Pharmaceuticals and Medical Devices Agency, Tokyo, 100-0013, Japan.
Office of New Drug V, Tokyo, Japan.
BMC Health Serv Res. 2022 Oct 26;22(1):1292. doi: 10.1186/s12913-022-08685-w.
Risk management in the post-marketing phase is crucial to minimize health problems caused by drugs. Because ethnic factors may affect drug safety, the objective of this study was to explore concrete approaches to reflecting ethnic factors in risk management under multi-regional drug development.
We assessed Pharmaceuticals and Medical Devices Agency (PMDA) review reports on antineoplastic drugs approved as new molecular entities in the last 10 years to identify any differences in the incidence of adverse drug reactions (ADRs) related to myelosuppression, hepatic impairment, renal impairment, and interstitial lung disease between Japanese and non-Japanese populations. In addition, we investigated how those ADRs were handled in the labeling of each drug.
In total, 44 drugs were available for comparing the incidence of ADRs between Japanese and non-Japanese populations. Of these, 32 drugs had a higher incidence of ADRs in the Japanese population. However, the incidence of ADRs in the Japanese population was described in the labeling for 7 drugs, and only the incidence in the overall population in multi-regional phase III trials was described in the labeling for the remaining 25 drugs. Of these 25 drugs, two drugs were immediately placed under emergency safety control measures after approval because of the high incidence of ADRs in Japanese patients.
For drugs that might cause serious ADRs and with a higher incidence in the Japanese population, information should be provided on the incidence in the Japanese population as well as in the overall population.
上市后阶段的风险管理对于最小化药物引起的健康问题至关重要。由于种族因素可能会影响药物安全性，因此本研究的目的是探讨在多区域药物开发中反映种族因素的具体方法。
我们评估了过去 10 年中作为新分子实体批准的抗肿瘤药物的药品和医疗器械管理局（PMDA）审查报告，以确定与骨髓抑制、肝损伤、肾损伤和间质性肺病相关的不良反应（ADR）在日本人和非日本人中的发生率是否存在差异。此外，我们还研究了这些 ADR 在每种药物标签中的处理方式。
共有 44 种药物可用于比较日本人和非日本人中 ADR 的发生率。其中，32 种药物在日本人群中的 ADR 发生率更高。然而，7 种药物的标签中描述了日本人群中 ADR 的发生率，而其余 25 种药物的标签中仅描述了多区域 III 期试验中总体人群中的 ADR 发生率。在这 25 种药物中，由于日本患者 ADR 发生率较高，有两种药物在批准后立即采取了紧急安全控制措施。
对于可能引起严重 ADR 且在日本人群中发生率较高的药物，应提供日本人群和总体人群中发生率的信息。
