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Revista Brasileira de Enfermagem 2023to analyze the incidence of preventable adverse events related to health care in adult patients admitted to public hospitals in Brazil. (Observational Study)
Observational Study
OBJECTIVES
to analyze the incidence of preventable adverse events related to health care in adult patients admitted to public hospitals in Brazil.
METHODS
observational, analytical, retrospective study based on medical records review.
RESULTS
medical records from 370 patients were evaluated, 58 of whom had at least one adverse event. The incidence of adverse events corresponded to 15.7%. Adverse events were predominantly related to healthcare-related infection (47.1%) and procedures (24.5%). Regarding the adverse event severity, 13.7% were considered mild, 51.0% moderate, and 35.3% severe. 99% of adverse events were classified as preventable. Patients admitted to the emergency room had a 3.73 times higher risk for adverse events.
CONCLUSIONS
this study's results indicate a high incidence of avoidable adverse events and highlight the need for interventions in care practice.
Topics: Adult; Humans; Retrospective Studies; Hospitalization; Emergency Service, Hospital; Hospitals, Public; Incidence; Medical Errors
PubMed: 37436233
DOI: 10.1590/0034-7167-2022-0025 -
BMC Pharmacology & Toxicology Aug 2023drug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs are reported most frequently... (Review)
Review
BACKGROUND
drug overdose is a common type of medication error, which caused significant patient injuries and economic losses. To determine which drugs are reported most frequently in association with drug overdose, a comprehensive search was conducted in the FDA Adverse Event Reporting System (FAERS) database. The study also sought to determine the top 10 drugs reported with drug overdose.
METHODS
FAERS database was searched for drug overdose records submitted from the first quarter of 2017 to the fourth quarter of 2021. Descriptive analyses were conducted based on the total counts and percentages of reports associated with the drug. Subgroup analyses were performed on drugs of different pharmacological classifications.
RESULTS
A total of 170,424 drug overdose reports were retrieved. The results revealed that antipyretics and analgesics took the highest risk for overdose, with 63,143 (37.05%) cases reported. Among them, opioids were associated with the most drug overdose events. The top 10 drug classes relating to drug overdose in FAERS were opioid analgesic, anilide antipyretic analgesic, 5-HT reuptake inhibitors, bronchodilators, monoclonal antibodies and antibody-drug conjugates, benzodiazepines, antipsychotics, GABA derivatives, antimanic agents, and propionic acid derivatives.
CONCLUSION
to reduce the occurrence of drug overdose events, some methods could be considered including applying a pre-prescription review system, drug safety education, developing warning lists, etc.
Topics: United States; Humans; Adverse Drug Reaction Reporting Systems; United States Food and Drug Administration; Medication Errors; Drug-Related Side Effects and Adverse Reactions; Drug Overdose; Analgesics; Analgesics, Opioid
PubMed: 37542326
DOI: 10.1186/s40360-023-00681-y -
Expert Review of Vaccines 2024The rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the...
INTRODUCTION
The rapid development of COVID-19 vaccines has provided crucial tools for pandemic control, but the occurrence of vaccine-related adverse events (AEs) underscores the need for comprehensive monitoring.
METHODS
This study analyzed the Vaccine Adverse Event Reporting System (VAERS) data from 2020-2022 using statistical methods such as zero-truncated Poisson regression and logistic regression to assess associations with age, gender groups, and vaccine manufacturers.
RESULTS
Logistic regression identified 26 System Organ Classes (SOCs) significantly associated with age and gender. Females displayed especially higher odds in SOC 19 (Pregnancy, puerperium and perinatal conditions), while males had higher odds in SOC 25 (Surgical and medical procedures). Older adults (>65) were more prone to symptoms like Cardiac disorders, whereas those aged 18-65 showed susceptibility to AEs like Skin and subcutaneous tissue disorders. Moderna and Pfizer vaccines induced fewer SOC symptoms compared to Janssen and Novavax. The zero-truncated Poisson regression model estimated an average of 4.243 symptoms per individual.
CONCLUSION
These findings offer vital insights into vaccine safety, guiding evidence-based vaccination strategies and monitoring programs for precise and effective outcomes.
Topics: Aged; Female; Humans; Male; Pregnancy; Adverse Drug Reaction Reporting Systems; COVID-19; COVID-19 Vaccines; United States; Vaccination; Vaccines
PubMed: 38063069
DOI: 10.1080/14760584.2023.2292203 -
The Journal of Allergy and Clinical... Apr 2024Benralizumab and mepolizumab are interleukin (IL)-5Rα/interleukin-5-targeted monoclonal antibodies indicated as add-on treatments for patients with uncontrolled severe...
BACKGROUND
Benralizumab and mepolizumab are interleukin (IL)-5Rα/interleukin-5-targeted monoclonal antibodies indicated as add-on treatments for patients with uncontrolled severe eosinophilic asthma (SEA).
OBJECTIVE
To evaluate and compare the safety of benralizumab and mepolizumab among patients with SEA treated in MELTEMI and COLUMBA open-label, long-term extension studies, respectively.
METHODS
MELTEMI was an extension study of benralizumab every 4 weeks (q4w) or every 8 weeks (q8w) for adults (aged 18-75 y) with SEA. MELTEMI participants transitioned from the BORA extension, preceded by participation in 1 of 3 placebo-controlled studies (SIROCCO, CALIMA, or ZONDA). COLUMBA was an extension study of mepolizumab for patients (aged ≥ 12 y) with SEA who transitioned from the dose-ranging DREAM study. Safety endpoints were presented as drug exposure patient-years (MELTEMI, q4w 784.28, q8w 797.03; COLUMBA 1,201) for nonserious adverse events, serious adverse events, and infections; malignancies were counted numerically.
RESULTS
This analysis included 446 MELTEMI patients (benralizumab q4w 220; benralizumab q8w 226) and 347 COLUMBA patients (mepolizumab q4w). Viral upper respiratory tract infection was the most common nonserious adverse event in both studies (MELTEMI q8w 46.5%; q4w 47.3%; COLUMBA, 48.7%). Asthma-related events were the most common serious adverse events in both studies: MELTEMI 8.0% (q8w) and 8.6% (q4w) and COLUMBA 9.5%. Serious infections included pneumonia (MELTEMI q8w, 2 [0.9%]; COLUMBA, 6 [1.7%]); cellulitis (MELTEMI q8w, 1 [0.4%]; COLUMBA, 2 [0.6%]); and respiratory tract infections (COLUMBA, 2 [0.6%]). COLUMBA reported 6 malignancies and MELTEMI reported 4 malignancies in each group.
CONCLUSIONS
This analysis demonstrated generally similar safety events between mepolizumab and benralizumab in patients with SEA.
PubMed: 38677588
DOI: 10.1016/j.jaip.2024.04.033 -
The Turkish Journal of Gastroenterology... Sep 2023The number of endoscopic procedures and related adverse events is increasing. We investigated South Korean endoscopists' awareness and experience of endoscopic adverse...
BACKGROUND/AIMS
The number of endoscopic procedures and related adverse events is increasing. We investigated South Korean endoscopists' awareness and experience of endoscopic adverse events.
MATERIALS AND METHODS
We used Google Forms to conduct an online questionnaire survey among South Korean endoscopists from December 11 to 29, 2020. The survey comprised 30 questions developed by members of the Quality Management Committee of the Korean Society of Gastrointestinal Endoscopy.
RESULTS
In total, 475 endoscopists participated in the survey. Of these, 454 (95.6%) were board-certified gastroenterologists and 255 (53.7%) had >10 years of endoscopy experience. Most participants had experienced serious adverse events requiring hospitalization (80.4%, 382/475); however, only 100 (21.1%) were aware of programs for the prevention and management of adverse endoscopic events in their affiliated endoscopy centers. Most participants (98.5%, 468/475) agreed with the need for education on medical accidents for healthcare workers. Responses were inconsistent regarding the definition of adverse events formulated by the 2010 American Society for Gastrointestinal Endoscopy Workshop. Most participants were not aware of the minimal standard terminology (76.6%, 364/475) and had not used it when writing endoscopy reports (88.8%, 422/475). Responses were inconsistent regarding which events to record in endoscopy records.
CONCLUSION
Further discussion on the nationwide adverse-event reporting system and education program for adverse events related to endoscopy is needed to ensure the safety of patients and endoscopists.
Topics: Humans; United States; Endoscopy, Gastrointestinal; Surveys and Questionnaires; Gastroenterologists; Republic of Korea
PubMed: 37565797
DOI: 10.5152/tjg.2023.22256 -
South African Family Practice :... Aug 2023In 2019, the World Health Organization (WHO) declared coronary artery disease (CAD) as the leading cause of death globally for the last 20 years. Early screening and... (Review)
Review
BACKGROUND
In 2019, the World Health Organization (WHO) declared coronary artery disease (CAD) as the leading cause of death globally for the last 20 years. Early screening and detection (primary prevention) and intervention (secondary prevention) are necessary to curb CAD and major adverse cardiovascular event (MACE) prevalence. A scoping review to assess the current literature on using cardiac scoring systems to predict CAD and MACE was performed.
METHODS
The research question 'What is the literature on using cardiac scoring systems to predict CAD and MACE?' was addressed. The updated Arksey and O'Malley and the Preferred Reporting Items for Systematic reviews and Meta-Analyses Extension for Scoping Reviews methodologies were used. The search terms 'coronary artery disease' and 'cardiac scoring systems' and 'major adverse cardiovascular events' were used in the Boolean search on PubMed, ScienceDirect, MedLine and Cochrane Library.
RESULTS
The final list consisted of 19 published English results after the year 2000. There were six results without participants (four clinical guidelines, one review article and one ongoing clinical trial). Scoring systems were cardiovascular risk estimation systems focusing on the primary prevention of CAD; MACE was discussed but not scored. There were 13 robust results published from completed multinational clinical trials with participants. These results focused on a scoring system for the secondary prevention of CAD and MACE.
CONCLUSION
Scoring systems remain an objective method for primary and secondary prevention of CAD and MACE.Contribution: Scoring systems may be helpful with clinical uncertainty or to standardise patient results for comparison in research.
Topics: Humans; Coronary Artery Disease; Clinical Decision-Making; Uncertainty; Heart; Cardiovascular System
PubMed: 37782230
DOI: 10.4102/safp.v65i1.5683 -
Frontiers in Pharmacology 2024Ticagrelor is a commonly used antiplatelet agent, but due to the stringent criteria for trial population inclusion and the limited sample size, its safety profile has...
BACKGROUND
Ticagrelor is a commonly used antiplatelet agent, but due to the stringent criteria for trial population inclusion and the limited sample size, its safety profile has not been fully elucidated.
METHOD
We utilized OpenVigil 2.1 to query the FDA Adverse Event Reporting System database and retrieved reports by the generic name "ticagrelor" published between 1 October 2010 and 31 March 2023. Adverse drug events (ADEs) were classified and described according to the preferred terms and system organ classes in the Medical Dictionary of Regulatory Activity. Proportional reporting ratio (PRR), reporting odds ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) were used to detect signals.
RESULTS
The number of ADE reports with ticagrelor as the primary suspect drug was 12,909. The top three ADEs were dyspnea [1824 reports, ROR 7.34, PRR 6.45, information component (IC) 2.68], chest pain (458 reports, ROR 5.43, PRR 5.27, IC 2.39), and vascular stent thrombosis (406 reports, ROR 409.53, PRR 396.68, IC 8.02). The highest ROR, 630.24, was found for "vascular stent occlusion". Cardiac arrest (137 reports, ROR 3.41, PRR 3.39, IC 1.75), atrial fibrillation (99 reports, ROR 2.05, PRR 2.04, IC 1.03), asphyxia (101 reports, ROR 23.60, PRR 23.43, IC 4.51), and rhabdomyolysis (57 reports, ROR 2.75, PRR 2.75, IC 1.45) were suspected new adverse events of ticagrelor.
CONCLUSION
The FAERS database produced potential signals associated with ticagrelor that have not been recorded in the package inserts, such as cardiac arrest, atrial fibrillation, asphyxia, and rhabdomyolysis. Further clinical surveillance is needed to quantify and validate potential hazards associated with ticagrelor-related adverse events.
PubMed: 38655177
DOI: 10.3389/fphar.2024.1251961 -
MedRxiv : the Preprint Server For... Nov 2023Social stress experienced in childhood is associated with adverse health later in life. Mitochondrial function has been implicated as a mechanism for how stressful life...
Social stress experienced in childhood is associated with adverse health later in life. Mitochondrial function has been implicated as a mechanism for how stressful life events "get under the skin" to influence physical wellbeing. Using data from the Study of Muscle, Mobility and Aging (n=879, 59% women), linear models examined whether adverse childhood events (i.e., physical abuse) were associated with two measures of skeletal muscle mitochondrial energetics in older adults: (1) maximal adenosine triphosphate production (ATP ) and (2) maximal state 3 respiration (Max OXPHOS). Forty-five percent of the sample reported experiencing 1+ adverse childhood event. After adjustment, each additional event was associated with -0.07 SD (95% CI= - 0.12, -0.01) lower ATP . No association was observed with Max OXPHOS. Adverse childhood events are associated with lower ATP production in later life. Findings indicate that mitochondrial function may be a mechanism in understanding how early social stress influences health in later life.
PubMed: 37986889
DOI: 10.1101/2023.11.07.23298177 -
Frontiers in Pharmacology 2023The promise of immune checkpoint inhibitors (ICIs) therapy in cancer treatment is tempered by the occurrence of immune-related adverse events (irAEs). Many patients...
The promise of immune checkpoint inhibitors (ICIs) therapy in cancer treatment is tempered by the occurrence of immune-related adverse events (irAEs). Many patients undergoing ICIs also take aspirin, but the association between aspirin and irAEs is not well understood. This study analyzed adverse reaction data associated with the use of ICIs in the US Food and Drug Administration (FDA) Adverse Event Reporting System FDA Adverse Event Reporting System database, from the approval date of each drug until 1 October 2022. Multivariate logistic regression was employed to assess the association of aspirin use with irAEs in patients receiving ICIs. The results indicated that aspirin use was associated with an increased risk of irAEs in a pan-cancer analysis, with a more pronounced association in specific cancer types such as lung cancer, mesothelioma, and pancreatic cancer. However, in lymphoma, aspirin use was associated with a reduced risk of irAEs. Furthermore, aspirin use was associated with an increased risk of certain irAEs, such as anemia, colitis, myocarditis, myositis, pancreatitis, pericarditis, and pneumonia, while it was associated with a reduced risk of rash, Stevens-Johnson syndrome, and thyroiditis. This study has unveiled an association between aspirin use and irAEs in cancer patients receiving ICIs therapy, emphasizing the need for individualized consideration of patients' medication history when devising cancer treatment plans to enhance efficacy and reduce risks.
PubMed: 38035011
DOI: 10.3389/fphar.2023.1259628 -
Frontiers in Immunology 2023Immune checkpoint inhibitors (ICIs) has emerged as a popular cancer treatment approach. However, non-specific activation of T cells by ICIs can lead to immune-related...
BACKGROUND
Immune checkpoint inhibitors (ICIs) has emerged as a popular cancer treatment approach. However, non-specific activation of T cells by ICIs can lead to immune-related adverse events (irAEs), including specific rheumatic manifestations. The study aimed to explore the current trend of ICIs associated rheumatic irAEs and summarize the knowledge structure through bibliometric methods.
METHODS
The Web of Science Core Collection database (WoSCC) was selected for retrieving literature on ICIs associated rheumatic irAEs. To evaluate contributions from different countries/regions, institutions, journals, and authors, bibliometric analysis software, including VOSviewer and CiteSpace, as well as bibliometric online platforms, were utilized to construct and visualize bibliometric networks. Through the systematic review of this knowledge domain, future research directions were determined.
RESULTS
In This study, a total of 803 publications on ICIs-associated rheumatic irAEs were included for analysis. The distribution of these publications revealed two distinct growth phases: a stable phase between 2007 to 2015 followed by rapid growth from 2016 to 2020. The United States emerged as the top contributor in terms of publications, citations, and h-index, with the majority of leading institutions and funding agencies located there. Apart from government funding, pharmaceutical companies such as Bristol Myers Squibb and Merck Company also play a significant role in drug development and research. Analysis of keywords and citation bursts indicated that the initial burst was related to "monoclonal antibody," "anti-CLTA4 antibody," and "melanoma". This was followed by a rise in interest related to "sarcoidosis," "safety," "inflammatory arthritis," and "preexisting autoimmune."
CONCLUSION
This study summarized the global research trends concerning ICIs associated rheumatic irAEs. The findings can provide valuable insights into the current understanding of rheumatic irAEs, highlight the research trend and developments in the field. Future efforts should focus on developing classification criteria and guidelines, conducting prospective studies, investigating the mechanisms involved, and identifying biomarkers for prediction and monitoring of these events.
Topics: Humans; Immune Checkpoint Inhibitors; Prospective Studies; Antibodies, Monoclonal; Arthritis; Bibliometrics
PubMed: 37869006
DOI: 10.3389/fimmu.2023.1242336