Capillary electrophoresis (CE) is one of the techniques that have been successfully applied to the assay of multi-component samples containing AAs and their derivatives. This paper discusses a new CE method for the simultaneous determination of two acetylated AAs in solutions for parenteral nutrition. A background electrolyte (BGE) was developed based on borate buffer with alkaline pH. The method is selective and enables the separation and assay of analytes without special sample pretreatment. Validation parameters confirmed sufficient precision and accuracy of the method. Its applicability was verified by testing several medicinal...

Methods to Identify and Compare Parenteral Nutrition Administered From Hospital‐Compounded and Premixed Multichamber Bags in a Retrospective Hospital Claims Database

Use of parenteral nutrition (PN) is indicated for patients who are unable to meet their needs enterally. PN may be administered via custom-compounded mix or commercially available ready-to-use multichamber bags (MCB), but little is known about potential differences in clinical outcomes between these delivery systems. This study was undertaken to assess the feasibility of comparing custom-compounded and MCB PN in a large hospital claims database. Hospital claims data from the Premier Perspective Comparative Hospital Database (PCD) reported from 2005 through 2007 were analyzed. The authors searched the data for patients who received any PN products, including compounded PN and MCB PN. Coding algorithms for identifying patient characteristics, risk factors, and outcomes of interest were explored. Using hospital billing claims, the authors identified patients in the database treated with premixed PN from multichamber bags ("MCB only," n = 4699) and patients treated with custom-compounded PN solution ("compounded PN," n = 64,315). Methods of identifying PN administration groups, patient characteristics and risk factors, outcomes of interest, and data limitations are described. Exploratory analysis suggests that comparisons of PN administered via compounding and MCB are possible using the Premier data. The ability to control for many identifiable risk factors allows data to be presented for the use of PN and related outcomes in both a clinically sensible and relevant manner, albeit with some limitations.

Aluminum in Pediatric Parenteral Nutrition Products: Measured Versus Labeled Content

Aluminum is a contaminant in all parenteral nutrition solutions. Manufacturers currently label these products with the maximum aluminum content at the time of expiry, but there are no published data to establish the actual measured concentration of aluminum in parenteral nutrition solution products prior to being compounded in the clinical setting. This investigation assessed quantitative aluminum content of products commonly used in the formulation of parenteral nutrition solutions. The objective of this study is to determine the best products to be used when compounding parenteral nutrition solutions (i.e., those with the least amount of aluminum contamination). All products available in the United States from all manufacturers used in the production of parenteral nutrition solutions were identified and collected. Three lots were collected for each identified product. Samples were quantitatively analyzed by Mayo Laboratories. These measured concentrations were then compared to the manufacturers' labeled concentration. Large lot-to-lot and manufacturer-to-manufacturer differences were noted for all products. Measured aluminum concentrations were less than manufacturer-labeled values for all products. The actual aluminum concentrations of all the parenteral nutrition solutions were significantly less than the aluminum content based on manufacturers' labels. These findings indicate that 1) the manufacturers should label their products with actual aluminum content at the time of product release rather than at the time of expiry, 2) that there are manufacturers whose products provide significantly less aluminum contamination than others, and 3) pharmacists can select products with the lowest amounts of aluminum contamination and reduce the aluminum exposure in their patients.

Childhood cancer: Do females experience more acute toxicities than males? A report from the Children's Oncology Group.

9515 Background: Drug dosing is based on a gender-independent estimate of body surface area. In childhood acute lymphoblastic leukemia (ALL), females have a consistently better event-free survival than males. However, long-term follow-up studies often find an increase in treatment-related late effects among female cancer survivors. The purpose of this study is to determine if females also experience more acute toxicities during active treatment. Methods: We reviewed data collected on the Children's Cancer Group (CCG) high-risk ALL study, CCG-1961. We studied 830 female and 1,224 male patients enrolled between 1996 and 2002, ages 1-21 years. Linear and logistic regression were used to analyze differences in hospital days, length of treatment courses, incidence of grade 3 and 4 toxicities (CCG Toxicity Rating Scale) and reported supportive care use between males and females for the first four phases of treatment. Analyses were adjusted for age, race, treatment regimen, phase and body surface area. Results: Females had significantly more hospital days than males (D1.6, 1.3, 1.2 and 1.4 days, p<0.001,<0.01,<0.001 and <0.001, for Induction, Consolidation, Interim Maintenance and Delayed Intensification, respectively). Females had more grade 3 and 4 toxicities: nervous system (OR=1.6, p<0.01), gastrointestinal (OR=1.6, p<0.0001), pancreas (OR=1.7, p<0.0001), and infections (OR=1.6, p<0.001). Risk of having therapy delayed more than a week due to treatment-related toxicities was significantly higher for females (OR=1.2, p<0.02). Females received more IV antibiotics (OR=1.2, p<0.01), IV antifungals (OR=1.7, p<0.0001), IV analgesics (OR=1.3, p<0.05), parenteral nutrition (OR=1.9, p<0.0001) and blood products (OR=1.8, p<0.0001). Conclusions: Females treated on CCG-1961 experienced more acute toxicities than males. It appears that female pediatric cancer patients may be at higher risk of developing both acute and long-term complications. Sex-specific differences in outcomes may be due to factors such as differences in body composition, endogenous hormones and drug metabolism. Further study is needed to better understand the disparities in treatment-related toxicities found among male and female pediatric cancer patients. No significant financial relationships to disclose.

Aluminum Content of Parenteral Nutrition in Neonates: Measured Versus Calculated Levels

Aluminum (Al) is associated with significant central nervous system toxicity and bone and liver damage. Because Al is a contaminant of parenteral nutrition (PN) components including calcium and phosphate additives, premature infants are at potentially high risk for toxicity. The US Food and Drug Administration (FDA) has mandated PN component product labeling and recommended maximum Al daily exposure limits. The objective of this article is to determine the actual Al content of neonatal PN solutions, compare these values to the calculated amounts from manufacturers' PN product labels, and ascertain whether the actual Al exposure exceeds the FDA recommended maximum of 5 microg . kg(-1) . day(-1). Samples from 40 neonatal patient PN solutions were selected for sampling and Al content determination. Samples were also taken from 16 manufacturer's component products used in PN formulation. All of the samples were sent to Mayo Laboratories for Al content measurement. The calculated Al concentrations in PN samples were determined from the manufacturer's labeled content. Both measured and calculated Al concentrations exceeded the FDA recommended safe limit of <5 microg . kg(-1) . day(-1). The actual measured Al content was significantly lower than the calculated Al content in both the patient PN solutions and the component product samples. Al exposure exceeded the FDA recommended maximum limit for all patient samples; however, the actual measured Al content of all the samples was significantly less than the calculated Al content based on manufacturer's labels. These findings suggest that manufacturers label their products with actual Al content at the time of product release rather than at time of expiration. Periodic monitoring of Al levels should be considered with prolonged PN therapy. Changes in manufacturing processes, including the use of better raw materials, are essential to reduce Al contamination to meet FDA mandates.

Manganese in Parenteral Nutrition: Who, When, and Why Should We Supplement?

Micronutrient requirements are not fully understood. Parenteral nutrition (PN) usually contains the trace element (TE) manganese (Mn) from fixed-concentration TE supplements. Multiple TE formulations may not be optimal in pediatric and home PN. Moreover, most PN products contain Mn as a ubiquitous contaminant. Excessive Mn can lead to Parkinson-like symptoms resulting from hypermanganesemia. A survey of 40 Australasian hospitals that contributed data on 108 patients to the annual home PN register and a systematic review of the literature were conducted to establish the scope of the potential problem of Mn toxicity in PN patients. Exposure to Mn doses 5-6 times current daily requirements, together with the TE contamination that is reported in PN products, can lead to neurotoxicity. Whole-blood levels are more accurate for monitoring and correlate well with signal intensity of magnetic resonance imaging. Current TE formulations restrict prescribing options. The regulatory mechanisms of Mn homeostasis are bypassed via the parenteral route so elimination via the hepatobiliary system is impaired, resulting in tissue or brain accumulation. Published dosage recommendations may be excessive and official guidelines require revision. Variability in clinical practices necessitates that individual TE additives are more widely available and multiple TE products reformulated. More frequent monitoring for any brain accumulation is recommended. The scarcity of PN-associated Mn deficiency, plus the growing evidence for Mn toxicity, leads to the conclusion that it is unnecessary for Mn to be prescribed routinely for pediatric or long-term PN patients.

Commercial Premixed Parenteral Nutrition: Is It Right for Your Institution?

Two-compartment premixed parenteral nutrition (PN) products are heavily promoted in the United States. These products may present safety advantages over PN solutions mixed by a local pharmacy, although clinical data to support this assertion are scarce. Multicompartment products can be labor-saving for pharmacy and therefore may be cost-effective for some institutions. Before adopting such products for use, an institution must determine that standardized PN solutions are acceptable for many or most of their patients compared with customized PN compounded specifically for individual patients. A larger selection of premixed products is available in Europe and some other parts of the world compared with the United States. Availability of a broader selection of products in the United States, including 3-compartment bags and a wider range of macronutrient concentrations and volumes, may make the use of such products more desirable in the future.

Educational strategy to reduce medication errors in a neonatal intensive care unit

We aimed to evaluate the effect of a comprehensive preventive educational strategy on the number and type of drug errors in the prescription process in a regional neonatal intensive care unit (NICU). Medication errors during prescription were recorded in a 41 bed, level III regional neonatal unit by a pharmacist. Data were retrieved from handwritten doctor's orders and introduced at bedsite into an e-database. Each prescription, not related to enteral and parenteral nutrition and blood products, was evaluated for dosage, units, route and dosing interval. The study was developed in three phases: pilot phase to know the baseline drug error rate and estimate sample size; pre-intervention (4182 drug orders reviewed); and post-intervention seven months after a comprehensive preventive educational intervention consisting sessions about drug errors and study's aims was implemented. After the preventive educational intervention was implemented, the prescription error rate and the percentage of registers with one or more incident decreased significantly from 20.7 to 3% (p < 0.001) and from 19.2 to 2.9% (p < 0.001), respectively. Simultaneously, an improvement in correct identification of the prescribing physician was registered (from 1.3 to 78.2%). The rest of items analysed were similar in both periods. The implementation of a structured preventive educational intervention for health professionals in a regional NICU reduced the medication error rate, possibly by the dissemination of a patient safety culture.