INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

BackgroundMedical errors are one of the most important factors affecting patient safety and the quality of health care services, and are affected by many factors.ObjectiveWe aimed to investigate the relationship between hospital and medical error types, seasonality, and work shifts with the severity of medical errors (no harm, near miss, and harmful incident) in Iran's hospitals.MethodsWe conducted a cross-sectional study in 39 hospitals in a province of Iran. Data were collected using voluntary reporting forms and analyzed using multiple logistic regressions.ResultsOf 10,384 medical errors, 68.4% were no harm. Medical error type and hospital type had a significant relationship with the severity of medical errors. In terms of seasonality, all types of medical errors were more frequently reported during fall and winter as follows: no harm medical errors (28.4% and 28.3%), near miss (28.9% and 28.2%), and harmful incidents (31.0% and 26.5%). The incidence of errors in public non-educational (OR = 0.22, 95% CI: 0.17-0.30, p<0.001) and public educational hospitals (OR = 0.27, 95% CI: 0.21-0.36, p<0.001) has been significantly less as compared to other types of hospitals.ConclusionPolicymakers should pay attention to hospital types and common medical error types when developing evidence-based interventions and policies to decrease the medical error severity in Iranian and similar countries' context hospitals.

BackgroundNational guidance attempts to prevent tubes remaining undetected and being used when misplaced in the respiratory tract. The 'elephant in the room' is that this guidance detects misplacement too late to prevent most pneumothoraces and pneumonias.ObjectiveReview risks of undetected and detected respiratory or oesophageal tube misplacements and how 'in-procedure' methods of determining tube position might reduce them.MethodsTube misplacement risk was compared for different methods of checking tube position. Data were obtained from UK NHS England (NHSE), a literature search between 1986 and 12/07/2024 using CINAHL, Embase, Medline and Emcare and from a local database.ResultsPost-procedure pH or X-ray checks on tube position have failed to prevent a rising incidence of undetected respiratory misplacements (NEVER events) (0.013%). Worse, current checks cannot prevent the 0.52% of placements that lead to in-procedure pneumothorax, constituting 97% of lung complications. In addition, pH may fail to prevent aspiration risk from oesophageal misplacement. Conversely, pneumothorax-risk would be reduced to 0.021% by using a supplementary mid-procedure CO₂ check or to 0.005% with expert guided tube placement (both p < 0.0001). Guided tube placement can additionally pre-empt oesophageal-related complications, but its safety is expert-dependent, with higher rates of undetected misplacement and pneumothorax in low-use Cortrak centres (0.10%) than expert centres (0%, p < 0.009).ConclusionThe high health burden from feeding tube-related complications could be almost eliminated if regulatory authorities recommended a mid-procedure CO₂ check for respiratory placement or expert guided tube placement, alongside mandates for the necessary training.

BackgroundCardiac damage is a significant risk of chemotherapy. Elevated circulating cardiac troponin I was suggested as a marker for early detection of cardiac damage.ObjectiveWe aim to assess the predictive value of cardiac troponin I for chemotherapy-induced cardiotoxicity in cancer patients.MethodsWe searched PubMed, Web of Science, Embase, and CNKI. Nine prospective studies involving 2033 cancer patients (pts) were included in the meta-analysis. Troponin I (TnI) levels in patients who underwent chemotherapy were categorized into cardiac troponin I (cTnI) positive and negative groups based on the cutoff concentrations described in the included studies. The cumulative effects of chemotherapy-induced cardiotoxicity between the cTnI-positive and cTnI-negative patients were represented as a summarized risk difference (RD) value with a 95% confidence interval. Subgroup analysis and sensitivity analysis were employed to address heterogeneities. Stata software (version 12.0) was utilized for the analysis.ResultscTnI-positive pts represented significant cardiotoxicity compared to cTnI-negative pts, as a decline in left ventricular ejection fraction (LVEF): RD = 0.279 [95% CI (0.248-0.311), p = 0.000, I² = 81.3%, 8 trials], heart failure (HF): RD = 0.117, [95% CI (0.090-0.144), p = 0.000, I² = 77.8%, 6 trials], arrhythmias: RD = 0.057 [95% CI (0.028-0.086), p = 0.000, I² = 0.0%, 3 trials], and cumulative events: RD = 0.318 [95% CI (0.272-0.364), p = 0.000, I² = 73.5%, 3 trials]. No statistically significant difference in cardiac death, acute pulmonary edema, and acute coronary syndromes between cTnI-positive pts and cTnI-negative pts was identified.ConclusionsAn increase in circulating troponin I serve as a potential biomarker that reflecting the high risk of early cardiotoxicity in cancer patients who have undergone chemotherapy. The presence of intrinsic unadjusted confounding factors in the reports suggests the need for further study to address this question.

BackgroundBurnout and medical errors are the most prevalent issues affecting health and life outcomes among healthcare professionals.ObjectiveThis study aimed to investigate the longitudinal association between burnout and medical errors in healthcare workers in Japan.MethodsWe conducted a prospective cohort study involving 539 healthcare workers from January 2017 to January 2018. Burnout was evaluated using the Maslach Burnout Inventory-General Survey (MBI-GS), which included exhaustion, cynicism, and professional efficacy dimensions. Medical errors during the previous year were measured by self-assessment at follow-up. Multivariate modified Poisson regressions estimated the association between baseline burnout and follow-up medical errors.ResultsIn the age and sex-adjusted model, overall burnout was significantly associated with medical errors (p = 0.008). Participants with high burnout levels exhibited a greater risk of medical errors than those with low or moderate levels (RR = 1.19, 95% CI: 1.05-1.35). Exhaustion and cynicism correlated significantly with medical errors (p < 0.05). High or moderate levels of exhaustion and cynicism were associated with elevated risks of medical errors (RR = 1.31 [95% CI: 1.10-1.55]; 1.25 [1.02-1.53]), (RR = 1.31 [95% CI: 1.13-1.53]; 1.20 [1.03-1.41]), compared to low-level counterparts, respectively.ConclusionHealthcare workers who experience burnout may be at an increased risk for medical errors.

BackgroundThe safety of medicines is a critical public health concern that requires continuous monitoring and evaluation throughout a drug's lifecycle, including post-authorization. Over the past decade, Portugal has undergone significant changes in its pharmaceutical sector, driven by regulatory actions from the National Authority of Medicines and Health Products (INFARMED, I.P.), which ensures the safety, effectiveness, and quality of medicines.ObjectiveThis study aimed to analyze the regulatory actions taken due to safety concerns in Portugal from 2013 to 2023.MethodsA retrospective analysis was conducted using safety alerts published by INFARMED, I.P. between January 2013 and December 2023. The analysis focused on changes in marketing status, drugs involved, causes of regulatory actions, and yearly patterns.ResultsDuring the study period, 602 safety and quality alerts were issued, being 41 from safety and 561 from quality. The highest number of regulatory actions occurred in 2018, with 172 cases (28.57%). Generic drugs accounted for the majority, with 432 cases (72.19%). Batch recalls (76.65%) corresponded to the main regulatory action related to quality. Quality alerts were often related to impurities or stability (65.42%), non-conformity with GMP standards (11.76%), and labeling or packaging problems (10.70%). Unfavorable risk-benefit ratios were the cause of 100% of safety-related alerts.ConclusionsThe findings highlight the importance of robust surveillance systems and continuous evaluation of manufacturing and regulatory processes to enhance drug safety. Collaboration between regulators, the pharmaceutical industry, and healthcare professionals is essential to ensure that the benefits of medicines consistently outweigh the risks associated with their use.

BackgroundOver the years, it has been observed that adverse drug reaction (ADR) is a major cause of mortality and morbidity and a major cause of concern for all healthcare professionals. ADR is a leading cause for hospitalisation and increases the financial burden of the patient. Thus, it is imperative that we need steps and strategies to decrease the burden of ADRs and effectively reduce the cost of therapy to treat ADR.ObjectiveThis study evaluated the pattern, severity, and preventability of ADRs in a tertiary care hospital.MethodsA retrospective observational study of all the ADR reports due to medications submitted to the ADR monitoring centre in a Northern Indian tertiary care hospital from October 2017 to December 2019. Causality assessment of the ADRs was done using the WHO-UMC causality assessment scale, and the severity was assessed using the modified Hartwig scale. Furthermore, the preventability of the ADR was assessed using the Schumock and Thornton scale.ResultsA total of 252 ADRs were reported. A maximum number of the ADRs (33%) were due to antimicrobials followed by analgesics (16%) and antihypertensives (10%). Amongst the analgesics, a majority of ADRs were associated with Diclofenac (16 ADRs). Amlodipine was associated with maximum ADRs (10) amongst the antihypertensives. The ADRs of gastrointestinal systems (34.5%) were most common among all system organ class (SOCs) followed by skin and subcutaneous tissue disorders (32%). Majority of ADRs were probable and mild in severity. According to the Schumock and Thornton preventability scale 69% were not preventable while 12% were definitely preventable.ConclusionsAntimicrobials were associated with majority of ADRs with gastrointestinal system being the most commonest organ involved. It was also observed that most of the ADRs were not preventable but some were definitely preventable. The awareness regarding preventability of ADRs needs to be emphasised and further studies to elaborate on the preventability of ADRs needs to be carried out.

Background: Haemophilus influenzae type b (HIB) is a gram-negative pathogenic bacterium that mostly impacts the pediatric and geriatric population, sometimes resulting in permanent sequelae or death.

Objective: In this study we set out to discover adverse outcomes from the thimerosal-free HibTITER^® vaccine derived from a Florida Medicaid dataset spanning from January 2003 to June 2007 (n = 277,484).

Methods: HIB vaccinated children were isolated from the Florida Medicaid dataset. Using other HIB vaccines as the control, we analyzed diagnoses for statistically significant adverse outcomes related to the HibTITER^® vaccine (only the strictest p-value of <0.0001 was used in analyzing this dataset). We simultaneously and independently examined the statistical significance of symptoms reported to VAERS related to HIB vaccines to corroborate our findings (p-value significance was reported at <0.05, <0.001, and <0.0001).

Results: The study revealed 19 individual ICD-9 codes positively associated (p-value<0.0001 post Bonferroni correction) with recipients of the HibTITER^® vaccine within 30-days of vaccination. Of these conditions, 14 have VAERS corroborators. The diseases span severity from mild to life-threatening and areas of respiration (e.g., asthma), gastrointestinal, otolaryngologic (e.g., common cold), dermatologic, generalized infections (e.g., tuberculosis), and other conditions.

Conclusion: Incidence of 19 different medical conditions was significantly higher compared to the control group who received other HIB vaccine formulations. These results were corroborated using the VAERS database, and have profound medical implications for the estimated 35 million Americans between the ages of 16 and 33 who received the vaccine.