International Journal of Risk & Safety in Medicine - Volume 4, 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: In vitro there was no indication that either inorganic mercury (vapor or metallic) or hydrogen peroxide catalyzed a rapid formation of peroxides in a polyunsaturated fatty acid as linoleic acid. When mercury and hydrogen peroxide were combined in a solution of linoleic acid, a notable amount of peroxide was registered by thin layer chromatography. As hydrogen peroxide is an inevitable intermediate product of oxygen metabolism and also a component of the immunologic defense system, the interaction between mercury and hydrogen peroxide must be considered an important fact in knowledge of the mechanisms of mercury toxicity. When natrium selenite was added…to a linoleic acid containing mercury, an initial rise in peroxidation was observed. In a few days, however, the increase in peroxidation turned to a decrease. We consider dental amalgam as a source of mercury, and, therefore, toxicologically unsuitable as a tooth filling material.
Abstract: This article examines sources of information on drug use during pregnancy in the northeastern part of The Netherlands, comparing data from a congenital anomalies registry and figures obtained from community pharmacy records for a drug utilization study. Physicians and midwives report to the congenital anomalies registry on a voluntary basis. A limited quantity of exposure data is registered. According to the congenital anomalies registry, drug use during pregnancy is significantly less than it is according to the drug utilization study in the same area, suggesting that the former obtains incomplete data. For anomalies occurring spontaneously in a relatively high…frequency, any link between a small further increase in the frequency of these anomalies and the maternal use of certain drugs is likely to go undetected if one monitors only the frequency of these anomalies, the increase being rendered inconspicuous by spontaneous variations. Routine monitoring of drug use in association with congenital anomalies will be needed if such links are to be profiled. Preferably, a complete and correct registration of all drug use should be assured, from three months before conception to the time of delivery. Data retrieved from the records of community pharmacies on the use of prescription drugs, complemented by data on hospital drug use and information from the women themselves on their self-medication is likely to produce a relatively complete picture of drug utilization for the purpose of a register of congenital anomalies.
Keywords: Monitoring, Birth defects, Registries, Drug utilization, Pregnancy
Abstract: The reasons for differences in adverse reaction reporting rates between countries are partly methodological, partly due to the ways in which drugs are used and partly due to factors affecting the populations within countries such as disease prevalence, age distribution, genetic differences amongst others. Whilst these factors make international comparisons difficult to interpret, there can be some advantages in the global approach since some of the differences (e.g. a drug used in a special way for a disease seen only in some countries) may provide situations where early signals of drug problems are accentuated. Also the systems used to detect…ADR's in one country may have advantages over others though this has yet to be agreed. On the other hand methodological problems arising out of discrepancies in definitions and terminology can give rise to apparent differences between countries and should be obviated by international agreement. There is very little published information on international differences but a careful analysis of the data may give new insights into drug safety and lead to a general improvement in pharmacovigilance methodology.
Keywords: Adverse drug reactions, International comparisons, Monitoring
Abstract: We studied the relationship between (potentially harmful) medication use during pregnancy and maternal characteristics (alcohol drinking, smoking, occupation, age, native language, education level) in a population-based study of 2060 women, who were delivered of infants in the catchment areas of 21 participating Child Health Clinics in The Netherlands between 1988 to 1989. Of all women, 23% reported the use of at least one drug. We could not confirm the hypothesis that women who engage in “risk-taking” behaviour during pregnancy, such as drinking and smoking, use more drugs while pregnant. The only statistically significant relationship we found was that between potentially…harmful drug use and educational level of the women. Mothers with the lowest educational level consumed almost four times more of these drugs than mothers with the highest educational level. This finding suggests that women with a relatively low educational level may be less aware of the potentially harmful effects of medication use during pregnancy.
Abstract: Bioengineered human growth hormone (hGH) was released in the USA as an “orphan drug” intended for use in hypopituitary dwarfism. In fact it has been widely and increasingly used in healthy short-stature children and to improve performance in athletes. The National Institutes of Health also embarked upon controlled clinical trials with hGH in short-stature children and in children with Turner's syndrome, some of the latter received combined treatment with estrogen, others placebo. The situation has been challenged on the basis of the legal provisions applicable to “orphan drugs” but also in the light of the rules governing clinical trials. As…a result, the experiments are to be subjected to independent review.
Keywords: Human growth hormone, Treatment of healthy children, Athletes, Ethics of clinical trials