International Journal of Risk & Safety in Medicine - Volume 2, issue 4
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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: Five ways to compare drug companies' replies to enquiries about drugs are reviewed. Classification of improvements to marketing and justifications for claims of efficacy are the most useful measures. Between July 1989 and June 1990 eight transnational drug companies were asked to supply their best evidence to support their claims for nine products. There was no reply from two companies: Abbott and Takeda. Improvements in the marketing of five products were promised ranging from withdrawal of claims to withdrawal of the drug. Justifications for claims of efficacy ranged from endorsement by the company's own staff to use of a clinical…trial with severe methodological flaws. Possible reasons for pharmaceutical executives deciding not to answer questions about their products are discussed.
Abstract: Deciding whether a drug caused a particular unwanted event in a given patient, or at least what degree of probability attaches to the association, is a medically important issue. The elements in the case history which are most likely to determine the conclusion are well known and they are often employed instinctively by the experienced physician. It can be helpful to draw up a checklist of the factors to be borne in mind, and some workers have gone so far as to develop algorithms and apply mathematical principles to the issue Algorithms can be helpful in the individual patient but…they are probably more trouble than they are worth if used routinely.
Keywords: Drug adverse reaction, Causality, Algorithm
Abstract: In the hope of reducing the cardiovascular complications of severe hyperlipidaemia a series of lipid-lowering drugs have, in the course of the years, been developed and brought into use. The question of their efficacy/safety balance in long-term prophylaxis has remained an important one, repeatedly prompted by studies suggesting either that the benefit is limited or that there are risks in such prolonged treatment which cannot be detected during premarketing investigations. A long period may elapse before a clear picture emerges of the extent to which such drugs influence the atherosclerotic process or measures such as total mortality, carcinogenesis, mental function…or fertility, or if these drugs give rise to interactions. Repeated efforts will be needed to maintain a consensus on the state of knowledge and the information which should be provided to the public and medical media.
Abstract: Just as the treatment of hypertension and the avoidance of smoking have become recognized as meaningful approaches to the prevention of serious cardiovascular disorders, one can consider it necessary for the same reason to treat hypercholesterolaemia. Where diet alone proves insufficient or compliance is understandably poor there is a case for using lipid-lowering drugs. Various problems have arisen with earlier drugs of this type, and the newest generation of lipid-lowering drugs (the HMG-CoA) may usefully complement them. Because of the long-term use which is required, safety must be assessed over long periods, and this new class of agents may well…prove to be the most extensively studied of any class of hypolipidaemic agent, many tens of thousands of patients already being involved in safety studies. Up to the present there is very little evidence that these agents will produce serious adverse reactions.
Keywords: Lipid-lowering drug, Adverse reaction monitoring, Research
Abstract: Since 1970 the World Health Organization has maintained an international centre for the monitoring of adverse reactions to drugs, based on standardized methods and instruments and with input from a large group of participating countries. The method of spontaneous reporting by health professionals of suspected adverse effects, on which the WHO venture is based, is intended to accelerate the detection of side effects and to provide a constantly updated picture of their profile. Despite setbacks, it has moved steadily closer to the attainment of this ideal. Operation of such a system involves problems relating to confidentiality, the setting of priorities,…availability of background information and funding; if input from the medical profession is to be greater and of better quality, both undergraduate and post-graduate training will have to attune the doctor better to this task. A complementary responsibility clearly devolves on the pharmaceutical industry. At the national level there must be an efficient monitoring centre, capable of interfacing physicians on the one hand and with WHO on the other.
Abstract: Continuous registration of postoperative wound infections reduces the rate of infection per se at the same time as enabling special risk groups to be identified. By improving or changing hygiene and antibiotic routines, the rate of infection in these especially exposed groups can be reduced. Major postoperative infectious complications prolong postoperative hospital stay by 17 days on average. Reduction of the rate of infections would save hundreds of treatment days.