Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Pharmacoepidemiol Drug Saf. 2013 Mar;22(3):306-18. doi: 10.1002/pds.3408. Epub 2013 Jan 28.
Despite globalization of drug approvals, there is a disparity in drug safety regulations among the USA, Europe, and Japan. We sought to determine differences in safety information on drug labels among the three regions.
This was a cross-sectional study with quantitative survey of safety information on labels of 189 new molecular entities approved in the USA, the UK, and Japan. Outcome measures were the proportions of total safety information (PSI), of contraindications (PCI), and of boxed warnings (PBW) to all information on the label. We identified a boxed warning (BW) on US and Japanese labels through a manual search. These measures were analyzed according to therapeutic indications.
On the Japanese labels, PSI was smaller than that on the US and UK labels for cardiovascular diseases. For neoplastic and immunologic diseases, PSI on the Japanese labels was larger than that on the UK labels. For nervous system diseases, PSI on the US labels was larger than that on the UK and the Japanese labels. PCI showed contrasting results with PSI except for neoplastic and immunologic diseases. BWs showed a poorer concordance between the USA and Japan in hematologic and genitourinary diseases than in other therapeutic areas.
Substantial differences in safety information exist depending upon outcome measures and therapeutic areas among the US, the UK, and the Japanese labels. This underscores the need for further analyses to determine causes of these differences to optimize drug safety regulations.
尽管药品审批已实现全球化，但美国、欧洲和日本在药品安全监管方面仍存在差异。我们旨在确定这三个地区药品标签上的安全信息差异。
这是一项横断面研究，对美国、英国和日本批准的 189 种新分子实体的标签上的安全信息进行了定量调查。主要结局指标是标签上的总安全性信息（PSI）、禁忌症（PCI）和警示信息（PBW）占所有信息的比例。我们通过手动搜索确定了美国和日本标签上的警示信息（BW）。根据治疗指征分析了这些措施。
在日本标签上，心血管疾病的 PSI 小于美国和英国标签上的 PSI。对于肿瘤和免疫疾病，日本标签上的 PSI 大于英国标签上的 PSI。对于神经系统疾病，美国标签上的 PSI 大于英国和日本标签上的 PSI。除肿瘤和免疫疾病外，PCI 的结果与 PSI 相反。在血液学和泌尿生殖系统疾病方面，BW 在美日之间的一致性较差，而在其他治疗领域则较好。
美国、英国和日本标签上的安全信息存在显著差异，具体取决于结局指标和治疗领域。这突显出需要进一步分析这些差异的原因，以优化药品安全监管。
