Parenteral Drug Administration Research Articles

The effect of education provided with the escape room game on nursing students' learning of parenteral drug administration

AimThe present study was conducted to determine the effect of education provided to first-year nursing students with the escape room game on their learning of parenteral drug administration. BackgroundThe use of escape room games in education supports formal education in providing students with professional knowledge and skills. DesignA randomized controlled study design was used in this study. MethodThe current study was conducted with 72 first-year nursing students. Data were collected with the Descriptive Characteristics Questionnaire (DCQ), Parenteral Drug Administration Information Test (PDAIT), Parenteral Drug Administration Sub-Checklists (PDASC) and Game Evaluation Form (GEF) between May and June 2022. The initial knowledge and skills of all students participating in the study were measured after completing the parenteral drug administration theoretical course and laboratory skills course. Students were assigned to the intervention (n=36) and control (n=36) groups by the stratified block randomization method according to their initial knowledge and skill measurements. Unlike the control group, the intervention group played the escape room game once in groups of four. The control group was allowed to work freely in the laboratory during this period. The final knowledge and skills of the intervention and control groups were measured immediately after the intervention. Students' skills were measured with an objective structured clinical examination. ResultsIt was determined that the post-test knowledge level of the students in the intervention group and their post-test skill mean scores for drug withdrawal from an ampoule, subcutaneous injection administration, intradermal injection administration and intravenous push drug administration were higher than those of the students in the control group (p<0.05). Additionally, Intervention group students evaluated the escape room game positively. ConclusionThis study concluded that the escape room game supported formal education and could be used in teaching parenteral drug administration.

Innovations and advancements in pediatric parenteral drug administration

Innovations and advancements in pediatric parenteral drug administration

Evaluating the efficacy of simulation-based training on clinical competency transfer

Introduction. Efficient learning transfer is crucial for training specialists to ensure the provision of quality medical services. This study investigates the impact of simulation-based training on the transfer of medical students' clinical competencies in parenteral drug administration: subcutaneous (SC), intramuscular (IM), and intravenous (IV). Material and methods. Using a quasi-experimental design, the research incorporates pre- and post-intervention testing, observational assessments, and a satisfaction survey to evaluate the educational impact. Results. The results indicate significant improvements in theoretical knowledge and practical skills post-intervention, with notable score increases for all types of injections (SC: from 50% to 83.33%, IM: from 57.14% to 85.71%, IV: from 42.86% to 85.71%; p&lt;0.001). Similarly, improved clinical performance was demonstrated, highlighting the transferability of the learned competencies to real settings. Student satisfaction recorded a score of 4.71 (95% CI 4.64; 4.79), reflecting strong acceptance and appreciation of the training. Conclusions. The study emphasizes the crucial role of simulation in competency-based medical education, bridging the gap between theoretical knowledge and practical application, and advocates for the systematic integration of simulation into the medical curriculum, suggesting future research directions for optimizing the design and implementation of simulations.

Study draft: "UVC-You Will See" study: longer vs. shorter umbilical venous catheter (UVC) dwell time (6-10 vs. 1-5days) in very premature infants with birth weight < 1250 g and/or gestational age < 30weeks.

Umbilical venous catheters (UVCs) are often used in preterm infants. Their use is associated with complications (infections, clot formation, organ injury). Very preterm infants with acquired bloodstream infection are at ahigher risk for death and important morbidities (e.g., adverse neurodevelopmental outcomes). It is standard clinical practice to remove UVCs in the first days of life. Replacement of intravenous access is often performed using percutaneously inserted central catheters (PICCs). It is unclear whether serial central line use affects the rates of catheter-related complications. Amulticenter randomized controlled trial (random group assignment) was performed in 562 very premature (gestational age < 30weeks) and/or very low birth weight infants (< 1250 g) requiring an UVC for administration of parenteral nutrition and/or drugs. Group allocation was random. AUVC dwell time of 6-10days (281 infants) is not associated with an increased rate of central venous catheter (UVC, PICC)-related complications compared to 1-5days (281 infants), and alonger UVC dwell time will significantly reduce the number of painful, invasive procedures associated with the need for vascular access as well as radiation exposure, use of antibiotics, and medical costs. The number of catheter-related bloodstream infections and/or catheter-related thromboses and/or catheter-associated organ injuries related to the use of UVC/PICC was the primary outcome. Extending the UVC dwell time may significantly reduce the number of painful invasive procedures, with the potential to positively impact not only long-term pain perception but also important social competencies (attention, learning, and behavior). Thus, the "UVC-You Will See" study has the potential to substantially change current neonatal intensive care practice.

СОЦИОЛОГИЧЕСКАЯ ОЦЕНКА УРОВНЯ ИНФОРМИРОВАННОСТИ НАСЕЛЕНИЯ ПО ВОПРОСАМ ВИЧ-ИНФЕКЦИИ В РАЗНЫХ ВОЗРАСТНЫХ ГРУППАХ (НА ПРИМЕРЕ РЕСПУБЛИКИ СЕВЕРНАЯ ОСЕТИЯ-АЛАНИЯ)

Relevance: HIV infection remains an urgent, socially significant disease in modern society. In the modern world, absolutely everyone is at risk of contracting HIV infection to one degree or another. Despite active preventive work, new cases of infection are registered every year, which makes the problem of HIV infection strategically important. Objective: To determine the level of awareness of the population of the Republic of North Ossetia–Alania on HIV infection in different age groups. Materials and methods: The questionnaires of 600 respondents were analyzed. Respondents are represented in four age groups from 15 to 35 years in equal numbers – 25%. The questionnaire included the most relevant questions about the ways of HIV transmission. Empirical data were processed and analyzed using the capabilities of the IBM SPSS Statistics 27.0.1 software and analytical complex. Results: Of the 137 new HIV cases recorded in 2022, men predominate - 59.1%, while women – 40.9%. Among the established transmission routes, the highest proportion falls on the sexual (heterosexual) pathway of infection – 51.8%, the homosexual pathway – 5.1%. The proportion of people infected with parenteral administration of narcotic drugs was 41.6%, perinatal contact was 1.4%. There is a continuing trend of HIV infection among residents of working and reproductive age from 20 to 49 years old, which makes the issue of preserving the health of this group strategically important. The 18-22 age group of people studying in higher and secondary educational institutions has the most positive idea of the ways of HIV transmission and the risk of infection, which indicates the importance of awareness-raising activities. In the adolescent group of 15-17 years, there is a misconception about the ways of HIV transmission. The misconception about the possibility of contracting HIV infection in everyday conditions persists in 20.7% of respondents in the 30-35 age group and 13.3% in the 15-17 age group. The majority of respondents in each age group gave a negative answer: 15-17 years old – 44%; 18-22 years old – 44.7%; 23-29 years old – 41.3% and in the 30-35 years old group – 44%, which indicates a misunderstanding of the vertical path of transmission from an HIV-infected mother to a child, more than 40% of negative responses from respondents in each the age group. Conclusion: The level of awareness of the population of the Republic of North Ossetia-Alania on HIV infection is quite high. At the same time, the adolescent age group, which is the most vulnerable in matters of risky behavior, is the least informed about the ways of HIV transmission and requires special attention. The results of the study will make it possible to contribute to the development and implementation of HIV prevention measures/AIDS and related diseases in the Republic of North Ossetia-Alania.

АНАЛИЗ АССОРТИМЕНТА РАСТВОРИТЕЛЕЙ И РАЗБАВИТЕЛЕЙ ИНЪЕКЦИОННЫХ РАСТВОРОВ ДЛЯ ПЕДИАТРИЧЕСКОЙ ПРАКТИКИ

Introduction. Solvents and diluents for parenteral medicines are widely used in pediatric hospitals and occupy leading positions in terms of the number of packages in purchases. Injectables are prescribed to children in reduced volumes, as compared to adults. In this regard, it is relevant to study the solvents and diluents available for parenteral administration of drugs in terms of packaging types and reduced volumes for use in pediatrics in the domestic pharmaceutical market. Aim of the study is to analyze the available solvents and diluents for parenteral medicines, such as water for injection, isotonic solutions of sodium chloride, Ringer, and Ringer lactate, on the Russian pharmaceutical market and in a multidisciplinary children’s hospital. Material and Methods. Objects of the study were data from the State Register of Medicines of Russia, the requisition slips of Medical Devices and Pharmacy of Tatarstan for medicines shipped from a warehouse to the Republic Clinical Children’s Hospital of the Ministry of Health of the Republic of Tatarstan in 2022, the price lists for medicines of pharmaceutical wholesalers (September 2023), and the data from scientific publications. Results and Discussion. The data obtained indicate that the regional pharmaceutical market has about twice as many options for the supply of medicinal solvents and diluents than in a children’s multidisciplinary hospital, and this allows expanding the range of this group of medicines. It can be assumed that pharmaceutical industrial enterprises do not produce a full range of options for the volume of primary packaging of solvents and diluents registered in the State Register of Medicines. Conclusions. In Russia, reduced volumes (20-30 ml) of 0.9% sodium chloride, 5% glucose, Ringer, and Ringer lactate solutions in vials for intravenous drip administration in pediatric practice are neither registered nor produced. The depth coefficient of the assortment of the studied solvents and diluents for parenteral medicines in relation to the volume of primary packaging in a children’s multidisciplinary hospital is 0.102. This indicates the need for medical organizations to consider the possibilities of the pharmaceutical market when drawing up applications for the supply of medicines.

Meaningful learning in a realistic drug simulation scenario

This study addresses the use of David Ausubel's Theory in a didactic sequence developed specifically for realistic drug simulations. Objective: to test the usability of a didactic sequence developed for realistic simulation in the preparation and administration of parenteral drugs in critically ill patients; to improve the applicability strategy of the didactic sequence for adjustments and subsequent validation. Methodology: qualitative observational study, which took place in May 2023 during a workshop on the preparation and administration of medication, using the evaluation tool validated by Raurell-Torredà as a model for data collection. Nursing undergraduate students from the 5th period onwards were invited to take part in the research to carry out a medication simulation during the workshop, A pre- and post-intervention questionnaire was carried out using a QR code to capture the answers, a semi-structured questionnaire with 11 questions on the subject, the data collected was arranged in an information bank using Microsoft Office Excel software and analyzed using descriptive statistics. Results and Discussions: It can be seen that realistic simulation is a teaching-learning method that is little used, with 77.8% of the students having had contact with it for the first time. Conclusion: Although it is an effective teaching-learning strategy, undergraduate courses should structure their teaching strategy to include this teaching model in the course curriculum in order to improve teaching on the preparation and administration of medicines.

Comparison of Combined Parenteral and Oral Hormonal Contraceptives: A Systematic Review and Meta-Analysis of Randomized Trials.

Delivering contraceptive hormones through a transdermal patch or a vaginal ring might have advantages over the traditional oral route. To compare the effectiveness, compliance, and side effect profile of oral and parenteral drug administration methods. We performed a systematic literature search in four medical databases-MEDLINE (via PubMed), Cochrane Library (CENTRAL), Embase, and Scopus-from inception to 20 November 2022. Randomized controlled trials assessing the efficacy, compliance, and adverse event profile of combined parenteral and oral hormonal contraceptives were included. Our systematic search provided 3952 records; after duplicate removal, we screened 2707 duplicate-free records. A total of 13 eligible studies were identified after title, abstract, and full-text selection. We observed no significant difference in contraceptive efficacy (Pearl Index) between oral and parenteral drug administration (MD = -0.06, CI: -0.66-0.53; I2 = 0%). We found significant subgroup differences between parenteral methods in terms of compliance (χ2 = 4.32, p =0.038, I2 = 80%) and certain adverse events: breast discomfort (χ2 = 19.04, p =0.001, I2 = 80%), nausea (χ2 = 8.04, p =0.005, I2 = 75%), and vomiting (χ2 = 9.30, p =0.002; I2 = 72%). Both parenteral and oral contraceptives can be used as an effective contraceptive method, and the route of administration should be tailored to patient needs and adverse event occurrence.

Comparative study of effectiveness of video- versus mannequin-based demonstration for teaching parenteral drug administration

Background: Competency-based medical education involves continuous and multi-tiered assessment. Acquiring basic procedural skill competencies is essential to ensure patient safety. Simulation incorporates both training and feedback and provides opportunities to learners to practice skills and procedures in life-like settings. Aims and Objectives: The objective of this study was to assess the effectiveness in improving the knowledge, perception, and skill of the 2nd-year medical students after video- and mannequin-based demonstration for parenteral routes of drug administration. Materials and Methods: A cross-sectional and questionnaire-based study was conducted from November 2019 to January 2020 in the department of pharmacology. The technique of parenteral routes of drug administration was explained to the participants using two teaching methods – PowerPoint presentation with video demonstration and demonstration on mannequins. The knowledge of all the participants was assessed before demonstration. At the end of each teaching method, the knowledge, perception, and skill of all the participants were assessed. The responses of participants after each teaching method were compared and analyzed. Results: A total of 132 students participated in PowerPoint with video demonstration-based teaching and 115 students participated in mannequin-based teaching. Significant increase in the knowledge mean score was observed due to the introduction of both the methods of teaching when compared with pre-intervention score. However, gain in knowledge was better with video-based teaching than mannequin-based teaching. Mean perception and skill of the students was significantly higher in mannequin-based teaching. Conclusion: The study concludes that knowledge of medical undergraduates regarding parenteral drug administration was good with both the teaching methods, but confidence- and hassle-free administration skill, following all the steps can be achieved only by hands-on training like using mannequin.

ЭФФЕКТИВНОСТЬ ЛЕЧЕНИЯ БОЛЬНЫХ ТУБЕРКУЛЕЗОМ ЛЕГКИХ С ПРЕ-ШЛУ И ШЛУ M. tuberculosis C ИСПОЛЬЗОВАНИЕМ РАЗЛИЧНЫХ СПОСОБОВ ВВЕДЕНИЯ ПРОТИВОТУБЕРКУЛЕЗНЫХ ПРЕПАРАТОВ

Aim: to evaluate effectiveness of treatment of patients with extensively drug resistant (XDR) or pre-extensively drug resistant (pre-XDR) pulmonary TB using parenteral administration of TB drugs. Materials and methods. We carried out a prospective open cohort study of 143 patients with pulmonary TB hospitalized in 2022. The patients were divided into two groups according to the route of drug administration. The main group consisted of 74 patients, who received parenteral TB drugs before sputum conversion followed by oral drug administration. Parenteral drug administration was indicated to patients with severe intoxication syndrome, advanced TB process, or concomitant gastrointestinal diseases. The control group consisted of 69 patients, who received all TB drugs orally. Oral drug administration was also indicated to patients with difficult venous access. Results. Sputum conversion was observed by the third month of treatment much faster in the main group than in the control group. Treatment effectiveness by cavity closure did not differ between the groups. Conclusion. Intravenous administration of TB drugs contributes to rapid sputum conversion, which allows earlier patient discharge from hospital or surgical treatment.

The effect of patient's body weight, infusion connection point, and infusion pump position on intravenous multi-infusion drug delivery at low infusion rates suitable for premature neonates.

Parenteral drug administration in the neonatal intensive care involves complex pharmacotherapy adjusted for the patient's weight, fluid allowance, and complex multi-infusion systems. We investigated the delivery rate of a model drug through a multi-infusion system consisting of six intravenous infusions. Delivery rate of the model drug was determined after infusion initiation and termination. Measurements were collected spectrophotometrically in real time. Time to drug delivery and the amount of drug delivered were measured. The longest time to drug delivery was observed for a 500 g neonate model with a distal infusion connection point and neutral pump position (337 ± 30 min, P < 0.001). The shortest time was observed for a 1000 g neonate model in the combination of proximal infusion connection point and neutral pump position (18 ± 12 min, P < 0.05). The expected 100% of the drug was delivered only in two combinations: 500 g and 1000 g neonate models, proximal infusion connection point and neutral pump position (100.4 ± 4.7%, P = 0.819 and 100.2 ± 2.7%, P = 0.874, respectively). While the least drug was delivered to a 500 g neonate model in the combination of distal infusion connection point and neutral pump position (27.5 ± 5.8%, P < 0.001). Delayed drug delivery to premature neonates due to multi-infusion systems may compromise accurate drug administration and lead to dosing errors.

Oral Drug Absorption and Drug Disposition in Critically Ill Cardiac Patients.

(1) Background: In critically ill cardiac patients, parenteral and enteral food and drug administration routes may be used. However, it is not well known how drug absorption and metabolism are altered in this group of adult patients. Here, we analyze drug absorption and metabolism in patients after cardiogenic shock using the pharmacokinetics of therapeutically indicated esomeprazole. (2) Methods: The pharmacokinetics of esomeprazole were analyzed in a consecutive series of patients with cardiogenic shock and controls before and after elective cardiac surgery. Esomeprazole was administered orally or with a nasogastric tube and once as an intravenous infusion. (3) Results: The maximum plasma concentration and AUC of esomeprazole were, on average, only half in critically ill patients compared with controls (p < 0.005) and remained lower even seven days later. Interestingly, esomeprazole absorption was also markedly compromised on day 1 after elective surgery. The metabolites of esomeprazole showed a high variability between patients. The esomeprazole sulfone/esomeprazole ratio reflecting CYP3A4 activity was significantly lower in critically ill patients even up to day 7, and this ratio was negatively correlated with CRP values (p = 0.002). The 5'-OH-esomeprazole and 5-O-desmethyl-esomeprazol ratios reflecting CYP2C19 activity did not differ significantly between critically ill and control patients. (4) Conclusions: Gastrointestinal drug absorption can be significantly reduced in critically ill cardiac patients compared with elective patients with stable cardiovascular disease. The decrease in bioavailability indicates that, under these conditions, any vital medication should be administered intravenously to maintain high levels of medications. After shock, hepatic metabolism via the CYP3A4 enzyme may be reduced.

Effect of Addition a Sodium Deoxycholate as an Edge Activator -for Preparation of Ondansetron HCl Tansfersomal Dispersion

In ordinary clinical practice, poor patient compliance with oral and parenteral drug administration modalities is a prevalent problem. As a result, pharmaceutical research has developed a strong interest in the transdermal route of drug delivery.&#x0D; They are non-invasive that can improve patient compliance, however, The barrier function of the skin's top layer presents the biggest challenge for transdermal delivery systems. Transfersomes are vesicles composed of phospholipids and edge activators, used to transport drug from outer skin layer into the systematic circulation through semipermeable membrane. Ondansetron is an anti-emetic medication that has been given parenterally and orally. Formulating this medication as transdermal transfersomes may provoke a great advantage in medical adherence.&#x0D; Conclusion; Ondansetron has been successfully delivered transdermally by Using a transfersomal gel formulation by vortexing sonication method.

Proportion of medical admissions that may be hospitalised at home and their service utilisation patterns: a single-centre, descriptive retrospective cohort study in Singapore

ObjectivesFor eligible patient groups, hospital-at-home (HaH) programmes have been shown to deliver equivalent patient outcomes with cost reduction compared with standard care. This study aims to establish a benchmark of...

Comparison of recent anaphylaxis diagnostic criteria in real life: Can more patients be diagnosed as having anaphylaxis?

IntroductionIn 2020, World Allergy Organization (WAO) updated their diagnostic criteria for anaphylaxis, which differed as a result from the National Institute of Allergy and Infectious Diseases/Food Allergy and Anaphylaxis Network (NIAID/FAAN) criteria which were still used in the 2021 update of the European Academy of Allergy and Clinical Immunology (EAACI) anaphylaxis guideline. Our aim was to evaluate and to compare both diagnostic criteria and attempt to identify factors affecting severity of anaphylaxis. MethodsThe medical records of the patients who were evaluated with suspected anaphylaxis at 3 medical centers in Türkiye between 2014 and 2021, and underwent a detailed diagnostic work-up, were analyzed retrospectively. Diagnosis of anaphylaxis was evaluated based on the WAO 2020 and EAACI 2021 and NIAID/FAAN diagnostic criteria. The severity of anaphylaxis was determined according to the WAO systemic allergic reaction grading system. Grade 5 anaphylaxis was defined as having respiratory failure, collapse/hypotension, loss of consciousness. Patients’ demographic and clinical characteristics were further analyzed depending on the severity of the reaction. ResultsOne thousand and six patients were evaluated and 232 patients without a convincing diagnosis of anaphylaxis were excluded from the study. The remaining 774 patients (70.6% female, median [Inter quartile range (IQR) 25–75] age: 42 [33–52]) were included for further examination. Anaphylaxis was diagnosed in 729 (94.2%) patients meeting both criteria whereas 35 patients (4.5%) with isolated laryngeal involvement and 10 (1.3%) patients with isolated respiratory involvement were only diagnosed according to the WAO 2020 criteria. Twenty-three patients (3.0%) had a diagnosis of indolent systemic mastocytosis. Mastocytosis was related to grade 5 anaphylaxis [p = 0.022, OR (CI) = 2.9 (1.1–7.6)]. Venom allergy was a risk factor for grade 5 anaphylaxis among those for whom an eliciting allergen could be determined [p = 0.03, OR (CI) = 2.7 (1.1–6.8)]. For drug induced anaphylaxis, parenteral route of drug administration and proton pump inhibitor (PPI) allergy were considered as risk factors for grade 5 anaphylaxis [p < 0.001, OR (CI) = 6.5 (2.5–17.0); p = 0.011, OR (CI) = 10.3 (1.6–63.3)]. ConclusionThis multicenter study demonstrated that both criteria identified the majority of patients with anaphylaxis, but the WAO 2020 diagnostic criteria identified an additional 6%. Hymenoptera stings, PPI allergy, parenteral drug administration, and underlying mastocytosis were associated with more severe episodes.

Phase I Pharmacokinetics Study of Drug for Infusion «Areplivir» (INN: Favipiravir) (LLC "PROMOMED RUS", Russia)

Introduction. The novel coronavirus infection COVID-19 (Coronavirus Disease 2019) is caused by an enveloped, positive-sense, single-stranded ribonucleic acid (RNA) virus SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2). Favipiravir is the antiviral drug recommended for etiotropic treatment of COVID-19. Parenteral therapy has advantages over the other routes of the drug administration: there are no interaction with food and digestive enzymes, may be used for patients with diseases of the digestive system and unconscious patients. For parenteral drug administration of favipiravir the drug "Areplivir" has been registered in Russia.Aim. The aim is pharmacokinetics study of drug "Areplivir", a lyophilisate for the preparation of a concentrate for the infusion solution (the manufacturer is JSC "Biokhimic", LLC "Promomed RUS" as registration certificate holder) by intravenous infusion in healthy volunteers in a phase I pharmacokinetics study.Materials and methods. The clinical and analytical phases of the pharmacokinetic study as well as pharmacokinetic analyses have been performed as part of a clinical trial of the drug "Areplivir" in different doses, a lyophilisate for the preparation of a concentrate for the infusion solution (LLC "Promomed RUS", Russia). Chromatographic separation and detection were carried out on a LC-2040C high-performance liquid chromatograph (Shimadzu Corporation, Japan) with a built-in UV detector, a low-pressure four-component gradient pump, a degasser, an autosampler, a column thermostat and a controller. The pharmacokinetic parameters were calculated with the Boomer pharmacokinetic analysis add-in for Microsoft Excel (Department of Pharmacokinetics and Drug Metabolism, Allergan, Irvine, CA 92606, USA). Descriptive pharmacokinetic statistics were calculated with Microsoft Excel (Microsoft Corporation, USA). Correlation and Regression Analysis were conducted with IBM SPSS Statistics (version 23.0), IBM, USA.Results and discussion. For single dose administration of 400, 800, 1600 and 1800 mg in 4 cohorts of 5 volunteers pharmacokinetic parameters were calculated. For Cmax and an administered dose the strong correlation coefficient on the Chaddock scale (r = 0,98; p = 0,02; r – Pearson correlation coefficient; p – the reached significance value) and the determination coefficient (R2 = 0,96; F = 45,97; p = 0,02; R2 – determination coefficient; F – the actual value of the Fisher's criterion) were statistically significant. For AUC0-t and an administered dose the strong correlation coefficient on the Chaddock scale (r = 0,97; p = 0,03) and the determination coefficient (R2 = 0,94; F = 33,54; p = 0,03) were statistically significant. The obtained results show the linearity of Cmax and an administered dose and the linearity of AUC0-t and an administered dose (400–1800 mg).Conclusion. According to the concentrations of favipiravir from the analytical phase of the pharmacokinetic study the pharmacokinetic parameters were calculated, averaged pharmacokinetic profiles in linear and log-linear scales were plotted after single dose administrations of the drug "Areplivir" in different doses, a lyophilisate for the preparation of a concentrate for the infusion solution (LLC "Promomed RUS", Russia). The linearity of Cmax and a single administered dose and the linearity of AUC0-t and a single administered dose of the drug "Areplivir" have been demonstrated for doses of 400 to 1800 mg. The results justified the study of multiple dose administration of "AREPLIVIR" and the subsequent phases of clinical trials.

Prefilled Syringe Injection Force Impact Assessment from Back Pressure: An Approach for Testing Syringe Injectability In Situ vs. In Vitro.

Prefilled syringes are commonly used combination products for parenteral drug and vaccine administration. The characterization of these devices is through functionality testing, such as injection and extrusion force performance. This testing is typically completed by measuring these forces in a nonrepresentative environment (i.e., dispensed in-air) or route of administration conditions. Although injection tissue may not always be feasible or accessible for use, questions from the health authorities make it increasingly important to understand the impact of tissue back pressure on device functionality. Particularly for injectables containing larger volumes and higher viscosities, which can widely impact injection and user experience. This work evaluates a comprehensive, safe, and cost-effective in situ testing model to characterize extrusion force while accounting for the variable range of opposing forces (i.e., back pressure) experienced by the user during injection into live tissue with a novel test configuration. Due to the variability of back pressure presented by human tissue for both subcutaneous and intramuscular injections, tissue back pressure was simulated (0 psi-13.1 psi) using a controlled, pressurized injection system. Testing was conducted across different syringe sizes (2.25 mL, 1.5 mL, and 1.0 mL) and types (Luer lock and stake needle) with two simulated drug product viscosities product (1 cP and 20 cP). Extrusion force was measured using a Texture Analyzer mechanical testing instrument with crosshead speeds of 100 mm/min and 200 mm/min. The results demonstrated that there is a contribution of increasing back pressure on extrusion force across all syringe types, viscosities, and injection speeds that can be predicted using the proposed empirical model. Moreover, this work demonstrated that the factors that largely influence the average and maximum extrusion force during injection are syringe and needle geometries, viscosity, and back pressure. This understanding of the device usability may aid in the development of more robust prefilled syringe designs to minimize use-related risks.

Recent Developments in Pharmacotherapy of Depression: Bench to Bedside.

For the last 70 years, we did not move beyond the monoamine hypothesis of depression until the approval of the S-enantiomer of ketamine, an N-methyl-D-aspartate (NMDA) receptor blocker and the first non-monoaminergic antidepressant characterized by rapid antidepressant and antisuicidal effects. A similar profile has been reported with another NMDA receptor antagonist, dextromethorphan, which has also been approved to manage depression in combination with bupropion. More recently, the approval of a positive allosteric modulator of GABA-A receptors, brexanolone, has added to the list of recent breakthroughs with the relatively rapid onset of antidepressant efficacy. However, multiple factors have compromised the clinical utility of these exciting discoveries in the general population, including high drug acquisition costs, mandatory monitoring requirements, parenteral drug administration, lack of insurance coverage, indirect COVID-19 effects on healthcare systems, and training gaps in psychopharmacology. This narrative review aims to analyze the clinical pharmacology of recently approved antidepressants and discuss potential barriers to the bench-to-bedside transfer of knowledge and clinical application of exciting recent discoveries. Overall, clinically meaningful advances in the treatment of depression have not reached a large proportion of depressed patients, including those with treatment-resistant depression, who might benefit the most from the novel antidepressants.

The novelties of adult advanced life support and post-resuscitation therapy

The fourth element of chain-of-survival contains advanced life support and post-resuscitation treatment. Both treatment options influence the outcome of patients suffering cardiac arrest. Advanced life support includes all interventions that require special medical equipment and expertise. High-quality chest compressions and early defibrillation (if indicated) compose the main elements of advanced life support. Clarifying and treating the cause of cardiac arrest have also high priority, in which point-of-care ultrasound plays an important role. In addition, securing higher level of airway and capnography, securing intravenous or intraosseous line, and the parenteral administration of drugs - such as epinephrine or amiodarone - are the most important steps of advanced life support. If conventional therapy is unsuccessful, extracorporeal circulatory support can be used in special patient populations. The protection of vital organs that are sensitive to hypoxia (brain and heart) has a high priority after the return of spontaneous circulation beside the causative treatment of cardiac arrest. The most important parts of the supportive post-resuscitation treatment are: targeting normoxia, normocapnia, normotension, normoglycemia, and the application of target temperature management. Orv Hetil. 2023; 164(12): 454-462.

A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug- and Medical Device-Borne Endotoxin.

A thorough and systematic analysis of potential endotoxin-related safety issues from parenteral drugs and devices is important to ensure appropriate current Good Manufacturing Practices, compendial requirements, standards and regulatory guidance. Lately, the US Food and Drug Administration has been expecting pharmaceutical firms to apply an arbitrary safety factor to compendial compliant drug specifications for endotoxin, potentially causing manufacturing challenges, supply issues and additional unwarranted costs. The aim of this study was to evaluate data from three disparate sources over an extended period of time, from 2008 to 2021, to determine if there exists an industry-wide risk to patients from parenteral drugs and devices, thereby evaluating if changes to current Good Manufacturing Practices or compendial requirements are indeed warranted. Food and Drug Administration data from current Good Manufacturing Practices non-compliance observations, product recalls and the FDA Adverse Event Reporting System were used as the three sources of data. Parenteral products were separated into drugs and devices, potential endotoxin-related patient safety issues were characterised in terms of the available non-compliance information, the type and number of product recalls, and the type and number of potential adverse events. Descriptive statistics in Microsoft Excel 2019 and Pivot tables were used for the analysis and presentation of the data. From 2011 to 2021, a total of 188 endotoxin-related current Good Manufacturing Practices compliance observations were recorded, 70% and 30% were associated with laboratory and manufacturing origins, respectively. Finished drug product testing accounted for 56% of these. In contrast, 95% of all endotoxin-related product recalls were associated solely with medical devices. Over the years 2008-2021, approximately 1.4% of all adverse events (23,663,780) were recorded with some reference to pyrexia (fever); however, there are sparse data categorically attributing this to the administration of parenteral drugs or devices or combinations of these possessing high levels of endotoxin. Analysis of data concerning drug- and device-borne endotoxin obtained from FDA data from current Good Manufacturing Practices non-compliance observations, product recalls and the FDA Adverse Event Reporting System demonstrated the absence of industry-wide issues with endotoxin contamination. Based upon these data, changes to current Good Manufacturing Practices and the compendial methodology of setting endotoxin specifications (and hence the compendial methodology of testing for endotoxins) are unwarranted.