Metabolic Side Effects of Risperidone in Pediatric Patients with Neurological Disorders: A Prospective Cohort Study.

Background/Objectives: Risperidone-related metabolic side effects in children have been primarily linked to variations between guideline-recommended and clinical treatment procedures. We explored the metabolic effects of risperidone administration in pediatric patients diagnosed with neurological disorders, thus evaluating its influence on metabolic indicators. Methods: This prospective cohort study gathered data from electronic health records, medical databases, and clinical reports. These data included patient demographics (e.g., age, sex, and body mass index) and information on risperidone use, including dosage, dosing frequency, and treatment duration. Additionally, laboratory tests were conducted at baseline and during treatment, along with other pertinent clinical variables. Result: A total of 52 eligible children (male; 73.1%) with neurological disorders treated with risperidone were included. The mean age was 13.4 ± 2.2 years. Risperidone was administered to 32.7% of patients for <2 years, 40.4% for 2-5 years, and 26.9% for 6-9 years, with a mean duration of 3.6 years. Most (53.8%) of the children experienced at least one metabolic side effect, with hyperlipidemia being the most common (34.6%). The median prolactin level increased slightly from 448.5 ng/mL at baseline to 479 ng/mL after 6-8 weeks. No significant associations were found between age, sex, duration of treatment, dosage form, dosing frequency, and hemoglobin A1c levels. Conclusion: Monitoring metabolic and anthropometric parameters in children receiving risperidone for neurological disorders is cardinal. Clinicians should consider individualized treatment plans, closely monitor metabolic markers, and address potential risks associated with long-term risperidone use in this vulnerable population.

Closing the loop: Strengthening course quality of Pharm.D. program via applying a comprehensive four-step review approach.

This study explores the course review process implemented by the College of Pharmacy at King Saud University for its Pharm.D. program. Through a qualitative research design, a dedicated course review committee was established to oversee the evaluation process. The committee gathered and analyzed data from various sources, including course reports, student evaluations, and exam center reports, to achieve a holistic understanding of each course's effectiveness. The evaluation process was structured into a Four-Step Course Evaluation Approach: data collection, data review and recommendations, taking appropriate action, and communicating the outcomes. The "closing the loop" stage ensured that recommendations were effectively implemented, and course evaluation data were systematically archived for future reference. The results of this study, based on the evaluation of 25 courses, revealed significant improvements in course quality, alignment with program learning outcomes, and adherence to accreditation standards. Key findings included the identification of gaps and discrepancies, leading to targeted interventions and enhanced course content. Overall, this study highlights the effectiveness of a structured course review process in enhancing the quality of education and ensuring continuous improvement within the college. The committee focuses on refining evaluation criteria, conducting workshops, and providing training to stay current with emerging accreditation standards and best practices. This systematic course review process demonstrates the College's commitment to providing high-quality education and preparing students for successful careers in pharmacy, with significant implications for the improvement of pharmacy education and the overall student learning experience.

A novel vaccine construct against Zika virus fever: insights from epitope-based vaccine discovery through molecular modeling and immunoinformatics approaches.

The Zika virus (ZIKV) is an emerging virus associated with the Flaviviridae family that mainly causes infection in pregnant women and leads to several abnormalities during pregnancy. This virus has unique properties that may lead to pathological diseases. As the virus has the ability to evade immune response, a crucial effort is required to deal with ZIKV. Vaccines are a safe means to control different pathogenic infectious diseases. In the current research, a multi-epitope-based vaccination against ZIKV is being designed using in silico methods. For the epitope prediction and prioritization phase, ZIKV polyprotein (YP_002790881.1) and flavivirus polyprotein (>YP_009428568.1) were targeted. The predicted B-cell epitopes were used for MHC-I and MHC-II epitope prediction. Afterward, several immunoinformatics filters were applied and nine (REDLWCGSL, MQDLWLLRR, YKKSGITEV, TYTDRRWCF, RDAFPDSNS, KPSLGLINR, ELIGRARVS, AITQGKREE, and EARRSRRAV) epitopes were found to be probably antigenic in nature, non-allergenic, non-toxic, and water soluble without any toxins. Selected epitopes were joined using a particular GPGPG linker to create the base vaccination for epitopes, and an extra EAAAK linker was used to link the adjuvant. A total of 312 amino acids with a molecular weight (MW) of 31.62762 and an instability value of 34.06 were computed in the physicochemical characteristic analysis, indicating that the vaccine design is stable. The molecular docking analysis predicted a binding energy of -329.46 (kcal/mol) for TLR-3 and -358.54 (kcal/mol) for TLR-2. Moreover, the molecular dynamics simulation analysis predicted that the vaccine and receptor molecules have stable binding interactions in a dynamic environment. The C-immune simulation analysis predicted that the vaccine has the ability to generate both humoral and cellular immune responses. Based on the design, the vaccine construct has the best efficacy to evoke immune response in theory, but experimental analysis is required to validate the in silico base approach and ensure its safety.

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study.

Investigating pharmacovigilance (PV) practices among oncology healthcare providers (HCPs) is crucial for patient safety in oncology settings. This study aimed to assess the awareness, attitudes, and practices towards PV and identify barriers to effective adverse drug reaction (ADR) reporting for HCPs working in oncology-related settings. Employing a cross-sectional survey design, we collected data from 65 HCPs, focusing on their experiences with ADR reporting, education on ADR management, and familiarity with PV protocols. The results showed that about half of the responders were pharmacists. Around 58.9% of the respondents reported ADRs internally, and 76.9% had received some form of ADR-related education. However, only 38.5% were aware of formal ADR review procedures. Methotrexate and paclitaxel emerged as the drugs most frequently associated with ADRs. The complexity of cancer treatments was among the common reasons for the low reporting of ADRs by the study participants. The findings highlight the need for enhanced PV education and standardized reporting mechanisms to improve oncology care. We conclude that reinforcing PV training and streamlining ADR-reporting processes are critical to optimizing patient outcomes and safety in oncology, advocating for targeted educational interventions and the development of unified PV guidelines.

Evaluating the Use of Selective Serotonin Reuptake Inhibitors (SSRIs) and Male Infertility: A Critical Retrospective Study.

Background: The use of selective serotonin reuptake inhibitors (SSRIs) has been associated with potential effects on male fertility, although the exact mechanisms are not fully understood. The aim of this study was to understand the relationship between SSRIs and male infertility; Methods: A retrospective chart review of Saudi males who were treated with SSRIs and attended an infertility clinic in KSMC was undertaken. The medical records of men from an infertility clinic were reviewed to screen the quality of the sperm parameters in patients taking SSRIs; Results: In total, 299 men were identified, of whom 29 (9.6%) were exposed to SSRIs, while 270 (90.4%) did not receive SSRIs, defined as the control infertile group. When comparing the mean ages, a notable disparity was observed between the control group of infertile men (34.2 ± 6.9 years) and the infertile group using SSRIs (41.5 ± 3.2 years) (p < 0.001). Regarding the sperm analysis and the use of SSRIs, the impact of SSRIs use showed no significant differences in sperm liquefaction (p = 0.1), motility (p = 0.17), viscosity (p = 0.16), or count (p = 0.069) with escitalopram, fluoxetine, or paroxetine use; Conclusions: Our study showed no significant difference in the sperm analysis between the SSRI and non-SSRI cohorts. However, the relationship between SSRI use and sperm count warrants further investigation and consideration in clinical practice.

A content-quality and optimization analysis of YouTube as a source of patient information for bipolar disorder.

Background: The goal of this study was to identify and evaluate the use of Arabic YouTube videos on BD as a resource for patient education. Methods: A cross-sectional evaluation of YouTube videos as a source of information for patients with BD in Arabic was performed. The study was observational and, because it did not involve human subjects, it followed the STROBE guidelines whenever possible. The quality of the videos was assessed using the validated DISCERN instrument. The search strategy involved entering the term "bipolar disorder" in the YouTube search bar, and only YouTube videos in Arabic were included. Results: A total of 58 videos were included in this study after removing duplicates and videos unrelated to BD (Figure 1). The most common source of videos was others (38%), followed by physician (33%), educational (26%), and hospital (3%). Resources covering symptoms and prognosis were mostly in the "others" category (41%). The resources or videos that covered treatment options were mainly created by physicians (41%). However, resources or videos that included a personal story mainly belonged to the "others" category (67%). Conclusion: Visual health-related instructional resources still have a significant shortage. This study highlights the poor quality of videos about serious illnesses like BD. Evaluation and promotion of the creation of visual health-related educational resources should be the primary goal of future study.

Prescribing pattern of antipsychotics for patients with schizophrenia using the total daily dose online tool.

This study aimed to investigate the prescribing pattern of antipsychotic medications for schizophrenia using the British National Formulary total daily dose (TDD) online tool. We analysed data from the electronic medical records at King Khalid University Hospital (KKUH) of 272 patients diagnosed with schizophrenia who were prescribed both typical and atypical antipsychotic medications. The results showed that aripiprazole was the most commonly prescribed antipsychotic drug, followed by haloperidol then risperidone. The TDD online tool was used to calculate the TDD of each prescribed antipsychotic medication. Most patients were prescribed doses within the recommended range for each medication, although some were prescribed doses above or below the recommended range. Moreover, a high recommended TDD was associated with the combined use of antipsychotics rather than monotherapy. Additionally, high TDD levels were associated with the following antipsychotics: haloperidol, olanzapine, paliperidone, and quetiapine. Our findings highlight the importance of using evidence-based tools such as the TDD online tool to guide prescribing practices and ensure optimal dosing of antipsychotic medications for patients with schizophrenia.

Development and Pharmacokinetic Evaluation of Novasomes for the Trans-nasal Delivery of Fluvoxamine Using Arachidonic Acid-Carboxymethyl Chitosan Conjugate.

Depression is the major mental illness which causes along with loss of interest in daily life, a feeling of hopelessness, appetite or weight changes, anger and irritability. Due to the hepatic first-pass metabolism, the absolute bioavailability of fluvoxamine (FVM) after oral administration is about 50%. By avoiding the pre-systemic metabolism, nasal delivery would boost bioavailability of FVM. Additionally, the absorption is anticipated to occur more quickly than it would via the oral route because of the existence of microvilli and high vasculature. A nonionic surfactant, cholesterol and an arachidonic acid-carboxymethyl chitosan (AA-CMCS) conjugate were used to develop FVM-loaded novasomes. To investigate the effects of surfactant concentration, AA-CMCS conjugate concentration and stirring speed on the novasomes' characteristics, a Box-Behnken design was used. The dependent variables chosen were zeta potential, polydispersity index and particle size. The AA-CMCS conjugate was confirmed by 1H-NMR and FTIR. Using Design Expert software (version 7; Stat-Ease Inc., Minneapolis, MN, USA), novasomes were further optimized. The chosen optimal formulation (NAC8) was made up of AA-CMCS conjugate, Span 60 and cholesterol. Particle size, zeta potential and PDI values for NAC8 formulation were 101 nm, -35 mV and 0.263, respectively. The NAC8 formulation's DSC and TGA analysis demonstrated that the medication had been uniformly and amorphously distributed throughout the novasomes. The NAC8 formulation showed 99% and 90% FVM release and permeation, respectively, and the novasome adherence time was 24 h. An improved antidepressant effect along with five-fold increase in bioavailability of FVM was observed after trans-nasal administration of NAC8 formulation compared to the reference commercially available Flumin® tablets. FVM-loaded novasomes administered via the nasal route may therefore constitute an advancement in the management of depression.

Inflammation and Treatment-Resistant Depression from Clinical to Animal Study: A Possible Link?

The aim of this study was to investigate the relationship between treatment-resistant depression (TRD) and inflammation in humans and experimental models. For the human study, a retrospective cohort study was conducted with 206 participants; half were on antidepressants for major depressive disorder. The patients were divided into healthy and depressed groups. Inflammation was assessed based on the values of the main inflammatory biomarkers (CRP, WBC and ESR). For the animal experiments, 35 adult male Wistar rats were assigned to stressed and non-stressed groups. Inflammation and stress were induced using lipopolysaccharide and chronic unpredictable mild stress. A 10 mg/kg intraperitoneal injection of fluoxetine (FLX), a known antidepressant, was simultaneously administered daily for 4 weeks. Behavioral tests were performed. The plasma levels of inflammatory and stress biomarkers were measured and were significantly higher in the stressed and non-responsive groups in both studies. This study provides evidence of the link between inflammation and TRD. We further observed a possible link via the Phosphorylated Janus Kinase 2 and Phosphorylated Signal Transducer and Activator of Transcription 3 (P-JAK2/P-STAT3) signaling pathway and found that chronic stress and high inflammation hinder the antidepressant effects of FLX. Thus, non-response to antidepressants could be mitigated by treating inflammation to improve the antidepressant effect in patients with TRD.