Purpose: To quantify the risk of ocular adverse events with immune checkpoint inhibitors (ICIs) as reported to the Food and Drug Administration (FDA). Methods: Disproportionality analysis using data from U. S. FDA's Adverse Events Reporting System (FAERS) database 2003 to 2018. Data from pharmaceutical manufacturers, healthcare providers, consumers in the U. S., and post-marketing clinical trial reports from U. S. and non-U. S. studies. All cases of uveitis, dry eye syndrome, ocular myasthenia and eye inflammation with use of the following ICIs: atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab and pembrolizumab. Reported odds ratios (RORs) and corresponding 95% confidence intervals (CIs) were computed for all drugs as a group or as individual agents. Results: We identified 113 ocular adverse events for all ICIs of interest including uveitis, dry eye, ocular myasthenia and eye inflammation. Nivolumab had the highest number of adverse events (N ¼ 68) associated with use of the ICI. Nivolumab had the highest association with ocular myasthenia [ROR ¼ 22. 82, 95% CI (7. 18e72. 50)] followed by pembrolizumab [ROR ¼ 20. 17, 95% CI (2. 80e145. 20)]. Among all ICIs approved in North America, atezolizumab had the highest association with eye inflammation [ROR ¼ 18. 89, 95% CI (6. 07e58. 81)] and ipilmumab had the highest association with uveitis [ROR ¼ 10. 54, 95% CI (7. 30e15. 22)]. Conclusion: The results of this disproportionality analysis suggest use of ICIs is associated with an increase risk for ocular adverse reactions. Future epidemiologic studies are needed to better quantify these adverse events.

Introduction: An adverse event is defined as an unexpected event such as a patient fall, a drug reaction or an infection, which leads to patient injury and is caused by healthcare management rather than patient own diseases. There is evidence to suggest that adverse events frequently occur in modern health systems. However, there is a lack of knowledge about the nature of adverse events and the performance of different methods to explore them. This survey is part of a PhD project, which aims to investigate the scale and nature of adverse events and compare different methods to identify them. The project has not been completed yet. The aim of this abstract is to explain the design and methodology of the project. Objectives: To explore the relative performance of two promising methods of medical record review (18 item and 8 item-screening criteria) for detecting adverse events and to compare this method with the routine hospital incident reporting system for detecting adverse  events.Methods: A proportionate stratified random sample of 1000 patient records from Surgery, Medicine, Elderly, Orthopaedics and Urology specialties of a large UK hospital were selected and reviewed by nurses using a list of explicit criteria. Identification of one or more positive criteria was considered as an indicator of a potential adverse event. Doctors then reviewed these records in more depth and decided if there was an adverse event. If the doctor was fairly convinced that there was an adverse event, a structured review form was completed to explore the nature and likely causes of adverse event. We also check the hospital incident reporting systems to see if any adverse events were reported to the system about any of the patients in our sample. The data collection and analysis has not been completed yet. A preliminary analysis of the data showed that in 407(40.7% of) cases at least one criterion was recorded positive by the nurses. Positive criteria do not necessarily mean an adverse event; however, these cases are considered as potential for adverse events and are forwarded for further review by the doctors to check if there is any adverse event. This study has the potential to contribute to methods of research in this field, which will inform future quality improvement initiatives and contribute to future research.  

Background: Nursing adverse events (AEs) are well‑ defined problems in the healthcare system and may have irreparable consequences. Due to the complexity of care, many factors contribute to AEs and affect patient safety, one of which is occupational stress. The present study aimed to determine the relationship between nursing AEs and occupational stress in nurses in centers affiliated to Isfahan University of Medical Sciences, Isfahan, Iran, in 2015. Materials and Methods: In this descriptive correlational study, the participants were selected through random and quota sampling methods. The data collection tool was a three‑ part questionnaires consisting of a demographic characteristics form, the Nurses’ Job Stress Questionnaire, and Nursing Adverse Events Questionnaire. Descriptive and analytical statistics were used to analyze the data in Statistical Package for the Social Sciences software. Results: Among the four factors affecting occupational stress in nurses, administrative factors had the highest impact; subsequently followed, by environmental factors and interpersonal factors. The mean score of AEs was reported as 30 cases per year. There was a significant correlation between the overall mean score of occupational stress and AEs (r = 0. 12, p = 0. 04). Conclusions: According to the results of this study, moderate to high levels of job stress were observed among nurses. The results also showed that occupational stress can lead to nursing AEs. Given that nurses believe the highest mean of occupational stressors is related to administrative factors, an appropriate and comprehensive leadership is necessary to improve the current conditions.