International Journal of Risk & Safety in Medicine - Volume 3, 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: In 1991, Denmark established a Patient Insurance Scheme, the fourth Nordic country to do so. Under the various national Nordic schemes, patients can receive indemnification for the consequences of medical injury even where the injury is not caused by negligent treatment. Instead emphasis is laid on whether the injury, viewed in retrospect, could have been avoided or whether the injury, though unavoidable, clearly exceeds the risk that the patient must accept. Differences in the four national approaches are analyzed and it is concluded that a no-fault scheme presents an elegant alternative to the tort law system, which proves to be…particularly unsatisfactory in the field of medical accidents.
Keywords: Patient Insurance Act, Medical injury, Denmark, Scandinavia
Abstract: This study describes the use of the ovulation stimulating drugs clomifene, human chorionic gonadotropin (hCG) and human menopausal gonadotropin (hMG) in a representative sample of a population of Dutch women in the child-bearing age group. Clomifene or hMG/hCG are seldom used alone. A considerable percentage of the women received at least four different ovulation-inducing and related drugs during the observation period of two years. Thirty percent of the women who used clomifene were treated for 6 or more cycles. These findings argue for a relative “overuse” and “misuse” of clomifene. Buserelin, a drug not registered for the indication ovulation induction…in The Netherlands but used in in vitro fertilization (IVF) programs as inhibitors of pituitary gonadotropin production, was nevertheless prescribed to 38% of the hMG /hCG users and to 11 % of the clomifene users. Our study indicates that, though the potential risks of congenital malformations due to clomifene are difficult to assess, they may be considerable; this, and the fact that different ovulation-inducing drugs are used together with clomifene, emphasizes the need for post-marketing surveillance.
Keywords: Clomifene, Human chorionic gonadotropin (hCG), Human menopausal gonadotropin (hMG), Drug utilization, Pharmacy records