International Journal of Risk & Safety in Medicine - Volume 19, issue 1-2
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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: Recent regulatory warnings about adverse behavioural effects of antidepressants in susceptible individuals have raised the profile of these issues with clinicians, patients, and the public. We review available clinical trial data on paroxetine and sertraline and pharmacovigilance studies of paroxetine and fluoxetine, and outline a series of medico-legal cases involving antidepressants and violence. Both clinical trial and pharmacovigilance data point to possible links between these drugs and violent behaviours. The legal cases outlined returned a variety of verdicts that may in part have stemmed from different judicial processes. Many jurisdictions appear not to have considered the possibility that a prescription…drug may induce violence. The association of antidepressant treatment with aggression and violence reported here calls for more clinical trial and epidemiological data to be made available and for good clinical descriptions of the adverse outcomes of treatment. Legal systems are likely to continue to be faced with cases of violence associated with the use of psychotropic drugs, and it may fall to the courts to demand access to currently unavailable data. The problem is international and calls for an international response.
Abstract: Following a summary of the American legal doctrine of informed consent and its ethical underpinnings and a description of the risk management reasons that health care providers should comply with the legal requirements associated with this doctrine, this article presents a preliminary argument for an additional incentive for such compliance. Specifically, this article enunciates the outline of a business case for informed consent in health care in the United States, urging by analogy to the widely advocated business case for quality and safety in health care that more conscientious adherence to the principles of informed consent will serve the self-interests…of health care providers trying to maintain financial viability within an increasingly competitive marketplace for patients.
Abstract: This article is dedicated to the Memory of Professor Nadine Lambert, October 21 1926 – April 26 2006. There is a paradox that the amphetamine class of drugs used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) are also abused widely in society. This article reviews possible legal issues related to the topic and the historical discourse concerning addiction associated with the use of amphetamines and methylphenidate for the treatment of ADHD, Lambert's theories and the research counterclaims that are used to support the pharmaceutical manufacturer's report that ‘adequate treatment of ADHD may reduce the risk of substance abuse’.…There are limitations in the Lambert studies and also limitations with other studies in the area. Further research and independent scientific and statistical analyses are required to determine any definitive conclusion. The author concludes that the claim and counterclaims cannot easily be resolved without a significant independent international inquiry.
Keywords: Attention Deficit Hyperactivity Disorder (ADHD), children rights, risks, amphetamines, methylphenidate hydrochloride, substance abuse, addiction, substance use disorder
Abstract: The impact of medical litigation and its controversial and damaging consequences are reviewed, along with a number of the proposals for tort and other reforms. As an important effect of the threat of litigation, the practice of defensive medicine is discussed. Proposals are made for improvements in the quality of doctor–patient relationships as a significant contribution to improved clinical care and reduction in the risk of doctors being sued.