Department of Pharmacy, Miyagi Cancer Center, 47-1 Nodayama, Medeshimashiote, Natori, Miyagi, 981-1293, Japan.
Laboratory of Clinical Pharmacy, Tohoku University Graduate School of Pharmaceutical Sciences, 1-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan.
Int J Clin Pharm. 2020 Apr;42(2):728-736. doi: 10.1007/s11096-020-00969-7. Epub 2020 Feb 4.
Background The quality of adverse drug reaction reports can have a strong influence on the causality assessment or the detection of safety signals. Various methods have been used to evaluate the quality of adverse drug reaction reports. Objective We used the vigiGrade completeness score to evaluate the quality of the Japanese adverse drug event report database (JADER). Methods Among all reports in the JADER (cases received by regulatory authorities from April 2004 to November 2018), 427,797 cases that did not meet the exclusion criteria were analyzed using vigiGrade. An report was considered a 'well-documented' report if the completeness score > 0.8. For each dimension, the proportion of incomplete information was calculated. Main outcome measure Proportion of 'well-documented' reports. Results A total of 211,774 (49.5%) cases were classified as 'well-documented' reports. When classified by sender, 6240 out of 8257 cases (75.6%) from medical institutions were 'well-documented', while 205,534 out of 419,540 cases (49.0%) from pharmaceutical companies were categorized as such. 'Time-to-onset' could not be calculated in 173,027 (41.2%) cases from the pharmaceutical companies and in 1228 (14.9%) cases from medical institutions. Conclusion In the JADER, the proportion of 'well-documented' adverse drug reaction reports from medical institutions was higher than that from pharmaceutical companies, and reports from medical institutions could help to clarify generated safety signals. We also found that more than 40% of the reports from pharmaceutical companies did not include information that is considered essential for the evaluation of any causal relationship between suspected drugs and adverse drug reactions, which could pose challenges to the detection of safety signals.
药物不良反应报告的质量对因果关系评估或安全信号的检测有很大影响。已经使用了各种方法来评估药物不良反应报告的质量。目的：我们使用 vigiGrade 完整性评分来评估日本药物不良反应事件报告数据库（JADER）的质量。方法：在 JADER 中的所有报告（监管机构从 2004 年 4 月至 2018 年 11 月收到的病例）中，使用 vigiGrade 分析了 427,797 例不符合排除标准的病例。如果完整性评分>0.8，则认为报告为“记录完整”报告。对于每个维度，计算不完整信息的比例。主要结局指标：“记录完整”报告的比例。结果：共有 211,774 例（49.5%）被归类为“记录完整”报告。按发送方分类，来自医疗机构的 8257 例中的 6240 例（75.6%）为“记录完整”，而来自制药公司的 419,540 例中的 205,534 例（49.0%）为“记录完整”。来自制药公司的 173,027 例（41.2%）和来自医疗机构的 1228 例（14.9%）无法计算“发病时间”。结论：在 JADER 中，来自医疗机构的“记录完整”药物不良反应报告比例高于来自制药公司的报告，医疗机构的报告有助于澄清产生的安全信号。我们还发现，制药公司超过 40%的报告未包含评估可疑药物与药物不良反应之间因果关系所需的基本信息，这可能对安全信号的检测构成挑战。
