The Medical Dictionary for Regulatory Activities (MedDRA) is a terminology developed by the International Council for Harmonisation (ICH). While it is useful for precise coding of adverse events of medicines for data analysis, its high granularity can obscure the communication of adverse reactions in product labeling for healthcare practitioners.
Many sponsors and regulators have therefore begun to develop their own approaches to clustering similar adverse reaction terms in medical product prescribing information on a product-by-product basis. However, there are no agreed-upon conventions that describe which adverse reaction terms may be appropriate to group together.
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 terms, or “MedDRA Labeling Groupings (MLGs)”, in medical product prescribing information.
Based on its long-standing experience with MedDRA and with grouping of MedDRA terms, the Council for International Organization of Medical Sciences (CIOMS) Expert Working Group (EWG) proposed a concept, identified the scope and potential benefits and limitations of MLGs. The EWG also agreed on a set of guiding principles underpinning the creation and use of MLGs.
MLGs are groupings of near-synonymous MedDRA Preferred Terms (PTs) that convey substantially similar clinical concepts for presentation of information on adverse reactions in product
safety labeling. This grouping is performed to communicate information on an adverse reaction (AR) in a manner that is expected to give the most accurate and understandable description in product safety labeling (PSL).
MLGs are different from the existing Standardised MedDRA Queries (SMQs), which are groupings of adverse reactions used for safety signal detection.
MLGs can help to achieve harmonization of safety information shared in PSL. This would be a significant advance over the current situation of different institutions either taking different approaches when creating their own groupings or not creating groupings at all when presenting safety information in PSLs. It is expected that MLGs, when used appropriately,
would enhance the communication of the true safety profile of medicinal products in product safety labeling, thus benefiting healthcare professionals (HCP).
Example: MLG Hyperkalemia
MLG concept/name: Hyperkalemia
PTs considered for inclusion in MLG Hyperkalemia:
– PT Blood potassium increased (System Organ Class (SOC) Investigations)
– PT Hyperkalaemia (SOC Metabolism and nutrition disorders).
PT examples not included in MLG Hyperkalemia:
– PT Blood potassium abnormal
– PT Pseudohyperkalaemia
Discussion:
(1) The two included PTs belong to two different MedDRA SOCs but are seen as
describing the same medical concept. As these are near-synonymous PTs, even
though they are representing signs, symptoms and diagnosis, they are grouped together.
(2) PTs that indicate nonspecific laboratory results such as “abnormal” may be
included in an MLG only if the lab abnormality is clinically meaningful in only one direction, e.g., PT Blood potassium increased. On the other hand, PT Blood potassium abnormal is clinically meaningful in both directions of laboratory abnormality and hence is not included under MLG Hyperkalemia.
(3) The PT Pseudohyperkalaemia represents a false elevation in potassium that reflects a different medical concept than Hyperkalemia. Therefore, it is not included in the MLG Hyperkalemia.
MLG=MedDRA Labeling Grouping; PT=Preferred Term; SOC=System Organ Class
The guidance document explained the MLG principles, concepts, differentiation to SMQs along with examples.
Reference and link to download the guidance document:
