International Journal of Risk & Safety in Medicine - Volume 28, 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: BACKGROUND: Non-steroidal anti-inflammatory drugs are considered potentially harmful for patients with heart failure. OBJECTIVE: To determine the prevalence of in-hospital NSAID use, their type, associated diagnosis and impact in clinical outcomes among patients with a diagnosis of heart failure. METHODS: The University Health System Consortium Database was used to identify all first hospitalizations with an International Classification of Diseases-9 discharge diagnosis code of systolic heart failure as the primary diagnosis between January 1, 2011, and December 31st 2014. RESULTS: Among 65,902 patients admitted for a primary diagnosis of SHF, 2675 (4.1%) were exposed…to NSAID. The most frequent NSAID used was ibuprofen (51.63%), followed by ketorolac (29.38%) naproxen (8.07%) celecoxib (5.61%), and others. On multivariable analyses, the length of stay of patients exposed to NSAID was longer compared to non-exposed (OR: 4.67, p < 0.001, 95% CI 4.10–5.25), but differences in mortality were not statistically different (OR: 0.90, p = 0.476, 95% CI 0.69–1.19). CONCLUSION: The use of NSAID in patients admitted with a primary diagnosis of systolic heart failure was low but was associated with longer length of stay. Further studies are needed to understand the impact of NSAID use in this patient population.
Keywords: Heart failure, non-steroidal anti-inflammatory agents, length of stay
Abstract: An association between non-opioid analgesic agents and chronic kidney disease has long been suspected. The presumed development of chronic renal impairment following protracted excessive use of non-opioid analgesia is known as analgesic nephropathy. Many accept analgesic nephropathy as a real entity despite a paucity of robust scientific evidence. The weight of available observational literature suggests that long-term ingestion of paracetamol and combination mixtures of aspirin and paracetamol probably contribute to chronic renal impairment, however there is no convincing data to implicate non-steroidal anti-inflammatory drugs or aspirin monotherapy. While controversy persists most physicians consider all non-narcotic analgesics nephrotoxic and discourage heavy…use where possible.
Abstract: OBJECTIVES: Concerns about safety and complexity of diabetes treatments have increased overtime. We assessed secular trends in the FDA approvals, market discontinuations, and safety actions of all antidiabetic drugs marketed in the US in the period 1980–2015. METHODS: Regulatory and safety related information about FDA-approved pharmaceuticals for diabetes treatment was collected from the FDA databases, the Orange Book, and Drugs@FDA. Descriptive statistics were performed to describe trends in approvals, discontinuations, and safety actions. RESULTS: The number of insulins and analogue approvals declined after the 1980s; whereas, the approvals of non-insulin antidiabetic drugs increased after 1995.…The number of antidiabetic drugs with FDA safety actions significantly increased overtime. Overall, 59.0% of insulins and analogues and 5.7% of non-insulin antidiabetic drugs were discontinued from the market. The FDA released at least one safety action for 7.7% of insulins and analogues and 88.7% of non-insulin antidiabetic drugs. CONCLUSION: Newly approved antidiabetic drugs have raised safety concerns and led to FDA safety regulatory actions including boxed warnings, risk evaluation and mitigation strategies, medication guides, and safety communications to health care providers. There is a need for systematic post-marketing studies assessing the long-term safety of antidiabetic drugs to improve patient safety and health outcomes.
Keywords: FDA, drug safety, drug approvals, market discontinuations, antidiabetic drugs
Abstract: Discussions regarding defensive medical practice often result in proposals for public policy actions. Such proposals generally are premised on assumptions about defensive medicine, namely, that it (a) is driven by physicians’ legal anxieties, (b) constitutes bad medical practice, (c) drives up health care costs, (d) varies depending on a jurisdiction’s particular tort law climate, (e) depends on medical specialty and a physician’s own prior experience as a malpractice defendant, and (f) is a rational response to actual legal risks confronting physicians. This article examines a sample of recent literature focusing on defensive medicine and finds that the messages conveyed vary…widely, helping to explain the confusion experienced by many policymakers trying to improve the quality and affordability of health care.
Keywords: Medical malpractice, defensive medicine, health care costs, tort reform
Abstract: Kazan hosted Russia’s second International Conference QiQUM 2015 on Cochrane evidence for health policy, which was entirely independent of the pharmaceutical or other health industry, bringing together 259 participants from 11 countries and 13 regions of the Russian Federation. The Conference was greeted and endorsed by world leaders in Evidence-based medicine, health and pharmaceutical information, policy and regulation, and the World Health Organization. Participants discussed the professional and social problems arising from biased health information, unethical pharmaceutical promotion, misleading reporting of clinical trials with consequent flaws in health care delivery and the role of Cochrane evidence for informed decisions and…better health. The first in history Cochrane workshop, facilitated jointly by experts from Cochrane and the WHO, with 40 participants from Kazakhstan, Kyrgyzstan, Tajikistan and Russia introduced the concept of Cochrane systematic review and the Use of Cochrane evidence in WHO policy setting. Websites document conference materials and provide interface for future collaboration: http://kpfu.ru/biology-medicine/struktura-instituta/kafedry/kfikf/konferenciya/mezhdunarodnaya-konferenciya-39dokazatelnaya.html and http://russia.cochrane.org/news/international-conference .
Keywords: Cochrane, evidence, independent, conflicts of interest, bias, medicine information, drug promotion, ethical standards, pharmaceutical policy, health system, Russia