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: The emerging COVID-19 pandemic poses a threat to the global health care system. Given the lack of antiviral therapies or vaccines for the disease, the antimalarial drug hydroxychloroquine (HCQ) obtained much attention as a treatment for COVID-19. However, there are limited and uncertain clinical data to support the beneficial effect of this drug in COVID-19 treatment. HCQ has several side effects and warnings, including blindness, heart failure, and renal toxicity, even with recommended doses. For severe cases of COVID-19 or in patients with preexisting conditions, administering such a drug could be fatal, particularly when taken at high doses or in…combination with other antibiotics. However, further well-designed studies that would address the optimal dose, duration of treatment, possible side effects, and long-term usage outcomes are needed to make the final decision. In this paper, we aim to discuss the risk of using HCQ in treating COVID-19 patients, including its possible side effects.
Abstract: BACKGROUND: Antidepressants are much used and have been tested for many conditions. OBJECTIVE: To investigate the type of diagnoses in placebo-controlled trials apart from depression and anxiety. METHODS: This was a systematic review. RESULTS: We downloaded 5471 records from PubMed and excluded 3017 that contained depression or anxiety . After exclusion of non-eligible studies, meta-analyses and reviews, and records that were unclear, 1273 records remained. We counted 214 unique diagnoses, of which the most common were abuse of drugs or substances (227), pain or neuropathy (170), obesity (125), other eating disorders (45), obsessive…compulsive disorder (66), sexual dysfunction (41), gastrointestinal disorders (40), menopausal symptoms/hot flashes (36), premenstrual dysphoric disorder (27), urinary incontinence (21), post-traumatic stress disorder (38), schizophrenia (31), dementia or cognition problems (25), insomnia (19), ADHD (17), autism spectrum disorders (14), and stroke or traumatic brain injury (15). CONCLUSIONS: Trials of antidepressants may be driven mainly by commercial interests, focusing on prevalent diseases and everyday problems. No one can live a full life without experiencing several of the problems for which these drugs were tested. Antidepressants, sometimes called happy pills, could be seen as the modern version of Aldous Huxley’s soma pill intended to keep everyone happy in the “Brave New World”.
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 having any cancer, administered with bevacizumab (monotherapy/ combination) and reporting 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 16cases 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; real world, cancer patients, off-label use
Abstract: Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the way in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.
Abstract: Medicines are an integral part of the health system and the accessibility hugely depends on affordability and availability of medicines. Oral health is an integral component of overall well-being but is ironically often one of the most neglected areas of healthcare. There is paucity of data on the pharmaceutical cost components of dental disease, so this study aims to address this lacuna on the pricing of medicines. This research study can be considered a partial economic evaluation that focuses on an estimation of costs associated with medicines used in treatment of selected oral diseases to suggest policy measures to reduce…out-of-pocket expenditure on medicines. Using cost analysis research design on Pharmatrac dataset and cross-comparing it with public procurement rates of Rajasthan Medical Services Corporation (RMSC) indicates pharmaceutical cost of treating caries and periodontitis is approximately three times higher if median retail prices are considered instead of RMSC public procurement costs. Medicine cost of treating a single episode of caries or periodontitis using RMSC medicine rates at all levels of care is approximately 1.9–2.5 times lower than retail prices of the same formulations. This strongly suggests that centralized public procurement of dental medicines with an efficient monitoring and control can reduce the out-of-pocket expenditure.
Abstract: Background: Disease-modifying therapies for multiple sclerosis have been developed tremendously over the last two decades. Objective: The aim of this study was to review the short-, medium-, and long-term safety of alemtuzumab in relapsing remitting multiple sclerosis (RRMS). Method: This retrospective observational study (2015–2019) included all patients with highly active or rapidly progressing and aggressive RRMS who were treated with alemtuzumab at the Cabueñes University Hospital. The short-, medium-, and long-term adverse effects were evaluated following the risk management program of the European Medicines Agency. Results: 39 patients were included, 23 of them received…at least two cycles of treatment. Most patients showed at least one adverse event. The following adverse reactions were reported: infusional reactions (17), urinary tract infections (six), thrombopenia (five), and thyroid dysfunction (six). Conclusion: In clinical practice alemtuzumab showed an acceptable safety profile in selected patients even if all of them suffered at least one adverse effect. Thorough and prolonged follow-up is required to further confirm the safety of this drug.
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 (TPB) is able to 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: The correct and safe use of electrosurgery requires medical specialists to be proficient. Minimum proficiency requirements and proficiency tests are a manner to structurally assure proficiency. The objective of this study is to explore attitudes and perceptions of medical specialists on proficiency, proficiency requirements and proficiency tests for the safe use of electrosurgery. METHODS: A qualitative study among medical specialists using semi-structured interviews. RESULTS: The participants recognized that the use of electrosurgery poses risks to the safety of patients and perioperative staff. According to some participants, increased awareness on the risks of electrosurgery is required.…Most medical specialists however thought that proficiency of users of electrosurgery is sufficiently assured. Medical specialists stated to support proficiency requirements when they are endorsed by their scientific association. Proficiency tests encountered much resistance. Medical specialists argued that electrosurgery should not be tested as a single device but should be embedded in a larger entity, for example in a broader course or proficiency test. CONCLUSIONS: When assuring proficiency of users of electrosurgery, the positive attitude towards proficiency requirements and the more negative attitude towards proficiency tests should be taken into account.
Keywords: Proficiency, competency, requirements, tests, medical specialists, electrosurgery