International Journal of Risk & Safety in Medicine - Volume 26, 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: BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different…reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24–26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance.
Abstract: BACKGROUND: The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain. OBJECTIVE: To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals. METHODS: Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM. A structured form was used to identify the harms information reported in the RCTs, following the recommendations of the CONSORT statement extension. RESULTS: The…most frequently met CONSORT recommendation was the mention of harms in the title or abstract of the paper (72.1% of the papers analysed); the least-met recommendation was the reporting of how the harms information was collected (10.7%). The studies that focused on harms presented better information on safety, but only 10.8% met all recommendations in the CONSORT statement. CONCLUSION: The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement.
Keywords: Adverse drug reactions, adverse events, drug safety, randomised clinical trials, CONSORT statement, quality
Abstract: BACKGROUND: Central Venous Catheterisation (CVC) has occasionally been associated with cases of retained guidewires in patients after surgery. In theory, this is a completely avoidable complication; however, as with any human procedure, operator error leading to guidewires being occasionally retained cannot be fully eliminated. OBJECTIVE: The work described here investigated the issue in an attempt to better understand it both from an operator and a systems perspective, and to ultimately recommend appropriate safe design solutions that reduce guidewire retention errors. METHODS: Nine distinct methods were used: observations of the procedure, a literature review, interviewing CVC end-users, task analysis construction, CVC…procedural audits, two human reliability assessments, usability heuristics and a comprehensive solution survey with CVC end-users. RESULTS: The three solutions that operators rated most highly, in terms of both practicality and effectiveness, were: making trainees better aware of the potential guidewire complications and strongly emphasising guidewire removal in CVC training, actively checking that the guidewire is present in the waste tray for disposal, and standardising purchase of central line sets so that differences that may affect chances of guidewire loss is minimised. CONCLUSIONS: Further work to eliminate/engineer out the possibility of guidewires being retained is proposed.
Keywords: Central venous catheterisation, guidewire, patient safety, human factors, safe design
Abstract: Over the past two decades Russia has gone through dramatic “democratic” changes resulting in unprecedented deterioration of health, loss of lives and extinction of population. The health system turned into a ridiculous monster of poorly organized business exploiting reminiscent social values of the past to build profits on selling sickness-for-all in consumer culture. We present facts and conclude that introduction of palivizumab into clinical practice for the most vulnerable patient category was done without confirmation of efficacy, without pharmacoeconomics evaluations, without any precautionary measures in a country with undeveloped pharmacovigilance system. The situation calls for immediate action of responsible authorities…and the society as a whole.
Abstract: AIMS: The Windscale (UK) fire of 1957 carried radioactive fallout according to the then prevailing wind patterns, in a North-Easterly direction across the Nordic countries, toward Norway. The male:female ratio at birth (M/F) is known to be increased after parental exposure to ionising radiation due to foetal losses that affect female more than male pregnancies. This study was carried out in order to ascertain whether the Windscale fire had any effects on M/F and birth rates in the United Kingdom and Scandinavia. METHODS: Annual live births by gender were obtained from a World Health Organization dataset. The null hypothesis was…that there were no significant changes in M/F or in births in temporal association with the 1957 Windscale event in abovementioned countries. RESULTS: There were no significant effects on the UK and most of Scandinavia but there was a significant rise in M/F for Norway and Finland with an aggregate deficit of around 4000 births in each country. CONCLUSIONS: A recent study suggests that the plume from the reactor extended further east than previously believed. This study confirms that contamination from the Windscale fire had a negligible impact on the UK (as measured by birth effects) but had a significant impact on births in Norway and Sweden.
Keywords: Great Britain/epidemiology, Scandinavia, sex Ratio, birth Rate/*trends, infant, newborn, radiation, Ionizing