Guidelines for submitting adverse event reports for publication
Guidelines for submitting adverse event reports for publication
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DOI：
10.2165/00002018-200730050-00001
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发表时间：
2007-01-01
期刊：
影响因子：
4.2
通讯作者：
Wise, Robert P.
中科院分区：
文献类型：
--
作者：
Kelly, William N.;Arellano, Felix M.;Wise, Robert P.
发布描述药物和医疗产品（包括草药和补充药物、疫苗以及其他生物制品和设备）可疑不良反应的病例报告对于上市后监测非常重要。出版物为这些不良事件报告中提出的重要信号提供了可信度。不幸的是，已发表病例中重要信息的缺陷往往会限制此类报告的价值，因为无法为（i）因果关系的鉴别诊断或临时评估，或（ii）合理的药理学或生物学解释提供足够的细节。正确描述后，一份或多项不良事件的已发表报告可以提供与使用药物或医疗产品相关的可能风险的有用信号，这可能值得进一步探索。工作组作者进行的一项审查发现，许多主要期刊对发表不良事件报告有最低要求，有些甚至根本没有。根据文献综述以及我们在监管、学术和行业环境中审查不良事件案例报告的集体经验，我们确定了我们建议应始终考虑将其纳入提交出版的报告中的信息。这些指南已得到国际药物流行病学协会 (ISPE) 和国际药物警戒协会 (ISoP) 的认可，并可在协会网站上免费获取。鼓励其广泛传播。 ISPE 和 ISoP 敦促生物医学期刊采用这些指南并将其应用于提交出版的病例报告。他们还鼓励医学院、药学和护理学院将其纳入相关课程，以解决可疑药物或其他医疗产品不良事件的检测、评估和报告问题。
Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.