Laboratory of Clinical Pharmacy, Tohoku University Graduate School of Pharmaceutical Sciences, Sendai, Japan.
Drug Informatics, Faculty of Pharmacy, Meijo University, Nagoya, Japan.
Pharmacoepidemiol Drug Saf. 2021 Aug;30(8):1091-1100. doi: 10.1002/pds.5231. Epub 2021 Mar 27.
Spontaneous reporting constitutes one of the most fundamental and important systems for pharmacovigilance. In Japan, important regulation changes in the vaccine spontaneous reporting were implemented between 2009 and 2013; however, no studies had yet assessed the impact of the changes. The objective of this study was to assess the impact on the reporting trends in vaccine reports and on signal detection for vaccines.
For assessment of the impact on the reporting trends, we performed the joinpoint trend analysis and descriptively considered number of vaccine reports grouped by the timing of the regulation change. For assessment of the impact on signal detection, we performed signal detection using dataset during the pre or postperiod of the regulation changes, and compared their agreement rates, which was calculated with a reference set for vaccines, created by the Global Research in Paediatrics project.
We retrieved 467 635 spontaneous reports, including 12 287 vaccine reports from April 2004 to March 2019. The average number of vaccine reports per year increased from 231 reports during the preperiod to 1227 during the postperiod. The joinpoint trend analysis found two joinpoints and differentiated three trends, significant increased trend of which was observed when regulations had changed. For signal detection, the agreement rate was improved when using data during the postperiod.
We concluded that the regulation changes increased the number of vaccine reports, and could have improved signal detection performance for vaccines by accelerating accumulation of reports, while more spontaneous reports are necessary to optimize signal detection.
自发报告构成了药物警戒最基本和最重要的系统之一。在日本，疫苗自发报告的重要监管规定在 2009 年至 2013 年期间发生了变化；然而，尚未有研究评估这些变化的影响。本研究的目的是评估这些变化对疫苗报告趋势和疫苗信号检测的影响。
为了评估对报告趋势的影响，我们进行了 joinpoint 趋势分析，并根据监管变化的时间对疫苗报告的数量进行了描述性分组。为了评估对信号检测的影响，我们使用了监管变化前后的数据进行信号检测，并比较了它们的符合率，这是使用 Global Research in Paediatrics 项目创建的疫苗参考集计算得出的。
我们从 2004 年 4 月至 2019 年 3 月检索到 467635 份自发报告，其中包括 12287 份疫苗报告。每年疫苗报告的平均数量从前期的 231 份增加到后期的 1227 份。joinpoint 趋势分析发现了两个 joinpoint，并区分了三种趋势，当法规发生变化时，观察到显著的增加趋势。对于信号检测，使用后期数据时，符合率有所提高。
我们得出结论，监管变化增加了疫苗报告的数量，并通过加速报告的积累，可能提高了疫苗的信号检测性能，同时需要更多的自发报告来优化信号检测。
