Intravenous Preparations Research Articles

Retrospective analysis of ferrotherapy methodology in patients with chronic heart failure and chronic kidney disease

The course of chronic non-infectious diseases is often accompanied by the development of comorbid conditions. In chronic heart failure and chronic kidney disease, special attention is drawn to iron deficiency and anemia. Intravenous iron preparations have become widely used for the prevention and treatment of anemia. Their use contributes to the progression of structural changes in vital organs. However, attempts to implement high-dose intravenous ferrotherapy as a routine strategy for compensating iron deficiency in patients with heart failure, with or without anemia, raise questions related to the search for diagnostic markers of iron deficiency states, goals, and conditions for its use. The article discusses the influences of a combination of opposing factors (inflammation, hypoxia) on the erythron system, its humoral regulators, and iron metabolism based on the author’s own research to justify the choice of strategy and tactics for ferrotherapy in patients with heart failure and chronic kidney disease.

IV Ciprofloxacin-Induced Phlebitis: Investigating the Impact of Pharmaceutical and Process-Related Factors on Patient Safety

Transient phlebitis is a rare but notable adverse reaction that can occur following intravenous administration of various medications, including ciprofloxacin, an antibiotic recognized for its broad-spectrum activity. This case report discusses a 48-year-old male patient with poorly controlled type 2 diabetes who developed phlebitis after receiving undiluted ciprofloxacin via a peripheral intravenous line. Symptoms emerged within 24 hours, characterized by swelling and redness at the injection site, prompting the discontinuation of the medication. Analysis revealed that improper dilution and rapid infusion rate were major factors contributing to the development of phlebitis. This underscores the importance of adhering to guidelines provided in product information leaflets for intravenous drug preparation and administration. The case emphasizes the critical need for healthcare professionals to follow recommended protocols to reduce the risk of infusion-related complications, especially in patients with underlying comorbidities.

6970 Severe Symptomatic Hypophosphatemia After Intravenous Iron Therapy: An Under-recognized Adverse Reaction

Abstract Disclosure: A. Morvant: None. O. Olajide: None. Introduction: Iron deficiency is a common condition that is often treated with intravenous preparations of iron supplementation. It has been documented in the literature that ferric carboxymaltose is the form of intravenous iron supplementation that is associated with the highest incidence of hypophosphatemia, when compared to other formulations of intravenous iron therapy. This case highlights a severe case of hypophosphatemia after ferric carboxymaltose therapy that led to multiple hospitalizations and required several months of oral and intravenous phosphorus repletion. Clinical Case A 36-year-old woman presented to the ED with severe diffuse arthralgias, generalized muscle weakness, and fatigue. Laboratory analysis revealed the following: phosphorus 1.2 mg/dL (2.3-4.7 mg/dL), 25-hydroxyvitamin D 13 ng/mL (25-80 ng/mL), parathyroid hormone 220 pg/mL (16-77 pg/mL), and calcium 8.5 mg/dL (8.4-10.5 mg/dL). She was admitted and started on intravenous and oral phosphorus repletion as well as oral ergocalciferol. She was subsequently discharged home on oral phosphorus and ergocalciferol supplementation, with a phosphorus level of 1.8 mg/dL. She was readmitted one day later with persistent arthralgias, myalgias, and severe fatigue, and found to have a phosphorus level of 1.1 mg/dL. Additional laboratory studies revealed the following: FGF23 41 pg/mL (<59 pg/mL) and 24-hour urine phosphorus 2191 mg/24hr (400-1300 mg/24hr). The patient notably had a history of chronic severe iron deficiency anemia due to menorrhagia and had been treated with intravenous iron sucrose infusions 7 months prior to her presentation. Due to adverse reactions to iron sucrose, this was switched to ferric carboxymaltose, and she had received two doses; one month and two weeks prior to her initial presentation. She was treated again with intravenous and oral phosphorus repletion and ergocalciferol and discharged after two weeks on oral phosphorus and ergocalciferol as well as thrice-weekly intravenous phosphorus infusions in the outpatient setting. She continued intravenous phosphorus infusions for about three months, and this was subsequently discontinued without recurrent hypophosphatemia. She is currently on low doses of oral phosphorus with normophosphatemia. Conclusion: Intravenous ferric carboxymaltose therapy can lead to severe and long-lasting, treatment-resistant hypophosphatemia due to increased urinary phosphate excretion. An increased awareness about this is needed by clinicians in treating patients who receive ferric carboxymaltose and monitoring phosphorous levels is crucial.

Case report: A novel high-dose intravenous immunoglobulin preparation for the treatment of severe pemphigus vulgaris failing standard therapy.

Pemphigus vulgaris (PV) is a severe autoimmune bullous dermatosis that is characterized by autoantibodies against epidermal adhesion proteins causing painful mucosal and skin blistering. Standard treatments for PV include corticosteroids, steroid-sparing immunosuppressants, or intravenous monoclonal anti-CD20-antibody therapy. The European guidelines suggest high-dose intravenous immunoglobulin (IVIg) therapy as a promising approach for severe or treatment-resistant cases. We report on a 65-year-old woman with severe and recurrent disease who achieved long-term disease stabilization with IVIg treatment. Because of recurrent fatigue and headache, the patient was switched to an alternative IVIg preparation with a novel manufacturing process, thus ensuring high purity and better tolerability. We observed excellent efficacy, yet side effects remained largely unchanged. Further studies are necessary to evaluate the long-term efficacy and tolerability of this new IVIg preparation.

Association between body weight and tocilizumab effectiveness in rheumatoid arthritis: results from the BSRBR-RA.

Tocilizumab is an IL-6 receptor humanised monoclonal antibody for the treatment of rheumatoid arthritis (RA) with intravenous (IV) and subcutaneous (SC) preparations available. Only IV tocilizumab is dosed adjusting for weight. Therefore, we aimed to study the association between body weight and the effectiveness of tocilizumab by the route of administration. Patients with RA administered tocilizumab in the BSRBR-RA were included in the analysis and stratified by route of administration. Outcomes included the 6 month change in DAS28, the proportion of patients achieving DAS28 remission, 6-month EULAR response and persistence of the first route of tocilizumab administration. The exposure was every increase in 10 kg of body weight. Adjusted regression models appropriate to outcome were used to study the associations between body weight and outcomes. Multiple imputations accounted for missing data. 2612 patients were included. Body weight was associated with reduced response to SC tocilizumab measured by change in DAS28: adjusted regression coefficient (95% CI) all patients 0.01 (-0.04, 0.07); IV: -0.03, (-0.1, 0.5); SC: 0.1 (0.02, 0.2) but not odds in achieving DAS28 remission or EULAR response. There was no significant association between body weight and the persistence of IV or SC tocilizumab. Body weight was associated with the initial response to SC tocilizumab, although the difference in response was small, but not drug persistence. Physicians should monitor the body weight of patients and consider interventions to promote maintenance of a healthy weight.

Comparison of oral caffeine and oral theophylline for apnea of prematurity: A randomized clinical trial

Background Caffeine and theophylline are methylxanthine compounds that have been widely used in the treatment of apnea of prematurity (AOP). Previous studies comparing the two agents have shown inconsistent results and have mostly used intravenous preparations. Objective To assess the effectiveness of oral administration of caffeine compared to oral theophylline as therapy for apnea of prematurity. Methods Fifty consecutively recruited premature neonates (gestational age 28-34 weeks, birth weight <2,500 g) with AOP who were able to tolerate at least 10 mL/kg of enteral feeding were randomized to receive either oral caffeine or oral theophylline for seven days. The main outcome was the daily frequency of apnea after treatment. Secondary outcomes were duration of oxygen or CPAP administration, duration of oxygen fraction (FiO2) taper to reach 21%, time to achievement of full feeding tolerance, length of hospital stay, and side effects. Results We randomized 25 subjects into each group. The distribution of baseline characteristics (gender, gestational age, mode of delivery, birth weight and length, age at onset of AOP, and initial frequency of AOP) was similar between both groups. The mean daily number of apnea episodes after treatment was significantly higher in the caffeine group compared to the theophylline group [3.16 (SD 1.31) vs. 2.28 (SD 1.40); P=0.031]. The caffeine group, compared to the theophylline group, also had a longer mean duration of oxygen or CPAP use [12.56 (SD 7.67) days vs. 8.40 (SD 6.41) days; P=0.030] and duration of FiO2 taper [5.76 (SD 2.68) vs. 4.08 (SD 2.54); P=0.035]. There were no significant differences in mean time to full feeding and mean length of hospital stay. There was no significant difference in the occurrence of side effects between the two groups. Conclusion In premature neonates with AOP, oral theophylline is slightly more effective than oral caffeine in reducing the frequency of apnea and is associated with a shorter duration of oxygen or CPAP use and duration to reach 21% FiO2.

Antibodies against glutamic acid decarboxylase in intravenous immunoglobulin preparations can affect the diagnosis of type 1 diabetes mellitus.

Intravenous immunoglobulins (IVIgs) contain various autoantibodies, including those against glutamic acid decarboxylase (GADAb), a valuable biomarker of type 1 diabetes mellitus. Passive transfer of GADAb from IVIgs to patients poses a risk of misdiagnosis, and information on the specific titres of GADAb and their impact on diagnostic accuracy remains limited. This study aimed to provide further insights into the origin of GADAb detected in patient serum following IVIg infusion. GADAb titres in IVIg products from Japan and the United States were measured using enzyme-linked immunosorbent assay-based assays. For reliable quantification, GADAb titres in pooled plasma were quantified and compared with those in the IVIg products. The determined titres were used to estimate the likelihood of passively detecting acquired GADAb in individuals receiving IVIgs. GADAbs were prevalent in IVIg products; however, the titres varied significantly among different lots and products. Importantly, IVIg-derived GADAb was estimated to remain detectable in patient serum for up to 100 days following a dosage of 2000 mg/kg. Clinicians should consider that IVIg preparations may contain GADAb, which can lead to false-positive results in serological assays. Careful interpretation of the assay results is key to the definitive diagnosis of type 1 diabetes mellitus.

Analysis of reconstitution process, stability, stability of intravenous antibiotics in hospitalised patients in a private hospital

Introduction: reconstitution of sterile preparations is a series of changes in the drug from its original condition to a new product by dissolving or adding other ingredients carried out aseptically by the pharmacy. Aim: determine the suitability of the reconstitution technique, the suitability of stability (solvent type and solvent volume), and the suitability of the sterility of the reconstitution product. Methods: data collection obtained by observation is carried out with the help of a checklist that is adapted to hospital standard operating procedures (SOPs), Inject-able Drug Guide, guidelines for mixing inject-able drugs, and preparations. 48 processes of reconstitution of intravenous antibiotics were carried out in hospitals that could be observed as samples. Results: conformity to the preparation stage were 99%, the mixing stage was 73%, the labelling was 100%, and the labelling was 90%. In evaluating the stability of the solvent type category, the suitability of 100%. In the volume category of the solvent used, 90% were suitable, and 10% were unsuitable for the antibiotic’s cefotaxime 1 gram, vancomycin 1 gram, and sulbactam + ampicillin Na 1 gram. From the sterility test results, the reconstitution of ceftriaxone intravenous antibiotic preparations showed that the bacterial preparations were free of microorganisms (sterile). Conclusion: the personnel performing the reconstitution are nurses trained in intravenous antibiotic recovery. One of the factors that caused the reconstitution process not to be under the hospital's KSB was the lack of training and supervision from the hospital management. SPO recovery is not installed in an intravenous drug mixing room.

Efficacy of ferric carboxymaltose therapy in celiac patients

Aims: Iron deficiency anemia (IDA) is the most common cause of anemia worldwide. IDA can be caused by reduced iron intake, impaired iron absorption or losses. Celiac disease can cause iron malabsorption by decreasing the surface absorption area in the duodenum and consequently can cause IDA. Oral or intravenous iron preparations are used in the treatment of IDA. In this study, we wanted to investigate the efficacy of ferric carboxymaltose (FCM) in celiac patients with RIA. Methods: Twenty-three patients who were followed up in the gastroenterology outpatient clinic of İnönü University Medical Faculty Hospital Turgut Özal Medical Center with the diagnosis of CD and who received FCM were included in the study. The hemogram, ferritin, iron and iron binding levels of the patients were retrospectively screened through the hospital medical record system. Results: Of the 23 patients included in the study, 3 (13.05%) were male and 20 (86.95%) were female. Hemoglobin concentration, iron and iron binding capacity before and after treatment showed a significant increase in all parameters after treatment. Ferritin value increased, although not significantly. Conclusion: In our study, we found that FCM is an effective and safe treatment modality in the treatment of IDA in celiac patients.

THE POTENTIAL OF HUMAN PLASMA AND HUMAN BLOOD PRODUCTS FOR IMMUNE PROTECTION

Intravenous Immunoglobulin (IVIg) were used for the first time at the late seventies for treatment of patient with primary and secondary immunodeficiencies. Тhe first observations opened a wide field for basic and clinical research leading to a rapidly expanding use of IVIg for the treatment of patients with multiple diseases. The immunoglobulin preparations contain large amount of intact form of IgG molecules with comparable values of subclasses as in native plasma. Тhose properties account for the normal half-life of injected immunoglobulin of three weeks, and its ability to react normal with the complement components and with the specific Fcγ-receptors on the surface of phagocytes and lymphocytes. IVIg is produced from plasma pules from several thousand donors, which leads to wide spectre of variable regions of IgG molecules in the product. Some of the antibodies in the product can recognize bacterial, virus and fungal antigens are essential in replacement therapy in patients with antibody deficiency. А good understanding of the molecular and cellular basis of the immunoregulatory actions of intravenous immunoglobulin preparations is important for optimizing their use in inflammatory diseases for conducting new clinical observations.

IBUPROFEN INJECTABLE MICROEMULSION PREPARATION COATED BY CHITOSAN: FORMULATION, CHARACTERIZATION, IN VITRO PERFORMANCE, ANTI-INFLAMMATION ACTIVITY, AND HEMATOLOGY ASSESSMENT

Objective: This study aimed to develop, characterize, and conduct stability evaluations to ensure compliance with intravenous administration for microemulsion ibuprofen injection. In addition, hematology assessment and profile of drug release kinetics were analyzed. Methods: The formulation process commenced by introducing various chitosan concentrations into microemulsion ibuprofen injection, following a method established in a previous study. Formulation parameters studied include particle size, polydispersity index (PDI), zeta potential, kinetic of drug release, anti-inflammation activity using the 1% carrageenin induction method, and hematology assessment. Results: The results showed that the addition of 1% chitosan solution allowed for the development of the ideal microemulsion formula, with droplet size, zeta potential, and PDI of 19.37±0.32 nm,-1.53±0.12 mV, and 0.38±0.02, respectively. Kinetics of chitosan-coated ibuprofen microemulsion (MK) were governed by the squared root of time paradigm, suggesting that drug release proceeded by diffusion and was influenced by the carrier. Compared to the other groups, the paw injected with MK indicated a strong anti-inflammatory effect and did not differ significantly from the control group (p>0.05). However, Hematology analysis showed no statistically significant variations in leukocyte and erythrocyte profiles between the treatment and control groups (p>0.05). Conclusion: MK met the criteria as an intravenous preparation based on the characteristics and safety.

Abstract CT058: A multicenter phase 1-2a clinical study of Orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors

Abstract Background: Intravenous irinotecan hydrochloride (IRN-IV) is approved for the treatment of adult colorectal cancer. An off-label regimen of IRN-IV administered as a 60-min i.v. infusion daily for 5-10 days, bi-weekly in combination with other agents such as temozolomide has been recommended for use in treating children with solid tumors (Blaney. ClinCanRes, 2001; Slotkin. PedBloodCan, 2023). While this regimen has shown promise in published clinical trials across a range of pediatric cancers including Ewing sarcoma, neuroblastoma, rhabdomyosarcoma, hepatoblastoma and medulloblastoma, the protracted administration schedule of IRN-IV is costly and inconvenient thereby negatively impacting patients’ quality of life. Oral regimens utilizing IRN-IV have been developed and implemented with favorable tumor responses (Wagner. ClinSarcRes, 2015). Unfortunately, the palatability of the IRN-IV is poor, leading to reduced compliance. Development of an advanced oral formulation to improve tolerability and patient compliance is an important unmet need. VAL-413 is a novel formulation developed to improve the palatability of oral irinotecan. This Phase 1-2a multi-center clinical trial seeks to examine the safety and tolerability of this novel formulation and assess pharmacokinetics compared to the already established oral regimen. This trial is ongoing (CT.gov: NCT04337177) and currently enrolling the 110mg/m2/day cohort, with no dose limiting toxicity observed to date. Initial pharmacokinetic observations demonstrate similarity for the VAL-413 formulation and i.v. irinotecan given orally for both the parent compound and SN38 active metabolite. TABLE 1. NAND Methods Eligibility: Up to 20 patients ≥ 1 year of age or ≤ 30 years of age with recurrent pediatric solid tumors and adequate bone marrow, renal and liver function, for whom irinotecan therapy is a treatment option will be enrolled. Trial Design: Two different dose levels of VAL-413, 90mg/m2/day or 110mg/m2/day are being studied in combination with fixed-dose temozolomide (100mg/m2/day) using a standard 3 + 3 phase I design. In the event a dose of 90 mg/m2/day is not tolerable due to toxicity, a lower dose of 75 mg/m2/day may be implemented. Treatment: During the first cycle of treatment, each patient will receive 4 daily doses of VAL-413 and one daily dose of the intravenous preparation of irinotecan taken orally (IRN-IVPO). During all subsequent cycles, only VAL-413 will be given with temozolomide in 5-day courses administered every 21 days, as tolerated. Outcome Measures: Toxicity is assessed by NCI CCTCAEv5; tumor response is assessed by RECIST 1.1. A taste survey instrument will assess palatability of VAL-413 vs. IRN-IVPO; comparative intrapatient pharmacokinetics of irinotecan and its metabolites is assessed. Citation Format: James Geller, Patrick Thompson, Javier Oesterheld, Aerang Kim, Meghann McManus, Jeffrey Bacha, Dennis M. Brown, Markos Leggas, Sarath Kanekal, Neil Sankar, Lorena Lopez, Noymi Yam, Lars M. Wagner. A multicenter phase 1-2a clinical study of Orotecan (oral irinotecan HCl, VAL-413) in patients with recurrent pediatric solid tumors [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT058.

A meta-analysis of ferric carboxymaltose versus other intravenous iron preparations for the management of iron deficiency anemia during pregnancy.

We conducted a meta-analysis of randomized clinical trials evaluating the clinical effects of ferric carboxymaltose therapy compared to other intravenous iron in improving hemoglobin and serum ferritin in pregnant women. We also assessed the safety of ferric carboxymaltose vs. other intravenous iron. EMBASE, PubMed, and Web of Science were searched for trials related to ferric carboxymaltose in pregnant women, published between 2005 and 2021. We also reviewed articles from google scholar. The keywords "ferric carboxymaltose," "FCM," "intravenous," "randomized," "pregnancy," "quality of life," and "neonatal outcomes" were used to search the literature. The search was limited to pregnant women. Studies related to ferric carboxymaltose in pregnancy were scanned. Observational studies, review articles, and case reports were excluded. Randomized studies in pregnant women involving ferric carboxymaltose and other intravenous iron formulations were shortlisted. Of 256 studies, nine randomized control trials were selected. Two reviewers independently extracted data from nine selected trials. The final effect size for increase in hemoglobin after treatment was significant for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 0.89g/dl [95% confidence interval 0.27,1.51]). The final effect size for the increase in ferritin after treatment was more for ferric carboxymaltose vs. iron sucrose/iron polymaltose (standard mean difference 22.53µg/L [-7.26, 52.33]). No serious adverse events were reported with ferric carboxymaltose or other intravenous iron. Ferric carboxymaltose demonstrated better efficacy than other intravenous iron in increasing hemoglobin and ferritin levels in treating iron deficiency anemia in pregnant women.

Retrospective Study Comparing Treatment Outcomes in Obstetric Patients With Iron Deficiency Anemia Treated With and Without Intravenous Ferric Carboxymaltose.

Introduction Iron deficiency anemia is associated with an increased risk of adverse maternal and perinatal outcomes. Intravenous iron preparation containing ferric carboxymaltose has been shown to be a safe and effective way of increasing hemoglobin (Hb) and mean corpuscular volume (MCV) levels and reducing the need for blood transfusion. In our center, it used to be given as an inpatient procedure because of the risks of potential drug reactions. In 2021, we initiated the administration of intravenous ferric carboxymaltose as an outpatient procedure. We compared the outcomes of patients between 2021 and 2023 after the initiation of outpatient administration of intravenous ferric carboxymaltose in 127 obstetric patients with iron deficiency anemia in the second and third trimesters. Methods In this study conducted in a large maternity unit in Singapore between 2021 to 2023, we compared the changes in maternal hematological parameters among obstetric patients with iron deficiency anemia presenting to the day care unit in the second or third trimester with a Hb level of <8 g/dl treated with a single dose of ferric carboxymaltose injection (Ferinject) against a control group who were referred for treatment but defaulted on and declined treatment. Results Ferric carboxymaltose significantly increased the Hb and MCV levels at delivery in obstetric patients with iron deficiency. The mean Hb at delivery was 10.8 g/dL in the case group compared to 8.8 g/dL in the control group. The percentage of patients with Hb ≥10.0 g/dL was 73.4% in the case group compared to 27.8% in the control group. The incidence of adverse side effects was low and mild (2/127; 1.6%). None of the patients received were hospitalized because of ferric carboxymaltose. Conclusion A single injection dose of ferric carboxymaltose as an outpatient antenatal procedure was easily administered and well tolerated. Obstetric patients with iron deficiency anemia who received intravenous ferric carboxymaltose had a significantly higher level of Hb than those who did not.

Review of available therapies for the treatment of pediatric COVID-19-associated polyarticular inflammatory syndrome

Recently, there have been an increasing number of reports from around the world describing children and adolescents with multisystemic inflammatory conditions associated with COVID-19. The clinical features of these pediatric cases are both similar to and different from other well-described inflammatory syndromes, including Kawasaki disease. Symptoms appear to develop after infection, rather than in the acute phase of COVID-19. Regarding the clinical spectrum, much remains unknown.&#x0D; The new disease entity challenges specialists around the world in developing universal management protocols. In the fight for the health and lives of patients, treatment according to standard protocols for Kawasaki disease has been used. However, further clinical trials are required to prove the effectiveness and safety of these treatments. There are reports of successful therapy using intravenous immunoglobulin preparations and steroid therapy. Biologic, antiviral, antibiotic, antiplatelet and anticoagulant therapies are also used. The described pediatric disease can be associated with hemodynamic failure, so treatment should take place in a hospital setting, under the watchful eye of a multidisciplinary team.

Use of Preoperative Oral Paracetamol

Paracetamol is a widely used analgesic in the perioperative period. Studies have shown that there is no significant difference between intravenous and oral preparations in postoperative pain outcomes. We proposed moving towards routine administration of oral paracetamol before surgery to reduce the use of IV preparations, with benefits of carbon and cost reduction.

Drug compatibility with various closed intravenous infusion containers.

Objective: The aim was to systematically compare the drug compatibility with various closed intravenous (i.v.) infusion containers, to provide a reference for selecting a relatively superior infusion container and improve the medication safety for patients in clinical practice. Methods: The compatibility of four commonly used clinical injections (ceftazidime, pantoprazole sodium, ambroxol hydrochloride, edaravone) with three representative closed i. v. infusion containers (non-PVC infusion bags, upright polypropylene infusion bags, inner sealed polypropylene infusion bags) prefilled with infusion fluids (0.9% sodium chloride or 5% dextrose) in the Chinese market were investigated in this study. The particle counts of both infusion fluids and diluted chemical injections by infusion fluids in various infusion containers were determined by the light obscuration method. At 0, 2 and 6h after four injections following dilution with infusion fluids in each container, the pH of the solutions was detected, and the physical properties were examined by visual inspection. Meanwhile, the drug concentrations were assessed by high performance liquid chromatography (HPLC). Results: As for either infusion fluids or diluted injections by infusion fluids, the particle counts in non-PVC infusion bags were significantly greater than those in the other two bags under some circumstances. The particle counts in diluted injections by infusion fluids increased dramatically compared with those in infusion fluids in all infusion containers, especially for the small-size particles. But pH, physical properties and drug concentrations of diluted infusion solutions in all infusion containers remained nearly unchanged over the test period. Conclusion: Closed i. v. infusion containers included in this study are all well-compatible with four injections. Moreover, the closed infusion containers produced by Chinese manufacturers have met the international quality standard. Particularly, the intravenous admixture preparation process needs to be optimized to reduce the overall particulate contaminants.

A facility-level self-assessment of Autonomous Pharmacy Framework levels.

The objective of this study was to understand at what level of the Autonomous Pharmacy Framework facilities are operating, in terms of the current state of data collection and analysis in the medication-use process, and to gather insights about systems integration and automation use. The Autonomous Pharmacy Advisory Board, a group of chief pharmacy officers and operational leaders, developed a self-assessment instrument based on the previously published Autonomous Pharmacy Framework, made the self-assessment instrument available via the internet, and reviewed respondents' self-reported results. The data collection period for the survey started in March of 2021 and ended in January of 2023. A total of 119 facility-level self-assessments were completed and analyzed. On a scale of 1 to 5, where 1 represented little or no data-driven automation with lots of manual tasks and 5 represented the utmost data-driven automation with few manual tasks, the average overall facility-level score was 2.77 (range, 1.38-4.41). Results revealed slight variance by facility bed capacity. Much more variation was found in the degrees to which individual facilities have automated core processes like inventory management, intravenous medication preparation, and financial reporting. As a baseline, this automation-focused facility self-assessment suggests that for essentially all health-system pharmacy facilities and their larger organizations, a substantial body of work needs to be done to further develop and upgrade technology and practice in tandem, greatly expand data collection and analysis, and thereby achieve better operational, financial, and clinical outcomes. Significant advancements are needed to arrive at the highly reliable, highly automated, data-driven medication-use process involving few repetitive manual tasks envisioned in the Autonomous Pharmacy Framework.

Evaluation of errors in preparation and administration of intravenous medications in critically ill patients.

Intravenous medications have greater complexity and require multiple steps in their preparation and administration, which is considered a high risk for patients. To determine the incidence of intravenous medications preparation and administration errors in critically ill patients. This was an observational, cross-sectional, prospective study design. The study was performed conducted in Wad Medani Emergency Hospital, Sudan on with 33 nurses. All nurses working at the study setting were observed over nine days. During the study period, a total number of 236 drugs were observed and evaluated. The total error rate was 940 (33.4%), of which 136 (57.6%) errors with no harm, 93 (39.4%) errors with harm and 7 (3%) of errors associated with mortality. 17 different drug categories were involved, in which antibiotic was the highest error rate 104 (44.1%) and 39 different drugs were involved, in which metronidazole was the most drug involved 34 (14.4%). The total error rate was associated with nurse experience, OR (95% CI); 3.235 (1.834-5.706), and nurse education level, OR (95% CI); 0.125 (0.052-0.299). The study reported high frequency of IV medications preparation and administration errors. Nurse education level, and experiences were influenced the total errors.

Masking of an intravenous preparation of ceftriaxone for use in clinical trials: A technical report

BackgroundIntravenous antibiotics are often evaluated in clinical trials in hospitalised patients but for blinded trials masking of antibiotics is required. ObjectiveTo evaluate the effectiveness of masking of ceftriaxone and amoxicillin / clavulanic acid for use in blinded clinical trials. Design, setting, and participantsAmoxicillin / clavulanic acid (1.2g) and ceftriaxone (1g and 2g) were diluted in 100mL of sodium chloride. Clinicians from a single centre were asked to attempt to distinguish solutions containing antibiotics from solutions without added antibiotics at time points up to 12 hours following dilution. Results1g of ceftriaxone diluted in 100 mL of 0.9 sodium chloride stored in a light-protected bag and refrigerated at 3–4 °C for up to 10 h could not readily be distinguished from 100 mL of 0.9 % sodium chloride. However, solutions containing either amoxicillin / clavulanic acid (1.2g) or ceftriaxone (2g) were readily identifiable. Conclusions1 g of ceftriaxone can be effectively masked by dilution in 100mL of sodium chloride.