International Journal of Risk & Safety in Medicine - Volume 6, issue 3
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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: In the Netherlands, the incidence of fractured Björk-Shiley convexo-concave heart valves led to investigations regarding the extent, impact, and management possibilities of this public health problem. Apart from an epidemiological study, we performed a safety management study. This study led us to conclude that: (1) the Björk-Shiley convexo-concave heart valve is perceived as a safety risk by patients, doctors, and health care administrators alike; (2) doctors and health care administrators rely heavily on the technical information regarding artificial heart valves that is provided by the manufacturer; (3) the professionals best qualified to assess and control the risks of heart valve…replacement are cardiac surgeons. Based on these conclusions, this report provides recommendations regarding safety risk assessment and the participation of doctors in preimplantation and clinical research programmes in order to improve the safety of newly designed heart valves.
Abstract: In the direct technique described, a composite material acts both as cement and filling between a prefabricated prosthetic crown and the tooth. The fillings contain less composite, and thus fewer components which might cause allergic reactions, and they are aesthetically and mechanically satisfactory.
Keywords: Dental composite, Prefabricated tooth material
Abstract: The assessment of the teratogenic risk of many drugs is very difficult or impossible because data are not available, and documentation is insufficient or based on minimal human information. The present study summarizes the outcome of newborns of women who took drugs during pregnancy and/or lactation without receiving adequate counselling. All calls received by the Beilinson Teratology Information Service during the last three years (1991–1993) were analyzed regarding the adequacy of the risk assessment process. These findings were compared to those for two control groups: women exposed to drugs with no known teratogenic effect, and women not exposed to drugs…at all. We could not provide adequate counselling for 14 cases (in 1991), 17 (in 1992), and 14 (in 1993), or 6.6%, 4.8%, and 3%, respectively, of the total annual number of calls. The three groups studied proved to be similar in all maternal and neonatal characteristics, except for the number of abortions and prevalence of major congenital malformations which were higher in control group 1. The absence of data for a specific drug is disappointing and stressful for both the woman and her physician. The present small sample showed a good prognosis for the patients receiving inadequate counselling. These findings may provide some reassurance to the parents, but emphasize the need for caution and close monitoring of the fetus and newborn.
Keywords: Teratology, Teratogenic counselling, Teratology information service (TIS), Drugs in pregnancy and lactation
Abstract: The use of acupuncture is widespread. The procedure is often claimed to be totally, or at least reasonably, safe. The published evidence regarding its potential risks is reviewed. The repeated and/or inappropriate use of an acupuncture needle carries the risk of infections. Amongst others, AIDS and hepatitis have been transmitted. Acupuncture needles may also traumatise tissues and organs. Pneumothorax is the most frequent complication caused in this way. Finally, needles may break and fragments can be dislodged into distant organs. A serious and more general concern related to the safety of acupuncture is the competence of the therapist, whether or…not medically qualified. The “philosophy” of acupuncture is not in line with orthodox diagnostic skills; therefore acupuncturists can be dangerously unconcerned with diagnostic categories. Thus indirect risks might add significantly to the direct risks of acupuncture. It is concluded that the true risk of acupuncture cannot be estimated. Whatever its extent, it could and probably should be lowered by enforcing educational and clinical standards.