The Challenge and Implication of MedDRA Coding and Adverse Event Reports

Regulatory authorities and the pharma/biopharmaceutical industry frequently use MedDRA, or the Medical Dictionary for Regulatory Activities, which is a clinically validated and internationally recognized medical terminology. It is utilized throughout the entire regulatory process, from pre-marketing to post-marketing, and serves as a critical tool for:

• Data entry.
• Retrieval.
• Evaluation.
• Presentation.

MedDRA covers a vast range of medical domains, including:

• Medical conditions.
• Indications.
• Investigations.
• Medical and surgical procedures.
• Product quality issues.
• Device-related issues.
• Pharmacogenetic terms.
• Toxicologic issues.

?However, it is essential to note that it does not include a drug dictionary, equipment, device, diagnostic product dictionary, clinical trial study design terms, patient demographic terms, frequency qualifiers, numerical values for results, or severity descriptors.

MedDRA coding can be complex and time-consuming due to the large volume of adverse event reports that need to be processed. Each report must be reviewed, coded, and categorized according to the MedDRA hierarchy (see picture below), which is crucial in identifying potential risks associated with a product.[mo1]? Another challenge in MedDRA coding is the subjective nature of the process. Adverse event reports often contain vague or incomplete information, making it difficult to code the event accurately. Additionally, different reporters may describe the same event differently, further complicating the coding process.

Furthermore, the MedDRA terminology can be quite intricate and detailed, with multiple levels of hierarchy and specificity. This can make it challenging for coders to select the most appropriate term to describe the event accurately. Sometimes, the event may not fit neatly into a single MedDRA term, requiring the coder to make a judgment call and select the most appropriate term based on the available information.

?Aggregate reports are reports submitted to regulatory authorities, such as the Food and Drug Administration (FDA) or the European Medicines Agency (EMA), that contain information on adverse events associated with a particular product. These reports must be accurately coded and submitted on time to ensure compliance with regulatory requirements.

Failure to accurately code and report adverse events can have serious consequences for pharmaceutical companies, including:

• Regulatory fines and penalties.
• Legal liability.
• Damage to their reputation.

Companies must have robust pharmacovigilance processes to ensure that adverse events are correctly coded and reported per regulatory guidelines and permit an adequate assessment during the analysis of similar events and periodic reports.

The complexity arises from MedDRA's five-level hierarchical structure.

?From highest to lowest, these levels are System Organ Class (SOC), High-Level Group Term (HLGT), High-Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

Each level provides a different level of specificity. The same event can be coded differently depending on the level of detail required. This necessitates a deep understanding of the MedDRA terminology, adding to the complexity of the process. To illustrate, let's take the adverse event "headache." It would be coded as follows in MedDRA:

• SOC: Nervous system disorders
• HLGT: Headaches
• HLT: Migraines
• PT: Headache
• LLT: Severe headache

The new MedDRA Labeling Group

Recently, MedDRA released the MedDRA Labeling Grouping (MLG), a new feature in the Medical Dictionary for Regulatory Activities (MedDRA) designed to enhance the coding process for adverse event data in pharmacovigilance. This grouping system categorizes MedDRA terms into groups based on their clinical similarity, making it easier for coders to code adverse events accurately and efficiently.

MedDRA, has recently introduced the MedDRA Labeling Grouping (MLG), an innovative feature aimed at improving the coding process for adverse event data in pharmacovigilance. The MLG system classifies MedDRA terms into groups based on their clinical similarity, thereby facilitating the accurate and efficient coding of adverse events by coders. This feature is expected to streamline the coding process and enhance the overall efficiency of the pharmacovigilance system.

One of the main advantages of using the MLG is that it helps to streamline the coding process by reducing the time and effort required to search for and select the appropriate MedDRA terms. Instead of manually searching through thousands of terms to find the most relevant to a specific adverse event, coders can simply use the MLG to quickly identify the appropriate group and select the specific term from within that group.

MLG provides an essential framework for improving the accuracy and consistency of adverse event categorization.? allowing them to:

• Minimize Variability: Ensures consistent coding across individuals and teams, reducing subjective interpretation.
• Increase Accuracy: Helps to identify the most appropriate MedDRA terminology, resulting in more accurate adverse event reporting.
• Improve Clarity: Provides clearer guidelines for classifying nuanced medical situations, easing complex decision-making.

These benefits collectively mitigate common errors and discrepancies when coders independently navigate the extensive MedDRA terminology. Additionally, the strategic application of the MLG extends these benefits to streamline the coding workflow. Building on this foundation, the MLG further optimizes the coding process by reducing duplicative efforts. It achieves this by:

• Preventing Redundancy: By clustering similar medical terms, the MLG discourages the selection of multiple descriptors for the same condition.
• Saving Time: This organization enables coders to swiftly identify the most fitting terms, reducing the time spent sifting through potential duplicates.
• Streamlining Processes: This leads to a more efficient coding operation, allowing coders to allocate their resources to more critical tasks within the pharmacovigilance spectrum.

Optimizing Adverse Event Reporting with MedDRA Labeling Grouping: A New Paradigm in Pharmacovigilance

The new MedDRA Labeling Grouping (MLG) approach offers several advantages for recording adverse event data in pharmacovigilance. It promises to improve the coding process by increasing uniformity and accuracy while decreasing duplication and redundancy. Such enhancements improve the efficiency and overall effectiveness of adverse event reporting. Pharmaceutical businesses and regulatory authorities must consider integrating MLG into their coding procedures to gain these benefits and improve the quality of adverse event data.

Embracing the MedDRA Labeling Grouping (MLG) is just the beginning. Effective pharmacovigilance demands a broader, more holistic strategy. The cornerstone of this strategy is the creation of solid, clear-cut processes for adverse event coding and reporting. Key components include:

1. Rigorous Guidelines: Unambiguous directives that leave no room for doubt in coding procedures.
2. Regular Audits: These checks keep coding practices sharp and accurate.
3. Continuous Reviews: An ongoing process to catch and correct coding errors.

Conclusion

Implementing such steadfast measures is critical for pharmaceutical organizations aiming to refine MedDRA coding's accuracy and efficiency. The industry protects patients and ensures strict compliance with regulatory requirements by taking these steps. This proactive approach to pharmacovigilance maintains the industry's commitment to drug safety and the confidence that both patients and healthcare professionals have in it.

Pharmaceutical organizations must refine MedDRA coding for accuracy and efficiency to protect patients and ensure regulatory compliance. This proactive stance in pharmacovigilance reinforces the industry's commitment to drug safety and maintains trust with healthcare providers and patients.

References

1. MedDRA Coding Basic. Link: https://meddra.org/sites/default/files/training/file/000411_meddra_coding_basics_webinar.pdf
2. MedDRA Hierarchy. Link: https://www.meddra.org/how-to-use/basics/hierarchy
3. Medical Dictionary for Regulatory Activities - MedDRA. Link: https://www.tga.gov.au/resources/resource/guidance/medical-dictionary-regulatory-activities-meddra ?https://www.meddra.org/about-meddra/evolving-meddra ?
4. What is MedDRA, and How is it used?. Link: https://admin.meddra.org/sites/default/files/page/documents_insert/000688_What_is_MedDRA_and_How_is_It_Used_Webinar.pdf
5. MedDRA Medical Dictionary for Regulatory Activities. Link: https://www.meddra.org/basics
6. MedDRA Medical Dictionary for Regulatory Activities - Regulatory Use. Link: ?https://www.meddra.org/how-to-use/case-studies/regulatory-case-study
7. Understanding MedDRA. Link: https://admin.meddra.org/sites/default/files/main_page_slideshow/meddra2013_0.pdf
8. Challenges in Coding Adverse Events in Clinical Trials: A Systematic Review Jeppe Bennekou Schroll ,?*?Emma Maund , and??Peter C. G?tzsche , National Library of Medicine Published online 2012 Jul 20.?doi:?https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3401103/
9. Challenges in MedDRA Coding: Identifying Common Causes. Link: https://www.dhirubhai.net/pulse/challenges-meddra-coding-identifying-common-causes-drugvigil-nhssc?trk=organization_guest_main-feed-card_feed-article-content ?
10. MedDRA Coding Quality: How to avoid Common Pitfalls: Patricia Mozzicato, MD Chief Medical Officer MedDRA MSSO, DIA Chicago, Illinois, 2011. Link: https://admin.meddra.org/sites/default/files/page/documents_insert/meddra_coding_quality-how_to_avoid_common_pitfalls_mozzicato_2011.pdf
11. CIOMS: Council for International Organizations of Medical Sciences .Link : https://cioms.ch/publications/product/introduction-mlg-report/