Adverse drug reactions and toxicological reviews最新文献

{"title":"Review of national spontaneous reporting schemes. Strengths and weaknesses.","authors":"M Louise Hughes,&nbsp;Cate M C Whittlesea,&nbsp;David K Luscombe","doi":"10.1007/BF03256199","DOIUrl":"https://doi.org/10.1007/BF03256199","url":null,"abstract":"<p><strong>Objective: </strong>To investigate and compare the operation of different national spontaneous reporting schemes for adverse drug reactions.</p><p><strong>Design: </strong>Drug safety agencies in 18 countries were contacted by letter to request information about their spontaneous reporting scheme for adverse drug reactions. This information related to the background of the scheme, operational aspects of the scheme and numbers of reports received.</p><p><strong>Results: </strong>Replies were received from 12 countries. Many differences were found between the schemes operating in different countries. Some schemes had been in operation for over 30 years, while others were more recently established. While most schemes rely on voluntary reports, in two countries (France and Spain), reporting is a legal requirement for healthcare professionals. Reports are accepted from doctors, dentists and pharmacists in all of the countries surveyed; however the role of other health professionals and the general public was found to vary. There were also differences in the types of reactions for which reports are requested, and the products covered by the schemes. In some countries (e.g. Denmark) reports of all reactions are sought, while other countries focus on only serious reactions or reactions to newly marketed products. In Australia, there is a separate scheme for drug-induced congenital malformations and Canada, South Africa and the US run separate schemes for reactions to vaccines. However, other countries include these reactions in the general spontaneous reporting schemes. The numbers of reports received by the countries also varies considerably--from a few hundred each year in South Africa to over 20,000 in the US.</p><p><strong>Conclusion: </strong>While the schemes all operate on the basic principle of collecting reports of adverse reactions to identify potential hazards, they showed many different approaches to the spontaneous reporting of adverse drug reactions. Features of one scheme may serve to improve reporting rates for another. In addition, all 12 countries participate in the World Health Organization International Drug Monitoring Programme, thus helping to inform the whole international community of drug safety problems.</p>","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"21 4","pages":"231-41"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/BF03256199","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22172885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse drug reaction update.","authors":"","doi":"10.1007/BF03256201","DOIUrl":"https://doi.org/10.1007/BF03256201","url":null,"abstract":"<p><p>Increasing numbers of articles on adverse drug reactions are published in a wide range of medical journals. To help keep you up-to-date with the latest advances worldwide on all aspects of adverse drug reactions, this section of the journal brings you information selected from the drug safety alerting service Reactions Weekly. The following reports are selected from the latest issues, summarizing the most important clinical studies, adverse reaction news, and expert opinion pieces published across a broad range of literature sources.</p>","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"21 4","pages":"253-60"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1007/BF03256201","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"22172887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Dihydropyrimidine Dehydrogenase Deficiency on Outcomes with Fluorouracil","authors":"S. Gardiner, E. Begg, B. Robinson","doi":"10.1007/BF03256180","DOIUrl":"https://doi.org/10.1007/BF03256180","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"3 1","pages":"1-16"},"PeriodicalIF":0.0,"publicationDate":"2002-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84121576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Resistance to antimicrobial agents: can we make a difference?","authors":"S T Chambers","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"207-21"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887203","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic applications of medicinal plants in the treatment of breast cancer: a review of their pharmacology, efficacy and tolerability.","authors":"D Mantle,&nbsp;T W Lennard,&nbsp;A T Pickering","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Various active compounds (or their semi-synthetic derivatives) derived from medicinal plants have been assessed for their efficacy and tolerability in the treatment of breast cancer. Some of these plant species, including Taxus baccata (paclitaxel, docetaxel), Podophyllum peltatum (etoposide), Camptotheca acuminata (camptothecin) and Vinca rosea (vinblastine, vinorelbine) have well recognized antitumour activity in breast cancer, and have been evaluated in clinical trials. For example, results from recent Phase II/III trials have established docetaxel as the most active single agent in the treatment (first or second-line) of advanced metastatic breast cancer. For other plant species such as Panax ginseng and Allium sativum, antitumour activity has been evaluated in experimental studies using cultured cells and animal models, but the therapeutic potential in patients remains to be determined. Antitumour activity derived from medicinal plants may produce results via a number of mechanisms, including effects on cytoskeletal proteins which play a key role in mitosis (paclitaxel), inhibition of activity of topoisomerase enzymes I (camptothecin) or II (etoposide), stimulation of the immune system (Viscum album), or antiprotease-antioxidant activity. Medicinal plant-derived antineoplastic agents may be used in single agent or in combinational therapies, and have been used in first-line or second-line (including anthracycline-refractory patients) treatment of localized or metastatic breast cancer. Adverse effects resulting from the use of these agents include neutropenia and peripheral neuropathies.</p>","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"223-40"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Do NICE and CHI have no interest in safety? Opinion of the book NICE, CHI and the NHS reforms. Enabling excellence or imposing control?","authors":"P Fletcher","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Seventeen eminent and experienced people have contributed to this most valuable review of NICE and CHI and their potential impact on clinical practice in the UK. There is essentially 100% agreement that the basic concept is a good one; we all want to have the highest possible quality of clinical practice and improvements in health care. This is all motherhood and apple-pie stuff which goes without question but the problem is how it is put into effect. The contributors are also in agreement and fear that central desire for control will outweigh the benefits. The most recent NICE action, which was leaked to the media as a 'preliminary opinion', concerned the use of beta-interferon for the treatment of multiple sclerosis (MS). The opinion seems to be that beta-interferon is very expensive, that, yes, it does help some sufferers but, no, it does not help others and because it costs more than the NHS can afford no one can have it. This seems to me to be a most unsatisfactory outcome. Surely what clinical excellence demands is the refinement of diagnostic capabilities so that those who will benefit may be distinguished from those who will not. In the meantime we do the best we can even if it does mean that the NHS has to pay for some patients who do not respond. This is the inevitable consequence of the belief that a 'free' and comprehensive health service can be provided out of general taxation. Beta-interferon for the treatment of MS is an example of the observable fact that medical science is advancing at a rate considerably in excess of possible increases in funding. Possibly the most important problem identified in this book is the absence of a relevant, high quality data source for the preparation of the numerous guidelines that NICE is expected to produce each year. In a fully grown science a starting point for a quantitative procedure is the establishment of a baseline and, having done that, the scientist's next step is to produce a standard curve for use in the measurement of further investigations. I have said previously that medicine is not a fully grown science (which is one of the problems) but that does not mean that basic scientific method can be abandoned. What is the baseline for the evaluation of clinical practice? The best would be records of the progression of a disease-state in untreated patients. That, for obvious reasons, is clearly not possible so a compromise is unavoidable. Unfortunately we do not even have that compromise baseline so how do we know what is better and what is worse? In simple, single disease states and within the limits of RCTs that is sometimes possible but in a population composed of many elderly people with multiple pathology it is greatly more difficult. If NICE is to produce authoritative guidelines then its first task is to define a (compromise) baseline. For the readers of this journal the absence of safety as one of the measures of clinical excellence must be a matter of concern. All clinical int","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"167-76"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Does the GMC fulfil its mission statement--\"protecting patients, guiding doctors\"?","authors":"J P Griffin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"163-6"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887199","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Drug regulation in the European Union.","authors":"J P Griffin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"179-206"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887202","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prepulsid withdrawn from UK & US markets.","authors":"J P Griffin","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 3","pages":"177"},"PeriodicalIF":0.0,"publicationDate":"2000-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21887201","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EU pharmacovigilance guidelines. Review.","authors":"A P Fletcher","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":7401,"journal":{"name":"Adverse drug reactions and toxicological reviews","volume":"19 2","pages":"123-6"},"PeriodicalIF":0.0,"publicationDate":"2000-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21802874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}