International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press
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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: 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: Coronavirus disease 2019 (COVID-19) is a viral illness caused by severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2) presenting with pulmonary and extra-pulmonary manifestations. The first case was reported in Wuhan, China in December 2019 and has rapidly progressed to the form of a pandemic. The presentation is mild in about 80 percent of the cases, but the disease can also progress to a severe form of respiratory illness leading to acute respiratory distress syndrome (ARDS) and sometimes multi-organ failure, especially in people with other co-morbidities. Pregnant women also appear to be at a greater risk of acquiring a severe…infection due to physiological changes during pregnancy. Many drugs with in vitro activity against the virus or an immunomodulatory effect have been considered for repurposing or have been tried as off-label drugs. The safety data regarding the use of newly approved or off-label or investigational drugs in pregnant women is limited and this poses a great challenge for clinicians. It is thus important to know the utility and safety of the medications to avoid untoward adverse effects on pregnant women and fetuses. In this review, we aim to provide an overview of the approved, off-label, unlicensed, new and some promising medications for their use in the treatment of COVID-19 and the safety profile in pregnancy in an Indian scenario.
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: Ranitidine injection is not well-known to cause cardiac arrest except in few published case reports. The Eritrean Pharmacovigilance Centre received four cases of cardiac arrest associated with ranitidine injection. AIM: To assess the causal relationship between cardiac arrest and ranitidine, and to identify possible risk factors. METHODS: This is a descriptive case series assessment of cardiac arrest associated with ranitidine and data was mined to supplement the cases from the WHO global database of individual case safety reports. RESULTS: In all cases, ranitidine injection was administered fast IV bolus without proper dilution and…the outcome was fatal in three. All patients encountered cardiac arrest within 20 minutes of intravenous use. Causality was found to be probable in two cases and possible in the other two. Cardiac arrest could have been prevented in all cases. On top of this, from the WHO global database, 185 cases of cardiac arrest and cardio-pulmonary arrest associated with ranitidine were retrieved and 49.7% were fatal. In 40% of the cases, ranitidine was reported as a single suspect. In 36 cases, cardiac arrest resolved following withdrawal of ranitidine and reaction recurred in one case after re-introduction of the product. CONCLUSION: There appears a causal link between ranitidine and cardiac arrest, possibly related to medication errors that warrants immediate attention from healthcare professionals.
Keywords: Intravenous ranitidine, administration error, cardiac arrest, WHO global database, healthcare, risk factors
Abstract: BACKGROUND AND OBJECTIVE: Improving the safety of surgical care is an area of growing interest in Sierra Leona, a low resource setting where health outcomes remain poor. One tool shown to improve outcomes is the WHO Surgical Safety Checklist. We report an approach for optimising adherence in a public referral hospital in Freetown, Sierra Leone. METHODS: A multi-faceted series of interventions was proposed. Planning involved service evaluation, discussion with key stakeholders and formation of a working group to develop tailored interventions. Implementation involved reformatting the local checklist, formal classroom and simulation training and introduction of protocols and visual…aids. Analysis of impact was performed by prospective observation of safety processes both pre- and post-intervention. RESULTS: Following the intervention, there was a significant increase in the total number of intraoperative safety processes performed (38.1% pre vs 73.0% post, p < 0.001). A significant improvement was noted in the performance of airway evaluation, correct administration of antibiotics, marking of the surgical site and preoperative team briefing. CONCLUSION: This project describes a series of interventions taken to improve the performance of the WHO Surgical Safety Checklist in a low resource setting. We highlight the importance of local partnership working and stakeholder engagement in implementing successful change.
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: Selective reporting of trial results is common. OBJECTIVE: To study selective reporting in clinical study reports, company trial registers and publications of quality of life in placebo-controlled trials of antidepressants. METHODS: We compared clinical study reports of four antidepressants (fluoxetine, duloxetine, paroxetine and sertraline) obtained from two European drug regulators, data from online company registers, and publications received or retrieved from Eli Lilly and GlaxoSmithKline. Pfizer was also contacted but did not provide any publications. RESULTS: We included 15 trials (19,015 pages) and 4717 patients. Six trials had used SF-36, seven EQ-5D and…two both instruments. Nine of the 15 CSRs (60%) displayed selective reporting. In the companies’ online registers, there was selective reporting for all 15 trials (100%). We received 20 publications from Eli Lilly and retrieved six from the GlaxoSmithKline register. There was selective reporting in 24 of the 26 publications (92%). Despite extensive selective reporting, we found only small differences between placebo and active drugs. CONCLUSIONS: Access to the full raw data from clinical trials and to case report forms for all patients are needed to evaluate the effect of antidepressants on quality of life. Regulatory agencies should refuse to approve drugs or new indications based on incomplete reporting.
Keywords: Quality of life, SF-36, EQ-5D, clinical study reports, antidepressants, publication bias, selective reporting, placebo
Abstract: BACKGROUND: The prevention of nonsteroidal anti-inflammatory drugs (NSAIDs) adverse reactions should start from the primary health center (PHC), as the first gatekeeper in community health services. However, there is no specific module available for health care professionals (HCPs) in Indonesia for the prevention of adverse drug reactions (ADR) at PHCs. NSAID is commonly used for the elderly treated at PHC in Indonesia, even though the ADR risk is well-known. OBJECTIVE: We aimed to develop a module to be used in PHC for preventing NSAID-associated upper gastrointestinal (GI) ADRs in elderly patients treated for musculoskeletal diseases. METHODS:…The module was developed based on inputs from focus group discussions (FGD) among government health officers, PHC representatives, clinical pharmacologists, internal medicine and community medicine clinicians, pharmacovigilance experts, and professional organizations. A pilot implementation was conducted to test its feasibility and its effect on the HCPs’ knowledge. RESULTS: Capacity building of HCPs, development of intra-HCP cooperation, as well as standard operating procedure (SOP) for the prescription of NSAID constituted important components of the module. A pilot study of the module in two PHCs showed that it was applicable with some recommendations for improvement in duration, number of participants, room space, presentation, and use of credit points as compliments. The HCPs’ knowledge was improved after following the module. CONCLUSIONS: Our study showed that the module is feasible in PHC in Indonesia and useful in improving knowledge of HPC.
Keywords: NSAIDs, primary health center, health care professional, elderly, adverse drug reactions, Indonesia
Abstract: BACKGROUND: The vaccine/autism controversy has caused vast scientific and public confusion, and it has set back research and education into genuine vaccine-induced neurological disorders. The great strawman of autism has been so emphasized by the vaccine industry that it, and it alone, often appears in authoritative discussions of adverse effects of the MMR and other vaccines. By dismissing the chimerical vaccine/autism controversy, vaccine defenders often dismiss all genuinely neurological aftereffects of the MMR (measles, mumps, and rubella) and other vaccines, including well-documented events, such as relatively rare cases of encephalopathy and encephalitis. OBJECTIVE: This report explains that…autism is not a physical or neurological disorder. It is not caused by injury or disease of the brain. It is a developmental disorder that has no physical origins and no physical symptoms. It is extremely unlikely that vaccines are causing autism; but it is extremely likely that they are causing more neurological damage than currently appreciated, some of it resulting in psychosocial disabilities that can be confused with autism and other psychosocial disorders. This confusion between a developmental, psychosocial disorder and a physical neurological disease has played into the hands of interest groups who want to deny that vaccines have any neurological and associated neuropsychiatric effects. METHODS: A review of the scientific literature, textbooks, and related media commentary is integrated with basic clinical knowledge. RESULTS: This report shows how scientific sources have used the vaccine/autism controversy to avoid dealing with genuine neurological risks associated with vaccines and summarizes evidence that vaccines, including the MMR, can cause serious neurological disorders. Manufacturers have been allowed by the US Food and Drug Administration (FDA) to gain vaccine approval without placebo-controlled clinical trials. CONCLUSIONS: The misleading vaccine autism controversy must be set aside in favor of examining actual neurological harms associated with vaccines, including building on existing research that has been ignored. Manufacturers of vaccines must be required to conduct placebo-controlled clinical studies for existing vaccines and for government approval of new vaccines. Many probable or confirmed neurological adverse events occur within a few days or weeks after immunization and could be detected if the trials were sufficiently large. Contrary to current opinion, large, long-term placebo-controlled trials of existing and new vaccines would be relatively easy and safe to conduct.