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: Environmental hazards in healthcare institutions affect the quality of patient care as well as personnel and patient safety. OBJECTIVE: The aim of this study was to develop and apply a semi-quantitative risk assessment method to calculate occupational health risk levels with regard to the sensitivities of healthcare institutions. METHODS: The present research was conducted in three phases. In phases 1 and 2, the model was developed using a review of different risk assessment methods, extracting expert opinions (N = 10) through semi-structured interviews, and using the fuzzy analytical hierarchy process (FAHP). In phase 3, in…order to validate the proposed method, one of the five public hospitals was randomly selected and a case study comprising 6 sections was performed. RESULTS: A total of 43 health risks were identified and evaluated using the present method, 41.86% of which were at very high levels, 16.27% at high levels, 30.23% at substantial ones, 9.3% at medium and 2.32% at low levels. The highest health risks were found in paraclinical and operating room wards. CONCLUSION: To overcome the shortcomings of the proposed health risk assessment methods, a semi-quantitative method was used in the present study to more accurately calculate the risk levels in the healthcare institutions and also calculate the risk level of each hospital unit. The proposed semi-quantitative method can be used as a tool for assessing occupational health risks as a key element of risk management. In addition, by focusing on an appropriate framework for occupational health risk assessment, specialists in the organization will be able to take significant and effective steps to implement an efficient risk management system.
Keywords: Healthcare institutions, risk assessment, semi-quantitative method, occupational health
Abstract: BACKGROUND: Off-label drug (OLD) use is common in neonates. There is a dearth of information associating the OLD use and the risk of medication errors in critically ill neonates. Hence, the present study was carried out. METHODS: Drug prescriptions in neonates admitted to the intensive care unit of a tertiary care hospital between September 2018 and June 2019 were evaluated. Details on their demographics, reason for admission in intensive care unit, drug-related information and serum creatinine were extracted. United States Food and Drug Administration approved drug labels were compared. World Health Organization (WHO) anatomy, therapeutic and chemical (ATC)…classification was used for drug categorization. We assessed the risk of medication errors using a validated tool, medication risk score (MERIS). RESULTS: One hundred and seventy-one neonates with 2394 prescriptions were included in this study. Seventy one percent of the neonates in the present study received at least one OLD/unlicensed prescription item. A trend in increased numbers of OLD/unlicensed drug use in more premature and lower birth weight neonates were observed. Medication risk score was significantly higher in neonates receiving OLD/unlicensed drugs compared to those with only labelled drugs. Very and extreme pre-term (along with very low and extremely low birth weight) neonates were at higher risk of medication errors compared to others. Presence of OLD/unlicensed prescribed items is associated with an increased risk of medication errors by an odds ratio of 20.4 compared to labelled drugs. CONCLUSION: Significant proportions of critically ill neonates received at least one OLD/unlicensed drug and such use was associated with potentially increased risk of medication errors.
Keywords: FDA, off-label drug, drug regulatory authority, labelled drug
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: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and…Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.
Keywords: SARS-CoV-2, healthcare risk, medicines, supply, European Union
Abstract: OBJECTIVE: In 2012, Patient Safety (PS) in AstraZeneca was facing a situation with multiple challenges, scientifically and structurally. 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.
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: 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.