Safety Evaluation and Reporting, Worldwide Safety & Regulatory Operations, Pfizer Medical, Milan, Italy.
Drug Saf. 2010 Sep 1;33(9):765-73. doi: 10.2165/11537500-000000000-00000.
Case reports of suspected adverse drug reactions (ADRs) are common in the biomedical literature. Standards for authors and editors for writing, submitting and publishing ADR case reports have been empirically established since the 1980s; however, these recommendations have not been widely disseminated or incorporated into practice. Comprehensive and standardized guidelines on good publication practice have recently been proposed. No study has been performed so far to assess the adherence of published ADR case reports to these guidelines.
To describe the current situation with regards to the reliability and completeness of published ADR case reports.
A random sample of 100 single ADR case reports published between 2005 and 2008 (25 for each year) was retrieved from Pfizer's pharmacovigilance database. Reliability and completeness were assessed by comparing the relevant information contained in the retrieved ADR case reports against the recommendations prescribed by the guidelines. Descriptive statistics and correlation analysis using the Statistical Package for Social Science (SPSS) were undertaken.
The patient's medical history relevant to the ADR was reported in 92% of the case reports. Concerning the suspected drug, 11% of the reports included the proprietary name; duration, dosage, route and formulation were reported in 87%, 85%, 37% and 21% of the reports, respectively. Information on concomitant therapies was included in 71% of the reports. The description of the ADR contained details on management (99%), time-course (97%) and diagnostic tests (95%), while final outcome and seriousness were reported in 73% and 52% of the reports, respectively. A discussion on the possible mechanism for the ADR was present in 70% of the case reports. The possible implications for clinical practice of the reported drug-event association were described in 75% of the cases. Causality assessment was reported in 81%, and rating scales to support the causal link were used in 20% of the reports. The major predictive factor for the presence of an objective causality assessment was found to be publication in specialized pharmacoepidemiology or clinical pharmacology journals: 47% specialized versus 11% non-specialized (odds ratio = 6.93; 95% CI 2.37, 20.26).
The findings of this study show that published ADR case reports, especially those coming from non-specialized journals, still lack important information necessary for comprehensive evaluation. As published ADR case reports are expected to be reported to regulatory authorities using the same approach as for spontaneous cases, it is paramount for their effective integration in the pharmacovigilance system that pharmaceutical companies and learned societies actively promote a culture of good publication practices.
疑似药物不良反应（ADR）的病例报告在生物医学文献中很常见。自 20 世纪 80 年代以来，已经根据经验为撰写、提交和发表 ADR 病例报告的作者和编辑制定了标准；然而，这些建议并未得到广泛传播或纳入实践。最近提出了关于良好出版实践的综合和标准化指南。迄今为止，尚无研究评估已发表的 ADR 病例报告对这些指南的遵守情况。
描述已发表的 ADR 病例报告的可靠性和完整性现状。
从辉瑞的药物警戒数据库中随机抽取 2005 年至 2008 年间发表的 100 篇单一 ADR 病例报告（每年 25 篇）作为样本。通过将检索到的 ADR 病例报告中的相关信息与指南规定的建议进行比较，评估可靠性和完整性。使用社会科学统计软件包（SPSS）进行描述性统计和相关性分析。
92%的病例报告报告了与 ADR 相关的患者病史。关于可疑药物，11%的报告包含专有名称；报告中分别有 87%、85%、37%和 21%的报告包含了药物的持续时间、剂量、途径和制剂。71%的报告中包含了伴随治疗信息。ADR 的描述包含了管理（99%）、时间进程（97%）和诊断测试（95%）的详细信息，而报告中分别有 73%和 52%报告了最终结果和严重程度。70%的病例报告中讨论了 ADR 发生的可能机制。75%的病例报告描述了报告的药物事件关联对临床实践的可能影响。81%的病例报告报告了因果关系评估，20%的病例报告使用了支持因果关系的评分量表。存在客观因果关系评估的主要预测因素是发表在专业的药物流行病学或临床药理学杂志上：47%的专业杂志与 11%的非专业杂志（优势比=6.93；95%可信区间 2.37-20.26）。
本研究结果表明，已发表的 ADR 病例报告，尤其是来自非专业期刊的报告，仍然缺乏全面评估所需的重要信息。由于预计监管机构将使用与自发报告相同的方法报告已发表的 ADR 病例报告，因此制药公司和学术团体积极促进良好出版实践文化对于将其有效纳入药物警戒系统至关重要。
