INTERNATIONAL JOURNAL OF RISK & SAFETY IN MEDICINE最新文献

Background: The ubiquity of social media has ushered in an era where uncontrolled content sharing extends to all subjects, including sensitive topics such as medication consumption.

Objective: To quantify the prevalence of YouTube videos providing information on glucocorticoids and to underscore the risks associated with inaccurate information, which might inadvertently promote inappropriate use of these medications.

Methods: The YouTube videos were selected using predefined keywords from February 20 to March 4, 2023. The videos were categorized into two groups. Category 1 promotes the misuse of corticosteroids, while Category 2 raises awareness about the risks associated with these drugs.

Results: In total, 843 YouTube videos were included. Approximately 76% of the creators were women. Of these, category 1 videos (69.63%) predominated over Category 2 videos (30.37%). Regarding Category 1, dexamethasone was mentioned in 41.53% of cases, followed by hydrocortisone (17.30%). According to these YouTubers, these products/medications are mainly obtained from community pharmacies (58.09%), online shops (20.01%), and through illicit markets and the black market (13.46%). Weight gain was the most common objective, according to 32.62% of the YouTubers.

Conclusion: This study highlights the prevalence of YouTube videos regarding the misuse of corticosteroids. The common focus on weight gain as an objective underscores the importance of educating content creators and viewers about responsible corticosteroid use. Targeted interventions are needed to promote safe and informed medication practices within this online environment.

Background: Recently, antivirals, including remdesivir, have been repurposed to treat COVID-19 infections. Initial concerns have been raised about the adverse renal and cardiac events associated with remdesivir.

Objective: This study aimed to analyse the adverse renal and cardiac events associated with remdesivir in patients with COVID-19 infections using the US FDA adverse event reporting system.

Method: A case/non-case method was used to determine adverse drug events associated with remdesivir as the primary suspect drug between January 1, 2020, and November 11, 2021, for patients with COVID-19 infections. Cases were reports for remdesivir with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'Renal and urinary disorders' or 'cardiac' disorders. To measure disproportionality in reporting of ADEs, frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, and EBGM > 1 for ADEs with ≥4 reports. Sensitivity analyses were undertaken by excluding reports for non-Covid indications and medications strongly associated with AKI and cardiac arrhythmias.

Results: In the main analysis for remdesivir use in patients with COVID-19 infections, we identified 315 adverse cardiac events comprising 31 different MeDRA PTs and 844 adverse renal events comprising 13 different MeDRA PTs. Regarding adverse renal events, disproportionality signals were noted for "renal failure" (ROR = 2.8 (2.03-3.86); EBGM = 1.92 (1.58-2.31), "acute kidney injury" (ROR = 16.11 (12.52-20.73); EBGM = 2.81 (2.57-3.07), "renal impairment" (ROR = 3.45 (2.68-4.45); EBGM = 2.02 (1.74-2.33). Regarding adverse cardiac events, strong disproportionality signals were noted for "electrocardiogram QT prolonged" (ROR = 6.45 (2.54-16.36); EBGM = 2.04 (1.65-2.51), "pulseless electrical activity" (ROR = 43.57 (13.64-139.20); EBGM = 2.44 (1.74-3.33), "sinus bradycardia" (ROR = 35.86 (11.16-115.26); EBGM = 2.82 (2.23-3.53), "ventricular tachycardia" (ROR = 8.73 (3.55-21.45); EBGM = 2.52 (1.89-3.31). The risk of AKI and cardiac arrythmias were confirmed by sensitivity analyses.

Conclusion: This hypothesis-generating study identified AKI and cardiac arrhythmias associated with remdesivir use in patients with COVID-19 infections. The relationship between AKI and cardiac arrhythmias should be further investigated using registries or large clinical data to assess the impact of age, genetics, comorbidity, and the severity of Covid infections as potential confounders.

Background: Antimuscarinics are the backbone of the pharmacological management of overactive bladder. Still, concerns have been raised over the nervous system (NS) adverse drug events (AEs) due to their dissimilarities to muscarinic receptor-subtype affinities.

Objective: This study aimed to identify the nervous system and gastrointestinal adverse drug events (ADEs) associated with solifenacin use in older adults (≥65 years).

Methods: A case/non-case analysis was performed on the reports submitted to the FDA Adverse Event Reporting System (FAERS) between 01/01/2004 and 30/06/2020. Cases were reports for solifenacin with ≥1 ADEs as preferred terms included in the Medical Dictionary of Regulatory Activities (MedDRA) system organ classes 'nervous system' or 'gastrointestinal' disorders. Non-cases were all other remaining reports for solifenacin. The case/non-cases was compared between solifenacin and other bladder antimuscarinics. Frequentist approaches, including the proportional reporting ratio (PRR) and reporting odds ratio (ROR), were used to measure disproportionality. The empirical Bayesian Geometric Mean (EBGM) score and information component (IC) value were calculated using a Bayesian approach. A signal was defined as the lower limit of 95% confidence intervals of ROR ≥ 2, PRR ≥ 2, IC > 0, EBGM > 1, for ADEs with ≥4 reports.

Results: 107 MedDRA preferred terms (PTs) comprising 970 ADE reports were retrieved for nervous system disorders associated with solifenacin. For gastrointestinal disorders, 129 MedDRA PTs comprising 1817 ADE reports were retrieved. Statistically significant results were found for 'altered state of consciousness': ROR = 9.71 (2.13-44.35), PRR = 9.69 (2.12-44.2) and IC = 1.29 (0.93-1.66).

Conclusions: The disproportionality reporting of 'altered state of consciousness', a previously unidentified ADE, was unexpected. Further monitoring of this ADE is needed to ensure patient safety, as this could be linked to poor balance and falls in older adults.

Background: Morbidity and Mortality meetings (M&Ms) are a fundamental element of surgical practice. However, there has been little investigation into best practices, to maximise education and improvement outcomes.

Objective: Create a new, evidence-based M&M methodology, that facilitates standardised analysis of errors in a non-judgemental fashion, and highlights areas for improvement.

Methods: A Quality Improvement (QI) methodology was used. This project encompassed a literature review and two sequential QI cycles. A literature review and initial survey highlighted best practice and identified areas for improvement. From this information, a new standardised format was created, which centred around a new modified Fishbone framework, incorporating the London Protocol methodology. The project then sequentially tested new formats, with feedback collected for every new format.

Results: The literature review and surveys guided improvement of the M&M. The need for standardisation was highlighted. The new PowerPoint template and modified Fishbone ensured presentations and analysis were consistent and systematic. Participants reported that M&Ms were more engaging, interactive and structured, ensuring improved discussion of errors. The modified Fishbone framework reinforced a blame-free, system-focused analysis.

Conclusion: M&Ms are a critical aspect of patient safety. This project utilised simple QI tools to encourage collaborative reflection, learning and improvement.

Background: Since randomized controlled trials have indicated that adjuvant chemotherapy prolongs survival and reduces recurrence rates after surgical resection of pancreatic adenocarcinoma, a gemcitabine based chemotherapy has become part of the interdisciplinary treatment concept for pancreatic cancer in accordance to current guidelines.

Objectives: The aim of this project was to analyse the validity of the CONKO-001 trial as a basis for the recommendation of adjuvant chemotherapy in many international guidelines.

Methods: We analysed the validity of the CONKO-001 trial regarding study design, recruitment period, participating institutions, patient selection, randomisation, stratification, standardization of surgical treatment and histological examination, statistical methods and interpretation of results. We additionally analysed the study regarding the risk of bias using the RoB 2 Tool. Finally we reviewed the influence of the pharmaceutical industry and potential conflicts of interest.

Results: We identified several shortcomings of the study concerning the study protocol, the participating clinics, the patient recruitment, the randomization pattern, the standardization of surgical treatment and histological examination, the statistical methods, the evaluation of the results and the influence of the pharmaceutical industry. According to the Cochrane RoB 2 Tool the study was judged to raise some concerns in three of the five risk domains for the outcome "overall survival".

Conclusions: Based on our review, the results of the CONKO-001-study should be revisited and critically reviewed. The recommendation to include adjuvant chemotherapy with gemcitabine deserves a critical appraisal.

Background: According to the World Health Organization (WHO), any woman in childbearing age who have decided not to take permanently an oral contraceptive but who are sexually active has the right to access emergency contraception (EC). Despite this, in many European countries there are no specific laws governing the criteria for access to emergency oral contraceptives (EOCs) for girls under 18, especially about the need for third party consent. This normative vacuum is dangerous as it risks creating confusion and entrusting the management of the fundamental right of self-determination to the discretion of others. Moreover, in European Union (EU) countries, there is an inequality in terms of access to contraceptive supplies, reimbursement criteria and the availability of information online.

Objective: Our article compares the criteria for access to EOCs (Ulipristal Acetate-UPA and Levonorgestrel-LNG) in the various EU countries to highlight possible disparities and consequent inequalities.

Methods: Government and ministerial websites, European agencies websites, and Contraceptive Use by Method 2019 (WHO) have been consulted.

Results: There are some differences between the various European countries that could configure inequality in EU countries.

Conclusions: It would be appropriate a definitive levelling of the legislation of the European Union on emergency contraception associated with massive information and awareness campaigns.

Background: The COVID-19 pandemic highlighted the need for a new dynamic in the organization and practices of health services, as it required rapid restructuring to promote safe and harm-free assistance.

Objective: To assess the dimensions of the patient safety culture (PSC) from the perspective of the health team professionals in clinical-surgical ICU (G1) compared to a COVID-19 ICU (G2).

Methods: Cross-sectional, analytical, descriptive and inferential study, using the "Hospital Survey on Patient Safety Culture" questionnaire.

Results: The domain "Supervisor/Manager Expectations and Actions Promoting Patient Safety (PS)" was a potential weakness for G1 (p = 0.003). G2 was most positive on improving PS, being informed about errors, considering PS as a top priority to management, and that the units work together to provide the best care (p > 0.05). G1 was most negative about the work culture with staff from other units, exchange of information across units, and shift changes (p > 0.05). The highest PS grade was related to greater communication, and a smaller frequency of events was reported only for G2 (p > 0.05).

Conclusion: There must be a balance in terms of attention focused on PS between different ICUs in times of crisis, especially regarding the supervisors/managers actions.

Background: Acinetobacter baumannii is a major cause of nosocomial infections and high mortality rates. Evaluation of risk factors for such resistant infections may aid surveillance and diagnostic initiatives, as well as, can be crucial in early and appropriate antibiotic therapy.

Objective: To identify the risk factors in patients with resistant A. baumannii infection with respect to controls.

Methods: Prospective or retrospective cohort and case-control studies reporting the risk factors for resistant A. baumannii infection were collected through two data sources, MEDLINE/PubMed and OVID/Embase. Studies published in the English language were included while animal studies were excluded. The Newcastle-Ottawa Scale was used to assess the quality of studies. The odds ratio of developing antibiotic resistance in patients with A. baumannii infection was pooled using a random-effect model.

Results: The results are based on 38 studies with 60878 participants (6394 cases and 54484 controls). A total of 28, 14, 25, and 11 risk factors were identified for multi-drug resistant (MDRAB), extensive-drug resistant (XDRAB), carbapenem-resistant (CRAB) and imipenem resistant A. baumannii infection (IRAB), respectively. In the MDRAB infection group, exposure to carbapenem (OR 5.51; 95% CI: 3.88-7.81) and tracheostomy (OR 5.01; 95% CI: 2.12-11.84) were identified with maximal pool odd's ratio. While previous use of amikacin (OR 4.94; 95% CI: 1.89-12.90) and exposure to carbapenem (OR 4.91; 95% CI: 2.65-9.10) were the foremost factors associated with developing CRAB infection. Further analysis revealed, mechanical ventilation (OR 7.21; 95% CI: 3.79-13.71) and ICU stay (OR 5.88; 95% CI: 3.27-10.57) as the most significant factors for XDRAB infection.

Conclusion: The exposure of carbapenem, amikacin (previous) and mechanical ventilation were the most significant risk factors for multidrug, extensive-drug, and carbapenem resistance in patients with A. baumannii infection respectively. These findings may guide to control and prevent resistant infections by identifying the patients at higher risk of developing resistance.

Background: As Twitter has gained significant popularity, tweets can serve as large pool of readily available data to estimate the adverse events (AEs) of medications.

Objective: This study evaluated whether tweets were an early indicator for potential safety warnings. Additionally, the trend of AEs posted on Twitter was compared with AEs from the Yellow Card system in the United Kingdom.

Methods: English Tweets for 35 drug-event pairs for the period 2017-2019, two years prior to the date of EMA Pharmacovigilance Risk Assessment Committee (PRAC) meeting, were collected. Both signal and non-signal AEs were manually identified and encoded using the MedDRA dictionary. AEs from Yellow Card were also gathered for the same period. Descriptive and inferential statistical analysis was conducted using Fisher's exact test to assess the distribution and proportion of AEs from the two data sources.

Results: Of the total 61,661 English tweets, 1,411 had negative or neutral sentiment and mention of at least one AE. Tweets for 15 out of the 35 drugs (42.9%) contained AEs associated with the signals. On pooling data from Twitter and Yellow Card, 24 out of 35 drug-event pairs (68.6%) were identified prior to the respective PRAC meetings. Both data sources showed similar distribution of AEs based on seriousness, however, the distribution based on labelling was divergent.

Conclusion: Twitter cannot be used in isolation for signal detection in current pharmacovigilance (PV) systems. However, it can be used in combination with traditional PV systems for early signal detection, as it can provide a holistic drug safety profile.