INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: Since the mid-20th century, contrast agents have been widely used in radiology due to their ability to provide high-definition radiographic images and greater precision in diagnostic exams. Different types of contrast agents are used in image diagnosis, namely radiological media. Despite being considered safe, there are still uncertainties about their safety profile, interactions, and incidence of adverse drug reactions in real-world settings.

Objective: To characterise the pattern of adverse events, during 7 years, in a radiology unit.

Methods: We performed a retrospective observational and descriptive study at an Image Center in Portugal between August 2012 and October 2019. A total of 77,449 computed tomography (CT) were registered, and from those 15,640 cases of iopromide were used as a contrast agent. The authors have accessed, under the authorization, the data of adverse events and procedures after the event.

Results: Most of the hypersensitivity events were immediate or with a short time of onset, with the majority of cases developing events with skin involvement and mild degree, where the most common events were papules (n = 60), pruritus (n = 42), erythema (n = 27) and urticaria (n = 14). Severe events, including hypersensitivity, were mainly represented by vomiting (n = 11), stridor (n = 8), breathing difficulties (n = 7) and syncope (n = 3). Abdominal-pelvic CT exam presented a higher frequency of adverse events.

Conclusion: Despite all the current information about iopromide usage, the utilization of this agent is not abstent of risks and its safety profile not fully established. Most frequent symptoms were local, as skin adverse events, including papules, pruritus and erythema. Common medications used to treat or control adverse events were frequently hydrocortisone, clemastine and methylprednisolone.

Background: Depression drugs can be difficult to come off due to withdrawal symptoms. Gradual tapering with tapering support is needed to help patients withdraw safely.

Objective: To review the withdrawal success rates, using any intervention, and the effects on relapse/recurrence rates, symptom severity, quality of life, and withdrawal symptoms.

Methods: Systematic review based on PubMed and Embase searches (last search 4 October 2022) of randomised trials with one or more treatment arms aimed at helping patients withdraw from a depression drug, regardless of indication for treatment. We calculated the mean and median success rates and the risk difference of depressive relapse when discontinuing or continuing depression drugs.

Results: We included 13 studies (2085 participants). Three compared two withdrawal interventions and ten compared drug discontinuation vs. continuation. The success rates varied hugely between the trials (9% to 80%), with a weighted mean of 47% (95% confidence interval 38% to 57%) and a median of 50% (interquartile range 29% to 65%). A meta-regression showed that the length of taper was highly predictive for the risk of relapse (P = 0.00001). All the studies we reviewed confounded withdrawal symptoms with relapse; did not use hyperbolic tapering; withdrew the depression drug too fast; and stopped it entirely when receptor occupancy was still high.

Conclusion: The true proportion of patients on depression drugs who can stop safely without relapse is likely considerably higher than the 50% we found.

Background: Most research on the impact of medication reconciliation on patient safety focused on the retroactive model, with limited attention given to the proactive model.

Objective: This study was conducted to compare the proactive and retroactive models in patients hospitalized for acute decompensated heart failure.

Methods: This prospective, quasi-experimental study was conducted over six months, from June to November 2022, at the cardiology unit of an academic hospital in Iran. Eligible patients were those hospitalized for acute decompensated heart failure using a minimum of five regular medications before admission. Medication reconciliation was performed in 81 cases using the proactive model and in 81 using the retroactive model.

Results: 556 medications were reconciled using the retroactive model, and 581 were reconciled using the proactive model. In the retroactive cases, 341 discrepancies (both intentional and unintentional) were identified, compared to 231 in the proactive cases. The proportion of patients with at least one unintentional discrepancy was significantly lower in the proactive cases than in the retroactive cases (23.80% versus 74.03%). Moreover, the number of unintentional discrepancies was significantly lower in the proactive cases compared to the retroactive cases (22 out of 231 discrepancies versus 150 out of 341 discrepancies). In the retroactive cases, medication omission was the most frequent type of unintentional discrepancy (44.00). About, 42.70% of reconciliation errors detected in the retroactive cases were judged to have the potential to cause moderate to severe harm. While the average time spent obtaining medication history was similar in both models (00:27 [h: min] versus 00:30), the average time needed to complete the entire process was significantly shorter in the proactive model compared to the retroactive model (00:41 min versus 00:51).

Conclusion: This study highlighted that the proactive model is a timely and effective method of medication reconciliation, particularly in improving medication safety for high-risk patients.

Background: Angioneurotic edema is the most dangerous complication in angiotensin-converting enzyme inhibitors (ACEIs) therapy. Based on the current data, the clinical and genetic predictors of angioedema development are still understudied, which demonstrates the relevance of this study.

Objective: To reveal the pharmacogenetic predictors of the angioedema as a secondary side effect to enalapril in patients with essential arterial hypertension.

Methods: The study enrolled 111 subjects randomized into two groups: study group, patients with the angioedema as a secondary side effect to enalapril; and control group, patients without adverse drug reaction. All patients underwent pharmacogenetic testing.

Results: An association between the development of the angioneurotic edema and the genotypes AA rs2306283 of gene SLCO1B1, TT rs4459610 of gene ACE, and CC rs1799722 of gene BDKRB2 in patients was revealed.

Conclusion: The findings justify further investigations of the revealed genetic predictors of angioedema with larger-size patient populations.

Background: Delamanid (DLM) is a relatively new drug for drug-resistant tuberculosis (DR-TB) that has been used in Indonesia since 2019 despite its limited safety data. DLM is known to inhibit hERG potassium channel with the potential to cause QT prolongation which eventually leads to Torsades de pointes (TdP).

Objective: This study aims to analyse the changes of QTc interval in DR-TB patients on DLM regimen compared to shorter treatment regimens (STR).

Methods: A retrospective cohort was implemented on secondary data obtained from two participating hospitals. The QTc interval and the changes in QTc interval from baseline (ΔQTc) were assessed every 4 weeks for 24 weeks.

Results: The maximum increased of QTc interval and ΔQTc interval were smaller in the DLM group with mean difference of 18,6 (95%CI 0.3 to 37.5) and 31.6 milliseconds (95%CI 14.1 to 49.1) respectively. The proportion of QTc interval prolongation in DLM group were smaller than STR group (RR=0.62; 95%CI 0.42 to 0.93).

Conclusion: This study has shown that DLM regimens are less likely to increase QTc interval compared to STR. However, close monitoring of the risk of QT interval prolongation needs to be carried out upon the use of QT interval prolonging antituberculoid drugs.

Background: Organizational learning (OL) and interprofessional collaboration (IPC) are said to enhance medical safety in hospitals, but the relationship between these variables has not been quantitatively tested.

Objective: This study examines the mediating effects of IPC on the relationship between OL and safety climate (improvement, compliance, and patient/family involvement).

Methods: An anonymous self-reporting questionnaire was administered to 1,495 healthcare workers from November 2021 to January 2022. The questions regarded the hospital's safety climate, OL, and IPC. A mediation analysis using structural equation modeling was conducted to examine the mediating role of IPC on the relationship between OL and the three safety climates. The indirect effect was estimated using 2,000 bootstrap samples.

Results: Responses from 643 healthcare workers were analyzed. The direct effects of OL were 𝛽 = .74, 75 (p < .001) on improvement and involvement and 𝛽 = 0.1 (p > .05) on compliance. The indirect effects of IPC on improvement and involvement were 𝛽 = .14 (95%CI: .00 ∼ .06) and 𝛽 = .37 (95%CI: .04 ∼ .09), respectively.

Conclusion: This study determined the mechanisms that enhance a hospital's safety climate, demonstrating that IPC mediates the relationship between OL and improvement and patient/family involvement. However, OL and IPC are not related to compliance.

Background: Healthcare organizations are among high-risk organizations due to the nature of their work as well as structural, physical and technological complexities. Accordingly, it is important to use risk management and control programs in all departments of these organizations.

Objective: The present study was conducted for the first time to evaluate the risk management status of the operating room and laboratory departments of Hamadan hospitals in 2022.

Methods: In this descriptive-observational cross-sectional study, laboratory and operating room departments were selected as the research environment. To conduct this research, a valid and reliable questionnaire was used to collect data, and the data were analyzed using SPSS 22 statistical software.

Results: The findings of the present study showed that the overall mean score of risk management status for the laboratory and operating room departments was 2.66 ± 0.15 and 2.89 ± 0.13, respectively. Furthermore, there was no statistically significant difference in the mean scores of the research components based on work experience, education level, and gender.

Conclusion: It is suggested that the laboratory and operating room departments should focus more on adopting policies and solutions to improve the position of risk management, training and budget allocation for risk management.

Background: The self-controlled case series (SCCS) is often used to monitor vaccine safety. The evaluation of intussusception after the rotavirus vaccine is complicated because the baseline rate varies with age. Time-varying baseline risk adjustments with data from unexposed cohorts are utilised. Self-controlled risk interval (SCRI), with a shorter observation period, can also mitigate the problem by studying a control period close to the risk period.

Objective: An Indian rotavirus vaccine has previously been studied using SCCS. The risk of intussusception in the high-risk windows (21 days after vaccination) was comparable to the background risk. The aim was to re-analyse data of an existing SCCS study using alternate statistical methods to examine vaccine safety.

Methods: We examined the mean age of intussusception in the vaccinated and the unvaccinated. We performed an SCRI analysis of the surveillance data from the SCCS study, limiting the observation period to 180 days. We analysed the time-to-intussusception from the last vaccination. Finally, we performed an SCCS analysis, excluding unvaccinated cases from the analysis.

Results: We found that the mean age of intussusception was significantly lower in the vaccinated (205 days) compared to the unvaccinated (223 days) (p-value 0.0026). The Incident Risk Ratio (IRR) on SCRI analysis was 1.62 (95% CI 1.07-2.44). There were significantly more intussusceptions in the first 30 days after vaccination compared to the next 30-day window. (92 vs 63 p-value = 0.009). We found that excluding unvaccinated infants from the SCCS analysis demonstrated significantly increased risk for the risk period 1-21 days after the 3rd dose (IRR 2.47, 95% CI 1.70-3.59). The risks of intussusception were missed in traditional SCCS analysis using unvaccinated infants as controls.

Conclusion: Traditional risk adjustments using data from unexposed cohorts in SCCS may not be appropriate for investigating the risk of intussusception where vaccination lowers the mean age of intussusception.

Background: The global COVID-19 pandemic has forced people to obtain health products and services from home. Similar to other e-commerce, medicines are bought online and delivered using a courier service.

Objective: By being fully concerned to patient safety, this study aims to determine development strategies to increase intention in purchasing prescription drugs through e-pharmacy.

Methods: Two stages of measurement are employed in this study, namely confirmatory factor analyis using PLS-SEM and pairwise comparison using AHP method. To discover consumer perception in using e-pharmacy, the basic model of Theory of Planned Behavior (TPB) is employed with several extensions.

Results: The results of PLS-SEM express that Trust has a major role as an intervening variable to enhance the indirect effect of Subjective Norms and Perceived Values on Purchase Intention. In general, PLS-SEM structural model is declared "fit" (GFI = 0.93 ≥ 0.90; RMSEA = 0.045 ≤ 0.08; SRMR = 0.033 ≤ 0.05). Measurement model test proves that all selected indicators are valid to represent their related constructs (Loading Factor ≥ 0.50), and all selected constructs are reliable to build the whole path model (CR ≥ 0.7; AVE ≥ 05). Meanwhile, the results of AHP indicate that strengthening government policies and regulations is prioritized to increase consumer intention of purchasing prescription drugs through e-pharmacy, followed by protection of user confidential data in the second place. Those two eigenvectors are 0.236 and 0.185 respectively.

Conclusion: Future research is suggested to add perceived risk as latent variable in the study of consumer behavior for any high-risk products.