BACKGROUND: With the rise in medical errors, establishing a strong safety culture and an effective incident reporting system is crucial. As part of the Saudi National Health Transformation Vision of 2030, multiple projects have been initiated to periodically assess healthcare quality measures and ensure a commitment to continuous improvement. Among these is the Hospital Survey on Patient Safety Culture National Project (HSPSC), conducted regularly by the Saudi Patient Safety Center (SPSC). However, comprehensive tools for assessing reporting culture are lacking. Addressing this gap can enhance reporting, efficiency, and health safety.
OBJECTIVE: This paper aims to investigate the reporting practices among healthcare professionals (HCPs) in Saudi Arabian hospitals and examine the relationship between reporting culture domains and other variables such as hospital bed capabilities and HCPs\' work positions.
METHODS: The study focuses on measuring the reporting culture-related items measures and employs secondary data analysis using information from the Hospital Survey on Patient Safety Culture conducted by the Saudi Center for Patient Safety in 2022, encompassing hospitals throughout Saudi Arabia. Data incorporated seven items in total: four items related to the Response to Error Domain, two related to the Reporting Patient Safety Events Domain, and one associated with the number of events reported in the past 12 months.
RESULTS: The sample for the analyzed data included 145,657 HCPs from 392 hospitals. The results showed that the average positive response rates for reporting culture-related items were between 50% and 70%. In addition, the research indicated that favorable response rates were relatively higher among managerial and quality/patient safety/risk management staff. In contrast, almost half had not reported any events in the preceding year, and a quarter reported only 1 or 2 events. Pearson correlation analysis demonstrates a strong negative correlation between bed capacity and reporting safety events, response to error, and number of events reported (r = -0.935, -0.920, and - 0.911, respectively; p < 0.05), while a strong positive correlation is observed between reporting safety events and response to error (r = 0.980; p < 0.01).
CONCLUSIONS: Almost 75% of the HCPs reported fewer safety events over the last 12 months, indicating an unexpectedly minimal recorded occurrence variance ranging from 0 to 2 incidents.

OBJECTIVE: The study is aimed to evaluate the impact of safety events in the Eurofever registry for Autoinflammatory diseases.
METHODS: This was a retrospective and longitudinal observational multicentre study. Data were retrieved from the international registry Eurofever, starting patients\' enrolment since 2009. All moderate, severe, or very severe AEs reported by treating physician in Eurofever were analyzed regardless of a possible suspected causal relationship to any therapies and according to the latest release of the Medical Dictionary for Regulatory Activities.
RESULTS: Complete information on safety were available in 2464 patients enrolled in the registry. In 1499 of them retrospective data encompassing the period from disease onset to enrolment were available, whereas 965 consecutive patients entered in the longitudinal part of the study. A total of 479 AEs have been reported in 275 patients. Eighty-two AEs were reported as serious and 99 were drug-related according to the physicians. Infections or infestations (94; 19.6%), gastrointestinal disorders (66; 13.8%), nervous system disorders (41; 8.6%) and systemic disorders or administration site reactions (35; 7.3%) were the most frequent reported events. The highest absolute number of drug-related AEs were related to biologic DMARDs (40/99 reports, 40,4%) and colchicine (31/99 reports, 31.3%).
CONCLUSIONS: Present study shows the importance of a longitudinal and homogeneous registration of the AEs in rare conditions, with a particular focus on the safety profile of the treatments used in these conditions.

Reporting and understanding patient safety incidents is a cornerstone of improving patient care quality and safety. The Accreditation Council for Graduate Medical Education specifically mandates that physician trainee education include participation in the recognition, reporting, and root cause analysis of patient safety incidents. Studies on safety event reporting, however, have consistently shown that attending physicians submit few safety reports, and trainees submit even fewer. We undertook a study to assess the rate at which pathology trainees report patient safety events relative to the rates at which trainees in other medical specialties do. We performed a retrospective analysis of 13,722 safety reports submitted to our medium-sized Academic Medical Center\'s incident reporting system. We then analyzed those reported by trainees (residents and fellows), and then further drilled down on the subset of trainee-reported safety events reported by pathology trainees. Despite accounting for over 5% of all types of trainees at the enterprise level, pathology trainees accounted for only 0.5% of all trainee safety reports. Our findings represent a call to action for pathology training programs to engage their residents and fellows in quality and safety initiatives, to understand and remove barriers to safety event reporting for vulnerable populations such as trainees, and to empower trainees to confidently report safety risks as valued frontline care providers.

Background Although safety and tolerability of vericiguat were established in the VICTORIA (Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction) trial in patients with heart failure with reduced ejection fraction, some subgroups may be more susceptible to symptomatic hypotension, such as older patients, those with lower baseline systolic blood pressure (SBP), or those concurrently taking angiotensin receptor neprilysin inhibitors. We described the SBP trajectories over time and compared the occurrence of symptomatic hypotension or syncope by treatment arm in potentially vulnerable subgroups in VICTORIA. We also evaluated the relation between the efficacy of vericiguat and baseline SBP. Methods and Results Among patients receiving at least 1 dose of the study drug (n=5034), potentially vulnerable subgroups were those >75 years old (n=1395), those with baseline SBP 100-110 mm Hg (n=1344), and those taking angiotensin receptor neprilysin inhibitors (n=730). SBP trajectory was plotted as mean change from baseline over time. The treatment effect on time to symptomatic hypotension or syncope was evaluated overall and by subgroup, and the primary efficacy composite outcome (heart failure hospitalization or cardiovascular death) across baseline SBP was examined using Cox proportional hazards models. SBP trajectories showed a small initial decline in SBP with vericiguat in those >75 years old (versus younger patients), as well as those receiving angiotensin receptor neprilysin inhibitors (versus none), with SBP returning to baseline thereafter. Patients with SBP <110 mm Hg at baseline showed a trend to increasing SBP over time, which was similar in both treatment arms. Safety event rates were generally low and similar between treatment arms within each subgroup. In Cox proportional hazards analysis, there were similar numbers of safety events with vericiguat versus placebo (adjusted hazard ratio [HR], 1.18; 95% CI, 0.99-1.39; P=0.059). No difference existed between treatment arms in landmark analysis beginning after the titration phase (ie, post 4 weeks) (adjusted HR, 1.14; 95% CI, 0.93-1.38; P=0.20). The benefit of vericiguat compared with placebo on the primary composite efficacy outcome was similar across the spectrum of baseline SBP (P for interaction=0.32). Conclusions These data demonstrate the safety of vericiguat in a broad population of patients with worsening heart failure with reduced ejection fraction, even among those predisposed to hypotension. Vericiguat\'s efficacy persisted regardless of baseline SBP. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02861534.

UNASSIGNED: To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.
UNASSIGNED: We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST).
UNASSIGNED: From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST.
UNASSIGNED: Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

Common cause analysis of hospital safety events that involve radiology can identify opportunities to improve quality of care and patient safety.
To study the most frequent system failures as well as key activities and processes identified in safety events in an academic children\'s hospital that underwent root cause analysis and in which radiology was determined to play a contributing role.
All safety events involving diagnostic or interventional radiology from April 2013 to November 2018, for which the hospital patient safety department conducted root cause analysis, were retrospectively analyzed. Pareto charts were constructed to identify the most frequent modalities, system failure modes, key processes and key activities.
In 19 safety events, 64 sequential interactions were attributed to the radiology department by the patient safety department. Five of these safety events were secondary to diagnostic errors. Interventional radiology, radiography and diagnostic fluoroscopy accounted for 89.5% of the modalities in these safety events. Culture and process accounted for 55% of the system failure modes. The three most common key processes involved in these sequential interactions were diagnostic (39.1%) and procedural services (25%), followed by coordinating care and services (18.8%). The two most common key activities were interpreting/analyzing (21.9%) and coordinating activities (15.6%).
Proposing and implementing solutions based on the analysis of a single safety event may not be a robust strategy for process improvement. Common cause analyses of safety events allow for a more robust understanding of system failures and have the potential to generate more specific process improvement strategies to prevent the reoccurrence of similar errors. Our analysis demonstrated that the most common system failure modes in safety events attributed to radiology were culture and process. However, the generalizability of these findings is limited given our small sample size. Aligning with other children\'s hospitals to use standard safety event terminology and shared databases will likely lead to greater clarity on radiology\'s direct and indirect contributions to patient harm.

Tramadol is a low-level opioid increasingly recommended to treat moderate-to-severe acute and chronic pain. Although characterized as having fewer opioid-related adverse events, the longer term safety of tramadol use among older adults has not been thoroughly documented. Thus, the primary objective was to examine the risk of safety events associated with chronic tramadol use compared to other chronic opioid use or no opioids among older adults with osteoarthritis. Safety events considered included: ≥3 emergency room (ER) visits, falls/hip fractures, cardiovascular (CVD) hospitalization, composite safety event hospitalization, and all-cause mortality. The study population included older adults ages ≥65 years diagnosed with osteoarthritis and classified into new or continuing tramadol use, new or continuing other opioid use, or nonuse. Inclusion criteria included: 6-month pre period and up to 33 months post period. Tramadol, other opioid, and no opioid users were 1:1 propensity-matched providing study populations of 25,899 within each category; 72% were new chronic opioid users. Multiple logistic regression or Cox proportional hazard ratios were used to document risk. Generally, tramadol users had fewer adverse event risks compared to other opioid users but higher risks than nonusers. New users of tramadol or other opioids had higher risks than continuing users. Tramadol use was associated with increased risk of multiple ER utilizations, falls/fractures, CVD hospitalizations, safety event hospitalizations, and mortality (new users only) compared to nonuse. Thus, although tramadol use may be appropriately recommended within a pain management strategy for older adults with osteoarthritis, careful monitoring for adverse safety events is warranted.

Background: Adverse safety events in healthcare are of great concern, and despite an increasing focus on the prevention of error and harm mitigation, the epidemiology of safety events remains incomplete. Methods: We performed an analysis of all reported safety events in an academic medical center using a voluntary incident reporting surveillance system for patient safety. Safety events were classified as: serious (reached the patient and resulted in moderate to severe harm or death); precursor (reached the patient and resulted in minimal or no detectable harm); and near miss (did not reach the patient). Results: During a three-year period, there were 31,817 events reported. Most of the safety events were precursor safety events (reached the patient and resulted in minimal harm or no detectable harm), corresponding to 77.3%. Near misses accounted for 10.8%, and unsafe conditions for 11.8%. The number of reported serious safety events was low, accounting for only 0.1% of all safety events. Conclusions: The reports analysis of these events should lead to a better understanding of risks in patient care and ways to mitigate it.

Acid suppression with histamine-2 receptor antagonists (H2RAs) or proton pump inhibitors (PPIs) is recommended for children with persistent gastroesophageal reflux disease symptoms. In this retrospective, observational postauthorization study, we aimed to assess and compare safety outcomes in pediatric first-time users of esomeprazole, other PPIs or H2RAs.
Data on children (aged 0-18 years) first dispensed esomeprazole, other PPIs or H2RAs between September 2008 and August 2011 was obtained from the Dutch PHARMO Database Network. Hospitalizations for seven predefined safety outcomes were evaluated (maximum follow-up: 18 months). Rate ratios were calculated using Poisson regression adjusted for baseline imbalances. Discharge letters were reviewed for event occurrence confirmation.
Of 23,470 included children, 2820 (median age: 3 years) were prescribed esomeprazole, 13,818 (median age: 15 years) other PPIs and 6832 (median age: 5 years) H2RAs. In total, 504 (2%) children were hospitalized for 762 predefined events: gastroenteritis (246); convulsion/seizure (200); pneumonia (154); failure to thrive (119); acute interstitial nephritis (19); thrombocytopenia (23); and angioneurotic edema (1). Significant differences between cohorts were observed only for failure to thrive, with adjusted rate ratios (95% confidence interval) for esomeprazole of 6.1 (2.4-15.7) vs. other PPIs and 6.1 (2.9-12.8) vs. H2RAs among current users. Occurrence was confirmed for 74% of assessable events. Confirmation rates were highest for pneumonia (81%) and lowest for failure to thrive (40%).
Hospitalization rates for predefined outcomes were low and mostly similar in pediatric first-time users of PPIs and of H2RAs.
NCT01338363.