.•* MedDRA Coding: Core Principles Explained

This blog covers:

Core principles for coding with MedDRA
Practical examples to illustrate concepts
Key takeaways for effective application

Table of Contents:

Introduction
MedDRA coding
General Principles of MedDRA Coding
Key Takeaways
Conclusion
References

Introduction

This blog provides a comprehensive guide to the key principles of coding with MedDRA. With these points, you can improve your coding practices, reduce errors, and ensure consistency and accuracy.

MedDRA Coding

MedDRA coding plays a vital role in the clinical study process, particularly in pharmacovigilance.

Accurate coding is essential for data quality and safety reporting. Despite its importance, errors in MedDRA coding are common.

There are several lesser-known principles and best practices for MedDRA coding.

A frequent challenge is encountering multiple codes that appear similar. Yet, selecting the most closest LLT (Lowest Level Term) is important. In respect to maintaining efficiency and adhering to high-quality standards in case processing.

📢 Recommendation: Before getting dive in to exploring this blog, i recommend checking the article where we discusses about common causes that challenges case processors in MedDRA coding.

“Efficiency in MedDRA coding is not just about accuracy—it’s about transforming complex data into clear insights while upholding the highest standards of quality and consistency.”

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1. Quality of Source Data

The clarity and accuracy of MedDRA coding are directly proportionate to the quality of the source data.

High-quality reports lead to more reliable coding outcomes.

Always seek clarification for ambiguous, unclear, or unintelligible data. Clear, precise data ensures accurate term selection and reduces errors.

Example:

Reported	LLT Selected	Comment
Hyperkalaemia with a serum potassium of 1.6 mEq/L	Serum potassium abnormal	LLT Serum potassium abnormal covers both of the reported concepts (note: serum potassium of 1.6 mEq/L is a low result, not high)

📢 Recommendation: Check our here, If you would prefer to explore about the origins of sources of ICSR reports.

2. Quality Assurance

The quality and consistency of source depends on who the reporter is (e.g., investigator, physician, or consumer).

Reports from healthcare professionals (HCPs) are often more precise, while those from non-HCPs may need review by qualified personnel.

The use of auto-encoders can assist in maintaining accuracy, though the final result aligns with the reported term.

3. Do Not Alter MedDRA

MedDRA is a standardized terminology with a predefined hierarchical structure. Modifying it compromises the integrity of this global standard.

If you identify a term that seems misplaced within the MedDRA hierarchy, submit a change request to the MSSO rather than making internal adjustments.

4. Always Select a Lowest Level Term (LLT)

Choose the LLT that most accurately represents the reported information. LLTs ensure precision and maintain the quality of case processing.

📢 Recommendation: I recommend checking our blog solely discussed about identifying closest LLTs in MedDRA: A best practices.

5. Select Only Current LLTs

Always prioritize current LLTs over non-current ones to ensure consistency with MedDRA standards.

6. When to Request a Term

If no suitable MedDRA term exists to reflect the reported information, submit a request to MSSO instead of creating organization-specific solutions.

Example:

Change Request for a New Term
LLT “HBV coinfection” was added to MedDRA following a user request.

7. Use Medical Judgment in Term Selection

When difficult in finding, apply medical judgment to select a term that reflects the concept within MedDRA’s framework.

8. Selecting More Than One Term

If a single MedDRA term does not fully capture a medical concept, consider using multiple terms temporarily while awaiting approval for a new term request.

Why and Why Not?

Selecting one term may sacrifice specificity.
Selecting multiple terms might lead to redundancy in counts.

Document procedures to maintain consistency.

Example:

More Than One LLT Selected
For “metastatic gingival cancer,” the options include:
1. Select LLT Gingival cancer OR LLT Metastatic carcinoma
2. Select LLT Gingival cancer AND LLT Metastatic carcinoma

9. Check the Hierarchy

When selecting an LLT, review the hierarchy (PT, HLT, HLGT, and SOC levels) to ensure the term aligns with the reported concept.

📢 Recommendation: Here i suggest checking the blog where we discusses about hierarchy of MedDRA with terms..

10. What to Code?

Code all reported adverse reactions (AR) or adverse events (AE), regardless of causality.
Code terms related to devices, product quality issues, medication errors, medical history, investigations, social history, and indications.

11. What Not to Code?

If a diagnosis is reported alongside characteristic signs and symptoms, code only the diagnosis.

Example:

Reported	LLT Selected	Comment
Abdominal pain, increased serum amylase, and increased serum lipase	Abdominal pain, Serum amylase increased, Lipase increased	Avoid coding pancreatitis unless explicitly reported.

Key Takeaways

Efficient MedDRA coding significantly impacts safety monitoring.

Accurate coding depends on the quality of source data.

Seek medical judgment when uncertain.

Not every detail needs to be coded; prioritize between diagnoses and symptoms.

Conclusion

These principles aim to enhance your MedDRA coding practices, minimizing errors and ensuring high-quality outputs. We hope this guide provides valuable insights to refine your skills.

Have additional suggestions or feedback? Feel free to share, and don’t forget to pass this content along to others in your network!

References:

MedDRA Term Selection

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.