Bayer AG, Research & Development, Pharmaceuticals, Leverkusen, Germany.
The U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, USA.
Ther Innov Regul Sci. 2023 Jan;57(1):1-6. doi: 10.1007/s43441-022-00393-1. Epub 2022 Aug 8.
The granularity and structure of the International Council for Harmonisation's (ICH) Medical Dictionary for Regulatory Activities (MedDRA) are useful for precise coding of adverse events (AEs) for data analysis. In product labeling for healthcare practitioners, however, the granularity of MedDRA Preferred Terms (PTs) can obscure the communication of adverse reactions (ARs). Driven by a focus on patient safety, business needs, and regulatory guidance, many sponsors and regulators have begun to develop institution-specific approaches to clustering similar AR terms in medical product prescribing information on a product-by-product basis. However, there are no agreed upon conventions that describe which AR terms may be appropriate to group together. In order to improve safety communication to patients and healthcare providers, there is an urgent need for a harmonized international approach to the creation and use of groups of MedDRA PTs which we refer to as "MedDRA Labeling Groupings (MLGs)" in medical product prescribing information. Given its long-standing contributions towards the design of Standardised MedDRA Queries (SMQs), the Council for International Organizations of Medical Sciences (CIOMS) convened an Expert Working Group (EWG) with involvement of multiple major stakeholders to produce a consensus document on principles and points to consider in the development of MLGs. The CIOMS MLG EWG identified variations in grouping of MedDRA PTs in product labels, and in the current document, proposes a strategy for improving the communication of drug safety labeling. It is envisaged that the use of these consensus recommendations would be voluntary and applied to product labels in a manner that is consistent with existing regulatory frameworks.
国际协调理事会（ICH）医学用语词典（MedDRA）的粒度和结构对于精确编码不良事件（AE）进行数据分析非常有用。然而，在面向医疗保健从业者的产品标签中，MedDRA 首选术语（PT）的粒度可能会掩盖不良反应（AR）的传达。出于对患者安全、业务需求和监管指导的关注，许多赞助商和监管机构已开始针对特定机构的方法，在产品上市信息中针对特定产品的基础上，对类似 AR 术语进行聚类。然而，目前还没有商定的约定来描述哪些 AR 术语可以适当地组合在一起。为了改善向患者和医疗保健提供者传达安全性信息，迫切需要一种协调一致的国际方法来创建和使用 MedDRA PT 组，我们在医疗产品上市信息中称之为“MedDRA 标签分组（MLG）”。鉴于其在标准化 MedDRA 查询（SMQ）设计方面的长期贡献，国际医学组织理事会（CIOMS）召集了一个专家工作组（EWG），邀请多个主要利益相关者参与，以制定关于 MLG 开发的原则和注意事项的共识文件。CIOMS MLG EWG 确定了产品标签中 MedDRA PT 分组的差异，并在本文件中提出了一种改进药物安全标签传达的策略。预计这些共识建议的使用将是自愿的，并以符合现有监管框架的方式应用于产品标签。
