International Journal of Risk & Safety in Medicine - Volume 11, 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: Electroconvulsive treatment (ECT) is increasingly used in North America and there are attempts to promote its further use world‐wide. However, most controlled studies of efficacy in depression indicate that the treatment is no better than placebo with no positive effect on the rate of suicide. ECT is closed‐head electrical injury, typically producing a delirium with global mental dysfunction (an acute organic brain syndrome). Significant irreversible effects from ECT are demonstrated by many studies, including: (1) Inventories of autobiographic and current events memories before and after ECT; (2) Retrospective subjective observations on memory; (3) Autopsy studies of animals and some…of humans. ECT causes severe and irreversible brain neuropathology, including cell death. It can wipe out vast amounts of retrograde memory while producing permanent cognitive dysfunction. Contemporary ECT is more dangerous since the current doses are larger than those employed in earlier clinical and research studies. Elderly women, an especially vulnerable group, are becoming the most common target of ECT. Because of the lopsided risk/benefit ratio, because it is fundamentally traumatic in nature, because so many of the patients are vulnerable and unable to protect themselves, and because advocates of ECT fail to provide informed consent to patients – ECT should be banned.
Abstract: A total of 437 patients with 463 cervical hip fractures were analyzed to determine whether perioperative urinary tract infection was related to postoperative wound and deep infection. Approximately 27% had a urinary tract infection and 6% had a wound or deep infection (following either the primary operation or an eventual reoperation) but only in two cases was the same organisms (E. coli) cultured from the urine and the wound infection. Bacteriuria should not be considered a cause for postponement of surgical treatment of a fracture of the neck of the femur.
Abstract: The purpose of the present study was to examine the rate of pharmacist counseling of women who use drugs during pregnancy and/or breast feeding. The data were collected by personal interview (taken by a physician specially trained in teratology) with 204 mothers at discharge from the maternity ward (2–3 days after delivery) and by telephone or personal visit with 66 hospital and private pharmacists. Of the 204 women questioned, only 18 (8.8%) were counseled by the pharmacist and always at their initiative and 16 women (7.8%) had read the information leaflet accompanying the drug. Six (9%) of the pharmacists interviewed…provided information to the pregnant or breast feeding women. Therefore, very few pharmacists counsel their pregnant and breast feeding patients. Pharmacists must be made aware of the active nature of their duty to provide appropriate drug information to this group of patients. Strategies are needed to increase pharmacists’ compliance in this area.
Keywords: Pharmacist counseling, drugs in pregnancy and breast feeding
Abstract: The outcome of the drug approval process plays a major role in determining how drugs will be prescribed in Canada. The objective of this paper is to examine the nature of the regulatory approval process, its decisions, how these are expressed in pharmaceutical promotion and the ultimate impact of these factors on the prescribing of psychotropic drugs in general and particularly with regard to the benzodiazepines. There is strong circumstantial evidence that the benzodiazepines were approved on the basis of inadequate clinical trials resulting in these drugs being indicated for conditions for which they were not useful and significant safety…issues being ignored. These deficiencies in the regulatory process were magnified in the advertising of these products to physicians thus contributing to inappropriate prescribing in four areas: prescribing for psychosocial problems, overprescribing for somatic complaints, overprescribing to women and overprescribing for anxiety disorders. Problems in the approval process continue to exist and these will manifest themselves in ongoing inappropriate prescribing of psychotropic and other medications.
Abstract: There is little knowledge as to tolerance of and compliance with traditional Chinese drug treatment among Western patients. We surveyed 168 consecutive in‐patients of a hospital for traditional Chinese medicine in Germany to collect data on these issues. Of the 145 patients responding (86.3% response rate) 77 (53.1%) reported having experienced at least one side effect (mainly gastrointestinal symptoms and temporary deterioration of symptoms) attributable to traditional Chinese drug treatment. 86 (59.5%) and 66 patients (45.5%), respectively, did not like the taste and the smell of the preparations, but only 7 reported deviations from the prescribed schedule. Not one patient…considered that he would be unwilling to continue medication if prescribed. The results of this survey indicate that an appreciable proportion of Western patients experience gastrointestinal side effects from traditional Chinese drug treatment. Due to the highly selected patient sample (all patients had opted for treatment in this hospital specializing in traditional Chinese medicine) the results relating to compliance have to be interpreted cautiously. Given its popularity and increasing use, further research on safety of and compliance with traditional Chinese drug treatment is clearly warranted.
Keywords: Traditional Chinese medicine, herbal remedies, traditional drug treatment, safety, compliance, survey
Abstract: A characteristic historical example of defensive medicine is referred to and analysed. The case relates to Alexander the Great’s almost fatal disease which he suffered during his campaign in Asia. Physicians were afraid to undertake the treatment of the Emperor because of the severity of the disease and the uncertain outcome which could draw upon them the anger of Macedonians and could result in their punishment. Furthermore, their fears were increased because the king of Persia, Darius, declared a reward for the murder of Alexander. In addition the Emperor himself was known for his strictness – at a later stage…he indeed crucified or hanged the physician of his close friend Hephaestion because he had failed in the treatment of the latter. Finally Philip, a physician who was a friend of the family of Alexander, undertook his treatment and cured him, after the persistent requests of the Emperor and his openly‐declared trust in his person.