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. 2023 Jan;57(1):1-6.
doi: 10.1007/s43441-022-00393-1. Epub 2022 Aug 8.

MedDRA Labeling Groupings to Improve Safety Communication in Product Labels

Ilona Große-Michaelis  1 , Scott Proestel  2 , Radhika M Rao  3 , Brian S Dillman  4 , Silvia Bader-Weder  5 , Lynn Macdonald  6 , William Gregory  7
Affiliations

MedDRA Labeling Groupings to Improve Safety Communication in Product Labels

Ilona Große-Michaelis et al. Ther Innov Regul Sci. 2023 Jan.

Abstract

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.

Keywords: Adverse reactions; ICH; MedDRA; MedDRA Labeling Groupings (MLG); Product labels.

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Conflict of interest statement

No potential conflicts of interest were declared. The views expressed in this article are those of the authors and do not necessarily reflect the official position of the institutions to which they are affiliated.

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