International Journal of Risk & Safety in Medicine - Volume 2, issue 6
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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: During the period 1968–88 a total of 27,938 reports on adverse drug reactions (ADR) were received through the voluntary reporting system in Denmark, of which 713 concerned fatal reactions. Excluding cases of overdosage, congenital malformations and unclassifiable reactions, 590 reports were selected for analysis. Of 215 drugs involved, 41% were marketed before 1968. When corrected for drug consumption figures no significant differences in incidence were found with age and gender. The most frequently reported drug groups were antirheumatics (92), cytostatics (54), antibiotics (53) and oral contraceptives (50). Over-the-counter drugs were involved in 13 reports. Fatal drug interactions were reported in…17 cases. In general the duration of treatment was longer in cases of fatal ADR than the average for ADR as a whole. The diagnoses most frequently reported were bone marrow depression (105), “sudden unexpected death” (57), anaphylactic shock (30) and malignant disease (23). The incidence of fatal thromboembolism involving oral contraceptives was halved following the withdrawal of high-estrogen preparations resulting in an incidence over the period 1983–88 of 1 per 141, 000 user years. The corresponding figure concerning non-steroidal antiinflammatory agents was 1 fatal ADR per 26,000 treatment years. Halothane-induced hepatic damage was reported in 33 cases during 1968–83, but only in 2 cases over the period 1983–88. The number of fatal ADR following use of inhaled adrenergic antiasthmatics was 19 during 1968–83, but 0 during 1983–88 despite a sale corresponding to 360,000 treatment years. Lactate acidosis following oral antidiabetics was reported in 18 cases during 1968–78, but only in 1 during 1978–88 following the withdrawal of phenformin. The annual number of reported fatal ADR remained fairly constant throughout the period despite the introduction of numerous potent drugs. Subject to reservations reflecting the shortcomings inherent in a retrospective analysis of data from a voluntary ADR reporting system, the risk of a fatal ADR is considered extremely low, being estimated at 6 per million inhabitants per year and 1 per 180,000 treatment years.
Keywords: Fatal adverse drug reactions, Voluntary reporting
Abstract: The risks of estrogens are a matter of concern both within the the medical community and in society at large. Estrogen products are a technology in manu medici. They have been prescribed and used in medical practice for over 180 bodily conditions. Experimentation with estrogens has from the 1930s been accompanied with warnings of the risks of cancer and other disease. Successively evidence of iatrogenic disease due to estrogens has accumulated but total consensus has not yet been reached. The social interaction over the risks of estrogens within the medical community as well as in society at large is described.…The societal evaluation of the risks of estrogens reveals that not only factual data but also values and culture influence the evaluation of medical technology.