International Journal of Risk & Safety in Medicine - Volume 24, issue 4
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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 and objectives: Patient safety is a discipline that emphasizes the reporting, analysis and prevention of medical errors leading to adverse events. Many patients are harmed from health care, resulting in permanent injury, increased hospital stay or even death. This study attempts to gain knowledge on the practices and attitude existing for patient safety and indicate knowledge gaps, to help improve the situation. Methods: The study was carried out using an anonymous, self reporting questionnaire structured to analyse the scenario of patient safety in the hospital and the attitude of 100 Healthcare workers towards safety. Results: Of the subjects included…in the study, only 55% knew of the existence of an infection control policy in the institution. A large majority of respondents (94%) believed that reporting of errors will help in reducing their incidence. Top reasons for adverse events were high workload (82%) and incomplete information from patients (71%). Interpretation and conclusions: Patient safety is still in its infant stages in India, despite the emphasis by WHO. The problem areas, including high work load, lack of communication by supervisory staff and recording of ‘near-miss’ and adverse events with feedback, if addressed, would minimise harm to patients and cut costs.
Keywords: Patient safety, adverse events, hand hygiene, health care workers, infection control, near-miss events, patient feedback
Abstract: Background: The transfer of care from one provider to another is fraught with potential failures. Unfortunately the consequences of a poorly conducted patient handoff can be quite high. In the last five years there have been many descriptions of this problem as well as suggested solutions. Commonly authors have focused on utilization of a formatted tool for the off-going provider to help improve patient handoffs. While this is certainly a requirement for a high quality transfer of care, it is not the only needed component. Objectives: We seek to describe a novel approach to handoffs and focus on the early…findings from our pilot projects. Methods: The handoff typically involves two clinicians; an off-going or sending provider and an oncoming or receiving provider, there are therefore dual responsibilities in performing a high quality handoff. The off-going provider should structure their patient handoff in an easily assimilable format as earlier work has described. However a high quality handoff also needs to set the expectation that the oncoming provider must be certain that they have heard the relevant patient information. Therefore a tool to assist with this process is warranted. We describe our early experience of utilization of a structured handoff receiver tool. Results: Clinicians report higher quality handoffs as a result of the addition of the dual responsibility handoff. Use of the I-5 Tool improved transfer of care. Also early results suggest that there are failures in care that would have occurred without this intervention. Conclusions: Early results from pilot testing reveal after designing and testing the dual responsibility model that patient handoffs are increasingly successful and more reliable.
Abstract: Background: Prescribing errors are one of the most common adverse events in healthcare. Previous research in patient safety has highlighted the importance of error awareness education to enhance professional attitudes and reduce errors. Systems of contemporaneous prescribing feedback previous researched are limited by shift working. Objectives: We introduced a departmental prescribing feedback system to address this limitation. Methods: We used a Before and After study design. The setting was a single inpatient paediatric unit and 26 Paediatric medical staff participated. Baseline assessment of prescribing errors and safety attitudes took place, followed by 3 weekly reassessments over a 3 month period.…After each assessment, a feedback poster was displayed and emailed to staff, giving general and anonymous personalised feedback. Results: 205 medication orders representing 3,280 opportunities for error were examined. There was a statistically significant reduction in the error rate (P < 0.0001) between baseline (8.8%, 69 out of 784 possibilities for error) and completion at 3 months (1.8%, 12 out of 656 possibilities for error). There was an improvement in patient safety attitudes, but this was not statistically significant. Conclusions: This pilot project has demonstrated an error feedback system can reduce errors. This technique could be easily adopted and introduced, warranting further research.
Abstract: Background: Screening of the WHO global individual case safety report database (VigiBase) has recently identified case reports with HMG CoA reductase inhibitors and muscle symptoms co-reported with spinal stenosis. In some reports spinal stenosis appears to have been listed as a coincidental finding. Objective: To assess reports with sufficient information to ascertain if they suggested that there may have been diagnostic confusion between muscle symptoms attributable to HMG CoA reductase inhibitors with or without ezetimibe and symptoms of spinal stenosis. Method: Reports were examined for patient demographics, past history, clinical and investigational findings, co-prescribed medicines and outcomes. Results: Three case…histories recorded details suggestive of diagnostic confusion between severe and disabling muscle symptoms affecting the lower limbs attributable to an HMG CoA reductase inhibitor with and without ezetimbe and symptoms of neurogenic claudication due to spinal stenosis. The statins were not discontinued promptly leading to prolonged morbidity. Serum creatine kinase levels (CK) were normal in two patients and not recorded for the third. Conclusion: The reports include two safety issues, firstly the need to consider HMG CoA reductase inhibitors as a cause of severe lower limb muscle symptoms even in the presence of spinal stenosis and normal CK levels and the second, the need to measure serum creatine kinase when these symptoms occur to detect progression of myopathy and potentially serious outcomes.
Abstract: Background: The problem of ghostwriting in corporate-sponsored clinical trials is of concern to medicine, bioethics, and government agencies. We present a study of the ghostwritten archival report of an industry-sponsored trial comparing antidepressant treatments for bipolar depression: GlaxoSmithKline (GSK) paroxetine study 352. This analysis is based upon publicly available evidence presented in a complaint of research misconduct filed with the Office of Research Integrity of the Department of Health and Human Services. Objectives: We performed a deconstruction of the published study to show how primary and secondary outcome analyses were conflated, turning a ‘negative’ clinical trial into a ‘positive’ study…– with conclusions and recommendations that could adversely affect patient health. Methods: The paroxetine 352 study was a randomized, double-blind, placebo-controlled, 19-site trial comparing paroxetine and imipramine in 117 patients with bipolar type I major depressive episode which was unresponsive to prior lithium carbonate therapy. Results: Analysis of the primary outcome measures found no statistically significant difference between paroxetine or imipramine versus placebo. However, the published article concluded that both drugs were efficacious versus placebo for a post hoc subgroup of patients. Conclusions: Few industry-sponsored studies gain public scrutiny. It is important to make these articles transparent to the scientific and medical community.
Abstract: Background: Pharmaceutical companies fund the vast majority of the clinical research that is undertaken on medications but face a conflict of interest between producing good science and results that will enhance the sales of their products. Objectives: To document concrete examples of bias in clinical research induced by pharmaceutical industry sponsorship. Methods: This paper uses a thematic approach to documenting the extent of these biases in the following areas: research question/topic, choice of doses and comparator agents, control over trial design and changes in protocols, early termination of clinical trials, reporting to regulatory authorities, reinterpretation of data, restrictions on publication…rights, use of fake journals, journal supplements and symposia, ghostwriting, publication and reporting of results and outcomes. Results: Bias in favour of industry is apparent in every one of the themes examined with the result that research funded by industry undermines confidence in medical knowledge. Conclusions: Bias induced by commercial concerns can be countered in one of two ways. The first is to erect a firewall between the money and the people doing the research and the data analysis. The other approach is to develop an entirely separate funding source that is independent of the pharmaceutical industry.