International Journal of Risk & Safety in Medicine - Volume 32, issue 3
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: BACKGROUND: Real-world safety of bevacizumab in cancer patients is limited. OBJECTIVE: To review the adverse drug reactions (ADRs) due to bevacizumab in cancer patients, in published case reports. METHODS: PubMed was searched; case reports of patients with any type of cancer, administered with bevacizumab (monotherapy/combination) and reported ADRs were included. Causality of ADRs was presented as reported in individual papers. ADRs were classified using the information in the USFDA-approved prescribing information (PI) of bevacizumab as ‘Serious’, ‘Common’, and ‘Post-marketing surveillance’ ADRs; ADRs not mentioned in the bevacizumab PI were termed as ‘Non-label ADRs’. RESULTS:…A total of 130 published papers comprising 154 cases from 22 different countries were included. Most papers (102/130; 78.46%) had moderate methodological quality. Age range of patients was 9-77 years. Off-label use of bevacizumab was found in 34/154 cases (22.08%). Ninety-six unique ADRs were found among 154 ADRs; most reported ADRs affected circulatory, digestive, and respiratory systems (33, 32, and 26 cases respectively). Most commonly reported ADRs were posterior leukoencephalopathy, fistulae, and gastrointestinal perforation (17, 17, and 16 cases respectively). Twenty-eight unique non-label ADRs (29.17%) were found. CONCLUSION: Bevacizumab is associated with more ADRs in the real world among cancer patients than those reported during clinical trials.
Keywords: Bevacizumab, safety, cancer patients, off-label use, real world
Abstract: BACKGROUND: Neurosensory impairment is a common complication following inferior alveolar nerve (IAN) damage. OBJECTIVE: To document and report the various causes, diagnosis, and management of IAN damage secondary to orthodontic treatment. METHODS: An electronic search for studies that reported IAN damage in patients undergoing orthodontic treatment was performed up to July 15, 2020 using MEDLINE, Embase, and PubMed databases. Descriptive analyses and linear regression model were performed. RESULTS: A total of 15 case reports were identified including 16 patients with an overall mean age of 23.3. All the included studies reported temporary sensory alterations…which manifested as anesthesia (19%, n = 3), paresthesia (75%, n = 12), or combined (6%, n = 1). The majority of cases managed by stopping the orthodontic force (75%, n = 12), followed by appliance adjustments (19%, n = 3), providing a bite plate (13%, n = 2), and/or providing pharmacological management (38%, n = 6). Full recovery median duration reported in all cases following the aforementioned managements was 17.5 days. CONCLUSIONS: IAN damage secondary to orthodontic treatment is emerging in the literature in recent years. Identifying high risk patients with close proximity to the IAN canal is a must to formulate a proper treatment plan to avoid such complications.
Abstract: BACKGROUND: Nurses often face professional risks in their work. Most research in Russia dedicated to professional risks of nurses are quantitative studies and deal with a limited range of issues. There is an apparent lack of qualitative studies on this problem. OBJECTIVE: The aim of this research is to study opinions of oncology nurses concerning their working conditions from the point of view of their professional risks assessment and their minimization. METHOD: The research was conducted by an independent researcher using a method of semi-structured interview. The content-analysis with inductive approach was used for the data…analysis. RESULTS: According to the data analysis there was singled out five main topics, in particular, professional risks that are appreciated by nurses, assessment of professional risks as employment obstacles, permitted ways of psychoemotional risks mastering, permitted ways of physical exertion mastering, effective external mechanisms of risks mastering. In general, nurses do not consider their professional risks as employment obstacles. They lay special emphasis on psychosocial risks, which are the core of all other professional risks. CONCLUSION: This research shows the opinion of the nursing service heads of oncology departments about professional risks arising in the process of their staff performing the duties. The results of the research demonstrate that the main perceived dangers are psychosocial, biological and chemical risks specific to the work with oncology patients. Possible ways to reduce the impact of professional risks on nurses can be both external institutional mechanisms and internal personal resources. Determining the working conditions of oncological nurses allows to manage occupational risks, to form a valuable attitude to health, as well as to identify indicators that form a social perception of the profession. The study of the working conditions of oncological nurses allows to manage professional risks, form a value-based attitude to health, and also identify indicators that form a social idea of the profession.
Keywords: Nursing, oncology nurses, interview, professional risks
Abstract: BACKGROUND: In antidepressant trials for pediatric patients with depression or anxiety disorders, the risk of suicidal events and other severe psychiatric adverse events such as aggression and agitation is increased with antidepressants relative to placebo. OBJECTIVE: To examine whether largely mentally healthy adolescents treated for a non-psychiatric condition are also at increased risk of suicidality and other severe psychiatric disorders. METHODS: This is a re-analysis of a placebo-controlled duloxetine trial for juvenile fibromyalgia based on the main journal article and additional data published in the online supplementary material and on ClinicalTrials.gov. Both serious adverse events related…to psychiatric disorders and adverse events leading to treatment discontinuation were defined as severe treatment-emergent psychiatric adverse events. RESULTS: We found that a significant portion of adolescents had treatment-emergent suicidal ideation and behaviour as well as other severe psychiatric adverse events with duloxetine, but no such events were recorded on placebo. The incidence of severe treatment-emergent psychiatric adverse events was statistically significantly higher with duloxetine as compared to placebo. CONCLUSIONS: Antidepressants may put adolescents at risk of suicidality and other severe psychiatric disorders even when the treatment indication is not depression or anxiety.
Abstract: BACKGROUND: Inappropriate repeat testing is an objectively measurable type of health service overutilization which may harm patients. OBJECTIVE: To evaluate both the frequency and cost of inappropriate repeat testing in a tertiary hospital in terms of specialties. METHODS: This cross-sectional study was conducted in a tertiary hospital. Laboratory results of 26 tests ordered between 1 July 2014 and 30 June 2017 were evaluated retrospectively. Test that were repeated earlier than the minimum re-test interval were accepted as inappropriate repeat testing. After analyzing the descriptive statistics, the cluster analysis method was used to determine whether groups were…formed within specialties. RESULTS: Specialties form two clusters were found: the first cluster included specialties mostly from surgical science and the second cluster included specialties mostly from medical science. It was found that the cluster that includes mostly surgical specialties repeats laboratory tests at a higher rate but causes a waste of less resources, whereas the cluster that includes mostly medical specialties repeats laboratory tests at a lower rate but causes a waste of more resources due to a higher volume of test orders. CONCLUSION: Due to the high rates of inappropriate repeat testing, surgical specialties seem to be the first target of intervention strategies, but medical specialties, which account for a higher volume of inappropriate repeat testing and higher unnecessary cost, should be the primary target of intervention strategies.
Keywords: Patient safety, overutilization of health services, cost, tertiary care, medical specialties, inappropriate repeat testing
Abstract: BACKGROUND: Post-SSRI Sexual Dysfunction (PSSD) is characterized by sexual and emotional symptoms associated to the exposure to Selective Serotonin Reuptake Inhibitors (SSRI) or Serotonin Noradrenaline Reuptake Inhibitors (SNRI). OBJECTIVE: The present study provides a comprehensive picture on demographic and clinical characteristics associated to PSSD. METHODS: An online survey was run on subjects self-declaring as affected by PSSD. The survey collected socio-demographic and clinical data via questions created ad hoc and three standardized scales (Arizona Sexual Experiences Scale, Hospital Anxiety and Depression Scale, World Health Organization Wellbeing Index). RESULTS: A total of 135 subjects (115…males; mean age 31.9 ± 8.9 years) was analysed. The syndrome was more represented among young, heterosexual males after the exposure to SSRI/SNRI at relatively high doses. The major findings involved the temporal sequence of symptoms: 118 subjects had symptoms both during and after SSRI/SNRI administration, and 17 only after, thus deposing for a iatrogenic action of SSRI/SNRI. Different variables, represented by both emotional and sexual symptoms, accounted for the variability of the severity of the sexual dysfunction as well as of wellbeing. CONCLUSIONS: Based on the present results, PSSD is a complex iatrogenic syndrome in need of being further studied and understood.
Keywords: Sexual dysfunction, SSRI, PSSD, discontinuation, SNRI
Abstract: BACKGROUND: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. OBJECTIVE: To meet these and support AstraZeneca’s ambition to return to growth after years of patent expiry, we undertook a project to fundamentally revisit ways of working to create an organisation set up to provide strategic safety in support of drug project decision-making. METHOD: In this paper, we describe the challenges we faced, the project to deliver changes to respond to them, and the methodology used. The project had two main components: creating a new operating model and…simplifying the procedural framework. RESULTS: It was delivered in a focused effort by internal PS resources with cross-functional input. The framework simplification resulted in a 71% reduction in procedural documents and a survey of PS staff revealed an increase in satisfaction of 10%–20% across all scores. CONCLUSIONS: With >3 years of observation time, this project has provided AstraZeneca with a PS organisation able to provide strategic safety, supporting successful portfolio delivery, while ensuring patient safety and maintaining compliance with global pharmacovigilance regulations. It has driven efficiency and set the foundation for continued organisational evolution to meet future business needs in an everchanging environment.