International Journal of Risk & Safety in Medicine - Volume 32, issue 1
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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: 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 it 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. Therefore, it is 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 pharmacological options for their use in the treatment of COVID-19 and the safety profile in pregnancy in an Indian scenario.
Abstract: BACKGROUND: Paresthesia is defined as a burning or prickling sensation or partial numbness caused by neural injury. OBJECTIVE: The purpose of this paper is to present a rare and unusual case report of odontogenic infection-induced inferior alveolar nerve (IAN) paresthesia along with cutaneous draining sinus on the face of a pediatric patient and to discuss the possible pathophysiologic mechanism of nerve injury. METHODS: A 14-year-old female patient with cutaneous sinus and paresthesia associated with inferior alveolar nerve was enrolled in the study and the clinical and radiological manifestations of sinus lesion were carefully evaluated.…RESULTS: The most appropriate treatment was carried out not only to resolve extraoral sinus but also to ensure progressive healing for the complete resolution of neurological disturbance. CONCLUSION: The simultaneous occurrence of infection and paresthesia strongly suggested a definitive relationship. Therefore, there seems to be a correlation between duration, origin, significance of the injury and the prognosis of paresthesia.
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.
Abstract: BACKGROUND: Sleep health is a prerequisite for mental and physical health. The family affects the sleeping habits of the child. OBJECTIVE: The purpose of this study was to investigate the theory of mothers’ planned behavior in predicting sleeping habits of toddlers. METHODS: The participants of this descriptive-analytical study were 120 mothers of 12- to 36-month-old children living in Razan, Hamadan province, Iran. Data were collected in three stages in order to develop a theory-based tool. Semi-structured qualitative interviews with mothers were conducted to investigate the application of theory in predicting mothers’ intention and behavior (n…= 25). The face and content validity of the questionnaire was confirmed by a panel of experts. Test-retest method was used to determine the reliability of the questionnaire at 3 weeks interval (n = 25). Validity of Structural Convergence and Divergence with Factor Analysis, Internal Consent with Cronbach’s Alpha and predictive validity was determined by multiple regression coefficients (n = 120). RESULTS: The mean age of the children was 22.8 ± 7.5 months, 55% (66 children) were boys, the mean score of the children’s sleep questionnaire was 49 ± 6, and the children’s sleep duration was 9 ± 1 hour. Theoretical constructs have a positive and direct correlation with each other and with children’s sleep habits, which demonstrates the validity of the theory in predicting toddler sleep habits. Regression analysis showed that perceived behavioral control was the strongest predictor of sleeping habits of toddlers (𝛽 = 0.446) (P = 0.000). The theory of planned behavior can explain 30.5 to 25.7% of the variance of toddler sleep habits. CONCLUSION: While recommending more comprehensive studies, the findings of the study emphasize the application of the theory of planned behavior in identifying factors influencing sleep habits and designing child sleep improvement interventions.
Keywords: Theory of planned behavior, toddler, sleep habits, perceived behavioral control
Abstract: BACKGROUND: Receiving safe health care services is among the first rights of patients. Ethical predictability is influential to identify the patient safety concerns in hospitals. OBJECTIVE: This study aimed to ascertain and compare ethical predictability of patient safety in selected hospitals in Mazandaran Province in Iran. METHODS: A cross-sectional design was applied in the current study. By applying the multistage method for sampling, the statistical population consisted of clinical units of selected public, social security, and private hospitals. Out of the 18 public hospitals, five teaching hospitals, nine private and five social security hospitals, one hospital…was randomly selected in Mazandaran Province from each cluster. In total, 938 patients participated in the study. Data entry and analysis was carried out by SPSS version 22 software. RESULTS: The results showed that ethical predictability in social security hospitals was higher than the results in private and public hospitals (p < 0.001). In addition, among the selected dimensions of ethical predictability of patient safety in the selected hospitals, blood management was the highest dimension. Safe drug management, error management, infection control, and safe clinical services were the middle priorities and management and leadership of patient safety had the lowest mean in the ethical predictability of patient safety in the selected hospitals in the province. CONCLUSION: Identifying the factors causing ethical predictability in order to improve patient safety and service quality, is of great help to managers and authorities in the field of health services. Such awareness helps managers to consider these factors in all decision making processes.
Keywords: Ethical predictability, quality of care, patient safety
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