International Journal of Risk & Safety in Medicine - Volume 34, issue 2

Article Type: Editorial

DOI: 10.3233/JRS-235000

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 81-85, 2023

Authors: Orogun, Lisajo | Chyou, Te-yuan | Nishtala, Prasad S.

Article Type: Research Article

Abstract: 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. Show more

Keywords: Antivirals, patient safety, pharmacovigilance, pharmacoepidemiology, elderly, Bayesian

DOI: 10.3233/JRS-220009

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 87-99, 2023

Authors: Alyahya, Mohammad S. | Momani, Salam | Alolayyan, Main Naser | Khader, Yousef S.

Article Type: Research Article

Abstract: BACKGROUND: Many healthcare organizations place a high value on quality of work-life (QoWL). The healthcare system’s long-term sustainability and capability to offer high-quality services to patients depend on improving QoWL for their healthcare workers. OBJECTIVE: The study aimed to explore the impact of Jordanian hospitals’ workplace policies and measures in three main domains: (I) Infection prevention and control (IPC) measures, (II) Supply of personal protective equipment (PPE), and (III) COVID-19 precautionary measures on the QoWL among healthcare workers during the COVID-19 pandemic. METHODS: A cross-sectional survey was conducted from May to June 2021 through an online self-reported …questionnaire (Google Form) targeting hospital healthcare professionals working at Jordanian hospitals (public, private, military, and university). The study used a valid work-related quality of life (WRQoL) scale to study the QoWL. RESULTS: A total of 484 HCWs in Jordanian hospitals participated in the study with a mean age of (34.8 ± 8.28 years). 57.6% of the respondents were females. 66.1% were married, with 61.6% having children at home. An average QoWL among healthcare workers in Jordanian hospitals during the pandemic was observed. The study results also showed a significant positive correlation between workplace policies (IPC measures, supply of PPE, and COVID-19 preventive measures) and the WRQoL among healthcare workers. CONCLUSION: Our findings highlighted the vital need for QoWL and psychological well-being support services for healthcare staff during pandemics. Improved IPC systems and other precautionary measures at the national and hospital management levels are required to help minimize the stress and fear that healthcare workers experience and lower the risk of COVID-19 and future pandemics. Show more

Keywords: Quality of work-life, COVID-19, coronavirus, pandemic, health policy, infection prevention and control, precautionary measures

DOI: 10.3233/JRS-220039

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 101-119, 2023

Authors: Healy, David | Germán Roux, Augusto | Dressen, Brianne

Article Type: Position Paper

Abstract: Best practice consent forms in company clinical trials detail the financial coverage for medical treatment of injuries. In trials undertaken for licensing purposes these arrangements can raise concerns. We detail three cases in which elements of the consent forms appear misleading and designed to elicit a consent to participation that might not be forthcoming if volunteers for these clinical trials were aware that what is outlined in principle is not likely to happen in practice. Beyond clinical trial participants, these consent forms have wider implications. Medical coverage of injuries sustained in a clinical trial is a nexus where business, scientific …and ethical considerations meet. It is not clear that anyone to date has grappled with the issues posed. This paper uses three clinical trials to illustrate the problems to be addressed. Show more

Keywords: Consent, injuries, cause and effect, licensing applications, medical treatment, COVID-19

DOI: 10.3233/JRS-220043

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 121-128, 2023

Authors: Bolcato, Vittorio | Tronconi, Livio Pietro | Odone, Anna | Blandi, Lorenzo

Article Type: Article Commentary

Abstract: In the context of the Sars-Cov-2 pandemic, according to the various periods of emergency and the rate of infections, hospitalized subjects also contracted the infection within the ward, sometimes with the development of disease (COVID-19) and sometimes with permanent damage. The authors wondered if Sars-Cov-2 infection should be considered on a par with other infections acquired in the healthcare setting. The non-diversified diffusion between the health and non-health sectors, the ubiquity of the virus and the high contagiousness, together with the factual inability to prevent it by the health structures, despite the adoption of entry control, practices of isolation of …positive subjects, and staff surveillance, lead to consider COVID-19 in a different way, in order to otherwise burden health structures in the face of unmanageable risks, clearly also dependent on exogenous and uncontrollable factors. The guarantee of care safety must, in the pandemic, be able to compare with the real capacity for intervention according to the asset of the current health service, requesting State intervention with alternative instruments, such as una tantum compensation, for COVID-19 damage reparation occurred in the health sector. Show more

Keywords: Sars-Cov-2 infection, COVID-19, hospital acquired infection, health professional liability, reparation

DOI: 10.3233/JRS-220062

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 129-134, 2023

Authors: Sridharan, Kannan | Shah, Shamik | Al Segai, Ola | Mansoor, Eman | Hammad, Mustafa | Farid, Eman

Article Type: Research Article

Abstract: BACKGROUND: Renal transplant patients receive several drugs concomitantly. OBJECTIVE: Limited literature exists evaluating the drug use in this population that is at high risk for drug-induced acute kidney injury and complications due to under-or over-dosage of immunosuppressant drugs due to drug–drug interactions. METHODS: A retrospective observational study was carried out in 269 renal transplant patients in whom either oral or parenteral drugs were evaluated. World Health Organization (WHO) indicators of drug utilization such as the average number of drugs prescribed, daily defined dose, and proportion of drugs listed as WHO essential drugs were evaluated. Details on …the drugs with nephrotoxic potential were obtained. Drug–drug interactions were assessed concerning the severity (major, moderate, and minor) as well as type (pharmacokinetic, pharmacodynamic, and toxicity). RESULTS: One-hundred and ninety-eight drugs were administered to the study participants. The median (range) total number of drugs received by the study participants was 23 (6–55). The proportion of drugs listed in the WHO essential drug database was 57.1 (16.7–100)%. Forty-six drugs with potential nephrotoxicity and seven drugs that were contra-indicated in patients with chronic renal disease/end-stage renal disease were administered to the study participants. The mean (SD) numbers of drug interactions observed amongst the study participants were 18.4 (10.1). Age (β: 0.2, 95% CI: 0.1, 0.3) and duration of renal transplantation (β: −0.3, 95% CI: −0.5, −0.1) were the significant predictors of drug burden. A total of 645 drug interactions were identified amongst the study participants (major – 240; moderate – 270; and minor – 135) of which the majority were pharmacokinetic followed by toxicity risk. Age was significantly associated with the risk of potential drug interaction (OR: 2.6, 95% CI: 1.8, 12.4; p = 0.001). CONCLUSION: Drug treatment in renal transplant patients poses a significant burden in terms of nephrotoxicity potential and drug–drug interactions. A dedicated ambulatory clinical pharmacy service monitoring the drug use coupled with drug deprescribing strategies are the need of the hour in this population. Show more

Keywords: Drug utilization study, immunosuppressants, organ transplantation

DOI: 10.3233/JRS-210072

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 135-143, 2023

Authors: Quiney, Gabriella | Colucci, Gianluca

Article Type: Research Article

Abstract: 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. Show more

Keywords: M&M, quality improvement, fishbone, healthcare

DOI: 10.3233/JRS-210077

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 145-154, 2023

Authors: Del Fabro, Giovanni | Mileto, Palmiro | Castelli, Francesco | Quiros-Roldan, Eugenia

Article Type: Case Report

Abstract: BACKGROUND: Two-drug regimens antiretroviral therapies are increasingly prescribed to HIV patients, as they are recommended by international guidelines, and they show an excellent efficacy, safety, and tolerability profile. Regimens administered as single tablets (STRs) are usually preferred by patients and they are associated with higher adherence. CASE REPORT: We report two cases of drug-induced hypersensitivity (DIH) that occurred after switching from dolutegravir (DTG) plus rilpivirine (RPV) in separate pills to a fixed dose combination containing the same molecules (DTG/RPV; Juluca® ). Following the DIH event, DTG/RPV coformulation was discontinued. At symptomatic resolution, they continued to receive DTG plus …RPV in separate pills uneventfully. The component present only in the DTG/RPV coformulation was iron oxide red (E172), contained in the film-coating. Iron oxide red is an approved colorant, used as drug excipient. Patch test with DTG/RV coformulation performed several months after the DIH event was negative. Drug allergy to excipients remains underappreciated and underreported and frequently leads to inappropriate medication discontinuation. CONCLUSION: Our case underscores the role of meticulous medication allergy history in differentiating true medication allergy from excipient allergy. This observation may be useful in the era of antiretroviral simplification to two-drug regimens. Show more

Keywords: Drug induced hypersensitivity, single tablet regimen, DTG/RPV, iron oxide red, excipient

DOI: 10.3233/JRS-220022

Citation: International Journal of Risk & Safety in Medicine, vol. 34, no. 2, pp. 155-159, 2023