Elevated blood cholesterol and triglyceride levels induced by secondary causes are frequently observed. The identification and appropriate handling of these causes are essential for secondary dyslipidemia treatment. Major secondary causes of hypercholesterolemia and hypertriglyceridemia include an unhealthy diet, diseases and metabolic conditions affecting lipid levels, and therapeutic side effects. It is imperative to correct secondary causes prior to initiating conventional lipid-lowering therapy. Guideline-based lipid therapy can then be administered based on the subsequent lipid levels.

BACKGROUND: The development of immune checkpoint inhibitors (ICIs) represents one of the most significant advancements in cancer treatment over the past decade. Nivolumab, a widely used ICI, has been incorporated into the therapeutic regimens for various cancers. As with any drug, this drug also has side effects, including class-specific immune-related adverse effects (irAEs). Although irAEs are not rare, their diagnosis can be challenging. This study examines the emergency department (ED) visits of patients undergoing nivolumab therapy, focusing on diagnostic challenges, evaluating the management, and outcomes of irAEs in the ED setting.
METHODS: A retrospective cohort study was conducted on adult patients who received nivolumab therapy for any cancer between April 1, 2018, and March 31, 2023, at a large, urban tertiary care center. In this study, we evaluated the ED visits of patients receiving nivolumab. In addition to previous studies, we evaluated irAEs in detail (percentage, recognizability, risk factors, reasons for late recognition, and outcome). Patient data were collected from electronic medical records and patient\'s medical files. The anamnesis, laboratory, and imaging results, ED management, and consultation notes were examined separately for each ED visit. Logistic regression models were employed to identify significant univariable predictors of ED visits and irAEs.
RESULTS: A total of 199 patients were included in the study, all of whom had metastatic cancer. Of these, 154 patients (77.4%) received nivolumab therapy for non-small cell lung cancer. Most patients (71.9%, n = 143) had at least one additional comorbidity. One hundred and eleven patients (55.8%) presented to the ED. Hypertension (OR: 2.425, 95% CI: 1.226-4.795, p = 0.011) and chronic obstructive pulmonary disease (OR: 2.489, 95% CI: 1.133-5.468, p = 0.023) were identified as risk factors for ED visits. A total of 21 irAEs were diagnosed (14 in ED, 6 in the oncology clinic, and 1 in the inpatient ward). Univariate analysis found no significant association between irAE diagnosis and any specific factors.
CONCLUSIONS: A significant proportion of the patients treated with nivolumab for advanced cancer present to ED for ICI-related adverse events, although most cases were not attributable to irAEs. Due to the vague symptomatology of irAEs, their recognition and diagnosis in the ED can be challenging. Close collaboration between ED physicians and oncologists is paramount to the management of patients with cancer in the ED.

BACKGROUND: This study will pilot-test the mobile app, Medication Safety @HOME-Meds@HOME intervention to improve medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management for children with medical complexity (CMC). The Meds@HOME app was co-designed with CMC families, secondary caregivers (SCGs), and health professionals to support medication management for primary caregivers (PCGs) and SCGs of CMC. We hypothesize that Meds@HOME will improve caregivers\' medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management.
OBJECTIVE: This study aims to evaluate the effectiveness of Meds@HOME on medication administration accuracy for PCGs and SCGs.
METHODS: This study will recruit up to 152 PCGs and 304 SCGs of CMC who are prescribed at least 1 scheduled high-risk medication and receive care at the University of Wisconsin American Family Children\'s Hospital. PCGs will be randomly assigned, for the 6-month trial, to either the control group (not trialing Meds@HOME) or the intervention group (trialing Meds@HOME) using 1:1 ratio. The Meds@HOME app allows caregivers to create a child profile, store medication and care instructions, and receive reminders for upcoming and overdue care routines and medication refills. Surveys completed both at the start and end of the trial measure demographics, medication delivery knowledge, confidence in the CMC\'s caregiving network, and comfort with medical information. Univariate and multivariate generalized estimation equations will be used for primary statistical analysis. The primary outcome is the PCG\'s rate of medication administration accuracy measured as correct identification of each of the following for a randomly selected high-risk medication: indication, formulation, dose, frequency, and route at baseline and after 6 months. Secondary outcomes include SCG medication administration accuracy (indication, formulation, dose, frequency, and route), count of University of Wisconsin hospital and emergency department encounters, PCG-reported medication adherence, count of deaths, and PCG medication confidence and understanding.
RESULTS: Recruitment for this study began on November 29, 2023. As of May 15, 2024, we have enrolled 94/152 (62%) PCGs. We expect recruitment to end by August 1, 2024, and the final participant will complete the study by January 28, 2025, at which point we will start analyzing the complete responses. We expect publication of results at the end of 2025.
CONCLUSIONS: The Meds@HOME mobile app provides a promising strategy for improving PCG medication safety for CMC who take high-risk medications. In addition, this protocol highlights novel procedures for recruiting SCGs of CMC. In the future, this app could be used more broadly across diverse caregiving networks to navigate complex medication routines and promote medication safety.
BACKGROUND: ClinicalTrials.gov NCT05816590; https://clinicaltrials.gov/study/NCT05816590.
UNASSIGNED: DERR1-10.2196/60621.

The global burden of Inflammatory bowel disease (IBD) has been rising over the last decades. IBD is an intestinal disorder with a complex and largely unknown etiology. The disease is characterized by a chronically inflamed gastrointestinal tract, with intermittent phases of exacerbation and remission. This compromised intestinal barrier can contribute to, enhance, or even enable the toxicity of drugs, food-borne chemicals and particulate matter. This review discusses whether the rising prevalence of IBD in our society warrants the consideration of IBD patients as a specific population group in toxicological safety assessment. Various in vivo, ex vivo and in vitro models are discussed that can simulate hallmarks of IBD and may be used to study the effects of prevalent intestinal inflammation on the hazards of these various toxicants. In conclusion, risk assessments based on healthy individuals may not sufficiently cover IBD patient safety and it is suggested to consider this susceptible subgroup of the population in future toxicological assessments.

BACKGROUND: Immune-related adverse events (irAEs) always occur during treatment with immune checkpoint inhibitors (ICIs). Patients with nervous system cancer (NSC) may gain clinical benefit from ICIs, but irAEs in NSC patients are rarely examined. Therefore, our study systematically summarized reports of irAEs in NSC.
METHODS: We obtained information from the FDA adverse event reporting system from the first quarter (Q1) of 2013 to the fourth quarter (Q4) of 2022. We examined use of a combination of ICIs and chemotherapy (ICI_Chemo) or chemotherapy only (ICI_Chemo) for patients with NSC. Multiple disproportionality analyses were applied to assess irAEs. Multiomics data from the gene expression omnibus (GEO) database were analyzed to explore potential molecular mechanisms associated with irAEs in NSC patients.
RESULTS: Fourteen irAEs were identified in 8,357 NSC patients after removing duplicates; the top five events were seizure, confused state, encephalopathy, muscular weakness and gait disturbance. Older patients were more likely to develop irAEs than were younger patients. From the start of ICIs_Chemo to irAE occurrence, there was a significant difference in the time to onset of irAEs between age groups. irAEs may occur via mechanisms involving the inflammatory response, secretion of inflammatory mediators, and aberrant activation of pathologic pathways.
CONCLUSIONS: This study helps to characterize irAEs in NSC patients treated with ICIs. We combined GEO database analysis to explore the potential molecular mechanisms of irAEs. The results of this study provide a basis for improving the toxic effects of ICIs in NSC patients.

Immune checkpoint inhibitors (ICIs) reinvigorate anti-tumor immune responses by disrupting co-inhibitory immune checkpoint molecules such as programmed cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4). Although ICIs have had unprecedented success and have become the standard of care for many cancers, they are often accompanied by off-target inflammation that can occur in any organ system. These immune related adverse events (irAEs) often require steroid use and/or cessation of ICI therapy, which can both lead to cancer progression. Although irAEs are common, the detailed molecular and immune mechanisms underlying their development are still elusive. To further our understanding of irAEs and develop effective treatment options, there is pressing need for preclinical models recapitulating the clinical settings. In this review, we describe current preclinical models and immune implications of ICI-induced skin toxicities, colitis, neurological and endocrine toxicities, pneumonitis, arthritis, and myocarditis along with their management.

Background: Analysing data on adverse drug reactions (ADRs) in health facilities is an essential step to help develop effective strategies to reduce their incidence. The objective was to analyse spontaneous ADR reports sent to the Ghanaian Food and Drugs Authority (FDA) by two reporting health facilities over 5 years. Methods: Data from duplicate spontaneous ADR reports sent to the FDA (Ghana) from 2014 to 2018 were extracted. The relationship between independent variables such as age, sex, and source of drugs and ADR outcomes was assessed with either chi-square or a Cramer\'s V test for association where appropriate. Results: Type A reactions (65.2%) were the most prevalent of the ADRs, followed by Type B (34.1%), with the majority (80%) of patients affected recovering fully. The majority of Type A reactions (54.1%) occurred in the clinic, while the majority of Type B reactions (43.5%) occurred in the hospital. The skin and central nervous system (CNS) were the most affected (70.8%) organs. A higher incidence of CNS and skin-related ADRs was recorded in patients older than 30 (RR = 1.28 (1.07-1.53)). Also, females were more likely to experience a CNS-related ADR. The seriousness of the ADR was found to be significantly associated with the (1) type of prescriber, (2) whether the drug was prescribed, or (3) whether the drug regimen prescribed was appropriate. Even though, in 86% of cases, the offending drug was withdrawn within the first 5 days, it exceeded 20 days in about 6% of cases. The record of allergy status in a patient\'s folder and the source of the drug were significantly associated with the chance that the offending drug was withdrawn. However, recording ADRs did not influence whether the offending drug was stopped. Conclusion: Most of the ADRs experienced by patients could be avoided if the current systems are improved to prevent the rechallenge of offending drugs. Efforts to improve and update patient medication records and steps to ensure continuity of care are essential in preventing these adverse drug events.

High-risk drugs, which are potentially a source of serious adverse reactions, are a major concern in healthcare establishments, particularly for geriatric patients, who often have multiple medications and co-morbid conditions. With a view to continuously improving the quality and safety of care, we have embarked on a proactive approach aimed at identifying, securing and improving the management of medicines at risk in geriatric wards.

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BACKGROUND: Adverse drug events pose an enormous public health burden, leading to hospitalization, disability, and death. Even the adverse events (AEs) categorized as nonserious can severely impact on patient\'s quality of life, adherence, and persistence. Monitoring medication safety is challenging. Web-based patient reports on social media may be a useful supplementary source of real-world data. Despite the growth of sophisticated techniques for identifying AEs using social media data, a consensus has not been reached as to the value of social media in relation to more traditional data sources.
OBJECTIVE: This study aims to evaluate and characterize the utility of social media analysis in adverse drug event detection and pharmacovigilance as compared with other data sources (such as spontaneous reporting systems and the clinical literature).
METHODS: In this scoping review, we searched 11 bibliographical databases and Google Scholar, followed by handsearching and forward and backward citation searching. Each record was screened by 2 independent reviewers at both the title and abstract stage and the full-text screening stage. Studies were included if they used any type of social media (such as Twitter or patient forums) to detect AEs associated with any drug medication and compared the results ascertained from social media to any other data source. Study information was collated using a piloted data extraction sheet. Data were extracted on the AEs and drugs searched for and included; the methods used (such as machine learning); social media data source; volume of data analyzed; limitations of the methodology; availability of data and code; comparison data source and comparison methods; results, including the volume of AEs, and how the AEs found compared with other data sources in their seriousness, frequencies, and expectedness or novelty (new vs known knowledge); and conclusions.
RESULTS: Of the 6538 unique records screened, 73 publications representing 60 studies with a wide variety of extraction methods met our inclusion criteria. The most common social media platforms used were Twitter and online health forums. The most common comparator data source was spontaneous reporting systems, although other comparisons were also made, such as with scientific literature and product labels. Although similar patterns of AE reporting tended to be identified, the frequencies were lower in social media. Social media data were found to be useful in identifying new or unexpected AEs and in identifying AEs in a timelier manner.
CONCLUSIONS: There is a large body of research comparing AEs from social media to other sources. Most studies advocate the use of social media as an adjunct to traditional data sources. Some studies also indicate the value of social media in understanding patient perspectives such as the impact of AEs, which could be better explored.
UNASSIGNED: RR2-10.2196/47068.