A novel method for signal detection of adverse drug reactions based on proportional reporting ratios

作者：Wei Jian Xiang; Li Ming; Sun Yue Hong; Lu Ye; Xu Hou Ming^*

来源：Pharmacy World and Science, 2010, 32(5): 658-662.

DOI：10.1007/s11096-010-9421-x

• Adverse drug reactions
• Drug safety
• Signal detection
• Methodology

Objective The proportional reporting ratio (PRR) is a statistical method for signal detection of adverse drug reactions (ADRs) based on unbalanced proportions. Although effective, this method only takes into account the proportional relation based on target adverse reactions and ignores the relation between a given ADR and the others for the same drug. Therefore, it is necessary to improve the calculation deviation in PRR. In this study, we developed a novel PRR (NPRR) method and compared it with the original PRR method for the purpose of a combined application of these two methods for ADR signal detection. Methods NPRR is also based on unbalanced proportions, in which the proportion for a given ADR is linked to a specific drug (or all other drugs), and then divided by the corresponding proportion for all other ADRs. Results Applying this method to the ADR data of Jiangsu Province, China in 2008 and 2009, we detected 3,021 signals. Compared with the PRR method, the sensitivity of our method is 0.99, the specificity is 0.97, and the Youden index is 0.96. Conclusion NPRR is an excellent method supplementary to PRR. The combination of these two methods can reduce calculation deviation and detect ADRs more effectively.

• 出版日期2010-10
• 单位南京师范大学; 南京人口管理干部学院