Parenteral Nutrition Products Research Articles

Stability of lipids in parenteral nutrition products admixed with nano-iron medicinal drugs

Stability of lipids in parenteral nutrition products admixed with nano-iron medicinal drugs

Automation of parenteral nutrition: impact on process and cost analysis

ObjectivesOn the basis of its safety and accuracy, automation is recommended for parenteral nutrition (PN). The aim of this study was to highlight the changes in practices related to the...

Parenteral nutrition in clinical practice: International challenges and strategies.

Parenteral nutrition (PN) is an established therapy when oral/enteral feeding is not sufficient or is contraindicated, but nevertheless PN remains a complex, high-alert medication that is susceptible to errors that may affect patient safety. Over time, considerable progress has been made to make PN practices safer. The purpose of this article is to address ongoing challenges to improve the PN use process from prescription to administration and monitoring, and to outline practical aspects fostering the safety, quality, and cost-effectiveness of PN, as discussed at the International Safety and Quality of PN Summit. Opportunities to improve the PN use process in clinical practice include the promotion of inter-disciplinary communication, vigilant surveillance for complications, staff education to increase competency, and more consistent use of advanced technologies that allow automated safety checks throughout the PN process. Topics covered include considerations on PN formulations, including the value of intravenous lipid emulsions (ILEs), trends in compounding PN, the current and future role of market-authorized multi-chamber PN bags containing all 3 macronutrients (amino acids, glucose/dextrose, and ILE) in the United States and in Europe, and strategies to cope with the increasing global problem of PN product shortages. This review outlines potential strategies to use in clinical practice to overcome ongoing challenges throughout the PN use process, and ultimately promote PN patient safety.

False-positive Aspergillus galactomannan immunoassay in the glucose component of total parenteral nutrition products.

In October 2022, we experienced a significant increase in samples showing high galactomannan (GM) indexes ranging from 6.22 to 10.58, as determined by the Platelia Aspergillus antigen immunoassay, also known as the GM test. After reviewing the medical records of nine GM antigenemia cases that did not show evidence of invasive aspergillosis, we found that these patients had received total parenteral nutrition (TPN) products from the same manufacturer, whose supplier of the glucose component had recently changed. The TPN products supplied by the specific manufacturer in October were subjected to a GM assay. The glucose component of the products from three different lot numbers exhibited strong positive results in the GM assay. Microbiological investigations through fungal culture and PCR on the TPN products were negative. The present study demonstrated that the glucose component of the TPN products contained a high level of GM antigen, which caused false-positive GM test results. The source of GM in the glucose component was glucoamylase, which was produced from Aspergillus niger to obtain glucose monohydrate from starch. Investigation of three commercially available glucoamylase products exhibited positive GM and 1,3-β-D-glucan tests with various titers positive up to 1:1,000 dilutions, while fungal cultures were all negative. Quality assurance measures of TPN products to prevent GM contamination should be emphasized during the manufacturing process to avoid unnecessary additional diagnostic procedures and overtreatment of invasive aspergillosis due to false-positive GM tests.IMPORTANCEThis manuscript describes an occurrence of false-positive GM tests in patients receiving TPN products from a manufacturer who had recently changed the supplier of the glucose component. We describe the clinical presentation of nine false-positive cases and the results of serologic and microbiological investigations of the TPN products suspected of contamination with GM. Attempts to detect GM in parenteral nutrition products were made since the detection of GM in sodium gluconate-containing solutions in 2007, but none of them identified the source of elevated GM indexes in TPN products. However, the present study demonstrated that the glucose component of the TPN products contained a high level of GM antigen, which caused false-positive GM assay results. The source of GM was glucoamylase, which was derived from A. niger in the manufacturing process. Physicians and clinical microbiology laboratories should be aware of this issue to improve interpretation and patient care.

Bacteraemia caused by Lactobacillus casei in a patient after cardiac surgery. A case report

BackgroundBacteria of the Lactobacillus family are a part of the physiological flora of the oral cavity, gastrointestinal tract, and urinary tract. We have used them in the food industry as probiotics and supplements. In some settings, rod-shaped lactic acid bacteria may become pathogenic. It may occur in immunocompromised or heart disease patients after cardiac surgery, patients with disturbed intestinal wall permeability, or those treated with broad-spectrum antibiotics.Case presentationWe present rare bacteraemia induced by the probiotic bacterium Lactobacillus casei in a 63-year-old patient after the attempted removal of ICD electrodes, complicated by acute regurgitation of the tricuspid valve. The patient underwent urgent cardiac surgery, the electrode elements were removed, and the tricuspid valve was replaced with a biological prosthesis. After surgery, the patient required intensive, multidisciplinary treatment with mechanical ventilation, continuous renal replacement therapy, broad-spectrum empirical antibiotic therapy, parenteral nutrition, and blood product transfusion because of multiple organ failure. On the 14th day of hospitalisation, the clinical symptoms of septic shock were observed. The microbiological investigation was performed, and Lactobacillus casei was cultured from a dialysis catheter sample. Dedicated antimicrobials were administered, and the patient was discharged home in good overall condition.ConclusionsThe present case shows that the promoted use of probiotics must be cautiously administered to patients in severe conditions, especially when accompanied by reduced immune system efficiency symptoms.

Clinical impacts of the concomitant use of L-asparaginase and total parenteral nutrition containing L-aspartic acid in patients with acute lymphoblastic leukemia.

L-asparaginase (ASNase) depletes L-asparagine and causes the death of leukemic cells, making it a mainstay for the treatment of acute lymphoblastic leukemia (ALL). However, ASNase's activity can be inhibited by L-aspartic acid (Asp), which competes for the same substrate and reduces the drug's efficacy. While many commercially used total parenteral nutrition (TPN) products contain Asp, it is unclear how the concomitant use of TPNs containing Asp (Asp-TPN) affects ALL patients treated with ASNase. This propensity-matched retrospective cohort study evaluated the clinical effects of the interaction between ASNase and Asp-TPN. The study population included newly diagnosed adult Korean ALL patients who received VPDL induction therapy consisting of vincristine, prednisolone, daunorubicin, and Escherichia coli L-asparaginase between 2004 and 2021. Patients were divided into two groups based on their exposure to Asp-TPN: (1) Asp-TPN group and (2) control group. Data, including baseline characteristics, disease information, medication information, and laboratory data, were collected retrospectively. The primary outcomes for the effectiveness were overall and complete response rates. Relapse-free survival at six months and one year of treatment were also evaluated. The safety of both TPN and ASNase was evaluated by comparing liver function test levels between groups. A 1:1 propensity score matching analysis was conducted to minimize potential selection bias. The analysis included a total of 112 ALL patients, and 34 of whom received Asp-TPN and ASNase concomitantly. After propensity score matching, 30 patients remained in each group. The concomitant use of Asp-TPN and ASNase did not affect the overall response rate (odds ratio [OR] 0.53; 95% confidence interval [CI] = 0.17-1.62) or the complete response rate (OR 0.86; 95% CI = 0.29-2.59) of the ASNase-including induction therapy. The concomitant use of Asp-TPN and ASNase also did not impact relapse-free survival (RFS) at six months and one year of treatment (OR 1.00; 95% CI = 0.36-2.78 and OR 1.24; 95% CI, 0.50-3.12, respectively). The peak levels of each liver function test (LFT) and the frequency of LFT elevations were evaluated during induction therapy and showed no difference between the two groups. There is no clear rationale for avoiding Asp-TPN in ASNase-treated patients.

The effect of parenteral nutrition products on infection parameters in patients receiving long-term mechanical ventilation support

Aim: Malnutrition can increase the frequency of infections by reducing the immune system response. Parenteral nutrition (PN) is considered an important treatment for patients who cannot receive adequate oral or enteral nutrition. The contents of nutritional products may be different. In this study, we aimed to investigate the effects of soy-based and olive oil-based parenteral nutrition products on infection parameters.
 Material and Method: A total of 82 patients were included in the study, 50 of which were soy (Group 2) and 32 were olive-based (Group 1) parenteral nutrition. Patient files and laboratory results were reviewed. Age, gender, 1st, 7th, 14th and 21st days in intensive care, leukocyte and platelet counts, Neutrophil lymphocyte ratio (NLR), C-Reactive Protein (CRP) values, Acute Physiology and Chronic Health Evaluation (Apache II) score and first blood culture results after hospitalization were recorded.
 Results: The 7th and 21st day CRP values in Group 1 were statistically significantly lower than the 7th and 21st days CRP values in Group 2. In Group 1, growth in blood culture was statistically significantly lower and in Group 2 there was a statistically significant early growth.
 Conclusion: As a result, it was found that olive oil-based lipid-containing nutritional solutions were more advantageous in terms of infection on intensıve care than soy-based nutrition products. It was concluded that patients who received postoperative mechanical ventilator support fed with olive oil-based parenteral nutrition products had less infectious growth.

Simultaneous determination of 22 fatty acids in total parenteral nutrition (TPN) components by gas chromatography-mass spectrometry (GC-MS).

Evaluating total parenteral nutrition (TPN) products for quality assurance and quality control is crucial due to the chemical complexity of its components. With the advent of exploring different approaches for analysing TPN components using tandem mass spectrometry techniques, there is still a need for a robust and reproducible method for industrial routine analyses. This study allows simple, simultaneous determination of 22 fatty acids (FAs) commonly found in TPN components using gas chromatography-mass spectrometry (GC-MS). Five different transesterification techniques were applied for the FA standards and the sodium methoxide in methanol-dimethyl carbonate method was selected due to its good methylation efficiency. Fatty acid methyl esters (FAMEs) were separated in gas chromatography using an HP-5MS UI column with helium as the carrier gas. Mass spectrometry was used to fragment and quantify FAMEs using electron ionization (EI) and selected ion monitoring (SIM) mode. The analytical method was evaluated using the guidelines from the US Food and Drug Agency (FDA) and European Medicines Agency (EMA) in compliance with the International Council for Harmonization (ICH) document Q2(R2). Correlation coefficients (R2) of the calibration curves for FAMEs were 0.99, except for C24:1 n-9 and C24:0, both R2 = 0.98. The limits of detection (LOD) and quantification (LOQ) were found to be 1.69 μg mL-1 and 5.14 μg mL-1, respectively. The linear range was from 3.10-179.9 μg mL-1 for most FAMEs, except for C18:1 n-7 (3.96-224.9 μg mL-1) and C18:1 n-9 (6.30-349.57 μg mL-1). The intra-day and inter-day precision coefficients of variance (CV) of the method were less than 11.10% and 11.30%, respectively. Freeze-thaw cycles and ambient temperature measurements were performed for assessing sample stability. The validated method was applied to analyse major TPN components-fish and olive oils, and an unidentified lipid sample. The presented GC-MS method is simple and robust in the identification and quantification of 22 fatty acids simultaneously in the tested TPN components.

Managing nutrition support product shortages: What have we learned?

Product shortages related to the components of parenteral nutrition (PN) therapy have been well described over the past decade. The situation has more recently worsened and expanded globally because of the impact the COVID-19 pandemic has placed on supply chain issues and workforce demand. The impact of enteral nutrition (EN) product shortages is less well documented when compared with PN, and development of management strategies is often left up to the discretion of individual providers. The recent crisis in infant formula supply has heightened the national awareness of how a nutrition support product shortage can significantly impact patient safety. This review provides a historical perspective of PN and EN product shortages to gain insight into the lessons learned and applies this to strategies for managing current and future product shortages. Strategies for managing PN and EN shortages can best succeed if they are tailored to address aspects that are unique to the inpatient and outpatient care setting. In addition, patients who transition between care settings are vulnerable to harm related to product shortages if measures are not in place to communicate and address these shortages. Teamwork and communication within an organization and among key stakeholders are necessary to develop processes that aim to minimize patient harm related to product shortages.

Randomized controlled phase I trial for a novel peripheral parenteral nutrition formula containing dextrose, amino acids, fat emulsion, electrolytes, and FDA2000 recommendation-based vitamins

We developed the world's first all-in-one type peripheral parenteral nutrition product containing dextrose, amino acids, fat emulsion, electrolytes and vitamins, according to the FDA 2000 recommendation. This phase I trial examined the safety and changes in nutritional parameters in healthy participants. A single-center, randomized, open-label, active-controlled trial was performed in single ascending dose (SAD: Step 1-3) and multiple dose (Step 4) studies. Participants were administered a single dose of OPF-105 (test solution: 150g of dextrose, 60g of amino acids, 40g of fat, 1240kcal of total energy per 2200mL, and 106 NPC/N ratio, with multivitamins, n=17) or BFI (control solution: 150g of dextrose, 60g of amino acids, 840kcal of total energy per 2000mL, and 64 NPC/N ratio, with vitamin B1, n=18) with three ascending doses (Step 1: 550mL, Step 2: 1100mL, and Step 3: 2200mL) in the SAD study, or received multiple doses with Step 3 amount of OPF-105 (n=5) or BFI (n=6) for 3 days (Step 4) via peripherally inserted venous catheters. The safety and nutritional parameters were assessed. There were no serious adverse events or events requiring discontinuation of the solution administration in either group. Blood urea nitrogen (BUN) levels remained within the normal range in both groups (Step 1-4). However, they gradually increased during the time course of the study in the BFI group but not in the OPF group (Step 4), suggesting the prevention of body protein breakdown. Blood triglyceride (TG) levels increased after administration in the OPF group but promptly returned to the pre-administration level (Step 1-4). Blood total ketone body levels increased the day after administration in both groups, which may imply a lower degree of starvation (Step 1-3), but the increase in the OPF group was milder than that in the BFI group (Step 4). Blood vitamin B6 and folic acid levels were maintained within the normal ranges in the OPF group but were near the lower limit in the BFI group (Step 1-4). Blood vitamin C levels showed almost lower limit in the two groups (Step 1-3), but increased only in the OPF group (Step 4). Blood vitamin K levels in the BFI group remained near the lower limit of the normal range, but those in the OPF group were higher than the upper limit at the end of administration and quickly returned to the pre-administration level (Step 1-4). This trial suggests that the newly developed formula (OPF-105) improves fat metabolism, maintains vitamin profiles, and may prevent body protein and fat breakdown and can be safely administered to healthy participants. Registration number of Clinical Trial: UMIN000046915; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053479.

#49: Results of 10 Years of Peripherally Inserted Central Catheter Use and the Association with Infections in Pediatric Patients at a Tertiary Care Oncology Hospital

Abstract Introduction Pediatric cancer patients merit the placement of central lines for the treatments they receive. Subcutaneous central ports (SCs) and peripherally inserted central catheters (PICCs) are the most frequently used lines. PICCs have gained popularity due to the ease of insertion, which can be invaluable in the pediatric oncology setting for administration of intravenous therapy, parenteral nutrition, and/or blood products. Since central-line-associated bloodstream infections increase the morbidity and mortality of cancer patients, as well as increase the cost generated by their treatment, active surveillance of these healthcare-associated infections is warranted. Methods This is a retrospective descriptive study of pediatric patients treated via PICCs at the Hospital SOLCA Núcleo Quito between 2009 and 2019. Results During the study period, 70 PICC lines were placed in 66 patients, totaling 1862 catheter-days. The majority of patients (75.7%) were diagnosed with leukemia or lymphoma. As of 2011, all PICCs were placed in the operating room by a surgeon. Ultrasound was used 39 times for the insertion of PICCs. Inadequate peripheral venous access was the most common indication (64.2%) for placement. Twenty-nine PICCs had complications, of which 13 were infectious complications and 16 were noninfectious. The most common infectious complication was PICC-related bloodstream infection (13), and the most frequent noninfectious complication was occlusion (10). The overall complication rate was 15.5 complications per 1000 catheter-days, and the overall infectious complication rate was 6.9 complications per 1000 catheter days. Annual complication rates fluctuated over the study period. The PICC line-associated infection rate per 1000 catheter-days was 13.1‰ in 2009, 12.4‰ in 2010, 5.0‰ in 2011, 7.9‰ in 2012, 0 in 2013, 13.4‰ in 2014, 4.8‰ in 2015, 16.2‰ in 2016, 8.2‰ in 2017, and 4.3‰ in 2018. Conclusion In general, complications related to PICC in pediatric patients at a tertiary care oncology hospital have fluctuated over the years. Our findings indicate the need for further efforts in staff education and training in the insertion, care, and maintenance of PICC lines. Best practice guidelines are also critical to reducing complications, especially occlusion and infection rates, to thereby improve patient outcomes.

Risks associated with the evolution in the compounding process of parenteral nutrition solutions: use of the “FMECA” method

Abstract Objectives An audit of the practices of our compounding unit was performed in 2016: areas of improvement were proposed, such as the automatization of our process. An automated compounder was acquired (MediMixmulti® MF4120R). The aim of the study was to anticipate the risks of the new process, in order to improve its security and to support the professionals during this evolution of our compounding process. Methods The Failure Modes, Effects and Criticality Analysis (FMECA) method was carried out in order to detect potential failures brought by the automatization of parenteral nutrition (PN) manufacturing in the new process. The FMECA method included four steps that were divided into five work sessions of one and a half hour each over a period of two months. A working group made up of professionals involved in the PN production process was set up (pharmacists, pharmacy resident, manager and pharmaceutical technician). Results Fifty failure modes were determined by this analysis, of which 96% could have an impact on the patient, 90% on the health staff and 74% on the product. The FMECA shows that 18 failure modes have a tolerable or unacceptable CI (CI≥100) for which it is necessary to implement preventive measures as a priority. This work also made it possible to review the barrier measures already in place for the current process. Conclusions The risk analysis allowed us to analyze the failures of both the actual and the future manufacturing processes. Once the most critical failure modes were identified, specific recommendations were proposed and an improvement plan was established. First, the compounder needs to be fully qualified. Then, the quality manual of the PN process will be reviewed and updated. Once these steps are completed, the pharmacy professionals (pharmacists, pharmacy technicians) will be trained and the PN production will be performed using the automated compounder on a daily basis.

Strengths, weaknesses, opportunities, threats analysis on choice of multi chamber bag or compounded parenteral nutrition

Reasons for choosing parenteral nutrition (PN) products depend on healthcare institutions internal and external factors. A decision to start, continue, scale-up, scale down, or stop compounding of PN involves multiple stakeholders. This study is an effort to analyze such factors and recommendations on decision-making. A strength, weakness, opportunities, threats (SWOT) analysis was prepared in consultation with major PN providers in the UAE and comparing to international best practices. Based on the SWOT analysis, a set of recommendations was prepared using the GRADE system (classification of quality of evidence and strength of recommendation). Feedback on the SWOT analysis and recommendations were collected from the PN providers. The SWOT analysis and recommendations address aspects of the choice of MCB-PN or compounded PN. It includes considerations on PN indication, availability of ingredients, types of patients, safety, and cost management with labor, automation, and outsourcing. It was received well. The SWOT analysis and recommendations are useful in decision-making in complex therapy like PN. It helps in institutional decisions on choices of MCB-PN or compounded PN. The impact of the recommendations is to be measured in the future.

A comparison of clinical, hepatic and immunological effects of three different parenteral lipid emulsions in children

Objectives: Lipid emulsions are not only considered as a source of energy, but also as a regulatory substance for key metabolic functions in different diseases. The aim of the present study was to compare clinical, biochemical and immunological effects of olive oil, soybean oil and omega-3 fatty acid which are administrated to the children in parenteral nutrition products. Methods: Patients who were admitted to pediatric intensive care unit and had parenteral nutrition for 7 days are included in the study. The patients were randomised into 3 groups based on the admission order, including 10 patients in each group. The children in Group O were fed by a lipid emulsion based on olive oil; the children in Group S were fed by a soybean based lipid emulsion and the children in group F were fed by soybean based lipid emulsion with omega-3 based solution. Analysis were made on the first and the seventh day. Laboratory parameters as well as hemogram, biochemical analysis, immunoglobulins, lymphocyte subgroup panel and cytokine levels were evaluated just before parenteral nutrition (day 0, basal value) and at day 7 of parenteral nutrition. Clinical monitoring parameters included body weight, and circumference of the mid-upper arm. Results: Thirty children were enrolled into the study. Total cholesterol and triglyceride levels significantly increased in Group O whereas triglyceride level significantly increased in Group S. Hemogram, liver function tests, cytokine levels, lymphocyte sub-group distribution, immunoglobulin levels and total antioxidant capacity measurements were not different. Conclusions: Three lipid emulsions which are used for parenteral nutrition treatment in intensive care unit patients are clinically and biochemically useful.

Parenteral Nutrition–Associated Liver Disease in Adult Inpatients Receiving Commercial Premixed Parenteral Nutrition for More Than 2 Weeks

AbstractBackgroundLong‐term use of parenteral nutrition (PN) may elicit complications, including PN‐associated liver disease (PNALD), which may yield critical outcomes. This study intended to investigate the development of complications associated with commercial premixed PN in adult patients.MethodsAdult patients who received nutrition support with commercial PN without enteral intake for >14 consecutive admission days were included in the analysis.ResultsSeventy‐two adults, from 2001 to 2016, were reviewed. Mean length of hospital stay was 43.0 days. A mean of 27.3 days of PN was given. Mean energy supplied by PN was 29 kcal/kg/d. Ten patients (13.8%) developed PNALD. Length of stay was significantly longer (P = .034), and duration of PN administration was significantly longer (P = .022) in patients who developed PNALD. The proportion of PN products with soybean oil–based lipids was significantly higher, and fish oil– or medium‐chain triglyceride–containing combination lipids were significantly lower in the patient group with PNALD (P = .02). Multivariate logistic regression analysis showed that longer duration of days receiving PN support was an independent risk factor for PNALD (odds ratio, 1.052; P = .029).Conclusion: The incidence of PNALD in hospitalized adult patients who received daily PN support with commercial premixed 3‐in‐1 products for >2 weeks was 13.8%. Longer duration of days receiving PN support was an independent risk factor for PNALD.

A survey on total parenteral nutrition in 55,000 hospitalized patients: Retrospective cohort study using a medical claims database.

Identifying the prevalence of underfed patients and risk factors for underfeeding in patients with total parenteral nutrition (TPN) is essential to improve the management of patients receiving TPN. The aim of this study was to examine the prevalence and risk factors for underfeeding using a medical claims database. In this retrospective cohort study using a medical claims database, we analyzed patient characteristics, timing and duration of nutrition prescription, daily dose of nutrients, and types of parenteral nutrition products administered after central venous catheter (CVC) insertion in hospitalized Japanese patients between 2009 and 2018. The mean prescriptions of energy <20kcal/kg/day, amino acids <1.0g/kg/day, and fat <2.5g/day received by patients between the 4th and 10th day after CVC insertion were regarded as underfeeding. To study the association between nutritional adequacy and body mass index (BMI) with TPN, the proportions of patients with a prescription of energy ≥20kcal/kg/day or amino acids ≥1.0g/kg/day were calculated and categorized according to BMI, and the Cochran-Armitage trend test was performed. Of 54,687 patients included in the study, 70.3% were aged ≥70 years, and 31.3% had a BMI <18.5. The mean prescription of energy was insufficient in 49.9% of patients, and 82.9% were insufficiently prescribed with amino acids. In addition, 44.4% of the patients were never prescribed a single dose of fat emulsion during their hospital stay. On the 10th day after CVC insertion, the majority of patients used commercial 2-in-1 compounds containing carbohydrates and amino acids. A higher BMI was associated with underfeeding of energy and amino acids (both p<0.001). It is important to adjust the nutrition dose according to the patient's body size and weight, and it is necessary to supplement inadequate nutrients by single-nutrition solutions in addition to compounded solutions.

Assessment and Optimization of the Pediatric Parenteral Nutrition Preparation Process in a Hospital Pharmacy.

Parenteral nutrition (PN) is associated with risks that could threaten the clinical condition of premature neonates hospitalized in the neonatal intensive care unit. In this work, risk-analysis methodology was implemented to contain the risks associated with the PN production process and improve PN safety. The Failure Modes, Effects, and Criticality Analysis was performed by a multidisciplinary team. All potential failure modes of the PN preparation process were recorded, and associated risks were scored based on their severity, occurrence, and detectability, with a risk priority number (RPN). All identified failure scenarios and the respective work stages were ranked in descending order of criticality. Corrective actions were proposed to address critical points, and the safety of the process was reassessed by the same method in a prospective manner. The highest RPN scores were obtained with the PN composition calculation performed manually (RPN: 530) or electronically (RPN: 478), completion of the PN medical order form (RPN: 354), manual compounding of PN admixtures (RPN: 258), and the structure/organization/maintenance of the PN preparation unit (RPN: 133). The quality and safety of PN admixtures could be compromised by many critical factors, such as the increased particle-microbial load in the unit and the inadequate training/experience of the involved health professionals and their incompliance with the given instructions. The implementation of the proposed corrective measures is expected to reduce the risks of the overall PN production process by 67.5%. Improvement of the PN production process through risk-analysis methodologies enhances safety for premature neonates.

Tutorial on How the US Food and Drug Administration Regulates Parenteral Nutrition Products.

Parenteral nutrition (PN) products are regulated in the United States by the Food and Drug Administration (FDA). The FDA regulates PN products as "drugs," and the approval of a new product depends on there being "substantial evidence" of safety and efficacy obtained from "adequate and well-controlled studies." The processes by which the FDA approves PN products in the United States are designed to protect patients from unsafe or ineffective products, but they may also contribute to delaying and preventing access to certain valuable new products. This tutorial is designed to inform the PN community about FDA processes with regard to PN products, including the structure of FDA review teams, requirements for investigational studies, applications for marketing approval, postapproval clinical trial requirements, and requirements for studies in pediatric populations. Knowledge of how the FDA process works and how the FDA regulates PN products can help the PN community work together in advancing the development of new products.

Parenteral Nutrition Preparation Procedure: A Hazard Analysis and Critical Control Points Approach at a Pediatric Hospital in Vietnam

Background: Hazard analysis and critical control points (HACCP) is a tool for food safety assurance, but the application of HACCP in healthcare facilities in Vietnam has been understudied and underregulated given a lack of governmental guidelines. This study aimed to explore the hazards and determine the critical control points related to the parenteral nutrition (PN) preparation procedures in a pediatric hospital in Vietnam. Methods: A cross-sectional study was conducted at Children Hospital No. 2 in Ho Chi Minh City, Vietnam, from July to September 2019. The study subjects were eleven standard operating procedures for preparation of a PN product called Vaminolact 6.5%. The hazards were explored based on the probability of occurrence, the severity of consequence, and the quantity of influenced individuals. Each step in the PN procedure was determined by multiplying the points of three standards. A step with a point equal to or higher than 18 was considered a hazard. The critical control point (CCP) was determined by following the five-question decision tree. Results: Eight hazards were explored via hazard analysis, including sanitation prior to compounding, measurement of basal solution, compounding, labeling, sanitation of preparation room, in-out control, air flow control, and primary filter system. Nine critical control points were determined as follows: sterilization by alcohol, glove change per every 10 vials, basal solution measurement, compounding, mini-spike change per every 10 vials, syringe change per every 10 vials, air flow control, primary filter system, and sterilization check-up. Conclusion: The hospital manager should consider this study as support for an evidence-based adjustment to improve PN preparation procedure.

An Overview of Pharmaceutical Production in Thai Hospitals.

Purpose: The purpose of this research was to provide an overview of pharmaceutical production in Thai hospitals. Methods: A cross-sectional survey was developed to study pharmaceutical production in the 1347 Thai hospitals. A representative sample was chosen using multistep selection arriving at a final total of 750 hospitals. Five experts in hospital pharmacy production were recruited to evaluate the content validity. The questionnaire consisted of 2 parts: (1) general details of the hospitals and (2) the type of pharmaceutical products. The latter classification were further divided into 6 types: (1) nonsterile products, (2) extemporaneous preparations, (3) total parenteral nutrition, (4) intravenous admixtures, (5) cytotoxic preparations, and (6) herbal medicine products. All data were analyzed via descriptive statistics. Results: From the 750 questionnaires sent out, 395 hospitals (52.67%) responded to the questionnaires. Regarding the 395 respondent sample group, approximately 60% of the hospitals were involved in pharmaceutical production. The top 3 pharmaceutical products were as follows: (1) cytotoxic preparations (315 items); (2) liquid nonsterile preparations (60 items), and (3) liquid extemporaneous preparations (52 items). The most frequently mentioned reasons for the production of each dosage form were as follows: (1) no commercially available product in appropriate dosage form or strength needed and (2) product was prepared following the hospital's policy. The support needs in hospital pharmacy production were revealed as follows: (1) master formula, (2) quality assurance and quality control processes, (3) equipment, (4) standard references, (5) buildings, (6) personnel, (7) budget, (8) raw material suppliers, and (9) the coordination between the faculties of pharmaceutical sciences and hospitals. Conclusions: Approximately 60% of the respondents had pharmaceutical production in their hospitals. The greatest need for support was for a master formula to inform hospital-based pharmaceutical production. These findings provide essential information, especially for stakeholders, to understand the professional challenges and likely pharmaceutically related health service changes in the future.