Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Minato-ku, Japan.
Pharmacoepidemiol Drug Saf. 2021 May;30(5):561-572. doi: 10.1002/pds.5203. Epub 2021 Feb 18.
It is important to make the most up-to-date drug safety information available to the public in a timely manner so that health care professionals and patients can consider the information. The aim of the present study was to investigate the consistency and simultaneity of safety related updates in product labeling in Japan and the United States.
New safety label changes that were made for new drugs approved concurrently both in Japan and the United States in the recent 5 years were identified and reviewed for concordance and time lag analysis. Factors associated with the time lag were also investigated.
Despite similar medical practices, population health and regulation in the countries, a low level of concordance (40/115, 34.8%) in the decision of labeling change was found in 31 new active substances. Only 3/40 (7.5%) of the concordant changes were made simultaneously. Labeling change orders issued by regulators and domestic postmarketing adverse event reports were associated with a significant difference in the timing of labeling change between the countries.
We found a low level of concordance between regulators in the decision of labeling changes and the timeliness of the changes. The low concordance and time lag highlighted the need for further international collaboration between regulators and industry and greater transparency in the decision-making process for the label change.
及时向公众提供最新的药物安全信息非常重要，以便医疗保健专业人员和患者能够考虑这些信息。本研究旨在调查日本和美国药品标签中与安全性相关的更新的一致性和同步性。
确定并审查了最近 5 年内日本和美国同时批准的新药的新安全标签变更，以进行一致性和时滞分析。还调查了与时滞相关的因素。
尽管两国的医疗实践、人口健康和监管情况相似，但在 31 种新活性物质的标签变更决策中发现一致性水平较低（40/115，34.8%）。只有 3/40（7.5%）的一致变更同时进行。监管机构发布的标签变更令和国内上市后不良事件报告与两国标签变更时间的显著差异有关。
我们发现监管机构在标签变更决策中的一致性水平和变更的及时性都较低。低一致性和时滞突出表明监管机构和行业之间需要进一步的国际合作，以及在标签变更决策过程中提高透明度。
