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Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics

机译:发表不良药物反应病例报告的重要性:促进公共卫生并促进药理学和治疗学

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摘要

This article, which encourages physicians to publish case reports of adverse drug reactions (ADRs), is a review of how well-documented published case reports have contributed to promoting public safety and health and thus served to advance basic pharmacology. The origin of a number of regulatory guidelines can ultimately be traced to safety concerns triggered by such reports. It illustrates how case reports of ADRs, when coupled with simultaneous monitoring of drug pharmacokinetics, have also led to further investigations resulting in major advances in pharmacology, especially pharmacogenetics, mechanisms of drug–drug interactions and modulation of drug metabolism during inflammatory co-morbidities. Published case reports differ significantly from spontaneous case reports since they enjoy quality-compliant peer review and an immediate wider visibility among the readership, triggering others to report similar cases, and ultimately leading to prescribing restrictions on or withdrawals of the drug from the market depending on the risk. Therefore, the reporter should not be discouraged by (a) the unusual or bizarre nature of the reaction; (b) the interval, however long, from commencing drug administration to the onset of the suspected reaction; (c) however well-known the drug or the period for which it has been on the market; and (d) any pressure not to publish. Case reports should be published in reputable journals that are searchable through databases such as PubMed.
机译:这篇文章鼓励医生发布药物不良反应(ADR)病例报告,是对文献记载充分的病例报告如何促进公众安全与健康,从而促进基本药理学的综述。许多法规指南的起源最终可以追溯到此类报告引发的安全隐患。它说明了ADR的病例报告,结合对药物药代动力学的同时监测,还导致了进一步的研究,从而导致了药理学特别是药物遗传学,药物-药物相互作用的机制以及炎性合并症期间药物代谢的调控取得了重大进展。已发布的病例报告与自发病例报告有显着不同,因为它们享有质量合格的同行评审,并在读者中立即享有更广泛的知名度,从而触发其他人报告类似病例,最终导致对药物的限制或从市场上撤出的规定取决于风险。因此,报告人不应因(a)反应的异常或奇异性质而灰心。 (b)从开始给药到怀疑反应开始的时间间隔,无论多长时间; (c)无论该药物或其在市场上的知名度如何; (d)任何不公开的压力。案例报告应发布在可通过数据库(例如PubMed)进行搜索的知名期刊上。

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