International Journal of Risk & Safety in Medicine - Volume 12, issue 3-4
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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: Oral anticoagulation requires INR and dosage control. The availability of a portable device, called the CoaguChek® system, allows patient self‐monitoring. In this study, this self‐monitoring system is described. Then a risk analysis by means of Failure Mode & Effect Analysis and Fault Tree Analysis was applied. This systemic risk analysis revealed system weaknesses with respect to education, compliance, and technical reliability. This type of risk analysis used by the prescribing physicians can assist in recognizing increased risks of failure in the individual case as well as in analysing adverse events.
Abstract: There is a controversy about whether or not ECT is a “beneficial” treatment. Critics have emphasised the major side effects, such as disturbed memory, impaired comprehension, automatic movements, dazed facial expressions, motor restlessness, confusion, dizziness, nausea, vomiting and headaches. Supporters have argued it is a safe, reliable, effective procedure. Testimonies of eighteen ECT survivors were subjected to document analysis and content analysis, to determine the main themes/effects ECT had on recipients. The main themes identified were: fear, physical symptoms after ECT, consent, memory loss, attitudes towards ECT, degradation/dehumanisation, control, information about treatment. These data suggest that ECT is not…a form of healing, but instead the cause of more damage. Alternatives to ECT should be used more frequently, as ECT removes feelings of control. Human rights are often ignored. ECT is invasive and destructive and should be prohibited.
Abstract: To determine the long‐term (3 years) response to hepatitis B vaccine, 246 full‐term healthy children, aged 10–44 months, who had been given three doses of Engerix B vaccine were studied. Children were divided into three groups by age at the time of the study: group I, 10–19 months (mean, 13.6 months) (n = 117) ; group II, 20–29 months (mean, 24.7 months) (n = 63) , and group III, 30–44 months (mean, 37.7 months) (n = 62) . The groups were compared for seroprotection rate by measuring the anti‐HBs titers (Abbott Axsym System). Anti‐HBs levels above the…presumed protection limit were found in 96.6% of group I, 95.2% of group II and 83.8% of group III. The respective geometric mean titers (GMT) were 429.6, 185.7 and 186.5 mIU/ml. There was a significant difference in seroprotection between group I and II (p = 0.0001) , group I and III (p < 0.0001) , and group I and groups II and III combined (p < 0.0001) . The specific response to the recombinant hepatitis B vaccine in this specific infant population was characterized by high immunogenicity with rates of nonresponse of 3.4–4.8% but with an early decline in antibody titer after 2 years of age. At a mean age of 35 months, 16.2% of the children had antibody levels below the presumed protection limit.
Keywords: Hepatitis B vaccine, immune response, antibodies persistence