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Evaluating MedDRA-to-ICD Terminology Mappings: Bridging Drug Safety, Clinical and Epidemiological Data


The integration of medical coding systems plays a crucial role in healthcare drug safety data management, enabling standardized representation and analysis of clinical information. MedDRA (Medical Dictionary for Regulatory Activities) and ICD (International Classification of Diseases) are two widely used coding systems that serve distinct purposes in clinical practice and epidemiological research, respectively. MedDRA is a comprehensive terminology developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is primarily used for coding adverse events and medical product information in regulatory submissions. On the other hand, the ICD is maintained by the World Health Organization (WHO) and is the standard classification system for diseases and health-related conditions globally, facilitating epidemiological surveillance and healthcare management.

 

MedDRA and ICD serve distinct purposes; there is often a need to map terminologies between the two systems to facilitate data exchange and synergism. For example, in pharmacovigilance and post-marketing surveillance, adverse events coded using MedDRA may need to be translated into ICD codes for epidemiological analysis and public health reporting.  Similarly, in clinical research and healthcare delivery, translating diagnostic codes from ICD to MedDRA can streamline data integration and analysis.

 

Mapping terminologies between MedDRA and ICD poses several challenges due to differences in coding granularity, structure, and clinical concepts. MedDRA is more granular and focused on capturing specific adverse events and medical terms, whereas ICD codes are broader and designed to classify diseases and health conditions. As a result, mapping between the two systems may require manual review, clinical expertise, and iterative refinement to ensure accuracy and consistency. Furthermore, the evolving nature of medical knowledge and updates to coding systems can introduce complexities in maintaining mappings over time. Changes in coding guidelines, terminology updates, and new medical discoveries may necessitate periodic review and revision of mappings to reflect current clinical practice and terminology standards. Accurate mappings between MedDRA and ICD are essential for enabling seamless data exchange and compatibility across clinical and epidemiological domains. Improper mappings can lead to data discrepancies, misinterpretation of findings, and erroneous conclusions in research and public health surveillance. Moreover, transparent documentation and validation of mappings are critical for ensuring reproducibility and transparency in data analysis and interpretation. Researchers and healthcare professionals should be aware of the limitations and uncertainties associated with terminology mappings and exercise caution when interpreting findings based on mapped data.

 

Mapping terminologies between MedDRA and ICD is complex but essential as it bridges clinical and epidemiological data domains. By addressing challenges in mapping accuracy, granularity, and maintenance, stakeholders can enhance data interoperability, facilitate research collaboration, and improve public health surveillance. Continued efforts in standardization, validation, and transparency are needed to advance the reliability and utility of MedDRA-to-ICD terminology mappings in healthcare and research settings.

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