PMID- 35939205 OWN - NLM STAT- MEDLINE DCOM- 20221219 LR - 20230131 IS - 2168-4804 (Electronic) IS - 2168-4790 (Print) IS - 2168-4790 (Linking) VI - 57 IP - 1 DP - 2023 Jan TI - MedDRA Labeling Groupings to Improve Safety Communication in Product Labels. PG - 1-6 LID - 10.1007/s43441-022-00393-1 [doi] AB - 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. CI - (c) 2022. The Author(s). FAU - Grosse-Michaelis, Ilona AU - Grosse-Michaelis I AD - Bayer AG, Research & Development, Pharmaceuticals, Leverkusen, Germany. FAU - Proestel, Scott AU - Proestel S AD - The U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, USA. FAU - Rao, Radhika M AU - Rao RM AD - AbbVie, Pharmacovigilance and Patient Safety, North Chicago, USA. Radhika.Rao@abbvie.com. FAU - Dillman, Brian S AU - Dillman BS AD - Eli Lilly and Company, Lilly Research Laboratories, Global Patient Safety - Medical, Indianapolis, USA. FAU - Bader-Weder, Silvia AU - Bader-Weder S AD - F. Hoffmann-La Roche Ltd, Pharma Development, Safety, Basel, Switzerland. FAU - Macdonald, Lynn AU - Macdonald L AD - Independent, CIOMS MedDRA Labeling Grouping Expert Working Group, Ottawa, Canada. FAU - Gregory, William AU - Gregory W AD - Pfizer, Worldwide Safety and Regulatory, New York, USA. LA - eng PT - Journal Article DEP - 20220808 PL - Switzerland TA - Ther Innov Regul Sci JT - Therapeutic innovation & regulatory science JID - 101597411 SB - IM MH - Humans MH - *Adverse Drug Reaction Reporting Systems MH - *Drug-Related Side Effects and Adverse Reactions/prevention & control MH - Product Labeling MH - Drug Labeling MH - Communication PMC - PMC9810671 OTO - NOTNLM OT - Adverse reactions OT - ICH OT - MedDRA OT - MedDRA Labeling Groupings (MLG) OT - Product labels COIS- 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. EDAT- 2022/08/09 06:00 MHDA- 2022/12/20 06:00 PMCR- 2022/08/08 CRDT- 2022/08/08 11:19 PHST- 2021/09/07 00:00 [received] PHST- 2022/03/14 00:00 [accepted] PHST- 2022/08/09 06:00 [pubmed] PHST- 2022/12/20 06:00 [medline] PHST- 2022/08/08 11:19 [entrez] PHST- 2022/08/08 00:00 [pmc-release] AID - 10.1007/s43441-022-00393-1 [pii] AID - 393 [pii] AID - 10.1007/s43441-022-00393-1 [doi] PST - ppublish SO - Ther Innov Regul Sci. 2023 Jan;57(1):1-6. doi: 10.1007/s43441-022-00393-1. Epub 2022 Aug 8.