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: OBJECTIVE: Examination of de-classified Monsanto documents from litigation in order to expose the impact of the company’s efforts to influence the reporting of scientific studies related to the safety of the herbicide, glyphosate. METHODS: A set of 141 recently de-classified documents, made public during the course of pending toxic tort litigation, In Re Roundup Products Liability Litigation were examined. RESULTS: The documents reveal Monsanto-sponsored ghostwriting of articles published in toxicology journals and the lay media, interference in the peer review process, behind-the-scenes influence on retraction and the creation of a so-called academic website as a…front for the defense of Monsanto products. CONCLUSION: The use of third-party academics in the corporate defense of glyhphosate reveals that this practice extends beyond the corruption of medicine and persists in spite of efforts to enforce transparency in industry manipulation.
Keywords: Carcinogenicity, conflicts of interest, ghostwriting, genotoxicity, glyphosate, herbicides, Intertek, key opinion leaders, Monsanto, non-Hodgkins lymphoma, third parties, Roundup
Abstract: BACKGROUND: An adverse event is defined as any unintentional harm that results in temporary or permanent disability and/or prolongation of hospitalization time, or death of a patient; as a consequence of health care provided by any staff member of the health institution. OBJECTIVES: The aim was to describe the adverse events that affect patient safety, reported in 2015 in a private hospital in the city of Córdoba, Argentina. METHODS: We analyzed 678 events reported through the computer system on the hospital’s intranet. RESULTS: The highest frequency of events reported corresponded to the nursing professionals…(40.7% ). Problems related to drug therapy process showed the highest frequency of reports (17.7% ), followed by communication failures (11.1% ) and patient’s fall (10.3% ). In the notification of the causes of the incident, 51.9% of “No answer” was observed. CONCLUSION: In the case of this hospital, this valuable tool is being underutilized. The reports should allow identifying the entire chain of events that lead to the incidents to address effective interventions in patient safety that involve all hospital staff, with greater emphasis on senior staff.
Abstract: BACKGROUND: Paying attention to the safety of hospitals, as the most crucial institute for providing medical and health services wherein a bundle of facilities, equipment, and human resource exist, is of significant importance. OBJECTIVE: The present research aims at developing a model for assessing hospitals’ safety based on principles of inherent safety design. METHODS: Face validity (30 experts), content validity (20 experts), construct validity (268 examples), convergent validity, and divergent validity have been employed to validate the prepared questionnaire; and the items analysis, the Cronbach’s alpha test, ICC test (to measure reliability of the test), composite…reliability coefficient have been used to measure primary reliability. The relationship between variables and factors has been confirmed at 0.05 significance level by conducting confirmatory factor analysis (CFA) and structural equations modeling (SEM) technique with the use of Smart-PLS. RESULTS: R-square and load factors values, which were higher than 0.67 and 0.300 respectively, indicated the strong fit. Moderation (0.970), simplification (0.959), substitution (0.943), and minimization (0.5008) have had the most weights in determining the inherent safety of hospital respectively. CONCLUSIONS: Moderation, simplification, and substitution, among the other dimensions, have more weight on the inherent safety, while minimization has the less weight, which could be due do its definition as to minimize the risk.
Abstract: OBJECTIVE: To determine multi-disciplinary perceptions of the clinical significance of medication errors (MEs), the responsible health professional(s), the contributing factors and potential preventive strategies. METHODS: The five simulated ME cases represented errors from five wards at a children’s hospital in Australia. Pre-determined answers for each case were developed through consensus among the researchers. The root cause analysis (RCA) was undertaken via a questionnaire disseminated to physicians, nurses and pharmacists at the study hospital to seek their opinions on the ME cases. Agreement model between the participants and pre-determined responses regarding the contributing factors was conducted using general estimating…equation (GEE) analysis. RESULTS: Of the 111 RCA questionnaires distributed, 25 were returned. The majority (93%) of respondents rated the significance of the MEs as either ‘moderate’ or ‘life-threatening’. Furthermore, they correctly identified two contributing factors relevant to all cases: dismissal of policies/procedures or guidelines (90%) and human resources issues (87%). GEE analysis revealed varied agreement patterns across the contributing factors. Suggested prevention strategies focused on policy and procedures, staffing and supervision, and communication. CONCLUSION: Simulated case studies had potential use to seek front-line healthcare professionals’ understanding of the clinical significance and contributing factors to MEs, along with preventive measures.
Keywords: Medication error, root cause analysis, paediatrics
Abstract: OBJECTIVE: To examine primary care patients’ knowledge and attitudes on off-label treatment. METHODS: In 47 primary care offices in Osijek-Baranja County, 1300 patients were given questionnaires about their knowledge and attitudes on off-label treatment. Questionnaires were completed voluntarily and anonymously. RESULTS: Majority of patients (96.3%) had no knowledge about off-label treatment, and upon having it explained, 42.3% would not accept such treatment under any circumstances, while 54.5% would never accept such treatment for their children. Patients place more trust in primary care doctors than in hospital doctors; 69.6% of patients strongly believe that primary care doctors…would not expose them to off-label treatment while only 41.2% of them think the same in relation to hospital doctors. In case of serious consequences following off-label therapy 49.9% of patients would sue doctors who prescribed it. CONCLUSION: Patients in primary care possess limited knowledge about off-label treatment. Most patients do not wish to be exposed to such treatment, and are particularly reluctant to have their children exposed to it. In case of serious side effects, half of the patients would sue doctors who had prescribed the off-label therapy.
Keywords: Off-label treatment, patients’ knowledge, patients’ attitude, primary care
Abstract: BACKGROUND: Antidepressant withdrawal symptoms are well-recognised, but their potential duration remains uncertain. OBJECTIVE: We aimed to describe the characteristics of withdrawal associated with two popular classes of antidepressants, including duration. METHODS: We analysed the content of a sample of posts on an antidepressant withdrawal website. We compared the characteristics of withdrawal associated with SSRIs and SNRIs, including time of onset, duration and nature of symptoms. RESULTS: 110 posts about SSRI withdrawal, and 63 concerning SNRI withdrawal, were analysed. The mean duration of withdrawal symptoms was significantly longer with SSRIs than SNRIs: 90.5 weeks (standard…deviation, SD, 150.0) and 50.8 weeks (SD 76.0) respectively; p = 0.043). Neurological symptoms, such as ‘brain zaps,’ were more common among SNRI users (p = 0.023). Psychosexual/genitourinary symptoms may be more common among SSRI users (p = 0.054). LIMITATIONS: The website aims to help people with antidepressant withdrawal, and is therefore likely to attract people who have difficulties. Length of prior use of antidepressants was long, with a mean of 252.2 weeks (SD 250.8). CONCLUSIONS: People accessing antidepressant withdrawal websites report experiencing protracted withdrawal symptoms. There are some differences in the characteristics of withdrawal associated with different classes of antidepressants.
Abstract: OBJECTIVE: To investigate clinical reports of post-SSRI sexual dysfunction (PSSD), post-finasteride syndrome (PFS) and enduring sexual dysfunction following isotretinoin. METHODS: Data from RxISK.org, a global adverse event reporting website, have been used to establish the clinical features, demographic details and clinical trajectories of syndromes of persistent sexual difficulties following three superficially different treatment modalities. RESULTS We report on 300 cases of enduring sexual dysfunction from 37 countries following 14 different drugs comprised of serotonin reuptake inhibiting antidepressants, 5α -reductase inhibitors and isotretinoin. While reports of certain issues were unique to the antidepressants, such as the onset…of premature ejaculation and persistent genital arousal disorder (PGAD), there was also a significant overlap in symptom profile between the drug groups, with common features including genital anaesthesia, pleasureless or weak orgasm, loss of libido and impotence. Secondary consequences included relationship breakdown and impaired quality of life. CONCLUSIONS These data point to a legacy syndrome or syndromes comprising a range of disturbances to sexual function. More detailed studies will require developments in coding systems that recognise the condition(s). Further exploration of these tardive sexual syndromes may yield greater understanding of tardive syndromes in general.