International Journal of Risk & Safety in Medicine - Volume 1, issue 2
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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 prescription records of 1948 Dutch women who delivered a live-born infant during an 18 month period in 1987 and 1988 were set against the Australian classification of drugs with respect to the known or suspected risks in pregnancy. During pregnancy the use of drugs with proven or anticipated foetal toxicity proves to decrease, indicating that the medical profession is relatively well aware of these potential side effects. In the case of antibiotics the fall in the use of potentially toxic drugs is due to a shift to relatively less toxic drugs whereas the decreased use of analgesics and some…antirheumatic drugs is not accompanied by replacement by others. Prescriptions for hormonal contraceptives were sometimes actually filled in the first trimester of pregnancy, and the figures suggest that exposure to these products in early pregnancy may not be negligible. The present study shows that in spite of the generally favourable trends, 167.8 out of 1000 women received during the course of pregnancy one or more prescriptions from the higher risk categories (D, C or B3) in the Australian system. By combining such utilization studies with data from registries of birth defects one will be able to develop the fund of knowledge and to ensure that the classification of drugs with respect to their risks in pregnancy is as accurate as it can reasonably be.
Keywords: Drug utilization, Teratogenicity, Risk classification system, Pregnancy, Prenatal care
Abstract: The health professional caring for the unconscious patient is inclined to assume that it will be pointless to attempt to communicate with him or her. There are however valid reasons to talk to the unconscious individual. On the one hand it is a sign of respect and proper care and concern towards both the patient and the family. On the other hand evidence exists in various forms that speech can affect physiological function even in the unconscious and that in some instances there is even a potential for cortical response. Although one cannot know to what extent an unconscious patient…experiences the voice, it has been suggested that talking to the unconscious patient could favourably affect the recovery process.
Keywords: Patient care, Unconsciousness, Speech, Communication
Abstract: In much of the world, public health policy regarding medical devices and the need to ensure their safety is poorly defined and much less developed than that regarding pharmaceuticals. A small number of countries have now established systems to monitor risk and to ensure some form of assessment and approval of medical equipment, at least where an element of risk could be involved. In view of the very large number of medical devices and current evidence of their unwanted effects there is a reason for the extension of such monitoring and licensing systems, complemented by self-regulatory mechanisms. Measures are also…needed to ensure that when they enter the field devices are properly used and maintained. In various respects, the close analogy of pharmaceutical regulation can be applied.
Keywords: Medical device, Safety, Epidemiology of risk, Regulation, Pharmaceutical law
Abstract: Two patients developed superior vena cava syndrome following total parenteral nutrition through a central venous catheter. Infection may have contributed to the development of the thromboses. In one patient a “sleeve thrombus” probably fragmented when the catheter was withdrawn, leading to multiple pulmonary embolisms. The other patient had a mural thrombosis with complete occlusion of the superior vena cava. In view of the potentially high mortality of this serious complication, early diagnosis and treatment are essential.
Keywords: Total parenteral nutrition, Thrombosis, Superior vena cava syndrome
Abstract: Abdominal organ injuries caused by blunt trauma are notoriously difficult to diagnose and a vital operation may as a result be dangerously delayed. In a series of 331 patients admitted after blunt abdominal trauma, 426 abdominal organ injuries were registered. 152 of these patients had 199 abdominal organ injuries requiring surgical repair. In 31 of these patients (20%) with 44 organ injuries operation was delayed for more than 6 hours after admission, in most instances because the diagnosis had been missed. One of these patients died as a consequence. Hollow organ injuries were the most commonly missed. Peritoneal lavage, repeated…if necessary, and diagnostic imaging must be used as valuable tools in addition to repeated clinical evaluation, especially in comatose patients, in patients with multiple injuries, and in intoxicated patients.