Office of New Drug I, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.
Clin Pharmacol Ther. 2019 Jun;105(6):1471-1476. doi: 10.1002/cpt.1342. Epub 2019 Feb 10.
We investigated impacts of increased generic drug use on spontaneous adverse event reports (SAERs), because SAERs have been a major source of data for drug safety assessment at the postmarket stage. Reporting proportion of SAERs for the generic drugs was consistently and significantly lower than that for the original branded drugs. The reporting proportion targeting for 55 active product ingredients, which had the longest follow-up period after generic drug marketed, gradually decreased for the original branded drugs and increased for the generic drugs. However, these transitions did not parallel the changes in market share over the same period. These results suggest that the reporting proportion of SAERs for generic drugs may not keep pace with growth in market share. When generic drugs account for the majority of market share, utilization of multiple sources of information and data, in addition to SAERs, may be a key to assuring drug safety at the postmarket stage.
我们研究了增加仿制药使用对自发性不良事件报告（SAERs）的影响，因为 SAERs 一直是药物安全评估的主要数据来源。仿制药的 SAER 报告比例一直且显著低于原品牌药物。针对 55 种活性成分的报告比例，这些成分在仿制药上市后具有最长的随访期，原品牌药物的报告比例逐渐下降，而仿制药的报告比例逐渐增加。然而，这些转变与同期的市场份额变化并不平行。这些结果表明，仿制药的 SAER 报告比例可能跟不上市场份额的增长。当仿制药占据市场份额的大多数时，除了 SAERs 之外，利用多种信息和数据来源可能是确保药物安全的关键。
Zotero 插件